title: Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With a Combined Measles-mumps-rubella (MMR) Vaccine

acronym: BREMEAVAC

summary: In order to assess the safety of breastfed infants after their mother's postpartum immunization with a combined measles-mumps-rubella (MMR) vaccine, the purpose of this study is to investigate whether measles vaccine strain is excreted in breast milk of breastfeeding women with negative rubella and measles serologies.

ReferenceCitation: Alain S, Dommergues MA, Jacquard AC, Caulin E, Launay O. State of the art: Could nursing mothers be vaccinated with attenuated live virus vaccine? Vaccine. 2012 Jul 13;30(33):4921-6. doi: 10.1016/j.vaccine.2012.05.047. Epub 2012 May 31.

ReferenceCitation: Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Yellow fever virus transmission via breastfeeding: follow-up to the paper on breastfeeding travelers. J Travel Med. 2010 Jul-Aug;17(4):286-7. doi: 10.1111/j.1708-8305.2010.00430.x. No abstract available.

ReferenceCitation: Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. I. Development and characterization of specific immunologic reactivity in breast milk. J Infect Dis. 1982 May;145(5):654-60. doi: 10.1093/infdis/145.2.654.

ReferenceCitation: Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions. J Infect Dis. 1982 May;145(5):661-6. doi: 10.1093/infdis/145.2.661.

collaborators: Service de Bactériologie-Virologie-Hygiène, CHU Limoge

collaborators: GO-CIC network (Réseau Gynéco-Obstetrical des Centres d'Investigation Clinique)

collaborators: REIVAC network (Réseau National d'Investigation Clinique en Vaccinologie)

location_facility: Cochin Port Royal Hospital - Centre d'Investigation Clinique Cochin-Pasteur

acronyme: BREMEAVAC

titre: Recherche de l'excrétion du virus vaccinal de la rougeole dans le lait de femmes vaccinées en postpartum par un vaccin trivalent Rougeole-Rubéole-Oreillons(RRO)

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: LAUNAY

prenom_porteur: Odile


title: "Impacts of the Letter of Condolence to the Bereaved Families Experience After a Death in ICU " - Study Famirea 22

acronym: Famirea 22

summary:
After the death of a patient in the hyper-technical context of intensive care, his relatives are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic stress and complicated grief. The first results of a qualitative study Famiréa current (CAESAR) support the idea that the bereaved relatives suffer from persistent misunderstandings and a feeling of abandonment of the resuscitation team. Many families suggest the need for contact with the team after the patient's death. The letter of condolence received by some families allowed them to feel recognized in their pain resuscitation teams. This has led us to ask the question of post-death monitoring and interest to send to bereaved relatives a letter of condolence, as recommended by the American consensus conference in 2004 on good palliative care. This strategy would allow the recognition of both close to the pain but also the strong bond that united the resuscitation team. The hypothesis of the study is that the post-death followed in the form of a letter of condolence sent by the intensive care physician who was in charge of the patient, could reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and reduce the rate of complicated grief.

Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who did not receive a letter of condolence and a group that received a letter of condolence 15 days after the death.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kentish-Barnes N, Chevret S, Champigneulle B, Thirion M, Souppart V, Gilbert M, Lesieur O, Renault A, Garrouste-Orgeas M, Argaud L, Venot M, Demoule A, Guisset O, Vinatier I, Troche G, Massot J, Jaber S, Bornstain C, Gaday V, Robert R, Rigaud JP, Cinotti R, Adda M, Thomas F, Calvet L, Galon M, Cohen-Solal Z, Cariou A, Azoulay E; Famirea Study Group. Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial. Intensive Care Med. 2017 Apr;43(4):473-484. doi: 10.1007/s00134-016-4669-9. Epub 2017 Feb 14.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_normalized: HAL

version: submittedVersion

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - hprints.org

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

ReferenceCitation: Kentish-Barnes N, Chevret S, Azoulay E. Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial. Trials. 2016 Feb 20;17(1):102. doi: 10.1186/s13063-016-1212-9.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Optimize the Requirements and Preparations in Outpatient Chemotherapy

summary:
A prescription of injectable anticancer therapy requires the collection of medical data (interview and physical examination) and often allied (laboratory tests). This requirement is made on the day of the arrival of the patient to not prepare these treatments incorrectly.

After receiving the prescription of treatment, it will take about 1 hour to prepare for pharmacy and more in times of high activity, to provide the day hospital pockets treatment, incompressible time when the patient waits to have his treatment.

A process has been selected (Optima) to anticipate prescribing injectable cancer treatments and their manufacturing to reduce patient waiting times on the day of his coming François BaclesseCentre day hospital.

primary_purpose: Other

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
Roche Pharma AG

lead_sponsor_type: industriel


type: Other Identifier

title: Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools

acronym: NEUROSYLLABIC

summary: This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.

study_start_date_type: Actual

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hopital Edouard Herriot


title: Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia

acronym: ALLIUM

summary:
Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of the striated sphincter activity during voiding and characterizes the spinal cord injuries located under the protuberance. The standard treatment for DSSD is medical, either pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are unable to perform CISC and require alternative surgical techniques such as external sphincterotomy which is invasive, irreversible and with no adjustment period for the patient.

Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary stents provide a non-definitive treatment, especially for evolutionary pathologies, for patients refusing a destructive surgery (psychosocial impact), or for patients having not defined yet their therapeutic preference. The Allium company has developed the " Bulbar Urethral Stent " (BUS) system, which advantages are the possibility to perform the procedure under local anesthesia and to remove more easily the stent, with similar performances compared to the other devices. In order to quantify the interest of the BUS system, the investigators propose to perform a prospective study aimed at describing its technical and clinical results in terms of efficacy and safety.

primary_purpose: Treatment

location_facility: Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud

intervention_type: Device


title: Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.

acronym: CILICA-FS

summary:
Context: Chest compressions represent an important physical effort leading to fatigue and cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary resuscitation remains to be assessed.

Study design: simulated prospective monocentric randomized crossover trial. Participants and methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously).

Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Caen


title: Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism

summary: Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality in insulin resistant states. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL) with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48 overproduction appeared as a newly recognized component of insulin resistance. There is only a limited amount of information in the literature regarding the factors and the mechanisms modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Maraninchi M, Calabrese A, Nogueira JP, Castinetti F, Mancini J, Mourre F, Pietri L, Benamo E, Albarel F, Morange I, Dupont-Roussel J, Nicolay A, Brue T, Beliard S, Valero R. Role of growth hormone in hepatic and intestinal triglyceride-rich lipoprotein metabolism. J Clin Lipidol. 2021 Sep-Oct;15(5):712-723. doi: 10.1016/j.jacl.2021.08.003. Epub 2021 Aug 16.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Drug

status_simplified: Unknown


title: Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.

acronym: MUCO-IRC

summary:
Chronic renal failure is a serious complication of lung transplantation especially in patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has already exposed to kidney damage. Post-lung transplantation, these patients are subjected to renal toxicity anticalcineurins they receive large doses.

The measurement of renal function of patients by formula to estimate GFR in routine use is unreliable and other markers seem indispensable.

The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal peptide N), whose urinary levels was correlated to the intensity of fibrosis in different types of kidney disease.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

intervention_type: Biological


title: Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015

acronym: HEMATO-BIO

summary:
HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.

HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:

tumor samples: marrow aspiration, blood sampling.
non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.

status: Recruiting

ReferenceCitation: Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunes JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2020459118. doi: 10.1073/pnas.2020459118.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via page says license)

repository_normalized: medRxiv

repositories:
PubMed Central
medRxiv

repositories_concat: PubMed Central;medRxiv

unpaywall_oa_status: hybrid

publisher_dissemination: Proceedings of the National Academy of Sciences

lead_sponsor: Institut Paoli-Calmettes

status_simplified: Ongoing


title: Effect of Eccentric Exercise Training in Rheumatoid Cachexia

acronym: EECRA

summary: The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy of eccentric exercise training in restoring muscle mass and function in patients with rheumatoid cachexia.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Multicentric Descriptive Cross-sectional Study Evaluating Cocaine Users in Treatment Center

acronym: PSYCHOCOKE

summary: The aim of this study is to determine the clinical, genetic and environmental factors associated with the phenotype "severe psychotic symptoms" caused by cocaine.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Vorspan F, Fortias M, Zerdazi el-H, Karsinti E, Bloch V, Lepine JP, Bellivier F, Brousse G, van den Brink W, Derks EM. Self-reported cue-induced physical symptoms of craving as an indicator of cocaine dependence. Am J Addict. 2015 Dec;24(8):740-3. doi: 10.1111/ajad.12303. Epub 2015 Nov 6.

publisher_dissemination: Wiley

ReferenceCitation: Karsinti E, Jarroir M, Zerdazi el-H, Bloch V, Dupuy G, Belforte B, Coeuru P, Plat A, Deschenau A, Cottencin O, Gay A, Lack P, Pelissier-Alicot AL, Bellivier F, Lepine JP, Brousse G, Vorspan F. Childhood trauma are not associated with the intensity of transient cocaine induced psychotic symptoms. Psychiatry Res. 2015 Aug 30;228(3):941-4. doi: 10.1016/j.psychres.2015.05.065. Epub 2015 Jun 27.

ReferenceCitation: Vorspan F, Brousse G, Bloch V, Bellais L, Romo L, Guillem E, Coeuru P, Lepine JP. Cocaine-induced psychotic symptoms in French cocaine addicts. Psychiatry Res. 2012 Dec 30;200(2-3):1074-6. doi: 10.1016/j.psychres.2012.04.008. Epub 2012 May 1.

ReferenceCitation: Brousse G, Vorspan F, Ksouda K, Bloch V, Peoc'h K, Laplanche JL, Mouly S, Schmidt J, Llorca PM, Lepine JP. Could the inter-individual variability in cocaine-induced psychotic effects influence the development of cocaine addiction? Towards a new pharmacogenetic approach to addictions. Med Hypotheses. 2010 Dec;75(6):600-4. doi: 10.1016/j.mehy.2010.07.043.

ReferenceCitation: Icick R, Vorspan F, Karsinti E, Ksouda K, Lepine JP, Brousse G, Mouly S, Bellivier F, Bloch V. Gender-specific study of recurrent suicide attempts in outpatients with multiple substance use disorders. J Affect Disord. 2018 Dec 1;241:546-553. doi: 10.1016/j.jad.2018.08.076. Epub 2018 Aug 13.


title: Advanced Approach to Arterial Stiffness (AAA Study - Triple A Study)

acronym: AAA

summary: The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the "classic" carotid-femoral Pulse Wave Velocity (PWV).

lead_sponsor: International Society for Vascular Health


title: Treatment of Port-wine Stains by Bosentan in Addition to Pulsed Dye Laser (PDL) in Children or Young Adults Who Previously Failed to Respond to PDL Alone: a Monocentric Pilot Study

summary: Pulsed dye laser (PDL) is the gold standard treatment for port-wine stains (PWS). However, the outcomes are highly variable due to the new angiogenesis occurring after laser irradiation. Studies suggest that endothelin is involved in the neoangiogenesis that occurred after treatment of port-wine stains by PDL. The main objective of this pilot clinical trial is to evaluate the effectiveness and safety of an inhibitor of endothelin orally taken, the Bosentan, following PDL treatment. Four patients with facial port-wine stain resistant to the PDL treatment will be included. The treatment by Bosentan (2 mg/kg twice daily, maximum 62,5 mg twice daily) will be given one day before the PDL irradiation and continued for 14 days. Only one test area of PWS will be treated with PDL. The primary outcome measure will be an important or complete improvement (Investigator Global Assessment 3 or 4) between treated area and non treated one, 14 days after the end of the treatment which corresponds to one month after the laser PDL session. The evaluation will been performed on standardized pictures by 2 independent physicians blinded to the region treated or not.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - Dermatologie - Hôpital Archet


title: Development of a Multimodal Controlled Device for Improvement and Monitoring of Freezing in Parkinsonian Patients

acronym: demarpark

summary: Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier


title: Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - The PEPPER Pragmatic Randomised Controlled Trial

acronym: PEPPER

summary: This study evaluates the efficacy, in terms of energy expenditure, physical activity level, quality of life, blood pressure, waist circumference and weight, of a general practice based intervention involving a personalised physical exercise medical prescription, the structured delivery of information on the benefits of physical activity, a pedometer, and a pedometer log book, in 35 to 74 year old patients with cardiovascular risks factors.

ReferenceCitation: Missud DC, Parot-Schinkel E, Connan L, Vielle B, Huez JF. Physical activity prescription for general practice patients with cardiovascular risk factors-the PEPPER randomised controlled trial protocol. BMC Public Health. 2019 Jun 3;19(1):688. doi: 10.1186/s12889-019-7048-y.

lead_sponsor: University Hospital, Angers

intervention_type: Behavioral


title: OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma

summary: This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.

lead_sponsor: Hoffmann-La Roche


title: Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life

acronym: RESPECT

summary: The investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. Our primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to prevent disability.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging. 2008 Jan;12(1):29-37. doi: 10.1007/BF02982161.

ReferenceCitation: Ahmed N, Mandel R, Fain MJ. Frailty: an emerging geriatric syndrome. Am J Med. 2007 Sep;120(9):748-53. doi: 10.1016/j.amjmed.2006.10.018.

ReferenceCitation: Barlow J, Singh D, Bayer S, Curry R. A systematic review of the benefits of home telecare for frail elderly people and those with long-term conditions. J Telemed Telecare. 2007;13(4):172-9. doi: 10.1258/135763307780908058.

ReferenceCitation: Binder EF, Schechtman KB, Ehsani AA, Steger-May K, Brown M, Sinacore DR, Yarasheski KE, Holloszy JO. Effects of exercise training on frailty in community-dwelling older adults: results of a randomized, controlled trial. J Am Geriatr Soc. 2002 Dec;50(12):1921-8. doi: 10.1046/j.1532-5415.2002.50601.x.

ReferenceCitation: Boyd CM, Xue QL, Simpson CF, Guralnik JM, Fried LP. Frailty, hospitalization, and progression of disability in a cohort of disabled older women. Am J Med. 2005 Nov;118(11):1225-31. doi: 10.1016/j.amjmed.2005.01.062.

ReferenceCitation: Brown M, Sinacore DR, Ehsani AA, Binder EF, Holloszy JO, Kohrt WM. Low-intensity exercise as a modifier of physical frailty in older adults. Arch Phys Med Rehabil. 2000 Jul;81(7):960-5. doi: 10.1053/apmr.2000.4425.

ReferenceCitation: Cesari M, Kritchevsky SB, Penninx BW, Nicklas BJ, Simonsick EM, Newman AB, Tylavsky FA, Brach JS, Satterfield S, Bauer DC, Visser M, Rubin SM, Harris TB, Pahor M. Prognostic value of usual gait speed in well-functioning older people--results from the Health, Aging and Body Composition Study. J Am Geriatr Soc. 2005 Oct;53(10):1675-80. doi: 10.1111/j.1532-5415.2005.53501.x.

ReferenceCitation: Cesari M, Onder G, Russo A, Zamboni V, Barillaro C, Ferrucci L, Pahor M, Bernabei R, Landi F. Comorbidity and physical function: results from the aging and longevity study in the Sirente geographic area (ilSIRENTE study). Gerontology. 2006;52(1):24-32. doi: 10.1159/000089822.

ReferenceCitation: Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.

ReferenceCitation: Chan M, Campo E, Esteve D, Fourniols JY. Smart homes - current features and future perspectives. Maturitas. 2009 Oct 20;64(2):90-7. doi: 10.1016/j.maturitas.2009.07.014. Epub 2009 Sep 2.

ReferenceCitation: Daniels R, van Rossum E, de Witte L, Kempen GI, van den Heuvel W. Interventions to prevent disability in frail community-dwelling elderly: a systematic review. BMC Health Serv Res. 2008 Dec 30;8:278. doi: 10.1186/1472-6963-8-278.

ReferenceCitation: Dolansky MA, Moore SM. Effects of cardiac rehabilitation on the recovery outcomes of older adults after coronary artery bypass surgery. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):236-44. doi: 10.1097/00008483-200407000-00005.

ReferenceCitation: Ensrud KE, Ewing SK, Taylor BC, Fink HA, Stone KL, Cauley JA, Tracy JK, Hochberg MC, Rodondi N, Cawthon PM; Study of Osteoporotic Fractures Research Group. Frailty and risk of falls, fracture, and mortality in older women: the study of osteoporotic fractures. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):744-51. doi: 10.1093/gerona/62.7.744.

ReferenceCitation: Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31.

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

ReferenceCitation: Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.

ReferenceCitation: Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418.

ReferenceCitation: Gitlin LN, Hauck WW, Dennis MP, Winter L, Hodgson N, Schinfeld S. Long-term effect on mortality of a home intervention that reduces functional difficulties in older adults: results from a randomized trial. J Am Geriatr Soc. 2009 Mar;57(3):476-81. doi: 10.1111/j.1532-5415.2008.02147.x. Epub 2009 Jan 23.

ReferenceCitation: LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157. Erratum In: J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):337.

ReferenceCitation: Marshall SJ, Levy SS, Tudor-Locke CE, Kolkhorst FW, Wooten KM, Ji M, Macera CA, Ainsworth BE. Translating physical activity recommendations into a pedometer-based step goal: 3000 steps in 30 minutes. Am J Prev Med. 2009 May;36(5):410-5. doi: 10.1016/j.amepre.2009.01.021.

ReferenceCitation: Montero-Odasso M, Schapira M, Soriano ER, Varela M, Kaplan R, Camera LA, Mayorga LM. Gait velocity as a single predictor of adverse events in healthy seniors aged 75 years and older. J Gerontol A Biol Sci Med Sci. 2005 Oct;60(10):1304-9. doi: 10.1093/gerona/60.10.1304.

ReferenceCitation: Nelson ME, Layne JE, Bernstein MJ, Nuernberger A, Castaneda C, Kaliton D, Hausdorff J, Judge JO, Buchner DM, Roubenoff R, Fiatarone Singh MA. The effects of multidimensional home-based exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Feb;59(2):154-60. doi: 10.1093/gerona/59.2.m154.

ReferenceCitation: Ni Scanaill C, Carew S, Barralon P, Noury N, Lyons D, Lyons GM. A review of approaches to mobility telemonitoring of the elderly in their living environment. Ann Biomed Eng. 2006 Apr;34(4):547-63. doi: 10.1007/s10439-005-9068-2. Epub 2006 Mar 21.

ReferenceCitation: Penninx BW, Messier SP, Rejeski WJ, Williamson JD, DiBari M, Cavazzini C, Applegate WB, Pahor M. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med. 2001 Oct 22;161(19):2309-16. doi: 10.1001/archinte.161.19.2309.

ReferenceCitation: Sabatini AM, Martelloni C, Scapellato S, Cavallo F. Assessment of walking features from foot inertial sensing. IEEE Trans Biomed Eng. 2005 Mar;52(3):486-94. doi: 10.1109/TBME.2004.840727.

ReferenceCitation: Santos-Eggimann B, Cuenoud P, Spagnoli J, Junod J. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009 Jun;64(6):675-81. doi: 10.1093/gerona/glp012. Epub 2009 Mar 10.

ReferenceCitation: Savolainen L, Hanson E, Magnusson L, Gustavsson T. An Internet-based videoconferencing system for supporting frail elderly people and their carers. J Telemed Telecare. 2008;14(2):79-82. doi: 10.1258/jtt.2007.070601.

ReferenceCitation: Tien I, Glaser SD, Bajcsy R, Goodin DS, Aminoff MJ. Results of using a wireless inertial measuring system to quantify gait motions in control subjects. IEEE Trans Inf Technol Biomed. 2010 Jul;14(4):904-15. doi: 10.1109/TITB.2009.2021650. Epub 2009 May 5.

ReferenceCitation: Wu G, Keyes LM. Group tele-exercise for improving balance in elders. Telemed J E Health. 2006 Oct;12(5):561-70. doi: 10.1089/tmj.2006.12.561.

ReferenceCitation: Piau A, Steinmeyer Z, Charlon Y, Courbet L, Rialle V, Lepage B, Campo E, Nourhashemi F. A Smart Shoe Insole to Monitor Frail Older Adults' Walking Speed: Results of Two Evaluation Phases Completed in a Living Lab and Through a 12-Week Pilot Study. JMIR Mhealth Uhealth. 2021 Jul 5;9(7):e15641. doi: 10.2196/15641.

publisher_dissemination: JMIR Publications

ReferenceCitation: Piau A, Charlon Y, Campo E, Vellas B, Nourhashemi F. A Smart Insole to Promote Healthy Aging for Frail Elderly Individuals: Specifications, Design, and Preliminary Results. JMIR Rehabil Assist Technol. 2015 May 25;2(1):e5. doi: 10.2196/rehab.4084.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand


title: Long-term Additive Prognostic Value of Heterogeneity Myocardial Perfusion Imaging of SPECT Over Clinical and Ischemia in High-risk Diabetic Patients.

acronym: EVADIAB

summary: Long-term additive prognostic value of heterogeneity myocardial perfusion imaging of SPECT over clinical and ischemia in high-risk diabetic patients

ReferenceCitation: Djaileb L, Seiller A, Canu M, De Leiris N, Martin A, Poujol J, Fraguas-Rubio A, Leenhardt J, Carabelli A, Calizzano A, De Fondaumiere M, Broisat A, Desvignes M, Vanzetto G, Ghezzi C, Fagret D, Riou LM, Barone-Rochette G. Prognostic value of SPECT myocardial perfusion entropy in high-risk type 2 diabetic patients. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1813-1821. doi: 10.1007/s00259-020-05110-4. Epub 2020 Nov 20.

lead_sponsor: University Hospital, Grenoble


title: Microcephaly Genetic Deficiency in Neural Progenitors: Genotyping, Phenotyping and Functional Neuro-anatomy and Neurobiology Comparative Primitive Microcephaly (MCPH) and the Fanconi Anemia (FA)

acronym: MICROFANC

summary:
The purpose of this study is to:

I. Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by ASPM mutations already characterized and published (Passemard et al. 2009a) with other MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT mutations)

II. Describe the neuro-radiological and cognitive phenotype of microcephalic patients suffering from Fanconi anemia, and compared them to subjects with:

Fanconi anemia but normal OFC (head circumference)
MCPH patients
Healthy control subjects Our hypothesis is that mutations in genes responsible of microcephaly impact differentially cortical brain development and functioning

ReferenceCitation: Ruaud L, Drunat S, Elmaleh-Berges M, Ernault A, Guilmin Crepon S; MCPH Consortium; El Ghouzzi V, Auvin S, Verloes A, Passemard S. Neurological outcome in WDR62 primary microcephaly. Dev Med Child Neurol. 2022 Apr;64(4):509-517. doi: 10.1111/dmcn.15060. Epub 2021 Sep 25.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

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

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

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

ReferenceCitation: Nasser H, Vera L, Elmaleh-Berges M, Steindl K, Letard P, Teissier N, Ernault A, Guimiot F, Afenjar A, Moutard ML, Heron D, Alembik Y, Momtchilova M, Milani P, Kubis N, Pouvreau N, Zollino M, Guilmin Crepon S, Kaguelidou F, Gressens P, Verloes A, Rauch A, El Ghouzzi V, Drunat S, Passemard S. CDK5RAP2 primary microcephaly is associated with hypothalamic, retinal and cochlear developmental defects. J Med Genet. 2020 Jun;57(6):389-399. doi: 10.1136/jmedgenet-2019-106474. Epub 2020 Feb 3.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

unpaywall_oa_status: bronze

publisher_dissemination: British Medical Journal


title: Drug Interaction With Genes in Parkinson's Disease

acronym: DIGPD

summary: This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients will be followed annually for up to 5 years. A biological collection will be associated with a full clinical assessment of motor and non motor symptoms, medical and treatment history, environmental factors. The association between candidate gene polymorphisms and disease or treatment complications will be analyzed.

ReferenceCitation: Marques A, Vidal T, Pereira B, Benchetrit E, Socha J, Pineau F, Elbaz A, Artaud F, Mangone G, You H, Cormier F, Galitstky M, Pomies E, Rascol O, Derkinderen P, Weintraub D, Corvol JC, Durif F; DIGPD study group. French validation of the questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS). Parkinsonism Relat Disord. 2019 Jun;63:117-123. doi: 10.1016/j.parkreldis.2019.02.026. Epub 2019 Mar 4.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Corvol JC, Artaud F, Cormier-Dequaire F, Rascol O, Durif F, Derkinderen P, Marques AR, Bourdain F, Brandel JP, Pico F, Lacomblez L, Bonnet C, Brefel-Courbon C, Ory-Magne F, Grabli D, Klebe S, Mangone G, You H, Mesnage V, Lee PC, Brice A, Vidailhet M, Elbaz A; DIGPD Study Group. Longitudinal analysis of impulse control disorders in Parkinson disease. Neurology. 2018 Jul 17;91(3):e189-e201. doi: 10.1212/WNL.0000000000005816. Epub 2018 Jun 20.

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: No

location_facility: Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière


title: Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes

acronym: DIAB-EETs

summary: Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these patients.

ReferenceCitation: Duflot T, Moreau-Grange L, Roche C, Iacob M, Wils J, Remy-Jouet I, Cailleux AF, Leuillier M, Renet S, Li D, Morisseau C, Lamoureux F, Richard V, Prevost G, Joannides R, Bellien J. Altered bioavailability of epoxyeicosatrienoic acids is associated with conduit artery endothelial dysfunction in type 2 diabetic patients. Cardiovasc Diabetol. 2019 Mar 18;18(1):35. doi: 10.1186/s12933-019-0843-z.

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

lead_sponsor: University Hospital, Rouen


title: Comparison of Two Extracorporeal Liver Support System (With or Without Recirculation) : MARS (Molecular Adsorbents Recirculating System) Versus SPAD (Single Pass Albumin Dialysis) in Severe Liver Failure.

acronym: MARSPAD

summary:
A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove those substances. Albumin dialysis with recirculation (MARS) is the most used system but required specific system and expert environment. Alternative system without recirculation (SPAD) is less expensive and can be realised in critical care services trained to extrarenal epuration. The primary objective of this study is to compare biological and clinical efficacy, pulsatility index of middle cerebral artery modification and tolerance of both systems.

This is a prospective, open, cross-over comparative study of two albumin dialysis system. Each patient will receive the two systems in an randomly assessed order. Patients are divided up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and >400µmol/L).

location_facility: Hôpital de la Croix Rousse - Service de réanimation chirurgicale


type: Registry Identifier

title: Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery: Comparative Study, Randomized

acronym: EVECHE

summary:
The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor functions, languages and cognitive to better respect them. Indeed, the interindividual anatomo-functional variations, the lack of specificity of functional explorations radiological magnetic or nuclear, as well as the reorganization of the areas involved in these functions (mechanisms of brain plasticity) in epileptic patients or patients with cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an analysis and a precise real-time identification of areas and networks involved in these functions through a direct electrical stimulation (inhibitory or activatory). Thus, this surgical technique has become a gold standard in surgery of brain lesions located in functional areas.

However, although the brain awake surgery has been practiced since many years, the confidentiality of these informations until recent years explains probably that very little data to be available on the personal experience of this procedure by patients. Studies that have analyzed the perception of the patient or the satisfaction of the patient after surgery in awake conditions were retrospective and included few patients. The investigators experience of lived of this surgery that the investigators have developed in the investigators team since over four years is that on the whole awake surgery is well tolerated if adequate explanations are provided preoperatively and if a minimum of preoperative precautions are observed.

Thus, the investigators have decided to develop a preoperative device that could improve personal experience and well-being of patients undergoing this surgical approach.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes

acronym: ISOL/STAND

summary:
Application of isolation (=contact precautions) in hospitalized patients is recommended when patient is colonized (or infected) by micro-organism known for its outbreak capacity or high pathogenicity. It allows the reinforcement of universal precautions (=standard precautions) in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy of this measure is questioned and its impact on patient care seems deleterious.

In a particular context of Infectious Disease Unit, where standard precautions are handled (favorable architecture and appropriate practice for hand hygiene), assessment of contact precautions to reduce the incidence of acquired bacteria during hospitalization would be of interest.

The investigators design a non-inferiority comparative study to measure the colonization pressure in patients hospitalized in two different parts of the department: one unit only with standard precautions applied (intervention) and one unit with contact precautions (control) as current routine care.

lead_sponsor: Rennes University Hospital


title: Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

acronym: IRMf

summary: Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.

ReferenceCitation: Pickering G, Kastler A, Macian N, Pereira B, Valabregue R, Lehericy S, Boyer L, Dubray C, Jean B. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial. Drug Des Devel Ther. 2015 Jul 23;9:3853-62. doi: 10.2147/DDDT.S81004. eCollection 2015.

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

publisher_dissemination: Informa

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Dr. Gisèle PICKERING (MCU, PH)
Dr. Betty JEAN (PH)


title: Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC. GET-BETTER Study (Geriatric Environmental Telecare - Behavioral Engineering Technology To Enhance Rehabilitation)

acronym: GET-BETTER

summary: 2 URCC in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by ward's geriatrician and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed twice during the study, at admission in (inclusion visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as adverse events and will therefore be listed along the study and characterized in types and number.

lead_sponsor: University Hospital, Limoges


title: Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms

summary: This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).

lead_sponsor: W.L.Gore & Associates


title: Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma

summary:
Circadian rhythms, which play crucial roles in physiology, are emerging as important regulators of specific immune functions. Hospitalization in intensive care unit leads to a deep impairment of circadian rhythm. Infection is a frequent event during ICU hospitalization.

The investigators hypothesis is that in trauma patients the lack of circadian rhythm variations is associated with the occurrence of infection. The primary aim of the study is to assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related infection during the 30 days after inclusion. The secondary aims are to assess the plasma expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines in plasma, and the concentration of cortisol, according to the occurrence of an infection.

ReferenceCitation: Coiffard B, Diallo AB, Culver A, Antonini F, Hammad E, Leone M, Mege JL. Exacerbation of circadian rhythms of core body temperature and sepsis in trauma patients. J Crit Care. 2020 Dec;60:23-26. doi: 10.1016/j.jcrc.2020.07.010. Epub 2020 Jul 16.

evidence: open (author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement


title: Contributions From the Analysis of Graphs for Identification of Neural Cliques

acronym: BRAINGRAPH

summary: The aim of the study is to demonstrate that our semantic knowledge (elements of our long-term memory and the process we use them) respond to a graphic organisation and gather together following accurate patterns called cliques (neural networks).

ReferenceCitation: Mheich A, Dufor O, Yassine S, Kabbara A, Biraben A, Wendling F, Hassan M. HD-EEG for tracking sub-second brain dynamics during cognitive tasks. Sci Data. 2021 Jan 27;8(1):32. doi: 10.1038/s41597-021-00821-1.


title: Effect of Perioperative Factors on the Analgesia Nociception Index

acronym: ANIFACT

summary: The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However, many perioperative factors such as medications, position, maneuvers may influence the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid dosing has never been tested. Therefore, the aim of our study is to collect in a database all the perioperative factors and to study their influence on the ANI.


title: Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.

acronym: PUPIDOL

summary: The purpose is to study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone/buprenorphine in opiate-dependent patients following a substitution program.

time_perspective: Cross-Sectional

sponsor_collaborators:
University Hospital, Clermont-Ferrand
CSAPA ANPAA 63


title: Prospective, Randomized, Multi-center Trial Aiming to Determined the Impact of Changeovers of Norepinephrine on the Blood Pressure Stability With Patients in Shock in ICU.

acronym: CHIC

summary:
CHIC study's purpose is to compare the efficiency, in terms of blood pressure stability, of three changeovers of norepinephrine used routinely in ICU. The three techniques are:

Quick change
Double pumping
Smart infusion pumps

ReferenceCitation: Poiroux L, Le Roy C, Ramelet AS, Le Brazic M, Messager L, Gressent A, Alcourt Y, Haubertin C, Hamel JF, Piquilloud L, Mercat A. Minimising haemodynamic lability during changeover of syringes infusing norepinephrine in adult critical care patients: a multicentre randomised controlled trial. Br J Anaesth. 2020 Oct;125(4):622-628. doi: 10.1016/j.bja.2020.06.041. Epub 2020 Jul 29.

intervention_type: Procedure

appel_a_projets: PHRIP

region: Pays de la Loire

nom_etablissement: CHR ANGERS

type_etablissement: CH

acronyme: CHIC

titre: Impact de la méthode de relais de noradrénaline sur la stabilité de la pression artérielle chez le patients en état de choc en réanimation.

discipline_principale: projet non concerné par les plans de santé publique listés ci-dessus

nom_porteur: LE ROY

prenom_porteur: Cyril


title: Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study

acronym: STIMJEU

summary: The aim of this study is to evaluate the effect of repeated low-frequency Transcranial Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. Participants are pathological gamblers. A single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).


title: Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

summary: The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid

summary: The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.

acronym: KETADEP

summary: The objective of this study is to evaluate the effectiveness of ketamine (infusion of 0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major depression (MADRS score ≥ 20 ) to six weeks of treatment.


title: The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2

acronym: NIRS

summary: We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)

acronym: MOR-FO-SIA

summary:
Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms.

Without fully convincing model of the emergence and development of AIS, their multifactorial nature seems evident. Several pathophysiological theories involving the central nervous system have been proposed: the AIS would be associated with disturbances of proprioceptive or sensory perception, and/or with integration of this information. This would result in an abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the deformation.

The Main aim of this study is to find cortical and subcortical morphometric differences in the most common population of AIS (right thoracic AIS) compared to healthy adolescent control girls.

Secondary Objectives are to study the cerebral white matter of the same groups (fractional anisotropy in the main white matter tracts), and activation of sensorimotor neural networks (fMRI activation and functional brain connectivity).

Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and classification.

lead_sponsor: University Hospital, Tours


title: Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery, in Disease Prevention of the Cardiac and/or Lung Complications at the Patients at Risk.

acronym: CAPVNI

summary:
After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency and the hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and abdominal surgery services.

Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a decrease of ventilation work. According to these observations, the preventive NIV could reduce the incidence of appearance of the lung and/or cardiac complications at the patients to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect to obtain a benefit with this particular population. If we meet our goal (a significant difference in terms of morbi-mortality with the preventive NIV versus classical care), we expect the systematisation of this procedure to all cardiac surgery high risk patients.

lead_sponsor: University Hospital, Brest


title: Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers

summary:
Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal .

The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use.

The aim of this study is

verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.

It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator

Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks.

Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake).

Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months

Effective : 30 patients

ReferenceCitation: Kavuk I, Katsarava Z, Selekler M, Sayar K, Agelink MW, Limmroth V, Diener HC. Clinical features and therapy of medication overuse headache. Eur J Med Res. 2004 Dec 22;9(12):565-9.

ReferenceCitation: Lanteri-Minet M, Valade D, Geraud G, Chautard MH, Lucas C. Migraine and probable migraine--results of FRAMIG 3, a French nationwide survey carried out according to the 2004 IHS classification. Cephalalgia. 2005 Dec;25(12):1146-58. doi: 10.1111/j.1468-2982.2005.00977.x.

ReferenceCitation: Evers S, Marziniak M. Clinical features, pathophysiology, and treatment of medication-overuse headache. Lancet Neurol. 2010 Apr;9(4):391-401. doi: 10.1016/S1474-4422(10)70008-9.

lead_sponsor: Association pour la Recherche au Centre d'Urgence des Céphalées

location_facility: Centre d'Urgence des Céphalées, hôpital Lariboisière


title: Effects of Intranasal Oxytocin on Emotion Regulation to Stressful Interaction in Insecure Adolescents: a Study Protocol for a Double Blind Randomized Controlled Trial

acronym: ELOREA

summary: The purpose of this study is to determine the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with parents.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain

summary: The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response.

location_facility: CIC Clermont-Ferrand, CHU Clermont-Ferrand


title: Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)

acronym: RITCOLON

summary: Phase I/II, Open-labeled, Prospective, Multi-center study of a Pretargeted Radioimmunotherapy in metastatic colorectal cancer with ractionated injections of TF2 plus 90Y-IMP288 (RITCOLON).

lead_sponsor: Nantes University Hospital

appel_a_projets: PHRCK

nom_etablissement: CHU DE NANTES

acronyme: RITCOLON

titre: Etude de phase I/II de radioimmunothérapie préciblée du cancer colorectal métastatique avec la combinaison TF2-90-Yttrium-IMP288

discipline_principale: nuclear medicine

nom_porteur: TOUCHEFEU

prenom_porteur: Yann


acronym: TIPPS

summary: The purpose of the study is to assess skin blood flow after non-invasive local administration of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the fingers of healthy volunteers and patients with systemic sclerosis. The investigators also aim at assessing the systemic bioavailability and dermal diffusion of treprostinil iontophoresis.

ReferenceCitation: Blaise S, Roustit M, Millet C, Ribuot C, Boutonnat J, Cracowski JL. Cathodal iontophoresis of treprostinil and iloprost induces a sustained increase in cutaneous flux in rats. Br J Pharmacol. 2011 Feb;162(3):557-65. doi: 10.1111/j.1476-5381.2010.01045.x.

ReferenceCitation: Cracowski JL, Minson CT, Salvat-Melis M, Halliwill JR. Methodological issues in the assessment of skin microvascular endothelial function in humans. Trends Pharmacol Sci. 2006 Sep;27(9):503-8. doi: 10.1016/j.tips.2006.07.008. Epub 2006 Jul 31.

ReferenceCitation: Herrick AL. Vascular function in systemic sclerosis. Curr Opin Rheumatol. 2000 Nov;12(6):527-33. doi: 10.1097/00002281-200011000-00009.

ReferenceCitation: Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):619-58. doi: 10.1016/j.addr.2003.10.026.

ReferenceCitation: Murray AK, Moore TL, King TA, Herrick AL. Vasodilator iontophoresis a possible new therapy for digital ischaemia in systemic sclerosis? Rheumatology (Oxford). 2008 Jan;47(1):76-9. doi: 10.1093/rheumatology/kem314.

ReferenceCitation: Gaillard-Bigot F, Roustit M, Jourdil JF, Stanke-Labesque F, Cracowski JL. Vascular Effects of Treprostinil Cutaneous Iontophoresis on the Leg, Finger, and Foot. J Clin Pharmacol. 2017 Sep;57(9):1215-1220. doi: 10.1002/jcph.898. Epub 2017 Apr 7. No abstract available.

location_facility: CIC pharmacology - University Hopsital of Grenoble

title: Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers

source: euctr


title: Automatic Detection and Characterization of Residual Masses in Patients With Lymphomas Through Fusion of Whole-Body Diffusion-Weighted MRI on 3 Tesla and 18F-Fluorodeoxyglucose PET/CT

acronym: ADAMANTIUS

summary: The present study aims to further optimize a whole-body Diffusion-Weighted Magnetic Resonance Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and Positron Emission Tomography (PET), to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to Fluorodeoxyglucose-PET for the management of lymphoma patients.

lead_sponsor: The Lymphoma Academic Research Organisation


title: Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium, With a Limited Sampling Strategy for the Calculation of Glomerular Filtration Rate (GFR) and Validity Assessment Compared to the Renal Clearance of Inulin : DFGBay

acronym: DFGBay

summary:
Diagnosis of patients with renal insufficiency and recommendations for medical treatment of patients who suffer from chronic renal failure are based on the different stages of Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas are unreliable in many clinical situations (old people, obese patients…). Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers. Renal clearance of Inulin is the gold standard. However, using these methods is restricted to specialized services because it is long and expensive.

There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR. Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a tracer comes from its exclusive elimination by glomerular filtration.

Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every included patient during a hospital day care (First visit V1). For transplanted patients, plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less 48hours) during annual medical check-up of renal transplantation (Second visit V2).


title: Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation

summary: The low overall effectiveness of available smoking cessation treatment so far, indicate the need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a highly heterogeneous population. Identification of individual characteristics that predict success in smoking cessation is highly desirable to allow designing more specific strategies in order to enhance success in quitting tobacco.The main objective of this study is to assess whether the presence of certain neuropsychological deficits found before the initiation of smoking cessation is associated with a greater relapse rate.The secondary objectives concern how neuropsychological performance are involved in motivation and craving in the whole sample of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological factors associated with agood or poor prognosis for success and provived more specific and therefore more effective care.

ReferenceCitation: Flaudias V, Picot MC, Lopez-Castroman J, Llorca PM, Schmitt A, Perriot J, Georgescu V, Courtet P, Quantin X, Guillaume S. Executive Functions in Tobacco Dependence: Importance of Inhibitory Capacities. PLoS One. 2016 Mar 8;11(3):e0150940. doi: 10.1371/journal.pone.0150940. eCollection 2016.

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

publisher_dissemination: Public Library of Science

sponsor_collaborators:
University Hospital, Montpellier
University Hospital, Clermont-Ferrand


summary: The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.

lead_sponsor: Lionel Bouvet


title: Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.

acronym: MONILAG

summary: Continuous lactate and glucose blood levels

ReferenceCitation: Gouezel C, Lorne E, Bonnet V, Fradin S, Saplacan V, Gerard JL, Hanouz JL, Fellahi JL, Fischer MO; FHT (French Hemodynamic Team). Assessment of changes in lactate concentration with intravascular microdialysis during high-risk cardiac surgery using the trend interchangeability method. Br J Anaesth. 2017 Dec 1;119(6):1110-1117. doi: 10.1093/bja/aex338.

oa_host_type: publisher

lead_sponsor: University Hospital, Caen


title: LateR-Ac Study: Late Effects of Radiosurgery on Acromegaly Study

acronym: LateRAc

summary:
Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a highly precise stereotactic technique, that has been used as an effective treatment of acromegaly.

Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.

Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10 years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.

Expected results: We should be able to determine whether Gamma Knife radiosurgery is a long-term safe technique. This result might modify the management and follow-up of patients with acromegaly unsuccessfully treated by surgery.

lead_sponsor: Assistance Publique Hopitaux De Marseille

appel_a_projets: PHRCI

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

type_etablissement: CHUR

acronyme: LatER-Ac

titre: Late effects of radiosurgery on acromegaly study - LatER-Ac Study (effets tardifs de la radiochirugie dans l'acromégalie)

discipline_principale: endocrinologie, nutrition, diabète , obésité

nom_porteur: CASTINETTI

prenom_porteur: Frédéric


title: Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy

acronym: MAISAVEN

summary:
Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a very rapid increase in doses of venom extracts administered during the SIT in a day without systemic reaction of the patient which is not yet explained. The hypothesis is that this good tolerance is due to a rapid decrease in the response of mast cells and basophils to the allergen..

The main objective is to study basophil activation in response to the allergen during the first day of desensitization, measured by basophil activation test.

The initiation of desensitization follow a protocol of rapid growth rates. The basophil activation level in the course of desensitization will be analyzed by flow cytometry after in vitro stimulation by allergen.

Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the expression of different proteins in blood basophils will be studied by measuring their messenger RNAs


title: The North-West Inter Regional Female Cohort for Patients With Endometriosi

acronym: CIRENDO

summary:
All women managed for endometriosis are included and followed up through the CIRENDO database.

Information is obtained from surgical and histological records and from self-questionnaires completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER, FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient contact and follow-up are carried out by a clinical research technician. Postoperative follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7 years.

ReferenceCitation: Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3):e2014.00002. doi: 10.4293/JSLS.2014.00002.

evidence: open (via page says license)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: The Society of Laparoscopic and Robotic Surgeons

ReferenceCitation: Roman H, Auber M, Bourdel N, Martin C, Marpeau L, Puscasiu L. Postoperative recurrence and fertility after endometrioma ablation using plasma energy: retrospective assessment of a 3-year experience. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):573-82. doi: 10.1016/j.jmig.2013.02.016. Epub 2013 Jun 10.

ReferenceCitation: Roman H, Ness J, Suciu N, Bridoux V, Gourcerol G, Leroi AM, Tuech JJ, Ducrotte P, Savoye-Collet C, Savoye G. Are digestive symptoms in women presenting with pelvic endometriosis specific to lesion localizations? A preliminary prospective study. Hum Reprod. 2012 Dec;27(12):3440-9. doi: 10.1093/humrep/des322. Epub 2012 Sep 7.

ReferenceCitation: Rozsnyai F, Roman H, Resch B, Dugardin F, Berrocal J, Descargues G, Schmied R, Boukerrou M, Marpeau L; CIRENDO Study Group. Outcomes of surgical management of deep infiltrating endometriosis of the ureter and urinary bladder. JSLS. 2011 Oct-Dec;15(4):439-47. doi: 10.4293/108680811X13176785203798.

ReferenceCitation: Bridoux V, Roman H, Kianifard B, Vassilieff M, Marpeau L, Michot F, Tuech JJ. Combined transanal and laparoscopic approach for the treatment of deep endometriosis infiltrating the rectum. Hum Reprod. 2012 Feb;27(2):418-26. doi: 10.1093/humrep/der422. Epub 2011 Dec 8.

ReferenceCitation: Auber M, Bourdel N, Mokdad C, Martin C, Diguet A, Marpeau L, Roman H. Ultrasound ovarian assessments after endometrioma ablation using plasma energy. Fertil Steril. 2011 Jun 30;95(8):2621-4.e1. doi: 10.1016/j.fertnstert.2011.04.090. Epub 2011 May 31.

ReferenceCitation: Vassilieff M, Suaud O, Collet-Savoye C, Da Costa C, Marouteau-Pasquier N, Belhiba H, Tuech JJ, Marpeau L, Roman H. [Computed tomography-based virtual colonoscopy: an examination useful for the choice of the surgical management of colorectal endometriosis]. Gynecol Obstet Fertil. 2011 Jun;39(6):339-45. doi: 10.1016/j.gyobfe.2011.04.004. Epub 2011 May 18. French.

ReferenceCitation: Roman H, Pura I, Tarta O, Mokdad C, Auber M, Bourdel N, Marpeau L, Sabourin JC. Vaporization of ovarian endometrioma using plasma energy: histologic findings of a pilot study. Fertil Steril. 2011 Apr;95(5):1853-6.e1-4. doi: 10.1016/j.fertnstert.2010.11.038. Epub 2010 Dec 17.

ReferenceCitation: Badescu A, Roman H, Barsan I, Soldea V, Nastasia S, Aziz M, Puscasiu L, Stolnicu S. Patterns of Bowel Invisible Microscopic Endometriosis Reveal the Goal of Surgery: Removal of Visual Lesions Only. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):522-527.e9. doi: 10.1016/j.jmig.2017.10.026. Epub 2017 Oct 31.

ReferenceCitation: Darwish B, Stochino-Loi E, Pasquier G, Dugardin F, Defortescu G, Abo C, Roman H. Surgical Outcomes of Urinary Tract Deep Infiltrating Endometriosis. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):998-1006. doi: 10.1016/j.jmig.2017.06.005. Epub 2017 Jun 15.

ReferenceCitation: Roman H, Darwish B, Bridoux V, Chati R, Kermiche S, Coget J, Huet E, Tuech JJ. Functional outcomes after disc excision in deep endometriosis of the rectum using transanal staplers: a series of 111 consecutive patients. Fertil Steril. 2017 Apr;107(4):977-986.e2. doi: 10.1016/j.fertnstert.2016.12.030. Epub 2017 Jan 27.

ReferenceCitation: Roman H, Hennetier C, Darwish B, Badescu A, Csanyi M, Aziz M, Tuech JJ, Abo C. Bowel occult microscopic endometriosis in resection margins in deep colorectal endometriosis specimens has no impact on short-term postoperative outcomes. Fertil Steril. 2016 Feb;105(2):423-9.e7. doi: 10.1016/j.fertnstert.2015.09.030. Epub 2015 Oct 29.

sponsor_collaborators:
University Hospital, Rouen
University Hospital, Lille
University Hospital, Caen
Amiens University Hospital


title: Decoding of the Expression of Tumor Suppressor P2RX7 in Inflammatory and Malignant Colonic Mucosa

summary:
The inflammatory tumor micro-environment is a consequence and a driver of tumorogenesis. On one hand it promotes antitumor immune responses and on the other hand it favors development and progression of cancerous lesions.

Factors regulating the complex interplay between epithelial and immune cells are still poorly characterized. Extracellular ATP (eATP) acting on the purinergic P2X7 receptors (P2RX7) has recently emerged as a key signaling pathway in the immune response.

Recent data have revealed the crucial role of P2RX7-NLRP3-Caspase-1 for priming dendritic cells (DC) within the tumor microenvironment upon treatment with certain types of chemotherapy drugs. Despite this important discovery, no previous study has so far investigated the global in vivo effect of P2RX7 modulation in inflammation-induced carcinogenesis of mucosal tissues.

Our consortium, endowed by a long standing experience in the field of mucosal immunology, inflammation and signaling, already demonstrated that the P2RX7 is differentially expressed in the mucosa of patients with active and quiescent inflammatory bowel disease (IBD), where eATP is present at very high concentration, and that P2RX7 controls an amplification loop of the inflammatory response (Cesaro et al., 2010). Furthermore, we uncovered that P2RX7 controls homeostasis, survival and function of regulatory T cells (Hubert et al., 2010). In addition, our recent demonstration that P2RX7 deficiency lowered mucosal inflammation but unexpectedly enhanced tumor formation in vivo warrants additional efforts to explore the molecular and cellular mechanisms accounting for this effect and suggest that enhancing P2RX7 function may have an anti-tumor therapeutic effect.

These observations emphasize the tumor suppressor role of P2X7 receptor, warrant further investigation to better understand the molecular mechanisms responsible for this anti-tumor effect and suggest that enhancing the function of P2X7R could have a therapeutic effect significant antitumor.

Our main objectives is to explore the role of P2RX7 in healthy, inflammatory and cancerous colonic mucosa. For this we will map the expression of the protein P2RX7 and realize genotype of P2RX7 forms in inflammatory diseases and cancer of the colon.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Validation of a French Version of the PISQ-R: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse

summary: The main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.


title: Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract

acronym: TOQUAL

summary: This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.

lead_sponsor: Centre Francois Baclesse

intervention_type: Radiation


title: Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days

acronym: HANOX

summary: Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

ReferenceCitation: Peskine A, Cariou A, Hajage D, Deye N, Guerot E, Dres M, Sonneville R, Lafourcade A, Navarro V, Robert H, Azouvi P, Sharshar T, Bayen E, Luyt CE; Hanox Study Group. Long-Term Disabilities of Survivors of Out-of-Hospital Cardiac Arrest: The Hanox Study. Chest. 2021 Feb;159(2):699-711. doi: 10.1016/j.chest.2020.07.022. Epub 2020 Jul 20.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure.

acronym: PH-HF

summary: This study will better understand the post-capillary pulmonary hypertension in heart failure, to determine its prognostic role and to consider specific treatment of different forms of pulmonary hypertension in post-capillary pulmonary heart failure.

ReferenceCitation: Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, Dietz R, Gavazzi A, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, van Gilst WH, Widimsky J, Freemantle N, Eastaugh J, Mason J; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J. 2003 Mar;24(5):442-63. doi: 10.1016/s0195-668x(02)00823-0.

ReferenceCitation: Lainscak M, Cleland JG, Lenzen MJ, Follath F, Komajda M, Swedberg K. International variations in the treatment and co-morbidity of left ventricular systolic dysfunction: data from the EuroHeart Failure Survey. Eur J Heart Fail. 2007 Mar;9(3):292-9. doi: 10.1016/j.ejheart.2006.07.007. Epub 2006 Oct 4.

ReferenceCitation: Metra M, Ponikowski P, Dickstein K, McMurray JJ, Gavazzi A, Bergh CH, Fraser AG, Jaarsma T, Pitsis A, Mohacsi P, Bohm M, Anker S, Dargie H, Brutsaert D, Komajda M; Heart Failure Association of the European Society of Cardiology. Advanced chronic heart failure: A position statement from the Study Group on Advanced Heart Failure of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2007 Jun-Jul;9(6-7):684-94. doi: 10.1016/j.ejheart.2007.04.003. Epub 2007 May 3.

ReferenceCitation: Ghio S, Gavazzi A, Campana C, Inserra C, Klersy C, Sebastiani R, Arbustini E, Recusani F, Tavazzi L. Independent and additive prognostic value of right ventricular systolic function and pulmonary artery pressure in patients with chronic heart failure. J Am Coll Cardiol. 2001 Jan;37(1):183-8. doi: 10.1016/s0735-1097(00)01102-5.

ReferenceCitation: Kjaergaard J, Akkan D, Iversen KK, Kjoller E, Kober L, Torp-Pedersen C, Hassager C. Prognostic importance of pulmonary hypertension in patients with heart failure. Am J Cardiol. 2007 Apr 15;99(8):1146-50. doi: 10.1016/j.amjcard.2006.11.052. Epub 2007 Mar 8.

ReferenceCitation: Damy T, Viallet C, Lairez O, Deswarte G, Paulino A, Maison P, Vermes E, Gueret P, Adnot S, Dubois-Rande JL, Hittinger L. Comparison of four right ventricular systolic echocardiographic parameters to predict adverse outcomes in chronic heart failure. Eur J Heart Fail. 2009 Sep;11(9):818-24. doi: 10.1093/eurjhf/hfp111.

ReferenceCitation: Damy T, Goode KM, Kallvikbacka-Bennett A, Lewinter C, Hobkirk J, Nikitin NP, Dubois-Rande JL, Hittinger L, Clark AL, Cleland JG. Determinants and prognostic value of pulmonary arterial pressure in patients with chronic heart failure. Eur Heart J. 2010 Sep;31(18):2280-90. doi: 10.1093/eurheartj/ehq245. Epub 2010 Aug 5.

ReferenceCitation: Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J. 2009 Oct;30(20):2493-537. doi: 10.1093/eurheartj/ehp297. Epub 2009 Aug 27. No abstract available. Erratum In: Eur Heart J. 2011 Apr;32(8):926.

ReferenceCitation: Task Force for Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC); European Respiratory Society (ERS); International Society of Heart and Lung Transplantation (ISHLT); Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34(6):1219-63. doi: 10.1183/09031936.00139009. Epub 2009 Sep 12. No abstract available.

ReferenceCitation: Moraes DL, Colucci WS, Givertz MM. Secondary pulmonary hypertension in chronic heart failure: the role of the endothelium in pathophysiology and management. Circulation. 2000 Oct 3;102(14):1718-23. doi: 10.1161/01.cir.102.14.1718.

ReferenceCitation: Gehlbach BK, Geppert E. The pulmonary manifestations of left heart failure. Chest. 2004 Feb;125(2):669-82. doi: 10.1378/chest.125.2.669.

ReferenceCitation: Wharton J, Strange JW, Moller GM, Growcott EJ, Ren X, Franklyn AP, Phillips SC, Wilkins MR. Antiproliferative effects of phosphodiesterase type 5 inhibition in human pulmonary artery cells. Am J Respir Crit Care Med. 2005 Jul 1;172(1):105-13. doi: 10.1164/rccm.200411-1587OC. Epub 2005 Apr 7.

ReferenceCitation: Nagendran J, Archer SL, Soliman D, Gurtu V, Moudgil R, Haromy A, St Aubin C, Webster L, Rebeyka IM, Ross DB, Light PE, Dyck JR, Michelakis ED. Phosphodiesterase type 5 is highly expressed in the hypertrophied human right ventricle, and acute inhibition of phosphodiesterase type 5 improves contractility. Circulation. 2007 Jul 17;116(3):238-48. doi: 10.1161/CIRCULATIONAHA.106.655266. Epub 2007 Jul 2.

ReferenceCitation: Galie N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, Fleming T, Parpia T, Burgess G, Branzi A, Grimminger F, Kurzyna M, Simonneau G; Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) Study Group. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005 Nov 17;353(20):2148-57. doi: 10.1056/NEJMoa050010. Erratum In: N Engl J Med. 2006 Jun 1;354(22):2400-1.

ReferenceCitation: Lewis GD, Shah R, Shahzad K, Camuso JM, Pappagianopoulos PP, Hung J, Tawakol A, Gerszten RE, Systrom DM, Bloch KD, Semigran MJ. Sildenafil improves exercise capacity and quality of life in patients with systolic heart failure and secondary pulmonary hypertension. Circulation. 2007 Oct 2;116(14):1555-62. doi: 10.1161/CIRCULATIONAHA.107.716373. Epub 2007 Sep 4.

ReferenceCitation: Lewis GD, Lachmann J, Camuso J, Lepore JJ, Shin J, Martinovic ME, Systrom DM, Bloch KD, Semigran MJ. Sildenafil improves exercise hemodynamics and oxygen uptake in patients with systolic heart failure. Circulation. 2007 Jan 2;115(1):59-66. doi: 10.1161/CIRCULATIONAHA.106.626226. Epub 2006 Dec 18.

ReferenceCitation: Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available. Erratum In: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.

lead_sponsor: French Cardiology Society

sponsor_collaborators:
French Cardiology Society
CHRU Lille, Dr Nicolas LAMBLIN


title: Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients

acronym: SOCOG-MS

summary: In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Although recent behavioral studies indicated social disturbances in many of these patients, functional studies investigating specific theory of mind in MS are lacking. The use of new techniques for morphological and functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping the achievement and tissue integrity may be related to disorders of social cognition and cognitive. The investigators propose to study social cognition in MS patients using morphological and functional imaging to determine the mechanisms underlying phenomena such as cerebral compensation and its relationship with cognitive impairment.

lead_sponsor: University Hospital, Bordeaux

collaborators: La Ligue Française Contre la Sclérose en Plaques


title: Description and Evaluation of Eating Disorders in Elite Athletes

acronym: TCA SHN

summary:
Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. These eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described.

Our aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.


title: A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol in Healthy Volunteers

summary: This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.

lead_sponsor: Hoffmann-La Roche


title: Status of the Hypothalamic-pituitary-gonado- Adrenal Axis (HHSG) in Patients With Neuropathic Pain

acronym: HORMONES

summary: Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in maintaining homeostasis. The literature reports that pain in patients treated with opioids, significant changes are taking place in this axis with a collapse in hormone concentrations that are correlated with the decline on tests of quality of life and psychological testing. The investigators hypothesis is that this "endocrinopathy" could also be present in patients treated for neuropathic pain with other drug classes as opiates (antidepressants, antiepileptics), and may explain, at least in part, the impairement of the quality of life of these patients.

ReferenceCitation: Corriger A, Duclos M, Corcuff JB, Lambert C, Marceau G, Sapin V, Macian N, Roux D, Pereira B, Pickering G. Hormonal Status and Cognitivo-Emotional Profile in Real-Life Patients With Neuropathic Pain: A Case Control Study. Pain Pract. 2019 Sep;19(7):703-714. doi: 10.1111/papr.12800. Epub 2019 Jun 27.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effects of Curcumin Loading Dose on Vascular Reactivity of Healthy Middle-aged Smokers

acronym: CURCUMIN

summary: The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

ReferenceCitation: Barber-Chamoux N, Milenkovic D, Verny MA, Habauzit V, Pereira B, Lambert C, Richard D, Boby C, Mazur A, Lusson JR, Dubray C, Morand C. Substantial Variability Across Individuals in the Vascular and Nutrigenomic Response to an Acute Intake of Curcumin: A Randomized Controlled Trial. Mol Nutr Food Res. 2018 Mar;62(5). doi: 10.1002/mnfr.201700418. Epub 2018 Feb 12.

collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

collaborators: Association Régionale de Cardiologie d'Auvergne

collaborators: ARDEC Association de Recherche de Développement et d'Enseignement de la Cardiologie


title: Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study

summary: The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.

ReferenceCitation: Buzancais G, Roger C, Bastide S, Jeannes P, Lefrant JY, Muller L. Comparison of two ultrasound guided approaches for axillary vein catheterization: a randomized controlled non-inferiority trial. Br J Anaesth. 2016 Feb;116(2):215-22. doi: 10.1093/bja/aev458.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: SafEE : Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome

acronym: SafEE

summary:
All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance, training interface based on Kinect sensor...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Xylo-oligosaccharide (XOS) in Combination With Inulin Modulates Both the Intestinal Environment and Immune Status in Healthy Subjects, While XOS Alone Only Shows Prebiotic Properties

acronym: PIB

summary: The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.

lead_sponsor: Institut Pasteur de Lille

sponsor_collaborators:
Institut Pasteur de Lille
Institut Polytechnique LaSalle Beauvais


title: Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

acronym: VIDAZA-DLI

summary: Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion.


type: EudraCT Number

title: Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo

acronym: RopiMol

summary: The main objective of this study is to demonstrate the superiority of local analgesia with ropivacaine versus placebo on postoperative pain during the first 24 hours following bilateral surgery of all four third molars under general anesthesia.

ReferenceCitation: Ghezal H, Bouvet S, Kabani S, Ripart J, Cuvillon P. Ropivacaine versus placebo on postoperative analgesia and chronic pain following third molar extraction: A Prospective Randomized Controlled Study. J Stomatol Oral Maxillofac Surg. 2020 Apr;121(2):113-117. doi: 10.1016/j.jormas.2019.07.005. Epub 2019 Jul 18.


title: Is the Residual Gastric Volume After Sleeve Gastrectomy an Objective Criterion to Adapt the Treatment Strategy After Failure?

acronym: GASTROMANCH

summary:
Obesity is a worldwide health problematic whose incidence is increasing especially in developed countries. The surgical management of this illness consists in different techniques such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the residual gastric volume.

The aim of the present study was to determine whether the residual gastric volume is involved in Laparoscopic Sleeve Gastrectomy's failure.

ReferenceCitation: Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.

ReferenceCitation: Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.

ReferenceCitation: Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.

ReferenceCitation: Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.

ReferenceCitation: Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


acronym: FIBRECHO

summary:
The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. With these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. It would be particularly useful to have new generation techniques with a better diagnostic performance.

In this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.

lead_sponsor: University Hospital, Grenoble

collaborators: Clinical Investigation Centre for Innovative Technology Network