title: Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims

acronym: SUIVIPROCHE

summary: Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited

acronym: DGP-CeliacDis

summary:
Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small bowel mucosa, triggered by the ingestion of gluten-containing grains.

The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper endoscopy. Since 1990, the availability of serological tests has contributed to a different perception of the disease. Serological testing is now considered fundamental for celiac disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and anti-reticulin antibodies. Recently, several studies showed that deamidated products of gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced into the wide spectrum of serological tests for celiac disease.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: CHU de Reims

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Prevalence of Ophthalmological Abnormalities in Children and Adults Suffering From Hereditary Ichthyosis

summary: Presence/absence of subclinical keratoconus with corneal topographic abnormalities (skewed radial axes for forme fruste keratoconus, and inferior steepening for keratoconus suspect) on axial specular topography (TMS-4 Tomey), and elevation topographies: Pentacam (Oculus) and Orbscan (Bausch & Lomb).

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly

acronym: ANGIO SPIRUL

summary: The investigators hypothesize that spirulina-silicon supplementation will lead to an improvement in vasomotor endothelial function, followed by decreased arterial wave velocity on the aorta and central arterial pressure compared to placebo subjects.

status: Recruiting

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Dietary Supplement

status_simplified: Ongoing


title: Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography

acronym: NERVWATCH

summary: The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences

time_perspective: Prospective


title: Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery

acronym: SMART ANGEL 1

summary: This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient

ReferenceType: derived

ReferenceCitation: Chevallier T, Buzancais G, Occean BV, Rataboul P, Boisson C, Simon N, Lannelongue A, Chaniaud N, Gricourt Y, Lefrant JY, Cuvillon P. Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel™ app and an original web platform for patients following outpatient surgery: a prospective observational pilot study. BMC Anesthesiol. 2020 Oct 8;20(1):259. doi: 10.1186/s12871-020-01178-5.

family: Chevallier

full_name: Thierry Chevallier

given: Thierry

sequence: first

family: Buzancais

full_name: Gautier Buzancais

given: Gautier

sequence: additional

family: Occean

full_name: Bob-Valéry Occean

given: Bob-Valéry

family: Rataboul

full_name: Pierre Rataboul

given: Pierre

family: Boisson

full_name: Christophe Boisson

given: Christophe

family: Simon

full_name: Natacha Simon

given: Natacha

family: Lannelongue

full_name: Ariane Lannelongue

given: Ariane

family: Chaniaud

full_name: Noémie Chaniaud

given: Noémie

family: Gricourt

full_name: Yann Gricourt

given: Yann

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Anesthesiology

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

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

host_type: repository

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

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


title: Evaluation of Stress Sensitivity and Hyperemotivity in Temporal Lobe Epilepsy With Enlarged Amygdala Compared to Epilepsy Without Enlarged Amygdala (Temporal and Extra-temporal) and a Group of Healthy Volunteers: Pilot Study.

acronym: STELLA

summary: Recently, a possible subtype of temporal lobe epilepsy (TLE) has been proposed: this subtype presents ipsilateral amygdala enlargement (AE) without any other lesion. However, little is known about its clinical and psychiatric phenotype. The amygdala seems to play a major role in stress related disorders (including perception of stress). The hypothesis in this study is that patients with TLE-AE more frequently report emotional distress as a seizure-precipitating factor than any other epileptic patient.

primary_purpose: Other

ipd_sharing: No


title: Modification of Cortical Activation After Luminous Stimulation in Functional Magnetic Resonance Imaging (MRI) in Patients With Photophobia Related to Moderate to Acute Dry Eye Syndrome.

summary: Photophobia is a common and disabling symptom in patient with dry eye syndrome. The aim of this study is tried to better understand this complain analyzing brain activation during a luminous stimulation to highlight modification of cortical activation.

intervention_type: Radiation


title: Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

acronym: DYSDIA

summary: this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière

intervention_type: Device

lead_sponsor_type: industriel


title: Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years

acronym: DYSPHAGIE

summary: To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia

ReferenceType: background

ReferenceCitation: Fiori E, Lamazza A, Volpino P, Burza A, Paparelli C, Cavallaro G, Schillaci A, Cangemi V. Palliative management of malignant antro-pyloric strictures. Gastroenterostomy vs. endoscopic stenting. A randomized prospective trial. Anticancer Res. 2004 Jan-Feb;24(1):269-71.

ReferenceCitation: Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. Epub 2004 Aug 3.

ReferenceCitation: Jeurnink SM, Steyerberg EW, Hof Gv, van Eijck CH, Kuipers EJ, Siersema PD. Gastrojejunostomy versus stent placement in patients with malignant gastric outlet obstruction: a comparison in 95 patients. J Surg Oncol. 2007 Oct 1;96(5):389-96.

ReferenceCitation: ASGE guidelines enteral stents

lead_sponsor: Institut Paoli-Calmettes


title: Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study

acronym: ARISTOTE

summary:
Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter aortic valve replacement [TAVR]) in severe AS, as soon as symptoms or left ventricular (LV) dysfunction occur, in order to improve clinical outcome and achieve LV mass (LVM) regression. The highest amount of LVM regression is obtained during the first year. Nevertheless, there is heterogeneity in LV remodeling and residual LV hypertrophy is associated with poorer postoperative improvement in cardiac function and morphology. Incomplete regression of LV hypertrophy at 12 months after SAVR is a powerful predictor of adverse outcome. Yet, the use of specific pharmacological therapy to improve postoperative LVM regression could be an appealing therapeutic option after aortic valve intervention.

Renin-angiotensin-aldosterone system blockers (RAASb) and more particularly angiotensin-II receptor blockers (ARBs) are efficient in reducing LVM in hypertensive patients, as emphasized by several meta-analyses. In addition, ARBs improve myocardial relaxation, diastolic function, decreased hypertrophy and may have anti-fibrotic effects. In a recent retrospective study from our group, RAASb prescription after SAVR was associated with increased survival, but confirmation through a randomized trial is mandatory. In a prospective randomized single-center study, the use of candesartan was associated both with LV and LA remodeling as compared to the conventional management. Nevertheless, these results are based on echocardiographic data, which is not the gold standard for the assessment cardiac remodeling, and no placebo or active comparator was tested to control the impact of ARBs in these patients.

The primary objective of this Phase II study is to investigate the efficacy of valsartan, introduced postoperatively, as compared to placebo, on 1-year changes in indexed LVM, as assessed by CMR, in patients undergoing aortic valve intervention (SAVR or TAVR) for AS.

The secondary objectives are to compare the efficacy of valsartan vs. placebo in terms of one-year changes (difference from baseline) in cardiac function and in cardiac morphology, one-year exercise capacity and one-year changes in biomarkers related to cardiac function. In addition, the assessment of the safety of valsartan will also be considered as secondary objective.

The ARISTOTE trial is a multicenter prospective phase II, randomized, double-blind study including patients with the diagnosis of severe AS and indication for valve intervention.

The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist.

Patients will be randomized between 2 groups (valsartan versus placebo) and the treatment will be initiated (80 mg daily) at 5±4 days following aortic valve intervention. The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group.

The patients will be cautiously monitored and any adverse events will be collected. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study. The tolerance will be regularly assessed and dose adjusted according to a pre-specified algorithm.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Limoges

intervention_type: Drug


title: Effects of a Cocktail XXS-2A/Omega-3 on Insulin Sensitivity and Oxidative Stress During a 20-day Period of Physical Inactivity: a Controlled, Randomized Pilot Study on 20 Healthy Men

summary:
This experiment consists on a 20-day reduction in daily step in free-living active individuals to induce physical inactivity. This will be used to test the efficacy of the anti-oxidant cocktail we aim to test as a new countermeasure in 2016 during the 60-d bed rest planed by ESA/CNES.

The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the glucose intolerance and improve oxidative defenses induced by 20 days of physical inactivity through daily step reduction

Although physical inactivity is reported to affect glucose tolerance within days of inactivity, we selected a period of 20 days for the effect of the cocktail to take place and assess secondary molecular mechanisms. The effect of this short period of inactivity on metabolism will moreover be boosted during the last 10 days by taking fructose, a sugar found in abundance in fruits, honey and juices, which is known to quickly trigger metabolic deregulation.

primary_purpose: Basic Science

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ReferenceCitation: Blanc S, Normand S, Ritz P, Pachiaudi C, Vico L, Gharib C, Gauquelin-Koch G. Energy and water metabolism, body composition, and hormonal changes induced by 42 days of enforced inactivity and simulated weightlessness. J Clin Endocrinol Metab. 1998 Dec;83(12):4289-97.

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ReferenceCitation: Hokayem M, Blond E, Vidal H, Lambert K, Meugnier E, Feillet-Coudray C, Coudray C, Pesenti S, Luyton C, Lambert-Porcheron S, Sauvinet V, Fedou C, Brun JF, Rieusset J, Bisbal C, Sultan A, Mercier J, Goudable J, Dupuy AM, Cristol JP, Laville M, Avignon A. Grape polyphenols prevent fructose-induced oxidative stress and insulin resistance in first-degree relatives of type 2 diabetic patients. Diabetes Care. 2013 Jun;36(6):1454-61. doi: 10.2337/dc12-1652. Epub 2012 Dec 28.

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family: Vidal

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family: Lambert

full_name: K. Lambert

given: K.

family: Meugnier

full_name: E. Meugnier

family: Feillet-Coudray

full_name: C. Feillet-Coudray

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family: Coudray

full_name: C. Coudray

family: Pesenti

full_name: S. Pesenti

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family: Luyton

full_name: C. Luyton

family: Lambert-Porcheron

full_name: S. Lambert-Porcheron

family: Sauvinet

full_name: V. Sauvinet

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family: Fedou

full_name: C. Fedou

family: Brun

full_name: J.-F. Brun

family: Rieusset

full_name: J. Rieusset

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family: Bisbal

full_name: C. Bisbal

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given: A.

family: Mercier

full_name: J. Mercier

family: Goudable

full_name: J. Goudable

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

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

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

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

title: Grape Polyphenols Prevent Fructose-Induced Oxidative Stress and Insulin Resistance in First-Degree Relatives of Type 2 Diabetic Patients

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ReferenceCitation: Momken I, Stevens L, Bergouignan A, Desplanches D, Rudwill F, Chery I, Zahariev A, Zahn S, Stein TP, Sebedio JL, Pujos-Guillot E, Falempin M, Simon C, Coxam V, Andrianjafiniony T, Gauquelin-Koch G, Picquet F, Blanc S. Resveratrol prevents the wasting disorders of mechanical unloading by acting as a physical exercise mimetic in the rat. FASEB J. 2011 Oct;25(10):3646-60. doi: 10.1096/fj.10-177295. Epub 2011 Jun 29.

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ReferenceCitation: Rector RS, Thyfault JP, Laye MJ, Morris RT, Borengasser SJ, Uptergrove GM, Chakravarthy MV, Booth FW, Ibdah JA. Cessation of daily exercise dramatically alters precursors of hepatic steatosis in Otsuka Long-Evans Tokushima Fatty (OLETF) rats. J Physiol. 2008 Sep 1;586(17):4241-9. doi: 10.1113/jphysiol.2008.156745. Epub 2008 Jul 10.

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ReferenceCitation: Savage DB, Petersen KF, Shulman GI. Disordered lipid metabolism and the pathogenesis of insulin resistance. Physiol Rev. 2007 Apr;87(2):507-20. Review.

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ReferenceCitation: Sigaudo D, Fortrat JO, Allevard AM, Maillet A, Cottet-Emard JM, Vouillarmet A, Hughson RL, Gauquelin-Koch G, Gharib C. Changes in the sympathetic nervous system induced by 42 days of head-down bed rest. Am J Physiol. 1998 Jun;274(6):H1875-84. doi: 10.1152/ajpheart.1998.274.6.H1875.

ReferenceCitation: Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Dietary omega-3 fatty acid supplementation increases the rate of muscle protein synthesis in older adults: a randomized controlled trial. Am J Clin Nutr. 2011 Feb;93(2):402-12. doi: 10.3945/ajcn.110.005611. Epub 2010 Dec 15.

ReferenceCitation: Stein TP. Weight, muscle and bone loss during space flight: another perspective. Eur J Appl Physiol. 2013 Sep;113(9):2171-81. doi: 10.1007/s00421-012-2548-9. Epub 2012 Nov 29. Review.

ReferenceCitation: Stein TP, Leskiw MJ, Schluter MD, Hoyt RW, Lane HW, Gretebeck RE, LeBlanc AD. Energy expenditure and balance during spaceflight on the space shuttle. Am J Physiol. 1999 Jun;276(6 Pt 2):R1739-48.

ReferenceCitation: Stein TP, Blanc S. Does protein supplementation prevent muscle disuse atrophy and loss of strength? Crit Rev Food Sci Nutr. 2011 Oct-Nov;51(9):828-34. doi: 10.1080/10408398.2010.482679. Review. Erratum in: Crit Rev Food Sci Nutr. 2012;52(10):957.

ReferenceCitation: Stein TP, Schluter MD, Galante AT, Soteropoulos P, Ramirez M, Bigbee A, Grindeland RE, Wade CE. Effect of hind limb muscle unloading on liver metabolism of rats. J Nutr Biochem. 2005 Jan;16(1):9-16.

ReferenceCitation: Stein TP, Wade CE. Metabolic consequences of muscle disuse atrophy. J Nutr. 2005 Jul;135(7):1824S-1828S. Review.

ReferenceCitation: Stettler R, Ith M, Acheson KJ, Décombaz J, Boesch C, Tappy L, Binnert C. Interaction between dietary lipids and physical inactivity on insulin sensitivity and on intramyocellular lipids in healthy men. Diabetes Care. 2005 Jun;28(6):1404-9.

ReferenceCitation: Tappy L, Lê KA, Tran C, Paquot N. Fructose and metabolic diseases: new findings, new questions. Nutrition. 2010 Nov-Dec;26(11-12):1044-9. doi: 10.1016/j.nut.2010.02.014. Epub 2010 May 14. Review.

ReferenceCitation: Trudel G, Payne M, Mädler B, Ramachandran N, Lecompte M, Wade C, Biolo G, Blanc S, Hughson R, Bear L, Uhthoff HK. Bone marrow fat accumulation after 60 days of bed rest persisted 1 year after activities were resumed along with hemopoietic stimulation: the Women International Space Simulation for Exploration study. J Appl Physiol (1985). 2009 Aug;107(2):540-8. doi: 10.1152/japplphysiol.91530.2008. Epub 2009 May 28.

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ReferenceCitation: van der Zijl NJ, Goossens GH, Moors CC, van Raalte DH, Muskiet MH, Pouwels PJ, Blaak EE, Diamant M. Ectopic fat storage in the pancreas, liver, and abdominal fat depots: impact on β-cell function in individuals with impaired glucose metabolism. J Clin Endocrinol Metab. 2011 Feb;96(2):459-67. doi: 10.1210/jc.2010-1722. Epub 2010 Nov 17.

ReferenceCitation: Vitadello M, Germinario E, Ravara B, Libera LD, Danieli-Betto D, Gorza L. Curcumin counteracts loss of force and atrophy of hindlimb unloaded rat soleus by hampering neuronal nitric oxide synthase untethering from sarcolemma. J Physiol. 2014 Jun 15;592(12):2637-52. doi: 10.1113/jphysiol.2013.268672. Epub 2014 Apr 7.

ReferenceCitation: Zwart SR, Hargens AR, Smith SM. The ratio of animal protein intake to potassium intake is a predictor of bone resorption in space flight analogues and in ambulatory subjects. Am J Clin Nutr. 2004 Oct;80(4):1058-65.

ReferenceCitation: Zwart SR, Pierson D, Mehta S, Gonda S, Smith SM. Capacity of omega-3 fatty acids or eicosapentaenoic acid to counteract weightlessness-induced bone loss by inhibiting NF-kappaB activation: from cells to bed rest to astronauts. J Bone Miner Res. 2010 May;25(5):1049-57. doi: 10.1359/jbmr.091041.

ReferenceCitation: Damiot A, Demangel R, Noone J, Chery I, Zahariev A, Normand S, Brioche T, Crampes F, de Glisezinski I, Lefai E, Bareille MP, Chopard A, Drai J, Collin-Chavagnac D, Heer M, Gauquelin-Koch G, Prost M, Simon P, Py G, Blanc S, Simon C, Bergouignan A, O'Gorman DJ. A nutrient cocktail prevents lipid metabolism alterations induced by 20 days of daily steps reduction and fructose overfeeding: result from a randomized study. J Appl Physiol (1985). 2019 Jan 1;126(1):88-101. doi: 10.1152/japplphysiol.00018.2018. Epub 2018 Oct 4.

name: Université de Strasbourg, Centre national de la recherche scientifique, Institut pluridisciplinaire Hubert Curien UMR 7178, Strasbourg, France

name: Université de Montpellier, Institut National de la Recherche Agronomique, UMR866 34060, Dynamique Musculaire et Métabolisme, Montpellier, France

name: National Institute for Cellular Biotechnology and School of Health and Human Performance, Dublin City University, Dublin, Ireland

name: CARMEN, Centre de Recherche en Nutrition Humaine, Institut national de la santé et de la recherche médicale U1060/University of Lyon 1/INRA U1235 Lyon, France

name: Institut national de la santé et de la recherche médicale, UMR 1048, Obesity Research Laboratory, Institute of Metabolic and Cardiovascular Diseases, Toulouse, France

name: Paul Sabatier University, Toulouse, France

name: Institut national de la santé et de la recherche médicale, UMR1048, Obesity Research Laboratory, Institute of Metabolic and Cardiovascular Diseases and University of Toulouse, Paul Sabatier University and Toulouse University Hospitals, Departments of Clinical Biochemistry and Sports Medicine, Toulouse, France

name: Institut de Médecine et de Physiologie Spatiales, Toulouse, France

name: Laboratoire de Biochimie, Centre Hospitalier Lyon Sud, Pierre Bénite, France

name: Institute of Nutritional and Food Sciences, University of Bonn, Bonn, Germany

name: Centre National d’Etudes Spatiales, Paris, France

name: Laboratoire de recherches appliquées Spiral/Kirial International, Couternon, France

name: Anschutz Health and Wellness Center, Anschutz Medical Campus, Aurora, Colorado

name: Division of Endocrinology, Metabolism and Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, Colorado

name: 3U Diabetes Consortium, Dublin City University, Ireland

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

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

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

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

title: A nutrient cocktail prevents lipid metabolism alterations induced by 20 days of daily steps reduction and fructose overfeeding: result from a randomized study


title: Pharmacokinetic and Pharmacodynamic Modelling of Norepinephrine in Patients Under Target Controlled Infusions (TCI) for Anaesthesia : Plasma Concentration and "Site Effect"

acronym: NOR-PHARM

summary: Currently, administration of norepinephrine diluted at 5 µg/ml bolus or continuous infusion is common during sympatholysis hypotension of TCI following the elimination of hypovolemia or anesthetic overdosage. Continued intravenous administration must meet hemodynamic goals within a narrow time frame. Depending on the intensity of hypotension the dosage is variable. It is adjusted in real time while it is excessive or insufficient at times. Therefore, the development of modeling should predict the kinetic and hemodynamic effects based on dosage and individual.

ReferenceCitation: Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.

ReferenceCitation: Moerman AT, Vanbiervliet VM, Van Wesemael A, Bouchez SM, Wouters PF, De Hert SG. Assessment of Cerebral Autoregulation Patterns with Near-infrared Spectroscopy during Pharmacological-induced Pressure Changes. Anesthesiology. 2015 Aug;123(2):327-35. doi: 10.1097/ALN.0000000000000715.

location_facility: Service Anesthésie-Réanimation - Hôpital Lariboisière


type: EudraCT Number

title: Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting Programmed Cell Death 1 (PD-1)

summary:
Prospective, monocentric clinical study. Patients selected for nivolumab therapy in AP-HM for melanoma and non-small cell lung cancer will be eligible. Do not include patients with conditions that do not allow MRI, prior cardiovascular disease with LVEF<50%, cardiomyopathy, history of cardiac arrhythmia, history of cardiovascular toxicity under anticancer therapy, coronary artery disease or stroke less than 3 months Therapeutic management will not be modified and treatment will be administrated as usual.

Cardiovascular follow up will be identical to that recommended and realized in current care in the Cardio-Oncology unit of AP-HM. It will include clinical, biological (BNP and troponin) and trans-thoracic echocardiography (TTE) at baseline and then at 1, 3 and 6 months. Auto-antibodies against troponin I assay will be performed to avoid false negatives of normal blood level of troponin I at baseline and then at 6 months. Cardiac MRI will be performed as well at baseline and at the end of the study (6 months). MRI is the gold standard for ventricular function evaluation.

Primary endpoint will be left ventricular function evolution evaluated by global longitudinal strain (GLS, 2D speckles tracking) in TTE. Secondary endpoints will be left and right ventricular function parameters: LEVF by TTE and MRI, left ventricular indexed volumes by TTE and MRI, right ejection ventricular function and indexed volumes by TTE and MRI, systolic pulmonary arterial pressure by TTE, serum troponin I and BNP, arrhythmias and conduction disorders on the electrocardiogram (ECG).

Number of required subjects: GLS is recommended for following up left ventricular function under anticancer treatments. Based on the hypothesis of a significant GLS decrease (15%) in 20% of cases with alpha risk of 0.05 and accuracy of 0.12 which means expected confidence interval of 0.08-0.32, then the number of required subjects is 50 patients.

The inclusion period will be 18 months with a follow up if 6 months, ie a total duration of the study of 24 months.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma

acronym: IMMUQ

summary: The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Study of the Diaphragmatic Function by Transient Elastography : Comparison With Mechanical and Electrophysiological Variables

acronym: ELASTODIAPH

summary: The study of diaphragmatic function is usually measured by the pressures and volumes generated by contraction of the diaphragm, which is often difficult (cumbersome technique, difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically analyze the diaphragm compared to other accessory respiratory muscle groups). In this study, the investigators aimed at analysing diaphragmatic function by measuring the shortening, stiffness, strain and thickening of the diaphragm by ultrasound.


title: Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells

acronym: GAMAIT

summary:
Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. Corticosteroid therapy is the reference treatment for GCA. This treatment is highly effective but must be maintained for 12 to 24 months to avoid relapses, which causes the onset of numerous adverse effects in this elderly population.

Currently clinicians have no way to estimate this risk of relapse during the treatment of GCA.

Invariant T lymphocytes associated with the mucous membrane (MAIT), whose role in vasculitides has recently been shown and which produce IL-17 and IFN-γ, two key cytokines in the pathophysiology of GCA could be implicated in the pathophysiology of GCA and could constitute a predictive marker of relapse.

Our hypothesis is that blood MAIT are recruited in the artery wall in patients with GCA and that the number of circulating MAIT in the blood falls and then returns to normal if the corticoids are effective.

Given that it will be necessary to include a large number of patients to show that the persistence of a low number of circulating MAIT in patients treated with corticoids is a predictor of relapse, we propose, as the first step, to carry out a pilot study to obtain preliminary data on these new markers.

The study is classified as interventional because a lot of blood samples are taken

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


ReferenceCitation: Cameron E, Johnston G, Crofts S, Morton NS. The minimum effective dose of lignocaine to prevent injection pain due to propofol in children. Anaesthesia. 1992 Jul;47(7):604-6.

ReferenceCitation: Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110. Review.

ReferenceCitation: Nishimoto R, Kashio M, Tominaga M. Propofol-induced pain sensation involves multiple mechanisms in sensory neurons. Pflugers Arch. 2015 Sep;467(9):2011-20. doi: 10.1007/s00424-014-1620-1. Epub 2014 Oct 10.

ReferenceCitation: Depue K, Christopher NC, Raed M, Forbes ML, Besunder J, Reed MD. Efficacy of intravenous lidocaine to reduce pain and distress associated with propofol infusion in pediatric patients during procedural sedation. Pediatr Emerg Care. 2013 Jan;29(1):13-6. doi: 10.1097/PEC.0b013e31827b227e.

ReferenceCitation: Kuttner L. Pediatric hypnosis: pre-, peri-, and post-anesthesia. Paediatr Anaesth. 2012 Jun;22(6):573-7. doi: 10.1111/j.1460-9592.2012.03860.x. Review.

intervention_type: Procedure

acronym: PROPLIDHYPNO

location_facility: Hôpital des enfants - Pôle Anesthésie-Réanimation.

source: euctr

title: Pain Prevention During Propofol Infusion in Pediatric: Hypnoanalgesia of the Hand Versus Lidocaine.

summary:
The simplicity of the implementation and the effectiveness of hypno-analgesia (via the magic glove technique) has already been proven in some research work, during the installation of peripheral venous route. An unpublished preliminary study has shown that this method appears to be the most effective in preventing pain during pediatric propofol injection.

The purpose is to compare the effectiveness of hypno-analgesia of the hand by the "magic glove technique" to lidocaine used in an extemporaneous mixture in the prevention of pain with injection of propofol during intravenous induction in children aged 7 to 14 years


title: Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation

summary: Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.


title: Asthma, Smoking, Emotional Deficits

acronym: ASTADEM

summary: The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Pneumologie Hôpital de la Croix-Rousse


title: First Study Evaluating Efficiency and Safety of a Compressive Device to Prevent Keloid Scars Recurrence After Surgery

acronym: SCARWARS

summary: SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis

acronym: HYPOGRAFT

summary: The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.

status: Terminated


title: Pilot Study on the ADherence to Oral Antibiotics in Patients With BONE and Joint Infections (ADABONE)

acronym: OBSAIO

summary:
Bone and joint infection (BJI) are bacterial infections that can occur after surgery (nosocomial infections) or de novo. They constitute a public health problem in Western Countries . These infections are often difficult to treat, with a high rate of re-hospitalizations (19.5%) caused by relapses or recurrences. The treatment of Bone and joint infection can be surgical and / or pharmacological . Drug treatment is based on the use of parenteral and / or oral antibiotics. It is a curative therapy in most cases, with a prolonged duration ranging from 6 weeks to several months depending on the lesions .

Medication adherence, is a patients' behavior defined as drug intake with optimal attendance and regularity, as prescribed and explained by the physician. It is a key factor in the success of any drug therapy, as drugs don't work in patients who don't take them..

To the knowledge of investigators, there are no published data on the adherence to antibiotic therapy in patients treated for Bone and joint infection. In addition to its prolonged duration, the antibiotic treatment of the Osteoarticular Infections may require several daily drug intakes and may be responsible for severe adverse effects, these three factors being known to adversely affect adherence.

Prevalence, adherence patterns over time and determinants of adherence in this patient population are not known. Currently, drug adherence is not routinely evaluated and is not considered in the treatment of Bone and joint infection in the Regional Center for Complex Bone and joint infection of the investigators.

A specific study evaluating adherence to antibiotic therapy in patients treated for Bone and joint infection appears to be justified.

location_facility: Centre de référence des infections ostéo-articulaires de Lyon


title: Impact of the Reduction in Antihypertensive Treatment on Total Mortality in Frail Subjects With Low Systolic Blood Pressure: Randomized, Controlled Study in Subjects Over 80 Years Living in Nursing Homes

acronym: RETREAT-FRAIL

summary:
The investigators hypothesize that a gradual reduction in antihypertensive treatment in nursing home (NH) patients with low systolic blood pressure (SBP) can improve survival through a controlled increase in SBP and a decrease in secondary morbidity due to 'overmedication'.

Accordingly, the investigators propose a randomized, case/control trial in NH patients ≥ 80 years with a SBP<130 mmHg with >1 anti-Htn drugs. This trial will consist of two parallel arms: the intervention arm will entail antihypertensive drug step-down, while the control arm will comprise the standard anti-hypertensive treatment.


title: Toxicological Screening by GC-MS Among Children Admitted for a First Afebrile Seizure (CASTox): a Pilot Study

acronym: CASTox

summary:
Before the age of 14 years, 1% of the paediatric population will develop a seizure. The only systematically required complementary examination is an electroencephalogram (EEG). Additional biological or radiological examinations depend on the circumstances, the past medical history of the patient and other associated symptoms or clinical signs. A seizure can be the first sign of acute intoxication and represents a severity criterion. Failure to detect the toxic cause of a seizure can lead to a delay in the access or administration of an antidote if applicable. This can lead to target organ toxicity due to the absence of specific treatment. In the current French guidelines for a first seizure, a toxicological analysis is recommended if there is a possibility of exposure to toxic medications or products. However, this screening is often missing, unless a witness suggests that the child may have been exposed to a toxin.The recognition of a paediatric toxidrome is low among paediatricians, paediatric neurologists or emergency physicians. This is due to a lack of knowledge in clinical toxicology and the screening for toxic aetiology is not frequently or irrelevantly prescribed. There is an increasing number of proconvulsive molecules on the market. These molecules are not targeted in classic toxic screening. As result, a toxic cause of a seizure may be missed unless specific screening is performed. For all these reasons, little is known about the prevalence of toxic causes after a first episode of non-febrile seizure and probably under estimated in the paediatric population, especially in young children. New technologies for toxic detection like chromatography combined with mass spectrometry allow wide screening on different matrix. Initially dedicated to forensic analysis, they are more widely accessible for the exploration of the patients. The CASTox study is based on this context.

The first aim will be to evaluate the prevalence of a toxicological cause by a systematic blood and urine screening of children admitted to Toulouse paediatric emergency unit for a first afebrile seizure. Moreover, secondary aim will be to describe the effect of the systematic screening on the management of the children.

primary_purpose: Screening

ReferenceCitation: Bartoli M, Berny C, Danel V, Delahaye A, Desch G, Guitton J, Lacarelle B, Lapostolle F, Mathieu D, Mégarbane B, Nisse P, Szymanowicz A, Capolaghi B; Toxicology and Clinical Biology Working Group. [Recommendations for the prescription, implementation and interpretation of medical examinations in biology in the context of severe poisoning]. Ann Biol Clin (Paris). 2012 Jul-Aug;70(4):431-50. French.

ReferenceCitation: Hauser WA, Beghi E. First seizure definitions and worldwide incidence and mortality. Epilepsia. 2008;49 Suppl 1:8-12. doi: 10.1111/j.1528-1167.2008.01443.x. Review.

ReferenceCitation: Chelse AB, Kelley K, Hageman JR, Koh S. Initial evaluation and management of a first seizure in children. Pediatr Ann. 2013 Dec;42(12):244-8. doi: 10.3928/00904481-20131122-08. Review.

ReferenceCitation: Finkelstein Y, Hutson JR, Freedman SB, Wax P, Brent J; Toxicology Investigators Consortium (ToxIC) Case Registry. Drug-induced seizures in children and adolescents presenting for emergency care: current and emerging trends. Clin Toxicol (Phila). 2013 Sep-Oct;51(8):761-6. doi: 10.3109/15563650.2013.829233. Epub 2013 Aug 19.

ReferenceCitation: Thundiyil JG, Kearney TE, Olson KR. Evolving epidemiology of drug-induced seizures reported to a Poison Control Center System. J Med Toxicol. 2007 Mar;3(1):15-9.

ReferenceCitation: Reichert C, Reichert P, Monnet-Tschudi F, Kupferschmidt H, Ceschi A, Rauber-Lüthy C. Seizures after single-agent overdose with pharmaceutical drugs: analysis of cases reported to a poison center. Clin Toxicol (Phila). 2014 Jul;52(6):629-34. doi: 10.3109/15563650.2014.918627. Epub 2014 May 20.

ReferenceCitation: Thundiyil JG, Rowley F, Papa L, Olson KR, Kearney TE. Risk factors for complications of drug-induced seizures. J Med Toxicol. 2011 Mar;7(1):16-23. doi: 10.1007/s13181-010-0096-4.

ReferenceCitation: Citak A, Soysal DD, Uçsel R, Karaböcüoglu M, Uzel N. Seizures associated with poisoning in children: tricyclic antidepressant intoxication. Pediatr Int. 2006 Dec;48(6):582-5.

ReferenceCitation: Sharma AN, Hoffman RJ. Toxin-related seizures. Emerg Med Clin North Am. 2011 Feb;29(1):125-39. doi: 10.1016/j.emc.2010.08.011.

ReferenceCitation: Chen HY, Albertson TE, Olson KR. Treatment of drug-induced seizures. Br J Clin Pharmacol. 2016 Mar;81(3):412-9. doi: 10.1111/bcp.12720. Epub 2015 Sep 17. Review.

ReferenceCitation: Cerminara C, El-Malhany N, Roberto D, Lo Castro A, Curatolo P. Seizures induced by desloratadine, a second-generation antihistamine: clinical observations. Neuropediatrics. 2013 Aug;44(4):222-4. doi: 10.1055/s-0033-1333871. Epub 2013 Mar 1.


type: Other Grant/Funding Number

title: Combined Use of a Respiratory Broad Panel MULTIplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia: a Multicentre, Parallel-group, Open-label, Randomized Controlled Trial.

acronym: MULTI-CAP

summary:
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin (intervention) in severe CAP, as compared to a conventional strategy (control).

A multicentre, parallel-group, open-label, randomized controlled trial. The primary assessment criterion est the number of antibiotic-free days at 28 days

ReferenceCitation: Voiriot G, Fartoukh M, Durand-Zaleski I, Berard L, Rousseau A, Armand-Lefevre L, Verdet C, Argaud L, Klouche K, Megarbane B, Patrier J, Richard JC, Reignier J, Schwebel C, Souweine B, Tandjaoui-Lambiotte Y, Simon T, Timsit JF; MULTI-CAP study group. Combined use of a broad-panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group, open-label, individual randomised trial conducted in French intensive care units. BMJ Open. 2021 Aug 18;11(8):e048187. doi: 10.1136/bmjopen-2020-048187.

ReferenceCitation: Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713. Review.

family: Kerneis

full_name: Solen Kerneis

given: Solen

family: Visseaux

full_name: Benoit Visseaux

given: Benoit

family: Armand-Lefevre

full_name: Laurence Armand-Lefevre

given: Laurence

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

journal_name: Current Opinion in Infectious Diseases

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: Fertility Study of Women With Chronic Inflammatory Rheumatism

acronym: FERTIRHUM

summary:
Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Thus they are likely to affect female fertility through several mechanisms, including autoimmune since the association between immunity and fertility has already been demonstrated in other autoimmune diseases.

This study wants to evaluate and compare the birth rate between CIR and control group.


title: HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass

acronym: IMMUNOPED

summary:
The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss.

We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass

lead_sponsor: Nantes University Hospital


title: Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance

summary: Complex regional pain syndrome (CRPS) is a disease provoking chronic pain in the limbs, following a trauma. Patient care is complicated by the variable clinical picture and response to treatment. The stress level of the organization, for chronic pain impacts the regulation of the autonomic balance. The study of time and frequency domain analysis of Heart Rate Variability (HRV) allows non-invasive and reproducible assessment of the autonomic balance.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Reproductibility of Cystometry in Multiple Sclerosis Patient

summary: This study evaluates the reproductibility (quantitative and qualitative) of cystometry in mutiple sclerosis patients.

lead_sponsor: Pierre and Marie Curie University


title: Analysis of Immune Checkpoint Receptors Expression in the LIC Fraction pf AML Cells - ICAML-LIC

acronym: ICAML-LIC

summary: This project aim at deciphering immune mechanisms that allow the immunoescape of AML initiating cells.

lead_sponsor: University Hospital, Bordeaux


title: Stress Urinary Incontinence in Teenage Girls Practicing Sports

acronym: INCREASE

summary:
Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular practice. However, depending on the discipline and level of practice, it may be responsible for traumatic injuries, degenerative musculoskeletal injuries, overtraining, eating disorders or cardiovascular events. It also promotes urinary stress incontinence, by increasing intra-abdominal pressure in some situations.

The prevalence of urinary leakage in the athlete depends of the practiced physical activity. A classification of the sports activities can be carried out according to the risk of increased pressures on the pelvic floor:

high-risk sports: trampoline (10.17), acrobatic gymnastics, aerobics, athletics (jumping hedges, heights, triple jump), horse riding, basketball, volleyball, handball, martial arts;
moderate-risk sports: tennis, skiing ...
low risk sports: walking, swimming, cycling, rollerblading, golf ... In sports, urinary incontinence also depends of the practiced movements (jumps, abdominal exercises ...), and the occurence of sports activity. This disorder has even become one of the concerns of federal sports authority (INSEP).

However, there is no data regarding stress incontinence of sports teenagers found n the literature on

lead_sponsor: University Hospital, Brest


type: Registry Identifier

title: Construction and External Validation of a Predictive Clinico-biological Score of the Risk of Venous Thrombosis in Women Under Combined Oral Contraceptives

acronym: PILGRIM

summary:
the investigators hypothesize that some of these polymorphisms contribute to VTE risk in women using COC, and that their screening could to help assess individual risk of VTE before COC prescription.

In order to test this hypothesis the investigators propose to build a predictive score for VTE in women using COC based on clinical and biological factors. To this end the investigators have a large case study (including 766 patients) recruited at the "Centre d'Exploration des Pathologies Hémorragiques et Thrombotiques" (CEHT) of the laboratory of Hematology (La Timone Hospital, Marseille) between 2003 and 2013. The cases had a personal history of documented VTE while using COC (PILGRIM study). A great number of clinical and biological relevant phenotypes in the field of VTE have already been collected (including 14 polymorphisms selected on the basis of their biological plausibility and the existence association studies).To our knowledge it is the largest study specifically conducted in order to assess genetic factors associated with VTE in women using COC. These 766 cases will be compared to 766 controls from the general population (cohort Nutrinet-Santé). Then, the predictive values of the score will be assessed in an independent multicentric validation study that the investigators will set up in the field of this project. Our study should allow a better understanding of the genetic and environmental factors involved in VTE related to COC use. Besides, this project aims to respond to a major public health issue giving an effective tool for the decision of prescribing COC.


title: Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)

acronym: DOSAGE

summary: The DOSAGE Study is a qualitative transversal study aiming to describe and understand the subjective factors of polymedication in the elderly population (75 years old and more), defined as 10 simultaneous drugs. Semi-structured interviews will be conducted with patients, relatives and general practitioners in one French region. 20 situations will be included. After analysing the data of the individual interviews, focus groups will be conducted with health professionals.

time_perspective: Cross-Sectional


title: Multiple Breath Nitrogen Washout in Healthy Volunteers

acronym: HV-LCI

summary: This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)


title: Allocation of Physician Time in Anesthesiology Practice

summary:
The evolution of the health care system in Western countries has increased the scope of the tasks assigned to doctors in their daily lives. The burden of administrative tasks and the use of IT tools reduce the time spent with the patient. Indeed, in a very recent work published in the Annals of Internal Medicine, Sinsky et al. showed that in 4 different specialties (general medicine, internal medicine, cardiology and orthopaedics) for every hour spent in front of a patient, each physician spent two hours on tasks in the absence of the patient1. This distribution of time was found in the Wenger et al. study in 36 internal medicine interns, since a ratio of 1:3 between the working time spent in the presence of the patient (1.7 hours) and that spent in front of a computer (5.2 hours) was noted2.

The reduction in the clinical time devoted directly to the patient is a major source of dissatisfaction for physicians, which can even extend to burnout3. Moreover, it has been shown that the importance of computer tasks in everyday life is correlated with the occurrence of burnout4. Finally, beyond these clinical times directly or indirectly linked to patient care, the time spent on other tasks (administrative, travel time between different sites,...) appears to be significant (20% in Sinsky et al.)1.

The anesthesiologist faces the same constraints as other specialties, but no work has been specifically concerned with the distribution of time spent on the different tasks. Compared to other specialties, anesthesiologist is also regularly confronted with specific organisational tasks within the operating room that could reduce the time spent directly with patients.

The objective of this work is to determine the division of the different tasks in a anesthesiologist's work day by analysing the time spent directly with the patient but also that allocated to his or her care outside of his or her presence, as well as that devoted to organizational or administrative tasks.

lead_sponsor: University Hospital, Rouen


title: PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics

acronym: PREVATHLE

summary: The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred at least one injury during a season. The prevention of Athletics injuries thus represents a major challenge for all stakeholders around athletes. In team sports, injury prevention programs have been implemented and scientifically validated. However, no injury prevention programs have been implemented and scientifically validated for Athletics. In this context, a primary objective will be to analyze the effectiveness of an Athletics Injury Prevention Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one injury complaint related to athletic practice at long term (40 weeks). A statistician will carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP), multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs and followed during an athletic season.

ReferenceCitation: Edouard P, Steffen K, Peuriere M, Gardet P, Navarro L, Blanco D. Effect of an Unsupervised Exercises-Based Athletics Injury Prevention Programme on Injury Complaints Leading to Participation Restriction in Athletics: A Cluster-Randomised Controlled Trial. Int J Environ Res Public Health. 2021 Oct 28;18(21). pii: 11334. doi: 10.3390/ijerph182111334.

family: Edouard

full_name: Pascal Edouard

given: Pascal

family: Steffen

full_name: Kathrin Steffen

given: Kathrin

family: Peuriere

full_name: Marie Peuriere

given: Marie

family: Gardet

full_name: Pierre Gardet

given: Pierre

family: Navarro

full_name: Laurent Navarro

given: Laurent

family: Blanco

full_name: David Blanco

given: David

currency_apc_doaj: CHF

journal_name: International Journal of Environmental Research and Public Health

oa_host_type: publisher

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI


title: CIPTEx : Collection of Information by Tocography External

acronym: CIPTEx

summary:
The purpose of this trial is to create a comparative database, with data obtained with a new monitoring device of pregnant women,Toconaute, and two standard : a clinical cardiotocograph,and an electrophysiological signal medical device. It will allow to optimize the development of this new device.

The use of the Toconaute and/or the electrophysiological medical device will succeed to the usual monitoring of pregnant women with a cardiotocograph. It will not change their medical care.

The trial will include up to 35 pregnant women between 24 and 41 weeks of amenorrhea that requires discontinuous monitoring. It will last about 12 months, with an estimated inclusion period of 11 month.

lead_sponsor: BioSerenity


title: Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease

acronym: CHALNA

summary:
Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis (Non Alcoholic Steato-Hepatitis, NASH) and steatofibrosis leading to cirrhosis and hepatocellular carcinoma. NAFLD is one of the main causes of cirrhosis and increases the risk of liver-related death and hepatocellular carcinoma (developed in patients with or without cirrhosis). Despite this major public health concern, apart from lifestyle changes, treatment of NAFLD is still elusive as there is lack of efficacious pharmacological treatment. Alcoholic liver diseases are also frequent in Western countries. Alcoholic liver diseases and NAFLD share common pathological lesions and molecular pathways. This is illustrated by the emerging role of abnormalities of the microbiota (dysbiosis) in these 2 diseases leading to the concept of " liver-gut axis ". Whereas the molecular mechanisms responsible for the progression from a "safety" state to NASH or to a severe alcoholic steato-hepatitis are still unclear, hepatic inflammation is a key factor involved in the progression of NAFLD and alcoholic liver disease.

The hypothesis is that cellular and molecular abnormalities and gut dysbiosis could be present in patients with simple steatosis or with steato-hepatitis and could be responsible for the occurrence of hepatocellular carcinoma particularly without cirrhosis.

The main objective is to compare cellular and inflammatory pathways in liver with and without hepatocellular carcinoma in patients with alcoholic or non-alcoholic fatty liver diseases.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing

acronym: Suprasorb®C

summary: Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing

lead_sponsor: Lohmann & Rauscher


title: Comparison of the 20-gauge Procore® and 22-gauge Acquire® Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.

acronym: Mousquetaires

summary: This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.

lead_sponsor: Société Française d'Endoscopie Digestive


title: Transversal Study of Correlations Between Pain Catastrophizing Scale (PCS) and RAPID3 Score According to Ten Categories of Conditions Seen in an Outpatient Rheumatology Clinic

summary: Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including RAPID3 and pain catastrophizing scales.


title: Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management

summary: The aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. Half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a non-directive talking group. The educational intervention should give better results on patient emotional skills and quality of life than the control group.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Lille

intervention_type: Behavioral


title: Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

summary: Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

status: Active, not recruiting

lead_sponsor: Beaver-Visitec International, Inc.

location_facility: Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis


title: Multicenter Cohort Study on Duchenne Muscular Dystrophy Cardiomyopathy

acronym: DMD-HS

summary:
Retrospective cohort study including patients with genetically proven Duchenne muscular dystrophy, diagnosed from January 1993 to March 2020.

Inclusion of the data relative to genetic diagnosis, clinical characteristics at baseline, cardiac and respiratory workup, medical treatments (ACE inhibitors, steroids), surgical procedures, and occurrence during follow-up of cardiac, respiratory and fatal events.

Objectives are to describe long-term natural history of the disease, vital prognosis, genotype-phenotype correlations, effect of treatments.

ReferenceCitation: Porcher R, Desguerre I, Amthor H, Chabrol B, Audic F, Rivier F, Isapof A, Tiffreau V, Campana-Salort E, Leturcq F, Tuffery-Giraud S, Ben Yaou R, Annane D, Amédro P, Barnerias C, Bécane HM, Béhin A, Bonnet D, Bassez G, Cossée M, de La Villéon G, Delcourte C, Fayssoil A, Fontaine B, Godart F, Guillaumont S, Jaillette E, Laforêt P, Leonard-Louis S, Lofaso F, Mayer M, Morales RJ, Meune C, Orlikowski D, Ovaert C, Prigent H, Saadi M, Sochala M, Tard C, Vaksmann G, Walther-Louvier U, Eymard B, Stojkovic T, Ravaud P, Duboc D, Wahbi K. Association between prophylactic angiotensin-converting enzyme inhibitors and overall survival in Duchenne muscular dystrophy-analysis of registry data. Eur Heart J. 2021 May 21;42(20):1976-1984. doi: 10.1093/eurheartj/ehab054.

name: Université de Paris, CRESS UMR1153, INSERM, INRA, F-75004, Paris, France; Centre d'Epidémiologie Clinique, AP-HP, Hôtel-Dieu, F-75004 Paris, France

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

name: AP-HP, Centre de Référence des Maladies Neuromusculaires Nord/Est/Ile de France, Service de Neurologie Pédiatrique, Hôpital Necker, GH Necker-Enfants Malades, Paris, France

family: Desguerre

full_name: Isabelle Desguerre

given: Isabelle

name: Versailles Saint-Quentin-en-Yvelines University, INSERM U1179, LIA BAHN CSM, Montigny-le-Bretonneux, 78180, Neuromuscular Reference Centre, Paediatric Department, University Hospital Raymond Poincaré, Garches, 92380, France

family: Amthor

full_name: Helge Amthor

given: Helge

name: Hôpital Timone Enfants, Marseille, France

family: Chabrol

full_name: Brigitte Chabrol

given: Brigitte

name: Centre de Référence des Maladies Neuromusculaires Nord/Est/Ile de France, Service de Neuropédiatrie, Hôpital Roger Salengro, CHRU Lille, Lille, France

family: Audic

full_name: Frédérique Audic

given: Frédérique

name: Department of Paediatric Neurology & Reference Centre for Neuromuscular Diseases AOC, CHU Montpellier, France

name: PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France

family: Rivier

full_name: François Rivier

given: François

name: Centre de Référence des Maladies Neuromusculaires Nord/Est/Ile de France, Service de Neuropédiatrie, Hôpital Trousseau, Paris, France

family: Isapof

full_name: Arnaud Isapof

given: Arnaud

name: Physical and Rehabilitation Medicine Unit, University Hospital, Lille, France, URePSSS (Pluridisciplinary Research Unit: Sports, Health, Society) EA, 7369, Lille University

family: Tiffreau

full_name: Vincent Tiffreau

given: Vincent

name: APHM, Department of Neurology, Neuromuscular and ALS Reference Centre, La Timone University Hospital, Marseille, FranceAix Marseille Université, INSERM, GMGF, Marseille, France

family: Campana-Salort

full_name: Emmanuelle Campana-Salort

given: Emmanuelle

name: Laboratoire de Biochimie et Génétique Moléculaire, Hôpital Cochin et Institut de Myologie, Groupe Hospitalier La Pitié Salpétrière, APHP, France

family: Leturcq

full_name: France Leturcq

given: France

name: Laboratory of Genetics of Rare Diseases (LGMR), University of Montpellier, Montpellier, France

family: Tuffery-Giraud

full_name: Sylvie Tuffery-Giraud

given: Sylvie

name: Sorbonne Universités, INSERM UMRS 974, CNRS, UMR-7215, Centre for Research in Myology, Institut de Myologie, Pitié-Salpêtrière University Hospital, Paris, France

name: APHP, Centre de Référence de Pathologie Neuromusculaire Paris-Est, FILNEMUS, Myology Institute, Neurology Department, Pitié-Salpêtrière Hospital, Paris, France

family: Ben Yaou

full_name: Rabah Ben Yaou

given: Rabah

name: General Intensive Care Unit, Raymond Poincaré Hospital (AP-HP), Lab Inflammation & Infection, U1173 University Paris Saclay-UVSQ/INSERM, Garches, France

family: Annane

full_name: Djillali Annane

given: Djillali

name: Paediatric Cardiology, CHU Montpellier, France

family: Amédro

full_name: Pascal Amédro

family: Barnerias

full_name: Christine Barnerias

given: Christine

family: Bécane

full_name: Henri Marc Bécane

given: Henri Marc

family: Béhin

full_name: Anthony Béhin

given: Anthony

name: AP-HP, Unité Médico-Chirurgicale de Cardiologie Congénitale et Pédiatrique, Centre de Référence des Malformations Cardiaques Congénitales Complexes-M3C, Hôpital Necker Enfants Malades, Université Paris Descartes, Sorbonne Paris-Cité, Paris, France

family: Bonnet

full_name: Damien Bonnet

given: Damien

family: Bassez

full_name: Guillaume Bassez

given: Guillaume

family: Cossée

full_name: Mireille Cossée

given: Mireille

family: de La Villéon

full_name: Grégoire de La Villéon

given: Grégoire

name: Critical Care Centre, University Hospital of Lille, Lille Cedex, France

family: Delcourte

full_name: Claire Delcourte

given: Claire

name: APHP, Hôpital Raymond Poincaré, Centre de Référence des Maladies Neuromusculaires Nord-Est-Île de France, Garches, France

family: Fayssoil

full_name: Abdallah Fayssoil

given: Abdallah

name: Department of Neurology & Reference Centre for Neuromuscular Diseases AOC, CHU Montpellier, France

name: Pediatric Cardiology Department, Lille University Hospital, University Nord de France, Lille, France

name: Intensive Care Unit, CHU de Lille, Lille, France

name: Service d'Explorations Fonctionnelles, Hôpital Raymond Poincaré, Garches, FranceINSERM Université de Versailles Saint Quentin en Yvelines, France

name: APHP, Department of Cardiology, Bobigny Hospital, Paris, XIII University, INSERM UMR S-942, Paris, France

name: Réanimation Adultes, APHP, Hôpitaux Universitaires Paris Ile de France Ouest, site R. Poincaré, Garches, France; CIC1429 INSERM AP-HP, Hôpitaux Universitaires Paris Ile de France Ouest, site R. Poincaré, Garches, France

name: Pediatric and Congenital Cardiology, M3C Regional Reference CHD Centre, University Hospital, Marseille Medical Genetics, INSERM UMR 1251, Aix Marseille University, Marseille, France

name: Réanimation adultes, APHP, Hôpitaux Universitaires Paris Ile de France Ouest, site R. Poincaré, Garches, France

name: APHP, Cochin Hospital, Cardiology Department, FILNEMUS, Paris-Descartes, Sorbonne Paris Cité University, Paris, France

name: Unité de Cardiologie Congénitale, Hôpital Privé de La Louvière, Lille, France

name: INSERM Unit 970, Paris Cardiovascular Research Centre (PARCC), Paris, France

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

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

title: Association between prophylactic angiotensin-converting enzyme inhibitors and overall survival in Duchenne muscular dystrophy—analysis of registry data

location_facility: Cochin Reference Center for Neuromuscular Diseases


title: ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE - POSTULATE PRIOR TO HUMAN VACCINAL TRIALS Immune Response of Asymptomatic Carriers to L. Infantum

acronym: Asymptoleish

summary:
Leishmaniasis is considered by the WHO as emerging and uncontrolled diseases. They are the second leading cause of death and the fourth leading cause of morbidity in tropical diseases. Leishmaniasis is parasitic reticulo-endotheliosis, the pathogenic agent of which is a flagellated protozoan belonging to the genus Leishmania. It is estimated that there are about 2 million new cases per year. Effective treatments against visceral leishmaniasis are few and resistance problems appear. To date, only a canine vaccine is available protecting dogs from the development of canine leishmaniasis to L. infantum. In man, in parallel clinical cases, leishmaniasis is characterized by a large number of asymptomatic carriers. This is the case in the Alpes-Maritimes where 50% of the inhabitants of the hinterland of Nice are carriers of the parasite.

the investigators wish to study the protective immune response to the parasite and more particularly to the asymptomatic carriers. Indeed, these patients were infected with the parasite and did not develop the disease. Understanding the protective immune response in these patients against the parasite is therefore paramount in the development of a human leishmaniasis vaccine.

For this purpose, the investigator wants to make an ex vivo study of the immune response of lymphocytes coming from asymptomatic carriers after stimulation by Leishmania vaccine peptides. It also wants to describe the immune response, after stimulation by these peptides, in the lymphocytes of subjects asymptomatic carriers and lymphocytes from subjects not infected with the parasite and comparing them. This study is unicentric and non-randomized. It wishes to recruit 20 asymptomatic carriers of L. Infantum and 10 uninfected subjects. They will be selected from our database. A simple blood sample will be taken. After verification by quantitative PCR and western blotting of their status towards leishmaniasis, the team will divide them into two groups (asymptomatic or healthy). Then the blood samples will be sent to the team of Jean Loup Lemesre of the Laboratory INTERTRYP - UMR177 of the IRD in Montpellier. ELISPOT analysis and assay of cytokines and proteases to describe the immune response of the two groups and to compare them. In addition, cell typing will be performed by flow cytometry to determine the type of lymphocytes involved in the immune response against Leishmania peptides. HLA typing will also be performed to validate the HLA coverage of the peptides tested. Finally, an analysis of the transcryptome will be carried out, which will allow to identify the differential expression of genes and metabolic pathways involved in the immune response and thus to understand how asymptomatic people can control the infection.


title: The FGF/FGFR Signalling Pathway: a Novel Therapeutic Target in Liposarcomas

acronym: FILIPO

summary:
Liposarcomas are the most common type of soft tissue sarcomas (STS). Among liposarcomas, well-differentiated liposarcoma (WDLPS)/dedifferentiated liposarcoma (DDLPS) are the most frequent types. WDLPS are composed mostly of mature fat whereas DDLPS contain both a WDLPS component and a non-lipomatous sarcoma component mostly of high grade. More than 50% of DDLPS will relapse locally. A significant proportion of patients will remain with a non-resectable disease that will metastasize in 20% of cases. Standard chemotherapy is poorly efficient and alternative options are so far limited. Identification of new therapeutic targets is urgent and mandatory. the recent preliminary results as well as data from the literature led us to hypothesize that the FGF (Fibroblast Growth factor)/FGFR pathway is involved in liposarcomagenesis and might therefore be a novel relevant therapeutic target in WDLPS/DDLPS.

Description of the project The project associates 4 teams with a longstanding collaboration : 3 teams fom Nice (Nice University Hospital/IRCAN, Nice University Hospital, Comprehensive Cancer Center Centre Antoine Lacassagne and one team from Bordeaux (Comprehensive Cancer Center Institut Bergonié). These 4 teams are experts in the clinics, pathology and molecular genetics of sarcomas as well as in biostatistics.

Expression studies on the role of the syndecan-1 (SDC1)/FGFR pathway in WDLPS/DDLPS tumorigenesis

The recent studies provide original results that may have a direct application in treatments of liposarcomas. They suggest that SDC1 -an effector of the FGF/FGFR pathway- might be involved in DDLPS tumorigenesis. Staff will analyse:

The pattern of expression and localisation of syndecans, FGFs and FGFRs in WDLPS/DDLPS both in a large collection of 249 primary tumors and in our in-house panel of high quality and validated human WDLPS/DDLPS cell lines.
The prognostic value of SDC1, FGF2 and FGF18 expression by correlation to the patient clinical outcomes

Fonctional studies of the role of the SDC1/FGFR pathway in WDLPS/DDLPS tumorigenesis. We will analyse:

The effects of modulating SDC1, FGFR expression in WDLPS and DDLPS cells on cell proliferation, cell cycle, apoptosis and on their capacity to differentiate in adipocytes.
The sensitivity of WDLPS and DDLPS cells to the FGFR inhibitor JNJ-427556493 as a single agent or in combination with other antagonists.
The mechanisms of sensitivity and resistance to JNJ-427556493 by phosphoproteomic analysis of WDLPS and DDLPS cells before and after JNJ-427556493 treatment.
The involvement of SDC1 in the dedifferentiation process of liposarcoma. Expected results staff expect to demonstrate the relevance of the SDC1/FGFR pathway in liposarcomas. We also expect to link drug activity to genomics and proteomics data. This will allow the characterization of the activity of FGFR inhibitors and the identification of powerful preclinical biomarkers of drug activity and mechanisms of resistance in DDLPS. The availability of xenograft models will allow us to validate our in vitro findings in the in vivo setting with the ultimate goal to improve patient management.

The availability of an early clinical trial unit in Institut Bergonié, managed by A. Italiano, will give the immediate opportunity to transfer our data to the management of metastatic liposarcoma patients.


title: Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome

acronym: COVAP

summary: Pulmonary vascular dysfunction (DVP) is associated with a pejorative prognosis during ARDS. There is no specific therapeutic intervention to thwart it. Extracorporeal CO2 purification (ECCO2-R) is a technique that has been very rapidly diffused and adopted in intensive care since commercialization of the devices but, the formal clinical evaluation is insufficient. It could significantly improve the prognosis of patients with both DVP and refractory hypercapnia.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.

acronym: CoA

summary: Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try to establish the diagnosis since it has been shown that the prenatal diagnosis improves survival and reduces morbidity.

location_facility: Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant


title: Effects of Brisk Walking on Autonomic Nervous System Reactivation in Nursing Home Residents.

summary: It is well established that physical activity reduces the physiological effects of ageing. Among them, the decrease of the autonomic nervous system activity (ANS) is associated with the increase of cardiovascular events and sleep disorders occurence. It has been shown that high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years old. However, such trainings were done by old athletes used to train at intensities that could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking shall be defined to make it practicable for the many in convalescent homes. The investigators hypothesize that long term brisk walking training could lead to reactivate ANS in people living in convalescent homes.

lead_sponsor: Clinique Mutualiste Chirurgicale de la Loire


title: Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis

acronym: BIOSEP

summary: The purpose of this observational study is to collect efficacy and safety data in real life condition within the first year of treatment in patients with progressive multiple receiving a daily dose of biotine of 300 mg.


title: Evaluation of the Psychological Consequences of Complicated Childbirth

acronym: ESPT Obst

summary: Prospective, non-interventional, monocentric, case-control study

lead_sponsor: Rennes University Hospital

location_facility: Hospital-University Psychiatry Center for Children and Adolescents


title: CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology

acronym: CAP'ONCO

summary:
This patient support system is designed to help patients regain their professional activity after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:

A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist / Neuropsychologist)
Monthly information meetings and workshops (TIC'Onco reunions: collective information times and Cogit'Onco workshops: cognitive workshops
An information booklet "Prepare the work return" The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

lead_sponsor: Institut Bergonié


title: A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

acronym: SURIA

summary:
Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.

The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Project A3sc - An Atlas of Airways at a Single Cell Level

acronym: AAAsc

summary:
The increasing incidence of chronic respiratory diseases is a public health problem affecting hundreds of thousands of people around the world, including children. Directly exposed to atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a complex ecosystem that involves different cells that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and with the microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, we have identified broad gradients in gene expression between nasal and bronchial samples. This is why cellular variability throughout the respiratory tree needs to be studied in detail.

The sequencing of RNAs specifically present in a particular cell, and its comparison with neighboring cells, allows us to document precise cellular contributions and intercellular relationships. Our project will establish protocols to stabilize airway swabs by brushing and/or biopsy, under conditions that will then allow the analysis of gene expression profiles at the single cell level (single cell RNA sequencing).

The development of the "single cell" stabilisation and analysis protocol will first be carried out on primary respiratory epithelium cultures and then extended to respiratory specimens taken from healthy volunteers. Through sampling at several levels of the respiratory tree, variations in expression along the tracheobronchial axis will be fully documented. Finally, the interaction between the epithelial compartment and the immunological compartment will be studied by analyzing gene expression on a single cell in different physiopathological contexts.


title: Sensitivity to Acute Middle Cerebral or Intracranial Carotid Artery Occlusion in MIGrainers - SAMCO-MIG

acronym: SAMCO-MIG

summary: Sensitivity to Acute Middle cerebral or intracranial Carotid artery Occlusion in MIGrainers (SMCO-MIG) is a prospective multi-center study to determine if migraine induces a faster infarct growth as assessed by initial multimodal imaging.

lead_sponsor: University Hospital, Montpellier

location_facility: CHU de Montpellier - Neurology Departement


title: Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease

acronym: CHIMICI

summary:
Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Recently, major advances in the understanding of their pathophysiology have allowed to define them as heterogenic polygenic diseases, occurring in genetically susceptible patients. However, the whole genetic susceptibility does not explain the development of IBD and several data argue in favor of the involvement of environmental factors, which remain to be identified.

The aims of this clinical trial are:

As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.
As secondary objective, to assess in human the genetic susceptibility of intestinal mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual variability, and its potential involvement in the pathogenesis of IBD.


title: Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis

acronym: POMI-AF

summary: To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.


title: Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption in Double-jaw Surgery, a Retrospective Study

summary: Background and Objectives: Double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. The aim of this study was to evaluate the effectiveness of face block (mandibulary and maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted for double jaw surgery.

lead_sponsor: Hospices Civils de Lyon