title: Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs

acronym: MAGTOC

summary: Evaluate the therapeutic effect of a functional Magnetic Resonance Imaging (fMRI)-guided and robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind, randomized, placebo-controlled, monocentric study.

ReferenceCitation: Heyman I, Mataix-Cols D, Fineberg NA. Obsessive-compulsive disorder. BMJ. 2006 Aug 26;333(7565):424-9. doi: 10.1136/bmj.333.7565.424. No abstract available.

ReferenceCitation: Denys D. Pharmacotherapy of obsessive-compulsive disorder and obsessive-compulsive spectrum disorders. Psychiatr Clin North Am. 2006 Jun;29(2):553-84, xi. doi: 10.1016/j.psc.2006.02.013.

ReferenceCitation: Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.

ReferenceCitation: Baxter LR Jr, Phelps ME, Mazziotta JC, Guze BH, Schwartz JM, Selin CE. Local cerebral glucose metabolic rates in obsessive-compulsive disorder. A comparison with rates in unipolar depression and in normal controls. Arch Gen Psychiatry. 1987 Mar;44(3):211-8. doi: 10.1001/archpsyc.1987.01800150017003. Erratum In: Arch Gen Psychiatry 1987 Sep;44(9):800.

ReferenceCitation: Li CT, Chen MH, Juan CH, Huang HH, Chen LF, Hsieh JC, Tu PC, Bai YM, Tsai SJ, Lee YC, Su TP. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. Brain. 2014 Jul;137(Pt 7):2088-98. doi: 10.1093/brain/awu109. Epub 2014 May 10.

ReferenceCitation: Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.

ReferenceCitation: Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone P, Insola A, Ranieri F, Meglio M, Tonali PA, Rothwell JC. The physiological basis of the effects of intermittent theta burst stimulation of the human motor cortex. J Physiol. 2008 Aug 15;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736. Epub 2008 Jun 19.

ReferenceCitation: Prasko J, Paskova B, Zalesky R, Novak T, Kopecek M, Bares M, Horacek J. The effect of repetitive transcranial magnetic stimulation (rTMS) on symptoms in obsessive compulsive disorder. A randomized, double blind, sham controlled study. Neuro Endocrinol Lett. 2006 Jun;27(3):327-32.

ReferenceCitation: Sarkhel S, Sinha VK, Praharaj SK. Adjunctive high-frequency right prefrontal repetitive transcranial magnetic stimulation (rTMS) was not effective in obsessive-compulsive disorder but improved secondary depression. J Anxiety Disord. 2010 Jun;24(5):535-9. doi: 10.1016/j.janxdis.2010.03.011. Epub 2010 Mar 29.

ReferenceCitation: Sack AT, Cohen Kadosh R, Schuhmann T, Moerel M, Walsh V, Goebel R. Optimizing functional accuracy of TMS in cognitive studies: a comparison of methods. J Cogn Neurosci. 2009 Feb;21(2):207-21. doi: 10.1162/jocn.2009.21126.

ReferenceCitation: Sachdev PS, McBride R, Loo CK, Mitchell PB, Malhi GS, Croker VM. Right versus left prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. J Clin Psychiatry. 2001 Dec;62(12):981-4. doi: 10.4088/jcp.v62n1211.

ReferenceCitation: Wu CC, Tsai CH, Lu MK, Chen CM, Shen WC, Su KP. Theta-burst repetitive transcranial magnetic stimulation for treatment-resistant obsessive-compulsive disorder with concomitant depression. J Clin Psychiatry. 2010 Apr;71(4):504-6. doi: 10.4088/JCP.09l05426blu. No abstract available.

ReferenceCitation: Aron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003 Feb;6(2):115-6. doi: 10.1038/nn1003. No abstract available. Erratum In: Nat Neurosci. 2003 Dec;6(12):1329.

ReferenceCitation: Chambers CD, Bellgrove MA, Stokes MG, Henderson TR, Garavan H, Robertson IH, Morris AP, Mattingley JB. Executive "brake failure" following deactivation of human frontal lobe. J Cogn Neurosci. 2006 Mar;18(3):444-55. doi: 10.1162/089892906775990606.

ReferenceCitation: Verbruggen F, Aron AR, Stevens MA, Chambers CD. Theta burst stimulation dissociates attention and action updating in human inferior frontal cortex. Proc Natl Acad Sci U S A. 2010 Aug 3;107(31):13966-71. doi: 10.1073/pnas.1001957107. Epub 2010 Jul 14.

ReferenceCitation: Duncan J, Owen AM. Common regions of the human frontal lobe recruited by diverse cognitive demands. Trends Neurosci. 2000 Oct;23(10):475-83. doi: 10.1016/s0166-2236(00)01633-7.

ReferenceCitation: Verbruggen F, Schneider DW, Logan GD. How to stop and change a response: the role of goal activation in multitasking. J Exp Psychol Hum Percept Perform. 2008 Oct;34(5):1212-28. doi: 10.1037/0096-1523.34.5.1212.

ReferenceCitation: Boucher L, Palmeri TJ, Logan GD, Schall JD. Inhibitory control in mind and brain: an interactive race model of countermanding saccades. Psychol Rev. 2007 Apr;114(2):376-97. doi: 10.1037/0033-295X.114.2.376.

ReferenceCitation: Chambers CD, Bellgrove MA, Gould IC, English T, Garavan H, McNaught E, Kamke M, Mattingley JB. Dissociable mechanisms of cognitive control in prefrontal and premotor cortex. J Neurophysiol. 2007 Dec;98(6):3638-47. doi: 10.1152/jn.00685.2007. Epub 2007 Oct 17.

ReferenceCitation: Aron AR, Behrens TE, Smith S, Frank MJ, Poldrack RA. Triangulating a cognitive control network using diffusion-weighted magnetic resonance imaging (MRI) and functional MRI. J Neurosci. 2007 Apr 4;27(14):3743-52. doi: 10.1523/JNEUROSCI.0519-07.2007.

ReferenceCitation: Swann N, Tandon N, Canolty R, Ellmore TM, McEvoy LK, Dreyer S, DiSano M, Aron AR. Intracranial EEG reveals a time- and frequency-specific role for the right inferior frontal gyrus and primary motor cortex in stopping initiated responses. J Neurosci. 2009 Oct 7;29(40):12675-85. doi: 10.1523/JNEUROSCI.3359-09.2009.

ReferenceCitation: Hampshire A, Chamberlain SR, Monti MM, Duncan J, Owen AM. The role of the right inferior frontal gyrus: inhibition and attentional control. Neuroimage. 2010 Apr 15;50(3):1313-9. doi: 10.1016/j.neuroimage.2009.12.109. Epub 2010 Jan 4.

ReferenceCitation: Chikazoe J, Jimura K, Asari T, Yamashita K, Morimoto H, Hirose S, Miyashita Y, Konishi S. Functional dissociation in right inferior frontal cortex during performance of go/no-go task. Cereb Cortex. 2009 Jan;19(1):146-52. doi: 10.1093/cercor/bhn065. Epub 2008 Apr 28.

ReferenceCitation: Luders H, Lesser RP, Dinner DS, Morris HH, Wyllie E, Godoy J. Localization of cortical function: new information from extraoperative monitoring of patients with epilepsy. Epilepsia. 1988;29 Suppl 2:S56-65. doi: 10.1111/j.1528-1157.1988.tb05799.x. Erratum In: Epilepsia 1988 Nov-Dec;29(6):828.

ReferenceCitation: Johansen-Berg H, Behrens TE, Robson MD, Drobnjak I, Rushworth MF, Brady JM, Smith SM, Higham DJ, Matthews PM. Changes in connectivity profiles define functionally distinct regions in human medial frontal cortex. Proc Natl Acad Sci U S A. 2004 Sep 7;101(36):13335-40. doi: 10.1073/pnas.0403743101. Epub 2004 Aug 30.

ReferenceCitation: Marsh R, Horga G, Parashar N, Wang Z, Peterson BS, Simpson HB. Altered activation in fronto-striatal circuits during sequential processing of conflict in unmedicated adults with obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):615-22. doi: 10.1016/j.biopsych.2013.02.004. Epub 2013 Mar 13.

ReferenceCitation: de Wit SJ, de Vries FE, van der Werf YD, Cath DC, Heslenfeld DJ, Veltman EM, van Balkom AJ, Veltman DJ, van den Heuvel OA. Presupplementary motor area hyperactivity during response inhibition: a candidate endophenotype of obsessive-compulsive disorder. Am J Psychiatry. 2012 Oct;169(10):1100-8. doi: 10.1176/appi.ajp.2012.12010073. Erratum In: Am J Psychiatry. 2012 Nov 1;169(11):1218.

ReferenceCitation: Stein DJ, Goodman WK, Rauch SL. The cognitive-affective neuroscience of obsessive-compulsive disorder. Curr Psychiatry Rep. 2000 Aug;2(4):341-6. doi: 10.1007/s11920-000-0079-2.

ReferenceCitation: Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

ReferenceCitation: Stokes MG, Chambers CD, Gould IC, Henderson TR, Janko NE, Allen NB, Mattingley JB. Simple metric for scaling motor threshold based on scalp-cortex distance: application to studies using transcranial magnetic stimulation. J Neurophysiol. 2005 Dec;94(6):4520-7. doi: 10.1152/jn.00067.2005. Epub 2005 Aug 31.

ReferenceCitation: Stokes MG, Chambers CD, Gould IC, English T, McNaught E, McDonald O, Mattingley JB. Distance-adjusted motor threshold for transcranial magnetic stimulation. Clin Neurophysiol. 2007 Jul;118(7):1617-25. doi: 10.1016/j.clinph.2007.04.004. Epub 2007 May 23.

ReferenceCitation: Buch ER, Mars RB, Boorman ED, Rushworth MF. A network centered on ventral premotor cortex exerts both facilitatory and inhibitory control over primary motor cortex during action reprogramming. J Neurosci. 2010 Jan 27;30(4):1395-401. doi: 10.1523/JNEUROSCI.4882-09.2010.

ReferenceCitation: Neubert FX, Mars RB, Buch ER, Olivier E, Rushworth MF. Cortical and subcortical interactions during action reprogramming and their related white matter pathways. Proc Natl Acad Sci U S A. 2010 Jul 27;107(30):13240-5. doi: 10.1073/pnas.1000674107. Epub 2010 Jul 9.

ReferenceCitation: Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

lead_sponsor: University Hospital, Grenoble

location_facility: CHU de Grenoble - Pavillon Dominique Villars


title: Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades

acronym: COSQOL

summary: Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Unité de Neuro-Ophtalmologie Hôpital Neurologique

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia

acronym: HCD GENE

summary: In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the occurrence of novo mutations (dominant or recessive). Our objective is to test this hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations through whole exome sequencing in a homogenous group of patients.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Genetic


title: Identification of Patients/Families With a Paediatric Tumor and One or More Developmental Abnormalities - Characterization of New Tumor Predisposition Syndromes and Study Their Molecular Basis

acronym: TED

summary: The overall project goal is to build a database of childhood cancers associated with developmental anomalies; it aims at identifying new syndromes of genetic predisposition and at enabling the further study of their molecular basis.

study_start_date_type: Actual

time_perspective: Other


title: Inflammatory Signature of Chorionic Cells as Markers of Premature Labor

acronym: TROPHY

summary: The purpose of this study is to identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor.

ReferenceType: background

ReferenceCitation: Herve R, Schmitz T, Evain-Brion D, Cabrol D, Leroy MJ, Mehats C. The PDE4 inhibitor rolipram prevents NF-kappaB binding activity and proinflammatory cytokine release in human chorionic cells. J Immunol. 2008 Aug 1;181(3):2196-202. doi: 10.4049/jimmunol.181.3.2196.

ReferenceCitation: Mehats C, Schmitz T, Marcellin L, Breuiller-Fouche M. [Biochemistry of fetal membranes rupture]. Gynecol Obstet Fertil. 2011 Jun;39(6):365-9. doi: 10.1016/j.gyobfe.2011.04.006. Epub 2011 May 24. French.


title: Developing an Organization to Improve the Screening and Care of Starved Children in Hospital

acronym: PREDIRE

summary: This cluster-randomized trial will evaluate the impact of a multifaceted intervention (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence to recommended practices for care of starved children, among health personnel of a large university hospital. A key component of the study is to assess whether improved adherence to guidelines leads to a reduction in rates of complications.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Duclos A, Touzet S, Restier L, Occelli P, Cour-Andlauer F, Denis A, Polazzi S, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Implementation of a computerized system in pediatric wards to improve nutritional care: a cluster randomized trial. Eur J Clin Nutr. 2015 Jul;69(7):769-75. doi: 10.1038/ejcn.2014.288. Epub 2015 Feb 4.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Springer-Nature

ReferenceCitation: Touzet S, Duclos A, Denis A, Restier-Miron L, Occelli P, Polazzi S, Betito D, Gamba G, Cour-Andlauer F, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial. BMC Health Serv Res. 2013 Mar 22;13:107. doi: 10.1186/1472-6963-13-107.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

location_facility: Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant

intervention_type: Procedure


title: Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers

acronym: INFLUX-VS

summary: Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

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.

intervention_type: Drug


title: Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam -Comparative Study of 3% Versus 1% Concentration.

summary: To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol 400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study of 3% versus 1% Lauromacrogol 400 foam.

ReferenceCitation: Bosson JL, Riachi M, Pichot O, Michoud E, Carpentier PH, Franco A. Diameters of acute proximal and distal deep venous thrombosis of the lower limbs. Int Angiol. 1998 Dec;17(4):260-7.

ReferenceCitation: Ferretti GR, Bosson JL, Buffaz PD, Ayanian D, Pison C, Blanc F, Carpentier F, Carpentier P, Coulomb M. Acute pulmonary embolism: role of helical CT in 164 patients with intermediate probability at ventilation-perfusion scintigraphy and normal results at duplex US of the legs. Radiology. 1997 Nov;205(2):453-8. doi: 10.1148/radiology.205.2.9356628.

ReferenceCitation: Barro C, Bosson JL, Pernod G, Carpentier PH, Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalized patients. Thromb Res. 1999 Sep 1;95(5):263-9. doi: 10.1016/s0049-3848(99)00042-0. No abstract available.

ReferenceCitation: Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.

ReferenceCitation: Bosson JL, Labarere J, Barrellier MT, Belmin J, Couturier P, Le Roux P, Sevestre MA; Association pour la Promotion de l'Angiologie Hospitaliere (APAH). [Practice guidelines for the prevention of venous thromboembolism in elderly patients hospitalized in subacute care and rehabilitation facilities (short text). Association for the Promotion of Hospital Angiology]. J Mal Vasc. 2003 Oct;28(4):209-18. No abstract available. French.

location_facility: Center of Vascular Medecine - 7 rue Lesdiguières


title: Double-blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Erythropoietin on Different Markers of Cardiac Ischemia Induced by Cardiopulmonary Bypass

acronym: EPOetCEC

summary: The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.

ReferenceCitation: Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017.

ReferenceCitation: Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.

ReferenceCitation: Johnsson P, Backstrom M, Bergh C, Jonsson H, Luhrs C, Alling C. Increased S100B in blood after cardiac surgery is a powerful predictor of late mortality. Ann Thorac Surg. 2003 Jan;75(1):162-8. doi: 10.1016/s0003-4975(02)04318-7.

ReferenceCitation: Joyeux-Faure M, Godin-Ribuot D, Ribuot C. Erythropoietin and myocardial protection: what's new? Fundam Clin Pharmacol. 2005 Aug;19(4):439-46. doi: 10.1111/j.1472-8206.2005.00347.x.

ReferenceCitation: Kerbaul F, Giorgi R, Oddoze C, Collart F, Guidon C, Lejeune PJ, Villacorta J, Gouin F. High concentrations of N-BNP are related to non-infectious severe SIRS associated with cardiovascular dysfunction occurring after off-pump coronary artery surgery. Br J Anaesth. 2004 Nov;93(5):639-44. doi: 10.1093/bja/aeh246. Epub 2004 Sep 3.

sponsor_collaborators:
University Hospital, Grenoble
Roche Pharma AG

location_facility: Cardiac Surgery Department - CHU de Grenoble


title: Relevance of Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

summary: The main objective of this study is to demonstrate the relevance of Valganciclovir on recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for placebo treated patients) remission at 3 months (including the discontinuation of corticoids or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over the 6 following months.

status: Terminated

ReferenceCitation: Orvar K, Murray J, Carmen G, Conklin J. Cytomegalovirus infection associated with onset of inflammatory bowel disease. Dig Dis Sci. 1993 Dec;38(12):2307-10. doi: 10.1007/BF01299914. No abstract available.

ReferenceCitation: Hofkin GA, Ting CD. Case report: recurrence of chronic ulcerative colitis induced by intercurrent cytomegalic virus infection. Md Med J. 1995 Dec;44(12):1047-8.

ReferenceCitation: Rachima C, Maoz E, Apter S, Thaler M, Grossman E, Rosenthal T. Cytomegalovirus infection associated with ulcerative colitis in immunocompetent individuals. Postgrad Med J. 1998 Aug;74(874):486-9. doi: 10.1136/pgmj.74.874.486.

ReferenceCitation: Begos DG, Rappaport R, Jain D. Cytomegalovirus infection masquerading as an ulcerative colitis flare-up: case report and review of the literature. Yale J Biol Med. 1996 Jul-Aug;69(4):323-8.

ReferenceCitation: Vega R, Bertran X, Menacho M, Domenech E, Moreno de Vega V, Hombrados M, Cabre E, Ojanguren I, Gassull MA. Cytomegalovirus infection in patients with inflammatory bowel disease. Am J Gastroenterol. 1999 Apr;94(4):1053-6. doi: 10.1111/j.1572-0241.1999.01013.x.

ReferenceCitation: Kaufman HS, Kahn AC, Iacobuzio-Donahue C, Talamini MA, Lillemoe KD, Hamilton SR. Cytomegaloviral enterocolitis: clinical associations and outcome. Dis Colon Rectum. 1999 Jan;42(1):24-30. doi: 10.1007/BF02235178.

ReferenceCitation: Berk T, Gordon SJ, Choi HY, Cooper HS. Cytomegalovirus infection of the colon: a possible role in exacerbations of inflammatory bowel disease. Am J Gastroenterol. 1985 May;80(5):355-60.

ReferenceCitation: Pfau PR, Lichtenstein GR. Cytomegalovirus infection as a cause of ileoanal pouchitis. Dis Colon Rectum. 2000 Jan;43(1):113-4. doi: 10.1007/BF02237255. No abstract available.

ReferenceCitation: Pfau P, Kochman ML, Furth EE, Lichtenstein GR. Cytomegalovirus colitis complicating ulcerative colitis in the steroid-naive patient. Am J Gastroenterol. 2001 Mar;96(3):895-9. doi: 10.1111/j.1572-0241.2001.03672.x.

ReferenceCitation: Munoz-Juarez M, Pemberton JH, Sandborn WJ, Tremaine WJ, Dozois RR. Misdiagnosis of specific cytomegalovirus infection of the ileoanal pouch as refractory idiopathic chronic pouchitis: report of two cases. Dis Colon Rectum. 1999 Jan;42(1):117-20. doi: 10.1007/BF02235196.

ReferenceCitation: Moonka D, Furth EE, MacDermott RP, Lichtenstein GR. Pouchitis associated with primary cytomegalovirus infection. Am J Gastroenterol. 1998 Feb;93(2):264-6. doi: 10.1111/j.1572-0241.1998.00264.x.

ReferenceCitation: Papadakis KA, Tung JK, Binder SW, Kam LY, Abreu MT, Targan SR, Vasiliauskas EA. Outcome of cytomegalovirus infections in patients with inflammatory bowel disease. Am J Gastroenterol. 2001 Jul;96(7):2137-42. doi: 10.1111/j.1572-0241.2001.03949.x.

ReferenceCitation: Surawicz CM, Myerson D. Self-limited cytomegalovirus colitis in immunocompetent individuals. Gastroenterology. 1988 Jan;94(1):194-9. doi: 10.1016/0016-5085(88)90630-0.

location_facility: Gastroenterology Department - University Hospital of Grenoble

status_simplified: Unknown


title: Implication of Patient in the Making Ready of Recommendations for the Antivitamin K's Gestion in Case of Thrombosis Embolic Venous's Illness. Randomised Study for Clinical Validation.

summary: The objective of the project "Educ'Avk", is to document the efficacy of a strategy combining a specific follow up-notebook and education of attending patient with a pedagogic support, comparatively to an usual education on the impact of clinical events at three months (minor or major hemorrhagic events + recurrence of thrombi-embolic's disease).

ReferenceCitation: Gratacap-Cavallier B, Bosson JL, Morand P, Dutertre N, Chanzy B, Jouk PS, Vandekerckhove C, Cart-Lamy P, Seigneurin JM. Cytomegalovirus seroprevalence in French pregnant women: parity and place of birth as major predictive factors. Eur J Epidemiol. 1998 Feb;14(2):147-52. doi: 10.1023/a:1007450729633.

ReferenceCitation: Bertrand D, Francois P, Bosson JL, Fauconnier J, Weil G. Quality assessment of discharge letters in a French university hospital. Int J Health Care Qual Assur Inc Leadersh Health Serv. 1998;11(2-3):90-5. doi: 10.1108/09526869810213019.

ReferenceCitation: Mezin P, Payen JF, Bosson JL, Brambilla E, Stieglitz P. Histological support for the difference between malignant hyperthermia susceptible (MHS), equivocal (MHE) and negative (MHN) muscle biopsies. Br J Anaesth. 1997 Sep;79(3):327-31. doi: 10.1093/bja/79.3.327.

ReferenceCitation: Payen JF, Bosson JL, Bourdon L, Jacquot C, Le Bas JF, Stieglitz P, Benabid AL. Improved noninvasive diagnostic testing for malignant hyperthermia susceptibility from a combination of metabolites determined in vivo with 31P-magnetic resonance spectroscopy. Anesthesiology. 1993 May;78(5):848-55. doi: 10.1097/00000542-199305000-00007.

ReferenceCitation: Vermont J, Bosson JL, Francois P, Robert C, Rueff A, Demongeot J. Strategies for graphical threshold determination. Comput Methods Programs Biomed. 1991 Jun;35(2):141-50. doi: 10.1016/0169-2607(91)90072-2.

location_facility: Cardiovascular Departement - University Hospital of Grenoble - BP 217

intervention_type: Behavioral


title: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.

summary: The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).

status: Suspended

study_completion_date_type: Anticipated

ReferenceCitation: Bettega G, Cinquin P, Lebeau J, Raphael B. Computer-assisted orthognathic surgery: clinical evaluation of a mandibular condyle repositioning system. J Oral Maxillofac Surg. 2002 Jan;60(1):27-34; discussion 34-5. doi: 10.1053/joms.2002.29069.

ReferenceCitation: Bettega G, Dessenne V, Raphael B, Cinquin P. Computer-assisted mandibular condyle positioning in orthognathic surgery. J Oral Maxillofac Surg. 1996 May;54(5):553-8. doi: 10.1016/s0278-2391(96)90630-8.

ReferenceCitation: Dessenne V. Gestes médico-chirurgicaux assistés par ordinateur: applications à la ligamentoplastie du genou et à la chirurgie orthognatique. Thèse de Génie biologique et médical, Grenoble 1996

ReferenceCitation: Bettega G. La chirurgie orthognatique assistée par ordinateur: de la planification à la réalisation. Thèse de Génie biologique et médical, Grenoble 1997

location_facility: Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble

intervention_type: Device


title: Ultrasound Monitoring of Fetuses With Vascular Intra-uterine Growth Restriction (IUGR) Using the Isthmus Systolic Index (ISI): Feasibility, Comparison to Normal Fetuses and Association With Perinatal Mortality

acronym: f-ISI-RCIU

summary: Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The primary outcome of the study is to evaluate in an exploratory manner the feasibility and the potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic isthmus and the calculation of the ISI index.

status: Unknown status

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de gynécologie-obstétrique et de médecine fœtale


title: Familial Analysis of Keratoconus Risk

acronym: AFRIK

summary:
The principal objective of this study is to evaluate the frequency of KC inside family of patients with confirmed KC.

It's a familial, epidemiological, prospective, single-center study.

ReferenceCitation: Millodot M, Shneor E, Albou S, Atlani E, Gordon-Shaag A. Prevalence and associated factors of keratoconus in Jerusalem: a cross-sectional study. Ophthalmic Epidemiol. 2011 Apr;18(2):91-7. doi: 10.3109/09286586.2011.560747.

ReferenceCitation: Weed KH, MacEwen CJ, Giles T, Low J, McGhee CN. The Dundee University Scottish Keratoconus study: demographics, corneal signs, associated diseases, and eye rubbing. Eye (Lond). 2008 Apr;22(4):534-41. doi: 10.1038/sj.eye.6702692. Epub 2007 Jan 19.

ReferenceCitation: Assiri AA, Yousuf BI, Quantock AJ, Murphy PJ. Incidence and severity of keratoconus in Asir province, Saudi Arabia. Br J Ophthalmol. 2005 Nov;89(11):1403-6. doi: 10.1136/bjo.2005.074955. Erratum In: Br J Ophthalmol. 2006 Aug;90(8):1071.

ReferenceCitation: Owens H, Gamble G. A profile of keratoconus in New Zealand. Cornea. 2003 Mar;22(2):122-5. doi: 10.1097/00003226-200303000-00008.

ReferenceCitation: McMonnies CW, Boneham GC. Keratoconus, allergy, itch, eye-rubbing and hand-dominance. Clin Exp Optom. 2003 Nov;86(6):376-84. doi: 10.1111/j.1444-0938.2003.tb03082.x.

ReferenceCitation: Falls HF, Allen AW. Dominantly inherited keratoconus. J Genet Hum. 1969 Oct;17(3):317-24. No abstract available.

ReferenceCitation: Kemp EG, Lewis CJ. Measurement of total and specific IgE levels in the management of a family exhibiting a high incidence of keratoconus. Acta Ophthalmol (Copenh). 1984 Aug;62(4):524-9. doi: 10.1111/j.1755-3768.1984.tb03963.x.

ReferenceCitation: Ihalainen A. Clinical and epidemiological features of keratoconus genetic and external factors in the pathogenesis of the disease. Acta Ophthalmol Suppl (1985). 1986;178:1-64.

ReferenceCitation: Rabinowitz YS, Garbus J, McDonnell PJ. Computer-assisted corneal topography in family members of patients with keratoconus. Arch Ophthalmol. 1990 Mar;108(3):365-71. doi: 10.1001/archopht.1990.01070050063032.

ipd_sharing: No

location_facility: Centre de Référence National du Kératocône Service d'ophtalmologie - Hôpital Pellegrin


title: Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation

acronym: VISS

summary: It is a study of basic research with mechanistically objectives and including clinical biological samples.

primary_purpose: Other

sponsor_collaborators:
University Hospital, Bordeaux
Societe Francaise de Rhumatologie

location_facility: Service de Rhumatologie - Tripode - Hôpital Pellegrin

intervention_type: Biological


title: Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters

acronym: PERAGUS

summary:
Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is increasingly being used worldwide to treat symptomatic uterine fibroids because of its excellent therapeutic efficacy in controlling symptoms and its excellent safety record. Despite the benefits, it should be recognized that MR HIFU ablation does not always yield good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most well-known risk factors for poor ablation outcomes as measured with the non-perfused volume (NPV) ratio (ie, NPV divided by fibroid volume).

The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine fibroid treatment by MR-HIFU.

primary_purpose: Diagnostic


title: Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders

acronym: Easykrill

summary: Joints and muscles disorders are common symptoms in the population. They are characterized by swelling, pain, functional impairment and morning stiffness. These disorders can be really disabling and painful, affecting the person's quality life. The purpose of this clinical trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154 subjects complaining functional discomfort associated to joints and muscles disorders.

primary_purpose: Supportive Care

lead_sponsor: Vivatech

location_facility: Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN

lead_sponsor_type: industriel


title: Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).

acronym: IMMUNOSEP

summary: Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.

collaborators:
Merck Serono International SA
ADERA

sponsor_collaborators:
University Hospital, Bordeaux
Merck Serono International SA
ADERA

location_facility: Service de Neurologie - Tripode - Hôpital Pellegrin


title: Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors

acronym: ECLAIR

summary: Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised countries. There are few epidemiological studies on the incidence of this disease. Studying the incidence of AMD in an elderly French population and identifying the predisposing factors is very important to allow a major advance in the epidemiological knowledge of AMD. This study will contribute to the identification of the clinical, genetic and modifiable parameters associated at the risk of developing AMD. This could result in means prevention as well as in the identification of subjects as high risk of AMD

ReferenceCitation: Cougnard-Gregoire A, Delyfer MN, Korobelnik JF, Rougier MB, Malet F, Le Goff M, Dartigues JF, Colin J, Barberger-Gateau P, Delcourt C. Long-term blood pressure and age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):1905-12. doi: 10.1167/iovs.12-10192.

ReferenceCitation: Merle B, Delyfer MN, Korobelnik JF, Rougier MB, Colin J, Malet F, Feart C, Le Goff M, Dartigues JF, Barberger-Gateau P, Delcourt C. Dietary omega-3 fatty acids and the risk for age-related maculopathy: the Alienor Study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):6004-11. doi: 10.1167/iovs.11-7254.

ReferenceCitation: Delcourt C, Delyfer MN, Rougier MB, Amouyel P, Colin J, Le Goff M, Malet F, Dartigues JF, Lambert JC, Korobelnik JF. Associations of complement factor H and smoking with early age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5955-62. doi: 10.1167/iovs.10-6235.

location_facility: Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin


title: Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients

acronym: BIOLENS

summary:
Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP circadian rhythm is altered and varied widely between patients. To date, the only way to evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour hospitalization. This method is expensive and does not reflect physiological conditions because it requires IOP measurements during sleeping periods that may potentially produce artifacts.

Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical device might be influenced by corneal properties of the cornea as central corneal thickness, keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance, potential modifications of corneal parameters after a 24-hour wear of the lens, and its influence on data collected during the whole period of analysis. Then we will also analyze the influence of corneal parameters on continuous IOP fluctuations measured with the contact sensor and finally the correlation between data collected and the rate of progression (severity) of glaucoma evaluated with visual field test or optic nerve head damages.

location_facility: Service d'ophtalmologie Hôpital Pellegrin


title: Randomized Prospective Multicentric Study: Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Respectable Hilar Cholangiocarcinoma

acronym: TRANSPHIL

summary:
A prospective, open-label, randomised, multicentre, comparative study in two parallel groups comparing an interventional group with liver transplantation preceded by neoadjuvant radio-chemotherapy and a control group receiving conventional liver and bile duct resection.

The primary endpoint will be overall survival at 5 years in the intent-to-treat population. The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the intent-to-treat population.

The number of subjects necessary is 54 patients (27 x 2): this population will enable the demonstration of a significant difference is 5-year survival rates between the transplanted group and the resected group with a power of 80% and a first-species risk of 5%, under the hypothesis that these survival rates are 70% in the transplanted group and 30% in the resected group.

status: Active, not recruiting

location_facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

status_simplified: Ongoing


title: Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

acronym: ChemoRenCan

summary:
Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.

The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

ReferenceCitation: Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinie F, Danzon A, Bara S, Bouvier AM, Tretarre B, Binder-Foucard F, Colonna M, Daubisse L, Hedelin G, Launoy G, Le Stang N, Maynadie M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Cherie-Challine L, Esteve J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-175. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10.

ReferenceCitation: Raynal G, Bernhard JC. [Premature death from urologic cancer: the kidneys at the forefront]. Prog Urol. 2007 Apr;17(2):260-1. doi: 10.1016/s1166-7087(07)92277-0. No abstract available. French.

ReferenceCitation: Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. doi: 10.1200/JCO.1999.17.8.2530.

ReferenceCitation: Margulis V, Sanchez-Ortiz RF, Tamboli P, Cohen DD, Swanson DA, Wood CG. Renal cell carcinoma clinically involving adjacent organs: experience with aggressive surgical management. Cancer. 2007 May 15;109(10):2025-30. doi: 10.1002/cncr.22629.

ReferenceCitation: Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7.

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22;370(9605):2103-11. doi: 10.1016/S0140-6736(07)61904-7.

ReferenceCitation: Ravaud A, Wallerand H, Culine S, Bernhard JC, Fergelot P, Bensalah K, Patard JJ. Update on the medical treatment of metastatic renal cell carcinoma. Eur Urol. 2008 Aug;54(2):315-25. doi: 10.1016/j.eururo.2008.04.056. Epub 2008 May 5.

ReferenceCitation: Maione TE, Gray GS, Petro J, Hunt AJ, Donner AL, Bauer SI, Carson HF, Sharpe RJ. Inhibition of angiogenesis by recombinant human platelet factor-4 and related peptides. Science. 1990 Jan 5;247(4938):77-9. doi: 10.1126/science.1688470.

ReferenceCitation: Jouan V, Canron X, Alemany M, Caen JP, Quentin G, Plouet J, Bikfalvi A. Inhibition of in vitro angiogenesis by platelet factor-4-derived peptides and mechanism of action. Blood. 1999 Aug 1;94(3):984-93.

ReferenceCitation: Lasagni L, Francalanci M, Annunziato F, Lazzeri E, Giannini S, Cosmi L, Sagrinati C, Mazzinghi B, Orlando C, Maggi E, Marra F, Romagnani S, Serio M, Romagnani P. An alternatively spliced variant of CXCR3 mediates the inhibition of endothelial cell growth induced by IP-10, Mig, and I-TAC, and acts as functional receptor for platelet factor 4. J Exp Med. 2003 Jun 2;197(11):1537-49. doi: 10.1084/jem.20021897.

ReferenceCitation: Eisman R, Surrey S, Ramachandran B, Schwartz E, Poncz M. Structural and functional comparison of the genes for human platelet factor 4 and PF4alt. Blood. 1990 Jul 15;76(2):336-44.

ReferenceCitation: Struyf S, Burdick MD, Proost P, Van Damme J, Strieter RM. Platelets release CXCL4L1, a nonallelic variant of the chemokine platelet factor-4/CXCL4 and potent inhibitor of angiogenesis. Circ Res. 2004 Oct 29;95(9):855-7. doi: 10.1161/01.RES.0000146674.38319.07. Epub 2004 Sep 30.

ReferenceCitation: Struyf S, Burdick MD, Peeters E, Van den Broeck K, Dillen C, Proost P, Van Damme J, Strieter RM. Platelet factor-4 variant chemokine CXCL4L1 inhibits melanoma and lung carcinoma growth and metastasis by preventing angiogenesis. Cancer Res. 2007 Jun 15;67(12):5940-8. doi: 10.1158/0008-5472.CAN-06-4682.

ReferenceCitation: Pan J, Burdick MD, Belperio JA, Xue YY, Gerard C, Sharma S, Dubinett SM, Strieter RM. CXCR3/CXCR3 ligand biological axis impairs RENCA tumor growth by a mechanism of immunoangiostasis. J Immunol. 2006 Feb 1;176(3):1456-64. doi: 10.4049/jimmunol.176.3.1456.

ReferenceCitation: Klatte T, Seligson DB, Leppert JT, Riggs SB, Yu H, Zomorodian N, Kabbinavar FF, Strieter RM, Belldegrun AS, Pantuck AJ. The chemokine receptor CXCR3 is an independent prognostic factor in patients with localized clear cell renal cell carcinoma. J Urol. 2008 Jan;179(1):61-6. doi: 10.1016/j.juro.2007.08.148. Epub 2007 Nov 13.

ReferenceCitation: Kattan MW, Reuter V, Motzer RJ, Katz J, Russo P. A postoperative prognostic nomogram for renal cell carcinoma. J Urol. 2001 Jul;166(1):63-7.

ReferenceCitation: Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002 Jan 1;20(1):289-96. doi: 10.1200/JCO.2002.20.1.289.

ReferenceCitation: Zisman A, Pantuck AJ, Wieder J, Chao DH, Dorey F, Said JW, deKernion JB, Figlin RA, Belldegrun AS. Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol. 2002 Dec 1;20(23):4559-66. doi: 10.1200/JCO.2002.05.111.

ReferenceCitation: Bensalah K, Pantuck AJ, Crepel M, Verhoest G, Mejean A, Valeri A, Ficarra V, Pfister C, Ferriere JM, Soulie M, Cindolo L, De La Taille A, Tostain J, Chautard D, Schips L, Zigeuner R, Abbou CC, Lobel B, Salomon L, Lechevallier E, Descotes JL, Guille F, Colombel M, Belldegrun AS, Patard JJ. Prognostic variables to predict cancer-related death in incidental renal tumours. BJU Int. 2008 Nov;102(10):1376-80. doi: 10.1111/j.1464-410X.2008.07847.x. Epub 2008 Aug 22.

ReferenceCitation: Furniss D, Harnden P, Ali N, Royston P, Eisen T, Oliver RT, Hancock BW; National Cancer Research Institute Renal Clinical Studies Group. Prognostic factors for renal cell carcinoma. Cancer Treat Rev. 2008 Aug;34(5):407-26. doi: 10.1016/j.ctrv.2007.12.008. Epub 2008 Apr 28.


title: Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.

acronym: EPI-ENDO

summary:
Biventricular pacing is a validated treatment for patients suffering from heart failure resistant to medical treatment. However, up to 30% of the patients are non responsive to this strategy using the coronary sinus approach to pace the Left Ventricle (LV).

It has been demonstrated that the magnitude of the improvement was highly dependant on the LV pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing sites. Resynchronisation using a transeptal approach to pace the left ventricle on the cardiology has been shown feasible on small series. We therefore would like to compare these two approached in a randomised prospective study to confirm the hypotheses that endocardial LV pacing by offering multiple choices for the pacing sites reduces the number of non responders and is associated with greater hemodynamic benefit when compared to the conventional coronary sinus approach.


title: Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter

acronym: EvaMAP

summary:
Monophasic action potential (MAP) recording plays an important role in a more direct view of human myocardial electrophysiology under both physiological and pathological conditions. The MAP method represents a very useful tool for an electrophysiological research in cardiology. Its crucial importance lies in the fact that it enables the study of the action potential (AP) of myocardial cell in vivo and, therefore, the study of the dynamic relation of this potential with all the organism variables what can be particularly helpful in the case of arrhythmias.

Hundred and fifty patients will be included to explore mapping capabilities in cardiac chambers in patients suffering from regular or fibrillating tachycardia's with the following inclusion plan: i) Atrial fibrillation at a total of 50 patients ii) Ventricular fibrillation or patients at high risk of sudden cardiac death at a total of 50 patients iii) Junctional tachycardia at a total of 50 patients. We will focus on cardiac activation (depolarization and repolarization) in this population.

location_facility: Hôpital cardiologique du Haut-Lévêque, Cardiac arrhythmias department


title: Decision-making and Emotion Recognition in Essential Tremor

acronym: EMOTREM

summary: The present study aims at investigating cognitive functions requiring orbitofrontal control, namely decision-making and facial emotion recognition. The investigators hypothesize that decision-making and facial emotion recognition are impaired in patients with essential tremor (ET) due to frontal lobe dysfunction which may have consequences in daily social life.

location_facility: CHU de Bordeaux, Hôpital du Haut-Lévêque


type: Other Identifier

title: A Prospective, Multicentric Clinical Proof-of-concept Study to Stratify Targeted Therapies Adapted to Molecular Profiling of Relapsed or Refractory Pediatric Tumors

acronym: MAPPYACTS

summary:
In the light of the development of high-throughput technologies enabling a biology-based reclassification of tumors and the increasing number of available specifically targeting anticancer agents the era of "precision medicine" has begun. Several clinical precision medicine trials with the aim of stratifying treatment according to molecular profiles (for example in France: 'MOlecular Screening for CAncer Treatment Optimization' MOSCATO-01, SHIVA, PROFILER, Safir01, Safir02) are ongoing in adults and have shown the feasibility of this approach. MOSCATO-01 is the first trial worldwide including pediatric patients, performing an on-purpose intervention and molecular profiling in recurrent tumors. Together with more than 500 adult patients, between December 2012 to August 2014, the tumors of 35 children and adolescents have been profiled, confirming that this approach is feasible in pediatric patients albeit with accelerated time stringencies. Importantly, the results of the first children and adolescents profiled showed that 2/3 of patients had 'actionable' alterations using hot spot mutations sequencing and CGH array (Geoerger B et al, ASCO 2014).

The project 'MAPPYACTS' will use both Whole Exome Sequencing (WES) and RNA Sequencing of tumor tissue to increase the number of targetable genomic alterations. Furthermore to improve understanding of the overall molecular profile and possible response to treatment, methylation array, miRNA expression profiles, and study of immunomodulators will be performed on tumor samples subsequently. CLIP2 (INCa-labeled early phase clinical trials centers) - SiRIC (INCa- labeled comprehensive cancer centers) molecular profiling and bioinformatics platforms will contribute with their expertise in molecular profiling projects and characterization of pediatric cancers. Data interpretation of molecular genetic alterations detected by WES and RNA Seq and treatment recommendation will be done within a multidisciplinary therapeutic molecular biology tumor board.

'MAPPYACTS' will produce one of the largest cohorts of molecularly characterized relapsed tumors reported to date, and thanks to increased access to clinical trials since the European pediatric legislation, the investigators expect that 20-30% of patients can be stratified into a targeted trial based on the detected profile.

It is the investigators' intention that this initiative paves the way to enrich ongoing clinical targeted agent trials, to increase the numbers of stratified clinical trials, to an earlier access to targeted agents, and will play a crucial role in the relevant development of these new agents in pediatric malignancies.

primary_purpose: Screening

ReferenceCitation: Berlanga P, Pierron G, Lacroix L, Chicard M, Adam de Beaumais T, Marchais A, Harttrampf AC, Iddir Y, Larive A, Soriano Fernandez A, Hezam I, Chevassus C, Bernard V, Cotteret S, Scoazec JY, Gauthier A, Abbou S, Corradini N, Andre N, Aerts I, Thebaud E, Casanova M, Owens C, Hladun-Alvaro R, Michiels S, Delattre O, Vassal G, Schleiermacher G, Geoerger B. The European MAPPYACTS Trial: Precision Medicine Program in Pediatric and Adolescent Patients with Recurrent Malignancies. Cancer Discov. 2022 May 2;12(5):1266-1281. doi: 10.1158/2159-8290.CD-21-1136.

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)

version: submittedVersion

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

unpaywall_oa_status: hybrid

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Morscher RJ, Brard C, Berlanga P, Marshall LV, Andre N, Rubino J, Aerts I, De Carli E, Corradini N, Nebchi S, Paoletti X, Mortimer P, Lacroix L, Pierron G, Schleiermacher G, Vassal G, Geoerger B. First-in-child phase I/II study of the dual mTORC1/2 inhibitor vistusertib (AZD2014) as monotherapy and in combination with topotecan-temozolomide in children with advanced malignancies: arms E and F of the AcSe-ESMART trial. Eur J Cancer. 2021 Nov;157:268-277. doi: 10.1016/j.ejca.2021.08.010. Epub 2021 Sep 17.

oa_colors: green other

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 - Diderot

repositories_concat: HAL

publisher_dissemination: Elsevier

ReferenceCitation: Peneder P, Stutz AM, Surdez D, Krumbholz M, Semper S, Chicard M, Sheffield NC, Pierron G, Lapouble E, Totzl M, Erguner B, Barreca D, Rendeiro AF, Agaimy A, Boztug H, Engstler G, Dworzak M, Bernkopf M, Taschner-Mandl S, Ambros IM, Myklebost O, Marec-Berard P, Burchill SA, Brennan B, Strauss SJ, Whelan J, Schleiermacher G, Schaefer C, Dirksen U, Hutter C, Boye K, Ambros PF, Delattre O, Metzler M, Bock C, Tomazou EM. Multimodal analysis of cell-free DNA whole-genome sequencing for pediatric cancers with low mutational burden. Nat Commun. 2021 May 28;12(1):3230. doi: 10.1038/s41467-021-23445-w.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: Innovative Therapies For Children with Cancer Consortium

location_country: Ireland Italy France Spain Israel

location_facility:
Our Lady's Children's Hospital
Fondazione IRCCS Istituto
Gustave Roussy
Schneider Children's Medical Center
Hospital Universitari Vall D'Hebron


title: Multicenter Observational Retrospective French Study in Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab Via an Early Access Program

acronym: MESO-IMMUNE

summary:
Meso-Immune is a retrospective study to assess the efficacy and safety of the combination of Nivolumab and Ipilimumab used in first-line treatment of adult patients with unresectable Malignant Pleural Mesothelioma (MPM). This combination of treatments has been approved in Europe since June 2021 based on the results of the CheckMate 743 study. In France, the combination is not yet reimbursed for this population of patients. However, since April 01, 2021, newly diagnosed unresectable MPM patients may be treated with this combination via an early access program.

Meso-Immune study targets these patients included in the early access program with the objective to provide additional results to the CheckMate 743 study and confirm the benefit of using this combination in first-line of treatment in this category of patients.

Total study duration will cover 48 months with an inclusion period of 12 months and a follow-up until 3 years. Patients will be recruited retrospectively starting April 01, 2021 until April 01, 2022.

Meso-Immune study will be proposed to all the GFPC centers that have already included patients in the early access program and other centers wishing to participate, in order to analyze a minimum of 150 patients. The total number of sites is evaluated at around 120.

The principal investigator in each center will identify the patients eligible for the Meso-Immune study and will inform them on the study according to the local regulations.

Patient follow-up will be pursued regularly, in in-patient and out-patient clinics, according to the usual practices of the physicians in each participating center. Reevaluation workups will be pursued according to the practices of each center.

The information related to Patient characteristics, MPM characteristics, Treatment characteristics, Disease progression, Rebiopsy, Post treatments, Adverse events, Date and cause of death, Date of last news will be recorded in electronic case-report forms (eCRF).

Qualitative variables will be presented descriptively in the principal analysis.

time_perspective: Retrospective

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

sponsor_collaborators:
Groupe Francais De Pneumo-Cancerologie
Bristol-Myers Squibb

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Hôpital Haut-Lévèque - Groupe Hospitalier SUD


title: The Guarding Reflex Anal, Study of the Modulation Function of Rectal Distension

summary:
The term Guarding Reflex refers to a progressive, involuntary increase in the external urethral sphincter activity during bladder filling.This is a mechanism of continence, preventing from unwanted urine leakage in situation of stress.

Anal continence is essential, and any impairment of this function can have a severe impact on quality of life. Anal continence at rest is mainly insured by the tone of the internal anal sphincter. The external anal sphincter activity during gradually rectal filling is continuous and varies according to the volume of rectal distension.

During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the rectum. Increased intra-abdominal pressure during an expiratory against resistance effort proportionally increases the response of the external anal sphincter. The reflex contraction of the EAS is an active mechanism under spinal control, and result in a stronger contraction than a voluntary one. This reflex contraction is the equivalent of "Guarding Reflex" and provides part of the continence in situation of stress.

The main purpose of this study is to research a correlation between the ano rectal distension volume and the external anal sphincter response to a stress.

Patient over eighteen years old, consulting for anorectal manometry examination in order to explore anorectal disorders are included.

Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the curve for electromyography activity of the EAS and intercostal muscles during cough with a Valsalva effort are recorded. Slope curve representing the EAS response to stress according to the intercostal activity reflecting cough (intensity response curve) effort are calculated.

The protocol consists in distending the rectum at four different volumes. For each volume, the patient is asked to cough three times gradually, and perform a Valsalva effort three times gradually.

Primary outcome is the difference in curve slope (intensity response curves) between empty rectum and maximal tolerable volume at cough Secondary outcomes are the differences in curve slope between each volume of distension at cough, and Valsalva type effort.

ipd_sharing: Undecided

lead_sponsor: Gérard Amarenco

location_facility: Department of neuro-urology, hôpital Tenon


title: Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage

summary:
Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of 500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours after delivery.

In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. After obstetric maneuvers therapeutic, options begin with uterotonic treatments before considering invasive treatments such as embolization, vessel ligation and hysterectomy. However, the morbidity associated with these techniques and the desire to preserve fertility mean that new therapeutic solutions have been conceived, which has recently led to the development of an innovative intrauterine hemostasis medical device : a hemostatic intrauterine suction cup.

Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this biomedical research, the study of a new medical device. Our hypothesis is that the uterine walls will append to the walls of the suction cup after the latter is put under vacuum. The actuation of the suction cup will lead to the aspiration of all sides of the uterus.

Considering that postpartum haemorrhage is an emergency situation where vital prognosis of the patient is engaged, we selected to collect the consent of the patient using an emergengy procedure.

collaborators: Clinical Investigation Centre for Innovative Technology Network


title: Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study

acronym: CAPACITY

summary: Determination of vital and functional outcome in comatose survivors after cardiac arrest is principally based on the identification of predictors of non-awakening, using by clinical, biological and electrophysiological tools. In patients without presence of non-awakening predictors, it would be of interest to identify predictive criteria of awakening. The presence of mismatch negativity during the cortical auditory-evoked potential could contribute to further progress in neurological prognostication of these patients. However, at this time, its prognostic value has been insufficiently studied and the optimal time of realization remains unknown.

location_facility: Dr Stéphane LEGRIEL - Intensive Care Unit

location_facility: Lariboisière Hospital - Medical and toxicology unit


title: Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.

acronym: KTAP

summary: Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.

lead_sponsor: Pierre and Marie Curie University

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

summary: This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.

ReferenceCitation: Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kuhlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schroder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017.

ReferenceCitation: Edwards TL, Cottriall CL, Xue K, Simunovic MP, Ramsden JD, Zrenner E, MacLaren RE. Assessment of the Electronic Retinal Implant Alpha AMS in Restoring Vision to Blind Patients with End-Stage Retinitis Pigmentosa. Ophthalmology. 2018 Mar;125(3):432-443. doi: 10.1016/j.ophtha.2017.09.019. Epub 2017 Oct 27.

ipd_sharing_description: If data are shared, this will only be done in a pseudonymized manner.

lead_sponsor: Retina Implant AG

location_facility: Centre Hospitalier Universitaire La Milétrie de Poitiers


title: MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect

acronym: MS-DETECT

summary:
The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).

The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution.

A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients.

Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL).

Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression.

The study will include 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

status: Recruiting

lead_sponsor: Ad scientiam

location_country:
Germany
Italy
Denmark
United States
Spain
Canada
France

location_facility:
Mikael Cohen
Robert Carruthers
Galina Vorobeychik
Joash Lazarus Sr.
Universitätsklinikum Carl Gustav Carus
University Hospital San Carlos
Adil Maarouf
Boris-Alexander Kallman
Sivagini Prakash
IRCCS Ospedale San Raffaele
University Hospital of Southern Denmark
St. Michael's Hospital
Emanuele D'Amico
Lluís Ramió
Bertrand Bourre
Enric Monreal
Mark Freedman
Aaron Boster
Cécile Donzé
Ana Alonsa
Miguel Llaneza
Helene Hoejsgaard Chow
Henrik Boye Jensen
Damiano Paolicelli
Jesùs Martin
Craig E. Herrman
Hôpital Roger Salengro
Gabriel Pardo
Felix Bischof
Carla Tortorella
Emilio Portaccio
Stefan Ries


title: Pro-inflammatory Role of Blood Platelets in Critically Ill Patients With Septic Shock: an Observational Study.

acronym: PLAQSIS

summary: Blood platelets play a major role in the inflammatory response. A dysregulation of platelets activation may be one of the contributors to tissue damage in critically ill patients with septic shock. The main objective of this study is to compare platelet activation markers levels (including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1) at the early phase of a septic shock and a systemic inflammatory response syndrome (SIRS).

sponsor_collaborators:
University Hospital, Bordeaux
MSD France

location_facility:
Hôpital Saint Louis
Hôpital Haut Lévêque


title: Retrospective Efficacy and Safety Study With Elbasvir 50 mg/Grazoprevir 100 mg in HCV-infected Patients With Chronic Kidney Disease Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

summary: Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
MSD France

location_facility:
University Hospital Toulouse
University Hospital


title: Surgical Strategy for Repair of Type A Aortic Dissection: A Multicenter Registry

acronym: STAAD

summary:
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Rapid diagnosis and subsequent prompt surgical repair remain the primary goal for these patients.

In the last decade it has been observed that improvements in diagnostic techniques, initial management and increased clinical awareness have contributed to a substantial increase in the number of patients benefiting from a prompt diagnosis and undergoing surgery.However, survival after surgical repair has not yet reached optimal follow-ups and is burdened by high in-hospital mortality(16-18%)

status: Enrolling by invitation

ReferenceType: result

ReferenceCitation: Mahase E. Half of patients with acute aortic dissection in England die before reaching a specialist centre. BMJ. 2020 Jan 23;368:m304. doi: 10.1136/bmj.m304. No abstract available.

oa_host_type: closed

publisher_dissemination: British Medical Journal

ReferenceCitation: Braverman AC. Acute aortic dissection: clinician update. Circulation. 2010 Jul 13;122(2):184-8. doi: 10.1161/CIRCULATIONAHA.110.958975. No abstract available.

ReferenceCitation: Howard DP, Banerjee A, Fairhead JF, Perkins J, Silver LE, Rothwell PM; Oxford Vascular Study. Population-based study of incidence and outcome of acute aortic dissection and premorbid risk factor control: 10-year results from the Oxford Vascular Study. Circulation. 2013 May 21;127(20):2031-7. doi: 10.1161/CIRCULATIONAHA.112.000483. Epub 2013 Apr 18.

repositories_concat: PubMed Central

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Biancari F, Juvonen T, Fiore A, Perrotti A, Herve A, Touma J, Pettinari M, Peterss S, Buech J, Dell'Aquila AM, Wisniewski K, Rukosujew A, Demal T, Conradi L, Pol M, Kacer P, Onorati F, Rossetti C, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Rodriguez Lega J, Pinto AG, Acharya M, El-Dean Z, Field M, Harky A, Nappi F, Gerelli S, Di Perna D, Gatti G, Mazzaro E, Rosato S, Raivio P, Jormalainen M, Mariscalco G. Current Outcome after Surgery for Type A Aortic Dissection. Ann Surg. 2023 Oct 1;278(4):e885-e892. doi: 10.1097/SLA.0000000000005840. Epub 2023 Mar 13.

ReferenceCitation: Benedetto U, Dimagli A, Kaura A, Sinha S, Mariscalco G, Krasopoulos G, Moorjani N, Field M, Uday T, Kendal S, Cooper G, Uppal R, Bilal H, Mascaro J, Goodwin A, Angelini G, Tsang G, Akowuah E. Determinants of outcomes following surgery for type A acute aortic dissection: the UK National Adult Cardiac Surgical Audit. Eur Heart J. 2021 Dec 28;43(1):44-52. doi: 10.1093/eurheartj/ehab586.

repository_institution: University of Southampton - ePrints Soton

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

publisher_dissemination: Oxford University Press

ReferenceCitation: Geirsson A, Shioda K, Olsson C, Ahlsson A, Gunn J, Hansson EC, Hjortdal V, Jeppsson A, Mennander A, Wickbom A, Zindovic I, Gudbjartsson T. Differential outcomes of open and clamp-on distal anastomosis techniques in acute type A aortic dissection. J Thorac Cardiovasc Surg. 2019 May;157(5):1750-1758. doi: 10.1016/j.jtcvs.2018.09.020. Epub 2018 Sep 29.

ReferenceCitation: Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

ReferenceCitation: Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 2015 Jun 23;65(24):2628-2635. doi: 10.1016/j.jacc.2015.04.030.

ReferenceCitation: O'Hara D, McLarty A, Sun E, Itagaki S, Tannous H, Chu D, Egorova N, Chikwe J. Type-A Aortic Dissection and Cerebral Perfusion: The Society of Thoracic Surgeons Database Analysis. Ann Thorac Surg. 2020 Nov;110(5):1461-1467. doi: 10.1016/j.athoracsur.2020.04.144. Epub 2020 Jun 26.

lead_sponsor: Centre Cardiologique du Nord

sponsor_collaborators:
Centre Cardiologique du Nord
Henri Mondor University Hospital
Universita degli Studi di Genova
Pitié-Salpêtrière Hospital


title: Early Complication and Outcomes in Surgical vs no Surgical Involvement of Aortic Arch in Type A Aortic Dissection

acronym: AoArch

summary: Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD

repositories_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_institution: University of Southampton - ePrints Soton

sponsor_collaborators:
Centre Cardiologique du Nord
Henri Mondor University Hospital
Hokkaido University
Universita degli Studi di Genova
Pitié-Salpêtrière Hospital


title: Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study

acronym: STAFE

summary: The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.

ReferenceCitation: Rouze A, Loridant S, Poissy J, Dervaux B, Sendid B, Cornu M, Nseir S; S-TAFE study group. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1668-1677. doi: 10.1007/s00134-017-4932-8. Epub 2017 Sep 22.

lead_sponsor: University Hospital, Lille

location_facility: ICU, Salengro Hospital, University Hospital of Lille


type: EudraCT Number

title: Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse

acronym: DIAMA

summary:
Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.

However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.

The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.

location_facility: Outpatient Addiction Center "CSAPA - Le Pari"


lead_sponsor: Sanofi Pasteur, a Sanofi Company

summary:
The purpose of this study is to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalizations) in all infants under 12 months of age who are not eligible to receive palivizumab.

The visit frequency will be 1 in-person dosing/randomization visit, with monthly safety follow-up electronic contacts through the first 6 months post dosing/randomization for all participants. The study will also include a 12-month (Day 366) follow-up telephone call. The D366 follow-up telephone call will be the final follow-up telephone call for France, Germany and UK non-reconsented participants. The study will include an 18-month (D546) and a 24-month (D731, final telephone call) follow-up telephone call for UK reconsented participants.

sponsor_collaborators:
Sanofi Pasteur, a Sanofi Company
AstraZeneca

location_facility:
Investigational Site Number: 2760056
Investigational Site Number: 2760025
Investigational Site Number: 8260054
Investigational Site Number: 2760019
Investigational Site Number: 8260035
Investigational Site Number: 8260060
Investigational Site Number: 2500068
Investigational Site Number: 8260095
Investigational Site Number: 2760047
Investigational Site Number: 8260057
Investigational Site Number: 8260075
Investigational Site Number: 2500013
Investigational Site Number: 2760051
Investigational Site 8260023
Investigational Site Number: 2760046
Investigational Site Number: 8260040
Investigational Site Number: 8260087
Investigational Site Number: 2500029
Investigational Site Number: 2760084
Investigational Site Number: 2760091
Investigational Site Number: 2760061
Investigational Site Number: 2500032
Investigational Site Number: 8260069
Investigational Site Number: 8260045
Investigational Site Number: 8260059
Investigational Site 8260082
Investigational Site 2500059
Investigational Site Number: 8260104
Investigational Site Number: 2760032
Investigational Site 2500028
Investigational Site Number: 8260019
Investigational Site Number: 2760083
Investigational Site Number: 8260076
Investigational Site Number: 8260116
Investigational Site Number: 2500044
Investigational Site 2500020
Investigational Site Number: 8260111
Investigational Site Number: 2760036
Investigational Site Number: 2760015
Investigational Site Number: 2760005
Investigational Site Number: 8260107
Investigational Site Number: 8260008
Investigational Site Number: 8260093
Investigational Site Number: 2760076
Investigational Site Number: 2500051
Investigational Site Number: 2760033
Investigational Site Number:
Investigational Site Number: 8260100
Investigational Site Number: 2500078
Investigational Site Number: 8260041
Investigational Site Number: 2500006
Investigational Site 8260005
Investigational Site Number: 2500023
Investigational Site Number: 8260006
Investigational Site Number: 2760098
Investigational Site Number: 8260077
Investigational Site Number: 2760064
Investigational Site Number: 8260047
Investigational Site Number: 8260101
Investigational Site Number: 8260109
Investigational Site Number: 8260083
Investigational Site 2500041
Investigational Site Number: 2760062
Investigational Site Number: 2500063
Investigational Site 8260009
Investigational Site Number: 8260001
Investigational Site Number: 2760060
Investigational Site Number: 2500060
Investigational Site Number: 2760095
Investigational Site Number: 8260042
Investigational Site 2500007
Investigational Site Number: 8260105
Investigational Site Number: 8260020
Investigational Site Number: 2500010
Investigational Site Number: 8260027
Investigational Site Number: 2500064
Investigational Site Number: 8260117
Investigational Site Number: 2500035
Investigational Site Number: 2760013
Investigational Site Number: 8260119
Investigational Site Number: 2500026
Investigational Site Number: 8260074
Investigational Site 8260046
Investigational Site Number: 2500012
Investigational Site Number: 2500067
Investigational Site Number: 2760004
Investigational Site Number: 8260015
Investigational Site Number: 2500057
Investigational Site Number: 8260097
Investigational Site Number: 2500003
Investigational Site Number: 8260007
Investigational Site Number: 8260056
Investigational Site 2500046
Investigational Site 2760010
Investigational Site Number: 2500034
Investigational Site Number: 2500049
Investigational Site 8260018
Investigational Site 2500021
Investigational Site 8260043
Investigational Site Number: 2760096
Investigational Site Number: 2500040
Investigational Site Number: 2760057
Investigational Site Number: 2500027
Investigational Site Number: 2500074
Investigational Site Number: 2760071
Investigational Site Number: 2760043
Investigational Site Number: 2760101
Investigational Site Number: 2760050
Investigational Site Number: 2500001
Investigational Site Number: 2500050
Investigational Site Number: 8260030
Investigational Site Number: 2760008
Investigational Site Number: 2760034
Investigational Site Number: 2500042
Investigational Site Number: 8260103
Investigational Site Number: 8260102
Investigational Site Number: 2760081
Investigational Site Number: 2500072
Investigational Site Number: 2500037
Investigational Site Number: 8260106
Investigational Site Number: 2500077
Investigational Site Number: 2500047
Investigational Site Number: 2760002
Investigational Site 2760029
Investigational Site 2500030
Investigational Site Number: 2760079
Investigational Site Number: 2760040
Investigational Site Number: 2760038
Investigational Site Number: 8260108
Investigational Site 8260026
Investigational Site Number: 8260098
Investigational Site Number: 2760099
Investigational Site Number: 2760028
Investigational Site Number: 8260031
Investigational Site Number: 8260096
Investigational Site Number: 8260110
Investigational Site Number: 8260014
Investigational Site Number: 8260050
Investigational Site Number: 8260044
Investigational Site 2500002
Investigational Site Number: 2500018
Investigational Site Number: 8260068
Investigational Site Number: 2500073
Investigational Site Number: 8260081
Investigational Site Number: 8260024
Investigational Site Number: 8260012
Investigational Site Number: 2500043
Investigational Site Number: 2760067
Investigational Site Number: 8260062
Investigational Site 8260051
Investigational Site Number: 8260073
Investigational Site Number: 2760001
Investigational Site Number: 8260039
Investigational Site Number: 8260053
Investigational Site Number: 8260021
Investigational Site Number: 2500009
Investigational Site Number: 2760044
Investigational Site Number: 2500015
Investigational Site Number: 2500071
Investigational Site Number: 2760003
Investigational Site Number: 8260004
Investigational Site 8260064
Investigational Site Number: 8260058
Investigational Site Number: 8260025
Investigational Site Number: 8260092
Investigational Site Number: 2500052
Investigational Site 2500008
Investigational Site Number: 8260032
Investigational Site Number: 2760054
Investigational Site Number: 8260084
Investigational Site Number: 8260010
Investigational Site Number: 8260065
Investigational Site Number: 8260112
Investigational Site Number: 8260011
Investigational Site Number: 2500054
Investigational Site Number: 8260034
Investigational Site Number: 2760069
Investigational Site Number: 8260037
Investigational Site Number: 8260067
Investigational Site Number: 8260016
Investigational Site Number: 8260086
Investigational Site Number: 8260071
Investigational Site Number: 2760017
Investigational Site Number: 8260115
Investigational Site Number: 2500058
Investigational Site Number: 2760086
Investigational Site Number: 8260036
Investigational Site Number: 2760023
Investigational Site Number: 8260022
Investigational Site Number: 2760093
Investigational Site Number: 2760085
Investigational Site Number: 2760007
Investigational Site Number: 2500004
Investigational Site Number: 2500075
Investigational Site Number: 2500039
Investigational Site Number: 2760059
Investigational Site Number: 2760030
Investigational Site Number: 8260052
Investigational Site Number: 8260061
Investigational Site Number: 2500024
Investigational Site 2760006
Investigational Site Number: 8260002
Investigational Site Number: 8260038
Investigational Site Number: 8260091
Investigational Site Number: 2760027
Investigational Site Number: 8260003
Investigational Site Number: 2500011
Investigational Site Number: 2760045
Investigational Site Number: 8260029
Investigational Site Number: 2760092
Investigational Site Number: 8260066
Investigational Site Number: 8260088
Investigational Site Number: 2760049
Investigational Site Number: 8260072
Investigational Site Number: 2500019
Investigational Site Number: 8260079
Investigational Site Number: 2760094
Investigational Site 2500005
Investigational Site Number: 2500038
Investigational Site Number: 2760035
Investigational Site Number: 2500069
Investigational Site Number: 8260078
Investigational Site Number: 2500066
Investigational Site Number: 8260080
Investigational Site Number: 8260013
Investigational Site Number: 2760020
Investigational Site Number: 8260094
Investigational Site Number: 2760014
Investigational Site Number: 2500022
Investigational Site 8260028
Investigational Site Number: 2760065
Investigational Site Number: 2760016
Investigational Site Number: 2500045
Investigational Site Number: 8260085
Investigational Site Number: 2500065
Investigational Site Number: 2500014
Investigational Site Number: 2500055
Investigational Site Number: 2760018
Investigational Site Number: 8260063
Investigational Site Number: 8260017

title: A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)

type: Registry Identifier

source: euctr

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Germany
United Kingdom
France

ipd_sharing: Yes


title: Effect of Bladder Filling on Rectal Contractions During Cystometry

summary:
Increasing knowledge on rectal motility and bladder-rectum cross-talk has been published in recent years. However, whether bladder filling factors during multichannel urodynamic studies affect rectal contraction (RC) parameters has not been studied.

The primary aim of this study is to assess the impact of bladder filling and desire to void on rectal contraction amplitude or frequency.

Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment.

All patients referred for urodynamic assessment and with studies positive for rectal contractions as defined by the international continence society (ICS) will be included. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Standardized urodynamic evaluation will be conducted following ICS guidelines.

Mean amplitude, maximal amplitude (cmH20) and mean frequency of rectal contractions on all urodynamic studies will be visually measured on the recording software and compared depending on bladder sensation (First Desire to void (FDV), Strong Desire to Void (SDV) and filling volume (200ml, 400ml).

Demographic data (age, sex, BMI), underlying neurological disease, clinical symptoms, and scores (Neurogenic Bladder Symptom Score, Bristol Score, Cleveland Score), urodynamic parameters and treatments will be collected. Time since last defecation and meal will also be collected.

This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment.

location_facility: department of Neuro-Urology, Hôpital Teno


title: Is the Severity of Urinary Disorders Related to Falls in People With Multiple Sclerosis

summary:
Falls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe consequences (trauma, fear of falling, reduction of social activities). Prevention of falls is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can result of different factors (motor impairment, ataxia, sensitive disorders, fatigability…). Urinary incontinence has been evoked as predictive of falls. But lower urinary tract symptoms (LUTSs) are frequent in PwMS, the prevalence of LUTSs is high (32-96.8%) and increases with MS duration and severity of neurological deficiencies and disabilities. Overactive bladder (OAB) is the most common symptom. Despite its high prevalence and impact on quality of life, the severity of LUTSs has never been studied as specific risk factor of falling. However, urinary urgency and urinary incontinence could lead to precipitation and thus could increase the risk of falling in these patients.

The aim of the study was to assess the relationship between severity of LUTSs and risk of falling in PwMS.

Patients were asked about the number of falls in the past three months and in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia). Severity of LUTSs were assessed by the Urinary Symptoms Profile (USP) Score and patient were classified as with or without urinary incontinence. Number of micturition by night were specifically asked. To take into account motor difficulties and fear of falling, other clinical evaluations were done. The impact of MS on walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire, the Expanded Disability Status Scale score, and by clinical test with the Time to be Ready to Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy Scale-International (FES-I) Questionnaire.

The primary aim was to assess the relationship between severity of LUTSs and occurrence of falls during the past 3 months. The primary outcome was the importance of overactive bladder (OAB) symptoms with OAB USP score. The secondary outcomes were the existence of urinary incontinence, the warning time (defined as the time from the first sensation of urgency to voiding or incontinence), the importance of nocturia and the other scores of USP questionnaire (low stream and stress urinary incontinence).

The secondary aims were to look for the relationship between severity of LUTSs and occurrence of falls during the past year, and to assess the relationship between falls and the classical risk factors of falls.

ReferenceCitation: Hentzen C, Villaume A, Turmel N, Chesnel C, Le Breton F, Haddad R, Amarenco G. Are falls in people with multiple sclerosis related to the severity of urinary disorders? Ann Phys Rehabil Med. 2021 Jul;64(4):101452. doi: 10.1016/j.rehab.2020.10.006. Epub 2020 Dec 5.

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

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

location_facility: department of Neuro-Urology, Hôpital Tenon


title: Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment : Phase II Multicentric Randomized Double Bland Placebo Controlled Study

acronym: SOMILEO

summary:
During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure. This risk implies parenteral correction which may extend hospital stay and delay home return.

Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not routinely used for the treatment of patients with high-output enterostomy and their efficacy in the indication (off-label) was only tested in small case series. Pasireotide (SOM230, SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed.

As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual medical treatment associated with an oral fluid restriction has never been demonstrated before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled trial evaluating its impact on reduction of the effluent volume.

location_facility: Institut Regional Du Cancer Val D'Aurelle


title: What Are the Criteria for the Patient's Choice of Sel-catheterization Catheter

summary: The aim of this study is to evaluate which are the most important criteria guiding the choice of the catheter for the patient to perform clean intermittent self catheterization.


title: Time to be Ready to Void: a New Tool to Assess the Time Needed to Perform Micturition for Patients With Multiple Sclerosis

summary: The aim of the study is to create a specific test to assess the global time required to go to the toilet and to perform micturition, at the moment the patient decides to urinate in multiple sclerosis population, and to assess its reliability.


acronym: COLIN

lead_sponsor: University Hospital, Montpellier

summary:
Background:

Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.

More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor outcomes or longer stay at hospital.

Endpoints:

Main endpoint: AUC CRP during the initial hospital stay

Secondary endpoints:

Clinical: oucomes
Imaging: ETT, MRI
Biological: various biomarkers

Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine

location_facility: University Hospital Arnaud de Villeneuve

title: Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response


title: Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation : Contribution of Electrophysioly Study

acronym: TAVISTIM

summary:
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this intervention may induce heavy conduction disorder due to the proximity of the aortic annulus and the conduction pathways. So far, there is no clear recommandation for clinical management of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple comorbidity factors observed in these patients. As described in conventional aortic valve surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in the first days. This is the reason underlying the systematic implantation of epicardial electrodes. Such temporary back-up pacing is not possible in TAVI patients.

The primary end-point of this study is to confirm that standard criterion for pacing are reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic electrophysiological study (EPS).

In TAVI patients, indications for pacing were persistent high-degree atrioventricular block (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours after the procedure.

After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will be realized in patients without pacemaker and compared to data obtained from the devices in pacemaker-implanted patients (% of ventricular pacing > 1% ; presence of more than 1 AVB episod).


title: Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage

acronym: HEMOGYN

summary:
The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis.

The postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. With the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. The actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). The suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.

primary_purpose: Health Services Research

lead_sponsor: AdministrateurCIC