title: Acceptability Study of Sensor in Elderly People's House Living Alone

summary: The Fragility box is a project lead by Mines de Saint-Etienne, Gérontopôle Auvergne-Rhône-Alpes (AURA) and Eovi Mcd Mutually to prevent autonomy loss in the elderly dwelling population. With non-intrusive sensors installed in their residence, it is possible to monitor and forecast the frail state of elderly people living alone. The current study focuses on the technical feasibility of the project and the acceptability of these types of devices within the elderly's home. About ten participants have volunteered to be a part of this study. Therefore, they had the sensors installed at their home for a 12 months duration. A qualitative study with focus groups and individual interviews are carried out to evaluate the project: user satisfaction, expectations, and fears.


title: QUANTACT : Impact of Pangenomic QUANTitative Alterations in Cancer Therapy

acronym: QUANTACT

summary:
"Precision medicine and targeted therapies have played a crucial role over the past ten years in the personalized care of cancer patients. In this retrospective and observational study, we focused on patients for which no standard or curative treatment was available and for which the management was discussed in a Molecular Tumor Board (MTB).

The role of the MTB is to decide the most appropriate therapeutic options for patients according to the potential identification of molecular targets.

Among the analyses carried out, we focused on a quantitative genome-wide analysis: the CGH/SNP-array (Comparative Genomic Hybridization / Single Nucleotide Polymorphism on array). The objective was to evaluate the impact of CGH/SNP-array analyses in the identification of targeted molecular alterations.

"

study_start_date_type: Actual

status: Enrolling by invitation

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

lead_sponsor_type: academique

status_simplified: Unknown


status: Recruiting

primary_purpose: Treatment

acronym: ACUITY

intervention_type: Other

title: A Two-arm, Randomized, Double-blind, Placebocontrolled, Monocentric Study to Evaluate the Safety and Tolerability of ACT-01 Compared to Placebo in Patients With Acute Optic Neuritis

lead_sponsor: Accure Therapeutics

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

location_facility: CIC Neurosciences - La Pitié Salpêtrière

summary: To evaluate the safety and tolerability of ACT-01 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort

acronym: JAKIGREAT

summary: The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Lille


title: Prevalence and Factors Associated With Insomnia and Sleep Time in a Sample of Professional Flight Members

acronym: SOMNAVI

summary: Sleep is a physiological function that plays an essential role in many somatic, cognitive or psychological processes. Although the criteria for sleep effectiveness are multiple, its quantity is unanimously recognized as a major determinant of health. Too little sleep time is indeed associated with an increase in metabolic, cardiovascular and accidental morbidity and mortality, caused by sleepiness during journeys or at the workplace. In the wake of recent work in the general French population, a specific study on the prevalence and factors associated with sleeping time and chronic insomnia among flight members appears relevant. Chronic insomnia and sleep debt can thus be assumed to be more common among aircrews than in the general population, due to these specific operational constraints. Better consideration of certain sleep disorders in professional flight members could make it possible to adapt prevention or countermeasures strategies intended to optimize risk management with regard to flight safety.

time_perspective: Prospective

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy

acronym: CPABONE

summary: Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV & V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. The investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. The investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Impact of Intraoperative Instillation of Normothermal Saline on the Prevention of Intraoperative Hypothermia and Perioperative Morbidity of Prostatic Enucleation With Holmium Laser: a Prospective Randomized Controlled Study

acronym: THERMHOLEP

summary:
For the treatment of benign prostatic hyperplasia (BPH), 2 types of endoscopic surgery are currently performed: transurethral prostate resection (TPR), the reference surgery, and laser prostatic enucleation (LPE). These procedures can be performed under general anesthesia, or local anesthesia, such as spinal anesthesia. The EPL or RTUP procedure requires the instillation of continuous intra-vesical fluids throughout the procedure. These 3L bags are often kept at the ambient temperature of the operating room (around 17°C): the temperature of the instilled solution is therefore much lower than the average body temperature of the patient (37°C). Thus, and by heat exchange, it often results in per and postoperative hypothermia, which is all the more frequent and profound the longer the duration of the operation.

In spite of the usual procedures of warming by heating blanket, the prevalence of hypothermia, defined as a body temperature < 36°C, is 53.5% during surgical procedures. This hypothermia is all the more frequent and profound the older the patient is and the longer the duration of anesthesia.

Several studies have shown that hypothermia is particularly frequent during abdomino-pelvic surgery, notably due to pathophysiological phenomena induced by anesthetic procedures. Indeed, general anesthesia, or major locoregional anesthesia, disrupts the thermoregulation center upon anesthetic induction, with alteration of peripheral vasoconstriction and tremor capacity, leading to a rapid redistribution of body heat from the center to the periphery. Through exchanges with the environment, this results in a rapid linear decrease in central body temperature that exceeds the metabolic energy produced.

However, anesthetic procedures are not the only cause of hypothermic intraoperative phenomena. It has been shown that the decrease in body temperature associated with most genitourinary endoscopic procedures is multifactorial, taking into account the patient's body mass, the volume of fluids instilled, and the type and duration of the operation.

primary_purpose: Prevention

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

intervention_type: Device


type: Other Identifier

title: Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.

acronym: MONITOCOVAGING

summary: The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).

status: Active, not recruiting

intervention_type: Biological


title: Characteristics of Patients With Disruptive Vocalizations Residing in Nursing Homes Supported by the Mobile Gerontopsychiatry Team : Retrospective Study

summary:
Patients with dementia develop behavioral problems over time. Among these, the investigators object screams or cries or disruptives vocalizations. Their cause is multifactorial and their management difficult in nursing homes. Often this patients are polymedicated, sedated or/and isolated.

Many scientific studies are interested in drug and non-drug treatments. In this study, the investigators are looking for a profile for disruptives vocalizations's patients. Thus, the investigators will study the global profile of demented patients residing in EHPAD to determine if there are any similarities between them.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Neurorehabilitation Through Hippotherapy on Neurofunctional Sequels of Brain Stroke: (i) Effect on Patient's Functional Independence, Sensorimotor and Cognitive Capacities and Quality of Life (ii) Effect on Caregivers' Quality of Life

acronym: HippoPostCVA

summary:
Cerebrovascular accident [CVA] (medical term for stroke) is a high burden worldwide disorder and the second leading cause of disability. As illustrated by the number of survivors that remain disabled after a CVA (2 out of 3 according to the US National Stroke Association), recovery is limited, and novel neurorehabilitation approaches are urgently needed. Hippotherapy is an emerging specialized rehabilitation approach, performed by accredited health professionals on a specially trained horse via its movement. A body of scientific evidence has gradually emerged in recent years, showing robust benefits of hippotherapy in various massive neurological disabling conditions including brain stroke.

The aim of the study is to analyze the effect of a hippotherapy program of several cycles delivered during 22 weeks in total, on the functional and global evolution of post-stroke patients (with a score of Rankin ≥ 3 at inclusion) during the outpatient rehabilitation phase. A second purpose is to measure the impact of the intervention on the quality of life of their close caregivers.

A prospective clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone will be carried out. The 22-weeks program includes three cycles of hippotherapy as follows: an initial 2-weeks cycle, an intermediate 1-week cycle and a final 1-week cycle. One-hour daily sessions will be conducted during each cycle exclusive additional rehabilitation care. After each cycle, the patients will have a 9-weeks rest period where they will continue their conventional therapy. A battery of clinical tests will measure both functional and psychological outcome. The primary end point will be the functional independence of the patient. The secondary end points will consider the patient's sensorimotor and cognitive function, the severity of stroke and the quality of life, as well as the caregivers' burden and quality of life.

Program evaluation is important in neurorehabilitation to ensure that patients are achieving meaningful outcomes from the care. A primary question is how do stroke patients clinically evolve after being discharged from the hospital and how stable is the achieved rehabilitation outcome. Hippotherapy optimizes brain plasticity and has a strong impact on the global rehabilitation process and functional outcome of these patients. A remaining question concerns the improvement of the caregivers' quality of life.

ReferenceType: background

ReferenceCitation: Luengo-Fernandez R, Paul NL, Gray AM, Pendlebury ST, Bull LM, Welch SJ, Cuthbertson FC, Rothwell PM; Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke. 2013 Oct;44(10):2854-61. doi: 10.1161/STROKEAHA.113.001584. Epub 2013 Aug 6.

ReferenceCitation: Rice D, Janzen S, McIntyre A, Vermeer J, Britt E, Teasell R. Comprehensive Outpatient Rehabilitation Program: Hospital-Based Stroke Outpatient Rehabilitation. J Stroke Cerebrovasc Dis. 2016 May;25(5):1158-1164. doi: 10.1016/j.jstrokecerebrovasdis.2016.02.007. Epub 2016 Feb 28.

ReferenceCitation: Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krägeloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63.

ReferenceCitation: Dobkin BH. Neurobiology of rehabilitation. Ann N Y Acad Sci. 2004 Dec;1038:148-70. Review.

ReferenceCitation: Raineteau O, Schwab ME. Plasticity of motor systems after incomplete spinal cord injury. Nat Rev Neurosci. 2001 Apr;2(4):263-73. Review.

ReferenceCitation: Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16. Erratum in: N Engl J Med. 2011 Nov 3;365(18):1749.

ReferenceCitation: Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011 Jun;92(6):972-82. doi: 10.1016/j.apmr.2010.12.036. Review.

ReferenceCitation: Combs SA, Dugan EL, Passmore M, Riesner C, Whipker D, Yingling E, Curtis AB. Balance, balance confidence, and health-related quality of life in persons with chronic stroke after body weight-supported treadmill training. Arch Phys Med Rehabil. 2010 Dec;91(12):1914-9. doi: 10.1016/j.apmr.2010.08.025.

ReferenceCitation: Viruega H, Gaillard I, Briatte L, Gaviria M. Inter-Day Reliability and Changes of Surface Electromyography on Two Postural Muscles Throughout 12 Weeks of Hippotherapy on Patients with Cerebral Palsy: A Pilot Study. Brain Sci. 2020 May 6;10(5). pii: E281. doi: 10.3390/brainsci10050281.

ReferenceCitation: Viruega H, Gaillard I, Carr J, Greenwood B, Gaviria M. Short- and Mid-Term Improvement of Postural Balance after a Neurorehabilitation Program via Hippotherapy in Patients with Sensorimotor Impairment after Cerebral Palsy: A Preliminary Kinetic Approach. Brain Sci. 2019 Sep 29;9(10). pii: E261. doi: 10.3390/brainsci9100261.

ReferenceCitation: Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41.

ReferenceCitation: Rannikmäe K, Woodfield R, Anderson CS, Charidimou A, Chiewvit P, Greenberg SM, Jeng JS, Meretoja A, Palm F, Putaala J, Rinkel GJ, Rosand J, Rost NS, Strbian D, Tatlisumak T, Tsai CF, Wermer MJ, Werring D, Yeh SJ, Al-Shahi Salman R, Sudlow CL. Reliability of intracerebral hemorrhage classification systems: A systematic review. Int J Stroke. 2016 Aug;11(6):626-36. doi: 10.1177/1747493016641962. Epub 2016 Apr 18. Review.

ReferenceCitation: Leys D, Ringelstein EB, Kaste M, Hacke W; Executive Committee of the European Stroke Initiative. Facilities available in European hospitals treating stroke patients. Stroke. 2007 Nov;38(11):2985-91. Epub 2007 Sep 27.

ReferenceCitation: Wissel J, Olver J, Sunnerhagen KS. Navigating the poststroke continuum of care. J Stroke Cerebrovasc Dis. 2013 Jan;22(1):1-8. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.021. Epub 2011 Jul 5. Review.

ReferenceCitation: Ham TE, Sharp DJ. How can investigation of network function inform rehabilitation after traumatic brain injury? Curr Opin Neurol. 2012 Dec;25(6):662-9. doi: 10.1097/WCO.0b013e328359488f. Review.

ReferenceCitation: Sale A, Berardi N, Maffei L. Environment and brain plasticity: towards an endogenous pharmacotherapy. Physiol Rev. 2014 Jan;94(1):189-234. doi: 10.1152/physrev.00036.2012. Review.

ReferenceCitation: Kolb B, Muhammad A. Harnessing the power of neuroplasticity for intervention. Front Hum Neurosci. 2014 Jun 27;8:377. doi: 10.3389/fnhum.2014.00377. eCollection 2014. Review.

ReferenceCitation: Sterba JA. Does horseback riding therapy or therapist-directed hippotherapy rehabilitate children with cerebral palsy? Dev Med Child Neurol. 2007 Jan;49(1):68-73. Review.

ReferenceCitation: Bronson C, Brewerton K, Ong J, Palanca C, Sullivan SJ. Does hippotherapy improve balance in persons with multiple sclerosis: a systematic review. Eur J Phys Rehabil Med. 2010 Sep;46(3):347-53. Epub 2010 Apr 13. Review.

ReferenceCitation: Gabriels RL, Pan Z, Dechant B, Agnew JA, Brim N, Mesibov G. Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Jul;54(7):541-9. doi: 10.1016/j.jaac.2015.04.007. Epub 2015 May 5.

ReferenceCitation: Han JY, Kim JM, Kim SK, Chung JS, Lee HC, Lim JK, Lee J, Park KY. Therapeutic effects of mechanical horseback riding on gait and balance ability in stroke patients. Ann Rehabil Med. 2012 Dec;36(6):762-9. doi: 10.5535/arm.2012.36.6.762. Epub 2012 Dec 28.

ReferenceCitation: McGibbon NH, Benda W, Duncan BR, Silkwood-Sherer D. Immediate and long-term effects of hippotherapy on symmetry of adductor muscle activity and functional ability in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2009 Jun;90(6):966-74. doi: 10.1016/j.apmr.2009.01.011.

ReferenceCitation: Shurtleff TL, Standeven JW, Engsberg JR. Changes in dynamic trunk/head stability and functional reach after hippotherapy. Arch Phys Med Rehabil. 2009 Jul;90(7):1185-95. doi: 10.1016/j.apmr.2009.01.026.

ReferenceCitation: Kwon JY, Chang HJ, Lee JY, Ha Y, Lee PK, Kim YH. Effects of hippotherapy on gait parameters in children with bilateral spastic cerebral palsy. Arch Phys Med Rehabil. 2011 May;92(5):774-9. doi: 10.1016/j.apmr.2010.11.031.

ReferenceCitation: Silkwood-Sherer DJ, Killian CB, Long TM, Martin KS. Hippotherapy--an intervention to habilitate balance deficits in children with movement disorders: a clinical trial. Phys Ther. 2012 May;92(5):707-17. doi: 10.2522/ptj.20110081. Epub 2012 Jan 12.

ReferenceCitation: Diaz Heijtz R, Kolb B, Forssberg H. Can a therapeutic dose of amphetamine during pre-adolescence modify the pattern of synaptic organization in the brain? Eur J Neurosci. 2003 Dec;18(12):3394-9.

ReferenceCitation: Horn G. Pathways of the past: the imprint of memory. Nat Rev Neurosci. 2004 Feb;5(2):108-20. Review.

ReferenceCitation: Lee CW, Kim SG, Yong MS. Effects of hippotherapy on recovery of gait and balance ability in patients with stroke. J Phys Ther Sci. 2014 Feb;26(2):309-11. doi: 10.1589/jpts.26.309. Epub 2014 Feb 28.

ReferenceCitation: Camak DJ. Addressing the burden of stroke caregivers: a literature review. J Clin Nurs. 2015 Sep;24(17-18):2376-82. doi: 10.1111/jocn.12884. Epub 2015 Jun 10. Review.

ReferenceCitation: Denno MS, Gillard PJ, Graham GD, DiBonaventura MD, Goren A, Varon SF, Zorowitz R. Anxiety and depression associated with caregiver burden in caregivers of stroke survivors with spasticity. Arch Phys Med Rehabil. 2013 Sep;94(9):1731-6. doi: 10.1016/j.apmr.2013.03.014. Epub 2013 Mar 30.

ReferenceCitation: Creasy KR, Lutz BJ, Young ME, Ford A, Martz C. The impact of interactions with providers on stroke caregivers' needs. Rehabil Nurs. 2013 Mar-Apr;38(2):88-98. doi: 10.1002/rnj.69.

ReferenceCitation: Ostwald SK, Bernal MP, Cron SG, Godwin KM. Stress experienced by stroke survivors and spousal caregivers during the first year after discharge from inpatient rehabilitation. Top Stroke Rehabil. 2009 Mar-Apr;16(2):93-104. doi: 10.1310/tsr1602-93.

ReferenceCitation: Rode G, Lacour S, Jacquin-Courtois S, Pisella L, Michel C, Revol P, Alahyane N, Luauté J, Gallagher S, Halligan P, Pélisson D, Rossetti Y. Long-term sensorimotor and therapeutical effects of a mild regime of prism adaptation in spatial neglect. A double-blind RCT essay. Ann Phys Rehabil Med. 2015 Apr;58(2):40-53. doi: 10.1016/j.rehab.2014.10.004. Epub 2014 Oct 30.

ReferenceCitation: Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.

ReferenceCitation: Karahan AY, Kucuksen S, Yilmaz H, Salli A, Gungor T, Sahin M. Effects of rehabilitation services on anxiety, depression, care-giving burden and perceived social support of stroke caregivers. Acta Medica (Hradec Kralove). 2014;57(2):68-72. doi: 10.14712/18059694.2014.42.

ReferenceCitation: Costantino C, Galuppo L, Romiti D. Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Feb;53(1):32-40. doi: 10.23736/S1973-9087.16.04211-8. Epub 2016 Sep 6.

ReferenceCitation: Alisar DC, Ozen S, Sozay S. Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104454. doi: 10.1016/j.jstrokecerebrovasdis.2019.104454. Epub 2019 Nov 4.

ReferenceType: derived

ReferenceCitation: Viruega H, Imbernon C, Chausson N, Altarcha T, Aghasaryan M, Soumah D, Lescieux E, Flamand-Roze C, Simon O, Bedin A, Smadja D, Gaviria M. Neurorehabilitation through Hippotherapy on Neurofunctional Sequels of Stroke: Effect on Patients' Functional Independence, Sensorimotor/Cognitive Capacities and Quality of Life, and the Quality of Life of Their Caregivers-A Study Protocol. Brain Sci. 2022 May 9;12(5). pii: 619. doi: 10.3390/brainsci12050619.

ipd_sharing_description: Dissemination of study results will be done through a classic strategy for publications (reports, scientific publications) and communications (congresses, meetings). The coordinator will be in charge of the dissemination strategy. Controlled access to the final trial dataset will be given when a reasonable request has a precise and valid scientific aim. Thus, we will protect the rights of patients and the intellectual property of the scientists who designed the trial and collected the data.

lead_sponsor: Alliance Equiphoria


title: Development and Validation of a Machine Learning Based Virtual Biopsy System in Kidney Transplant Patients

summary: Currently, kidney allograft biopsies are routinely performed to determine diagnosis and prognosis of kidney allografts. The histological interpretation of these biopsies is based on the Banff consensus for renal allograft pathology. The purpose of this study is to provide to the physicians a reliable estimation of renal allograft lesions of the day zero biopsy (kidney donor biopsy performed before transplantation).

lead_sponsor: Paris Translational Research Center for Organ Transplantation

intervention_type: Diagnostic Test


title: Prospective Phase II Pilot Study, Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT (Positron Emission Tomography/Computerized Tomography) in Metastatic Triple Negative Breast Cancer Patients

acronym: OPALESCENCE

summary: The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.

primary_purpose: Diagnostic

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Drug


title: The Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Young Healthy Adults

acronym: AttNIRS

summary: Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus : internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty young healthy voluntary adults will participate in this study.

primary_purpose: Basic Science

ReferenceCitation: Wulf G, Höß M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334.

ReferenceCitation: Kim SA, Ryu YU, Shin HK. The effects of different attentional focus on poststroke gait. J Exerc Rehabil. 2019 Aug 28;15(4):592-596. doi: 10.12965/jer.1938360.180. eCollection 2019 Aug.

ReferenceCitation: Lu CF, Liu YC, Yang YR, Wu YT, Wang RY. Maintaining Gait Performance by Cortical Activation during Dual-Task Interference: A Functional Near-Infrared Spectroscopy Study. PLoS One. 2015 Jun 16;10(6):e0129390. doi: 10.1371/journal.pone.0129390. eCollection 2015.

ReferenceCitation: Herold F, Wiegel P, Scholkmann F, Thiers A, Hamacher D, Schega L. Functional near-infrared spectroscopy in movement science: a systematic review on cortical activity in postural and walking tasks. Neurophotonics. 2017 Oct;4(4):041403. doi: 10.1117/1.NPh.4.4.041403. Epub 2017 Aug 1. Review.

ReferenceCitation: Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe® Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.

ReferenceCitation: Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30.

ReferenceCitation: Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. Review.

ReferenceCitation: Wood JN, Grafman J. Human prefrontal cortex: processing and representational perspectives. Nat Rev Neurosci. 2003 Feb;4(2):139-47. Review.

ReferenceCitation: Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019.

ReferenceCitation: Shafizadeh M, Platt GK, Mohammadi B. Effects of different focus of attention rehabilitative training on gait performance in Multiple Sclerosis patients. J Bodyw Mov Ther. 2013 Jan;17(1):28-34. doi: 10.1016/j.jbmt.2012.04.005. Epub 2012 May 10.

ReferenceCitation: Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.

ReferenceCitation: Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.

ReferenceCitation: Udina C, Avtzi S, Durduran T, Holtzer R, Rosso AL, Castellano-Tejedor C, Perez LM, Soto-Bagaria L, Inzitari M. Functional Near-Infrared Spectroscopy to Study Cerebral Hemodynamics in Older Adults During Cognitive and Motor Tasks: A Review. Front Aging Neurosci. 2020 Jan 21;11:367. doi: 10.3389/fnagi.2019.00367. eCollection 2019. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.

acronym: CYPHOS

summary: Chronic Obstructive Pulmonary Disease (COPD) is a condition characterized by a progressive and incompletely reversible limitation of airborne gas flow . The association of co-morbidities with COPD and acute flare-ups of respiratory failure contribute to the overall severity of this disease. The prevalence of COPD is high, affecting up to 10% of people over the age of 40 years and causing high morbidity and mortality rates. While COPD is a disease primarily affecting the lungs, it is associated with many extra-pulmonary conditions including sleep apnea, depression, anemia, chronic kidney failure, wasting, cardiovascular disease, skeletal muscle weakness and osteoporosis (OP).

status: Not yet recruiting

ReferenceCitation: Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12.

ReferenceCitation: Cielen N, Maes K, Gayan-Ramirez G. Musculoskeletal disorders in chronic obstructive pulmonary disease. Biomed Res Int. 2014;2014:965764. doi: 10.1155/2014/965764. Epub 2014 Mar 25. Review.

ReferenceCitation: Decramer M, Janssens W, Miravitlles M. Chronic obstructive pulmonary disease. Lancet. 2012 Apr 7;379(9823):1341-51. doi: 10.1016/S0140-6736(11)60968-9. Epub 2012 Feb 6. Review.

ReferenceCitation: Eagan TM, Aukrust P, Ueland T, Hardie JA, Johannessen A, Mollnes TE, Damås JK, Bakke PS, Wagner PD. Body composition and plasma levels of inflammatory biomarkers in COPD. Eur Respir J. 2010 Nov;36(5):1027-33. doi: 10.1183/09031936.00194209. Epub 2010 Apr 22.

ReferenceCitation: Ekblom Ö, Ekblom-Bak E, Bolam KA, Ekblom B, Schmidt C, Söderberg S, Bergström G, Börjesson M. Concurrent and predictive validity of physical activity measurement items commonly used in clinical settings--data from SCAPIS pilot study. BMC Public Health. 2015 Sep 28;15:978. doi: 10.1186/s12889-015-2316-y.


title: Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma: a UNICANCER/GERICO Multicenter Program

lead_sponsor: UNICANCER

summary:
Most advanced or metastatic soft tissue sarcoma (STS) are unfortunately incurable, making the preservation of the patient's quality of life a major goal, along with prolonging survival.

Age is not a criterion for not providing effective treatment, but the goals of treatment change with age and must be integrated into the treatment decision. Elderly patients prioritise a life free of dependency, preservation of their cognitive functions and quality of life related to their state of health. They are therefore reluctant to receive a treatment that does little to improve life expectancy at the cost of significant functional losses.

Patients aged 65 years and older account for one third of all patients with STS. In the absence of dedicated recommendations, these elderly patients are currently receiving doxorubicin-based chemotherapy as first-line treatment (as recommended for younger patients), with a substantial risk of toxicity (especially cardiac). In this specific population, previous studies have shown that oral cyclophosphamide seems to have a promising activity, but also a very acceptable toxicity.

Thus, the GERICO study aims to compare standard doxorubicin chemotherapy with oral cyclophosphamide for the treatment of elderly patients with STS.


title: Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)

acronym: SART cohort

summary:
Aim of the study :

To evaluate postoperative outcomes of all surgical approach for retrorectal tumors.

Methods :

From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected.

Considering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra.

Short and longterm outcomes were compared between the two groups.

Primary outcome :

90 days postoperative morbidity rate

intervention_type: Procedure


title: Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay

acronym: CALIPREM

summary: The purpose of this study is to evaluate the benefits of an exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns. For that, we use of a specific neonatal device "Calinange" able to record maternal voice and heartbeats and to restore it with a sound level control. We hypothesize an improvement of the well being of the newborn under Calinange exposition.

design_allocation: Non-Randomized

primary_purpose: Supportive Care

ReferenceCitation: Alexandre C, De Jonckheere J, Rakza T, Mur S, Carette D, Logier R, Jeanne M, Storme L. [Impact of cocooning and maternal voice on the autonomic nervous system activity in the premature newborn infant]. Arch Pediatr. 2013 Sep;20(9):963-8. doi: 10.1016/j.arcped.2013.06.006. Epub 2013 Jul 23. French.

ReferenceCitation: Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.

ReferenceCitation: Williamson S, McGrath JM. What Are the Effects of the Maternal Voice on Preterm Infants in the NICU? Adv Neonatal Care. 2019 Aug;19(4):294-310. doi: 10.1097/ANC.0000000000000578.

ReferenceCitation: Provenzi L, Broso S, Montirosso R. Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development. Neurosci Biobehav Rev. 2018 May;88:42-50. doi: 10.1016/j.neubiorev.2018.03.009. Epub 2018 Mar 10.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital


title: Validation of DigiCog (BCCAMS App) and Konectom™ Tools, for Supporting Digitalized Clinical Assessment of Cognitive and Motor Functions in Patients With Multiple Sclerosis. DigiToms Study

acronym: DigiToms

summary:
The primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app] tests [Computerized Speed Cognitive Test (CSCT), Computerized Episodic Visual Memory Test (CEVMT) and the French Learning Test (FLT), a verbal memory test similar to the CVLT], using a tablet application in a sample of healthy participants matched to persons with MS (PwMS).

The secondary objectives of this study are to determine the ability of the DigiCog app to detect cognitive impairment (CI) compared to the classical Brief International Cognitive Assessment for MS (BICAMS) in PwMS; to determine the relationship between depressive symptoms and cognitive performance in Multiple Sclerosis (MS) sample; to determine the relationship between subjective perception of CI and cognitive performance ; to evaluate the reliability of Konectom™ digital outcome assessments (DOAs) in healthy subjects (HS) and PwMS; to evaluate the convergent validity of Konectom™ digital outcome assessments (DOAs) against in-clinic conventional disability outcome assessments in PwMS; to evaluate differences in Konectom™ DOAs [self administered at home and in-clinic] between PwMS and HS; to evaluate the variability of Konectom™ DOAs self-administered at home in free-living environment in HS and PwMS; to compare Konectom™ DOAs between in-clinic supervised administration versus self-assessments in free-living environment in HS and PwMS; to evaluate the clinical meaningfulness of Konectom™ DOAs against Patient-Reported Outcomes (PRO) in PwMS.

ipd_sharing: Yes

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen


title: Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room

acronym: ReVCVO

summary:
The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS). The place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel.

With Its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, Virtual Reality (VR) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data.

Our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of VOS in sickle cell patients in the ER.


title: Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine

summary: To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Chloride Transfer During Continuous Renal Replacement Therapy in the Intensive Care Unit: a Prospective Observational Cohort Study

acronym: CLODICUS

summary:
Acute kidney injury (AKI) is a frequently encountered complication in the intensive care unit (ICU), affecting on average 25 to 35% of patients. It is associated with an increased mortality, proportional to AKI severity. RRT induces important shifts of water and electrolytes. Thus, significant amount of chloride might unintentionally be transferred to patients.

Chloride is the main anion of the organism. It is involved in the regulation of numerous physiological processes. Thus, significant and rapid modification of chloride amount contained in the organism (as might be induced by renal replacement therapy) may be responsible for important, and potentially deleterious, consequences to critically ill patients.

Studies have shown that the administration of high amounts of chloride rich solutions (such as sodium chloride (NaCl) 0,9%) was associated with the development of hyperchloremic acidosis in a dose-dependent manner. This hyperchloremic acidosis could also be theoretically associated with deleterious physiological effects. However, the true clinical consequences of administration of high amounts of chloride rich solutions remains unclear. Their effect on mortality remains a matter of debate, the results of studies being very conflicting in that respect. Nevertheless, hyperchloremia itself and/or the rise of chloremia in the intensive care unit seems to be associated with increased mortality. Moreover, the impact of those chloride rich solutions on the development of acute kidney injury is also a subject of controversy, data from the literature being here again very conflicting.

A recent study already showed that continuous RRT (CRRT) techniques induce a significant transfer of sodium to patients benefiting from those techniques. In that study, the amount of sodium transferred depended mainly on the difference between patient's natremia and sodium concentration in dialysate and/or replacement fluid (usually higher than patient's natremia) used.

By analogy, it is likely that an occult transfer of chloride also happens during RRT, given the high chloride concentration of dialysate fluids (in continuous veno-venous dialysis, CVVD) and replacement fluids (in continuous veno-venous hemofiltration, CVVH), or when these 2 modalities are combined (continuous veno-venous hemodiafiltration, CVVHDF). Finally, the investigators suspect, although it remains undemonstrated so far, that the RRT technique (convective vs. diffusive) may influence this transfer, to an unknown extent. Nevertheless, this transfer and its potential determinants have never been studied yet.

If chloride overload (and its potential clinical consequences) induced by the administration of solutions such as NaCl 0,9% is being extensively studied, no study has ever focused on chloride transfer that may result from the use of renal replacement therapy. However, as mentioned above, it is very likely that such a chloride transfer to patients happens, and that its magnitude depends on different parameters such as RRT modality, RRT fluids characteristics, or patient's chloremia at the start of RRT.

The investigators conduct the present study to describe and compare the intensity of chloride transfer during the first 24 hours of renal replacement therapy by continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVD),or continuous veno-venous hemodiafiltration (CVVHDF), and to determine if that transfer is more important with one or the other of those two techniques, in ICU patients affected with severe AKI requiring RRT. Secondary aims are to describe and compare the effects of chloride transfer under 3 RRT modalities (CVVD, CVVH and CVVHDF) on patient's outcome, organ failures, electrolyte and acid-base balance, fluid balance and hemodynamics. Finally, the investigators aim to develop a pharmacokinetic compartment model of chloride transfer during different modalities of RRT.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de la Croix-Rousse (Hospices Civils de Lyon) / Médecine Intensive - Réanimation


title: Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis

acronym: TEMOBIC

summary:
The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined with PCV, will be defined by the pending results of phase III of the EORTC.

If the phase II study proposed here achieves its objective, it may help define a new treatment regimen that will be compared to the standard arm from phase III of the EORTC.

In addition, this study, by prospectively testing the predictive value of 1p and 19q deletions and of REGF amplification, may allow characterization of patients using these markers. If validated, this characterization can constitute a key element in any therapeutic evaluation (patient stratification), and potentially a major tool for medical decision support in these tumors.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Analysis of Motor Skills in the Elderly: the Role of Cognitive Abilities for Imagining and Planning Movement.

acronym: Vieillissement

summary: Falling is an event that is more frequent and severe in older age. It can lead to a loss of autonomy and a decrease in quality of life. It is therefore important to understand this phenomenon in order to better prevent it. Among the multiple risk factors associated with falling, recent research has shown a link between the decline in cognitive abilities (i.e., the mental processes that form our knowledge, such as memory) and the risk of falling. However, the impact of this cognitive decline on motor skills is still poorly understood. The purpose of this research is to study how the changes induced by aging affect motor skills. This would make it possible to take a new look at the phenomenon of falls occurring in the elderly and, in the long term, to improve the prevention and rehabilitation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition

acronym: NUTRIDREP

summary: This study is design to assess the effects of an increase in nutritional intake on the bone mineral density of children with sickle cell disease, for 12 months.

ReferenceCitation: Schnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; a general overview. Neth J Med. 2004 Nov;62(10):364-74. Review.

ReferenceCitation: Weatherall DJ. The inherited diseases of hemoglobin are an emerging global health burden. Blood. 2010 Jun 3;115(22):4331-6. doi: 10.1182/blood-2010-01-251348. Epub 2010 Mar 16. Review.

ReferenceCitation: Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.

ReferenceCitation: Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: a neglected cause of early childhood mortality. Am J Prev Med. 2011 Dec;41(6 Suppl 4):S398-405. doi: 10.1016/j.amepre.2011.09.013.

ReferenceCitation: Odièvre MH, Verger E, Silva-Pinto AC, Elion J. Pathophysiological insights in sickle cell disease. Indian J Med Res. 2011 Oct;134:532-7. Review.

ReferenceCitation: Kanter J, Kruse-Jarres R. Management of sickle cell disease from childhood through adulthood. Blood Rev. 2013 Nov;27(6):279-87. doi: 10.1016/j.blre.2013.09.001. Epub 2013 Sep 19. Review.

ReferenceCitation: Quinn CT, Rogers ZR, McCavit TL, Buchanan GR. Improved survival of children and adolescents with sickle cell disease. Blood. 2010 Apr 29;115(17):3447-52. doi: 10.1182/blood-2009-07-233700. Epub 2010 Mar 1.

intervention_type: Dietary Supplement


title: Translation and Transcultural Adaptation of the Arm Activity Measure (ArmA) and Motor Activity Log (MAL) to Assess Perceived Performance of the Upper Limb Use in Adults With Subacute and Chronic Stroke. F-ArmA

acronym: F-ArmA

summary: Upper limb impairment occurs in approximately 70 to 80 per cent of adults post stroke. These impairments will have consequences on functional performance in activities of daily living and hence quality of life. Assessment of upper limb function is a component of rehabilitation that contributes to the selection of optimal interventions according to patient individualized needs. The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance that is only available in it's English version. The aim of this study is to translate and conduct a cross-cultural adaptation of the ArmA is order to investigate its psychometric properties through a validation study among stroke patients.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Toulouse


title: Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients in 2017 and 2018

summary:
Many patients consult in pediatric endocrinology because of their small size. In the majority of cases, this growth delays can be explained by a hormonal, gastroenterological cause, or a chronic disease.

Sometimes the reason for stunted growth can be constitutional bone disease, a genetic cause of short stature that is still underdiagnosed.

The investigators wish to describe and take stock of the various additional analyzes carried out and the various diagnoses made in patients who consulted in endocrino-pediatrics at the Montpellier University Hospital due to their short stature, in 2017 and 2018, in order to better screen patients with constitutional bone disease


title: Impact of a Cross-legged Versus Traditional Sitting Position for the Success of an Epidural Analgesia Catheter Placement During Labor

summary:
The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist.

According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce.

The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.


title: Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device

summary: Postpartum hemorrhage (PPH) remains the leading cause of maternal death. PPH associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. Point of care hemostasis devices are helpful to develop this strategy. Quantra® (STAGO BIOCARE) use an innovative method to detect the clot formation. Pregnancy and non-hemorrhagic postpartum reference ranges are missing. The objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in PPH conditions.

lead_sponsor: University Hospital, Lille


title: Use of Discarded Surgery Human Tissue Specimens for Basic Science Research

acronym: HumTisRes

summary: Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. Highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. It is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. The use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.


title: Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.

acronym: DIASEM

summary: The sarcopenia diagnosis is based on the muscle mass and on impaired physical performance. The emerging field of ultrasound assessment of muscle mass in older patients is based on 2d parameters with prediction equations for muscle mass. For the moment, validation of prediction equations in older adults with varying function and health is lacking. The study aims to evaluate correlation of muscle mass between 3D muscle mass measurement and DXA, in order to dispense with the prediction equation.

lead_sponsor: Nantes University Hospital


title: Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department

acronym: OMA-IA

summary: Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis

lead_sponsor: Fondation Lenval


title: Assessment of Patient Preoperative Anxiety by Nurse Anesthetist

acronym: EVALANXI

summary: Preoperative anxiety is a major concern for patients who undergo surgery. To accurately identify anxious patient is therefore crucial to improve perioperative patient care. Preoperative anxiety remain highly difficult to quantify in current practice. Many patient fail to express their anxiety and the assessment of the level of anxiety is mainly based on heteroevaluation by caregivers. Nurse anesthetists provide closed support to patient prior to the induction of anesthesia. The aim of the study is to assess whether nurse anesthetist accurately assess patient preoperative anxiety from arrival to the operating room to the induction of anesthesia.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method

summary: Tinnitus and hyperacusis are two hearing disorders that can severely impact the patient and their quality of life, as they may induce sleeping disorders, concentration troubles, social life disturbances. Mayfair Developments has created and developed the innovating ØREBLUE® method in order to relieve, possibly completely, tinnitus and hyperacusis symptoms. The ØREBLUE® method relies on a medical device, CE marked, that consists of an auditory stimulation box associated with five softwares. This medical device diffuses thanks to a headphone a specific and personalized sound therapy treatment for the patient. This retrospective, observational study aims at collecting data about the ØREBLUE® method used in routine care and describing its efficacy on tinnitus and hyperacusis.

lead_sponsor: Mayfair Developments


title: Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).

summary:
Overall the issue of patients above 65-70 years of age being that it is impossible for most of them to undergo an intensive treatment like autologous stem cell transplant with little prospect of debulking effectively the bone marrow with chemotherapy, and also few possibilities to harass the bone microenvironment in the tumoral niche.

If, advanced age in frail patients is predictive of an increased risk of treatment-related toxicity, there is a growing number of elderly patients in regards to transplantation, but still fit if one considers the objectives of life characterized with prolonged survival. These patients might have the same treatment as to the transplant eligible, but without the transplant procedure. The development of immunotherapy has transformed the treatment landscape of cancer, particularly in MM, increasing the treatment possibilities with possibly fewer adverse events.

The therapeutic strategy and treatment options for NTE patients moved from melphalan-based induction regimens to lenalidomide-based associations, which is now the backbone of most treatment for NTE patients. Even though the latest melphalan, bortezomib and prednisone (MPV) association was considered somewhat effective it was not so well tolerated. Furthermore, MPV hardly prolonged PFS beyond 2 years. It was recently improved with the addition of Daratumumab, first in class anti CD38 Mab in the phase III ALCYONE.

The association lenalidomide and dexamethasone (Rd) has significantly improved the easiness of treating the NTE population and all drugs seem to be possible to combine to Rd. In that extent, proteasome inhibitors have always been one of the most impactful family of agents in MM, and as expected Bortezomib plus Rd has become a very relevant and commonly used regimen in NTE NDMM. These groundbreaking results have favored the development of 2 randomized phase 3 studies for registration of combination of antiCD38Mab (Daratumumab (Cepheus, NCT03652064), Isatuximab (Imroz, NCT03319667) +Rd +Velcade in comparison to VRd. Both studies have used as a comparator the VRd regimen which is today one of the safest, active and popular triplet based Rd regimen, approved, and therefore the best control arm possibly for these studies.

However, as much as there has been no direct head to head comparison of VRd to Dara Rd, when looking at the data from Maia it is anticipated that DRd will become a standard of care, and might challenge strongly VRd. Yet, multiple questions remain still, anticipating the change in backbone from VRd to antiCD38 +Rd becoming the new standard of care for NTE NDMM patients. The investigators have therefore planned to answer the critical question of the role of proteasome inhibitors in NTE non frail NDMM when considering anti CD38 +Rd as the backbone.

lead_sponsor: Poitiers University Hospital


title: Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells

acronym: JAK-SARC

summary: Recent studies suggest that the JAK/STAT signaling pathway constitutes a new step in the clinical and therapeutic progress of sarcoidosis. Further investigations are necessary to identify the most suitable patients to receive treatment targeting this pathway, in particular in cases of severe sarcoidosis refractory to the various therapeutic lines.

ReferenceCitation: Rotenberg C, Besnard V, Brillet PY, Giraudier S, Nunes H, Valeyre D. Dramatic response of refractory sarcoidosis under ruxolitinib in a patient with associated JAK2-mutated polycythemia. Eur Respir J. 2018 Dec 20;52(6). pii: 1801482. doi: 10.1183/13993003.01482-2018. Print 2018 Dec.


title: Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)

summary:
MAEVA, which stands for Meditation, Acceptance and Commitment towards Values, is an open and circular program, made up of 3 themed sessions, following a weekly rhythm. It is proposed here to study this program over a period of 3 months, which will give participants the opportunity to complete up to three complete cycles.

This program is based on the practice of and the processes of acceptance and commitment therapy. These approaches, used for several years, have proven their effectiveness in the management of stress, chronic anxiety, insomnia, chronic pain, distress in the face of chronic disease, as well as in the prevention of depressive relapses and management of impulsivity.

Unlike conventional 8-week meditation programs, the MAEva program allows patients to enter the study at any stage of the disease (within, outside the exclusion criteria) and from any session and to participate according to their possibilities.

The patient can participate in a weekly session of the program for 3 cycles. During the sessions, it will be proposed to train meditative practices and 3 different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.

.

lead_sponsor: Institut de Cancérologie de Lorraine

intervention_type: Behavioral


title: RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire

acronym: RFID

summary: The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device compared to the gold standard device.

lead_sponsor: Centre Jean Perrin


title: Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients

acronym: EPKIVA

summary:
An amputation represents a real ordeal for the person who will have to overcome the loss of a limb and face long months of rehabilitation. It is most often carried out following arterial insufficiency.

As paramedical professionals, we see in our daily practice a physical and psychological suffering for amputee patients. In spite of our skills acquired through training and professional experience, we are unable to offer comprehensive care for these patients and therefore feel that we are offering incomplete care. A multidisciplinary care, including a medical and paramedical team, would seem to us to be more appropriate for patients with lower limb amputations.

Following this observation, we would like to highlight the interest for the patient and the care team to include a psychologist and a physiotherapist in the care offer to evaluate the improvement of the physical and emotional state of the amputee patient.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections in Aesthetic Medicine.

summary: Transillumination (TL) is a noninvasive technique that appears to allow preliminary detection of superficial vascular structures of the face to avoid intravascular HA injection. The purpose of our study was to test the efficacy of TL in terms of its sensitivity to locate vessels in the areas undergoing treatment and to reduce post-injection vascular complications.

lead_sponsor: Helynck, Patrick, M.D.


title: Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

acronym: ARTHe 2

summary:
Osteoarthritis is the most common joint disease affecting the joint in a comprehensive and progressive manner. It leads to increasing disability.

The recommendations of recent years favor the non-pharmacological treatment of osteoarthritis including regular physical activity, therapeutic education and weight loss Osteoarthritis population has a low level of physical activity due to a lack of information, motivation and false beliefs related to physical activity and kinesiophobia (fear of movement) A preliminary qualitative study (ARTHe1) evaluating the barriers and levers of the use of an e-health therapeutic education application in patients with osteoarthritis was carried out in order to guide the development of the ARTHe application.

The objective of this study is to have the application tested on a panel of patients in order to assess the benefits of using the application in terms of adherence to the practice of physical activity but also in clinical terms on function and pain, and the satisfaction of the patient

lead_sponsor: University Hospital, Clermont-Ferrand


title: Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies: Incidence and Influence on Cognitive Control Capacities and on Seizure Control

acronym: SPIRALE

summary:
Epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. Many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. The objective of this research is to study the symptoms of post-traumatic stress disorder (PTS) in patients with epilepsy, and their relation to anxiety and depression in these patients. The investigators also wish to study how such symptoms may be associated with the subjective semiological manifestations of epileptic seizures. In addition, it has been shown that patients with epilepsy are able, from the identification of different warning signs, to anticipate their vulnerability to having an epileptic seizure allowing them to set up different types. strategies to control them. The investigators also wish to study the cognitive processes involved in this control and the influence of PTS symptoms, in particular hypervigilance on this behavior.

The investigators propose a protocol using different types of measures: emotional, cognitive and physiological in order to answer our questions. In addition to patients with epilepsy, two groups of patients will be included: a group of patients with another chronic non-neurological disease to compare the prevalence of PTS symptoms and a group of patients with post-traumatic stress disorder ( PTSD) to compare with patients with epilepsy, cognitive and physiological measures.

Finally, the results of this study should allow to develop tools for assessing PTS symptoms in epilepsy and to develop specific management approaches

primary_purpose: Other

location_facility: Assistance Publique Hopitaux de Marseille


title: Study of Leukocyte Populations in Patients With Chronic Inflammatory

acronym: LIMA

summary: Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Management of Constitutional Thinness Through an Adapted Physical Activity Program, Whether or Not Associated With Food Supplementation. Interventional Study Compared to Matched Controls: NUTRILEAN + Study

acronym: NUTRILEAN +

summary: The main aim of the present study is to compare the effect of a 12-week physical activity program on body weight gain and body composition changes between normal weight and constitutionally lean individuals. The second objective will be to question the potential additional effect of a protein supplementation coupled to the physical training intervention on body wright and body composition in constitutionally lean women.


title: Factors Associated With Quality of Life in Patients With Alcohol Use Disorder

acronym: QUALIFACT

summary: The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).

lead_sponsor: Hôpital le Vinatier


title: Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility: an Open Label Prospective Randomized Study

acronym: HyperBetashock

summary:
Several data emphasize the relation between tachycardia (>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock.

Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Access to Kidney Transplant of Obese Patients Beginning Dialysis

acronym: Transplantob

summary: Obesity is in constant increase all over the world and affects 35% of the global population according to the World Health Organisation. It is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. It is also responsible for an increase of the risk of developing chronic kidney diseases (CKD). In fact, obese patients represent 25% of the dialysis population and Picardy is one of the most affected areas. However, their access to kidney transplant is still restricted and the reasons are not completely understood.


type: Registry Identifier

title: Evaluation of Performance in Paralympic Athletes: Performance Outcomes in Sports

acronym: PARAPERF

summary:
The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes.

The secondary objectives of the study:

quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive competitions;
quantification and performances monitoring of physiological performances during the filed tests, the laboratory analysis and the sportive competitions;
quantification and risk monitoring of discipline-relative musculo-squeletic troubles, caused by training or using of sportive equipment;
quantification and mechanical monitoring by the made-to-measure or usual sportive material.

location_facility: Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP


title: Assessment of Prevalence and Prognostic Value of Acute Myocardial Dysfunction in Severe Trauma Patients With Chest Trauma Using 2D-strain Ultrasound: A Prospective Observational Study

acronym: Strainy trauma

summary:
This study aims to investigate whether the identification of acute myocardial dysfunction by 2D-strain transthoracic sonography in the first week following trauma would allow to better diagnose occult and severe patterns of myocardial contusion, in order to identify a subpopulation at higher risk of complications.

The measurement of myocardial strain (2D-strain) by transthoracic sonography is a robust tool to assess the myocardial function.

The investigators strongly suppose that the 2D-strain would allow to better identify subclinical MC in chest trauma, as well as the severe patterns that are associated with more organs dysfunctions and a worst outcome.

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study

acronym: GPR COVID

summary:
Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...Those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation.

For all these reasons the investigators fear that patients hospitalized in intensive care during COVID-19 pandemic develop psychological trouble with an increased risk for those who experienced COVID-19 infection. The hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during COVID-19 pandemic.

The investigators will compare two groups:

group receiving standard of care
group receiving standard of care and therapy group

lead_sponsor: Centre Hospitalier Metropole Savoie


title: Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19

acronym: COVIPACT 2

summary:
In the context of the COVID-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (PTSD). PTSD generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... The current health crisis also represents an increased risk of PTSD.

After the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... In some people, PTSD can lead to more disabling problems such as (crowd) avoidance.

In order to help patients with PTSD, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference.

A study initiated at the François Baclesse Centre during the first confinement, which included 735 patients from April to June 2020, made it possible to assess the impact of the pandemic linked to COVID-19 on the care of cancer patients treated in day hospitals, but also to evaluate the PTSD experienced by patients, sleep difficulties, quality of life, cognitive complaints and confinement conditions using validated questionnaires. This study showed that 21% of patients had proven PTSD and 23% had insomnia problem.

This study proposes to evaluate the value of adapted psychological care for patients with PTSD in relation to the pandemic on the improvement of PTSD, as well as on resilience, quality of life and sleep.

lead_sponsor: Centre Francois Baclesse


title: Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis Preliminary Study

acronym: CYSTALTERNA

summary:
Half of the women have a once-in-a-lifetime episode of cystitis. Recurrence occurs in about 20% to 30% of patients, and half of these patients will have more than 4 episodes per year, defining recurrent cystitis.

The clinical assessment sometimes brings to light favourable factors; variables in pre- or post-menopause; but in the majority of cases, no explanatory cause can solve the problem and some authors refer to resignation as a classic reaction to this problem.

several countries have already opted for alternative treatments (Nonsteroidal anti-inflammatory drugs, phytotherapy, diuresis treatment), especially since the pressure of antibiotic selection is at the root of the dramatic spread of bacterial resistances.

There is a growing interest in the potential of complementary medicine to assist in this care. Products based on cranberries, for example, have been particularly studied and a 2012 Cochrane review concluded that there is a benefit with an estimated risk reduction of between 10 and 20%. Another "alternative" approach is the use of Chinese medicinal herbs. These herbs have been used for more than 2000 years.

The implementation of phyto-aromatherapy treatment implies a global management of patients with recurrent cystitis. Initially, it involves a curative phase as soon as the first symptoms of the attack appear, thanks to a mixture of antibacterial essential oils. In a second phase, it integrates a preventive phase over several months thanks to an association of medicinal plants whose effects in this field have been proven in vitro and in vivo, allowing to rebalance a "terrain" associating anxiety, hypersensitivity to pain, a terrain willingly associated with the irritable bowel syndrome in these patients. While having few side effects, the plants will act, in the long term, at different levels: directly on the cause of the disease thanks to their antiseptic, antiadhesive and diuretic activities, but also by reducing the symptoms thanks to their anti-inflammatory, analgesic, antispasmodic and anxiolytic activities.

Investigators hypothesize that patients with recurrent cystitis can be improved by a two-phase, multi-plant, phyto-aromatherapy treatment combining several plants: the treatment of attacks, by aromatherapy, and a prophylactic treatment, by phytotherapy. In the absence of any such studies published in the literature, investigators propose a non-randomised prospective monocentric interventional pilot study on 15 patients with proof of concept and feasibility.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Combination Product


title: Impact of Exercise and Nutritional Support on the Frailty Syndrome of Eldery Patients in Phase of Post-cancer Treatment

acronym: PANACEE

summary: Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.

lead_sponsor: University Hospital, Grenoble


title: Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

acronym: ReLoT-TCCL

summary:
Mild traumatic brain injury (mTBI) accounts for 70-90% of brain injuries, with 600 cases of mTBI per 100 000 people in the united states, but only 100-300 mTBI patients per 100 000 people receive hospital-based care. Symptoms reported immediately after injury tend to diminish over the following 10 days and are generally resolved by 3 months. However, in 15-25% of cases , problems persist, and may even worsen, at 3 months. Physical, emotional, and behavioral factors can be affected. Physical disorders include pain and fatigue. Sleep disorders are also common. Persistent symptoms can affect patient outcomes (affecting all aspects of life) and increase public healthcare costs .In a previous study (NCT03811626, Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. The investigators were able to demonstrate that early multidisciplinary management improved the outcome and prognosis of patients by statistically significantly reducing the percentage of patients with Post traumatic syndrome distress at six months (6% for the treated group versus 52% for the control group, p < 0.001).

It seems important to verify that if this short-term improvement (6 months after the trauma) persists in the long term, and therefore at a distance from the end of the initially proposed rehabilitation.


title: New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

acronym: PACHIBA

summary:
The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.

Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.

To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients

intervention_type: Radiation


title: Evaluation of the Diagnostic Performances of the TEG 6s® Hemostasis Device and Its Platelet Mapping® Cartridge for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery

acronym: TEG-PM

summary: Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.

status: Terminated

location_facility: Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière


title: Cohort SURVI : Intestinal Ischemia and Vascular Diseases

acronym: Survibase

summary:
The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%.

Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors.

Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient.

The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described.

The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.

time_perspective: Other


title: Application of a Positive Psychology Program for the Development of Emotional Skills in Prison : Feasibility Study

summary:
Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care.

The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.


title: Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

acronym: SCLERO-PRL

summary: Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin

lead_sponsor: University Hospital, Lille


title: First-in-Human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of CKD-510 in Single Ascending Dose and Multiple Ascending Dose in Healthy Subjects

summary: This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.

lead_sponsor: Chong Kun Dang Pharmaceutical


title: Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand

acronym: FACEHAND

summary: The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.

lead_sponsor: Hospices Civils de Lyon

location_facility: Groupement Hospitalier du Sud - Hôpital Henry Gabrielle


title: Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.

acronym: MATUPUNCTURE

summary:
Brief Summary Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters)

Example: The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED). The first purpose of this randomized study is to determine if five points of acupuncture : 4GI, 6RP, 34VB, 36E, 3F could improve the bishop score for prolonged pregnancies and decrease the rate of maturation.

The protocol of our study consists of proposing to the pregnant women one or two acupuncture sessions the term's day and three days later. Once the consent is signed, women are randomly included in the experimental or placebo arm. In the experimental arm, midwives puncture five points : 4GI, 6 RP, 34VB, 36E, 3F on each side while in the placebo arm, they puncture just one point : 16 HM on each side.

The maturation's rate between the two groups will be compared by a Fisher's exact test and analyzed in function parity (nulliparous or multiparous) and number of sessions (one or two) with a model of univariate and multivariate logistic regression.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19

acronym: Oursyn

summary: Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

ReferenceType: result

ReferenceCitation: Rybak A, Levy C, Jung C, Bechet S, Batard C, Hassid F, Zouari M, Cahn-Sellem F, Bangert M, Cohen R. Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021. Pediatr Infect Dis J. 2021 Dec 1;40(12):e511-e514. doi: 10.1097/INF.0000000000003270.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


title: Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

acronym: VASC-UC

summary: An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.


title: The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)

acronym: OTEMACS

summary: Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH). The purpose of the OTEMACS Trial is to assess the safety and effect on recurrence rate and functional outcome of endovascular treatment in patients with CSDH.


title: ARIADE : Augmented Reality for Improving Autonomy in Dementia. Creation, Implementation and Testing of an Augmented Reality Tool to Help People With Alzheimer's Type Dementia in Their Travels.

acronym: ARIADE

summary:
Navigating according to a specific goal is a common activity of everyday life. Spatial navigation requires the implementation of motor and perceptual functions (sight, walking, proprioception), but also various cognitive functions (executive functions, memory, spatial orientation skills). Many people affected by a neurodegenerative disease have topographical difficulties which have a major impact on their autonomy in daily life, by gradually limiting their movements outside their home, then inside their home, and which are the main factor leading to the institutionalization of this population. People with dementia or MCI (Mild Cognitive Impairment) of the Alzheimer type, according to the definition of the NIAA (National Institute on Aging-Alzheimer's Association) have navigation and spatial memory disorders, with difficulty in acquiring mental spatial representations of their environment. These topographical difficulties have been shown to be related to the reduction in volume of the temporal cortex, in particular the hippocampal regions, as well as to atrophy of the retrosplenial cortex.

Augmented Reality (AR), often defined as an intermediary between the totally artificial world of VR and the real world in which we operate, makes it possible in particular to add summary information to the natural environment in which a participant operates. Even if, in particular in outside environment, AR must solve many challenges, such as the integration of the real and virtual worlds in real time, the selection of the modalities of restitution of information, its use is exponential in the medical field, in particular in surgery for the assistance of the practitioner, but also in the field of sensory substitution, in particular to facilitate the movements of people with visual impairment. Other works focused in helping people with dementia of the Alzheimer type, such as those of Quintana and Favela (2012) who proposed preliminary systems of annotations in AR. Hervás et al. were the first in 2014 to test the use of augmented reality to provide navigation assistance to people with dementia. In 2017, Firouzian et al. as well as Sejunaite et al. implemented related systems. Firouzian et al. have developed spectacle frames comprising around ten LED lights in order to provide directional indications to people who moved outdoor. However, the influence of this system on navigation performance has not been tested yet. On the other hand, although simple to develop, this system requires training on the part of the users and only makes it possible to provide directional information, which is not recommended for the implementation of a tool for this population. Finally, Sejunaite et al. used an environmentally tested smart glasses to allow users to display information in the form of a map to help older people navigate independently. However, the literature review indicates that even increased card use does not seem to be suitable for people with dementia or Alzheimer's-type MCI. Finally, these two tools do not allow navigational information to be co-located in the field of vision of people, which represents one of the major advantages of augmented reality. To our knowledge, there is not yet an AR device providing co-located information in the environment dedicated to outdoor navigation of people with dementia or Alzheimer's type MCI.

lead_sponsor: Rennes University Hospital


title: Comparison of the Effects of 2 Therapeutic Plasmapheresis Techniques: Single Plasma Exchange and Double Filtration Plasmapheresis (DFPP) on Peripheral Lymphocyte Phenotypes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). A Monocentric Prospective Study With a Single-Case Experimental Design

acronym: LYMPHOARESIS

summary: CIDP, a rare disorder affecting young adults, causes gradual weakness of the limbs, areflexia and impaired sensory function. New CIDP phenotypes without antibodies but with modified cell profiles have been described. Treatments include corticotherapy, IVIg and plasmapheresis but the latter's action mechanisms remain unclear. Plasmapheresis supposedly removes toxic agents like antibodies from plasma but it is uncertain whether it has an immune-modulating effect. Also, the refining mechanisms of the two main plasmapheresis techniques - single plasma exchange and double filtration plasmapheresis (DFPP) - are different and unclear. This study aims to compare the evolution of peripheral lymphocyte profiles in patients with CIDP according to their treatment (single centrifugation plasmapheresis or DFPP) to better grasp the action mechanisms of both techniques.

ReferenceCitation: Moranne O, Ion IM, Cezar R, Messikh Z, Prelipcean C, Chkair S, Thouvenot E, Tran TA, Corbeau P, Chevallier T. Protocol of comparison of the effects of single plasma exchange and double filtration plasmapheresis on peripheral lymphocyte phenotypes in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: a monocentric prospective study with single-case experimental design. BMC Neurol. 2022 Aug 5;22(1):293. doi: 10.1186/s12883-022-02816-w.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis

acronym: Aticks Live

summary: Anticoagulants influence either coagulation, inflammation and inflammatory processes in deep vein thrombosis (DVT). Acute DVT cause an inflammatory response that may persist for a long period of time. There is a need to describe patterns of change in serum biomarker levels after acute DVT, and explore the association between trajectory biological patterns and clinical evolution in the era of various anticoagulants in the acute phase of treatment in order to be able to further avoid recurrence and late sequelae. It appears that direct oral anticoagulants and heparin alter inflammatory markers in different ways. It is therefore important to study the evolution of markers according to the different treatments used and secondarily to compare them with each other. Tinzaparin is used in the long term in patients with DVT, it is necessary to measure the evolution of inflammatory markers and then in another study to compare with the other molecules.


title: Transverse Fractures +/- Posterior Wall of the Acetabulum: Predictors of the Quality of Surgical Reduction and Long-term Outcome

summary:
Acetabulum fractures are complex, relatively rare lesions linked to a more or less good functional prognosis and therefore represent a real surgical challenge.

In the literature, it is accepted that surgical delay, among other things, negatively impacts the quality of surgical reduction. However, this reduction must be a major priority since it is one of the factors conditioning the functional result.

In our study, we wish to analyze a particular type of fracture, less studied, or with small series, that are the transverse fractures (+/- posterior wall), known for their difficulty of reduction. The reduction is even greater as the fracture line often passes through the acetabular bearing zone, compromising the functional prognosis.

The choice of surgical approach for this type of fracture is controversial. More and more, a single approach, usually posterior, without compulsory fixation of the anterior component of the transverse fracture is preferred over the traditional double approach anterior and posterior, and this in particular to reduce the morbidity of this surgery.

But this one-size-fits-all approach does not always achieve a good reduction and it is believed that the time to surgery may play a role.

If it is accepted that the surgical delay before reduction in osteosynthesis of an acetabular fracture is involved in the quality of the reduction and therefore the functional result in these patients, the question asked is whether this delay should condition the choice of a double approach, anterior and posterior, for this type of fracture (transverse +/- posterior wall).

Indeed, with increasing surgical time, the risk of scar tissue formation and early callus increases, making bone fragments less mobile, reduction more difficult and indirect reduction techniques (which are used when single approach is chosen) less efficient.

In addition, most of the studies evaluating the quality of reduction of acetabular fractures use a radiographic score, that of Matta.

However, it has been shown that the CT scan was more efficient than the x-rays in detecting a residual displacement of the fracture. Also, in this study, we want to analyze the quality of reduction thanks to the scanner, which is rarely done in the literature.

This work aims to determine the predictive factors of the quality of reduction of transverse fractures +/- posterior wall of the acetabulum, evaluated on the postoperative CT scan.

ReferenceCitation: Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.

ReferenceCitation: Madhu R, Kotnis R, Al-Mousawi A, Barlow N, Deo S, Worlock P, Willett K. Outcome of surgery for reconstruction of fractures of the acetabulum. The time dependent effect of delay. J Bone Joint Surg Br. 2006 Sep;88(9):1197-203.

ReferenceCitation: Giordano V, do Amaral NP, Pallottino A, Pires e Albuquerque R, Franklin CE, Labronici PJ. Operative treatment of transverse acetabular fractures: is it really necessary to fix both columns? Int J Med Sci. 2009 Jul 12;6(4):192-9.

ReferenceCitation: Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Analysis of Killer Immunoglobulin-like Receptor Transcripts Expression for the Diagnosis of Epidermotropic Cutaneous T-cell Lymphomas (Mycosis Fungoid and Sézary Syndrome) in Patients With Erythroderma or Erythematous Patches/Plaques.

acronym: KIR

summary: The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome. The diagnosis of these lymphomas is difficult using current methods, especially because numerous benign dermatological conditions can mimick CTCL both clinically and under microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same family may help fro the diagnosis of these lymphomas. To address this issue, we will study the expression of all known KIR receptor in the skin of patients presenting with a skin eruption, which may correspond to either a cutaneous T-cell lymphoma or a benign dermatological disease. The final diagnosis will be established by a panel of experts, allowing constitution of 2 groups of patients : the cutaneous T-cell lymphoma group, and the benign inflammatory disease group. The expression of the different KIRs will be analyzed in both group in a blinded fashion, in order to determine whether one or a several KIRs may be differentially expressed.

location_facility: Groupe hospitalier Henri Mondor - Albert Chenevier


title: Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children

acronym: SICE

summary: To access CT Scan as a diagnostic tool for foreign bodies aspiration.

location_facility: Paris V University & Assistance Publique Hôpitaux de Paris