title: EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome in HIV-infected Patients. The EVERE2ST-HIV Study.

summary:
Elevated on-treatment platelet reactivity is an independent risk factor of major adverse cardiovascular events following percutaneous coronary intervention or ACS. People living with HIV patients have a higher risk of recurrent events after ACS than people without HIV.

The investigators hypothesized that this increased risk is driven by higher platelet reactivity.

Using a nested case-control study design, HIV-infected and HIV-uninfected patients with a first episode of Acute Coronary Syndrome (ACS) treated with percutaneous coronary intervention were matched for age, sex, known diabetes mellitus and anti-platelet therapy.

The primary end-point was the residual platelet reactivity (RPA) on dual antiplatelet therapy assessed by light transmission aggregometry (LTA, 20µM ADP).

The study was conducted in a two large public university hospitals in central Paris, France.

ReferenceCitation: Parodi G, Marcucci R, Valenti R, Gori AM, Migliorini A, Giusti B, Buonamici P, Gensini GF, Abbate R, Antoniucci D. High residual platelet reactivity after clopidogrel loading and long-term cardiovascular events among patients with acute coronary syndromes undergoing PCI. JAMA. 2011 Sep 21;306(11):1215-23. doi: 10.1001/jama.2011.1332.

ReferenceCitation: Boccara F, Mary-Krause M, Teiger E, Lang S, Lim P, Wahbi K, Beygui F, Milleron O, Gabriel Steg P, Funck-Brentano C, Slama M, Girard PM, Costagliola D, Cohen A; Prognosis of Acute Coronary Syndrome in HIV-infected patients (PACS) Investigators. Acute coronary syndrome in human immunodeficiency virus-infected patients: characteristics and 1 year prognosis. Eur Heart J. 2011 Jan;32(1):41-50. doi: 10.1093/eurheartj/ehq372. Epub 2010 Oct 21.

ReferenceCitation: Lang S, Mary-Krause M, Cotte L, Gilquin J, Partisani M, Simon A, Boccara F, Bingham A, Costagliola D; French Hospital Database on HIV-ANRS CO4. Increased risk of myocardial infarction in HIV-infected patients in France, relative to the general population. AIDS. 2010 May 15;24(8):1228-30. doi: 10.1097/QAD.0b013e328339192f.

ReferenceCitation: Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007 Jul;92(7):2506-12. Epub 2007 Apr 24.

ReferenceCitation: Friis-Møller N, Weber R, Reiss P, Thiébaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group. Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93.

ReferenceCitation: Kaplan RC, Kingsley LA, Sharrett AR, Li X, Lazar J, Tien PC, Mack WJ, Cohen MH, Jacobson L, Gange SJ. Ten-year predicted coronary heart disease risk in HIV-infected men and women. Clin Infect Dis. 2007 Oct 15;45(8):1074-81. Epub 2007 Sep 12.

ReferenceCitation: Patel P, Hanson DL, Sullivan PS, Novak RM, Moorman AC, Tong TC, Holmberg SD, Brooks JT; Adult and Adolescent Spectrum of Disease Project and HIV Outpatient Study Investigators. Incidence of types of cancer among HIV-infected persons compared with the general population in the United States, 1992-2003. Ann Intern Med. 2008 May 20;148(10):728-36.

ReferenceCitation: Savès M, Chêne G, Ducimetière P, Leport C, Le Moal G, Amouyel P, Arveiler D, Ruidavets JB, Reynes J, Bingham A, Raffi F; French WHO MONICA Project and the APROCO (ANRS EP11) Study Group. Risk factors for coronary heart disease in patients treated for human immunodeficiency virus infection compared with the general population. Clin Infect Dis. 2003 Jul 15;37(2):292-8. Epub 2003 Jul 7.

ReferenceCitation: Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. Review.

ReferenceCitation: Capeau J. From lipodystrophy and insulin resistance to metabolic syndrome: HIV infection, treatment and aging. Curr Opin HIV AIDS. 2007 Jul;2(4):247-52. doi: 10.1097/COH.0b013e3281e66919.

ReferenceCitation: Triant VA, Meigs JB, Grinspoon SK. Association of C-reactive protein and HIV infection with acute myocardial infarction. J Acquir Immune Defic Syndr. 2009 Jul 1;51(3):268-73. doi: 10.1097/QAI.0b013e3181a9992c.

ReferenceCitation: Mangili A, Polak JF, Quach LA, Gerrior J, Wanke CA. Markers of atherosclerosis and inflammation and mortality in patients with HIV infection. Atherosclerosis. 2011 Feb;214(2):468-73. doi: 10.1016/j.atherosclerosis.2010.11.013. Epub 2010 Nov 17.

ReferenceCitation: Coll B, Parra S, Alonso-Villaverde C, Aragonés G, Montero M, Camps J, Joven J, Masana L. The role of immunity and inflammation in the progression of atherosclerosis in patients with HIV infection. Stroke. 2007 Sep;38(9):2477-84. Epub 2007 Aug 2.

ReferenceCitation: Kaplan RC, Kingsley LA, Gange SJ, Benning L, Jacobson LP, Lazar J, Anastos K, Tien PC, Sharrett AR, Hodis HN. Low CD4+ T-cell count as a major atherosclerosis risk factor in HIV-infected women and men. AIDS. 2008 Aug 20;22(13):1615-24. doi: 10.1097/QAD.0b013e328300581d.

ReferenceCitation: Torre D, Pugliese A. Platelets and HIV-1 infection: old and new aspects. Curr HIV Res. 2008 Sep;6(5):411-8. Review.

ReferenceCitation: Satchell CS, Cotter AG, O'Connor EF, Peace AJ, Tedesco AF, Clare A, Lambert JS, Sheehan GJ, Kenny D, Mallon PW. Platelet function and HIV: a case-control study. AIDS. 2010 Mar 13;24(5):649-57. doi: 10.1097/QAD.0b013e328336098c.

ReferenceCitation: Boccara F, Mary-Krause M, Teiger E, et al. HIV-infected patients have an increased risk of recurrent ischemic events as compared to the general population after an acute coronary syndrome. Paper presented at: American Heart Association; November 15th, 2011, 2011; Orlando, USA.

ReferenceCitation: Baker JV, Neuhaus J, Duprez D, Kuller LH, Tracy R, Belloso WH, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Nixon DE, Paton NI, Neaton JD; INSIGHT SMART Study Group. Changes in inflammatory and coagulation biomarkers: a randomized comparison of immediate versus deferred antiretroviral therapy in patients with HIV infection. J Acquir Immune Defic Syndr. 2011 Jan 1;56(1):36-43. doi: 10.1097/QAI.0b013e3181f7f61a.

ReferenceCitation: Scaradavou A. HIV-related thrombocytopenia. Blood Rev. 2002 Mar;16(1):73-6. Review.

ReferenceCitation: von Hentig N, Förster AK, Kuczka K, Klinkhardt U, Klauke S, Gute P, Staszewski S, Harder S, Graff J. Platelet-leucocyte adhesion markers before and after the initiation of antiretroviral therapy with HIV protease inhibitors. J Antimicrob Chemother. 2008 Nov;62(5):1118-21. doi: 10.1093/jac/dkn333. Epub 2008 Aug 27.

ReferenceCitation: Corrales-Medina VF, Simkins J, Chirinos JA, Serpa JA, Horstman LL, Jy W, Ahn YS. Increased levels of platelet microparticles in HIV-infected patients with good response to highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Jun;54(2):217-8. doi: 10.1097/QAI.0b013e3181c8f4c9.

ReferenceCitation: Baker J, Ayenew W, Quick H, Hullsiek KH, Tracy R, Henry K, Duprez D, Neaton JD. High-density lipoprotein particles and markers of inflammation and thrombotic activity in patients with untreated HIV infection. J Infect Dis. 2010 Jan 15;201(2):285-92. doi: 10.1086/649560.

ReferenceCitation: Daali Y, Ancrenaz V, Bosilkovska M, Dayer P, Desmeules J. Ritonavir inhibits the two main prasugrel bioactivation pathways in vitro: a potential drug-drug interaction in HIV patients. Metabolism. 2011 Nov;60(11):1584-9. doi: 10.1016/j.metabol.2011.03.015. Epub 2011 May 6.

ReferenceCitation: Collet JP, Cayla G, Cuisset T, Elhadad S, Rangé G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J. 2011 Jan;161(1):5-12.e5. doi: 10.1016/j.ahj.2010.09.029.

ReferenceCitation: Silvain J, Bellemain-Appaix A, Barthélémy O, Beygui F, Collet JP, Montalescot G. Optimal use of thienopyridines in non-ST-elevation acute coronary syndrome following CURRENT-OASIS 7. Circ Cardiovasc Interv. 2011 Feb 1;4(1):95-103. doi: 10.1161/CIRCINTERVENTIONS.109.910406.

ReferenceCitation: Silvain J, Collet JP, Nagaswami C, Beygui F, Edmondson KE, Bellemain-Appaix A, Cayla G, Pena A, Brugier D, Barthelemy O, Montalescot G, Weisel JW. Composition of coronary thrombus in acute myocardial infarction. J Am Coll Cardiol. 2011 Mar 22;57(12):1359-67. doi: 10.1016/j.jacc.2010.09.077.

ReferenceCitation: Hulot JS, Collet JP, Cayla G, Silvain J, Allanic F, Bellemain-Appaix A, Scott SA, Montalescot G. CYP2C19 but not PON1 genetic variants influence clopidogrel pharmacokinetics, pharmacodynamics, and clinical efficacy in post-myocardial infarction patients. Circ Cardiovasc Interv. 2011 Oct 1;4(5):422-8. doi: 10.1161/CIRCINTERVENTIONS.111.963025. Epub 2011 Oct 4.

ReferenceCitation: Silvain J, Cayla G, Hulot JS, Finzi J, Kerneis M, O'Connor SA, Bellemain-Appaix A, Barthélémy O, Beygui F, Collet JP, Montalescot G. High on-thienopyridine platelet reactivity in elderly coronary patients: the SENIOR-PLATELET study. Eur Heart J. 2012 May;33(10):1241-9. doi: 10.1093/eurheartj/ehr407. Epub 2011 Nov 7.

lead_sponsor: Saint Antoine University Hospital


title: Research for Genetic Factors Involved in Congenital Dislocation of Hip: Genome-wide Association Study in Grand West France

acronym: GENETHIP

summary:
The main objective is to identify the genes involved in congenital dislocation of the hip.

The secondary objectives are to measure the association between mechanical risk factors and congenital dislocation of hip and study the interactions between these factors and genetic factors.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Brest

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Influence of Local Biopsy of the Endometrium Prior to Controlled Ovarian Stimulation for IVF or ICSI Procedure on the Rates of Embryo Implantation, Clinical Pregnancy and Live Birth in ART

acronym: NIDABRECHE

summary: In vitro fertilization (IVF) is the only available solution for many couples with various forms of infertility. The embryo implantation step in the IVF procedure is a complex multistage process and represents the majority of the causes of the IVF failure. Several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. However, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of IVF patients improves the rates of embryo implantation, clinical pregnancy and live birth.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Bourgain C, Devroey P. The endometrium in stimulated cycles for IVF. Hum Reprod Update. 2003 Nov-Dec;9(6):515-22. Review.

ReferenceCitation: Richter KS, Bugge KR, Bromer JG, Levy MJ. Relationship between endometrial thickness and embryo implantation, based on 1,294 cycles of in vitro fertilization with transfer of two blastocyst-stage embryos. Fertil Steril. 2007 Jan;87(1):53-9. Epub 2006 Nov 1.

ReferenceCitation: Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22.

ReferenceCitation: Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201.

ReferenceCitation: Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. Review.

ReferenceCitation: Revelli A, Dolfin E, Gennarelli G, Lantieri T, Massobrio M, Holte JG, Tur-Kaspa I. Low-dose acetylsalicylic acid plus prednisolone as an adjuvant treatment in IVF: a prospective, randomized study. Fertil Steril. 2008 Nov;90(5):1685-91. Epub 2007 Dec 11.

ReferenceCitation: Khairy M, Banerjee K, El-Toukhy T, Coomarasamy A, Khalaf Y. Aspirin in women undergoing in vitro fertilization treatment: a systematic review and meta-analysis. Fertil Steril. 2007 Oct;88(4):822-31. Epub 2007 May 16. Review.

ReferenceCitation: Silver MM, Miles P, Rosa C. Comparison of Novak and Pipelle endometrial biopsy instruments. Obstet Gynecol. 1991 Nov;78(5 Pt 1):828-30.

ReferenceCitation: Gellersen B, Brosens IA, Brosens JJ. Decidualization of the human endometrium: mechanisms, functions, and clinical perspectives. Semin Reprod Med. 2007 Nov;25(6):445-53. Review.

ReferenceCitation: Lindhard A, Ravn V, Bentin-Ley U, Horn T, Bangsboell S, Rex S, Toft B, Soerensen S. Ultrasound characteristics and histological dating of the endometrium in a natural cycle in infertile women compared with fertile controls. Fertil Steril. 2006 Nov;86(5):1344-55. Epub 2006 Sep 14.

ReferenceCitation: Homburg R, Pap H, Brandes M, Huirne J, Hompes P, Lambalk CB. Endometrial biopsy during induction of ovulation with clomiphene citrate in polycystic ovary syndrome. Gynecol Endocrinol. 2006 Sep;22(9):506-10.

ReferenceCitation: Sulewski JM, Ward SP, McGaffic W. Endometrial biopsy during a cycle of conception. Fertil Steril. 1980 Dec;34(6):548-51.

ReferenceCitation: Wentz AC, Herbert CM 3rd, Maxson WS, Hill GA, Pittaway DE. Cycle of conception endometrial biopsy. Fertil Steril. 1986 Aug;46(2):196-9.

ReferenceCitation: Balasch J, Vanrell JA, Márquez M, González-Merlo J. Endometrial biopsy inadvertently taken in the cycle of conception. Int J Gynaecol Obstet. 1984 Apr;22(2):95-9.

ReferenceCitation: Giorgetti C, Terriou P, Auquier P, Hans E, Spach JL, Salzmann J, Roulier R. Embryo score to predict implantation after in-vitro fertilization: based on 957 single embryo transfers. Hum Reprod. 1995 Sep;10(9):2427-31.

ReferenceCitation: Abramov Y, Elchalal U, Schenker JG. Severe OHSS: An 'epidemic' of severe OHSS: a price we have to pay? Hum Reprod. 1999 Sep;14(9):2181-3. Review.

ReferenceCitation: Balasch J, Fábregues F, Arroyo V. Peripheral arterial vasodilation hypothesis: a new insight into the pathogenesis of ovarian hyperstimulation syndrome. Hum Reprod. 1998 Oct;13(1O):2718-30. Review.

ReferenceCitation: Govaerts I, Devreker F, Delbaere A, Revelard P, Englert Y. Short-term medical complications of 1500 oocyte retrievals for in vitro fertilization and embryo transfer. Eur J Obstet Gynecol Reprod Biol. 1998 Apr;77(2):239-43.

ReferenceCitation: Perrier D'hauterive S, Charlet-Renard C, Goffin F, Foidart M, Geenen V. [The implantation window]. J Gynecol Obstet Biol Reprod (Paris). 2002 Sep;31(5):440-55. Review. French.

ReferenceCitation: Bourgain C. [Endometrial biopsy in the evaluation of endometrial receptivity]. J Gynecol Obstet Biol Reprod (Paris). 2004 Feb;33(1 Pt 2):S13-7. Review. French.

ReferenceCitation: Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.

ReferenceCitation: Cornier E. The Pipelle: a disposable device for endometrial biopsy. Am J Obstet Gynecol. 1984 Jan 1;148(1):109-10.

ReferenceCitation: Check JH, Chase JS, Nowroozi K, Wu CH, Chern R. Clinical evaluation of the Pipelle endometrial suction curette for timed endometrial biopsies. J Reprod Med. 1989 Mar;34(3):218-20.

ReferenceCitation: Henig I, Chan P, Tredway DR, Maw GM, Gullett AJ, Cheatwood M. Evaluation of the Pipelle curette for endometrial biopsy. J Reprod Med. 1989 Oct;34(10):786-9.

ReferenceCitation: Machado F, Moreno J, Carazo M, León J, Fiol G, Serna R. Accuracy of endometrial biopsy with the Cornier pipelle for diagnosis of endometrial cancer and atypical hyperplasia. Eur J Gynaecol Oncol. 2003;24(3-4):279-81.

ReferenceCitation: Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv. 1989 Jun;44(6):430-40. Review.

ReferenceType: derived

ReferenceCitation: Frantz S, Parinaud J, Kret M, Rocher-Escriva G, Papaxanthos-Roche A, Creux H, Chansel-Debordeaux L, Bénard A, Hocké C. Decrease in pregnancy rate after endometrial scratch in women undergoing a first or second in vitro fertilization. A multicenter randomized controlled trial. Hum Reprod. 2019 Jan 1;34(1):92-99. doi: 10.1093/humrep/dey334.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction

location_facility: CHU de Toulouse, service de médecine et biologie de la reproduction

intervention_type: Procedure

status_simplified: Completed


title: Observatoire Multicentrique Français Des Porteurs de Défibrillateur Automatique Implantable en Prévention Primaire (Cardiopathie Ischémique ou Cardiomyopathie Dilatée)

acronym: DAI-PP

summary: The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death has been introduced later in France than in other parts of the World. Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.

time_perspective: Retrospective

ReferenceCitation: Escande W, Boveda S, Defaye P, Leclercq C, Sadoul N, Perier MC, Deharo JC, Fauchier L, Marijon E, Piot O; DAI-PP Investigators. Outcomes in Guideline-Based Versus Off-Guideline Primary Prevention Implantable Cardioverter-Defibrillator Recipients. J Am Coll Cardiol. 2017 Sep 5;70(10):1302-1303. doi: 10.1016/j.jacc.2017.07.711.

ReferenceCitation: Amara N, Boveda S, Defaye P, Klug D, Treguer F, Amet D, Perier MC, Gras D, Algalarrondo V, Bouzeman A, Piot O, Deharo JC, Fauchier L, Babuty D, Bordachar P, Sadoul N, Marijon E, Leclercq C; DAI-PP Investigators. Implantable cardioverter-defibrillator therapy among patients with non-ischaemic vs. ischaemic cardiomyopathy for primary prevention of sudden cardiac death. Europace. 2018 Jan 1;20(1):65-72. doi: 10.1093/europace/euw379.

ReferenceCitation: Clementy N, Challal F, Marijon E, Boveda S, Defaye P, Leclercq C, Deharo JC, Sadoul N, Klug D, Piot O, Gras D, Bordachar P, Algalarrondo V, Fauchier L, Babuty D; DAI-PP Investigators. Very high rate programming in primary prevention patients with reduced ejection fraction implanted with a defibrillator: Results from a large multicenter controlled study. Heart Rhythm. 2017 Feb;14(2):211-217. doi: 10.1016/j.hrthm.2016.10.024. Epub 2016 Oct 28.

ReferenceCitation: Escande W, Marijon E, Defaye P, Piot O, Leclercq C, Sadoul N, Deharo JC, Empana JP, Boveda S, Klug D. Electrical Storms in Patients With Implantable Cardioverter-Defibrillators for Primary Prevention. J Am Coll Cardiol. 2016 Sep 13;68(11):1248-1250. doi: 10.1016/j.jacc.2016.06.039.

ReferenceCitation: Providência R, Marijon E, Lambiase PD, Bouzeman A, Defaye P, Klug D, Amet D, Perier MC, Gras D, Algalarrondo V, Deharo JC, Leclercq C, Fauchier L, Babuty D, Bordachar P, Sadoul N, Piot O, Boveda S. Primary Prevention Implantable Cardioverter Defibrillator (ICD) Therapy in Women-Data From a Multicenter French Registry. J Am Heart Assoc. 2016 Feb 12;5(2). pii: e002756. doi: 10.1161/JAHA.115.002756.

lead_sponsor: Clinique Pasteur


title: Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group

acronym: POP-REMIND

summary:
Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical recurrence occurs in 60% by 10 years. The principal factors affecting postoperative recurrence are active smoking, penetrating disease, perianal lesions history, prior intestinal resection, small bowel resection extent, and prophylaxis treatment absence.

Ileocolonoscopy within one year of surgery can predict clinical recurrence risk.

Different therapies are proposed after surgery, to prevent post-operative recurrence : Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy.

Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role is clearly shown. Various changes in luminal flora with a possible link to local inflammation was also demonstrated. Bacteria associated with postoperative recurrence could be more pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through several mechanisms including increased mucosal colonization, adherence, replication and induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a protective commensal species lack, such as Faecalibacterium prausnitzii.

Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are associated with different rates of postoperative recurrence. It suggests cytokines implication in postoperative recurrence. T cells are major players in the intestinal immune response. The presence at time of surgery and persistence of disease inducing T cell clonal expansions could play an important role in post-operative recurrence.

The main objective is to define a classification of ileal Crohn's Disease based on data integration on a large cohort of patients.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Basic Science

ReferenceCitation: Sokol H, Brot L, Stefanescu C, Auzolle C, Barnich N, Buisson A, Fumery M, Pariente B, Le Bourhis L, Treton X, Nancey S, Allez M, Seksik P; REMIND Study Group Investigators. Prominence of ileal mucosa-associated microbiota to predict postoperative endoscopic recurrence in Crohn's disease. Gut. 2020 Mar;69(3):462-472. doi: 10.1136/gutjnl-2019-318719. Epub 2019 May 29.

ReferenceType: result

ReferenceCitation: Auzolle C, Nancey S, Tran-Minh ML, Buisson A, Pariente B, Stefanescu C, Fumery M, Marteau P, Treton X, Hammoudi N; REMIND Study Group Investigators, Jouven X, Seksik P, Allez M. Male gender, active smoking and previous intestinal resection are risk factors for post-operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study. Aliment Pharmacol Ther. 2018 Nov;48(9):924-932. doi: 10.1111/apt.14944. Epub 2018 Aug 20.

ReferenceCitation: Allez M, Auzolle C, Le Bourhis L, Seksik P. Editorial: predicting recurrence of Crohn's disease after surgical resection-Close to a crystal ball. Authors' reply. Aliment Pharmacol Ther. 2018 Nov;48(10):1157-1158. doi: 10.1111/apt.14998.

ReferenceCitation: Le Baut G, O'Brien C, Pavli P, Roy M, Seksik P, Tréton X, Nancey S, Barnich N, Bezault M, Auzolle C, Cazals-Hatem D, Viala J, Allez M; REMIND GROUP, Hugot JP, Dumay A. Prevalence of Yersinia Species in the Ileum of Crohn's Disease Patients and Controls. Front Cell Infect Microbiol. 2018 Sep 21;8:336. doi: 10.3389/fcimb.2018.00336. eCollection 2018.

ReferenceCitation: Allez M, Auzolle C, Ngollo M, Bottois H, Chardiny V, Corraliza AM, Salas A, Perez K, Stefanescu C, Nancey S, Buisson A, Pariente B, Fumery M, Sokol H, Tréton X, Barnich N, Seksik P, Le Bourhis L; REMIND Study Group. T cell clonal expansions in ileal Crohn's disease are associated with smoking behaviour and postoperative recurrence. Gut. 2019 Nov;68(11):1961-1970. doi: 10.1136/gutjnl-2018-317878. Epub 2019 Feb 12.

ReferenceCitation: Hammoudi N, Cazals-Hatem D, Auzolle C, Gardair C, Ngollo M, Bottois H, Nancey S, Pariente B, Buisson A, Treton X, Fumery M, Bezault M, Seksik P, Le Bourhis L; REMIND Study Group Investigators, Flejou JF, Allez M. Association Between Microscopic Lesions at Ileal Resection Margin and Recurrence After Surgery in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):141-149.e2. doi: 10.1016/j.cgh.2019.04.045. Epub 2019 Apr 28.

ReferenceCitation: Fumery M, Seksik P, Auzolle C, Munoz-Bongrand N, Gornet JM, Boschetti G, Cotte E, Buisson A, Dubois A, Pariente B, Zerbib P, Chafai N, Stefanescu C, Panis Y, Marteau P, Pautrat K, Sabbagh C, Filippi J, Chevrier M, Houze P, Jouven X, Treton X, Allez M; REMIND study group investigators. Postoperative Complications after Ileocecal Resection in Crohn's Disease: A Prospective Study From the REMIND Group. Am J Gastroenterol. 2017 Feb;112(2):337-345. doi: 10.1038/ajg.2016.541. Epub 2016 Dec 13.

ReferenceCitation: Khaloian S, Rath E, Hammoudi N, Gleisinger E, Blutke A, Giesbertz P, Berger E, Metwaly A, Waldschmitt N, Allez M, Haller D. Mitochondrial impairment drives intestinal stem cell transition into dysfunctional Paneth cells predicting Crohn's disease recurrence. Gut. 2020 Nov;69(11):1939-1951. doi: 10.1136/gutjnl-2019-319514. Epub 2020 Feb 28.

ReferenceCitation: Buisson A, Sokol H, Hammoudi N, Nancey S, Treton X, Nachury M, Fumery M, Hébuterne X, Rodrigues M, Hugot JP, Boschetti G, Stefanescu C, Wils P, Seksik P, Le Bourhis L, Bezault M, Sauvanet P, Pereira B, Allez M, Barnich N; Remind study group. Role of adherent and invasive Escherichia coli in Crohn's disease: lessons from the postoperative recurrence model. Gut. 2022 Mar 31. pii: gutjnl-2021-325971. doi: 10.1136/gutjnl-2021-325971. [Epub ahead of print]

lead_sponsor: Saint-Louis Hospital, Paris, France

location_country: France Belgium

location_facility:
Brabois Hospital
Saint Louis Hospital
Strasbourg Hospital
Haut-levêque Hospital
Henri Mondor Hospital
SART Tilman Hospital
Hôpital Nord, CHU Marseille
Nantes Hospital
Saint Antoine Hospital
Clermont-Ferrand Hospital
Kremlin-Bicêtre Hospital
Montpellier Hospital
Lille Hospital
Beaujon Hospital
Archet 2 Hospital
South Lyon Hospital
Amiens Hospital

status_simplified: Ongoing


title: Coordinated Research on Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With SARS-COV-2 Infection: a Transversal Study in Town in the Hauts de France Region

summary:
Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).

The objective of the COCO_Vi_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19

lead_sponsor: Tourcoing Hospital


title: Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

acronym: VISTA CARE

summary: The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.

lead_sponsor: University Hospital, Grenoble

intervention_type: Device


title: Retrospective Study on the Relationship Between Social Status and Use of Healthcare Services During the Confinement Period Linked to the COVID-19 Epidemic in Bas-Rhin, France

summary: Epidemics have always affected the most disadvantaged social categories more intensely. This social inequality is expressed in the use of care and emergencies: greater frequency but also greater seriousness. Our hypothesis is that, during a period of confinement, the most disadvantaged populations are more affected by the COVID-19 infection than the rest of the population. The number of remedies is greater, as is the severity of the forms of infection.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Adult Emergency Department - Strasbourg University Hospitals


title: Changes in the Consumption of Psychoactive Substances by People Incarcerated at the Villeneuve-Lès-Maguelone Prison During Containment Linked to COVID-19.

summary:
The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020.

On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention.

Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence.

However,prisoners have a higher prevalence of substance use disorders than the general population.

What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.

Anonymous questionnaire from the start
Collection of socio-demographic data
Collection of consumption data before and during containment
Collection of monitoring data

time_perspective: Cross-Sectional

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer.

acronym: PREOP-PSMA

summary:
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.

Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.

Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.

Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.

Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.

Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.

primary_purpose: Diagnostic

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

intervention_type: Diagnostic Test


title: Study of the Practice of Debiri in France: Indications, Associations to Systemic Treatments, Efficiency, Tolerance - Prospective Practice Survey

summary: In order to extract the profiles of patients receiving DEBIRI treatment at best, the investigators proposed the establishment of a national prospective cohort to collect information on the greatest number of patients treated with DEBIRI. This cohort will allow a better understanding of the effectiveness, tolerance, feasibility and differences of practices at national level for this approach. These data will assist in the development of clinical trials in situations that appear to be most promising in clinical practice.

status: Active, not recruiting

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

intervention_type: Drug

lead_sponsor_type: industriel


type: Other Identifier

title: Patients With Alzheimer's Disease or Related Youth Disease

acronym: PARMAAJJ

summary: This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France.

lead_sponsor: University Hospital, Lille


title: Dijon Stroke Cohort

acronym: DISCO

summary:
The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic attacks (TIAs) within the city of Dijon since 1985.

As a result of the development of therapies for acute disease, the prognosis of patients has improved over time. Thus, the number of stroke survivors has increased by 90% between the 1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and functional impact of stroke for motor, cognitive or thymic function. In the absence of available data in France, the investigators wish to set up an extended cohort follow-up of patients in order to study their long-term prognosis and to study the impact of future therapies on the evolutionary course of the disease.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France

summary: The goal of this study is to evaluate the knowledge of paramedical and medical care personnel concerning organ and tissue donations, as well as their opinions on this activity.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Hôpital Guy de Chauliac, CHU de Montpellier

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.

acronym: CYST-GEN

summary:
The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.

The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.

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ReferenceCitation: Farrell JJ, Fernández-del Castillo C. Pancreatic cystic neoplasms: management and unanswered questions. Gastroenterology. 2013 Jun;144(6):1303-15. doi: 10.1053/j.gastro.2013.01.073. Review.

ReferenceCitation: Terris B, Ponsot P, Paye F, Hammel P, Sauvanet A, Molas G, Bernades P, Belghiti J, Ruszniewski P, Fléjou JF. Intraductal papillary mucinous tumors of the pancreas confined to secondary ducts show less aggressive pathologic features as compared with those involving the main pancreatic duct. Am J Surg Pathol. 2000 Oct;24(10):1372-7.

ReferenceCitation: Crippa S, Fernández-Del Castillo C, Salvia R, Finkelstein D, Bassi C, Domínguez I, Muzikansky A, Thayer SP, Falconi M, Mino-Kenudson M, Capelli P, Lauwers GY, Partelli S, Pederzoli P, Warshaw AL. Mucin-producing neoplasms of the pancreas: an analysis of distinguishing clinical and epidemiologic characteristics. Clin Gastroenterol Hepatol. 2010 Feb;8(2):213-9. doi: 10.1016/j.cgh.2009.10.001. Epub 2009 Oct 14.

ReferenceCitation: Marchegiani G, Mino-Kenudson M, Sahora K, Morales-Oyarvide V, Thayer S, Ferrone C, Warshaw AL, Lillemoe KD, Fernández-Del Castillo C. IPMN involving the main pancreatic duct: biology, epidemiology, and long-term outcomes following resection. Ann Surg. 2015 May;261(5):976-83. doi: 10.1097/SLA.0000000000000813.

ReferenceCitation: Tanaka M, Fernández-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.

ReferenceCitation: Brugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6.

ReferenceCitation: Serikawa M, Sasaki T, Fujimoto Y, Kuwahara K, Chayama K. Management of intraductal papillary-mucinous neoplasm of the pancreas: treatment strategy based on morphologic classification. J Clin Gastroenterol. 2006 Oct;40(9):856-62.

ReferenceCitation: Bournet B, Kirzin S, Carrère N, Portier G, Otal P, Selves J, Musso C, Suc B, Moreau J, Fourtanier G, Pradère B, Lazorthes F, Escourrou J, Buscail L. Clinical fate of branch duct and mixed forms of intraductal papillary mucinous neoplasia of the pancreas. J Gastroenterol Hepatol. 2009 Jul;24(7):1211-7. doi: 10.1111/j.1440-1746.2009.05826.x. Epub 2009 May 19.

ReferenceCitation: Sugiyama M, Izumisato Y, Abe N, Masaki T, Mori T, Atomi Y. Predictive factors for malignancy in intraductal papillary-mucinous tumours of the pancreas. Br J Surg. 2003 Oct;90(10):1244-9.

ReferenceCitation: Kanno A, Satoh K, Hirota M, Hamada S, Umino J, Itoh H, Masamune A, Asakura T, Shimosegawa T. Prediction of invasive carcinoma in branch type intraductal papillary mucinous neoplasms of the pancreas. J Gastroenterol. 2010 Sep;45(9):952-9. doi: 10.1007/s00535-010-0238-0. Epub 2010 Apr 10.

ReferenceCitation: Crippa S, Salvia R, Warshaw AL, Domínguez I, Bassi C, Falconi M, Thayer SP, Zamboni G, Lauwers GY, Mino-Kenudson M, Capelli P, Pederzoli P, Castillo CF. Mucinous cystic neoplasm of the pancreas is not an aggressive entity: lessons from 163 resected patients. Ann Surg. 2008 Apr;247(4):571-9. doi: 10.1097/SLA.0b013e31811f4449.

ReferenceCitation: Cizginer S, Turner BG, Bilge AR, Karaca C, Pitman MB, Brugge WR. Cyst fluid carcinoembryonic antigen is an accurate diagnostic marker of pancreatic mucinous cysts. Pancreas. 2011 Oct;40(7):1024-8. doi: 10.1097/MPA.0b013e31821bd62f. Erratum in: Pancreas. 2013 May;42(4):728. Turner, Brian [corrected to Turner, Brian G].

ReferenceCitation: Sahora K, Mino-Kenudson M, Brugge W, Thayer SP, Ferrone CR, Sahani D, Pitman MB, Warshaw AL, Lillemoe KD, Fernandez-del Castillo CF. Branch duct intraductal papillary mucinous neoplasms: does cyst size change the tip of the scale? A critical analysis of the revised international consensus guidelines in a large single-institutional series. Ann Surg. 2013 Sep;258(3):466-75. doi: 10.1097/SLA.0b013e3182a18f48.

ReferenceCitation: Wu BU, Sampath K, Berberian CE, Kwok KK, Lim BS, Kao KT, Giap AQ, Kosco AE, Akmal YM, Difronzo AL, Yu W, Ngor EW. Prediction of malignancy in cystic neoplasms of the pancreas: a population-based cohort study. Am J Gastroenterol. 2014 Jan;109(1):121-9; quiz 130. doi: 10.1038/ajg.2013.334. Epub 2013 Oct 1.

ReferenceCitation: Grobmyer SR, Cance WG, Copeland EM, Vogel SB, Hochwald SN. Is there an indication for initial conservative management of pancreatic cystic lesions? J Surg Oncol. 2009 Oct 1;100(5):372-4. doi: 10.1002/jso.21260.

ReferenceCitation: Huang ES, Turner BG, Fernandez-Del-Castillo C, Brugge WR, Hur C. Pancreatic cystic lesions: clinical predictors of malignancy in patients undergoing surgery. Aliment Pharmacol Ther. 2010 Jan 15;31(2):285-94. doi: 10.1111/j.1365-2036.2009.04173.x. Epub 2009 Oct 21.

ReferenceCitation: Crippa S, Bassi C, Salvia R, Malleo G, Marchegiani G, Rebours V, Levy P, Partelli S, Suleiman SL, Banks PA, Ahmed N, Chari ST, Fernández-Del Castillo C, Falconi M. Low progression of intraductal papillary mucinous neoplasms with worrisome features and high-risk stigmata undergoing non-operative management: a mid-term follow-up analysis. Gut. 2017 Mar;66(3):495-506. doi: 10.1136/gutjnl-2015-310162. Epub 2016 Jan 7.

ReferenceCitation: Springer S, Wang Y, Dal Molin M, Masica DL, Jiao Y, Kinde I, Blackford A, Raman SP, Wolfgang CL, Tomita T, Niknafs N, Douville C, Ptak J, Dobbyn L, Allen PJ, Klimstra DS, Schattner MA, Schmidt CM, Yip-Schneider M, Cummings OW, Brand RE, Zeh HJ, Singhi AD, Scarpa A, Salvia R, Malleo G, Zamboni G, Falconi M, Jang JY, Kim SW, Kwon W, Hong SM, Song KB, Kim SC, Swan N, Murphy J, Geoghegan J, Brugge W, Fernandez-Del Castillo C, Mino-Kenudson M, Schulick R, Edil BH, Adsay V, Paulino J, van Hooft J, Yachida S, Nara S, Hiraoka N, Yamao K, Hijioka S, van der Merwe S, Goggins M, Canto MI, Ahuja N, Hirose K, Makary M, Weiss MJ, Cameron J, Pittman M, Eshleman JR, Diaz LA Jr, Papadopoulos N, Kinzler KW, Karchin R, Hruban RH, Vogelstein B, Lennon AM. A combination of molecular markers and clinical features improve the classification of pancreatic cysts. Gastroenterology. 2015 Nov;149(6):1501-10. doi: 10.1053/j.gastro.2015.07.041. Epub 2015 Aug 4.

ReferenceCitation: Al-Haddad MA, Kowalski T, Siddiqui A, Mertz HR, Mallat D, Haddad N, Malhotra N, Sadowski B, Lybik MJ, Patel SN, Okoh E, Rosenkranz L, Karasik M, Golioto M, Linder J, Catalano MF. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. 2015 Feb;47(2):136-42. doi: 10.1055/s-0034-1390742. Epub 2014 Oct 14.

ReferenceCitation: Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. Epub 2007 Dec 4.

ReferenceCitation: Boustière C, Veitch A, Vanbiervliet G, Bulois P, Deprez P, Laquiere A, Laugier R, Lesur G, Mosler P, Nalet B, Napoleon B, Rembacken B, Ajzenberg N, Collet JP, Baron T, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2011 May;43(5):445-61. doi: 10.1055/s-0030-1256317. Epub 2011 May 4.

ReferenceCitation: Dumonceau JM, Polkowski M, Larghi A, Vilmann P, Giovannini M, Frossard JL, Heresbach D, Pujol B, Fernández-Esparrach G, Vazquez-Sequeiros E, Ginès A; European Society of Gastrointestinal Endoscopy. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2011 Oct;43(10):897-912. doi: 10.1055/s-0030-1256754. Epub 2011 Aug 12.

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: CHU NANTES Institut des Maladies de l'Appareil Digestif

intervention_type: Genetic


title: Strategic Screening for Infectious Diseases (Tuberculosis, HIV, HBV, HCV) Amongst Migrants in France

acronym: STRADA

summary: To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen for HIV and hepatitis) amongst a population of legal migrants during their mandatory medical check-up. This study aims for a global improvement of screening and care for migrants.

ReferenceCitation: Meffre C, Le Strat Y, Delarocque-Astagneau E, Dubois F, Antona D, Lemasson JM, Warszawski J, Steinmetz J, Coste D, Meyer JF, Leiser S, Giordanella JP, Gueguen R, Desenclos JC. Prevalence of hepatitis B and hepatitis C virus infections in France in 2004: social factors are important predictors after adjusting for known risk factors. J Med Virol. 2010 Apr;82(4):546-55. doi: 10.1002/jmv.21734.

ReferenceCitation: Schneeberger Geisler S, Helbling P, Zellweger JP, Altpeter ES. Screening for tuberculosis in asylum seekers: comparison of chest radiography with an interview-based system. Int J Tuberc Lung Dis. 2010 Nov;14(11):1388-94.

ReferenceCitation: d'Almeida KW, Kierzek G, de Truchis P, Le Vu S, Pateron D, Renaud B, Semaille C, Bousquet V, Simon F, Guillemot D, Lert F, Crémieux AC; Emergency Department HIV-Screening Group. Modest public health impact of nontargeted human immunodeficiency virus screening in 29 emergency departments. Arch Intern Med. 2012 Jan 9;172(1):12-20. doi: 10.1001/archinternmed.2011.535. Epub 2011 Oct 24.

ReferenceCitation: d'Almeida KW, Pateron D, Kierzek G, Renaud B, Semaille C, de Truchis P, Simon F, Leblanc J, Lert F, Le Vu S, Crémieux AC. Understanding providers' offering and patients' acceptance of HIV screening in emergency departments: a multilevel analysis. ANRS 95008, Paris, France. PLoS One. 2013 Apr 29;8(4):e62686. doi: 10.1371/journal.pone.0062686. Print 2013.

ReferenceCitation: Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec.

ReferenceCitation: Haukoos JS, Lyons MS, Lindsell CJ, Hopkins E, Bender B, Rothman RE, Hsieh YH, Maclaren LA, Thrun MW, Sasson C, Byyny RL. Derivation and validation of the Denver Human Immunodeficiency Virus (HIV) risk score for targeted HIV screening. Am J Epidemiol. 2012 Apr 15;175(8):838-46. doi: 10.1093/aje/kwr389. Epub 2012 Mar 19.

lead_sponsor: University Paris 7 - Denis Diderot

location_facility:
OFII Metz
OFII Bordeaux
OFII Rouen
OFII Reims
OFII Toulouse
OFII Lyon
OFII Nantes
OFII Nice
OFII Melun
OFII Orléans
OFII Lille
OFII Marseille
OFII Montpellier
OFII Montrouge
OFII Rennes
OFII Cergy
OFII Clermont-Ferrand
OFII Grenoble


title: Objective Assessment for Caregivers With Work-related Musculoskeletal Disorders of the Shoulder

acronym: AWMSD

summary: Work-related musculoskeletal disorders (WMSD) are a major public health problem both in France and internationally. Our clinical research project focuses on WMSD of the shoulder (WMSD-S), which account for 32% and 23% of these disorders in France and Europe, respectively. In order to prevent WMSD-S, the assessment and rehabilitation of workers' physical and functional capacities (PFC) (e.g. joint amplitude) may complement current interventions (e.g. ergonomics) in a novel manner. As a result, the objectives of this project would be to conduct a cohort study assessing the PFC of caregivers with WMSD-S compared to those of healthy subjects and a randomised, controlled, single-blind, multicentre clinical study assessing the relevance of a rehabilitation program for caregivers with WMSD-S working in a hospital setting. This project would foster the promotion of evidence-based physiotherapy and lead to the development of a interdisciplinary research team dedicated to rehabilitation.

ReferenceCitation: DGAFP. Guide pratique-Démarche de prévention des troubles musculo-squelettiques.2015; 1-65.

ReferenceCitation: DIRECCTE de Normandie. Plan santé au travail 2016-2020 Normandie. oct 2017.

ReferenceCitation: INRS. Troubles musculosquelettiques (TMS). INRS; 2015.

ReferenceCitation: Schneider et al. OSH in figures: Work-related musculoskeletal disorders in the EU. 2010.

ReferenceCitation: ARS Haute-Normandie. Prévenir durablement les Troubles Musculo-Squelettiques. 2013

ReferenceCitation: Akkas O, Lee CH, Hu YH, Harris Adamson C, Rempel D, Radwin RG. Measuring exertion time, duty cycle and hand activity level for industrial tasks using computer vision. Ergonomics. 2017 Dec;60(12):1730-1738. doi: 10.1080/00140139.2017.1346208. Epub 2017 Jul 6.

ReferenceCitation: Ghasemi MS, Hosseinzadeh P, Zamani F, Ahmadpoor H, Dehghan N. Ergonomic design and evaluation of a diagnostic ultrasound transducer holder. Int J Occup Saf Ergon. 2017 Dec;23(4):519-523. doi: 10.1080/10803548.2016.1216763. Epub 2016 Sep 7.

ReferenceCitation: Padula RS, Comper MLC, Sparer EH, Dennerlein JT. Job rotation designed to prevent musculoskeletal disorders and control risk in manufacturing industries: A systematic review. Appl Ergon. 2017 Jan;58:386-397. doi: 10.1016/j.apergo.2016.07.018. Epub 2016 Aug 9. Review.

ReferenceCitation: Pransky G, Robertson MM, Moon SD. Stress and work-related upper extremity disorders: implications for prevention and management. Am J Ind Med. 2002 May;41(5):443-55. Review.

ReferenceCitation: Gutenbrunner C, Meyer T, Melvin J, Stucki G. Towards a conceptual description of Physical and Rehabilitation Medicine. J Rehabil Med. 2011 Sep;43(9):760-4. doi: 10.2340/16501977-0866.

ReferenceCitation: van den Noort JC, Wiertsema SH, Hekman KMC, Schönhuth CP, Dekker J, Harlaar J. Reliability and precision of 3D wireless measurement of scapular kinematics. Med Biol Eng Comput. 2014 Nov;52(11):921-931. doi: 10.1007/s11517-014-1186-2. Epub 2014 Sep 6.

ReferenceCitation: Krause DA, Neuger MD, Lambert KA, Johnson AE, DeVinny HA, Hollman JH. Effects of examiner strength on reliability of hip-strength testing using a handheld dynamometer. J Sport Rehabil. 2014 Feb;23(1):56-64. doi: 10.1123/jsr.2012-0070. Epub 2013 Nov 14.

ReferenceCitation: De Baets L, van der Straaten R, Matheve T, Timmermans A. Shoulder assessment according to the international classification of functioning by means of inertial sensor technologies: A systematic review. Gait Posture. 2017 Sep;57:278-294. doi: 10.1016/j.gaitpost.2017.06.025. Epub 2017 Jun 27. Review.

ReferenceCitation: Seitz AL, Uhl TL. Reliability and minimal detectable change in scapulothoracic neuromuscular activity. J Electromyogr Kinesiol. 2012 Dec;22(6):968-74. doi: 10.1016/j.jelekin.2012.05.003. Epub 2012 Jun 8.

ReferenceCitation: Sivan M, O'Connor RJ, Makower S, Levesley M, Bhakta B. Systematic review of outcome measures used in the evaluation of robot-assisted upper limb exercise in stroke. J Rehabil Med. 2011 Feb;43(3):181-9. doi: 10.2340/16501977-0674. Review.

ReferenceCitation: Hefford C, Abbott JH, Arnold R, Baxter GD. The patient-specific functional scale: validity, reliability, and responsiveness in patients with upper extremity musculoskeletal problems. J Orthop Sports Phys Ther. 2012 Feb;42(2):56-65. doi: 10.2519/jospt.2012.3953. Epub 2012 Feb 1.

ReferenceCitation: Fayad F, Lefevre-Colau MM, Gautheron V, Macé Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.

ipd_sharing_description: The data collected will be anonymized, computerized and stored by Maxime GILLIAUX. Only the investigators (Mr GILLIAUX and Mrs Julie VAN NIEUWENHOVE) will have access to the anonymized data in order to carry out the statistical work of this research.

lead_sponsor: Hopital La Musse


title: Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille

acronym: TROCENDO

summary:
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated .

French government recommendations aim to achieve elimination of hepatitis C virus HCV (as early as 2025) and since April 2018 the European Hospital Marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital.

Since 2017, direct-acting antiviral treatments have become available in France to all patients infected with HCV, regardless of the degree of severity of their disease. These treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. As of today, it is estimated that there are still 110,000 people likely to be treated in France. Among them, 75,000 are unaware of being HCV positive, people who need to be tested.

With one of the largest volumes of digestive endoscopic examinations in France, the European Hospital Marseille may be a significant source of screening for hepatitis C.

Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in the endoscopy department at the European Hospital Marseille.

lead_sponsor: Hôpital Européen Marseille


title: Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

summary:
Patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-ups. A blood sample will be proposed in the field of this research project, and the biological material will be stored at the DNA and Cell Bank of Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière Hospital, Paris). The clinical research network is already set up for Alzheimer's disease and frontotemporal dementias, which permits an evaluation according to a clinical standardized protocol.

Among these disorders, a monogenic sub-group has been identified. In Alzheimer's disease, it is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial forms with early onset. In frontotemporal dementias, the tau gene mutations account only for 10% of the cases with an autosomal dominant inheritance. The identification of familial forms with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular bases of forms not caused by the known genes, using linkage approaches and candidate gene analysis. The familial forms are also useful for identifying the modifier genes.

In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls matched for localizing and identifying susceptibility genetic factors. The strategies will use a candidate gene approach, and in the near future, studies of single nucleotide polymorphisms (SNPs) spread out in the whole genome. Meanwhile, similar approaches, particularly with candidate genes, could be used for identifying predictive factors of tolerance and response to the treatment.

Finally, correlations will be performed with seric markers according to each kind of dementia.

Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this project, and in the study of neurological disorders of genetic origin.

ReferenceCitation: Le Ber I, Guedj E, Gabelle A, Verpillat P, Volteau M, Thomas-Anterion C, Decousus M, Hannequin D, Véra P, Lacomblez L, Camuzat A, Didic M, Puel M, Lotterie JA, Golfier V, Bernard AM, Vercelletto M, Magne C, Sellal F, Namer I, Michel BF, Pasquier J, Salachas F, Bochet J; French research network on FTD/FTD-MND, Brice A, Habert MO, Dubois B. Demographic, neurological and behavioural characteristics and brain perfusion SPECT in frontal variant of frontotemporal dementia. Brain. 2006 Nov;129(Pt 11):3051-65.

ReferenceCitation: van der Zee J, Le Ber I, Maurer-Stroh S, Engelborghs S, Gijselinck I, Camuzat A, Brouwers N, Vandenberghe R, Sleegers K, Hannequin D, Dermaut B, Schymkowitz J, Campion D, Santens P, Martin JJ, Lacomblez L, De Pooter T, Peeters K, Mattheijssens M, Vercelletto M, Van den Broeck M, Cruts M, De Deyn PP, Rousseau F, Brice A, Van Broeckhoven C. Mutations other than null mutations producing a pathogenic loss of progranulin in frontotemporal dementia. Hum Mutat. 2007 Apr;28(4):416.

ReferenceCitation: Baba Y, Baker MC, Le Ber I, Brice A, Maeck L, Kohlhase J, Yasuda M, Stoppe G, Bugiani O, Sperfeld AD, Tsuboi Y, Uitti RJ, Farrer MJ, Ghetti B, Hutton ML, Wszolek ZK. Clinical and genetic features of families with frontotemporal dementia and parkinsonism linked to chromosome 17 with a P301S tau mutation. J Neural Transm (Vienna). 2007 Jul;114(7):947-50. Epub 2007 Feb 23.

ReferenceCitation: Le Ber I, van der Zee J, Hannequin D, Gijselinck I, Campion D, Puel M, Laquerrière A, De Pooter T, Camuzat A, Van den Broeck M, Dubois B, Sellal F, Lacomblez L, Vercelletto M, Thomas-Antérion C, Michel BF, Golfier V, Didic M, Salachas F, Duyckaerts C, Cruts M, Verpillat P, Van Broeckhoven C, Brice A; French Research Network on FTD/FTD-MND. Progranulin null mutations in both sporadic and familial frontotemporal dementia. Hum Mutat. 2007 Sep;28(9):846-55.

ReferenceCitation: Guedj E, Le Ber I, Lacomblez L, Dubois B, Verpillat P, Didic M, Salachas F, Vera P, Hannequin D, Lotterie JA, Puel M, Decousus M, Thomas-Antérion C, Magne C, Vercelletto M, Bernard AM, Golfier V, Pasquier J, Michel BF, Namer I, Sellal F, Bochet J, Volteau M, Brice A, Meininger V; French Research Network on FTD/FTD-MND, Habert MO. Brain spect perfusion of frontotemporal dementia associated with motor neuron disease. Neurology. 2007 Jul 31;69(5):488-90.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Pitié-Salpêtrière Hospital - Fédération de Neurologie

location_facility: Pitié-Salpêtrière Hospital - Centre du Langage et de Neuropsychologie


title: A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France

acronym: RIME

summary:
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries.

Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals.

Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.

primary_purpose: Treatment

lead_sponsor: Indivior Inc.

location_facility: CHU de Clermont-Ferrand, Centre Méthadone

location_facility: Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie

location_facility: CSST Centre Port Bretagne CH Charles Perrens


title: Pain and Schizophrenia

summary: The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.

status: Terminated

design_allocation: Non-Randomized

location_facility: Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg

location_facility: Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques

location_facility: Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg

location_facility: Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft

location_facility: Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg


title: A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France

acronym: B-SURE

summary: Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.

lead_sponsor: Swedish Orphan Biovitrum

location_facility: Swedish Orphan Biovitrum Research Site (CHU de Bordeaux)


title: Validation and Norms for Attention Deficit/Hyperactivity Disorder Scales in Children and Adults. Description of Associated Factors.

acronym: ChiP-ARD

summary:
Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not validated in France. This clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. This study is conceived to collect data in the general population of children aged from 4 to 18 years in public schools in the city of Nice.

Children are pseudo-randomly selected from classes of randomly selected schools in the city of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask parents to fill out a similar set of questionnaires regarding their child's behaviour at home. Since ADHD has a strong genetic components, parents are also asked to fill out questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.

Additionally, known factors related to ADHD and other disorders as well as other putative factors are tested in the epidemiologic study.

ReferenceCitation: Caci HM, Morin AJ, Tran A. Prevalence and correlates of attention deficit hyperactivity disorder in adults from a French community sample. J Nerv Ment Dis. 2014 Apr;202(4):324-32. doi: 10.1097/NMD.0000000000000126.

ReferenceCitation: Morin AJ, Tran A, Caci H. Factorial Validity of the ADHD Adult Symptom Rating Scale in a French Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 Jun;20(6):530-41. doi: 10.1177/1087054713488825. Epub 2013 May 31.

ReferenceCitation: Caci HM, Morin AJ, Tran A. Teacher Ratings of the ADHD-RS IV in a Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 May;20(5):434-44. doi: 10.1177/1087054712473834. Epub 2013 Feb 19.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Redictors of Non-accESs to therapeutiC EducAtion Programs Among Patients With Type 2 Diabetes, and/or Asthma, and/or Chronic Heart Failure in an Emergency Setting

acronym: ESCAPE

summary:
Chronic diseases are frequent and potentially severe. Type II diabetes, asthma and heart failure affect 3.3 million, 4 million and 1 million people respectively in France. They are sources of avoidable mortality as well as disabilities leading to a loss of years of full health life (DALYS). Cumulatively, they were responsible for the loss of more than 1 million DALYS in 2019 in France. National and international recommendations also include TVE in the management of these three diseases.

This severity can be reduced by better management underpinned by therapeutic education. By improving their knowledge of the disease, it allows a better adherence of patients to the care project, the achievement of clinical and biological objectives, a decrease in the number of emergency room visits and unscheduled hospitalizations, and an improvement in the quality of life during the course of three frequent chronic diseases such as type 2 diabetes, asthma and heart failure.

However, participation in a therapeutic education program remains highly variable depending on many parameters. Lack of information seems to play a major role in this context.

In the Ile de France region, the density of available TEP programs is high, particularly in Paris. The three chronic diseases that are managed by an advanced practice nurse with a PCS mention have the largest number of TVE programs in Paris: type 2 diabetes (32, and 6 for diabetic foot), asthma and heart failure.

In an urban area with a good supply of TVE facilities, how can investigators explain the lack of integration of these facilities into the care pathway? Among the diverse patient population consulting an emergency department suffering from type II diabetes, asthma or heart failure, investigators wish to determine the proportion of patients who have not been offered TVE during their care.

Investigators will then try to identify demographic, socioeconomic, and medical factors statistically associated with the absence of FTE proposal.

ReferenceCitation: Odgers-Jewell K, Ball LE, Kelly JT, Isenring EA, Reidlinger DP, Thomas R. Effectiveness of group-based self-management education for individuals with Type 2 diabetes: a systematic review with meta-analyses and meta-regression. Diabet Med. 2017 Aug;34(8):1027-1039. doi: 10.1111/dme.13340. Epub 2017 Mar 20. Review.

ReferenceCitation: McGhan SL, Cicutto LC, Befus AD. Advances in development and evaluation of asthma education programs. Curr Opin Pulm Med. 2005 Jan;11(1):61-8. Review.

ReferenceCitation: Rice H, Say R, Betihavas V. The effect of nurse-led education on hospitalisation, readmission, quality of life and cost in adults with heart failure. A systematic review. Patient Educ Couns. 2018 Mar;101(3):363-374. doi: 10.1016/j.pec.2017.10.002. Epub 2017 Oct 5.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress

acronym: TADDOR

summary:
Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in France since 2002.

Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary regarding the tumor localisation, the population, intensity of the symptoms...

Incidence of ENT cancer is highly significant in France, it is one of the most important in the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of depression is the most important (22%-57%).

Researches appears necessary to assessed the efficacy of antidepressant treatments with as primary objective not only the decrease of depressive symptoms but also an ensemble of physic and psychological symptoms.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Evaluation of the Efficiency of a Hydration by Isotonic Solution With or Without Muscular Exercise of the Fainting Whole Blood Donors

acronym: EVASION

summary:
Blood donation is a generous act carried out by healthy male and female volunteer donors. The safety of blood donation in France is based on rigorous well documented biological and medical criteria, in particular concerning the volume of blood to be taken. While whole blood donation is very safe, some donors experience faintness during or after donation. Any injury resulting from a fall increases its seriousness, especially when it happens outside the donation site.

According to various studies, adverse reactions are experienced by between 0.28% and 2.72% of all donors and occur in all categories (sex and age).

A retrospective evaluation of the frequency of faintness incidents on during whole blood donation over 2012 in the Rhone Alpes' region of France shows a frequency ranging from 1.05% in mobile donation units in towns to 4.24% in donation units in high schools, with no reporting of delayed incidents of faintness by this donor population.

primary_purpose: Prevention

ReferenceCitation: V. Candas, B. Bothorel : Hydratation, travail et chaleur. , INRS CDU 613-3 Fiche d'hygiène de vie au travail, Cahier de notes documentaires n° 135, 2ème trimestre 1989 : 241 - 245

ReferenceCitation: France CR, France JL, Kowalsky JM, Ellis GD, Copley DM, Geneser A, Frame-Brown T, Venable G, Graham D, Shipley P, Menitove JE. Assessment of donor fear enhances prediction of presyncopal symptoms among volunteer blood donors. Transfusion. 2012 Feb;52(2):375-80. doi: 10.1111/j.1537-2995.2011.03294.x. Epub 2011 Aug 16.

ReferenceCitation: Eder AF, Hillyer CD, Dy BA, Notari EP 4th, Benjamin RJ. Adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds. JAMA. 2008 May 21;299(19):2279-86. doi: 10.1001/jama.299.19.2279.

ReferenceCitation: P. Tomasulo, M. Bravo et H. Kamel : Time course of vasovagal syncope with whole blood donation. ISBT Science Series, 2010 ; 5 : 52 - 58

ReferenceCitation: Wieling W, France CR, van Dijk N, Kamel H, Thijs RD, Tomasulo P. Physiologic strategies to prevent fainting responses during or after whole blood donation. Transfusion. 2011 Dec;51(12):2727-38. doi: 10.1111/j.1537-2995.2011.03202.x. Epub 2011 Jun 3. Review.

ReferenceCitation: Kowalsky JM, France JL, Wissel ME, France CR. Effect of applied muscle tension on cerebral oxygenation in female blood donors. Transfusion. 2011 Aug;51(8):1802-8. doi: 10.1111/j.1537-2995.2011.03075.x. Epub 2011 Mar 7.

ReferenceCitation: Eder AF. Improving safety for young blood donors. Transfus Med Rev. 2012 Jan;26(1):14-26. doi: 10.1016/j.tmrv.2011.07.008. Epub 2011 Aug 26. Review.

ReferenceCitation: Eder AF. Current efforts to reduce the risk of syncope among young blood donors. Curr Opin Hematol. 2012 Nov;19(6):480-5. doi: 10.1097/MOH.0b013e328358b15c. Review.

ReferenceCitation: van den Berg K, Lam J, Bruhn R, Custer B, Murphy EL. Water administration and the risk of syncope and presyncope during blood donation: a randomized clinical trial. Transfusion. 2012 Dec;52(12):2577-84. doi: 10.1111/j.1537-2995.2012.03631.x. Epub 2012 Apr 4.

ReferenceCitation: Physiologie Humaine 3e édition Hervé Guénard, ed Pradel. Rein : 307 - 313

ReferenceCitation: Eder AF, Notari EP 4th, Dodd RY. Do reactions after whole blood donation predict syncope on return donation? Transfusion. 2012 Dec;52(12):2570-6. doi: 10.1111/j.1537-2995.2012.03666.x. Epub 2012 Apr 27.

ReferenceCitation: Eder A. Evidence-based selection criteria to protect blood donors. J Clin Apher. 2010;25(6):331-7. doi: 10.1002/jca.20257. Epub 2010 Sep 7. Review.

ReferenceCitation: Eder AF, Dy BA, Kennedy JM, Notari Iv EP, Strupp A, Wissel ME, Reddy R, Gibble J, Haimowitz MD, Newman BH, Chambers LA, Hillyer CD, Benjamin RJ. The American Red Cross donor hemovigilance program: complications of blood donation reported in 2006. Transfusion. 2008 Sep;48(9):1809-19. doi: 10.1111/j.1537-2995.2008.01811.x. Epub 2008 Jul 9.

ReferenceCitation: Bravo M, Kamel H, Custer B, Tomasulo P. Factors associated with fainting: before, during and after whole blood donation. Vox Sang. 2011 Nov;101(4):303-12. doi: 10.1111/j.1423-0410.2011.01494.x. Epub 2011 May 3.

ReferenceCitation: Carneiro-Proietti AB, Sabino EC, Sampaio D, Proietti FA, Gonçalez TT, Oliveira CD, Ferreira JE, Liu J, Custer B, Schreiber GB, Murphy EL, Busch MP. Demographic profile of blood donors at three major Brazilian blood centers: results from the International REDS-II study, 2007 to 2008. Transfusion. 2010 Apr;50(4):918-25. doi: 10.1111/j.1537-2995.2009.02529.x. Epub 2009 Dec 10.

ReferenceCitation: Trouern-Trend JJ, Cable RG, Badon SJ, Newman BH, Popovsky MA. A case-controlled multicenter study of vasovagal reactions in blood donors: influence of sex, age, donation status, weight, blood pressure, and pulse. Transfusion. 1999 Mar;39(3):316-20.

ReferenceCitation: Wiltbank TB, Giordano GF, Kamel H, Tomasulo P, Custer B. Faint and prefaint reactions in whole-blood donors: an analysis of predonation measurements and their predictive value. Transfusion. 2008 Sep;48(9):1799-808. doi: 10.1111/j.1537-2995.2008.01745.x. Epub 2008 May 14.

ReferenceCitation: Eder AF, Dy BA, Kennedy JM, Perez J, Demaris P, Procaccio A, Benjamin RJ. Improved safety for young whole blood donors with new selection criteria for total estimated blood volume. Transfusion. 2011 Jul;51(7):1522-31. doi: 10.1111/j.1537-2995.2011.03143.x. Epub 2011 Apr 29.

ReferenceCitation: Newman B, Tommolino E, Andreozzi C, Joychan S, Pocedic J, Heringhausen J. The effect of a 473-mL (16-oz) water drink on vasovagal donor reaction rates in high-school students. Transfusion. 2007 Aug;47(8):1524-33.

ReferenceCitation: Ando S, Kawamura N, Matsumoto M, Dan E, Takeshita A, Murakami K, Kashiwagi S, Kiyokawa H. Simple standing test predicts and water ingestion prevents vasovagal reaction in the high-risk blood donors. Transfusion. 2009 Aug;49(8):1630-6. doi: 10.1111/j.1537-2995.2009.02189.x.

ReferenceCitation: France CR, Ditto B, Wissel ME, France JL, Dickert T, Rader A, Sinclair K, McGlone S, Trost Z, Matson E. Predonation hydration and applied muscle tension combine to reduce presyncopal reactions to blood donation. Transfusion. 2010 Jun;50(6):1257-64. doi: 10.1111/j.1537-2995.2009.02574.x. Epub 2010 Jan 22.

ReferenceCitation: Tomasulo P, Kamel H, Bravo M, James RC, Custer B. Interventions to reduce the vasovagal reaction rate in young whole blood donors. Transfusion. 2011 Jul;51(7):1511-21. doi: 10.1111/j.1537-2995.2011.03074.x. Epub 2011 Mar 7.

ReferenceCitation: Scott EM, Greenwood JP, Stoker JB, Gilbey SG, Mary DA. Water drinking and sympathetic activation. Lancet. 2000 Dec 9;356(9246):2013.

ReferenceCitation: A. F. Eder : can we improve safety for young blood donors ?. ISBT Science Series 2012;7:226-229

ReferenceCitation: Custer B, Rios JA, Schlumpf K, Kakaiya RM, Gottschall JL, Wright DJ; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Adverse reactions and other factors that impact subsequent blood donation visits. Transfusion. 2012 Jan;52(1):118-26. doi: 10.1111/j.1537-2995.2011.03216.x. Epub 2011 Jun 17.

ReferenceCitation: France CR, France JL, Wissel ME, Ditto B, Dickert T, Himawan LK. Donor anxiety, needle pain, and syncopal reactions combine to determine retention: a path analysis of two-year donor return data. Transfusion. 2013 Sep;53(9):1992-2000. doi: 10.1111/trf.12069. Epub 2013 Jan 11.

ReferenceCitation: France CR, France JL, Himawan LK, Stephens KY, Frame-Brown TA, Venable GA, Menitove JE. How afraid are you of having blood drawn from your arm? A simple fear question predicts vasovagal reactions without causing them among high school donors. Transfusion. 2013 Feb;53(2):315-21. doi: 10.1111/j.1537-2995.2012.03726.x. Epub 2012 Jun 7.

ReferenceCitation: Veldhuizen I, Atsma F, van Dongen A, de Kort W. Adverse reactions, psychological factors, and their effect on donor retention in men and women. Transfusion. 2012 Sep;52(9):1871-9. doi: 10.1111/j.1537-2995.2011.03551.x. Epub 2012 Feb 10.

ReferenceCitation: Ditto B, France CR, Albert M, Byrne N, Smyth-Laporte J. Effects of applied muscle tension on the likelihood of blood donor return. Transfusion. 2009 May;49(5):858-62. doi: 10.1111/j.1537-2995.2008.02067.x. Epub 2009 Jan 21.

ReferenceCitation: Kamel H, Tomasulo P, Bravo M, Wiltbank T, Cusick R, James RC, Custer B. Delayed adverse reactions to blood donation. Transfusion. 2010 Mar;50(3):556-65. doi: 10.1111/j.1537-2995.2009.02397.x. Epub 2009 Oct 5.

ReferenceCitation: Ditto B, France CR, Holly C. Applied tension may help retain donors who are ambivalent about needles. Vox Sang. 2010 Apr;98(3 Pt 1):e225-30.

ReferenceCitation: Masser B. Experienced donors, adverse events, and retention. Transfusion. 2012 Sep;52(9):1844-8. doi: 10.1111/j.1537-2995.2012.03829.x. Review.

ReferenceCitation: Sinclair KS, Campbell TS, Carey PM, Langevin E, Bowser B, France CR. An adapted postdonation motivational interview enhances blood donor retention. Transfusion. 2010 Aug;50(8):1778-86. doi: 10.1111/j.1537-2995.2010.02618.x. Epub 2010 Apr 23.

ReferenceCitation: May M, Jordan J. The osmopressor response to water drinking. Am J Physiol Regul Integr Comp Physiol. 2011 Jan;300(1):R40-6. doi: 10.1152/ajpregu.00544.2010. Epub 2010 Nov 3. Review.

ReferenceCitation: Schroeder C, Bush VE, Norcliffe LJ, Luft FC, Tank J, Jordan J, Hainsworth R. Water drinking acutely improves orthostatic tolerance in healthy subjects. Circulation. 2002 Nov 26;106(22):2806-11.

ReferenceCitation: Endo Y, Yamauchi K, Tsutsui Y, Ishihara Z, Yamazaki F, Sagawa S, Shiraki K. Changes in blood pressure and muscle sympathetic nerve activity during water drinking in humans. Jpn J Physiol. 2002 Oct;52(5):421-7.

ReferenceCitation: Mathias CJ, Young TM. Water drinking in the management of orthostatic intolerance due to orthostatic hypotension, vasovagal syncope and the postural tachycardia syndrome. Eur J Neurol. 2004 Sep;11(9):613-9. Review.

ReferenceCitation: Moreno IL, Pastre CM, Ferreira C, de Abreu LC, Valenti VE, Vanderlei LC. Effects of an isotonic beverage on autonomic regulation during and after exercise. J Int Soc Sports Nutr. 2013 Jan 4;10(1):2. doi: 10.1186/1550-2783-10-2.

ReferenceCitation: Charkoudian N, Eisenach JH, Joyner MJ, Roberts SK, Wick DE. Interactions of plasma osmolality with arterial and central venous pressures in control of sympathetic activity and heart rate in humans. Am J Physiol Heart Circ Physiol. 2005 Dec;289(6):H2456-60. Epub 2005 Sep 30.

ReferenceCitation: Ditto B, France CR, Albert M, Byrne N. Dismantling applied tension: mechanisms of a treatment to reduce blood donation-related symptoms. Transfusion. 2007 Dec;47(12):2217-22. Epub 2007 Aug 21.

lead_sponsor: Etablissement Français du Sang

location_facility:
EFS Lyon
EFS Grenoble


title: A Pilot Study of the Effect of Individualized Clinical Management Among Parent/Child Dyads on Continuity of Care and Interaction. Phase 1 : Retrospective Evaluation

acronym: Rétro-GUIDANCE

summary: this project aims to collect retrospective data on the conitinuity/disconitnuity rate for child care in the child psychiatry unit of the université hospital of Besançon, France.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

acronym: FRENCH CORONA

summary:
Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France.

We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.


title: Impact Des inégalités Socio-économiques et Territoriales Sur la qualité de Vie pré et Post opératoire Des Scolioses Idiopathiques Prisent en Charge en Milieu pédiatrique

summary:
The incidence of idiopathic scoliosis is 3% or approximatively 300,000 new cases per year in France. It is estimated that between 0.1 and 0.3% of patients will eventually require surgical management, between 500 and 1000 scoliosis are operated per year in France. To our knowledge, the impact of socio-economic and territorial inequalities on the quality of life before and after surgery of idiopathic scoliosis has not been studied previously.

Main objective:

-Assess the impact of socio-economic and territorial inequalities on the pre- and post-operative quality of life at 1 year after surgical idiopathic scoliosis management, in a French pediatric surgery multicenter cohort.

Secondary objective:

Assess the impact of socio-economic and territorial inequalities on the quality of life pre and postoperative at 3 months after surgery on a French multicenter cohort.
To assess the impact of severity and type of scoliosis on pre- and post-operative quality of life at 3 months and 1 year after surgery on a French multicenter cohort.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Caen


title: Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

acronym: GONOCEF

summary:
Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.

Patients wanting STI screening can consult either they are symptomatic or not.

If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.

Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.

After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.

Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.

Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.

This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.

lead_sponsor: University Hospital, Montpellier


title: Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial

summary: This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) >8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose <70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]).

lead_sponsor: Hoffmann-La Roche

location_facility: Institut de diabétologie et Nutrition du Centre


title: Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France

acronym: COVICLOT

summary: The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events

time_perspective: Other

ReferenceCitation: Tacquard C, Mansour A, Godon A, Godet J, Poissy J, Garrigue D, Kipnis E, Rym Hamada S, Mertes PM, Steib A, Ulliel-Roche M, Bouhemad B, Nguyen M, Reizine F, Gouin-Thibault I, Besse MC, Collercandy N, Mankikian S, Levy JH, Gruel Y, Albaladejo P, Susen S, Godier A; French Working Group on Perioperative Hemostasis. Impact of High-Dose Prophylactic Anticoagulation in Critically Ill Patients With COVID-19 Pneumonia. Chest. 2021 Jun;159(6):2417-2427. doi: 10.1016/j.chest.2021.01.017. Epub 2021 Jan 16.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil


title: Medical Compression for Leg Chronic Wound in Patients With Arterial Peripheral Disease: A Practice Survey

summary: Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs


title: Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit

summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.

primary_purpose: Screening

lead_sponsor: University Hospital, Tours

intervention_type: Behavioral


title: Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease

acronym: ProdDiGYPark

summary: The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.

lead_sponsor: University Hospital, Lille


acronym: PELVICARE

summary: The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15% are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The invasion of the resection margins triples the risk of local recurrence. In the absence of surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative resection. The care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a difficult therapeutic problem with great variability in the methods of care and management around the world. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. With regards to the organization of its healthcare system, Australia is shown to be a leader as regards the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer.

ReferenceCitation: Denost Q, Saillour F, Masya L, Martinaud HM, Guillon S, Kret M, Rullier E, Quintard B, Solomon M. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design. BMC Cancer. 2016 Apr 4;16:262. doi: 10.1186/s12885-016-2286-1.

lead_sponsor: University Hospital, Bordeaux

location_country: Australia France

location_facility:
CLCC Val d'Aurelle
Institut Paoli Calmette
Hopital Beaujon
Peter Maccallum Cancer centre
Centre Oscar Lambret CLCC
Hopital A.Michallon
Royal Prince Alfred Hospital Sydney
Hopital Lyon Sud
Hôpital Saint-André
Hopital Charles Nicolle
Hôpital Purpan
Hôpital Saint-Antoine


title: Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study

summary:
The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients.

As routine care, each patient will be followed until 12 months after stent implantation.

lead_sponsor: Alvimedica Medical Technologies France

location_facility: Centre Hospitalier Saint-Joseph Saint-Luc

location_facility: Centre Hospitalier Universitaire Grenoble


title: A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM

summary:
The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.

As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.

status: Withdrawn

lead_sponsor: Aesculap AG


title: Investigator Centers Will Be All French Hematology Centers Performing Autologous Transplantation and Prescribing Mozobil in Hematopoietic Stem Cell Mobilization Willing to Participate In This Study

summary: The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.

lead_sponsor: Genzyme, a Sanofi Company


title: Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

summary: The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.

lead_sponsor: Medtronic Cardiovascular

location_facility:
CHl Toulon - La Seyne sur Mer
Polyclinique Quimper Sud
Hôpital Privé Sainte Marie
Clinique du Millenaire
CHU de Besancon, Hôpital Jean Minjoz
Clinique Belledonne
Clinique Sarrus Teinturiers
Hôpital Saint Joseph
Hôpital Privé Jean Mermoz
CHU Nice, Hôpital Saint-Roch
Clinique du Mousseau
Hôpital Ambroise Paré
CHU Limoges
Groupe Hospitalier Henri-Mondor
Clinique de la Présentation
Clinique Claude Bernard
Hôpital Paul Desbief
Médipôle de Savoie
Clinique Saint Joseph
Centre Hospitalier d'Avignon


title: Evaluation of a Complementary Action of Recruitment of Patients With a Positive Screening Test and Not Realizing Optical Colonoscopy as Part of Organized Colorectal Cancer Screening

acronym: COCAGI

summary:
France is among the countries with a high incidence of colorectal cancer. The prognosis associated with colorectal cancer is related to the development stage of the disease at diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate at 5 years was 90%. It is therefore a major issue of screening is widespread in France since the end of 2008.

This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and if positive 2) the realization of an optical colonoscopy examination currently regarded as the evaluation procedure colon reference. But as part of this organized screening, 13% of those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the refusal, virtual colonoscopy may be proposed as an alternative according to the recommendations of the National Health Authority in 2010. But it has never been assessed as part of organized screening. Similarly another alternative is recently developed colic capsule that benefits of development in recent years of the capsule for the small intestine which has become the gold standard for diagnosis of most diseases of the small intestine (bleeding occult, diagnosis of unknown colitis...).

Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive FOBT as part of organized screening and did not realize optical colonoscopy after the usual procedure and complete recovery. This study aims to answer the question of the place of colic capsule as part of organized screening. An economic component is integrated to assess, in terms of health insurance, the cost associated with these two exams, and compare them to the cost of optical colonoscopy.

The proposed study is an observational study of impact of an alternative screening strategy for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.

ReferenceCitation: Pioche M, Ganne C, Gincul R, De Leusse A, Marsot J, Balique J, Fond A, Bretagnolle M, Henry L, Billaud Y, Malezieux R, Lapalus MG, Chambon-Augoyard C, Del Tedesco E, Scalone O, Montoy JC, Russias B, Detry A, Veniat F, Qiu J, Valette PJ, Taillandier A, Saurin JC, Tomczyk-Ferrero J, Gandilhon C, Vecchiato L, Soler-Michel P, Ponchon T. Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trial. Endoscopy. 2018 Aug;50(8):761-769. doi: 10.1055/s-0044-100721. Epub 2018 Feb 27.

lead_sponsor: Hospices Civils de Lyon


title: Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?

acronym: APDT 2

summary:
The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in France and especially in the French West Indies.This chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle modification and medication. Despite numerous studies supporting the benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80% of this population remain sedentary. Promotion of physical activity in current diabetes care seems to be inadequate.

The aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with Type 2 diabetes.

lead_sponsor: University Hospital Center of Martinique

location_facility: CHU de Fort-de-France- Hôpital Pierre Zobda Quitman