title: Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

acronym: ENCOCHE

summary:
Data from the literature on the management of Chronic Coronary Occlusions (CTO) in France highlight a lack of epidemiological data on these patients at the national level.

For this reason, it was decided to set up this large-scale survey in order to have a picture of the management of patients with chronic coronary occlusion in France, to study the prevalence of CTOs in France as well as their management (medical, surgical or interventional), and then by analysing more precisely, over a second survey period, CTO angioplasties in terms of success rates, complications, medico-economic impact.

ReferenceCitation: Di Mario C, Werner GS, Sianos G, Galassi AR, Büttner J, Dudek D, Chevalier B, Lefevre T, Schofer J, Koolen J, Sievert H, Reimers B, Fajadet J, Colombo A, Gershlick A, Serruys PW, Reifart N. European perspective in the recanalisation of Chronic Total Occlusions (CTO): consensus document from the EuroCTO Club. EuroIntervention. 2007 May;3(1):30-43.

ReferenceCitation: Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4.

ReferenceCitation: Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.

ReferenceCitation: Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.

ReferenceCitation: Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. Outcomes after complete versus incomplete revascularization of patients with multivessel coronary artery disease: a meta-analysis of 89,883 patients enrolled in randomized clinical trials and observational studies. J Am Coll Cardiol. 2013 Oct 15;62(16):1421-31. doi: 10.1016/j.jacc.2013.05.033. Epub 2013 Jun 7.

ReferenceCitation: Sachdeva R. Effect of revascularization of chronic total occlusion on tandem stenoses in a "donor" artery. Tex Heart Inst J. 2014 Oct 1;41(5):547-50. doi: 10.14503/THIJ-13-3569. eCollection 2014 Oct.

ReferenceCitation: Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. Review.

ReferenceCitation: Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584.

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

family: Kappetein

full_name: A. Pieter Kappetein

given: A. Pieter

family: Colombo

full_name: Antonio Colombo

given: Antonio

family: Holmes

full_name: David R. Holmes

given: David R.

family: Mack

full_name: Michael J. Mack

given: Michael J.

family: Ståhle

full_name: Elisabeth Ståhle

given: Elisabeth

family: Feldman

full_name: Ted E. Feldman

given: Ted E.

family: van den Brand

full_name: Marcel van den Brand

given: Marcel

family: Bass

full_name: Eric J. Bass

given: Eric J.

family: Van Dyck

full_name: Nic Van Dyck

given: Nic

family: Leadley

full_name: Katrin Leadley

given: Katrin

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

family: Mohr

full_name: Friedrich W. Mohr

given: Friedrich W.

journal_name: New England Journal of Medicine

oa_host_type: repository

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease

ReferenceCitation: Olivari Z, Rubartelli P, Piscione F, Ettori F, Fontanelli A, Salemme L, Giachero C, Di Mario C, Gabrielli G, Spedicato L, Bedogni F; TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol. 2003 May 21;41(10):1672-8.

ReferenceCitation: Srivatsa SS, Edwards WD, Boos CM, Grill DE, Sangiorgi GM, Garratt KN, Schwartz RS, Holmes DR Jr. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition. J Am Coll Cardiol. 1997 Apr;29(5):955-63.

ReferenceCitation: Katsuragawa M, Fujiwara H, Miyamae M, Sasayama S. Histologic studies in percutaneous transluminal coronary angioplasty for chronic total occlusion: comparison of tapering and abrupt types of occlusion and short and long occluded segments. J Am Coll Cardiol. 1993 Mar 1;21(3):604-11.

ReferenceCitation: Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.

ReferenceCitation: de Labriolle A, Bonello L, Roy P, Lemesle G, Steinberg DH, Xue Z, Kaneshige K, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Comparison of safety, efficacy, and outcome of successful versus unsuccessful percutaneous coronary intervention in "true" chronic total occlusions. Am J Cardiol. 2008 Nov 1;102(9):1175-81. doi: 10.1016/j.amjcard.2008.06.059. Epub 2008 Aug 27.

ReferenceCitation: Suero JA, Marso SP, Jones PG, Laster SB, Huber KC, Giorgi LV, Johnson WL, Rutherford BD. Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience. J Am Coll Cardiol. 2001 Aug;38(2):409-14.

ReferenceCitation: Hoye A, van Domburg RT, Sonnenschein K, Serruys PW. Percutaneous coronary intervention for chronic total occlusions: the Thoraxcenter experience 1992-2002. Eur Heart J. 2005 Dec;26(24):2630-6. Epub 2005 Sep 23.

ReferenceCitation: Hannan EL, Racz M, Holmes DR, King SB 3rd, Walford G, Ambrose JA, Sharma S, Katz S, Clark LT, Jones RH. Impact of completeness of percutaneous coronary intervention revascularization on long-term outcomes in the stent era. Circulation. 2006 May 23;113(20):2406-12. Epub 2006 May 15.

ReferenceCitation: Farooq V, Serruys PW, Garcia-Garcia HM, Zhang Y, Bourantas CV, Holmes DR, Mack M, Feldman T, Morice MC, Ståhle E, James S, Colombo A, Diletti R, Papafaklis MI, de Vries T, Morel MA, van Es GA, Mohr FW, Dawkins KD, Kappetein AP, Sianos G, Boersma E. The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. J Am Coll Cardiol. 2013 Jan 22;61(3):282-94. doi: 10.1016/j.jacc.2012.10.017. Epub 2012 Dec 19.

ReferenceCitation: Patel VG, Brayton KM, Tamayo A, Mogabgab O, Michael TT, Lo N, Alomar M, Shorrock D, Cipher D, Abdullah S, Banerjee S, Brilakis ES. Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv. 2013 Feb;6(2):128-36. doi: 10.1016/j.jcin.2012.10.011. Epub 2013 Jan 23. Review.

ReferenceCitation: Prasad A, Rihal CS, Lennon RJ, Wiste HJ, Singh M, Holmes DR Jr. Trends in outcomes after percutaneous coronary intervention for chronic total occlusions: a 25-year experience from the Mayo Clinic. J Am Coll Cardiol. 2007 Apr 17;49(15):1611-1618. doi: 10.1016/j.jacc.2006.12.040. Epub 2007 Apr 2.

ReferenceCitation: Christakopoulos GE, Christopoulos G, Carlino M, Jeroudi OM, Roesle M, Rangan BV, Abdullah S, Grodin J, Kumbhani DJ, Vo M, Luna M, Alaswad K, Karmpaliotis D, Rinfret S, Garcia S, Banerjee S, Brilakis ES. Meta-analysis of clinical outcomes of patients who underwent percutaneous coronary interventions for chronic total occlusions. Am J Cardiol. 2015 May 15;115(10):1367-75. doi: 10.1016/j.amjcard.2015.02.038. Epub 2015 Feb 18. Review.

ReferenceCitation: Tomasello SD, Boukhris M, Giubilato S, Marzà F, Garbo R, Contegiacomo G, Marzocchi A, Niccoli G, Gagnor A, Varbella F, Desideri A, Rubartelli P, Cioppa A, Baralis G, Galassi AR. Management strategies in patients affected by chronic total occlusions: results from the Italian Registry of Chronic Total Occlusions. Eur Heart J. 2015 Dec 1;36(45):3189-98. doi: 10.1093/eurheartj/ehv450. Epub 2015 Sep 2.

ReferenceCitation: Godino C, Bassanelli G, Economou FI, Takagi K, Ancona M, Galaverna S, Mangieri A, Magni V, Latib A, Chieffo A, Carlino M, Montorfano M, Cappelletti A, Margonato A, Colombo A. Predictors of cardiac death in patients with coronary chronic total occlusion not revascularized by PCI. Int J Cardiol. 2013 Sep 30;168(2):1402-9. doi: 10.1016/j.ijcard.2012.12.044. Epub 2013 Jan 12.

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.

name: The BARC represents a collaboration of independent academic research organizations (Cardialysis, Rotterdam, the Netherlands; Cardiovascular Research Foundation, New York City, NY; Duke Clinical Research Institute, Durham, NC; TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA; Harvard Clinical Research Institute, Boston, MA; Green Lane Coordinating Centre, Auckland, New Zealand; Cleveland Clinic Coordinating Center for Clinical Research,...

title: Standardized Bleeding Definitions for Cardiovascular Clinical Trials

ReferenceCitation: International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals (excerpts). J Am Coll Dent. 2014 Summer;81(3):23-30.


title: Fabry Disease Prevalence in End-stage Renal Disease (ESRD) Patients on Dialysis or Transplant in West of France

acronym: SNOUFY

summary: Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Rennes University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


intervention_type: Drug

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Treatment

ipd_sharing: Undecided

type: EudraCT Number

source: euctr

title: A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)

summary: The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.

lead_sponsor_type: industriel


title: Measurement of Physical and Biochemical Markers of Reperfusion Edema During Primary Graft Dysfunction Following Lung Transplantation. Assessment of Their Diagnosis and Prognosis Values

summary: Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion Medical Systems) that also provides a physical estimate of pulmonary vascular permeability (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying physical and biochemical markers of PGD and assess their diagnosis and prognosis values.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Pottecher J, Roche AC, Dégot T, Helms O, Hentz JG, Schmitt JP, Falcoz PE, Santelmo N, Levy F, Collange O, Uring-Lambert B, Bahram S, Schaeffer M, Meyer N, Geny B, Lassalle P, Diemunsch P, Massard G, Kessler R, Steib A; Groupe de Transplantation Pulmonaire des Hôpitaux Universitaires de Strasbourg. Increased Extravascular Lung Water and Plasma Biomarkers of Acute Lung Injury Precede Oxygenation Impairment in Primary Graft Dysfunction After Lung Transplantation. Transplantation. 2017 Jan;101(1):112-121. doi: 10.1097/TP.0000000000001434.

family: Pottecher

full_name: Julien Pottecher

given: Julien

sequence: first

family: Roche

full_name: Anne-Claude Roche

given: Anne-Claude

sequence: additional

family: Dégot

full_name: Tristan Dégot

given: Tristan

family: Helms

full_name: Olivier Helms

given: Olivier

family: Hentz

full_name: Jean-Gustave Hentz

given: Jean-Gustave

family: Schmitt

full_name: Jean-Paul Schmitt

given: Jean-Paul

family: Falcoz

full_name: Pierre-Emmanuel Falcoz

given: Pierre-Emmanuel

family: Santelmo

full_name: Nicola Santelmo

given: Nicola

family: Levy

full_name: François Levy

given: François

family: Collange

full_name: Olivier Collange

family: Uring-Lambert

full_name: Béatrice Uring-Lambert

given: Béatrice

family: Bahram

full_name: Siamak Bahram

given: Siamak

family: Schaeffer

full_name: Mickaël Schaeffer

given: Mickaël

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

family: Geny

full_name: Bernard Geny

given: Bernard

family: Lassalle

full_name: Philippe Lassalle

given: Philippe

family: Diemunsch

full_name: Pierre Diemunsch

given: Pierre

family: Massard

full_name: Gilbert Massard

given: Gilbert

family: Kessler

full_name: Romain Kessler

given: Romain

family: Steib

full_name: Annick Steib

given: Annick

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Transplantation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital

location_facility: Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital

location_facility: Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital

status_simplified: Unknown


title: Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)

summary: Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.

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

location_facility: CEA / Centre National de Recherche en Génomique Humaine

intervention_type: Genetic


type: Other Identifier

title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France

summary: Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: CH d'Avignon - Centre Hospitalier Henri Duffaut

location_facility: Centre Hospitalier Général Louis Pasteur


title: A Descriptive Multicenter Investigation of Geriatrics Hotlines : Description of the Health Care Pathways and Conditions of Subjects Aged 75 and Over

summary:
In France, for general practitioners, the Emergency Hospitality Services (UAS) are the fastest and usual way to respond to the complexity of managing elderly polypathological patients. In 2013, the Regional Health Agencies proposed the creation of direct telephone assistance managed by geriatric doctors (geriatric hotlines) to promote interactions city - hospital. The aim of these hotlines is to improve the care pathways and health status of seniors. The objective of this study is to describe the care trajectories and health status of subjects over 75 years of age hospitalized in a short-term geriatric stay on the guidance of a Geriatric Hotline.

The study will take place over 24 months and in 7 French University Hospitallers Centres. The study will include all patients aged 75 and over, living at home or in an institution, who are hospitalized in a short-term geriatric ward on the guidance of a Hotline.

The results will show whether a management by the geriatric hotline is the most suitable for seniors, with an average length of stay probably shorter.

ReferenceCitation: Martinez L, Lacour N, Gonthier R, Bonnefoy M, Goethals L, Annweiler C, Salles N, Jomard N, Bohatier J, Tardy M, Ojardias E, Jugand R, Bongué B, Celarier T. Impact of Geriatric Hotlines on Health Care Pathways and Health Status in Patients Aged 75 Years and Older: Protocol for a French Multicenter Observational Study. JMIR Res Protoc. 2020 Feb 13;9(2):e15423. doi: 10.2196/15423.

family: Martinez

full_name: Laure Martinez

given: Laure

family: Lacour

full_name: Noémie Lacour

given: Noémie

family: Gonthier

full_name: Régis Gonthier

given: Régis

family: Bonnefoy

full_name: Marc Bonnefoy

given: Marc

family: Goethals

full_name: Luc Goethals

given: Luc

family: Annweiler

full_name: Cedric Annweiler

given: Cedric

family: Salles

full_name: Nathalie Salles

given: Nathalie

family: Jomard

full_name: Nathalie Jomard

family: Bohatier

full_name: Jérôme Bohatier

given: Jérôme

family: Tardy

full_name: Magali Tardy

given: Magali

family: Ojardias

full_name: Etienne Ojardias

given: Etienne

family: Jugand

full_name: Romain Jugand

family: Bongué

full_name: Bienvenu Bongué

given: Bienvenu

family: Celarier

full_name: Thomas Celarier

given: Thomas

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: Support and Education Technic Centre


title: Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention

acronym: Mindfulness

summary:
Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. This "to do with" training has yielded promising results in stress management, prevention of depressive relapse, management of craving and an increase in self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this technique on alcohol relapse, in particular by comparing it with a usual management strategy (conventional relapse prevention therapy).

The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).

design_allocation: Randomized

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe

acronym: Euro-COVIMID

summary:
The coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents.

In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases.

In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs.

Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.

status: Active, not recruiting

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Pope JE. What Does the COVID-19 Pandemic Mean for Rheumatology Patients? Curr Treatm Opt Rheumatol. 2020 Apr 30:1-4. doi: 10.1007/s40674-020-00145-y. [Epub ahead of print] Review.

ReferenceCitation: Favalli EG, Agape E, Caporali R. Incidence and Clinical Course of COVID-19 in Patients with Connective Tissue Diseases: A Descriptive Observational Analysis. J Rheumatol. 2020 Aug 1;47(8):1296. doi: 10.3899/jrheum.200507. Epub 2020 Apr 25.

ReferenceCitation: Mathian A, Mahevas M, Rohmer J, Roumier M, Cohen-Aubart F, Amador-Borrero B, Barrelet A, Chauvet C, Chazal T, Delahousse M, Devaux M, Euvrard R, Fadlallah J, Florens N, Haroche J, Hié M, Juillard L, Lhote R, Maillet T, Richard-Colmant G, Palluy JB, Pha M, Perard L, Remy P, Rivière E, Sène D, Sève P, Morélot-Panzini C, Viallard JF, Virot JS, Benameur N, Zahr N, Yssel H, Godeau B, Amoura Z. Clinical course of coronavirus disease 2019 (COVID-19) in a series of 17 patients with systemic lupus erythematosus under long-term treatment with hydroxychloroquine. Ann Rheum Dis. 2020 Jun;79(6):837-839. doi: 10.1136/annrheumdis-2020-217566. Epub 2020 Apr 24.

ReferenceCitation: Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2.

ReferenceCitation: Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16.

ReferenceCitation: Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2020 Mar 27:1-9. doi: 10.1007/s11469-020-00270-8. [Epub ahead of print]

ReferenceCitation: Saadoun D, Vieira M, Vautier M, Baraliakos X, Andreica I, da Silva JAP, Sousa M, Luis M, Khmelinskii N, Gracía JMA, Castrejon I, Gonzalez JCN, Scirè CA, Silvagni E, Bortoluzzi A, Penn H, Hamdulay S, Machado PM, Fautrel B, Cacoub P, Resche-Rigon M, Gossec L. SARS-CoV-2 outbreak in immune-mediated inflammatory diseases: the Euro-COVIMID multicentre cross-sectional study. Lancet Rheumatol. 2021 Jul;3(7):e481-e488. doi: 10.1016/S2665-9913(21)00112-0. Epub 2021 Apr 28.

family: Saadoun

full_name: David Saadoun

given: David

family: Vieira

full_name: Matheus Vieira

given: Matheus

family: Vautier

full_name: Mathieu Vautier

given: Mathieu

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Andreica

full_name: Ioana Andreica

given: Ioana

family: da Silva

full_name: José A P da Silva

given: José A P

family: Sousa

full_name: Marlene Sousa

given: Marlene

family: Luis

full_name: Mariana Luis

given: Mariana

family: Khmelinskii

full_name: Nikita Khmelinskii

given: Nikita

family: Gracía

full_name: José María Alvaro Gracía

given: José María Alvaro

family: Castrejon

full_name: Isabel Castrejon

given: Isabel

family: Gonzalez

full_name: Juan Carlos Nieto Gonzalez

given: Juan Carlos Nieto

family: Scirè

full_name: Carlo Alberto Scirè

given: Carlo Alberto

family: Silvagni

full_name: Ettore Silvagni

given: Ettore

family: Bortoluzzi

full_name: Alessandra Bortoluzzi

given: Alessandra

family: Penn

full_name: Henry Penn

given: Henry

family: Hamdulay

full_name: Shahir Hamdulay

given: Shahir

family: Machado

full_name: Pedro M Machado

given: Pedro M

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Cacoub

full_name: Patrice Cacoub

given: Patrice

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

family: Gossec

full_name: Laure Gossec

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
estudogeral.sib.uc.pt


title: Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis

acronym: CALPRO-HAA

summary:
Severe alcoholic hepatitis, defined by a "Maddrey discriminant function" above 32, is associated with significant short-term mortality. In patients with liver disease, studies have shown alterations of intestinal bacterial flora and an increase in intestinal permeability leading to bacterial translocation across the intestinal barrier. The mechanism involved may be an activation of intestinal macrophages with a local release of cytokines like interleukin-8 (IL-8).

Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic hepatitis has never been evaluated.

The main objective of this study was to determine if the initial level of fecal calprotectin and its variation after 7 days had a predictive value for the outcome of severe alcoholic hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and predictive of infections.

primary_purpose: Other

lead_sponsor: CHU de Reims

intervention_type: Biological


title: Evaluation de la Formation Des infirmières à la Stimulation de l'oralité Des Nouveau-nés Dans Une unité de Réanimation néonatale et Néonatologie : Impact Sur Les Connaissances, Les Pratiques et Sur la qualité Des Soins

acronym: TOP

summary:
Poor oral motor development in preterm neonates is common. Feeding problems lead to longer hospital stay and higher hospital cost. Different interventions have shown their efficacy to accelerate transition and move faster to full oral feeding autonomy. Our study aimed to evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay of preterm neonates.

This is an interrupted time series study placed in Intensive Care and Neonatal unit of an university hospital located in Lyon, France. All preterm neonates are included in the study, from April 2013 to January 2016.

ReferenceCitation: Touzet S, Beissel A, Denis A, Pillet F, Gauthier-Moulinier H, Hommey S, Claris O; TOP Study Group. Effectiveness of a nurse educational oral feeding programme on feeding outcomes in neonates: protocol for an interrupted time series design. BMJ Open. 2016 Apr 15;6(4):e010699. doi: 10.1136/bmjopen-2015-010699.

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

family: Beissel

full_name: Anne Beissel

given: Anne

family: Denis

full_name: Angélique Denis

given: Angélique

family: Pillet

full_name: Fabienne Pillet

given: Fabienne

family: Gauthier-Moulinier

full_name: Hélène Gauthier-Moulinier

given: Hélène

family: Hommey

full_name: Sophie Hommey

given: Sophie

family: Claris

full_name: Olivier Claris

given: Olivier

currency_apc_doaj: GBP

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon


title: Interaction Emotion-cognition in the Study of Literal and Figurative Language in Schizophrenia and Bipolar Disorders: Behavioral and Electrophysiological Studies

acronym: ELISE

summary: The initial aim of the project was to gain an understanding of the comprehension of "language-oriented" emotions among schizophrenic and bipolar patients. By "language-oriented" emotions, the investigators mean the emotions that are conveyed by means of language, whether through the emotional valence of the words, the expression of an emotional state or emotional prosody. Although they involve different diagnostic categories, schizophrenic and bipolar disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and do so to such an extent that the question of whether there may, at the clinical, cognitive and etiopathogenic levels, exist a continuum between these disorders is frequently raised. Taking this hypothesis of a clinical continuum as our starting point, the investigators explored the understanding of emotions contextualized by language in these two clinical populations, namely patients exhibiting schizophrenic and bipolar disorders. To these populations, the investigators also added the dimension of vulnerability in the form of non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus orienting this project toward the early identification of cognitive-emotional markers and possibly also their prevention.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Terrien S, Gobin P, Iakimova G, Coutté A, Thuaire F, Baltazart V, Mazzola-Pomietto P, Besche-Richard C. Electrophysiological correlates of emotional meaning in context in relation to facets of schizotypal personality traits: A dimensional study. Psychiatry Clin Neurosci. 2016 Mar;70(3):141-50. doi: 10.1111/pcn.12366. Epub 2015 Dec 22.

name: Cognition, Health, Socialisation Laboratory; University of Reims Champagne-Ardenne; Reims

family: Terrien

full_name: Sarah Terrien

given: Sarah

family: Gobin

full_name: Pamela Gobin

given: Pamela

name: Anthropology, Cognitive and Social Psychology Laboratory; LAPCOS; University of Nice-Sophia Antipolis; Nice

family: Iakimova

full_name: Galina Iakimova

given: Galina

family: Coutté

full_name: Alexandre Coutté

given: Alexandre

name: Timone Neuroscience Institute; Marseille

family: Thuaire

full_name: Flavien Thuaire

given: Flavien

family: Baltazart

full_name: Véronique Baltazart

given: Véronique

family: Mazzola-Pomietto

full_name: Pascale Mazzola-Pomietto

given: Pascale

name: French Universitary Institute; Paris France

family: Besche-Richard

full_name: Chrystel Besche-Richard

given: Chrystel

journal_name: Psychiatry and Clinical Neurosciences

oa_host_type: publisher

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Terrien S, Gobin P, Coutté A, Thuaire F, Iakimova G, Mazzola-Pomietto P, Besche-Richard C. Emotional Meaning in Context in Relation to Hypomanic Personality Traits: An ERP Study. PLoS One. 2015 Sep 22;10(9):e0138877. doi: 10.1371/journal.pone.0138877. eCollection 2015.

journal_name: PLOS ONE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

ReferenceCitation: Terrien S, Stefaniak N, Morvan Y, Besche-Richard C. Factor structure of the French version of the Hypomanic Personality Scale (HPS) in non-clinical young adults. Compr Psychiatry. 2015 Oct;62:105-13. doi: 10.1016/j.comppsych.2015.07.001. Epub 2015 Jul 8.


summary: The main objective of our study is to determine if the evaluation of ingesta of cancer patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of patients during hospitalization (for patients malnourished, at risk of malnutrition or risk free).

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: A Pilot, Single-blind, Forced-titration Study to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability of the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

summary: The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.

ReferenceCitation: Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.

family: Schumacher

full_name: Christoph D. Schumacher

given: Christoph D.

family: Steele

full_name: Ronald E. Steele

given: Ronald E.

family: Brunner

full_name: Hans R. Brunner

given: Hans R.

journal_name: Journal of Hypertension

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Amar L, Azizi M, Menard J, Peyrard S, Watson C, Plouin PF. Aldosterone synthase inhibition with LCI699: a proof-of-concept study in patients with primary aldosteronism. Hypertension. 2010 Nov;56(5):831-8. doi: 10.1161/HYPERTENSIONAHA.110.157271. Epub 2010 Sep 13.

name: From the Université Paris Descartes (L.A., M.A., J.M., S.P., P.-F.P.), Faculté de Médecine, Paris, France; Assistance Publique des Hôpitaux de Paris (L.A., M.A., J.M., S.P.), Hôpital Européen Georges Pompidou, Paris, France; Institut National de la Santé et de la Recherche Médicale (L.A., M.A., J.M., S.P., P.-F.P.), Clinical Investigation Centre 9201, Paris, France; Novartis Pharmaceuticals (C.W.), East Hanover, NJ.

family: Amar

full_name: Laurence Amar

given: Laurence

family: Azizi

full_name: Michel Azizi

given: Michel

family: Menard

full_name: Joël Menard

given: Joël

family: Peyrard

full_name: Séverine Peyrard

given: Séverine

family: Watson

full_name: Catherine Watson

given: Catherine

family: Plouin

full_name: Pierre-François Plouin

given: Pierre-François

journal_name: Hypertension

evidence: open (via free pdf)

title: Aldosterone Synthase Inhibition With LCI699

lead_sponsor: Novartis


title: Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

summary: A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.

lead_sponsor: Air Liquide Santé International


title: French Validation of the Dual Diagnosis Screening Interview (F_DDSI)

summary: In France, there are no tools for screening psychiatric comorbidities for individuals with Substance Use Disorders. The literature shows that the cooccurrence of these psychiatric disorders in the same individual is frequent. It negatively impacts the healing prognosis, complicates the diagnostic processes and the type of care to be introduced for patients. The creation of reliable, fast and easy-to-use tools for caregivers and researchers is therefore necessary to improve quantitatively and qualitatively the care of patients. There is a Spanish scale that meets these criteria, the Dual Diagnostic Screening Interview (S_DDSI). The main objective of this study is to validate the DDSI in French. The secondary objectives are the evaluation of the psychometric qualities of F_DDSI (French version) and adaptation of this scale into an application for Android and iOS.

location_facility:
CH Etienne Clémentel
CHU de Clermont-Ferrand


title: Creation of a Prospective Melanoma Database

summary:
In research on melanoma, translational research is the essential link between basic research and clinical research by facilitating the passage between discovery and improvement in the quality of patients care.That is the reason why it is very important to collect, and centralize clinical and biological data of patients with melanoma.

The aim of the project is to provide to scientific community a structured, mixed clinical and biological database, unique in France, in order to insure accessibility to clinical data.

status: Recruiting

lead_sponsor: Institut Claudius Regaud

status_simplified: Ongoing


title: Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.

summary: This study is a retrospective cohort trial to assess the efficacy of remdesivir in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial which will be carried out on different sites in France. This trial is retrospective and will analyze the data collected during treatment.

time_perspective: Retrospective

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

name: Chinese Center for Disease Control and Prevention, Beijing, China

family: Wu

full_name: Zunyou Wu

given: Zunyou

family: McGoogan

full_name: Jennifer M. McGoogan

given: Jennifer M.

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.

family: Huang

full_name: Chaolin Huang

given: Chaolin

family: Wang

full_name: Yeming Wang

given: Yeming

family: Li

full_name: Xingwang Li

given: Xingwang

family: Ren

full_name: Lili Ren

given: Lili

family: Zhao

full_name: Jianping Zhao

given: Jianping

family: Hu

full_name: Yi Hu

given: Yi

family: Zhang

full_name: Li Zhang

given: Li

family: Fan

full_name: Guohui Fan

given: Guohui

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Cheng

full_name: Zhenshun Cheng

given: Zhenshun

family: Yu

full_name: Ting Yu

given: Ting

family: Xia

full_name: Jiaan Xia

given: Jiaan

family: Wei

full_name: Yuan Wei

given: Yuan

full_name: Wenjuan Wu

given: Wenjuan

family: Xie

full_name: Xuelei Xie

given: Xuelei

family: Yin

full_name: Wen Yin

given: Wen

full_name: Hui Li

ReferenceCitation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

name: From the State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (W.G., W.L., J.H., R.C., C.T., T.W., S.L., Jin-lin Wang, N.Z., J.H., W.L.), the Departments of Thoracic Oncology (W.L.), Thoracic Surgery and Oncology (J.H.), and Emergency Medicine (Z.L.), First Affiliated Hospital of Guangzhou Medical University, and Guangzhou Eighth People’s Hospital,...

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Chan JF, Kok KH, Zhu Z, Chu H, To KK, Yuan S, Yuen KY. Genomic characterization of the 2019 novel human-pathogenic coronavirus isolated from a patient with atypical pneumonia after visiting Wuhan. Emerg Microbes Infect. 2020 Jan 28;9(1):221-236. doi: 10.1080/22221751.2020.1719902. eCollection 2020. Erratum in: Emerg Microbes Infect. 2020 Dec;9(1):540.

ReferenceCitation: Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet. 2020 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub 2020 Jan 31. Erratum in: Lancet. 2020 Feb 4;:.

ReferenceCitation: Friberg LE, Guedj J. Acute bacterial or viral infection-What's the difference? A perspective from PKPD modellers. Clin Microbiol Infect. 2020 Sep;26(9):1133-1136. doi: 10.1016/j.cmi.2019.12.008. Epub 2019 Dec 31.

ReferenceCitation: Gonçalves A, Bertrand J, Ke R, Comets E, de Lamballerie X, Malvy D, Pizzorno A, Terrier O, Rosa Calatrava M, Mentré F, Smith P, Perelson AS, Guedj J. Timing of Antiviral Treatment Initiation is Critical to Reduce SARS-CoV-2 Viral Load. CPT Pharmacometrics Syst Pharmacol. 2020 Sep;9(9):509-514. doi: 10.1002/psp4.12543. Epub 2020 Aug 7.

ReferenceCitation: Lo MK, Jordan R, Arvey A, Sudhamsu J, Shrivastava-Ranjan P, Hotard AL, Flint M, McMullan LK, Siegel D, Clarke MO, Mackman RL, Hui HC, Perron M, Ray AS, Cihlar T, Nichol ST, Spiropoulou CF. GS-5734 and its parent nucleoside analog inhibit Filo-, Pneumo-, and Paramyxoviruses. Sci Rep. 2017 Mar 6;7:43395. doi: 10.1038/srep43395.

ReferenceCitation: Lo MK, Feldmann F, Gary JM, Jordan R, Bannister R, Cronin J, Patel NR, Klena JD, Nichol ST, Cihlar T, Zaki SR, Feldmann H, Spiropoulou CF, de Wit E. Remdesivir (GS-5734) protects African green monkeys from Nipah virus challenge. Sci Transl Med. 2019 May 29;11(494). pii: eaau9242. doi: 10.1126/scitranslmed.aau9242.

ReferenceCitation: Warren TK, Jordan R, Lo MK, Ray AS, Mackman RL, Soloveva V, Siegel D, Perron M, Bannister R, Hui HC, Larson N, Strickley R, Wells J, Stuthman KS, Van Tongeren SA, Garza NL, Donnelly G, Shurtleff AC, Retterer CJ, Gharaibeh D, Zamani R, Kenny T, Eaton BP, Grimes E, Welch LS, Gomba L, Wilhelmsen CL, Nichols DK, Nuss JE, Nagle ER, Kugelman JR, Palacios G, Doerffler E, Neville S, Carra E, Clarke MO, Zhang L, Lew W, Ross B, Wang Q, Chun K, Wolfe L, Babusis D, Park Y, Stray KM, Trancheva I, Feng JY, Barauskas O, Xu Y, Wong P, Braun MR, Flint M, McMullan LK, Chen SS, Fearns R, Swaminathan S, Mayers DL, Spiropoulou CF, Lee WA, Nichol ST, Cihlar T, Bavari S. Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys. Nature. 2016 Mar 17;531(7594):381-5. doi: 10.1038/nature17180. Epub 2016 Mar 2. Erratum in: ACS Chem Biol. 2016 May 20;11(5):1463.

ReferenceCitation: Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ; PALM Writing Group, Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Vallée D, Nordwall J; PALM Consortium Study Team. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. N Engl J Med. 2019 Dec 12;381(24):2293-2303. doi: 10.1056/NEJMoa1910993. Epub 2019 Nov 27.

ReferenceCitation: Sheahan TP, Sims AC, Graham RL, Menachery VD, Gralinski LE, Case JB, Leist SR, Pyrc K, Feng JY, Trantcheva I, Bannister R, Park Y, Babusis D, Clarke MO, Mackman RL, Spahn JE, Palmiotti CA, Siegel D, Ray AS, Cihlar T, Jordan R, Denison MR, Baric RS. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med. 2017 Jun 28;9(396). pii: eaal3653. doi: 10.1126/scitranslmed.aal3653.

ReferenceCitation: Sheahan TP, Sims AC, Leist SR, Schäfer A, Won J, Brown AJ, Montgomery SA, Hogg A, Babusis D, Clarke MO, Spahn JE, Bauer L, Sellers S, Porter D, Feng JY, Cihlar T, Jordan R, Denison MR, Baric RS. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun. 2020 Jan 10;11(1):222. doi: 10.1038/s41467-019-13940-6.

ReferenceCitation: Agostini ML, Andres EL, Sims AC, Graham RL, Sheahan TP, Lu X, Smith EC, Case JB, Feng JY, Jordan R, Ray AS, Cihlar T, Siegel D, Mackman RL, Clarke MO, Baric RS, Denison MR. Coronavirus Susceptibility to the Antiviral Remdesivir (GS-5734) Is Mediated by the Viral Polymerase and the Proofreading Exoribonuclease. mBio. 2018 Mar 6;9(2). pii: e00221-18. doi: 10.1128/mBio.00221-18.

ReferenceCitation: de Wit E, Rasmussen AL, Falzarano D, Bushmaker T, Feldmann F, Brining DL, Fischer ER, Martellaro C, Okumura A, Chang J, Scott D, Benecke AG, Katze MG, Feldmann H, Munster VJ. Middle East respiratory syndrome coronavirus (MERS-CoV) causes transient lower respiratory tract infection in rhesus macaques. Proc Natl Acad Sci U S A. 2013 Oct 8;110(41):16598-603. doi: 10.1073/pnas.1310744110. Epub 2013 Sep 23.

ReferenceCitation: de Wit E, Feldmann F, Cronin J, Jordan R, Okumura A, Thomas T, Scott D, Cihlar T, Feldmann H. Prophylactic and therapeutic remdesivir (GS-5734) treatment in the rhesus macaque model of MERS-CoV infection. Proc Natl Acad Sci U S A. 2020 Mar 24;117(12):6771-6776. doi: 10.1073/pnas.1922083117. Epub 2020 Feb 13.

ReferenceCitation: Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4.

ReferenceCitation: Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, Feldt T, Green G, Green ML, Lescure FX, Nicastri E, Oda R, Yo K, Quiros-Roldan E, Studemeister A, Redinski J, Ahmed S, Bernett J, Chelliah D, Chen D, Chihara S, Cohen SH, Cunningham J, D'Arminio Monforte A, Ismail S, Kato H, Lapadula G, L'Her E, Maeno T, Majumder S, Massari M, Mora-Rillo M, Mutoh Y, Nguyen D, Verweij E, Zoufaly A, Osinusi AO, DeZure A, Zhao Y, Zhong L, Chokkalingam A, Elboudwarej E, Telep L, Timbs L, Henne I, Sellers S, Cao H, Tan SK, Winterbourne L, Desai P, Mera R, Gaggar A, Myers RP, Brainard DM, Childs R, Flanigan T. Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. 2020 Jun 11;382(24):2327-2336. doi: 10.1056/NEJMoa2007016. Epub 2020 Apr 10.

ReferenceCitation: Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.


title: Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

summary:
This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.

The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.

lead_sponsor: Nordic Pharma SAS


title: Qualitative Study of the Experience of Hospital Students in the Odontology Department

acronym: EQUAVECU

summary: During their studies, the dental students of Brest (France) learn their future profession by working in the Dental University Hospital, from the fourth academic year. This clinical activity is considered as both a source of satisfaction and stress by most of the students. The main objective of this study is to investigate the experience of Brest dental students through a qualitative methodology, with individual interviews, followed by an analysis by grounded theory (Paillé, 1994).

lead_sponsor: University Hospital, Brest


type: Registry Identifier

title: Prenatal Surgical Repair of Fetal Myelomeningocele

acronym: PRIUM

summary:
The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one corresponding to the anatomical defect (as defined by the last upper normal vertebra before the defect).

The purpose of this study is to introduce in France an innovative technique for prenatal repair of myelomeningocele until now developed only on the American continent.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Acute Dose-response Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects: Randomized, Cross-over, Double-blind Clinical Study

summary:
It is well established that endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. Finding safe and effective product able to improve endothelial function is of public health interest.

Many clinical studies have shown that monomer of flavanols from cocoa significantly improved endothelial function, in particular endothelium-dependent flow-mediated dilation (ED-FMD) after a single dose. Grape is also a main source of flavanol monomers, that's why many human studies have shown significant effects of grape-derived products on endothelial function within 2 hours following a single dose intake.

The objective of this study is to assess the effect of 2 doses of a proprietary and standardised botanical blend rich in polyphenols (SBRP), on ED-FMD in fasting conditions, in comparison to a placebo, in healthy adults. This blend is made of two botanical extracts: a grape extract and a blueberry extract. In order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.

lead_sponsor: Activ'inside

location_facility: CIC Inserm 1405, University Hospital Clermont-Ferrand,

intervention_type: Dietary Supplement


title: Sensory and Emotional Modulation of Dyspnea Under Artificial Ventilation in the Intensive Care Unit

summary:
Rationale: Half of the patients receiving mechanical ventilation in the intensive care unit (ICU) have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patients' comfort and could be involved in the genesis of post-traumatic stress syndromes, a frequent complication of intensive care. Modifying ventilation parameters does not always relieve dyspnea and administering morphine prolongs the duration of mechanical ventilation. Dyspnea has, in addition to its sensory component, an emotional component. The possibility to distract the patients' attention or to modulate their emotions in order to relieve their dyspnea could therefore represent an innovative therapeutic alternative devoid of side effects.

Objectives: To evaluate the effect of auditory and sensory extra respiratory stimuli on the sensation of dyspnea in intensive care patients undergoing mechanical, invasive or non-invasive ventilation.

Methods: 45 intensive care patients under artificial ventilation will be exposed, according to their randomization arm, to the following two stimuli for a duration of 10 minutes:

standard relaxing music piece versus "pink" noise;
fresh air on the face versus fresh air on the thigh. The effect of this stimulus will be compared to a randomized control, these two conditions will be separated by a wash-out period.

An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.

Dyspnea will be assessed in terms of intensity (visual analog scale) and characterized sensorially. Will also be evaluated during the different conditions: pain, anxiety and stress (sympathetic/parasympathetic balance) and extra-diaphragmatic electromyographic activity.

Ethical framework: research involving the human person at risk and minimal constraints (physiology study that does not entail any risk for the patients).

Expected results and prospects: the investigators hypothesize that pleasant extra-respiratory sensory stimulation significantly reduces the intensity of dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention. This reduction in dyspnea is associated with decreased anxiety and stress levels.

This study will bring new, easy-to-use and side-effect-free tools to the therapeutic arsenal for the relief of dyspnea in mechanically ventilated patients.

ReferenceCitation: Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

ReferenceCitation: Morélot-Panzini C, Demoule A, Straus C, Zelter M, Derenne JP, Willer JC, Similowski T. Dyspnea as a noxious sensation: inspiratory threshold loading may trigger diffuse noxious inhibitory controls in humans. J Neurophysiol. 2007 Feb;97(2):1396-404. Epub 2006 Jul 26.

ReferenceCitation: Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.

family: Schmidt

full_name: Matthieu Schmidt

given: Matthieu

family: Demoule

full_name: Alexandre Demoule

given: Alexandre

family: Polito

full_name: Andrea Polito

given: Andrea

family: Porchet

full_name: Raphaël Porchet

given: Raphaël

family: Aboab

full_name: Jerome Aboab

given: Jerome

family: Siami

full_name: Shidasp Siami

given: Shidasp

family: Morelot-Panzini

full_name: Capucine Morelot-Panzini

given: Capucine

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Sharshar

full_name: Tarek Sharshar

given: Tarek

journal_name: Critical Care Medicine

title: Dyspnea in mechanically ventilated critically ill patients*

ReferenceCitation: Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003 Sep 6;327(7414):523-8.

ReferenceCitation: Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25. Review.

family: Lansing

full_name: Robert W. Lansing

given: Robert W.

family: Gracely

full_name: Richard H. Gracely

given: Richard H.

family: Banzett

full_name: Robert B. Banzett

given: Robert B.

journal_name: Respiratory Physiology & Neurobiology

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: The multiple dimensions of dyspnea: Review and hypotheses

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

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière


title: Malvacdecision.Net

acronym: HPVAC

summary:
In France, the vaccination coverage observed for HPV vaccination is low for a full-scale regimen, and has been falling since 2010. A high rate of HPV vaccination coverage has a significant epidemiological impact with a reduction in cervical cancer mortality.

There is less data on vaccinated catch-up patients. In 2017, these patients are 25 years of age or older and carry out screening smears.

The aim of this study is to demonstrate whether HPV catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients.

If so, these data will help mobilize doctors to vaccinate patients against HPV, even in catching-up.

status: Terminated

ReferenceCitation: Baudoin A, Sabiani L, Oundjian F, Tabouret E, Agostini A, Courbière B, Boubli L, Carcopino X. [HPV prophylactic vaccine coverage and factors impacting its practice among students and high school students in Marseilles' area]. J Gynecol Obstet Biol Reprod (Paris). 2015 Feb;44(2):126-35. doi: 10.1016/j.jgyn.2014.02.005. Epub 2014 Apr 2. French.

ReferenceCitation: Doris B, Boyer L, Lavoué V, Riou F, Henno S, Tas P, Sévène L, Levêque J. [Cervical Pap smear in an epidemiologically exposed population: ideas, facts and arguments]. J Gynecol Obstet Biol Reprod (Paris). 2014 Jan;43(1):26-34. doi: 10.1016/j.jgyn.2013.11.012. Epub 2013 Dec 12. French.

ReferenceCitation: Carcopino X, Camus C, Halfon P. [Diagnosis and clinical management of cervical HPV infections]. Presse Med. 2015 Jul-Aug;44(7-8):716-26. doi: 10.1016/j.lpm.2015.02.020. Epub 2015 Jun 9. Review. French.

ReferenceCitation: Wafo E, Ivorra-Deleuze D, Thuillier C, Rouzier R. [Evolution of the awareness of Human Papillomavirus (HPV) in the French population: Results of a telephonic inquiry]. J Gynecol Obstet Biol Reprod (Paris). 2010 Jun;39(4):305-9. doi: 10.1016/j.jgyn.2010.03.007. Epub 2010 Apr 28. French.

ReferenceCitation: Bouvret P, Mougin C, Prétet JL, Meurisse A, Bonnetain F, Fiteni F. [Practices and attitudes regarding HPV vaccination among general practitioners from Besançon]. J Gynecol Obstet Biol Reprod (Paris). 2016 Oct;45(8):972-978. doi: 10.1016/j.jgyn.2015.12.002. Epub 2016 Jan 15. French.

ReferenceCitation: Riethmuller D, Ramanah R, Carcopino X, Levêque J. [The follow up of the women vaccinated against HPV]. J Gynecol Obstet Biol Reprod (Paris). 2013 Oct;42(6):525-33. doi: 10.1016/j.jgyn.2013.03.013. Epub 2013 May 10. Review. French.


title: Impact of Handing to Patients With Viral Gastroenteritis or Upper Respiratory Tract Infections a Copy of the Consultation Report on Their Medicine Consumption: a Randomized Controlled Trial

summary:
In France, patients with benign viral infections (ie: gastro enteritis and/or rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although there is evidence that these medicines are not efficient.

We hypothesize that patients could be reassured by health advices, especially if they are written. In addition, we believe that doctors would feel less guilty for not prescribing drugs if they could hand written consultation reports to patients, in these situations.

We aim to assess the impact of handing to patients with viral gastroenteritis or upper respiratory tract infections, a copy of the consultation report on their medicine consumption.

ReferenceCitation: Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4.

lead_sponsor: University Paris 7 - Denis Diderot


summary:
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of traveller's fever caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC traveller's fever tests .

The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a rectal swab would improve the etiological diagnosis of traveller's fever of at least 10%.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire

acronym: PREPA-CO

summary: In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold standard in France for colorectal cancer screening in populations at risk. However, it has a number of limitations. The quality of the bowel preparation is a critical step for the successful completion of this examination. The occurrence of interval cancers raises the problem of missed lesions. A literature review showed that there were differences between the endoscopy units on quality standards for bowel preparation. The rate of unprepared colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516 colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008. The establishment a predictive score for quality of bowel preparation based on a self-administered questionnaire completed by patients during the pre-colonoscopy consultation, would help identify patients at risk of poor preparation in order to optimize the prescribed preparation in this consultation.

lead_sponsor: University Hospital, Angers

location_facility:
Cholet hospital
Angers UH
La Roche sur Yon hospital
Nantes UH


title: A Pilot Study to Evaluate the Safety of a 3 Weeks Sitagliptin Treatment in HCC Patients Undergoing Liver Resection

acronym: HCC-DPPIV

summary: Boosting of tumor cell killing by cytotoxic lymphocytes may be a promising means to enhance anti-tumor immunity. Prior studies demonstrated that tumor infiltration by cytotoxic lymphocytes correlates with control of tumor growth and is associated with an improved prognosis in cancer patients. Trafficking of activated lymphocytes is a tightly regulated mechanism and the specific nature of the chemokine milieu is a crucial determinant for permitting T cell entry into the tumor microenvironment. CXCL10 is an interferon-inducible chemokine particularly important for the recruitment of activated T, and it has been shown to enhance anti-tumor responses through its action on cytotoxic T cells (e.g., glioblastoma, colorectal adenocarcinoma and lung carcinoma). Additionally, roles for CXCL10 as an anti-tumor effector include its ability to chemo-attract NK cells into sites of inflammation, and its ability to inhibit development of new vasculature and induce the regression of newly formed vessels. Adding a layer of complexity, the function of CXCL10 can be regulated by dipeptidylpeptidase IV (DPPIV), leading to the formation of a dominant negative, antagonist form of the chemokine. This was initially demonstrated in vitro, and recent work has provided convincing in vivo evidence that antagonist forms of CXCL10 regulate lymphocyte trafficking. The main goal of this protocol is to evaluate the tolerance of sitagliptin treatment in HCC patients, and secondary DPPIV inhibitors as a strategy for protecting CXCL10 chemokine agonist activity as a means to enhance tumor regression.

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


title: The SMS Study, a National Study on Prevalence of Unexplained Splenomegaly Etiologies

acronym: SMS

summary:
Primary Objective:

To estimate the prevalence of Gaucher disease and of other etiologies, in patients of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g. portal hypertension, diagnosis or suspicion of haematological malignancy, haemolytic anemia) based on basic physical and biological exams (e.g. full blood count, liver enzymes, reticulocytes)

Secondary Objective:

To describe the exams and tests conducted for diagnosis purpose and the more frequent associations

ipd_sharing: Yes

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

lead_sponsor: Sanofi


title: Analysis of Events of Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation

acronym: TubeObs-Covid

summary: The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.

time_perspective: Other

lead_sponsor: University Hospital, Strasbourg, France

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


title: PALUREA: Severe Falciparum Imported Malaria in Adults: Clinical and Physiopathological Study

acronym: PALUREA

summary:
Plasmodium falciparum malaria remains a major public health problem in endemic areas, with approximately 2 million deaths each year, especially in tropical African countries.

In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as well as immigrants from endemic countries. Such imported cases have increased worldwide, with approximately 7000 cases each year in France. Among these cases, 300 are severe requiring hospitalization in the intensive care unit (ICU) with an overall mortality rate of 10%, despite available effective care.

Many studies have been performed to evaluate clinical and physiopathological aspects of severe malaria in endemic areas but few data are available for imported malaria. Therefore, determinants of severe imported malaria are not well known. The majority of patients hospitalized in the ICU for severe malaria are white caucasians as well as those patients who die.

The present study has two main objectives:

(i) to describe the clinical spectrum of severe imported malaria and to assess outcome (mortality and neurological sequelae), and the biological interactions between host and the parasite,

(ii) to evaluate the role of gene polymorphisms, of parasitic factors in the occurrence of severe malaria with a case control study comparing severe and non-severe malaria in patients matched according to ethnic patterns. The intensity of the inflammatory response will also be studied in the two groups of patients.

ReferenceCitation: Bruneel F, Hocqueloux L, Alberti C, Wolff M, Chevret S, Bédos JP, Durand R, Le Bras J, Régnier B, Vachon F. The clinical spectrum of severe imported falciparum malaria in the intensive care unit: report of 188 cases in adults. Am J Respir Crit Care Med. 2003 Mar 1;167(5):684-9. Epub 2002 Oct 31.


acronym: Phenot IMVr

summary: France is one of the European countries with the highest rate of death by suicide, more than 10 400 deaths each year, about 16 people out of 100 000. Although suicide mortality rate tends to fall between 1987 and 2008 the number of suicide attempts (TS) against observed by an upward trend between 2005 and 2010. However, the most important predictor of death by suicide remains the TS. Now these are primarily TS Poisoning Drug-Volunteer (IMV), especially benzodiazepines. These IMV, there have been 16% recurrence in the past year and 21% at 4 years among hospitalized patients. Or a Health Barometer 2005 survey showed that 58% of respondents with a TS over the last 12 months had not been hospitalized. This type of acting out, especially the repeated IMV (IMVr) is underestimated epidemiologically because it is an unknown phenomenon and too little screened by health professionals.

lead_sponsor: University Hospital, Grenoble


type: Other Grant/Funding Number

title: Prognostic Positron Emission Tomography/Computed Tomogrpahy Model in Non Small Cell Lung Cancer

summary: Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer

lead_sponsor: Poitiers University Hospital


title: Thrombus and Inflammation in Sudden Cardiac DEath

acronym: TIDE

summary: Sudden death is a natural death occurring within one hour after the onset of symptoms. It remains a major public health problem and accounts for 5 to 10 % of the annual total mortality ie about 300.000 in the United States. Despite community-based interventions, overall survival remains below 5%. Better understanding of the mechanisms causing sudden death could allow early identification of high risk subjects and implementation of specific prevention strategies. The cause of more than 90% of sudden deaths is cardiac with ventricular fibrillation or fast ventricular tachycardia complicating an underlying heart disease. Coronary heart disease and its consequences account for at least 80% of sudden cardiac deaths. Several risk factors associated with sudden death and not with myocardial infarction have been identified in population-based studies. However, the relationship between the occurrence of a coronary artery occlusion and the onset of arrhythmia is unclear. In particular, coronary artery occlusion can be rapidly followed by chest pain, which acts as a signal and allows identification of patients for emergency reperfusion. However, in some cases, the coronary artery occlusion is followed by a sudden onset of arrhythmia and sudden death. Recent data suggest that acute coronary occlusion is caused by plaque erosion or rupture and is followed by an intense local inflammation and rapid thrombus formation. Our hypothesis is that the speed of thrombus formation and coronary occlusion determines the clinical symptoms. Slow and progressive thrombus formation is likely to induce myocardial pre-conditioning thereby reducing the occurrence of ventricular arrhythmia. In contrast, rapid thrombus formation followed by acute coronary artery occlusion and ischemia is more likely to trigger fatal ventricular arrhythmia. During angioplasty procedures, coronary artery thrombus are aspirated, providing the opportunity for pathological studies. The aim of the TIDE study (Thrombus and Inflammation in Sudden Death) is therefore to compare the composition and age of thrombus collected at the site of coronary occlusion in patients with sudden death due to acute coronary artery occlusion and patients with an acute myocardial infarction without ventricular arrhythmia. The following hypothesis will be tested : fresh thrombus is more frequent in patients with sudden cardiac death versus patients with acute myocardial infarction without ventricular arrhythmia.

primary_purpose: Basic Science


title: Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP

acronym: PREPADROP

summary: LASIK is a refractive surgery technique widely used in France. Postoperatively, the classic treatment after LASIK consists of instilling drops to reduce dry eyes. REPADROP® is an innovative eye drops stimulating corneal innervation. To date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using REPADROP®.

lead_sponsor: Hospices Civils de Lyon


title: Epidemiological Study on the Vaccination Coverage of the Population Aged 75 Years and Over in Picardy. According to the Study of 200 Patients Followed by General Practitioners of the Somme in 2016.

acronym: PICARVAC

summary: In France, the vaccination coverage of seniors is clearly deficient. It seems to be a cultural specificity, dating back more than 100 years, and which does not exist in Scandinavia, nor in much of the Anglo-Saxon world. Only influenza vaccination is a success for seniors. The high public health council sets the objective of immunization coverage in patients over 65 years of age to 80% whether or not the patient is benefiting from an exonerative ALD. The data collections carried out with the various pension funds objective have a lower immunization coverage with a rate ranging from 48.8 to 64%. Thus any medical consultation should be an opportunity to update the vaccination schedule of adults and the elderly.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Statins and Risk of Myocardial Infarction in Real Life in France

summary: The main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (MI) in a real life situation in France

lead_sponsor: AstraZeneca


title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis

acronym: MVP-France

summary: This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects.

primary_purpose: Screening

lead_sponsor: French Cardiology Society

location_facility:
Hôpital Henri Mondor
Hôpital Bichat
Hôpital Arnaud de Villeneuve
Hôpital G and R Laennec
Hôpital Pitié Salpêtrière
Institut Hospitalier Jacques Cartier
Hôpital Saint Antoine
Hôpital Sud
Groupement Hospitalier Est
Hôpital de la Timone
Hôpital Front-Pré
Hôpital du Bocage
Hôpital Lariboisière
Hôpital de la Cavale Blanche
Hôpital Rangueil
Hôpital Charles Nicolle
Hôpital Gabriel Montpied
Hôpital Cochin
Hôpital Cardiologique
CHU Nancy
Hôpital Cardiologique du Haut Lévêque
Clinique Saint Augustin
Hôpital Dupuytren
Hôpital Pontchaillou
Hôpital Européen Georges Pompidou
Hôpital Ambroise Paré


title: Feasibility of Implementing SIMEOX® Using Tele-physiotherapy and Evaluation of Compliance With SIMEOX® at Home for Bronchial Drainage in Patients With Bronchiectasis Other Than Cystic Fibrosis and Who Have Difficulties in Accessing Regular Respiratory Physiotherapy Sessions.

summary:
Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent dilatation of the caliber of the bronchial tree territory with an alteration of mucociliary clearance. This alteration causes mucus retention and leads to infections and chronic bronchial inflammation. Respiratory physiotherapy is one of the cornerstones of the management of these patients, particularly to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended to carry out airway clearance sessions daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy care isn't always easy for patients due to geographical, time, or professional availability limitations. In addition, few professionals are trained in France for this specific care dedicated to chronic lung disease. Finally with this kind of remote formation and follow up, it may be more suitable for this at-risk patient population in the context of the COVID-19 pandemic situation (limitation of physical contact).

SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for bronchial tree drainage. The use of this device in autonomy by the patient requires however a specific initial training of a few sessions (3-5 sessions). Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. This SIMEOX® device used autonomously at home, could provide patients with a practical and efficient bronchial clearance technique.

The overall objective of this pilot study is to evaluate the use of SIMEOX® at home after education in its use by telecare for bronchial drainage in patients with bronchiectasis (non-cystic Fibrosis Bronchiectasis) and who have difficulty accessing usual respiratory physiotherapy sessions.

lead_sponsor: Physio-Assist

location_facility: Grenoble University-Affiliated Hospital : Pneumology department

location_facility: Nice university-affiliated hospital : pneumonoly department

location_facility: Toulouse University-Affiliated Hospital : Pneumology department

intervention_type: Device


title: Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19

acronym: COVID-OLFA

summary: Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women - Tobacco Pregnancy Addictive Pregnant Women

acronym: T-CAFE

summary:
France is the country of Europe where the prevalence of pregnant women smokers is the highest (35.9% before pregnancy and in the 3rd quarter 21.8% in 2008).

In the investigator's country, among the smokers of early pregnancy with the usual care, only 30% manage to stop during pregnancy.

Maternal smoking during pregnancy is a clearly identified risk factor for the course of pregnancy and the unborn child.

The measurement of carbon monoxide (CO) expired in pregnancy monitoring consultation is part of the recommendations of the consensus conference "Pregnancy and Tobacco" (ANAES, October 2004) and the parliamentary report on smoking by JL Touraine and D. Jacquat (Feb 2012). However, this recommendation has not entered the current practice. The research aims to justify the clinical relevance of this recommendation by demonstrating the positive impact of expired CO measurement on the rate of discontinuation during pregnancy.

primary_purpose: Prevention

lead_sponsor: University Hospital, Limoges


title: Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France

acronym: Epi-Hypo

summary: Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none exists specifically for France. Hypoparathyroidism could led to complications. Here, the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

lead_sponsor: European Georges Pompidou Hospital

location_facility: European Georges Pompidou Hospital, APHP


title: Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)

acronym: Misoprostol

summary: In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.

study_start_date_type: Anticipated

status: Withdrawn


title: Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery

acronym: HYPOTHERMIE

summary:
The primary objectives of the study are

to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
to assess the impact of perioperative hypothermia on anemia and myocardial injury.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin


title: Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France

summary: Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever, cytopenia and hepatitis.This infection was initially described in United States. In Europe, its epidemiology is not well known. Some isolated cases have been diagnosed in several country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient living in Eastern France, and presenting with compatible clinical symptoms using a new diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our country and the clinical symptoms that are associated with Anaplasmosis.

location_facility: Service des Maladies Infectieuses et Tropicales - CHU de Besançon

location_facility: Service de Médecine Interne et Maladies Infectieuses - CHU de Reims

location_facility: Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg

location_facility: Département d'Infectiologie CHU de Dijon

location_facility: Service des Maladies Infectieuses et Tropicales - CHU de Nancy


title: Construction of a Database to Identify Early Indicators of Respiratory Muscle Dysfunction in Neuromuscular Patients From the Optoelectronic Plethysmography Assessment of the Thoracoabdominal Motion

acronym: DREM

summary: The aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. The final objective is to better select in the future the patients who need more specific assessment of diaphragmatic function like "maximal transdiaphragmatic pressure" measurement and "phrenic nerve stimulation".

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and Its Use in Routine Clinical Practice

acronym: PILOTE

summary: The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen


title: Population Genomic Diversity of France

acronym: POPGEN

summary:
Having access to DNA sequences from individuals that share common ancestry with patients is of interest when analysing individual genomes for diagnoses. Information regarding allele frequency distribution in the same geographic areas where patients have ancestry will be necessary to help select the variants that are the most likely involved in disease and should hence be tested in functional assays.

To provide such a general population panel for France, the POPGEN project will select 10,000 individuals from CONSTANCES cohort with ancestry in different regions of France outside western part. These participants will have their DNA extracted from salivary kits and genotyped using SNP-chip. Among these 10,000 individuals, 4,000 individuals will have their whole genome sequenced. This study is one of the four pilot projects of the France Genomic Medicine plan (FMG 2025). The FMG2025 plan aims at introducing genome sequencing in the routine clinical practice to accelerate and improve diagnoses. The POPGEN project will provide the required references from the general French population to help filter out common variants from the genomes of patients.

status: Enrolling by invitation


title: Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients. Qualitative Approach

summary:
Systematic screening for cervical cancer stops in France at 65 years old. The incidence of certain types of gynecological neoplasia increases with age (endometrium, vulva). Diagnosis delay of 8 months has been described for uterine cancer and longer delays for vulvar cancer.

The aim of our study is to understand help-seeking behavior and its delay for this type of cancer among patients older than 65.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility: Institut de Cancérologie de Lorraine (ICL)


ReferenceCitation: Mounie M, Costa N, Gaudineau A, Molinier L, Vayssière C, Derumeaux H. Cost-effectiveness analysis of vaginal misoprostol versus dinoprostone pessary: A non-inferiority large randomized controlled trial in France. Int J Gynaecol Obstet. 2021 Oct 29. doi: 10.1002/ijgo.13999. [Epub ahead of print]

name: The Health Economic Unit of the University Hospital of Toulouse  Toulouse 31059 France

name: UMR1295 CERPOP (Centre for Epidemiology and Population Health Research), Team EQUTY (Embodiment, social ineQualities, lifecoUrse epidemiology, cancer and chronIc diseases, intervenTions, methodologY) Toulouse III University  Toulouse France

name: University of Toulouse III  Toulouse 31330 France

family: Mounie

full_name: M. Mounie

given: M.

family: Costa

full_name: N. Costa

given: N.

name: University Hospitals of Strasbourg  Strasbourg 67091 France

name: Department of Obstetrics and Gynecology Centre Hospitalier Princesse Grace  Monaco

family: Gaudineau

full_name: A. Gaudineau

given: A.

family: Molinier

full_name: L. Molinier

given: L.

name: UMR1295 CERPOP (Centre for Epidemiology and Population Health Research), Team SPHERE (Study of Perinatal, paedriatric and adolescent Health : Epidemiological Research and Evaluation) Toulouse III University  Toulouse France

name: Department of Obstetrics and Gynecology Paule de Viguier Hospital CHU Toulouse  Toulouse France

family: Vayssière

full_name: C. Vayssière

given: C.

family: Derumeaux

full_name: H. Derumeaux

given: H.

journal_name: International Journal of Gynecology & Obstetrics

title: Cost‐Effectiveness Analysis of Vaginal Misoprostol versus Dinoprostone Pessary: a Noninferiority large RCT in France

ReferenceCitation: Gaudineau A, Senat MV, Ehlinger V, Gallini A, Morin M, Olivier P, Roth E, Orusco E, Javoise S, Fort J, Lavergne C, Arnaud C, Rozenberg P, Vayssiere C; Groupe de Recherche en Obstétrique rt Gynécologie. Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial. Am J Obstet Gynecol. 2021 Nov;225(5):542.e1-542.e8. doi: 10.1016/j.ajog.2021.04.226. Epub 2021 Apr 19.

full_name: Adrien Gaudineau

given: Adrien

family: Senat

full_name: Marie-Victoire Senat

given: Marie-Victoire

family: Ehlinger

full_name: Virginie Ehlinger

given: Virginie

family: Gallini

full_name: Adeline Gallini

given: Adeline

family: Morin

full_name: Mathieu Morin

given: Mathieu

family: Olivier

full_name: Pascale Olivier

given: Pascale

family: Roth

full_name: Emmanuel Roth

given: Emmanuel

family: Orusco

full_name: Emma Orusco

given: Emma

family: Javoise

full_name: Sophie Javoise

given: Sophie

family: Fort

full_name: Julie Fort

given: Julie

family: Lavergne

full_name: Cedric Lavergne

given: Cedric

family: Arnaud

full_name: Catherine Arnaud

given: Catherine

family: Rozenberg

full_name: Patrick Rozenberg

given: Patrick

family: Vayssiere

full_name: Christophe Vayssiere

given: Christophe

journal_name: American Journal of Obstetrics and Gynecology

location_facility:
Bicêtre Hospital
Hospital Poissy
Hôpitaux Universitaires de Strasbourg
University Hospital Toulouse

title: Comparison Between 25 µg Vaginal Misoprostol Versus Slow Release Pessary Prostaglandin-E2 (PGE2) : Could we Use Low Dose Vaginal Misoprostol as a First Line Treatment for Induction of Labor ?

summary:
For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication. It is in the form of gel or sustained release device whose effectiveness and side effects are comparable. The vaginal misoprostol has no marketing authorization in France, but is sometimes used. Some data in the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more complications, was at least as effective and seems to be cost-effective compared with dinoprostone. Misoprostol with this dose and route of administration is now recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on induction of labor). According to HAS, the investigators still lack data on large samples to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of cesarean section, and lower cost compared to dinoprostone.

The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs. dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5% difference.


title: Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

acronym: SISTOLA

summary: The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution


title: Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

summary: ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of cognitive training, reminiscence therapy and a "made-to-measure" program on the progression rate of dementia.

ReferenceCitation: Clare L, Woods RT, Moniz Cook ED, Orrell M, Spector A. Cognitive rehabilitation and cognitive training for early-stage Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2003;(4):CD003260. Review. Update in: Cochrane Database Syst Rev. 2013;6:CD003260.

lead_sponsor: University Hospital, Bordeaux

location_facility: CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble

location_facility: Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux

location_facility: Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "


title: Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality

acronym: PRODUCAN

summary:
Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections.

There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.

location_facility:
Centre Hospitalier Lyon Sud
Hôpital Hédouard Herriot


title: Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer

acronym: TEP Vessie

summary:
Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years.

Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC).

Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France

acronym: Prevalgeophagy

summary: Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.

ReferenceCitation: Decaudin P, Kanagaratnam L, Kmiec I, Nguyen Y, Migault C, Lebrun D, Hentzien M, Bertin E, Drame M, Bani-Sadr F. Prevalence of geophagy and knowledge about its health effects among native Sub-Saharan Africa, Caribbean and South America healthy adults living in France. Eat Weight Disord. 2020 Apr;25(2):465-469. doi: 10.1007/s40519-018-0624-9. Epub 2018 Dec 13.

lead_sponsor: CHU de Reims


title: Multicentric Cohort of Melanoma Patients in Ile de France Area

acronym: Melan-Cohort

summary: This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years.

lead_sponsor: Assistance Publique - Hôpitaux de Paris