title: Register of Cardiovascular Complications Among People Living With HIV

acronym: RECOVIH

summary: The REgister of cardiovascular COmplications among people living with HIV (RECOVIH) is a single hospital registry of adults living with HIV, with one or more other cardiovascular risk factor, who undergo cardiac examination at the Cardiac Center of the Saint Antoine Hospital. RECOVIH is an observational and prospective, monocentric (institutional) registry, with anonymized cardiac, biochemical and associated data collection.

ReferenceCitation: Wever Pinzon O, Silva Enciso J, Romero J, Makani H, Fefer J, Gandhi V, Bangalore S, Chaudhry FA. Risk stratification and prognosis of human immunodeficiency virus-infected patients with known or suspected coronary artery disease referred for stress echocardiography. Circ Cardiovasc Imaging. 2011 Jul;4(4):363-70. doi: 10.1161/CIRCIMAGING.110.961060. Epub 2011 Jul 12.

ReferenceCitation: Mariano-Goulart D, Jacquet JM, Molinari N, Bourdon A, Benkiran M, Sainmont M, Cornillet L, Macia JC, Reynes J, Ben Bouallègue F. Should HIV-infected patients be screened for silent myocardial ischaemia using gated myocardial perfusion SPECT? Eur J Nucl Med Mol Imaging. 2013 Jan;40(2):271-9. doi: 10.1007/s00259-012-2262-1. Epub 2012 Nov 14.

ReferenceCitation: Duong M, Cottin Y, Piroth L, Fargeot A, Lhuiller I, Bobillier M, Grappin M, Buisson M, Zeller M, Chavanet P, Wolf JE, Portier H. Exercise stress testing for detection of silent myocardial ischemia in human immunodeficiency virus-infected patients receiving antiretroviral therapy. Clin Infect Dis. 2002 Feb 15;34(4):523-8. Epub 2002 Jan 2.

ReferenceCitation: Catzin-Kuhlmann A, Orea-Tejeda A, Castillo-Martínez L, Colín-Ramírez E, Asz D, Aguirre VH, Herrera LE, Valles V, Aguilar-Salinas CA, Sierra J, Calva JJ. Human immunodeficiency virus-infected subjects have no altered myocardial perfusion. Int J Cardiol. 2007 Oct 31;122(1):90-2. Epub 2007 Jan 26.

ReferenceCitation: Mansoor A, Golub ET, Dehovitz J, Anastos K, Kaplan RC, Lazar JM. The association of HIV infection with left ventricular mass/hypertrophy. AIDS Res Hum Retroviruses. 2009 May;25(5):475-81. doi: 10.1089/aid.2008.0170.

ReferenceCitation: Mondy KE, Gottdiener J, Overton ET, Henry K, Bush T, Conley L, Hammer J, Carpenter CC, Kojic E, Patel P, Brooks JT; SUN Study Investigators. High Prevalence of Echocardiographic Abnormalities among HIV-infected Persons in the Era of Highly Active Antiretroviral Therapy. Clin Infect Dis. 2011 Feb 1;52(3):378-86. doi: 10.1093/cid/ciq066. Epub 2010 Dec 9.

ReferenceCitation: Reinsch N, Neuhaus K, Esser S, Potthoff A, Hower M, Brockmeyer NH, Erbel R, Neumann T; German Competence Network for Heart Failure; German Competence Network for HIV AIDS. Prevalence of cardiac diastolic dysfunction in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2010 May-Jun;11(3):156-62. doi: 10.1310/hct1103-156.

ReferenceCitation: Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Müller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Löffler M, Maisch B, Mügge A, Wasem J, Gerken G, Brockmeyer NH, Erbel R; HIV-HEART Study Investigative Group. Prevalence and natural history of heart failure in outpatient HIV-infected subjects: rationale and design of the HIV-HEART study. Eur J Med Res. 2007 Jun 27;12(6):243-8.

ReferenceCitation: Reinsch N, Buhr C, Krings P, Kaelsch H, Kahlert P, Konorza T, Neumann T, Erbel R; Competence Network of Heart Failure. Effect of gender and highly active antiretroviral therapy on HIV-related pulmonary arterial hypertension: results of the HIV-HEART Study. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28.

ReferenceCitation: Martínez-García T, Sobrino JM, Pujol E, Galvez J, Benítez E, Girón-González JA. Ventricular mass and diastolic function in patients infected by the human immunodeficiency virus. Heart. 2000 Dec;84(6):620-4.

ReferenceCitation: Hsue PY, Hunt PW, Ho JE, Farah HH, Schnell A, Hoh R, Martin JN, Deeks SG, Bolger AF. Impact of HIV infection on diastolic function and left ventricular mass. Circ Heart Fail. 2010 Jan;3(1):132-9. doi: 10.1161/CIRCHEARTFAILURE.109.854943. Epub 2009 Nov 20.

ReferenceCitation: Oliviero U, Bonadies G, Bosso G, Foggia M, Apuzzi V, Cotugno M, Valvano A, Leonardi E, Borgia G, Castello G, Napoli R, Saccà L. Impaired diastolic function in naïve untreated human immunodeficiency virus infected patients. World J Cardiol. 2010 Apr 26;2(4):98-103. doi: 10.4330/wjc.v2.i4.98.

ReferenceCitation: Lewden C, May T, Rosenthal E, Burty C, Bonnet F, Costagliola D, Jougla E, Semaille C, Morlat P, Salmon D, Cacoub P, Chêne G; ANRS EN19 Mortalité Study Group and Mortavic1. Changes in causes of death among adults infected by HIV between 2000 and 2005: The "Mortalité 2000 and 2005" surveys (ANRS EN19 and Mortavic). J Acquir Immune Defic Syndr. 2008 Aug 15;48(5):590-8. doi: 10.1097/QAI.0b013e31817efb54.

ReferenceCitation: Palella FJ Jr, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, Holmberg SD; HIV Outpatient Study Investigators. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006 Sep;43(1):27-34.

ReferenceCitation: Dubé MP, Stein JH, Aberg JA, Fichtenbaum CJ, Gerber JG, Tashima KT, Henry WK, Currier JS, Sprecher D, Glesby MJ; Adult AIDS Clinical Trials Group Cardiovascular Subcommittee; HIV Medical Association of the Infectious Disease Society of America. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis. 2003 Sep 1;37(5):613-27. Epub 2003 Aug 15. Review.

ReferenceCitation: Aberg JA, Gallant JE, Ghanem KG, Emmanuel P, Zingman BS, Horberg MA; Infectious Diseases Society of America. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jan;58(1):1-10. doi: 10.1093/cid/cit757.

ReferenceCitation: Lundgren JD, Battegay M, Behrens G, De Wit S, Guaraldi G, Katlama C, Martinez E, Nair D, Powderly WG, Reiss P, Sutinen J, Vigano A; EACS Executive Committee. European AIDS Clinical Society (EACS) guidelines on the prevention and management of metabolic diseases in HIV. HIV Med. 2008 Feb;9(2):72-81. doi: 10.1111/j.1468-1293.2007.00534.x.

ReferenceCitation: Prise en charge médical des personnes vivants avec le VIH. Recommandations du groupe d'experts. Sous la direction du Pr Philippe Morlat et sous l'égide du CNS et de l'ANRS. www.cns.sante.fr. 2013.

ReferenceCitation: European Association for Cardiovascular Prevention & Rehabilitation, Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.

ReferenceCitation: Nayak G, Ferguson M, Tribble DR, Porter CK, Rapena R, Marchicelli M, Decker CF. Cardiac diastolic dysfunction is prevalent in HIV-infected patients. AIDS Patient Care STDS. 2009 Apr;23(4):231-8. doi: 10.1089/apc.2008.0142.

ReferenceCitation: El Hattaoui M, Charei N, Boumzebra D, Aajly L, Fadouach S. [Prevalence of cardiomyopathy in HIV infection: prospective study on 158 HIV patients]. Med Mal Infect. 2008 Jul;38(7):387-91. doi: 10.1016/j.medmal.2008.03.006. Epub 2008 Jun 25. French.

ReferenceCitation: Karavidas A, Foukarakis M, Lazaros G, Chini M, Fotiadis I, Arapi S, Gialernios T, Potamitis N, Gargalianos P, Matsakas E, Stefanadis C. Assessment of cardiac function with Doppler tissue imaging in asymptomatic HIV-infected patients. Int J STD AIDS. 2008 Apr;19(4):227-31. doi: 10.1258/ijsa.2007.007225.

ReferenceCitation: Thöni GJ, Schuster I, Walther G, Nottin S, Vinet A, Boccara F, Mauboussin JM, Rouanet I, Edérhy S, Dauzat M, Messner-Pellenc P, Obert P. Silent cardiac dysfunction and exercise intolerance in HIV+ men receiving combined antiretroviral therapies. AIDS. 2008 Nov 30;22(18):2537-40. doi: 10.1097/QAD.0b013e328319806d.

ReferenceCitation: Lang S, Mary-Krause M, Cotte L, Gilquin J, Partisani M, Simon A, Boccara F, Costagliola D; Clinical Epidemiology Group of the French Hospital Database on HIV. Impact of individual antiretroviral drugs on the risk of myocardial infarction in human immunodeficiency virus-infected patients: a case-control study nested within the French Hospital Database on HIV ANRS cohort CO4. Arch Intern Med. 2010 Jul 26;170(14):1228-38. doi: 10.1001/archinternmed.2010.197.

ReferenceCitation: Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Physicians; American Association for Thoracic Surgery; Preventive Cardiovascular Nurses Association; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012 Dec 18;60(24):e44-e164. doi: 10.1016/j.jacc.2012.07.013. Epub 2012 Nov 19.

ReferenceCitation: Arbab-Zadeh A. Stress testing and non-invasive coronary angiography in patients with suspected coronary artery disease: time for a new paradigm. Heart Int. 2012 Feb 3;7(1):e2. doi: 10.4081/hi.2012.e2. Epub 2012 Feb 8.

lead_sponsor: Saint Antoine University Hospital

location_facility: Division of Cardiology, Saint Antoine University Hospital


title: Molecular Characterization of Apparently Balanced Chromosomal Rearrangements by Next-generation Sequencing in 55 Patients With Intellectual Disability and/or Multiple Congenital Anomalies

acronym: ANI

summary:
Apparently balanced chromosomal rearrangement (ABCR) associated with an abnormal phenotype is a rare but problematic event. It occurs in 6% of de novo reciprocal translocations and 9% of de novo inversions. Abnormal phenotype, including intellectual disability and / or multiple congenital anomalies (ID/MCA) may be explained either by associated cryptic genomic imbalances detectable by array-CGH or by gene disruption at the breakpoint. However, breakpoint cloning using conventional methods (i.e., fluorescent in situ hybridization (FISH), Southern blot) is often laborious and time consuming and cannot be performed routinely. Without complete investigation of these rearrangements, genetic counseling is a real challenge. Recently, the investigators and others showed that Next-Generation Sequencing (NGS) is a powerful and rapid technique to characterize ABCR breakpoints at the molecular level.

The ANI project (ABCR NGS ID) aims at characterizing at the molecular level ABCR in 55 patients presenting with intellectual disability and/or multiple congenital anomalies (ID/MCA) using NGS. The investigators make the hypothesis that ABCR account for the patient phenotype, either by gene disruption or position effect, since genomic imbalance would have been previously excluded by array-Comparative Genomic Hybridization (CGH).

The ANI project is a 3-year-long study that will be conducted by a consortium of 21 partners, including 19 french hospital cytogenetics laboratories, a research team (TIGER), and a cellular biotechnology center. Patients will be recruited by each Cytogenetics laboratory. ABCR breakpoints will be molecularly characterized by NGS and a first bio-informatics analysis. The results will be verified by amplification of junction fragments by polymerase Chain Reaction (PCR) followed by Sanger sequencing, allowing the localization of breakpoints at the base-pair level. In some complex cases, FISH experiment will be necessary to clarify the results. A second bio-informatics analysis will then determine breakpoints' characteristics (sequence, repeated elements, gene and regulatory elements). Finally, for each breakpoint, gene expression studies will be performed including the gene disrupted by the breakpoint and two neighboring genes. All these data, together with those already available in the literature and databases will be integrated to determine if the gene could account for the patient's phenotype, allowing an appropriate genetic counseling.

This project will identify new candidate genes involved in ID and developmental anomalies. It will also contribute to the development and evaluation of NGS as a diagnostic tool for ABCR and ID/MCA. It will also allow unraveling mechanisms and functional consequences of ABCR, in particular in term of position effect.

In conclusion, the ANI project will contribute to the improvement of diagnostic management and genetic counseling of patients with ID/MCA and ABCR. It will also contribute to the understanding of ABCR physiopathology and to the unraveling of pathway involved in development and brain function, thus improving genetic counseling for ID/MCA patients in general.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: laboratoire de Cytogénétique Constitutionnelle - Centre de Biologie et Pathologie Est

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


title: Predictive Ability of Alpha-GST to Detect Graft Primary Dysfunction After Liver Transplantation

acronym: GST-LT

summary: The primary objective of this study was to evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to predict primary dysfunction in liver recipient. The secondary objective was to study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Beaujon Hospital

status_simplified: Unknown


title: Safety and Efficiency of Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery

summary:
Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management.

The investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.

ReferenceType: result

ReferenceCitation: Schechter MA, Shortell CK, Scarborough JE. Regional versus general anesthesia for carotid endarterectomy: the American College of Surgeons National Surgical Quality Improvement Program perspective. Surgery. 2012 Sep;152(3):309-14. doi: 10.1016/j.surg.2012.05.008. Epub 2012 Jun 27.

family: Schechter

full_name: Matthew A. Schechter

given: Matthew A.

sequence: first

family: Shortell

full_name: Cynthia K. Shortell

given: Cynthia K.

sequence: additional

family: Scarborough

full_name: John E. Scarborough

given: John E.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Surgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Regional versus general anesthesia for carotid endarterectomy: The American College of Surgeons National Surgical Quality Improvement Program perspective

ReferenceCitation: Usui Y, Kobayashi T, Kakinuma H, Watanabe K, Kitajima T, Matsuno K. An anatomical basis for blocking of the deep cervical plexus and cervical sympathetic tract using an ultrasound-guided technique. Anesth Analg. 2010 Mar 1;110(3):964-8. doi: 10.1213/ANE.0b013e3181c91ea0. Epub 2009 Dec 15.

family: Usui

full_name: Yosuke Usui

given: Yosuke

family: Kobayashi

full_name: Toshiya Kobayashi

given: Toshiya

family: Kakinuma

full_name: Hiroyuki Kakinuma

given: Hiroyuki

family: Watanabe

full_name: Keisuke Watanabe

given: Keisuke

family: Kitajima

full_name: Toshimitsu Kitajima

given: Toshimitsu

family: Matsuno

full_name: Kenjiro Matsuno

given: Kenjiro

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: An Anatomical Basis for Blocking of the Deep Cervical Plexus and Cervical Sympathetic Tract Using an Ultrasound-Guided Technique

ReferenceCitation: Choquet O, Dadure C, Capdevila X. Ultrasound-guided deep or intermediate cervical plexus block: the target should be the posterior cervical space. Anesth Analg. 2010 Dec;111(6):1563-4; author reply 1564-5. doi: 10.1213/ANE.0b013e3181f1d48f.

family: Choquet

full_name: Olivier Choquet

given: Olivier

family: Dadure

full_name: Christophe Dadure

given: Christophe

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

title: Ultrasound-Guided Deep or Intermediate Cervical Plexus Block

lead_sponsor: Institut Mutualiste Montsouris

location_facility: Department of Anesthesia Institut Mutualiste Montsouris

intervention_type: Procedure

lead_sponsor_type: industriel


type: Other Identifier

title: Treatment of Epicondylitis by Ultrasound-guided Local Injections of Autologous Conditioned Plasma (ACP®): a Double-blind Placebo-controlled Randomized Clinical Trial With One-year Follow-up

summary: The purpose of this study is to assess efficacy of two intra-tendinous injections of platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared compared to two intra-tendinous injections of saline solution (placebo).

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: De Smedt T, de Jong A, Van Leemput W, Lieven D, Van Glabbeek F. Lateral epicondylitis in tennis: update on aetiology, biomechanics and treatment. Br J Sports Med. 2007 Nov;41(11):816-9. Epub 2007 Jul 6. Review.

ReferenceCitation: Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med. 1992 Oct;11(4):851-70. Review.

ReferenceCitation: McCormack RR Jr, Inman RD, Wells A, Berntsen C, Imbus HR. Prevalence of tendinitis and related disorders of the upper extremity in a manufacturing workforce. J Rheumatol. 1990 Jul;17(7):958-64.

ReferenceCitation: Ono Y, Nakamura R, Shimaoka M, Hiruta S, Hattori Y, Ichihara G, Kamijima M, Takeuchi Y. Epicondylitis among cooks in nursery schools. Occup Environ Med. 1998 Mar;55(3):172-9.

ReferenceCitation: Shiri R, Viikari-Juntura E. Lateral and medial epicondylitis: role of occupational factors. Best Pract Res Clin Rheumatol. 2011 Feb;25(1):43-57. doi: 10.1016/j.berh.2011.01.013. Review.

ReferenceCitation: Hamilton PG. The prevalence of humeral epicondylitis: a survey in general practice. J R Coll Gen Pract. 1986 Oct;36(291):464-5.

ReferenceCitation: Murtagh JE. Tennis elbow. Aust Fam Physician. 1988 Feb;17(2):90-1, 94-5.

ReferenceCitation: Smidt N, Lewis M, Hay EM, Van der Windt DA, Bouter LM, Croft P. A comparison of two primary care trials on tennis elbow: issues of external validity. Ann Rheum Dis. 2005 Oct;64(10):1406-9. Epub 2005 Mar 30.

ReferenceCitation: Bisset L, Beller E, Jull G, Brooks P, Darnell R, Vicenzino B. Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial. BMJ. 2006 Nov 4;333(7575):939. Epub 2006 Sep 29.

ReferenceCitation: Lindenhovius A, Henket M, Gilligan BP, Lozano-Calderon S, Jupiter JB, Ring D. Injection of dexamethasone versus placebo for lateral elbow pain: a prospective, double-blind, randomized clinical trial. J Hand Surg Am. 2008 Jul-Aug;33(6):909-19. doi: 10.1016/j.jhsa.2008.02.004.

ReferenceCitation: Newcomer KL, Laskowski ER, Idank DM, McLean TJ, Egan KS. Corticosteroid injection in early treatment of lateral epicondylitis. Clin J Sport Med. 2001 Oct;11(4):214-22.

ReferenceCitation: Roukis TS, Zgonis T, Tiernan B. Autologous platelet-rich plasma for wound and osseous healing: a review of the literature and commercially available products. Adv Ther. 2006 Mar-Apr;23(2):218-37. Review.

ReferenceCitation: Ranly DM, McMillan J, Keller T, Lohmann CH, Meunch T, Cochran DL, Schwartz Z, Boyan BD. Platelet-derived growth factor inhibits demineralized bone matrix-induced intramuscular cartilage and bone formation. A study of immunocompromised mice. J Bone Joint Surg Am. 2005 Sep;87(9):2052-64.

ReferenceCitation: Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. Review.

ReferenceCitation: Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. Epub 2006 May 30.

ReferenceCitation: Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.

ReferenceCitation: Borzini P, Mazzucco L. Tissue regeneration and in loco administration of platelet derivatives: clinical outcome, heterogeneous products, and heterogeneity of the effector mechanisms. Transfusion. 2005 Nov;45(11):1759-67. Review.

ReferenceCitation: de Mos M, van der Windt AE, Jahr H, van Schie HT, Weinans H, Verhaar JA, van Osch GJ. Can platelet-rich plasma enhance tendon repair? A cell culture study. Am J Sports Med. 2008 Jun;36(6):1171-8. doi: 10.1177/0363546508314430. Epub 2008 Mar 7.

ReferenceCitation: Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921. Review.

ReferenceCitation: Mazzocca AD, McCarthy MB, Chowaniec DM, Cote MP, Romeo AA, Bradley JP, Arciero RA, Beitzel K. Platelet-rich plasma differs according to preparation method and human variability. J Bone Joint Surg Am. 2012 Feb 15;94(4):308-16. doi: 10.2106/JBJS.K.00430.

ReferenceCitation: Mishra AK, Skrepnik NV, Edwards SG, Jones GL, Sampson S, Vermillion DA, Ramsey ML, Karli DC, Rettig AC. Efficacy of platelet-rich plasma for chronic tennis elbow: a double-blind, prospective, multicenter, randomized controlled trial of 230 patients. Am J Sports Med. 2014 Feb;42(2):463-71. doi: 10.1177/0363546513494359. Epub 2013 Jul 3.

ReferenceCitation: Creaney L, Wallace A, Curtis M, Connell D. Growth factor-based therapies provide additional benefit beyond physical therapy in resistant elbow tendinopathy: a prospective, single-blind, randomised trial of autologous blood injections versus platelet-rich plasma injections. Br J Sports Med. 2011 Sep;45(12):966-71. doi: 10.1136/bjsm.2010.082503. Epub 2011 Mar 15.

ReferenceCitation: Thanasas C, Papadimitriou G, Charalambidis C, Paraskevopoulos I, Papanikolaou A. Platelet-rich plasma versus autologous whole blood for the treatment of chronic lateral elbow epicondylitis: a randomized controlled clinical trial. Am J Sports Med. 2011 Oct;39(10):2130-4. doi: 10.1177/0363546511417113. Epub 2011 Aug 2.

ReferenceCitation: Raeissadat SA, Sedighipour L, Rayegani SM, Bahrami MH, Bayat M, Rahimi R. Effect of Platelet-Rich Plasma (PRP) versus Autologous Whole Blood on Pain and Function Improvement in Tennis Elbow: A Randomized Clinical Trial. Pain Res Treat. 2014;2014:191525. doi: 10.1155/2014/191525. Epub 2014 Jan 20.

ReferenceCitation: Giusti I, Rughetti A, D'Ascenzo S, Millimaggi D, Pavan A, Dell'Orso L, Dolo V. Identification of an optimal concentration of platelet gel for promoting angiogenesis in human endothelial cells. Transfusion. 2009 Apr;49(4):771-8. doi: 10.1111/j.1537-2995.2008.02033.x. Epub 2008 Dec 23.

ReferenceCitation: de Vos RJ, Windt J, Weir A. Strong evidence against platelet-rich plasma injections for chronic lateral epicondylar tendinopathy: a systematic review. Br J Sports Med. 2014 Jun;48(12):952-6. doi: 10.1136/bjsports-2013-093281. Epub 2014 Feb 21. Review.

ReferenceType: derived

ReferenceCitation: Montalvan B, Le Goux P, Klouche S, Borgel D, Hardy P, Breban M. Inefficacy of ultrasound-guided local injections of autologous conditioned plasma for recent epicondylitis: results of a double-blind placebo-controlled randomized clinical trial with one-year follow-up. Rheumatology (Oxford). 2016 Feb;55(2):279-85. doi: 10.1093/rheumatology/kev326. Epub 2015 Sep 8.

family: Montalvan

full_name: Bernard Montalvan

given: Bernard

family: Le Goux

full_name: Patrick Le Goux

given: Patrick

family: Klouche

full_name: Shahnaz Klouche

given: Shahnaz

family: Borgel

full_name: Delphine Borgel

given: Delphine

family: Hardy

full_name: Philippe Hardy

given: Philippe

family: Breban

full_name: Maxime Breban

given: Maxime

journal_name: Rheumatology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Arthrex SAS

intervention_type: Other


title: Prospective, Multicenter, Randomized, Evaluating Two Induction Therapies With Simulect® Versus ATG® Fresenius Associated With Tacrolimus and Myfortic® in the Prevention of Treatment Failure, in Sensitized Renal Transplant

acronym: SATIR

summary:
Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially in highly sensitized patients. Both induction therapy regimens have a different tolerance profile. Infections and haematological side-effects are more frequently reported in patients receiving ATG.

The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor specific antibodies (DSAs) detected by Luminex.

lead_sponsor: University Hospital, Toulouse

intervention_type: Drug


title: Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study

acronym: THETA-DEP

summary: This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.

ReferenceCitation: Bulteau S, Sébille V, Fayet G, Thomas-Ollivier V, Deschamps T, Bonnin-Rivalland A, Laforgue E, Pichot A, Valrivière P, Auffray-Calvier E, Fortin J, Péréon Y, Vanelle JM, Sauvaget A. Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial. Trials. 2017 Jan 13;18(1):17. doi: 10.1186/s13063-016-1764-8.

family: Bulteau

full_name: Samuel Bulteau

given: Samuel

family: Sébille

full_name: Veronique Sébille

given: Veronique

family: Fayet

full_name: Guillemette Fayet

given: Guillemette

family: Thomas-Ollivier

full_name: Veronique Thomas-Ollivier

family: Deschamps

full_name: Thibault Deschamps

given: Thibault

family: Bonnin-Rivalland

full_name: Annabelle Bonnin-Rivalland

given: Annabelle

family: Laforgue

full_name: Edouard Laforgue

given: Edouard

family: Pichot

full_name: Anne Pichot

given: Anne

family: Valrivière

full_name: Pierre Valrivière

given: Pierre

family: Auffray-Calvier

full_name: Elisabeth Auffray-Calvier

given: Elisabeth

family: Fortin

full_name: June Fortin

given: June

family: Péréon

full_name: Yann Péréon

given: Yann

family: Vanelle

full_name: Jean-Marie Vanelle

given: Jean-Marie

family: Sauvaget

full_name: Anne Sauvaget

currency_apc_doaj: GBP

journal_name: Trials

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

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Nantes University Hospital

intervention_type: Device


title: The Pulmonary Embolism Rule Out Criteria (PERC) Rule to Exclude the Diagnosis of Pulmonary Embolism in Emergency Low Risk Patients: a Non-inferiority Randomized Controlled Trial

acronym: PROPER

summary:
The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED) amongst low risk patients. Even though meta analyses have confirmed the safety of its utilization, equipoise remains - especially in European country where the prevalence of PE is higher than in the US- on whether this rule could be safely applied to all low risk emergency patients with a suspicion of PE.

The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months, and PERC based strategy for 6 months.

In the control group (usual strategy), patients will be tested for D-dimeres, followed if positive by a Computed Tomography of Pulmonary Artery (CTPA).

In the intervention group (PERC Based), patients will be first assessed with PERC score. If PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.

The primary outcome is the failure percentage of the diagnostic strategy, defined as diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom PE has been initially ruled out.

study_start_date_type: Actual

primary_purpose: Diagnostic

ReferenceCitation: Freund Y, Cachanado M, Aubry A, Orsini C, Raynal PA, Féral-Pierssens AL, Charpentier S, Dumas F, Baarir N, Truchot J, Desmettre T, Tazarourte K, Beaune S, Leleu A, Khellaf M, Wargon M, Bloom B, Rousseau A, Simon T, Riou B; PROPER Investigator Group. Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients: The PROPER Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):559-566. doi: 10.1001/jama.2017.21904.

name: Sorbonne Université, INSERM UMRS 1166, IHU ICAN, Paris, France

name: Emergency Department, Hôpital Universitaire Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France

family: Freund

full_name: Yonathan Freund

given: Yonathan

name: Clinical Research Platform (URC-CRC-CRB), AP-HP Hôpital Saint-Antoine, Paris, France

family: Cachanado

full_name: Marine Cachanado

given: Marine

family: Aubry

full_name: Adeline Aubry

given: Adeline

name: Emergency Department, Hôpital Avicenne, APHP, Bobigny, France

family: Orsini

full_name: Charlotte Orsini

given: Charlotte

name: Emergency Department, Hôpital Saint-Antoine, APHP, Paris, France

family: Raynal

full_name: Pierre-Alexis Raynal

given: Pierre-Alexis

name: Emergency Department, Hôpital Européen Georges Pompidou, APHP, Paris, France

family: Féral-Pierssens

full_name: Anne-Laure Féral-Pierssens

given: Anne-Laure

name: Université Toulouse III Paul Sabatier, INSERM UMR 1027, CHU Toulouse, Toulouse, Emergency Department, Toulouse, France

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

name: Université Paris Descartes, INSERM UMR970, APHP, Emergency Department, Hôpital Cochin, Paris, France

family: Dumas

full_name: Florence Dumas

given: Florence

name: Emergency Department, Hôpital Tenon, APHP, Paris, France

family: Baarir

full_name: Nacera Baarir

given: Nacera

name: Emergency Department, Hôpital Lariboisière, APHP, Paris, France

family: Truchot

full_name: Jennifer Truchot

given: Jennifer

name: Université Bourgogne Franche-Comté, Emergency Department, CHRU Minjoz, Besançon, France

family: Desmettre

full_name: Thibaut Desmettre

given: Thibaut

name: Université Claude Bernard Lyon1, HESPER EA 7425, Hospices Civils de Lyon, Emergency Department, Hôpital Edouard Herriot, Lyon, France

family: Tazarourte

full_name: Karim Tazarourte

given: Karim

name: Emergency Department, Hôpital Ambroise-Paré, APHP, Boulogne, France

family: Beaune

full_name: Sebastien Beaune

given: Sebastien

name: Emergency Department, Hôpital Bichat, APHP, Paris, France

family: Leleu

full_name: Agathe Leleu

given: Agathe

name: Université Paris Est, INSERM U955, APHP, Emergency Department, Hôpital Henri Mondor, Créteil, France

family: Khellaf

full_name: Mehdi Khellaf

given: Mehdi

name: Emergency Department, Hôpital Saint Camille, Bry sur Marne, France

family: Wargon

full_name: Mathias Wargon

given: Mathias

name: Emergency Department, Barts Health NHS Trust, London, United Kingdom

family: Bloom

full_name: Ben Bloom

given: Ben

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Riou

full_name: Bruno Riou

given: Bruno

journal_name: JAMA

oa_colors: green other

ReferenceCitation: Freund Y, Rousseau A, Guyot-Rousseau F, Claessens YE, Hugli O, Sanchez O, Simon T, Riou B. PERC rule to exclude the diagnosis of pulmonary embolism in emergency low-risk patients: study protocol for the PROPER randomized controlled study. Trials. 2015 Nov 25;16:537. doi: 10.1186/s13063-015-1049-7.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL


title: Contribution of Magnetic Resonance Imaging (Diffusion Tensor Imaging and Magnetic Susceptibility Imaging and Resting Activation Imaging) in the Diagnosis of Parkinsonian Syndromes in Elderly Subjects.

acronym: PARKIMAGE

summary:
Parkinsonian syndrome is clinically characterized by the presence of resting tremor, rigidity, bradykinesia and postural instability. Parkinsonian disorders include Parkinson's disease (PD), progressive supranuclear palsy (PSP), corticobasal dementia (CBD), multiple system atrophy (MSA) and vascular parkinsonism (VP). Each of these diseases has a singular physiopathological origin, course and prognosis. Numerous imaging studies consequently aimed at finding markers to early make the distinction between the different types of parkinsonism, in order to identify patients who could benefit from dopaminergic agonist therapy.

Excessive iron deposition in the subcortical and brainstem nuclei has been described in numerous neurodegenerative disorders including Parkinson's disease. Increased iron levels are more frequent in area that are rich in dopaminergic neurons and have been implicated in the development of movement disorders, the distribution of areas with increased iron deposition however varying according to parkinsonism types. Iron deposition quantification could thus potentially help in differentiating parkinsonism types and could improve therapy guidance. Quantitative susceptibility mapping (QSM) locally estimates the magnetic susceptibility of brain tissues based on gradient-echo signal phase. The local susceptibility being sensitive to the presence of paramagnetic susbtances, QSM allows the non-invasive evaluation of iron distribution and quantification in the brain with high image quality (Liu et al., 2013). However, since iron deposition followed an exponential curve during normal aging in most of the basal ganglia the potential of QSM to distinguish between healthy and parkinsonian subjects in elderly remains unclear.

The aim of this study was thus to determine susceptibility values in the basal ganglia of elderly patients with parkinsonian syndromes, to compare these values to healthy aged-matched controls and between parkinsonian syndrome types. Secondly, investigators aimed to evaluate microstructural changes in the basal ganglia using diffusion tensor imaging (DTI) in the same population and to determine whether susceptibility and DTI parameter changes are correlated. Finally investigators sought to assess the relation between susceptibility/DTI parameter values in the basal ganglia and behavioral measures of motor and cognitive abilities.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Montpellier

location_facility: Service de Neuroradiologie, Hopital Gui de Chauliac, CHU de Montpellier


title: Presbyopia Compensation: Looking for Electrophysiological Predictors

summary: The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.

ReferenceCitation: Imbeau L, Majzoub S, Thillay A, Bonnet-Brilhault F, Pisella PJ, Batty M. Presbyopia compensation: looking for cortical predictors. Br J Ophthalmol. 2017 Feb;101(2):223-226. doi: 10.1136/bjophthalmol-2015-307581. Epub 2016 Apr 22.

family: Imbeau

full_name: Léa Imbeau

given: Léa

family: Majzoub

full_name: Sadi Majzoub

given: Sadi

family: Thillay

full_name: Alix Thillay

given: Alix

family: Bonnet-Brilhault

full_name: Frederique Bonnet-Brilhault

given: Frederique

family: Pisella

full_name: Pierre-Jean Pisella

given: Pierre-Jean

family: Batty

full_name: Magali Batty

given: Magali

journal_name: British Journal of Ophthalmology

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Tours


title: Autism Spectrum Disorders: Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication

summary: This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention.

ReferenceCitation: Khanna RK, Kovarski K, Arsene S, Siwiaszczyk M, Pisella PJ, Bonnet-Brilhault F, Batty M, Malvy J. Ophthalmological findings in children with autism spectrum disorder. Graefes Arch Clin Exp Ophthalmol. 2020 Apr;258(4):909-916. doi: 10.1007/s00417-019-04594-7. Epub 2020 Jan 9.

family: Khanna

full_name: Raoul Kanav Khanna

given: Raoul Kanav

family: Kovarski

full_name: Klara Kovarski

given: Klara

family: Arsene

full_name: Sophie Arsene

given: Sophie

family: Siwiaszczyk

full_name: Marine Siwiaszczyk

given: Marine

full_name: Frédérique Bonnet-Brilhault

given: Frédérique

family: Malvy

full_name: Joëlle Malvy

given: Joëlle

journal_name: Graefe's Archive for Clinical and Experimental Ophthalmology


title: Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient

acronym: IVVI

summary: The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ?

acronym: STAR

summary: Up to one-third of patients with myotonic dystrophy type 1 die suddenly mainly from arrhythmias. Sleep apnea is prevalent in myotonic dystrophy (DM1) patients. Among the serious complications from sleep apnea, the most alarming are arrhythmias and sudden cardiac death (SCD). Diagnosis of sleep apnea using simple tools in ambulatory cardiology practice may improve therapy of cardiac arrhythmias in patients with DM1

lead_sponsor: University Hospital, Grenoble


title: Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities

acronym: SUIVIOBESITE

summary: The literature data show that long-term monitoring has an effect on weight loss, comorbidity and on improving the quality of life. However, there are still no studies on monitoring obese patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011 advocated "continuous monitoring needed to prevent weight regain, monitor the consequences of overweight and treat comorbidities. This requires a long-term support. "The frequency of follow-up consultations is not specified and "must be adapted to achieve a weight loss target and maintain." Having no specific recommendations on the frequency of monitoring, the investigators chose to experiment closer monitoring than our current monitoring to assess what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding behavior, changes in physical abilities, evolution of comorbidities associated with obesity. The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Limoges

location_facility: Centre de suivi de l'obésite Bernard Descottes


title: Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function

acronym: ANOSPIN

summary: The purpose of this study is to assess and explain (at least apart) anorectal disorders of patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system and epithelial barrier dysfunctions. The investigators' aim hypothetics is that autonomic neuropathy of patients with Spina Bifida induce enteric nervous sytem and epithelial barrier dysfunctions which explain anorectal disorders of these patients. Thexpect to show a decreased of 5% of enteric neurons per ganglia.

lead_sponsor: Rennes University Hospital


title: Use of the DBS for the Follow-up of Blood Clinical Parameters of Old People

acronym: DBSage

summary:
It is about an interventional study.The use of the blotting paper called "Dried Blood Spot" or DBS is a method of systematic neonatal screening of the metabolic diseases. Indeed, it has multiple interests: realized thanks to lancets, it is much less invasive than a classic blood collection. Besides, the transport of the blood sampling is facilitated because most of the analysts are stable on DBS at room temperature one week or more. Finally the use of this DM reduces the infectious risks bound to the manipulation of the blood sampling and to the inactivation of microorganisms. The moderate results are vitamin D, albumin, prealbumin, CRP, orosomucoide

The DBS presents a major interest for the care of the old and fragile people who have on one hand a low peripheral venous capital and on the other hand for whom the possibility of a dosage on DBS will allow a facilitated biological follow-up. Indeed it is very important to detect as soon as possible the most fragile old people, those who have the biggest risk of seeing their health degrading during a physical, psychic or social stress, to concentrate the efforts of coverage and limit these risks. The advantage of the biological criteria is the speed of the test making (a blood test), in the absence of necessity of active participation by the patient (the clinical criteria require to test the patient in the walking, to test its muscular strength, etc.) and in the saving of time diagnosis for the clinician. The blood biological markers of the fragility are essentially the rate of 25OH vitamin D, the markers of undernutrition (albumin, prealbumin) and of the inflammation (CRP, orosomucoïde). These last four parameters are now measurable from the DBS thanks to the quantitative mass spectrometry.

ReferenceCitation: Tall ML, Lehmann S, Diouf E, Gérard C, Filali S, Gabelle A, Hirtz C, Gabert L, Sauvinet V, Pirot F, Pivot C. [Injectable preparation of labeled leucine with the carbon 13 for a clinical research program on the Alzheimer disease: pharmaceutical control of raw materials and the finished product and stability study]. Ann Pharm Fr. 2015 Jan;73(1):43-59. doi: 10.1016/j.pharma.2014.06.002. Epub 2014 Jul 11. French.


title: Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Pilot Study

acronym: PilotTMS-COG

summary: The purpose of the study is to test a new treatment of social cognition deficits in patients with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation (theta-burst). The study will also identify clinical variables, cognitive and psychomotor most sensitive to treatment, to estimate the most sensitive treatment target, assess tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on the brain a multimodal imaging study and compare the imaging variables (resting network, Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients before treatment and healthy subjects.

lead_sponsor: University Hospital, Caen


title: Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response

acronym: ICD

summary: Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.

location_facility: Service d'Hygiène, Epidémiologie et Prévention - Hôpital Edouard Herriot


title: Impact of the Obstructive Sleep Apnea Syndrome (OSAS) on the Ventricular Remodeling After Acute Myocardial Infarction

acronym: SAS-IDM

summary:
Coronary artery disease is a common and serious disease, the leading cause of death worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in coronary artery disease where it could be involved in the pathophysiology and perhaps prognosis. The entanglement of the two pathologies is actually quite well known, in particular the consequences of one over the other just beginning to be studied. Understanding the pathophysiology through new imaging modalities should improve the management of patients to propose new approaches.

"SAS-IDM" is an interventional and prospective study conducted at the University Hospital of Montpellier. Patients will be divided in three groups depending of the results of the polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the group "severe OSA".

location_facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier


title: Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation

acronym: ElastoDéclench

summary: The primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal device releasing PGE2).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study

summary: The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.

lead_sponsor: Centre Oscar Lambret


title: Study of Normal Hip and Lumbar Bone Marrow With Dynamic Contrast Enhancement Magnetic Resonance Imaging

acronym: PERFOS

summary: DCE-MRI were performed in sixty adults (hips and lumbar spine). For each region of interest studied, the investigators determined the morphology of each time-concentration curve (TCC) and calculated semi-quantitative and pharmacokinetic parameters: initial slope (IS), area under the curve (AUC), time to peak (TTP), Ktrans, Kep and Ve. Clinical data were collected anamnestically.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Lille


title: Evaluation of Performances of Soluble Fibrin Assay for Diagnosing Pulmonary Embolism

acronym: SOFIE

summary: The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the Soluble Fibrin Assay and the D-Dimer test.

ReferenceCitation: Roy PM, Colombet I, Durieux P, Chatellier G, Sors H, Meyer G. Systematic review and meta-analysis of strategies for the diagnosis of suspected pulmonary embolism. BMJ. 2005 Jul 30;331(7511):259. Review.

ReferenceCitation: Ginsberg JS, Siragusa S, Douketis J, Johnston M, Moffat K, Donovan D, McGinnis J, Brill-Edwards P, Panju A, Patel A, Weitz JI. Evaluation of a soluble fibrin assay in patients with suspected pulmonary embolism. Thromb Haemost. 1996 Apr;75(4):551-4.

ReferenceCitation: Hetland Ø, Knudsen A, Dickstein K, Nilsen DW. Characteristics and prognostic impact of plasma fibrin monomer (soluble fibrin) in patients with coronary artery disease. Blood Coagul Fibrinolysis. 2002 Jun;13(4):301-8.

ReferenceCitation: Mirshahi S, Soria C, Kouchakji B, Kierzek G, Borg JY, Varin R, Chidiac J, Drouet L, Mirshahi M, Soria J. New combinational assay using soluble fibrin and d-dimer determinations: a promising strategy for identifying patients with suspected venous thromboembolism. PLoS One. 2014 Mar 24;9(3):e92379. doi: 10.1371/journal.pone.0092379. eCollection 2014.

ReferenceCitation: Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galiè N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. Erratum in: Eur Heart J. 2015 Oct 14;36(39):2666. Eur Heart J. 2015 Oct 14;36(39):2642.

ReferenceCitation: Klok FA, Mos IC, Nijkeuter M, Righini M, Perrier A, Le Gal G, Huisman MV. Simplification of the revised Geneva score for assessing clinical probability of pulmonary embolism. Arch Intern Med. 2008 Oct 27;168(19):2131-6. doi: 10.1001/archinte.168.19.2131.

ReferenceCitation: Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135. Erratum in: JAMA. 2014 Apr 23-30;311(16):1694.

name: Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland

family: Righini

full_name: Marc Righini

given: Marc

name: Department of Vascular Medicine, Amsterdam Medical Center, Amsterdam, the Netherlands

family: Van Es

full_name: Josien Van Es

given: Josien

name: Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

family: Den Exter

full_name: Paul L. Den Exter

given: Paul L.

name: Emergency Department, Centre Hospitalier Universitaire d’Angers, L'Université Nantes Angers Le Mans, Angers, France

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

name: Cliniques Universitaires Saint-Luc, Bruxelles, Belgium

family: Verschuren

full_name: Franck Verschuren

given: Franck

name: Liège University Hospital, Liège, Belgium

family: Ghuysen

full_name: Alexandre Ghuysen

given: Alexandre

name: Emergency Department, Geneva University Hospital, Geneva, Switzerland

family: Rutschmann

full_name: Olivier T. Rutschmann

given: Olivier T.

name: Hôpital Européen Georges-Pompidou, Paris, France

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

name: Emergency Department, Brest University Hospital, Brest, France

family: Jaffrelot

full_name: Morgan Jaffrelot

given: Morgan

family: Trinh-Duc

full_name: Albert Trinh-Duc

given: Albert

name: Centre Hospitalier d’Argenteuil, Argenteuil, France

family: Le Gall

full_name: Catherine Le Gall

given: Catherine

name: Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

family: Moustafa

full_name: Farès Moustafa

given: Farès

name: Centre Hospitalier de Morlaix, Morlaix, France

family: Principe

full_name: Alessandra Principe

given: Alessandra

name: Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands

family: Van Houten

full_name: Anja A. Van Houten

given: Anja A.

name: Department of Internal Medicine, Flevoziekenhuis Hospital, Almere, the Netherlands

family: Ten Wolde

full_name: Marije Ten Wolde

given: Marije

family: Douma

full_name: Renée A. Douma

given: Renée A.

name: Rijnstate Hospital, Arnhem, the Netherlands

family: Hazelaar

full_name: Germa Hazelaar

given: Germa

name: Maastricht University Medical Center, Maastricht, the Netherlands

family: Erkens

full_name: Petra M. G. Erkens

given: Petra M. G.

name: Van Weel-Bethesda Hospital, Dirksland, the Netherlands

family: Van Kralingen

full_name: Klaas W. Van Kralingen

given: Klaas W.

family: Grootenboers

full_name: Marco J. J. H. Grootenboers

given: Marco J. J. H.

name: Department of Hematology, Erasmus University Medical Center, Rotterdam, the Netherlands

family: Durian

full_name: Marc F. Durian

given: Marc F.

family: Cheung

full_name: Y. Whitney Cheung

name: Department of Vascular Medicine, University Medical Center Groningen, Groningen, the Netherlands

name: Ottawa Health Research Institute, Ottawa, Canada23Centre d’Investigations Cliniques, Université de Brest, Brest, France

repository_institution: University of Geneva - Archive ouverte UNIGE

title: Age-Adjusted D-Dimer Cutoff Levels to Rule Out Pulmonary Embolism


title: Study of Neuroplasticity on Depressed Patients Versus Healthy Subjects : Modulation of the MEP Size Induced by Theta Burst Stimulation

acronym: DEPLAS

summary: Neuroplasticity is supposed to be altered in patients suffering from a Major Depressive Disorder (MDD). Transcranial Magnetic Stimulation is a medical device which measures cerebral plasticity. Several parameters of cortical excitability are available for that purpose. These parameters are altered on patients wth MDD and these modifications are corrected after treatment. Therefore results in the studies are very heterogeneous. Theta Burst Stimulation (TBS) is a type a Transcranial Magnetic Stimulation (TMS) protocol and can induce cerebral plasticity. The cerebral plasticity induced by TBS was measured on a group of patients suffering from Asperger's disease (ASD) versus a control group. The plasticity was significantly different in patients with ASD. The aim of our study is to study the neuroplasticity induced by TBS on a patients with MDD.

primary_purpose: Basic Science

ReferenceCitation: Vignaud P, Damasceno C, Poulet E, Brunelin J. Impaired Modulation of Corticospinal Excitability in Drug-Free Patients With Major Depressive Disorder: A Theta-Burst Stimulation Study. Front Hum Neurosci. 2019 Feb 26;13:72. doi: 10.3389/fnhum.2019.00072. eCollection 2019.

family: Vignaud

full_name: Philippe Vignaud

given: Philippe

family: Damasceno

full_name: Caroline Damasceno

given: Caroline

family: Poulet

full_name: Emmanuel Poulet

given: Emmanuel

family: Brunelin

full_name: Jérôme Brunelin

given: Jérôme

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Human Neuroscience

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ipd_sharing: Undecided

lead_sponsor: Hôpital le Vinatier


title: Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis

acronym: MicroIskin

summary: This proof of concept study aims to assess in patients suffering from atopic dermatitis if polymeric microparticles reach the pilosebaceous follicles of inflamed skin.


title: Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis

acronym: TACOS

summary:
Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis.

The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT.

In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis.

The results of the CBCT will be compared to those of the CT scan.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A de Rothschild


title: Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

acronym: FRAILTY

summary:
Background: The cardiac resynchronization therapy (CRT) has been shown to improve symptoms and outcome of patients with congestive heart failure (HF), and depressed left ventricular ejection fraction (LVEF < 35 %). The rate of non-responders to CRT is estimated at 30 %. Yet, the impact of frailty on the response to CRT has not been studied, until now.

Purpose : To assess the impact of frailty in the elderly, on the response to CRT.

ReferenceCitation: Kubala M, Guédon-Moreau L, Anselme F, Klug D, Bertaina G, Traullé S, Buiciuc O, Savouré A, Diouf M, Hermida JS. Utility of Frailty Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1523-1533. doi: 10.1016/j.jacep.2017.06.012. Epub 2017 Sep 13.

family: Kubala

full_name: Maciej Kubala

given: Maciej

family: Guédon-Moreau

full_name: Laurence Guédon-Moreau

given: Laurence

family: Anselme

full_name: Frédéric Anselme

given: Frédéric

family: Klug

full_name: Didier Klug

given: Didier

family: Bertaina

full_name: Geneviève Bertaina

given: Geneviève

family: Traullé

full_name: Sarah Traullé

given: Sarah

family: Buiciuc

full_name: Otilia Buiciuc

given: Otilia

family: Savouré

full_name: Arnaud Savouré

given: Arnaud

family: Diouf

full_name: Momar Diouf

given: Momar

family: Hermida

full_name: Jean-Sylvain Hermida

given: Jean-Sylvain

journal_name: JACC: Clinical Electrophysiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque


title: Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors

acronym: PERFORM

summary:
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors.

In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.

status: Recruiting

status_simplified: Ongoing


title: Multimodal MRI Study of Ischemic Stroke

summary: Stroke is the second most frequent causes of mortality in the word after cardiovascular disease and the most frequent cause of disability. The majority of strokes are ischemic (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long term functional recovery is largely dependent from the ability of the brain to reorganize. Conventional magnetic resonance imaging represents the most sensitive tool to diagnose stroke at the acute phase. However, up to now, no imaging tool is available to determine the time of stroke onset. Moreover, no imaging tool is available to precisely quantify the functional and structural plasticity mechanisms occurring after stroke. The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset. The secondary objectives of the study are to determine the ability of non-conventional MRI techniques to quantify the degree of tissue damage and brain reorganization after stroke. Thirty patients will be included during the first 24 hours after stroke onset. Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


type: EudraCT Number

title: A Double Blind, Randomized, Placebo-controlled, Ascending Single and Multiple Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1707 in Healthy Young and Elderly Male Subjects and in Healthy Pre-menopausal Female Subjects Including an Open-label Comparison of Pharmacokinetics Under Fasted and Fed Conditions in Healthy Young Male Subjects

summary:
This study consists of four parts:

Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on certain hormones and if possible to determine the highest well-tolerated dose of ASP1707 in healthy young male subjects under fasted conditions.

Part 2 is an open label, randomized crossover, single dose study to determine the effect of food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male subjects.

Part 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly men and healthy premenopausal females, and to determine the effect on certain hormones in males. Age and gender is also evaluated.

Part 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in healthy pre-menopausal female subjects.

lead_sponsor: Astellas Pharma Europe B.V.


title: QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)

acronym: QUARTZ

summary: This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice

lead_sponsor: Ferring Pharmaceuticals

location_facility: Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)


title: Role of Endoplasmic Reticulum Stress in the Pathophysiology of Type 2 Diabetes

acronym: GLUCOSTRESS

summary:
The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients compared to healthy subjects normoglycemic matched for age and sex an to investigate whether ER stress pathway can be activated in response to insulin. Indeed, some preliminar on rates studies shows that ER stress pathway is activated by insulin in liver and adipose tissue showing that hyperinsulinemia might help trigger stress path ER.

For this, we propose a case control study of type 2 diabetic patients vs control subjects in which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial

acronym: START

summary:
The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years during which the psychotic symptoms are present at a subliminal level in severity or in frequency. The clinical criteria "mental status with risk" (AR) identifies patients among whom 10 in 40 % will make a psychotic transition in the year.

Our hypothesis is that interventions to reduce reactivity to stress are effective in reducing the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms. Our project is to evaluate a therapy for stress management in at risk patients, compared to a conventional monitoring, and implement a longitudinal follow-up concerning the reduction of psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these interventions offer an alternative to antipsychotics all the more interesting since they should also reduce the risk of depression and suicide.

lead_sponsor: Centre Hospitalier St Anne


title: Study of Ion Transport From Nasal Epithelial Cells Collected by Brushing (CCBN) in the Diagnosis of Atypical Forms of Cystic Fibrosis

acronym: MUCO-BROCC

summary: The diagnosis of CF is currently based on the discovery of two CFTR gene mutations and / or a positive sweat test (> 60mmol / l). A significant number of patients with atypical cystic fibrosis (chronic sino-pulmonary disease with a single mutation in the CFTR gene and / or a test of the intermediate sweat between 30 and 60 mmol / l) undetected by these techniques are behind specialized care while irreversible lung damage is already existed. Currently, the measurement of nasal potential difference in vivo (DPN), which evaluates the transportation of chlorine in the nasal epithelium with an electrode, is proposed for the diagnosis of atypical forms. However DPN dependent nasal local conditions when analysing do not always offer the possibility of concluding the diagnosis of cystic fibrosis. It is necessary to develop new and more reliable diagnostic tests for the detection of cases of atypical cystic fibrosis. The authors propose to develop a new diagnostic technique based on the study of bioelectric properties of a preparation of nasal cells of the subject obtained by brushing and placed in primary culture (CCBN).

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff

acronym: REASSE

summary: Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff

lead_sponsor: University Hospital, Clermont-Ferrand


title: Dynamic Real-time in Vivo Confocal Laser Endomicroscopy Cellvizio® of the Fallopian Tube During Laparoscopy

acronym: FALLOPTIC

summary:
High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with an important mortality due to late diagnosis. However the prognosis is excellent in the early stages of the disease. Recently it has been described a new serous carcinogenic sequence from the fallopian tube with tubal precancerous lesions. Therefore the identification of these early preinvasive lesions would be of great interest in the population with hereditary predisposition for ovarian cancer (concept of oncofertility) and in the general population (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for benign disease).

The optical biopsy has been developed and validated in the detection of early precancerous lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the study of fallopian tubes during laparoscopy with correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation. The second objective is to describe the optical biopsy pictures in order to state a classification.

primary_purpose: Screening

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Gynécologie, Hôpital Femme Mère Enfant, Lyon


title: A Pilot Clinical Trial of Reverse Transcriptase Inhibitors in Children With Aicardi-Goutières Syndrome (AGS)

acronym: RTIs in AGS

summary: The purpose of this study is to determine if treatment with reverse transcriptase inhibitors returns the interferon signature observed in patients with AGS to normal levels.

ReferenceCitation: Crow YJ, Vanderver A, Orcesi S, Kuijpers TW, Rice GI. Therapies in Aicardi-Goutières syndrome. Clin Exp Immunol. 2014 Jan;175(1):1-8. doi: 10.1111/cei.12115. Review.

ReferenceCitation: Rice GI, Meyzer C, Bouazza N, Hully M, Boddaert N, Semeraro M, Zeef LAH, Rozenberg F, Bondet V, Duffy D, Llibre A, Baek J, Sambe MN, Henry E, Jolaine V, Barnerias C, Barth M, Belot A, Cances C, Debray FG, Doummar D, Frémond ML, Kitabayashi N, Lepelley A, Levrat V, Melki I, Meyer P, Nougues MC, Renaldo F, Rodero MP, Rodriguez D, Roubertie A, Seabra L, Uggenti C, Abdoul H, Treluyer JM, Desguerre I, Blanche S, Crow YJ. Reverse-Transcriptase Inhibitors in the Aicardi-Goutières Syndrome. N Engl J Med. 2018 Dec 6;379(23):2275-7. doi: 10.1056/NEJMc1810983.

name: University of Manchester, Manchester, United Kingdom

family: Rice

full_name: Gillian I. Rice

given: Gillian I.

family: Meyzer

full_name: Candice Meyzer

given: Candice

family: Bouazza

full_name: Naïm Bouazza

given: Naïm

family: Hully

full_name: Marie Hully

given: Marie

family: Boddaert

full_name: Nathalie Boddaert

given: Nathalie

name: Université Paris Descartes, Paris, France

family: Semeraro

full_name: Michaela Semeraro

given: Michaela

family: Zeef

full_name: Leo A.H. Zeef

given: Leo A.H.

family: Rozenberg

full_name: Flore Rozenberg

given: Flore

family: Bondet

full_name: Vincent Bondet

given: Vincent

family: Duffy

full_name: Darragh Duffy

given: Darragh

family: Llibre

full_name: Alba Llibre

given: Alba

family: Baek

full_name: Jinmi Baek

given: Jinmi

family: Sambe

full_name: Mame N. Sambe

given: Mame N.

family: Henry

full_name: Elodie Henry

given: Elodie

family: Jolaine

full_name: Valerie Jolaine

given: Valerie

name: Hôpital Necker–Enfants Malades, Paris, France

family: Barnerias

full_name: Christine Barnerias

given: Christine

name: Centre Hospitalier Universitaire Angers, Angers, France

family: Barth

full_name: Magalie Barth

given: Magalie

family: Belot

full_name: Alexandre Belot

given: Alexandre

name: Centre Hospitalier Universitaire Toulouse, Toulouse, France

family: Cances

full_name: Claude Cances

given: Claude

family: Debray

full_name: François-Guillaume Debray

given: François-Guillaume

family: Doummar

full_name: Diane Doummar

given: Diane

family: Frémond

full_name: Marie-Louise Frémond

given: Marie-Louise

family: Kitabayashi

full_name: Naoki Kitabayashi

given: Naoki

name: Centre Hospitalier Annecy Genevois, Pringy, France

name: Université de Montpellier, Montpellier, France

name: Centre Hospitalier Universitaire de Montpellier, Montpellier, France

name: University of Edinburgh, Edinburgh, United Kingdom

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

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

repository_institution: University of Liège - Open Repository and Bibliography

title: Reverse-Transcriptase Inhibitors in the Aicardi–Goutières Syndrome


summary: The process of weaning from mechanical ventilation was decided after clinical judgment and weaning predictive index. Nevertheless, indexes predicting weaning outcome like Maximal Inspiratory Pressure (MIP) are frequently inaccurate. However the long-term involvement of respiratory muscles in critically ill patients has not been established. The objective of this study was to assess the relationship on MIP at extubation on one-year mortality in critically ill patients.

ReferenceCitation: Combret Y, Prieur G, Hilfiker R, Gravier FE, Smondack P, Contal O, Lamia B, Bonnevie T, Medrinal C. The relationship between maximal expiratory pressure values and critical outcomes in mechanically ventilated patients: a post hoc analysis of an observational study. Ann Intensive Care. 2021 Jan 13;11(1):8. doi: 10.1186/s13613-020-00791-4.

family: Combret

full_name: Yann Combret

given: Yann

family: Prieur

full_name: Guillaume Prieur

given: Guillaume

family: Hilfiker

full_name: Roger Hilfiker

given: Roger

family: Gravier

full_name: Francis-Edouard Gravier

given: Francis-Edouard

family: Smondack

full_name: Pauline Smondack

given: Pauline

family: Contal

full_name: Olivier Contal

given: Olivier

family: Lamia

full_name: Bouchra Lamia

given: Bouchra

family: Bonnevie

full_name: Tristan Bonnevie

given: Tristan

family: Medrinal

full_name: Clément Medrinal

given: Clément

journal_name: Annals of Intensive Care

repository_institution: HES-SO (https://www.hes-so.ch/) - ArODES

ReferenceCitation: Medrinal C, Prieur G, Combret Y, Quesada AR, Bonnevie T, Gravier FE, Frenoy E, Contal O, Lamia B. Reliability of respiratory pressure measurements in ventilated and non-ventilated patients in ICU: an observational study. Ann Intensive Care. 2018 Jan 30;8(1):14. doi: 10.1186/s13613-018-0362-1.

family: Quesada

full_name: Aurora Robledo Quesada

given: Aurora Robledo

full_name: Francis Edouard Gravier

given: Francis Edouard

family: Frenoy

full_name: Eric Frenoy

given: Eric

ReferenceCitation: Medrinal C, Prieur G, Frenoy É, Robledo Quesada A, Poncet A, Bonnevie T, Gravier FE, Lamia B, Contal O. Respiratory weakness after mechanical ventilation is associated with one-year mortality - a prospective study. Crit Care. 2016 Jul 31;20(1):231. doi: 10.1186/s13054-016-1418-y.

repositories_institution: University of Geneva - Archive ouverte UNIGE


title: A Study Evaluating Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia. A Phase III Double-blind Randomized Placebo-controlled Trial

acronym: DXA

summary: The main purpose of this study is to estimate the efficiency at 3 months of dexamfetamine sulphate on the MFI 20 scale in severe fatigue of patients with stabilized gliomas.


title: Identification of New Genes Causing Frontotemporal Lobar Degeneration by Whole Exome Sequencing and Characterization of the Associated Phenotypes

acronym: FTLD-Exome

summary:
The major objective of the project is to map/identify new loci/genes, by a combination of whole exome sequencing and genome-wide linkage in autosomal dominant FTLD families excluded for known mutations.

Several secondary goals will be attained in the course of during the project:

For each novel gene identified in this project, we will determine the spectrum of mutations, evaluate their frequency and characterize the associated phenotypes. This will allow us to establish genotype-phenotype correlations in a large number of families, which will improve the nosology of these disorders and the diagnostic procedures;

ReferenceCitation: Ceslis A, Argall R, Henderson RD, McCombe PA, Robinson GA. The spectrum of language impairments in amyotrophic lateral sclerosis. Cortex. 2020 Nov;132:349-360. doi: 10.1016/j.cortex.2020.09.003. Epub 2020 Sep 18.

family: Ceslis

full_name: Amelia Ceslis

given: Amelia

family: Argall

full_name: Rosemary Argall

given: Rosemary

family: Henderson

full_name: Robert D. Henderson

given: Robert D.

family: McCombe

full_name: Pamela A. McCombe

given: Pamela A.

family: Robinson

full_name: Gail A. Robinson

given: Gail A.

journal_name: Cortex

ReferenceCitation: Didic M, Aglieri V, Tramoni-Nègre E, Ronat L, Le Ber I, Ceccaldi M, Belin P, Felician O. Progressive phonagnosia in a telephone operator carrying a C9orf72 expansion. Cortex. 2020 Nov;132:92-98. doi: 10.1016/j.cortex.2020.05.022. Epub 2020 Aug 10.

family: Didic

full_name: Mira Didic

given: Mira

family: Aglieri

full_name: Virginia Aglieri

given: Virginia

family: Tramoni-Nègre

full_name: Eve Tramoni-Nègre

given: Eve

family: Ronat

full_name: Lucas Ronat

given: Lucas

family: Le Ber

full_name: Isabelle Le Ber

given: Isabelle

family: Ceccaldi

full_name: Mathieu Ceccaldi

given: Mathieu

family: Belin

full_name: Pascal Belin

given: Pascal

family: Felician

full_name: Olivier Felician

evidence: open (author manuscript)

version: acceptedVersion


title: Randomized Phase III Study Assessing the Interest of Primary Tumor Resection in Patients With Asymptomatic Colon Cancer and Unresectable Synchronous Liver Metastases.

acronym: CLIMAT

summary: The present study is a multicentric randomized phase III trial designed to assess whether overall survival and quality of life are improved in patients with asymptomatic colon cancer and unresectable SLM treated with resection of the PT followed by chemotherapy versus chemotherapy alone.


title: Exercise Testing in Metabolic Myopathies

acronym: RANNOU

summary: Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. The purpose of this study is to compare the results of exercise testing with to the data from muscle biopsy or genetic analysis.

lead_sponsor: University Hospital, Brest

location_facility: Centre Hospitalier Régional Universitaire


title: Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty

summary: Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. We therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.

lead_sponsor: Hospital Ambroise Paré Paris


title: Lung Aeration During WEANing From Mechanical Ventilation Determined by Electrical Impedance Tomography and Lung Ultrasound

acronym: IWEAN

summary: Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound


title: LPRobacus: Light Needle Positioning Robot Under MRI Guidance

acronym: LPRobacus

summary:
This study aim is to evaluate the needle positioning precision, compared to the real path planned by the physician on healthy voluntaries, by positioning a fictional needle, without inserting it.

Additionally, this study will evaluate:

the robot precision,
the robot detection robustness,
the software and device ergonomics,
the device security.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid

acronym: RECOPB

summary: Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.

primary_purpose: Prevention

lead_sponsor: University Hospital, Rouen


title: Evaluation of Minimally Invasive Bariatric Surgery Using a Single Laparoscopic Trocar (Single Incision of 2.5 to 3 cm) Versus 4 to 7 Trocars in Sleeve Gastrectomy

acronym: MINIOB

summary: Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality

status: Active, not recruiting


title: Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.

acronym: InfarctusGSI

summary:
The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.

This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.

intervention_type: Radiation


title: Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2

summary:
The purpose of the study is to demonstrate an improvement of vascular function, and particularly dependent vasodilation flow and micro-vasculature, by STENDO for diabetic patients compared to a control period in crossover.

Action by shear stress causing vasodilation away from the microcirculation, STENDO should have a beneficial effect on vascular function in type 2 diabetics. These effects could be both treble just after the completion of a session with the device, and chronic with a potentiating effect of different sessions.

The investigators propose to study the different vascular function evaluation parameters we have, to highlight these acute and chronic changes. The investigators will also study the physical abilities to change topics and behavioral changes (spontaneous physical activity in particular) and impact on subject quality of life.


title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 1.5 mg Nicotine Lozenge on Smoking Craving

summary: The purpose of this study is to evaluate the reduction of craving after administration of V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.

lead_sponsor: Pierre Fabre Medicament


title: Evaluation of the Impact of Sleep Apnea on Cerebral Volumetry According to Age

acronym: VOILAGE

summary:
Sleep apnea is a common disease in the general population and more particularly in elderly subjects in whom prevalence can reach 30 % after 70 years old. In adults (<55 years old) cardiovascular consequences are well known and make sleep apnea treatment necessary. However elderly (>70 years old) apneic subjects are less symptomatic in terms of sleepiness, they usually present a lower index of respiratory events and cardiovascular consequences in this population are still discussed, driving some authors to consider sleep apnea in the elderly as a specific disease and making the need for a treatment questionable.

In this study the investigators will focus on the comparison between adult and elderly apneic subjects in terms of cognitive and cardiovascular consequences. Adult apneic patients suffer from a decrease of cognitive performance as well as grey matter local atrophy, particularly in the hippocampus and in the frontal lobes. According to fewer studies, white matter can also be affected by a demyelinisation process. These structural modifications are sometimes associated with disorders of executive and memory functions. In the elderly, no clear association can be drawn between cognitive decline and sleep apnea. Moreover, to our knowledge, the cerebral state of elderly symptomatic apneic subjects has mostly not be investigated.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery

acronym: ThermoD-PAC

summary:
Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. The investigators currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. the investigators chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Allemagne). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique (Bein J Cardio Thorac Vasc Anesth 2004, Buhre Cardio thorac vasc anesth 1999, Felbinger J Clin ANesth 2005, Felbinger TW J Clin Anetsh 2002, Godie O Ann Thorac Surg 1999).

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. The investigators conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 2.5 mg Nicotine Lozenge on Smoking Craving

summary: The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.


title: Development of an Adjustment Assistance Tool Dosage of Fluoroquinolones in a Population Pharmacokinetic Model

acronym: FLUO-POP

summary:
Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat infections. Their efficacy has been shown to be linked to the ratio area under the curve (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to 40% in patients with an AUC/MIC below this threshold. These results have been reproduced recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of potential interest, particularly in case of severe infections (intensive care unit (ICU) patients) or complicated and cost-related infections (osteoarticular infected (OAI) patients), with an increasing level of evidence of its use.

However, FQ TDM requires access to the full AUC of the drug with the need of many samples drawn to patients. This appears to be irreconcilable with clinical practice but can be achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating pharmacokinetic parameters of the drug by introducing covariates (demographic, biological, clinical…) and modelling inter-individual pharmacokinetic variability. The model created allows then accessing to individual parameters of patients and thus, estimating concentrations and AUC of the FQ. This approach may also be used in clinical practice to determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum of samples.

lead_sponsor: Rennes University Hospital


title: Trial of a New Phototherapy Device for Treating Hyperbilirubinemia in Crigler-Najjar Patients : a New Concept

acronym: DRAP

summary: Evaluating the efficacity of a new device phototherapy by comparing it with conventional phototherapy. Jaundice occurs in many newborns, and is, in most cases benign, However, owing to the potential neurotoxicity of unconjugated bilirubin, newborns must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. Treatment of jaundice in newborn relies on phototherapy, exposing their skin to light of a specific wavelength . Fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. Light-emitting diodes (LEDs) are more recent sources which are power efficient, have a longer life and are portable with low heat production. Several technologies and devices are developed using LEDs and specially a compact system.