title: Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home Prospective, Monocentric and Open Study

acronym: CISPAD

summary:
Sleep disorder is often a complaint from the older people. Prevalence of sleep disorder increases with aging and reaches between 20 to 45% of the people of 65 years old and more. Sleep physiologically changes with aging. Sleep can also be disturbed by other factors such as intercurrent or related chronic pathologies, environmental change (institutionalized, death of a spouse…), or some medical treatments. Regardless of interindividual variabilities, normative criteria have been defined by a meta-analysis: insomnia can be diagnosed if night wakings are more than 60min and/or if sleep latency is more than 30 minutes.

Various studies have proved the major role of sleep on health and wellbeing. Sleep disorders have an impact on the quality of perception of health and on the quality of life of people and their spouse. According to the French High Health Authority recommendations, sleep diary and validated scales are the tools to use to investigate sleep disorders.

Results from previous studies brought us to consider sleep complaint more specifically and adjust to the heterogeneous population of the investigator's hospital with a subjective approach. This work intends to offer a program of individualized advice to older patients with no cognitive impairment, or with a mild or moderate cognitive impairment, who complain about their sleep quality. Patients with a moderate cognitive impairment who have a caregiver at home can also join the study. The main objective of the study is to evaluate the impact of individualized care for sleep disorders on quality of sleep using the Pittsburgh Sleep Quality Index which validity was demonstrated among the elderly.

ReferenceCitation: Ohayon MM, Lemoine P. [Sleep and insomnia markers in the general population]. Encephale. 2004 Mar-Apr;30(2):135-40. French.

ReferenceCitation: Kamel NS, Gammack JK. Insomnia in the elderly: cause, approach, and treatment. Am J Med. 2006 Jun;119(6):463-9. Review.

ReferenceCitation: Corman B, Léger D. [Sleep disorders in elderly]. Rev Prat. 2004 Jun 30;54(12):1281-5. Review. French.

ReferenceCitation: Edinger JD, Bonnet MH, Bootzin RR, Doghramji K, Dorsey CM, Espie CA, Jamieson AO, McCall WV, Morin CM, Stepanski EJ; American Academy of Sleep Medicine Work Group. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group. Sleep. 2004 Dec 15;27(8):1567-96. Review.

ReferenceCitation: Silva J, Truzzi A, Schaustz F, Barros R, Santos M, Laks J. Impact of insomnia on self-perceived health in the elderly. Arq Neuropsiquiatr. 2017 May;75(5):277-281. doi: 10.1590/0004-282X20170031.

ReferenceCitation: Nguyen-Michel VH, Vecchierini MF. Exploration of sleep disorders in the elderly: which particularities? Geriatr Psychol Neuropsychiatr Vieil. 2016 Dec 1;14(4):429-437. Review.

ReferenceCitation: Vecchierini MF. [Sleep disturbances in Alzheimer's disease and other dementias]. Psychol Neuropsychiatr Vieil. 2010 Mar;8(1):15-23. doi: 10.1684/pnv.2010.0203. Review. French.

ReferenceCitation: McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7. Review.

ReferenceCitation: McCurry SM, Logsdon RG, Teri L, Vitiello MV. Sleep disturbances in caregivers of persons with dementia: contributing factors and treatment implications. Sleep Med Rev. 2007 Apr;11(2):143-53. Epub 2007 Feb 6. Review.

ReferenceCitation: Thomas P, Hazif-Thomas C, Pareault M, Vieban F, Clément JP. [Sleep disturbances in home caregivers of persons with dementia]. Encephale. 2010 Apr;36(2):159-65. doi: 10.1016/j.encep.2009.06.010. Epub 2009 Sep 23. French.

ReferenceCitation: Gauriau C, Raffray T, Choudat D, Corman B, Léger D. [Objective improvement of sleep disorders in the elderly by a health education program]. Presse Med. 2007 Dec;36(12 Pt 1):1721-31. Epub 2007 Jul 30. French.

ReferenceCitation: Crawford-Achour É, Castro-Lionard K, Tardy M, Trombert-Paviot B, Barthélémy JC, Gonthier R. [Successful aging: how to improve its occurrence in the elderly?]. Geriatr Psychol Neuropsychiatr Vieil. 2012 Jun;10(2):207-14. French.

ReferenceCitation: E. Crawford-Achour et al. Can subjective sleep quality, evaluated at the age of 73, have an influence on successful aging? The PROOF study. Open Journal of Preventive Medicine 4 (2014) 51-56. http://dx.doi.org/10.4236/ojpm.2014.42008

ReferenceCitation: Grandner MA, Kripke DF, Yoon IY, Youngstedt SD. Criterion validity of the Pittsburgh Sleep Quality Index: Investigation in a non-clinical sample. Sleep Biol Rhythms. 2006 Jun;4(2):129-139. Epub 2006 Jun 9.

ReferenceCitation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213.

ReferenceCitation: Cole JC, Motivala SJ, Buysse DJ, Oxman MN, Levin MJ, Irwin MR. Validation of a 3-factor scoring model for the Pittsburgh sleep quality index in older adults. Sleep. 2006 Jan;29(1):112-6.

ReferenceCitation: Derouesne C, Poitreneau J, Hugonot L, Kalafat M, Dubois B, Laurent B. [Mini-Mental State Examination:a useful method for the evaluation of the cognitive status of patients by the clinician. Consensual French version]. Presse Med. 1999 Jun 12;28(21):1141-8. French.

ReferenceCitation: Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84.

ReferenceCitation: Novella JL, Dhaussy G, Wolak A, Morrone I, Drame M, Blanchard F, Jolly D. [Quality of life in dementia: state of the knowledge]. Geriatr Psychol Neuropsychiatr Vieil. 2012 Dec;10(4):365-72. doi: 10.1684/pnv.2012.0375. Review. French.

family: Novella

full_name: Jean-Luc Novella

given: Jean-Luc

family: Dhaussy

full_name: Gaëlle Dhaussy

given: Gaëlle

family: Wolak

full_name: Aurore Wolak

given: Aurore

family: Morrone

full_name: Isabella Morrone

given: Isabella

family: Drame

full_name: Moustapha Drame

given: Moustapha

family: Blanchard

full_name: François Blanchard

given: François

family: Jolly

full_name: Damien Jolly

given: Damien

journal_name: Gériatrie et Psychologie Neuropsychiatrie du Viellissement

publisher: John Libbey Eurotext

publisher_dissemination: John Libbey Eurotext

publisher_group: John Libbey Eurotext

publisher_normalized: John Libbey Eurotext

ReferenceCitation: Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.

ReferenceCitation: French High Health Authority. Alzheimer Disease and related pathologies : medical follow up of the natural caregivers. Guidelines (french recommendations) https://www.has-sante.fr/portail/upload/docs/application/pdf/2010-03/maladie_dalzheimer_-_suivi_medical_des_aidants_naturels_-_argumentaire_2010-03-31_15-38-54_749.pdf

ReferenceCitation: Higginson IJ, Gao W, Jackson D, Murray J, Harding R. Short-form Zarit Caregiver Burden Interviews were valid in advanced conditions. J Clin Epidemiol. 2010 May;63(5):535-42. doi: 10.1016/j.jclinepi.2009.06.014.

ReferenceCitation: Bédard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

intervention_type: Behavioral


title: Effects of a Nutritional Cocktail Consisting of Anti-oxidant and Anti-inflammatory Supplements to Prevent the Deconditioning Induced by 60 Days of Antiorthostatic Bed Rest

acronym: LTBRCocktail

summary:
The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A-BR2 comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the deleterious effects induced by long term physical inactivity through antiorthostatic bedrest. During a randomized 60 day bed rest study in 20 healthy male adults the two following aims will be undertaken:

Sixteen scientific protocols will assess the changes in the cardiovascular, metabolism, muscle, bone, neuro sensorial, hematological and immunology systems.
In the above mentioned systems, the potential beneficial effects of the countermeasure protocol will also be investigated.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Basic Science

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Austermann K, Baecker N, Zwart SR, Fimmers R, Frippiat JP, Stehle P, Smith SM, Heer M. Antioxidant Supplementation Does Not Affect Bone Turnover Markers During 60 Days of 6° Head-Down Tilt Bed Rest: Results from an Exploratory Randomized Controlled Trial. J Nutr. 2021 Jun 1;151(6):1527-1538. doi: 10.1093/jn/nxab036.

name: Nutritional Physiology, Institute of Nutritional and Food Sciences, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany

family: Austermann

full_name: Katharina Austermann

given: Katharina

sequence: first

name: IUBH International University of Applied Sciences, Bad Reichenhall, Germany

family: Baecker

full_name: Natalie Baecker

given: Natalie

sequence: additional

name: Department of Preventive Medicine and Community Health, The University of Texas Medical Branch at Galveston, Galveston, TX, USA

family: Zwart

full_name: Sara R Zwart

given: Sara R

name: Department of Medical Biometry, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany

family: Fimmers

full_name: Rolf Fimmers

given: Rolf

name: Stress, Immunity, Pathogens Laboratory, Lorraine University, Nancy, France

family: Frippiat

full_name: Jean-Pol Frippiat

given: Jean-Pol

family: Stehle

full_name: Peter Stehle

given: Peter

name: Human Health and Performance Directorate, National Aeronautics and Space Administration Johnson Space Center, Houston, TX, USA

family: Smith

full_name: Scott M Smith

given: Scott M

family: Heer

full_name: Martina Heer

given: Martina

bso_classification: Biology (fond.)

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Liu T, Melkus G, Ramsay T, Sheikh A, Laneuville O, Trudel G. Bone Marrow Reconversion With Reambulation: A Prospective Clinical Trial. Invest Radiol. 2021 Apr 1;56(4):215-223. doi: 10.1097/RLI.0000000000000730.

family: Liu

full_name: Tammy Liu

given: Tammy

family: Melkus

full_name: Gerd Melkus

given: Gerd

family: Ramsay

full_name: Tim Ramsay

given: Tim

family: Sheikh

full_name: Adnan Sheikh

given: Adnan

family: Laneuville

full_name: Odette Laneuville

given: Odette

family: Trudel

full_name: Guy Trudel

given: Guy

bso_classification: Medical research

journal_name: Investigative Radiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: Centre National d'Etudes Spatiales

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Electronic Cigarette and Perianesthesia : a Prospective Multicentric Survey

acronym: ECigarSurg

summary:
Since decades, literature has shown that smoking has negative effect on postoperative outcome. Recent systematic review and meta-analysis on clinical impact of smoking and smoking cessation showed that postoperative healing complications occur more often in smokers compared with nonsmokers.

The use of electronic cigarette (e-cigarette) is spreading through the world. Despite this fact, the health risk assessment studies on e-cigarette are limited and scientific evidences are inconsistent.

This prospective multicenter study aimed at assessing the use of e-cigarette whether patient undergoing elective surgery. The main objective of this study was to evaluate the prevalence of e-cigarette consumer in perioperative period. Secondary objectives were to analyze when patients consume e-cigarette in regard of surgery, how many dose they consume and if they also consume nicotine cigarette.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Versailles Hospital Cardiac Arrest Registry

summary:
Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.

Data collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).

On-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Versailles Hospital

status_simplified: Ongoing


title: Study of Left Ventricular Function of Patients With Type 2 Diabetes Without Cardiovascular Disease

acronym: DIACAR

summary:
Type 2 diabetes is associated with high cardiovascular risk. Recent meta-analyzes suggest that the risk of hospitalization for heart failure in the diabetic is increased by 20% for each hemoglobin A1c point and that the risk of death from all causes or cardiovascular cause and the risk of hospitalization is significantly increased by 30 to 40% in patients with acute or chronic heart failure with diabetes.

Systematic analysis of cardiac function is not currently proposed in international recommendations even though some antidiabetic drugs have been associated with an increased risk of heart failure in large randomized controlled trials or an increase in adverse events in proof-of-concept studies of heart failure with or without diabetes. Observational studies suggest that hypoglycemic sulfonamides may increase the risk of developing heart failure. In contrast, two sodium-glucose cotransporter type 2 inhibitors (empagliflozin and canagliflozin) have recently demonstrated a significant reduction in hospitalizations for heart failure in two large randomized controlled trials.

The detection of subclinical left ventricular dysfunction is therefore essential to better assess the risk of cardiac decompensation and to identify the existence of possible contraindications to the use of certain classes of drugs used in diabetes. Recent studies suggest that the left ventricular ejection fraction measured on three-dimensional acquisitions is a prognostic value index greater than the ejection fraction measured by Simpson biplane method in two-dimensional ultrasound. Similarly, it seems that the analysis of global longitudinal deformation is a prognostic factor superior to the analysis of the ejection fraction (two-dimensional or three-dimensional). The investigators will analyze these different parameters to confirm these data.

status: Active, not recruiting

primary_purpose: Diagnostic

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

intervention_type: Diagnostic Test


type: EudraCT Number

title: A Phase I/II Study of the Safety of CD34+ Haematopoietic Stem/Progenitor Cells and CD4+ T Lymphocytes Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, in HIV-1 Infected Patients With High-risk Lymphoma

acronym: GENHIV

summary: The purpose of this study is to evaluate the safety and the feasibility, and the success of engraftment of the introduction of Cal-1 gene-transduced haematopoietic cell populations (Ttn and HSPCtn) in patients with HIV-1-related high-risk lymphoma.

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


type: Other Identifier

title: Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa

acronym: ANOSTOOL

summary: Anorexia nervosa is an eating disorder whose symptomatology induces a modification of the intestinal microbiota. To date, studies have shown variable profiles without linking them to metabolic and neuropsychological energy phenotyping. This intestinal dysbiosis could be involved in the maintenance of the disorders. Bidirectional communication channels exist between the microbiota, the intestine and the brain. Anomalies in these pathways could explain the impact of the microbiota on the pathophysiology of anorexia nervosa. Therapeutic interventions would then be possible to restore the microbiota in anorexia nervosa and influence the treatment of this disease. This study aims to explore the hypothesis of disruption of the microbiota-intestinal-brain axis transversely and measuring the intestinal microbiota, urinary metabolome, biological factors nutritional, immunological and physiological plasma plasma of the intestine, and finally, the psychological dimensions characteristic of anorexia nervosa.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

status_simplified: Unknown


title: Cryoneurolysis of Arnold's Nerve and Follow-up by Tractography: Feasibility Study

acronym: CRYOARNOLD

summary:
According to the World Health Organization (WHO), headaches are one of the most common nervous system disorders. The therapeutic strategy is well established for certain subcategories of headache. On the other hand, when headaches become refractory, some nerves may become the target of targeted therapies. This is the case of the Arnold nerve, also called the great occipital nerve, which is involved in certain pathologies, both physiopathologically and therapeutically. The Arnold nerve infiltration has a relatively short duration of effectiveness (about 1 month on average), some teams have reported the interest of achieving a destruction of the Arnold nerve by radio frequency, with extended durations of efficiencies to several months. The use of cryoneurolysis has been known for a long time and its effectiveness in the management of cranio-facial pain is already reported. It is thus possible to obtain, at the end of the cryoanalgesia needle, very low temperatures around -40 ° C, which leads to the formation of an ice cube and, where appropriate, the freezing of the structures (nerves among others) to the needle contacts. This induces the formation of microcrystals leading to irreversible lesions of vasa-nervorums resulting in an endoneural edema. In the long run, it appears a Wallerian degeneration without destruction of this endoneurum. This is associated with the lack of destruction of the structure of the Schwann cell. Nerve regeneration is possible.

The diffusion MRI study allows tractographic reconstruction of the nerves. This is the only imaging technique that focuses on the fibrillar structure of the nerves, thus enabling the detection of nerves throughout its path. It is a morphological imaging technique nevertheless it also allows a quantitative analysis of the nerve through certain parameters.

The Investigators hypothesize that the cryoneurolysis of the Arnold nerve will result in the disappearance of visualization of the nerve by MRI tractography. The effect of cryoneurolysis on Arnold nerves, as on other peripheral nerves through diffusion MRI has never been described. The follow-up of MRI patients who had undergone cryoneurolysis would make it possible to study the behavior of these nerves after cryoneurolysis, and to correlate the aspect in tractography with the clinical data. Painful recurrence can then be correlated with visualization of the nerves by MRI.

status: Terminated

primary_purpose: Other

lead_sponsor: University Hospital, Grenoble


title: Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound

acronym: FIBER

summary:
The objective is to diagnose earlier and more precisely the occurrence of a weakness neuromuscular syndrome at the end of intensive care, or within 28 days if the stay is longer than 28 days. The amyotrophy has been shown to be proportional to muscle strength in healthy subjects. The amyotrophy can be reliably evaluated by measuring the cross-sectional area of the right femoral muscle. The hypothesis is that amyotrophy measured by muscle ultrasound can allow an early and reliable diagnosis of neuromuscular weakness syndrome (NMWS), even though the measurement of the MRC score (the Gold Standard), has shown its limitations in intensive care in terms of reliability and delayed diagnosis.

Moreover, this syndrome is associated with a loss of functionality and a deterioration of long-term quality of life. One of the objectives is thus to determine if the muscular ultrasound allows a prediction of the occurrence of these alterations far from the intensive care.

Early rehabilitation has shown a benefit on mortality, duration of stay, mechanical ventilation and on functional alteration after intensive care. This is why an earlier and more precise means of diagnostic of this pathology is searched.

The target population is therefore patients from 18 to 80 years hospitalized in intensive care for prolonged stay (> 5 days), and prolonged ventilation (> 48H).

status: Unknown status

ipd_sharing_description: There is not a plan to make IPD available to other researchers

lead_sponsor: Association Pro-arte

lead_sponsor_type: industriel


title: Bedside Assessment of Coagulation in Post-partum Hemorrhage by Thromboelastography (TEG ®6S)

summary:
Postpartum hemorrhage (PPH) is one of the leading causes of maternal deaths. Its prognosis is directly influenced by the early diagnosis and treatment of the associated coagulopathy. In this context, fibrinogen concentration is the best predictor of a severe PPH. The medical interest of thromboelastography/elastometry to early detect and guide the rapid correction of coagulopathy in PPH is regularly discussed.

The principal aim of this study is to evaluate the performance of a new hemostasis point of care device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH.

A secondary aim will be to determine the normal values of TEG6S at the end of a normal pregnancy.

study_start_date_type: Anticipated


title: Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

summary: This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.

time_perspective: Other


title: Choice and Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns < 30 Gestational Weeks

summary: Noninvasive respiratory supports (NRS), such as continuous positive airway pressure (CPAP), noninvasive ventilation, high flow nasal cannula (HFNC) or nasal oxygen (O2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit. However, given the lack of validated criteria, clinicians usually choose the NRS according to clinical parameters and patients' comfort. Several studies have demonstrated the interest of the measurement of the work of breathing (WOB) to optimize the settings of NRS in children, but no study has already demonstrated the utility of WOB to optimize the settings of NRS in preterm infants. Therefore, the aim of this study is to measure the WOB during the utilisation of three different NRS (CPAP, HFNC, O2), in order to optimize the choice of the type and settings of NRS in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring NRS at 29 post conceptual weeks. Moreover, the investigators will compare in the newborns with the optimized NRS by WOB vs. a standard care control group (NRS type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the NRS, 3) the incidence and severity of broncho-pulmonary dysplasia (BPD) at 36 weeks of age corrected. Indeed, incidence of BPD is still around 40% in premature infants born before 28 gestational weeks. The hypothesis of the investigators' study is that the optimization of the type and settings of the NRS could reduce the weaning delay and contribute to reduce the incidence and severity of BPD in premature newborns.

ReferenceType: result

ReferenceCitation: Liptsen E, Aghai ZH, Pyon KH, Saslow JG, Nakhla T, Long J, Steele AM, Habib RH, Courtney SE. Work of breathing during nasal continuous positive airway pressure in preterm infants: a comparison of bubble vs variable-flow devices. J Perinatol. 2005 Jul;25(7):453-8.

ReferenceCitation: Shetty S, Hickey A, Rafferty GF, Peacock JL, Greenough A. Work of breathing during CPAP and heated humidified high-flow nasal cannula. Arch Dis Child Fetal Neonatal Ed. 2016 Sep;101(5):F404-7. doi: 10.1136/archdischild-2015-309310. Epub 2016 Jan 14.

family: Shetty

full_name: Sandeep Shetty

given: Sandeep

family: Hickey

full_name: Ann Hickey

given: Ann

family: Rafferty

full_name: Gerrard F Rafferty

given: Gerrard F

family: Peacock

full_name: Janet L Peacock

given: Janet L

family: Greenough

full_name: Anne Greenough

given: Anne

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: de Jongh BE, Locke R, Mackley A, Emberger J, Bostick D, Stefano J, Rodriguez E, Shaffer TH. Work of breathing indices in infants with respiratory insufficiency receiving high-flow nasal cannula and nasal continuous positive airway pressure. J Perinatol. 2014 Jan;34(1):27-32. doi: 10.1038/jp.2013.120. Epub 2013 Sep 26.

family: de Jongh

full_name: B E de Jongh

given: B E

family: Locke

full_name: R Locke

given: R

family: Mackley

full_name: A Mackley

given: A

family: Emberger

full_name: J Emberger

given: J

family: Bostick

full_name: D Bostick

given: D

family: Stefano

full_name: J Stefano

family: Rodriguez

full_name: E Rodriguez

given: E

family: Shaffer

full_name: T H Shaffer

given: T H

journal_name: Journal of Perinatology

oa_host_type: repository

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

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Saslow JG, Aghai ZH, Nakhla TA, Hart JJ, Lawrysh R, Stahl GE, Pyon KH. Work of breathing using high-flow nasal cannula in preterm infants. J Perinatol. 2006 Aug;26(8):476-80. Epub 2006 May 11.

lead_sponsor: Hôpital Necker-Enfants Malades


title: Continuous Non-invasive Cardiac Output, an Evaluation of ccNexfin© in a Pregnant Population

acronym: CoNex

summary:
Variations of cardiac output are frequent in pregnant women during obstetrical procedures, and may participate to poor foetal outcomes through decrease of uteroplacental bloodflow. Thus, monitoring maternal cardiac output appears of major interest, as it would open the way to early initiation of hemodynamic supportive management.

The ccNexfin© is a non-invasive hemodynamic monitoring device, whose relevance for continuous monitoring of cardiac output has been reported in a non-pregnant population.

The hypothesis is that ccNexfin© gives acceptable measurement of maternal cardiac output in pregnant women.

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer Using Geometric Indexes

acronym: DEMETER

summary:
The initial staging of locally advanced prostate cancer is made with Computed Tomography scan (CT), Magnetic Resonance Imaging (MRI), and bone scan (BS).

For this type of cancer, reference treatment is radiotherapy combined with hormone therapy.

The added value of MRI in the delineation of volumes for radiotherapy is known, especially for the definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult. Indeed, acquisition of Magnetic Resonance Imaging parameters for diagnostic are not adapted to be fused with the planning Computed Tomography.

The literature shows that Positron Emission Tomography-Computed Tomography with Fluorocholine is better in terms of diagnostic performance compared to bone scan for bone metastases and to pelvic Magnetic Resonance Imaging for nodal extension.

It would therefore improve staging for these patients with a high risk of locoregional and metastatic invasion even if its use is currently not recommended in the initial staging.

Thanks to Magnetic Resonance Imaging acquisition parameters adapted to Radiotherapy and additional functional information, an acquisition in tri-modality Positron Emission Tomography/computed Tomography/ Magnetic Resonance Imaging could have an impact on the volumes definition for radiotherapy or even on the therapeutic strategy.

The aim of the study is to evaluate the volume modifications obtained on the trimodality evaluation, compared to the standard initial staging (geometric comparison).

In addition, it would be a preliminary study for a project using Prostate-specific membrane antigen (PSMA) in trimodality, and / or for a therapeutic interventional study.

lead_sponsor: Centre Henri Becquerel

intervention_type: Procedure


title: Modulation of Protein Intake to Target Gut-microbiota Derived Metabolites of Amino Acids in Individuals With Type 2 Diabetes From Varying Ethnic Backgrounds

acronym: MICRODIET

summary:
Context and justification:

There is growing evidence that the gut microbiota is a key element in the pathophysiology of cardio-metabolic diseases (CMD) such as Type 2 Diabetes (T2D). One hypothesis is that gut-derived metabolites (from diet) have an important role in the host metabolism. Preliminary results show that imidazole propionate (ImP), a degradation product of the essential amino acid histidine, is produced by the gut microbiota of T2D patients, but not healthy subjects. The gut microbiota itself is strongly influenced by diet and ethnicity. However, most dietary intervention studies have focused on the role of fiber intake and the effect of dietary protein on the gut microbiota composition and metabolite production is not well known. Our hypothesis is that, depending on the baseline gut microbiome composition, a diminution in protein intake could decrease the microbial production of metabolites such as ImP and improve the metabolism of the host. We also hypothesize that the effects of such an intervention could depend the ethnic background.

Objective:

To study the effects of a high protein (HP) vs a low protein (LP) diet on gut microbiota composition and production of pro-diabetic metabolites in type 2 diabetes (T2D) patients from Caucasian and Caribbean ethnicity depending on baseline metagenomics richness.

Study design:

Randomized controlled three months dietary intervention study

Study Population:

T2D patients from Caucasian (N=80) and Caribbean (N=40) background who are on a stable dose of metformin and do not use insulin or proton-pump inhibitors.

Intervention:

Subjects will be randomized to either a high protein (HP) or low protein (LP) diet for three months. Individuals of Caucasian ethnicity, will also be stratified according to either a high or low gut microbiota gene richness. All subjects will receive pre-cooked meals 6 days per week and daily food packages. Subjects are required to keep food diaries three days a week and will also have weekly contact with an Pitié-Salpêtrière dietician.

Outcome measures:

Primary endpoint is the change in glycemic excursion (area under the curve) after a mixed meal test between baseline and 12 weeks after the beginning of the intervention. Furthermore, we will study oral and fecal microbiota composition changes as well as serum levels of intestinal metabolites, such as ImP, body weight and body composition at baseline and after 12 weeks.

Sample Size:

It is calculated that a total of 20 patients per arm are needed so 120 patients in total.


title: Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance

acronym: OBSERVE

summary:
Health care renunciation is a factor that can alter patients' health status and increase the costs of its support.

To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes.

The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance.

The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ).

The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.

ReferenceType: background

ReferenceCitation: Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18. Review.

ReferenceCitation: Deniz S, Şengül A, Aydemir Y, Çeldir Emre J, Özhan MH. Clinical factors and comorbidities affecting the cost of hospital-treated COPD. Int J Chron Obstruct Pulmon Dis. 2016 Dec 2;11:3023-3030. eCollection 2016.

ReferenceCitation: Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

name: INSERM Unit 1042; Grenoble Alpes University; Grenoble France

name: Physiology and Sleep Unit; Michallon University Hospital; Grenoble France

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

family: Pepin

full_name: Jean-Louis Pepin

given: Jean-Louis

name: Pneumology Unit; Michallon University Hospital; Grenoble France

name: European Institute for Systems Biology and Medicine; EISBM; Lyon France

name: INSERM Unit 1055; Grenoble Alpes University; Grenoble France

family: Pison

full_name: Christophe Pison

given: Christophe

name: INSERM Unit 823; Grenoble Alpes University; La Tronche France

family: Vesin

full_name: Aurélien Vesin

given: Aurélien

name: Intensive Care and Pneumology Unit; Pitié-Salpêtrière University Hospital; Paris France

family: Gonzalez-Bermejo

full_name: Jesus Gonzalez-Bermejo

given: Jesus

name: Pneumology Unit; Saint-Etienne University Hospital; Saint Etienne France

family: Court-Fortune

full_name: Isabelle Court-Fortune

given: Isabelle

name: Intensive Care Unit, A; Michallon University Hospital; Grenoble France

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

journal_name: Respirology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Daabek N, Tamisier R, Foote A, Revil H, Joyeux-Jaure M, Pépin JL, Bailly S, Borel JC. Impact of Healthcare Non-Take-Up on Adherence to Long-Term Positive Airway Pressure Therapy. Front Public Health. 2021 Aug 17;9:713313. doi: 10.3389/fpubh.2021.713313. eCollection 2021.

family: Daabek

full_name: Najeh Daabek

given: Najeh

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Foote

full_name: Alison Foote

given: Alison

family: Revil

full_name: Hélèna Revil

given: Hélèna

family: Joyeux-Jaure

full_name: Marie Joyeux-Jaure

given: Marie

family: Pépin

full_name: Jean-Louis Pépin

family: Bailly

full_name: Sébastien Bailly

given: Sébastien

currency_apc_doaj: USD

journal_name: Frontiers in Public Health

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by


title: Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects: a Prospective Monocentric Study. PORTEAU Trial

acronym: PORTEAU

summary: Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. During fluid challenge in intensive care unit, fluid challenge is often administered to improve hepatic perfusion. That observation is not demonstrated. The aim of the study is to test buffer response and portal flow during fluid challenge.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Expanding the Biomarkers in Familial Amyloid Neuropathy: Magnetic Resonance Imaging (MRI) and Motor Unit Estimation by Electrophysiological Study

summary:
Familial amyloid neuropathies (FAP) are hereditary disease due to a mutation of the tranthyretin gene (TTR). These neuropathies are severe and life frightening.

Asymptomatic carrier of TTR mutation are now detected in large TTR-FAP family. However, it is very hard to detect the moment where a TTR mutation carrier become symptomatic: too early diagnosis exposes the patients to side effect of the treatment and too late diagnosis exposes the patient to disease progression and clinical sequels.

Neurological monitoring comprises clinical examination, electrophysiology and imaging. Sensitivity and specificity of these tools are not sufficient and we have to develop new biomarkers sensitive enough to detect modifications under treatment and the moment where a TTR mutation carrier become symptomatic Magnetic resonance imaging (MRI) can well evaluate neuromuscular diseases. Electrophysiological examination is also a good tool to evaluate NAF. MUNIX is a technique that permits to estimate the number of motor unit in one muscl. MUNIX is related to the disability in chronic inflammatory neuropathies and could be more sensitive than clinical scales and other electrophysiological data to detect modification of the disease in TTR-FAP.

The objective of this exploratory study is to test the applicability of MUNIX and MRI as early measures for detecting the transition from asymptomatic to symptomatic TTR-FAP.

In symptomatic TTR-FAP we will determine if MUNIX and MRI data are related to clinical deficiency and disability of the patients.

This is a transversal exploratory study. If we manage to demonstrate that MRI and MUNIX can segregate symptomatic versus asymptomatic TTR mutation gene carriers, we will propose a longitudinal study with a follow up of more asymptomatic gene carriers.

design_allocation: Non-Randomized

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


type: Registry Identifier

title: Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures

acronym: PONCTABCESEIN

summary:
Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess.

The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures.

The aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.

time_perspective: Cross-Sectional


title: Follow-up of Malnutrition Screening in Neurovascular Intensive Care Unit

acronym: DENUTRITION

summary: This aim of the study is to set up a procedure for screening for undernutrition in the neurovascular intensive care unit. This screening procedure follows a specific work concerning undernutrition in thrombolyzed patients (NCT03303820). This work was motivated by the fact that, despite a high frequency of undernutrition in the hospital (at least 30% of patients), undernutrition in neurovascular unit is studied very little. A cohort of thrombolysed patients in 2014 was studied retrospectively. Patients malnourished at the entrance had a non-significant, less good recovery of their stroke (+ 1 Rankin score point at 3 months in malnourished patients at the entrance).

ipd_sharing: Undecided


title: Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study

acronym: TOXART

summary: We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI).

status: Not yet recruiting

lead_sponsor: Lille Catholic University


title: Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux Over 5 Months

acronym: GERIATOX

summary:
Elderly is often associated with social, physiological and psychic changes. However, no study has examined accidental poisoning-induced changes.

The objective of the study is to identify and analyze the various causes of potentially toxic accidental exposure of the elderly to determine preventable causes and propose prevention strategies.

lead_sponsor: University Hospital, Bordeaux


title: Benign Gynecologic Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System in Length of Hospitalization, Pain and Aesthetics, a Randomized Study.

acronym: MiniTroc

summary:
During laparoscopy, trocars are essential: they allow the passage of instruments through the wall. In gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and forceps) and 10 to 12mm are used (especially for optics).

Trocars are responsible for complications, such as vascular wounds, digestive wounds, pain, infections or postoperative hernias, or aesthetic sequelae, and should be chosen with caution: most complications of laparoscopy are essentially due to their placement, and the complications at the introduction of the first trocar are the most frequent.

The MiniLap® system developed by Teleflex does not require trocars in the case of a single forceps, or a single 5mm trocar with the necessary forceps change (this is the Percuvance® system). The aim of the latter is to make minimally invasive surgery even less invasive, thanks to a reduction in the number of trocars used (in many cases, elimination of two trocars), smaller incisions (percutaneous use of instruments, with a diameter of 2,4mm) thus reducing the complications

primary_purpose: Prevention


title: Comparaison échographique Des Voies Sous Costale et Trans hépatique Dans l'évaluation de la Veine Cave inférieure

acronym: VCI ECHO

summary: Comparison of subcostal and transhepatic views to measure inferior vena cava diameter by echocardiography in intensive care unit patients

lead_sponsor: University Hospital, Caen

location_facility: Service de réanimation médicale CHU de Caen


title: Assess Prevalence of Urinary Functional Disorders in Women of 40 and More, Visiting a General Practitioner, Occupational Medicine or Health Examination Center in Puy-de-Dôme

summary: Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients

acronym: Easy EDSS

summary:
The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies.

Its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature.

The application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Tolerance to Light for Patients Suffering From Keratitis

acronym: EBLOUI

summary: In order to develop an innovative device to study infectious keratitis, we need to illuminate the cornea of patients suffering from an infectious keratitis with red or near-infrared light. Because of technical reasons the shortest possible wavelength (red) presents advantages.

ReferenceCitation: Courrier E, Lambert V, Renault D, Garcin T, Moine B, Herbepin P, Thuret G, Gain P. Tolerance to Light of Patients Suffering From Infectious Keratitis. Cornea. 2021 Jan;40(1):5-11. doi: 10.1097/ICO.0000000000002516.

family: Courrier

full_name: Emilie Courrier

given: Emilie

family: Lambert

full_name: Victor Lambert

given: Victor

family: Renault

full_name: Didier Renault

given: Didier

family: Garcin

full_name: Thibaud Garcin

given: Thibaud

family: Moine

full_name: Baptiste Moine

given: Baptiste

family: Herbepin

full_name: Pascal Herbepin

given: Pascal

family: Thuret

full_name: Gilles Thuret

given: Gilles

family: Gain

full_name: Philippe Gain

given: Philippe

journal_name: Cornea


title: Caractérisation de l'Autofluorescence Des Tissus Sains et Pathologiques Des Cordes Vocales

acronym: FLUOROCORD

summary:
The aim of this clinical trial is to provide information about autofluorescence of pathological versus healthy vocal folds tissues.

Experimentations are performed on vocal folds biopsies obtained from patients, surgered at ENT department, university hospital of Besançon. After being extracted, samples of vocal folds are submitted to excitations at 365 nm, 405 nm and 450 nm; light spectral absorptions are measured, and results are compared to reference anatomopathology.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Therapeutic Plasma Exchange, Rituximab and Intravenous Immunoglobulins for Severe Acute Exacerbation of Idiopathic Pulmonary Fibrosis Admitted in ICU: an Open, Randomized, Controlled Trial

acronym: EXCHANGE-IPF

summary: Idiopathic pulmonary fibrosis (IPF) is a fibroproliferative, irreversible disease of unknown cause, occurring mainly in patients older than 50. IPF is a rare but fatal lung disease, with an estimated prevalence of 14 to 28/100000 and a median survival time of 3 years. Acute exacerbation of IPF (AE-IPF) is a major event of IPF, as it is responsible for the death of 30-50 % of IPF patients; its annual incidence varies between 5 and 10%. The current literature indicates that IPF is associated with the development of an auto-immunity process targeting epithelial and endothelial lung cells. Autoantibodies have been associated with a poorer prognosis. A study by DONAHOE et al. (Plos One, 2015) indicates that the combination of corticosteroids, plasma exchanges, rituximab and immunoglobulins may improve the prognosis of the most severe forms of AE-IPF. In that study, the observed survival rate in patients receiving this combination of treatment was 70% as compared with 20% in historical controls. This therapeutic combination approach is designed both to eliminate and inhibit the production of circulating antibodies targeting the lungs. Considering the high mortality rate of an AE-IPF episode and the potential benefit of such an original approach, a well-conducted randomized controlled trial is critical.


acronym: CLONIPREM

source: euctr

title: Premedication by Clonidine Intranasal in Pediatric Surgery

summary:
There are few studies using intra nasal way to dispense premedication in pediatrics.

This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.

Two groups, randomized,

Total of 150 patients (75 in each group) :

Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)


title: Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked

acronym: STREAM

summary:
The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity.

It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.

lead_sponsor: BioSerenity


title: Cohort Study Evaluating 18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma

acronym: FDG-IMMUN

summary: The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to immunotherapy

lead_sponsor: Centre Antoine Lacassagne

intervention_type: Radiation


title: Evaluation of the Impact of an Optimized Communication Between Hospital and Community on the Readmission at the Emergency Department for an Adverse Drug Event : Randomized Controlled Trial

acronym: URGEIM

summary:
Emergency departments (EDs) are a crucial element of health care systems as they constitute the interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hours per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that not only pharmacists but also pharmacy student were one of the best health care providers to establish medication history and detected ADEs.

It has also been shown that a clinical pharmacist, within the emergency medical team, can improve the detection of ADE through drug expertise and reliable drug history. This approach has been adopted at Montpellier University Hospital since November 2011. During the initial diagnosis of the ADE, the revision of a drug treatment at risk cannot be carried out in emergency department by the emergency physician. Indeed, the latter intervenes punctually but he is not the patient's referring doctor. Guidance and follow-up of the patient throughout the care journey is the responsibility of the referring physician, sometimes accompanied by the pharmacist. It is therefore very important that a relevant information detected at the hospital can be passed on to the referring health professionals who will review and adapt the treatment. The city-hospital link is essential to guarantee the continuity and the consistence of the care process. When a patient is discharging with the emergency department, the outgoing mail often mentions only the reason for admission, and the information concerning the detection or suspicion of an ADE is not systematically stipulated. However, this information is essential to trigger a process of therapeutic revision (therapeutic modification, therapeutic education, referral to specialized consultations ...) that will prevent the recurrence of the ADE and therefore the readmission to emergency department. To date, the rate of readmission to emergency department after a first visit related to an ADE is between 3.6 and 18.7%.

Our goal is to evaluate the impact at 6 months of a medical-pharmaceutical follow-up and the optimization of the city-hospital link following an admission at emergency department for ADE, on the readmission to emergency department for the same ADE.

This is a single-center randomized, controlled, open-label, two-arm, parallel, "usual information transmission" or "optimized information transmission" study. The duration of a patient's follow-up is 6 months.

Each patient with an occurring ADE detected during emergency department admission could be participating in the study.

Specific management of the experimental group: Sending to the community referring physician by the emergency department an discharge report containing the reason for emergency consultations (report currently made as part of the treatment). Within 72 hours (working hours), the Emergency Clinical Pharmacist contacts the referring physician and the patient's community pharmacist to discuss how to manage the ADE. In parallel, a second report, summary of the ADE (ADE-report), is sent to them. The ADE-report, written and validated by the investigators (emergency physician and clinical pharmacist), includes the type of ADE, the suspected drug(s) and other recommendations: therapeutic modification, referral to specialized consultations (geriatrics ...)

Control group: The emergency department sends to the referring doctor a letter to inform him about the reason of consultations in the emergency department (mail currently realized as part of the care process).

Primary outcome measure: Percentage of patients who had at least one readmission for the same reason in the emergency department within 6 months of the initial exit. This information will be collected during a telephone call with the patient and the referring physician.

primary_purpose: Health Services Research

ReferenceCitation: Breuker C, Faucanié M, Laureau M, Perier D, Pinzani V, Marin G, Sebbane M, Villiet M. Impact of a medico-pharmaceutical follow-up and an optimized communication between hospital and community on the readmission to the emergency department for an adverse drug event: URGEIM, study protocol for a randomized controlled trial. Trials. 2021 Aug 6;22(1):521. doi: 10.1186/s13063-021-05501-4.

family: Breuker

full_name: Cyril Breuker

given: Cyril

family: Faucanié

full_name: Marie Faucanié

family: Laureau

full_name: Marion Laureau

given: Marion

family: Perier

full_name: Damien Perier

given: Damien

family: Pinzani

full_name: Véronique Pinzani

given: Véronique

family: Marin

full_name: Grégory Marin

given: Grégory

family: Sebbane

full_name: Mustapha Sebbane

given: Mustapha

family: Villiet

full_name: M. Villiet

given: M.

currency_apc_doaj: GBP

journal_name: Trials

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

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: University Hospital, Montpellier


title: Aromatherapy and Peri Operative Anxiety : Assessment in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia, a Randomized Controlled Study

acronym: AROMA

summary: AROMA study is a randomised controlled parallel-group single-site study. Patients randomized in the experimental group benefit from the aromatherapy at their arrival in the operating theatre in the recovery room. 2 drops of essential oils are applied on a compress placed next to the head of the patient. This compress is kept until the patient is leaving the operating theatre. Patients randomized in the control group don't benefit from the aromatherapy. The anxiety evolution is measured in both groups with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The hypothesis is that aromatherapy alleviate peri operative anxiety during an ambulatory elective upper limb surgery under loco-regional anesthesia.


title: A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population

acronym: FERTILEA

summary:
The French L.E.A. (Leucémie Enfant et Adolescent) program was implemented to prospectively evaluate the long-term health status, quality of life and socio-economic status of childhood acute leukemia (CAL) survivors enrolled in French treatment programs from 1980 to present, in 15 cancer centers. Eligible patients for the study are adult women (≥18 years) from L.E.A. cohort. Project has been approved by the Scientific Advisory Board and the Steering Committee of LEA Cohort. MRI uterus anatomy, follicular ovarian reserve and reproductive function will be assess in 212 adult women who received a hematopoietic stem cell transplantation (HSCT) for CAL. The investigator's objective is to correlate uterus and ovarian function to the conditioning regimen received before HSCT (total body irradiation (TBI) or busulfan - based conditioning) and the pubertal status at the HSCT (before or after puberty).Inclusion period is planned for 2 years. Four patient groups will be compared:

Group 1: HSCT before nine years and after conditioning regimen with TBI (12 Gy)
Group 2: HSCT before nine years and after a busulfan-based conditioning regimen
Group 3: HSCT after nine years and after conditioning regimen with TBI (12 Gy)
Group 4: HSCT after nine years and after a busulfan-based conditioning regimen

Information will be collected during specific medical visit in one of the investigatory centers. Pelvic MRI and hormonal blood tests will be performed and a medical consultation with a physician specialized in reproductive medicine and oncofertility will be proposed to eligible patients. Data assessed for each women are the following:

Disease type, age and pubertal status at HSCT, age at evaluation, therapy lines before and after HSCT, conditioning regimen, relapse after HSCT if applicable. Cumulative doses of cyclophosphamide, melphalan, busulfan and radiation will be collected from the LEA database.
Gynecological characteristics: spontaneous or induced puberty, spontaneous menstrual cycles or Hormone Substitutive treatment (HRT) or amenorrhea without HRT; gestity parity (if pregnancy: spontaneous, after Assisted Reproductive Technologies?), history of ovarian cryopreservation, was information given (and at what age?) about risk of premature ovarian failure and about the gyneco-obstetrical impact of conditioning regimen for HSCT?
Ovarian follicular reserve: FSH, LH, estradiol, Anti-Müllerian Hormon (AMH) at the day 2-3 of the cycle or whenever if amenorrhea. Ovarian volume and antral Follicle Count will be performed with pelvic sonography.
Uterine anatomy by MRI, at the end of follicular phase or after estrogen therapy, in order to measure proliferative endometrium. Anatomical parameters will be compare to normal measurements of uterus: uterine volume, myometrial, endometrial and junctionnal zone thickness, cervical length, apparent diffusion coefficient values.
Reproductive function: spontaneous pregnancy rate or after ART (IVF, oocyte donation), term and mode of delivery, health of the child.

location_facility: Assistance Publique Hopitaux de Marseille


title: Feasibility and Therapeutic Method of Endoscopic Treatment of Bronchial Carcinoid Tumors: 22 Years Experience of Saint-Etienne

summary: Carcinoid tumors of the lung are considered to be a low-grade malignancy. Surgical resection is considered the standard approach. Recent data has shown that a complete endoscopic treatment could be considered. An endoscopic treatment is can be a alternative to invasive surgery.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Laparoscopic Sacrocolpexy Versus Lateral Suspension With a Mesh for the Treatment of Pelvic Organ Prolapse : a Randomized Controlled Trial

acronym: SUSPENSION

summary:
Surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal vault. Most of studies shows a success rate of 80% of this procedure.

However, access to the promontory could be difficult in patients because of adherences or anatomical reasons. This step of the procedure also exposes to risk of ureteral or vascular injuries. Recent issues have also found spondylodiscitis cases.

The technique of laparoscopic lateral suspension with mesh was developed by Dubuisson in 1998 allows not to have to approach the promontory and avoids both the risk of vascular injury and ureteral damage of laparoscopic sacrocolpopexy. Instead of attach the mesh to the promontory, the procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall. The aim of this study is to compare the clinical and functional efficiency of the lateral suspension versus laparoscopic sacrocolpopexy.

It is a prospective, randomized, monocentric study compared two groups The study hypothesis is that the lateral suspension would provide correction than the laparoscopic sacrocolpopexy.

The primary outcome is the comparison of anatomic correction rates at 1 year Success is defined as 1 year Ba et C points < -1 centimeter in POP-Q international score.

Secondary endpoints are improve of quality of life evaluated with the validated P-QOL questionnaire, and complications rates, including post-operative posterior prolapse.

Number of subjects required is 72 patients, 36 in each group having a laparoscopic sacrocolpopexy or lateral suspension.

Outcomes will be evaluated at 1 month and 1 year post-operative consultation

location_facility: Assistance Publique Hôpitaux de Marseille


title: Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice

summary: A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.

lead_sponsor: Biotech Dental


title: Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease

acronym: AquaSUP PARK

summary: Postural instability is associated with falls and a decreased quality of life in Parkinson's disease (PD). Evidence supports physical activity rather than levodopa for postural instability management. Considering the proven effects of the Stand-up Paddle (SUP) activity on postural instability in sedentary people, the investigators wanted to develop this aquatic activity in a swimming pool on static conditions (Aqua SUP) for PD patients. The objective is to assess the postural instability change by measuring the Mini-Balance Evaluation Systems Test (miniBESTest) after 8 weeks of Aqua SUP compared to physiotherapy in PD patients with baseline postural instability.

ipd_sharing: Yes

ipd_sharing_description: All IPD

lead_sponsor: FLABEAU Olivier


title: Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans

acronym: STRECH

summary:
The links between systemic inflammation, endothelial dysfunction and endoplasmic reticulum (ER) stress in pre-clinical models make it an interesting potential therapeutic target, but there are no data describing SRE during severe inflammation in humans .

For an approach to the study of SRE in humans in a situation of systemic inflammation, the analysis of patients benefiting from an extra-corporeal circulation for a programmed cardiac surgery would allow a study under well described conditions of inflammation, standardized, with the possibility for each patient to be his own witness. Compared to a situation of secondary inflammation (sepsis, acute pancreatitis, trauma ...) the analysis of the patients under CEC allows more precise description of the kinetics of the activation of the SRE because the beginning of the inflammatory mechanism is known with precision.

lead_sponsor: University Hospital, Rouen


title: Is the Distance of Patients From Rouen University Hospital Influencing the Time Between Colectomy and First Chemotherapy Cure for Colon Cancer?

acronym: DICHIMIO

summary: This project has for objective to demonstrate that the increase of the distance "Patient home - center of treatment" may be associated with significant, other noticeable, noted events. This distance may also be available in the Rouen University Hospital. The study of the association in this distance and the delay in initiating chemotherapy after surgery in patients treated at the CHU correspond to a pilot study prior to the completion of the analysis at the regional scale.


title: Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.

summary: Functional electrical stimulation (FES) has been used for decades in rehabilitation centers. Having demonstrated efficacy for prevention of muscle atrophy following spinal cord injury (SCI), FES can also be considered for functional restoration of hand movements in the patients with complete tetraplegia belonging to group 0 or 1 of the classification of Giens. However, the majority of the systems using the FES directly stimulates the muscles (surface electrodes, intramuscular or epimysial), which increases the number of components and requires more electrical energy for the muscle activation. Nerve stimulation would activate more muscles through a reduced number of electrodes, limiting the number of internal components, reduces the risk of spreading infections and require less electrical energy for its operation.

primary_purpose: Device Feasibility

ReferenceCitation: Tigra W, Dali M, William L, Fattal C, Gélis A, Divoux JL, Coulet B, Teissier J, Guiraud D, Azevedo Coste C. Selective neural electrical stimulation restores hand and forearm movements in individuals with complete tetraplegia. J Neuroeng Rehabil. 2020 May 19;17(1):66. doi: 10.1186/s12984-020-00676-4.

apc_source: openAPC

family: Tigra

full_name: Wafa Tigra

given: Wafa

family: Dali

full_name: Mélissa Dali

given: Mélissa

family: William

full_name: Lucie William

given: Lucie

family: Fattal

full_name: Charles Fattal

given: Charles

family: Gélis

full_name: Anthony Gélis

given: Anthony

family: Divoux

full_name: Jean-Louis Divoux

given: Jean-Louis

family: Coulet

full_name: Bertrand Coulet

given: Bertrand

family: Teissier

full_name: Jacques Teissier

given: Jacques

family: Guiraud

full_name: David Guiraud

given: David

family: Azevedo Coste

full_name: Christine Azevedo Coste

given: Christine

journal_name: Journal of NeuroEngineering and Rehabilitation

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

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

lead_sponsor: Clinique Beau Soleil


title: Consequence of Unilateral Vestibular Loss on Visual Abilities

acronym: SVorthoptie

summary:
Unilateral vestibular lesions are frequent and disabling pathologies causing a set of oculomotor, postural and perceptual symptoms. These symptoms reduce over time according to a vestibular compensation. However, vestibular compensation should be considered as a set of sub-processes whose duration and recovery level differ. Indeed, after a unilateral vestibular loss, some functions remain asymmetrical as a long-term effect, and these disorders may be observed among patients with no functional complaints. Balance disorders may persist in some patients.

The equilibration consists in handling real-time a considerable amount of information coming from the environment and the subject himself, allowing an adaptation of the position and movements of his body to satisfy the needs of posture, balance and orientation. This information comes mainly from the vision, the vestibule and the somesthesic system. It is pre-treated and harmonized in the brainstem, before being transmitted to the higher brain centres. Brain centers thus learn about peripheral conditions. According to these and the project of the movement, brain centers address in response orders to ophtalmological and motor effectors ensuring look, posture and balance to be provided. The eye is a cornerstone of the balancing system through the retina, an environmental sensor, and its extraocular muscles, effectors of the system.

The aim of this study is to assess the effects of acute unilateral vestibular loss on visual abilities evaluated by orthoptic balance in patients who presented acute unilateral vestibular loss by surgical deafferentation (removal of vestibular schwannoma, vestibular neurotomy or surgical labyrinthectomy for Meniere's disease), during the early phase and decline of vestibular compensation.

Our secondary objective is to evaluate the effect of a pre-existing anomaly of the visual abilities evaluated by orthoptic assessment on the vestibular compensation capacities.

All in all, this study seems crucial to improve the management of patients with unilateral vestibular dysfunction and contribute to improving their clinical management.

As a standardized management of these patients, an audio-vestibular evaluation will be performed before surgery (-1D), after acute unilateral vestibular loss at the early stage (+7D), and then after vestibular compensation (+2M) as well as an orthoptic evaluation. A good tolerance of the orthoptic evaluation is expected in this surgical context.


title: Validation of a French-language Version of Specific Quality of Life Questionnaires in Patients With Peripheral Facial Palsy

acronym: PFQDV

summary:
Facial palsy is a serious and disabling disease whose drudgery and sensation are probably underestimated. Psychological, social and economic issues have major impacts although vital prognosis is not engaged in this pathology. Facial palsy remains a personal drama for patient. Consequences may take the form of: aesthetic deformation, modification of body image, with socio-professional consequences. Beside unsightly facial aspects, weakness of facial muscles can cause troubles in eating, drinking, talking, communicating personal emotions and communication. Facial palsy impacts patients' quality of life (QOL) and affects mental health. This wide multidimensional concept usually includes self-measures of physical and mental health. QOL is evaluated with general and specific scales. General scales allow to compare QOL of different diseases, when specific scales focus on one disease and consider all aspects related to this disease and therefore are more appropriate and sensitive in dimensions related to patient disease and health.

"Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE) are the most used validated questionnaires to assess QOL of patients suffering from peripheral facial palsy (PFP). There is no existing validated questionnaire or scale in French version despite many French studies on PFP available. Using these questionnaires in French language requires translation and strict approval of the new language version. The aim of the study is to translate and validate French versions of specific scales of QOL in peripheral facial palsy patients: FDI and FaCE. Secondary objective is to evaluate QOL of patients depending on PFP etiology. Translation process will be done respecting internationally recognized rules. A pilot study will be performed on 5 physicians and 5 patients in order to validate the questionnaires translations. French versions obtained will be used for their validation on 80 patients suffering from PFP.

Cronbach's alpha will be estimated to check internal consistency of FDI and FaCE scales. Test re-test reliability will be calculated with inter-class correlation, reiterating questionnaires one week later. Scores of FDI and FaCE scales will be compared to other clinical evaluation scales, estimating correlation coefficient. Social function of FDI and FaCE scales will be compared with general scale SF-36 scores, estimating a correlation coefficient.


title: Addition of Azathioprine to the Switch of Anti-TNF Drug in IBD Patients in Clinical Relapse With Undectectable Anti-TNF Trough Levels and Anti-drug Antibodies : a Prospective Randomized Trial

acronym: Comboswitch

summary: Loss of response under anti-TNF is frequent. 20% of patients with clinical relapse present an immune mediated pharmacokinetic failure. In the last AGA recommendations, switch to another anti-TNF drug is suggested with no indication of immunosuppressive agent. In a recent study, 70% of patients with an immunogenic failure to a first anti-TNF agent developed a new immunogenic failure to the second anti-TNF drug using alone.

lead_sponsor: Védrines, Philippe, M.D.


title: Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples

acronym: OLFADIAG

summary:
The investigators don't know yet how the nose and the brain decode the smells. Scientific studies in neuroscience have shown that people who have tumors may have changes in the smell of secretions. Dogs are extremely efficient at detecting these changes, even before imaging studies. A review of the recent literature shows the different work done on the diagnosis of dogs on human pathologies, especially oncology. It is now known that the smell of exhaled gases is representative of the intestinal biotope and that a large number of pathologies are related to the type of microbial populations that inhabit the intestines.

Copying the olfactory organs could thus be of major interest for the early diagnosis of pathologies. More and more works are interested in the diagnostic power of electronic noses. From a technical point of view, these are nano-sensors that mimic the olfactory receptors from the breath gas of the subjects. They analyze the molecules present and compare them with a database to establish a diagnosis according to a probabilistic algorithm.

The use of exhaled air for the diagnosis of cancerous pathologies has already been the subject of scientific work. A classification using the SVM (support vector machine) method using data from 320 sensors made it possible to differentiate patients with lung cancer from controls in 98.8% of cases. The differential diagnosis of obstructive bronchopneumopathy was also very well done in this same study. Another study shows equally encouraging results, highlighting sensitivities and specificities above 80%.

lead_sponsor: Nouvelle Clinique Bonnefon


title: Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

acronym: CAMVIC

summary:
"Indocyanine Green (ICG) is a dye used as an indicator of hepatic function considering its capacity to be eliminated only by the bile. Thus, ICG tend to remain in liver tumors.

The hypothesis of CAMVIC study is that the use of fluorescence imaging during laparoscopic hepatic surgery will allow to detect small subcapsular superficial lesions undetected by other diagnostic methods, which will improve the results of the oncologic treatment."

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hépato Biliaire de l'hopital Paul Brousse


title: Does the Performance of the Ductus Venosus Doppler at 16 Weeks Allow to Increase the Screening of the Twin-twin Transfusion Syndrome and to Reduce the Neonatal Mortality?

acronym: DVSTT

summary: Studies shows that the realization of the Ductus venosus Doppler may improve the screening of the twin-twin transfusion syndrome. In this study, we want to compare the outcome of monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and when it wasn't. In order to do that, we will compile past reports (January 2015/ January 2018) of all monochorial pregnancy handled in the hospital of Montpellier and Kremlin Bicêtre. We will establish if the Doppler was done or not, if the twin-twin transfusion syndrome appears and the neonatal outcome.

ipd_sharing_description: NC


title: Modeling of the Geriatric Multidisciplinary Meeting of the Angers University Hospital

acronym: GRIMM

summary:
The primary objective of this study is to develop a typology of patients referred to the Geriatric Multidisciplinary Meeting (GMM) according to their demographic and clinical profile.

The secondary objectives are:

To distinguish the different types of answers given by the GMM according to the demands and situations.
To study the factors associated with the orientation proposed by the GMM
To examine the adequacy between the orientation proposed by the GMM and the pathway actually taken
To compare the diagnoses made during the following year with the data collected during the GMM

lead_sponsor: University Hospital, Angers


title: Influence of Main Psychological and Social Factors on Primary Headaches

acronym: CEPHAPSY

summary: This study aims to describe the psychological and social characteristics of patients suffering from primary headache and monitored in Neurology department of Besançon University Hospital

ReferenceCitation: Belot RA, Bouteloup M, Bonnet M, Parmentier AL, Magnin E, Mauny F, Vuillier F. Evaluation of Attachment Style and Social Support in Patients With Severe Migraine. Applications in Doctor-Patient Relationships and Treatment Adherence. Front Neurol. 2021 Jul 12;12:706639. doi: 10.3389/fneur.2021.706639. eCollection 2021.

family: Belot

full_name: Rose-Angélique Belot

given: Rose-Angélique

family: Bouteloup

full_name: Margaux Bouteloup

given: Margaux

family: Bonnet

full_name: Magalie Bonnet

given: Magalie

family: Parmentier

full_name: Anne-Laure Parmentier

given: Anne-Laure

family: Magnin

full_name: Eloi Magnin

given: Eloi

family: Mauny

full_name: Frédéric Mauny

given: Frédéric

family: Vuillier

full_name: Fabrice Vuillier

given: Fabrice

journal_name: Frontiers in Neurology

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Bouteloup M, Belot RA, Noiret N, Sylvestre G, Bertoux M, Magnin E, Vuillier F. Social and emotional cognition in patients with severe migraine consulting in a tertiary headache center: A preliminary study. Rev Neurol (Paris). 2021 Oct;177(8):995-1000. doi: 10.1016/j.neurol.2020.09.013. Epub 2021 Jan 13.

full_name: M. Bouteloup

full_name: R.-A. Belot

family: Noiret

full_name: N. Noiret

given: N.

family: Sylvestre

full_name: G. Sylvestre

given: G.

family: Bertoux

full_name: M. Bertoux

full_name: E. Magnin

given: E.

full_name: F. Vuillier

given: F.

journal_name: Revue Neurologique

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


title: Impact of Appearance and Control of Emotions in Virtual Reality on Behaviour in Children and Young Adults: Link With Feeling of Presence

acronym: EPREV-EA

summary:
Recently, researchers in the field of cognitive psychology have shown a great interest in Virtual Reality (VR). Indeed, this technology is the most advanced to create immersion and sense of presence in a virtual environment (VE) and gives the opportunity to study cognitive mechanisms in more ecological way. However, little is known about the impact of VR on the cognition and emotional states of the VR users. According to the scientific literature, the sense of presence (the fact that the user experiences the sense of being in the VE) is strongly related to the emotional experience, but it is not clear what mechanisms underline this relation. Thus, more research is necessary to its better understanding. Moreover, a few studies have shown age related differences in sense of presence, with children having greater inclination for sense of presence than adults. This might be explained by the fact that frontal cortex (which is responsible for a control of the sense of presence) is still developing in childhood (the maturation last for the beginning of adulthood).

The goal of the present study is to examine which factors might be responsible of the interaction between the sense of presence, the immersion and the emotional experience in Virtual Reality, and the age-related difference. Thus, the investigator study 2 types of healthy participants (volunteers) in order to examine the age-related difference in this interaction: young adults between 18 and 25 years old and children between 8 to 14 years old. To study different factors potentially involved in the interaction four experiments will be conducted. In each experiment the investigator manipulate one type of factor to study its impact on emotions and the sense of presence in a VE: (1) the image quality, (2) the fact that participant had an avatar (body) in the VE, (3) the possibility to interact or not in VE and (4) the nature of elements with which it is possible to interact (objects or living being). In the end of this study the investigator hope to contribute to the knowledge of adapted use of VR for different type of users, such as children and young adults.

lead_sponsor: Hospices Civils de Lyon

location_facility: EA3082 Laboratoire d'Etude des Mécanismes Cognitifs Institut de Psychologie Université Lyon 2


title: Pyrophosphate Homeostasis and Hepatic Expression of ABCC6. Pilot Study in Liver Transplantation

acronym: Pyro-TH

summary:
In animals, normal hepatic expression of ABCC6 (ATP-binding transporter cassette, subfamily C, member 6) determines plasma pyrophosphate (PPi) concentration. PPi prevents the formation of hydroxyapatite crystals on tissues by precipitation of calcium and inorganic phosphate (Pi). It is an endogenous compound whose deficiency causes diffuse vascular calcifications in certain rare monogenic diseases, including the elastic pseudoxanthoma caused by the mutation of ABCC6. PPi is produced by enzymatic transformation of extracellular ATP and, in animals, the liver is the main supplier of ATP and PPi (more than 90%). In humans, liver transplantation offers the possibility of correlating the plasma concentration of PPi ([PPi]pl) with hepatic expression of ABCC6. Liver transplantation is performed in the treatment of chronic liver failure (Child B or C) or, in the absence of liver failure, in the treatment of hepatocellular carcinoma. By measuring[PPi]pl before transplantation and after liver function restoration and by measuring ABCC6 in the diseased liver and healthy liver, it is possible to determine whether liver failure is associated with decreased[PPi]pl and decreased liver expression of ABCC6, which is the objective of our pilot study. Its interest is to establish a physiopathological link between the frequent vascular calcifications in obese patients with hepatic steatosis and the production of PPi.

prupose: Look for a deficit in[PPi]pl in patients before the transplant compared to the phase of restoration of liver function


title: A Phase III Randomized Trial of Post-operative Adjuvant Nivolumab and Concomitant Chemo-radiotherapy in High-risk Patients With Resected Squamous Cell Carcinoma of Head and Neck

acronym: NIVOPOSTOP

summary: The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint )

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou


title: Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis

acronym: MICROLUPS

summary: Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - service de rhumatologie

intervention_type: Biological


title: Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women

summary: This study is designed to evaluate the impact of oral consumption of the probiotic yeast CNCM I-3856 on healthy vaginal microbiota

lead_sponsor: Lesaffre International

intervention_type: Dietary Supplement