title: Assessment of Desogestrel for a Pharmacological Recovery of Ventilatory Activity in Congenital Central Hypoventilation Syndrome - Ondine Syndrome

acronym: RESPIRONDINE

summary:
The congenital central hypoventilation syndrome (CCHS), also known as the Ondine syndrome, is a very rare genetic disorder. In contrast with healthy people, patients do not increase breathing in response to an excess of carbon dioxide (CO2). As a consequence, they do not breath sufficiently, or even stop breathing, during sleep. Their survival depends only on mechanical respiratory assistance, all life long.

We have recently published two cases of recovery of a response to CO2 in patients taking desogestrel as a contraceptive pill. The goal of the study is therefore to assess the hypothesis that desogestrel will restore a respiratory response to CO2 in CCHS patients and allow them to breath sufficiently during sleep without mechanical assistance.

ReferenceCitation: Sharman M, Gallea C, Lehongre K, Galanaud D, Nicolas N, Similowski T, Cohen L, Straus C, Naccache L. The cerebral cost of breathing: an FMRI case-study in congenital central hypoventilation syndrome. PLoS One. 2014 Sep 30;9(9):e107850. doi: 10.1371/journal.pone.0107850. eCollection 2014.

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Straus C, Similowski T. Congenital central hypoventilation syndrome and desogestrel: a call for caution: addendum to "C. Straus, H. Trang, M.H. Becquemin, P. Touraine, T. Similowski, Chemosensitivity recovery in Ondine's curse syndrome under treatment with desogestrel" [Respir. Physiol. Neurobiol. 171 (2010) 171-174]. Respir Physiol Neurobiol. 2011 Sep 15;178(2):357-8. doi: 10.1016/j.resp.2011.07.007. Epub 2011 Jul 23.


title: Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).

acronym: TAG

summary: The management of glioblastoma in elderly patients with poor performance status (KPS<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Association de Neuro-Oncologues d'Expression Francaise

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


acronym: ScS-REINBO

summary: Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Actelion

location_facility: Pôle de médecine interne Centre de référence Maladies rares Groupe I Maladies systémiques et maladies auto-immunes rares en particulier Vascularites nécrosantes et les sclérodermies - Hôpital Cochin

title: Effect of Bosentan in the Course of Scleroderma Renal Crisis

source: euctr


title: Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years

acronym: PVTE

summary: The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Vergniol J, Boursier J, Coutzac C, Bertrais S, Foucher J, Angel C, Chermak F, Hubert IF, Merrouche W, Oberti F, de Ledinghen V, Cales P. Evolution of noninvasive tests of liver fibrosis is associated with prognosis in patients with chronic hepatitis C. Hepatology. 2014 Jul;60(1):65-76. doi: 10.1002/hep.27069.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

version: publishedVersion

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, Couzigou P, de Ledinghen V. Noninvasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1970-9, 1979.e1-3. doi: 10.1053/j.gastro.2011.02.058. Epub 2011 Mar 2.

lead_sponsor: Association HGE CHU Bordeaux Sud

location_facility: Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque


title: Effect of Whole Grain Inclusion in the Diet on Abdominal Fat Regain After a Weight Loss Diet

summary:
Epidemiological studies suggest that whole grain consumption affects measures of obesity including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate rather consistently an inverse association between BMI and whole grain consumption. Furthermore, prospective cohort studies suggest that people with high whole grain consumption have less risk for body weight gain compared with low whole grain consumption.

The purpose of this study is to assess the effects of inclusion of whole grain in the diet on anthropometric measures, particularly abdominal fat regain after a weight loss diet.

It is anticipated that the short-term regain of abdominal fat after a weight loss diet is lower in volunteers consuming whole grain than in volunteers consuming refined grain.

design_allocation: Randomized

lead_sponsor: Cereal Partners Worldwide

intervention_type: Other

lead_sponsor_type: industriel


title: French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010

acronym: FAST-MI 2010

summary:
The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months.

Patients will be followed up at 1 month and then followed annually for 10 years.

Patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. The study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

ReferenceCitation: Danchin N, Fauchier L, Marijon E, Barnay C, Furber A, Mabo P, Bernard P, Blanc JJ, Jouven X, Le Heuzey JY, Charbonnier B, Ferrieres J, Simon T; French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Investigators. Impact of early statin therapy on development of atrial fibrillation at the acute stage of myocardial infarction: data from the FAST-MI register. Heart. 2010 Nov;96(22):1809-14. doi: 10.1136/hrt.2010.201574.

ReferenceCitation: Zeller M, Danchin N, Simon D, Vahanian A, Lorgis L, Cottin Y, Berland J, Gueret P, Wyart P, Deturck R, Tabone X, Machecourt J, Leclercq F, Drouet E, Mulak G, Bataille V, Cambou JP, Ferrieres J, Simon T; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction investigators. Impact of type of preadmission sulfonylureas on mortality and cardiovascular outcomes in diabetic patients with acute myocardial infarction. J Clin Endocrinol Metab. 2010 Nov;95(11):4993-5002. doi: 10.1210/jc.2010-0449. Epub 2010 Aug 11.

ReferenceCitation: Danchin N, Coste P, Ferrieres J, Steg PG, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Gueret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou JP, Simon T; FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation. 2008 Jul 15;118(3):268-76. doi: 10.1161/CIRCULATIONAHA.107.762765. Epub 2008 Jun 30.

ReferenceType: result

ReferenceCitation: Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrieres J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

ReferenceCitation: Puymirat E, Aissaoui N, Simon T, Bataille V, Drouet E, Mulak G, Ferrieres J, Danchin N. [Acute myocardial infarction in the elderly. The FAST-MI registry]. Presse Med. 2013 Nov;42(11):1432-41. doi: 10.1016/j.lpm.2013.04.010. Epub 2013 Jul 22. French.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Simon T, Puymirat E, Lucke V, Bouabdallaoui N, Lognone T, Aissaoui N, Cohen S, Ashrafpoor G, Roul G, Jouve B, Levy G, Charpentier S, Grollier G, Ferrieres J, Danchin N; au nom des investigateurs FAST-MI 2010. [Acute myocardial infarction in women. Initial characteristics, management and early outcome. The FAST-MI registry]. Ann Cardiol Angeiol (Paris). 2013 Aug;62(4):221-6. doi: 10.1016/j.ancard.2013.06.003. Epub 2013 Jul 4. French.

oa_host_type: closed

ReferenceCitation: Puymirat E, Teixeira N, Simon T, Steg PG, Schiele F, Lamblin N, Probst V, Juilliere Y, Ferrieres J, Danchin N; FAST-MI investigators. Patient education after acute myocardial infarction: cardiologists should adapt their message--French registry of acute ST-elevation or non-ST-elevation myocardial infarction 2010 registry. J Cardiovasc Med (Hagerstown). 2015 Nov;16(11):761-7. doi: 10.2459/JCM.0000000000000092.

ReferenceCitation: Puymirat E, Schiele F, Ennezat PV, Coste P, Collet JP, Bonnefoy-Cudraz E, Roul G, Richard P, Simon T, Danchin N. Impact of fondaparinux versus enoxaparin on in-hospital bleeding and 1-year death in non-ST-segment elevation myocardial infarction. FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) 2010. Eur Heart J Acute Cardiovasc Care. 2015 Jun;4(3):211-9. doi: 10.1177/2048872614544857. Epub 2014 Jul 29.

publisher_dissemination: Oxford University Press

ReferenceCitation: Puymirat E, Aissaoui N, Cottin Y, Vanzetto G, Carrie D, Isaaz K, Valy Y, Tchetche D, Schiele F, Steg PG, Simon T, Danchin N. Effect of coronary thrombus aspiration during primary percutaneous coronary intervention on one-year survival (from the FAST-MI 2010 registry). Am J Cardiol. 2014 Dec 1;114(11):1651-7. doi: 10.1016/j.amjcard.2014.08.039. Epub 2014 Sep 16.

ReferenceCitation: Puymirat E, Schiele F, Steg PG, Blanchard D, Isorni MA, Silvain J, Goldstein P, Gueret P, Mulak G, Berard L, Bataille V, Cattan S, Ferrieres J, Simon T, Danchin N; FAST-MI investigators. Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: insights from the French FAST-MI program over 15 years. Int J Cardiol. 2014 Nov 15;177(1):281-6. doi: 10.1016/j.ijcard.2014.09.023. Epub 2014 Sep 28.

ReferenceCitation: Puymirat E, Caudron J, Steg PG, Lemesle G, Cottin Y, Coste P, Schiele F, de Labriolle A, Bataille V, Ferrieres J, Simon T, Danchin N; FAST-MI investigators. Prognostic impact of non-compliance with guidelines-recommended times to reperfusion therapy in ST-elevation myocardial infarction. The FAST-MI 2010 registry. Eur Heart J Acute Cardiovasc Care. 2017 Feb;6(1):26-33. doi: 10.1177/2048872615610893. Epub 2016 Sep 20.

evidence: open (via free article)

unpaywall_oa_status: bronze

ReferenceCitation: Bailleul C, Puymirat E, Aissaoui N, Schiele F, Ducrocq G, Coste P, Blanchard D, Brasselet C, Elbaz M, Steg PG, Le Breton H, Bonnefoy-Cudraz E, Montalescot G, Cottin Y, Goldstein P, Ferrieres J, Simon T, Danchin N; FAST-MI Investigators. Factors Associated With Infarct-Related Artery Patency Before Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (from the FAST-MI 2010 Registry). Am J Cardiol. 2016 Jan 1;117(1):17-21. doi: 10.1016/j.amjcard.2015.09.043. Epub 2015 Oct 23.

ReferenceCitation: Sokoloff A, Lefevre G, Teixeira N, Puymirat E, Beygui F, Vanzetto G, Richard P, Khalife K, Blanchard D, Gilard M, Coste P, Farah B, Elbaz M, Leclercq F, Ferrari E, Bonnet JL, Meyer P, Belle L, Funck F, Motreff P, Virot P, Geugniaud PY, Ferrieres J, Simon T, Danchin N. [Characteristics and management of ST-elevation myocardial infarction in France: Regional variations in 2010]. Ann Cardiol Angeiol (Paris). 2015 Dec;64(6):427-33. doi: 10.1016/j.ancard.2015.10.001. Epub 2015 Nov 5. French.

ReferenceCitation: Puymirat E, Lamhaut L, Bonnet N, Aissaoui N, Henry P, Cayla G, Cattan S, Steg G, Mock L, Ducrocq G, Goldstein P, Schiele F, Bonnefoy-Cudraz E, Simon T, Danchin N. Correlates of pre-hospital morphine use in ST-elevation myocardial infarction patients and its association with in-hospital outcomes and long-term mortality: the FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) programme. Eur Heart J. 2016 Apr 1;37(13):1063-71. doi: 10.1093/eurheartj/ehv567. Epub 2015 Nov 17.

evidence: open (via free pdf)

ReferenceCitation: Massoullie G, Wintzer-Wehekind J, Chenaf C, Mulliez A, Pereira B, Authier N, Eschalier A, Clerfond G, Souteyrand G, Tabassome S, Danchin N, Citron B, Lusson JR, Puymirat E, Motreff P, Eschalier R. Prognosis and management of myocardial infarction: Comparisons between the French FAST-MI 2010 registry and the French public health database. Arch Cardiovasc Dis. 2016 May;109(5):303-10. doi: 10.1016/j.acvd.2016.01.012. Epub 2016 Apr 20.

oa_colors: green hybrid

oa_host_type: publisher;repository

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

ReferenceCitation: Schiele F, Puymirat E, Bonello L, Meneveau N, Collet JP, Motreff P, Ravan R, Leclercq F, Ennezat PV, Ferrieres J, Simon T, Danchin N. Switching between thienopyridines in patients with acute myocardial infarction and quality of care. Open Heart. 2016 May 23;3(1):e000384. doi: 10.1136/openhrt-2015-000384. eCollection 2016.

ReferenceCitation: Aissaoui N, Puymirat E, Juilliere Y, Jourdain P, Blanchard D, Schiele F, Gueret P, Popovic B, Ferrieres J, Simon T, Danchin N. Fifteen-year trends in the management of cardiogenic shock and associated 1-year mortality in elderly patients with acute myocardial infarction: the FAST-MI programme. Eur J Heart Fail. 2016 Sep;18(9):1144-52. doi: 10.1002/ejhf.585.

ReferenceCitation: Puymirat E, Aissaoui N, Lemesle G, Cottin Y, Coste P, Schiele F, Ferrieres J, Simon T, Danchin N; FAST-MI Investigators. Long-Term Clinical Outcomes According to Previous Manifestations of Atherosclerotic Disease (from the FAST-MI 2010 Registry). Am J Cardiol. 2017 Mar 1;119(5):692-697. doi: 10.1016/j.amjcard.2016.11.032. Epub 2016 Dec 2.

ReferenceCitation: Puymirat E, Aissaoui N, Cayla G, Lafont A, Riant E, Mennuni M, Saint-Jean O, Blanchard D, Jourdain P, Elbaz M, Henry P, Bataille V, Drouet E, Mulak G, Schiele F, Ferrieres J, Simon T, Danchin N; FAST-MI investigators. Changes in One-Year Mortality in Elderly Patients Admitted with Acute Myocardial Infarction in Relation with Early Management. Am J Med. 2017 May;130(5):555-563. doi: 10.1016/j.amjmed.2016.12.005. Epub 2017 Jan 5.

ReferenceCitation: Schiele F, Gale CP, Simon T, Fox KAA, Bueno H, Lettino M, Tubaro M, Puymirat E, Ferrieres J, Meneveau N, Danchin N. Assessment of Quality Indicators for Acute Myocardial Infarction in the FAST-MI (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) Registries. Circ Cardiovasc Qual Outcomes. 2017 Jun;10(6):e003336. doi: 10.1161/CIRCOUTCOMES.116.003336.

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

ReferenceCitation: Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labeque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Gueret P, Belle L, Aissaoui N, Ferrieres J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

ReferenceCitation: Bailleul C, Aissaoui N, Cayla G, Dillinger JG, Jouve B, Schiele F, Ferrieres J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Prognostic impact of prepercutaneous coronary intervention TIMI flow in patients with ST-segment and non-ST-segment elevation myocardial infarction: Results from the FAST-MI 2010 registry. Arch Cardiovasc Dis. 2018 Feb;111(2):101-108. doi: 10.1016/j.acvd.2017.04.004. Epub 2017 Sep 19.

ReferenceCitation: Puymirat E, Aissaoui N, Bonello L, Cayla G, Labeque JN, Nallet O, Motreff P, Varenne O, Schiele F, Ferrieres J, Simon T, Danchin N; FAST-MI Investigators. Clinical outcomes according to symptom presentation in patients with acute myocardial infarction: Results from the FAST-MI 2010 registry. Clin Cardiol. 2017 Dec;40(12):1256-1263. doi: 10.1002/clc.22819. Epub 2017 Dec 15.

ReferenceCitation: Aissaoui N, Riant E, Lefevre G, Delmas C, Bonello L, Henry P, Bonnefoy E, Schiele F, Ferrieres J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Long-term clinical outcomes in patients with cardiogenic shock according to left ventricular function: The French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) programme. Arch Cardiovasc Dis. 2018 Nov;111(11):678-685. doi: 10.1016/j.acvd.2017.11.002. Epub 2017 Dec 28.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

ReferenceCitation: Isorni MA, Aissaoui N, Angoulvant D, Bonello L, Lemesle G, Delmas C, Henry P, Schiele F, Ferrieres J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Temporal trends in clinical characteristics and management according to sex in patients with cardiogenic shock after acute myocardial infarction: The FAST-MI programme. Arch Cardiovasc Dis. 2018 Oct;111(10):555-563. doi: 10.1016/j.acvd.2018.01.002. Epub 2018 Feb 22.

ReferenceCitation: Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015". Circulation. 2018 May 22;137(21):2307-2308. doi: 10.1161/CIRCULATIONAHA.118.033969. No abstract available.

ReferenceCitation: Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labeque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrieres J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment elevation myocardial infarction according to use of reperfusion therapy: Data from the FAST-MI program 1995-2015. Am Heart J. 2019 Aug;214:97-106. doi: 10.1016/j.ahj.2019.05.007. Epub 2019 May 16.

evidence: open (via crossref license, author manuscript)

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

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

ReferenceCitation: Schiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

ReferenceCitation: Tea V, Bonaca M, Chamandi C, Iliou MC, Lhermusier T, Aissaoui N, Cayla G, Angoulvant D, Ferrieres J, Schiele F, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Appropriate secondary prevention and clinical outcomes after acute myocardial infarction according to atherothrombotic risk stratification: The FAST-MI 2010 registry. Eur J Prev Cardiol. 2019 Mar;26(4):411-419. doi: 10.1177/2047487318808638. Epub 2018 Oct 24.

ReferenceCitation: Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrieres J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries. Arch Cardiovasc Dis. 2019 Aug-Sep;112(8-9):459-468. doi: 10.1016/j.acvd.2019.04.002. Epub 2019 May 22.

ReferenceCitation: Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrieres J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention in the light of the French Registry of Acute ST Elevation or non-ST Elevation Myocardial Infarction registries. Clin Cardiol. 2019 Feb;42(2):227-234. doi: 10.1002/clc.23131. Epub 2018 Dec 27.

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

ReferenceCitation: Ferrieres J, Bataille V, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI investigators. Applicability of the REDUCE-IT trial to the FAST-MI registry. Are the results of randomized trials relevant in routine clinical practice? Clin Cardiol. 2020 Nov;43(11):1260-1265. doi: 10.1002/clc.23437. Epub 2020 Jul 28.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Garcia R, Marijon E, Karam N, Narayanan K, Anselme F, Cesari O, Champ-Rigot L, Manenti V, Martins R, Puymirat E, Ferrieres J, Schiele F, Simon T, Danchin N. Ventricular fibrillation in acute myocardial infarction: 20-year trends in the FAST-MI study. Eur Heart J. 2022 Dec 14;43(47):4887-4896. doi: 10.1093/eurheartj/ehac579.

ReferenceCitation: Dillinger JG, Achkouty G, Albert F, Muller G, Labeque JN, Moisson L, Morelle JF, Cottin Y, Pezel T, Lim P, Aissaoui N, Schiele F, Ferrieres J, Angoulvant D, Henry P, Puymirat E, Simon T, Danchin N; FAST-MI investigators. Deleterious synergistic effects of acute heart failure and diabetes mellitus in patients with acute coronary syndrome: Data from the FAST-MI Registries. Arch Cardiovasc Dis. 2022 May;115(5):264-275. doi: 10.1016/j.acvd.2022.02.004. Epub 2022 Mar 4.

ReferenceCitation: Danchin N, Puymirat E, Cayla G, Cottin Y, Coste P, Gilard M, Goldstein P, Braun F, Belle L, Montalescot G, Ferrieres J, Schiele F, Simon T; FAST-MI Investigators. One-Year Survival After ST-Segment-Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.


title: Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant

acronym: GREFE

summary: The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot

intervention_type: Device

status_simplified: Unknown


title: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service

acronym: PREOXY

summary: Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

study_start_date_type: Actual

status: Withdrawn

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: Hopital of Melun

collaborators: Service d'Aide Médicale Urgente de Seine et Marne


title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.

acronym: AutoSop-Foie

summary: The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers supervision, virtual reality, pharmacology) among the "Réseau Eveil Sommeil Attention et Transports" (RESAT) network.

primary_purpose: Prevention

lead_sponsor: University Hospital, Caen


title: Study of Bronchoalveolar Lung Remodeling in Subjects From 60 Years Free of Progressive Lung Disease: Structure-function Analysis

summary: The aim of the study is to investigate the relationship between aging and morphological changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for this trial.

status: Terminated

ReferenceCitation: Bommart S, Marin G, Bourdin A, Molinari N, Klein F, Hayot M, Vachier I, Chanez P, Mercier J, Vernhet-Kovacsik H. Relationship between CT air trapping criteria and lung function in small airway impairment quantification. BMC Pulm Med. 2014 Feb 28;14:29. doi: 10.1186/1471-2466-14-29.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: University Hospital, Montpellier


title: Effects of Treatment of Post-traumatic Stress Disorder on Reduced Recall for Fear Extinction

summary: This preliminary study will examine the differential effects of rTMS on the recall of extinction of conditioned fear in patients suffering from PTSD (post-traumatic stress disorder ) compared with subjects without PTSD but with high risk of relapse.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan

summary: This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC).

location_facility: Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud

intervention_type: Procedure


title: Multicenter Open and Prospective Trial Assessing the Efficacy of Vitamin D Supplementation in Addition to Pegylated Interferon Plus Ribavirin in Null-Responders Patients With Chronic Viral Hepatitis C Genotype 1 or 4

acronym: ANRS VITAVIC

summary: Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

ReferenceCitation: Terrier B, Lapidus N, Pol S, Serfaty L, Ratziu V, Asselah T, Thibault V, Souberbielle JC, Carrat F, Cacoub P. Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study. World J Gastroenterol. 2015 May 14;21(18):5647-53. doi: 10.3748/wjg.v21.i18.5647.

evidence: open (via page says license)

publisher_dissemination: Baishideng Publishing Group Inc.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


acronym: ProphyloCHIP

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

summary: Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).

ReferenceCitation: Goere D, Glehen O, Quenet F, Guilloit JM, Bereder JM, Lorimier G, Thibaudeau E, Ghouti L, Pinto A, Tuech JJ, Kianmanesh R, Carretier M, Marchal F, Arvieux C, Brigand C, Meeus P, Rat P, Durand-Fontanier S, Mariani P, Lakkis Z, Loi V, Pirro N, Sabbagh C, Texier M, Elias D; BIG-RENAPE group. Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study. Lancet Oncol. 2020 Sep;21(9):1147-1154. doi: 10.1016/S1470-2045(20)30322-3. Epub 2020 Jul 24.

version: acceptedVersion

title: Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treated With Surgery and Adjuvant Chemotherapy Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis

type: EudraCT Number


acronym: Interaction tropisétron / Granisétron - paracétamol

lead_sponsor: University Hospital, Clermont-Ferrand

summary: This is a Crossover study, double-blind, randomized, controlled versus placebo.

title: Comparative Study of the Influence of Two Antagonist Receptors 5-HT3, tropisétron and granisétron, on the Analgesic Effect of Paracétamol


type: Other Identifier

title: Study of Efficacy and Tolerance of Early Launching of Nocturnal Non Invasive Ventilation in Adults With Myotonic Dystrophy Type 1(DM1)

acronym: DYVINE

summary: This is a multicenter randomized controlled open labeled study testing efficacy and tolerance of early launching of night non invasive ventilation in patients with myotonic dystrophy type 1(DM1). The object of this project is to estimate the effects of the early introduction of non invasive ventilation on the arisen of complication (non expected hospitalization, tracheostomy even death) with regard to a simple respiratory follow-up in patients affected by myotonic dystrophy.

collaborators: Association Française contre les Myopathies (AFM), Paris

location_facility: Home ventilation unit and intensive care, centre of neuromuscular disease (Garches Mondor Necker Hendaye), Raymond Poincaré hospital Versailles Saint Quentin University.


title: Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study

summary:
Study objectives:

To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis
To assess the impact of tobacco discontinuation
Study Design Multicentric prospective cohort study
Main endpoint: Pulmonary deterioration
Sample size : 40 patients

ReferenceCitation: Tazi A, de Margerie C, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. The natural history of adult pulmonary Langerhans cell histiocytosis: a prospective multicentre study. Orphanet J Rare Dis. 2015 Mar 14;10:30. doi: 10.1186/s13023-015-0249-2.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

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

publisher_dissemination: Springer-Nature

ReferenceCitation: Tazi A, de Margerie-Mellon C, Vercellino L, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. Extrathoracic investigation in adult patients with isolated pulmonary langerhans cell histiocytosis. Orphanet J Rare Dis. 2016 Feb 2;11:11. doi: 10.1186/s13023-016-0387-1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

intervention_type: Behavioral


title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

acronym: BCDE

summary:
The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.

The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Mobilization by Plerixafor of Haematopoietic Stem Cells in Children

summary: This is a prospective Phase II, monocentre study.


title: Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index

acronym: SALIVENDO

summary: Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Bordeaux

location_facility: Service of Endocrinology, Diabetology, metabolic diseases - Hôpital du Haut Lévêque - CHU de BORDEAUX

intervention_type: Biological


title: TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

summary:
Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia. They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1 (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the cytochrome p450 ( CYP4F2).

No etiological treatment is available. Symptomatic treatment consists on twice application of emollients and keratolytic ointments which decrease the dryness of the skin and reduce scales. Oral isotretinoin is usually partially effective but is only suspensive and has numerous side effects.

Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from green tea increases the differentiation of the normal human keratinocytes, as showedb by the increase of the involucrine, TG1 and caspase-14 genes expression.

The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.

The secondary objectives

To estimate the duration of remission obtained after the treatment
To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement.
To estimate the action of cutaneous Veregen on the pruritus
And to estimate the global level of acceptability by the patient of the Veregen 10 %

location_facility: Toulouse University Hospital, Dermatology Department


title: Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.

acronym: L-Lysine

summary: Data from the literature and previous in vitro research conducted in the investigators' laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid secretion might be controlled by a paracrine mechanism involving serotonin type IV receptor (5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels will be measured under treatment with aprepitant versus placebo, in both basal conditions and after activation of the adrenocortical function by various stimuli, including upright posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be given two substances (L-lysine and placebo) in a random order during two 13 days periods separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4 receptors in the control of corticosteroid production in normal man.

lead_sponsor: University Hospital, Rouen

location_facility: Rouen Clinical research Centre (CIC 0204)

intervention_type: Dietary Supplement


title: Evaluation of the Predictive Ability of Urinary NGAL as an Early Marker of Acute Kidney Injury Following Cardiac Surgery in Neonates and Infants

acronym: NGAL

summary:
Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not been studied in neonates after open heart surgery, neither has been identified the threshold for accurate prediction of severe AKI requiring renal replacement therapy.

The aim of this observational cohort study is to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy in neonates and infants undergoing cardiac surgery

ReferenceCitation: Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, Syed H, Ali S, Barasch J, Devarajan P. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol. 2008 May;3(3):665-73. doi: 10.2215/CJN.04010907. Epub 2008 Mar 12.

ReferenceCitation: Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X.

ReferenceCitation: Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21.

ReferenceCitation: Bojan M, Basto Duarte MC, Lopez V, Tourneur L, Vicca S, Froissart M. Low perfusion pressure is associated with renal tubular injury in infants undergoing cardiac surgery with cardiopulmonary bypass: A secondary analysis of an observational study. Eur J Anaesthesiol. 2018 Aug;35(8):581-587. doi: 10.1097/EJA.0000000000000782.

ReferenceCitation: Bojan M, Basto Duarte MC, Ermak N, Lopez-Lopez V, Mogenet A, Froissart M. Structural equation modelling exploration of the key pathophysiological processes involved in cardiac surgery-related acute kidney injury in infants. Crit Care. 2016 Jun 5;20(1):171. doi: 10.1186/s13054-016-1350-1.

repositories_concat: PubMed Central

ReferenceCitation: Bojan M, Vicca S, Lopez-Lopez V, Mogenet A, Pouard P, Falissard B, Journois D. Predictive performance of urine neutrophil gelatinase-associated lipocalin for dialysis requirement and death following cardiac surgery in neonates and infants. Clin J Am Soc Nephrol. 2014 Feb;9(2):285-94. doi: 10.2215/CJN.04730513. Epub 2013 Nov 21.

oa_colors: green other


title: Benefits Study of a Respiratory Gating Protocol for 18F-FDG PET: Application on the Liver

acronym: RespiTEP

summary:
Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion and because the liver is intrinsically FDG avid, some tumours (especially the smallest ones) can be occulted and missed by the clinician.

The investigators developed a respiratory-gated PET method in order to reduce the motion issue. This protocol has been validated on lung pathologies. The investigators designed a study to investigate its effect on liver cancer (primary or metastasis) to check if it allows the detection of a higher number of tumour lesions.

To that aim, patients who are planned to undergo a surgical intervention on the liver can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (~10s) CT is performed.

ReferenceCitation: Fin L, Daouk J, Bailly P, Slama J, Morvan J, El Esper I, Regimbeau JM, Chatelain D, Diouf M, Meyer ME. Improved imaging of intrahepatic colorectal metastases with 18F-fluorodeoxyglucose respiratory-gated positron emission tomography. Nucl Med Commun. 2012 Jun;33(6):656-62. doi: 10.1097/MNM.0b013e328351fce8.

ReferenceCitation: Daouk J, Fin L, Bailly P, Slama J, Diouf M, Morvan J, El Esper I, Regimbeau J-M, Chatelain D, Meyer M-E. The Benefits of Respiratory Gating in 18F-FDG PET Imaging of the Liver, The International Journal of Nuclear Energy Science and Engineering 2(1):5-10, 2012

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: centre hospitalier universitaire d'Amiens


title: Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities

acronym: ALLOPULM

summary: This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

ReferenceCitation: Bergeron A, Chevret S, Peffault de Latour R, Chagnon K, de Margerie-Mellon C, Riviere F, Robin M, Mani J, Lorillon G, Socie G, Tazi A. Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation. Eur Respir J. 2018 May 3;51(5):1702617. doi: 10.1183/13993003.02617-2017. Print 2018 May.

publisher_dissemination: European Respiratory Society


title: Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.

summary:
The aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first week and the first six months after SAH.

The study hypothesis is that the evolution of the cardiac disturbances follows the clinical evolution.

ReferenceCitation: Banki NM, Kopelnik A, Dae MW, Miss J, Tung P, Lawton MT, Drew BJ, Foster E, Smith W, Parmley WW, Zaroff JG. Acute neurocardiogenic injury after subarachnoid hemorrhage. Circulation. 2005 Nov 22;112(21):3314-9. doi: 10.1161/CIRCULATIONAHA.105.558239. Epub 2005 Nov 14.

ReferenceCitation: Meaudre E, Jego C, Kenane N, Montcriol A, Boret H, Goutorbe P, Habib G, Palmier B. B-type natriuretic peptide release and left ventricular filling pressure assessed by echocardiographic study after subarachnoid hemorrhage: a prospective study in non-cardiac patients. Crit Care. 2009;13(3):R76. doi: 10.1186/cc7891. Epub 2009 May 20.

ReferenceCitation: Prunet B, Basely M, D'Aranda E, Cambefort P, Pons F, Cimarelli S, Dagain A, Desse N, Veyrieres JB, Jego C, Lacroix G, Esnault P, Boret H, Goutorbe P, Bussy E, Habib G, Meaudre E. Impairment of cardiac metabolism and sympathetic innervation after aneurysmal subarachnoid hemorrhage: a nuclear medicine imaging study. Crit Care. 2014 Jun 25;18(3):R131. doi: 10.1186/cc13943.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Intensive Care Unit, Military Teaching Hospital sainte Anne


title: IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years

acronym: IT-DIAB

summary: The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population.

ReferenceCitation: Croyal M, Wargny M, Chemello K, Chevalier C, Blanchard V, Bigot-Corbel E, Lambert G, Le May C, Hadjadj S, Cariou B. Plasma apolipoprotein concentrations and incident diabetes in subjects with prediabetes. Cardiovasc Diabetol. 2022 Feb 7;21(1):21. doi: 10.1186/s12933-022-01452-5.

ReferenceCitation: Chavez-Talavera O, Wargny M, Pichelin M, Descat A, Vallez E, Kouach M, Bigot-Corbel E, Joliveau M, Goossens JF, Le May C, Hadjadj S, Hanf R, Tailleux A, Staels B, Cariou B. Bile acids associate with glucose metabolism, but do not predict conversion from impaired fasting glucose to diabetes. Metabolism. 2020 Feb;103:154042. doi: 10.1016/j.metabol.2019.154042. Epub 2019 Nov 27.

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

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

version: submittedVersion

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive)

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

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

ReferenceCitation: Wargny M, Smati S, Pichelin M, Bigot-Corbel E, Authier C, Dierry V, Zair Y, Jacquin V, Hadjadj S, Boursier J, Cariou B. Fatty liver index is a strong predictor of changes in glycemic status in people with prediabetes: The IT-DIAB study. PLoS One. 2019 Aug 29;14(8):e0221524. doi: 10.1371/journal.pone.0221524. eCollection 2019.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org


title: Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma

summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see how well they work in treating patients with metastatic melanoma of the eye.

lead_sponsor: Institut Curie


title: Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities

summary: Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on clinical factors (extension of the disease, achievement of the perianal ring, requirement of surgery, treatment by immunomodulators…). All IBD specific immunological or serological markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs Crohn Disease) but were never able to be considered as predictive elements of adults IBD evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their combination present an average sensibility about 85 % and a 85 % specificity. However, 8 other antibody types were recently isolated and estimated individually during IBD in particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA, AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These complementary assays improve significantly the reliability of the diagnosis. However, if the use of these new markers has an indisputable diagnostic role, their predictive role in the evolution of IBD was estimated at the adult's only rarely during Crohn diseases. Consequently, the investigators suggest realizing an exhaustive analysis of all these new immunological markers to define, if their association can have an interest in the differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary) clinical forms.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Comparison of Axillary Block Under Ultrasound With 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

acronym: COMBAX

summary:
Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography.

The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

lead_sponsor: University Hospital, Brest


acronym: NET

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
The purpose of this study is to identify predictive molecular markers of response to continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.

Hypothesis:

To distinguish molecular markers based on their expression at the initial biopsy, their detection by proteomic analysis and demonstrating that tumor or vascular cells are straightaway sensitive to sunitinib (markers sensitivity).
The presence of these markers at the initial biopsy predict the sensitivity to sunitinib(Positive predictive value of markers)

title: A Multicenter Phase II Open Study Coupled With a Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.


acronym: Fibrolam

summary:
The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with advanced/inoperable fibrolamellar hepatocellular carcinoma.

Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

title: A Multicenter National Phase II Open Study Coupled With Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Hepatocellular Carcinoma.


title: Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase

summary: This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.

lead_sponsor: Hoffmann-La Roche


title: A Randomized, Double-Blind, Sponsor Unblinded, Placebo Controlled, 5-Way, Crossover Study To Evaluate The Effects Of Single Oral Administrations of PF-05212377 (SAM-760), A 5-HT6 Antagonist, On Scopolamine Induced Deficits In Psychomotor And Cognitive Function In Healthy Young Adults

summary: It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.

primary_purpose: Other

lead_sponsor: Pfizer


title: Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?

acronym: NATRIPHAR

summary:
Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently, association between hyponatremia and bone fractures in the ambulatory elderly has been shown.

Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention deficit.

Symptoms related to hyponatremia can be very subtle and difficult to detect clinically. Twenty elderly patients, retirement homes residents, with serum sodium < 135mEq/L will be included. They will be randomised. The physician will review the drug treatment of ten patients in coordination with the opinion of pharmacologists. Drug treatment for ten other patients wil remained unchanged during the three months of inclusion.

Useful elements of the medical records of patients randomized to the experimental arm will be forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice, subject to the attention of physician of retirement homes, give rise to a therapeutic approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4 weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical intervention will be evaluated by an objective biological criteria: serum sodium in the fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium and check the interest of correcting hyponatremia to improve postural capacities and eventually reduce the number of falls in the medium term (three months).


type: Registry Identifier

title: Impact of Quality of Life Assessment in Routine Oncology Practice for Head and Neck's Cancer Patients, Treated by Radiotherapy: Impact on the Satisfaction With Care, the Health Related Quality of Life and on the Toxicity

summary:
RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction with care may help doctors plan the best treatment and help patients live more comfortably.

PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients with head and neck cancer treated with radiation therapy.

lead_sponsor: Centre Georges Francois Leclerc

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: Reversion of the Anticoagulant Effect of the New Antithrombotic Agents Anti-Xa and Anti IIa by Specific and Non-specific Haemostatic Drugs,: an Ex-Vivo Study in Healthy Volunteers

acronym: REVNEWANTICO

summary: The purpose of this study is to evaluate whether the effect of the two new anticoagulants, Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex concentrate (PCC), recombinant activated coagulation factor VII, and activated prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from healthy male volunteers.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinical Research Centre, University Hospital Grenoble


title: GENEWING - A Genome Wide Association Study in Ewing Sarcoma

acronym: GENEWING

summary:
RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their relatives may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples collected from patients with Ewing sarcoma and their relatives.

time_perspective: Retrospective


title: Modelling of 24h Energy Expenditure From Heart Rate, Actimetry and Other Parameters Recorded Under Free-living Conditions

acronym: Modelheart

summary:
At this time, 24h energy expenditure is rarely assessed under free-living conditions for specific individuals because of the lack of cheap and accurate software/materials to record the energy expenditure. Some affordable and convenient tools (Polar heart rate monitor, Actiheart, SenseWear Armband) are available on the market but the predictive equations comprised into the software provided with these tools generally miscalculate the energy expenditure (by about +/-10%). Because of this deficiency, the investigators have a poor knowledge of the modification of the energy expended during daily life activities and over 24h in subjects belonging to groups of various ages and physiological states. The investigators hypothesise that it could be possible to improve the energy expenditure prediction.

The project aims at providing a mathematical model (equations) that predicts energy expenditure with an error near to 5%. Two groups of 60 sedentary to athletic normal weight volunteers aged between 18-60 years participate to this study. The first group stay for 26h in calorimetric chambers. During this stay energy expenditure ,heart rate, accelerometry, and other parameters are recorded during various activities. These data will serve to construct the model. The same type of recordings are performed on second group of volunteers in free living conditions. Their energy expenditure is measured overall by doubly labeled water. The data of the second group will serve to validate the model. The error percentage of the model is defined by the ratio of the value of the difference between prediction and reference measure to the reference measure. Concordance between predictions and measures will be evaluated by Bland - Altman plots.

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne

collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe


title: Emergence of Fluoroquinolone Resistance in the Commensal Flora of Patients Receiving Fluoroquinolone Treatment.

acronym: FQEMERG

summary: The emergence of resistance to fluoroquinolone (FQ) is a major problem worldwide. The commensal flora is the main reservoir for antibiotic resistance. Understanding the factors (environmental, patient-related, dosis-related, drug-related…) involved in the emergence of resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help prevent it and preserve the efficiency of these important antibiotics. Samples of rectal, nasal and pharyngeal flora will be collected from hospitalized patients before receiving a FQ, at the end of the treatment and 1 month after the end of treatment. Clinical data will be collected. The incidence and risk-factors associated with the emergence of resistance to FQ will be assessed by comparing groups with and without resistance both at the end of treatment and 1 month later.

ReferenceCitation: de Lastours V, Chau F, Roy C, Larroque B, Fantin B. Emergence of quinolone resistance in the microbiota of hospitalized patients treated or not with a fluoroquinolone. J Antimicrob Chemother. 2014 Dec;69(12):3393-400. doi: 10.1093/jac/dku283. Epub 2014 Jul 24.


title: The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction

summary: After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.

ReferenceCitation: Thuny F, Lairez O, Roubille F, Mewton N, Rioufol G, Sportouch C, Sanchez I, Bergerot C, Thibault H, Cung TT, Finet G, Argaud L, Revel D, Derumeaux G, Bonnefoy-Cudraz E, Elbaz M, Piot C, Ovize M, Croisille P. Post-conditioning reduces infarct size and edema in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2012 Jun 12;59(24):2175-81. doi: 10.1016/j.jacc.2012.03.026.

lead_sponsor: Hospices Civils de Lyon


title: Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study

acronym: EP48 HIV CHEST

summary: Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography (CT) in a HIV-infected population with an important smoking history. Other objectives are (1) the evaluation of the types of lung cancers in this population, as well as (2) the staging of non small cell lung cancers, (3) the description of risk factors for all lung cancers, if they are numerous enough, and (4) the number of complications of diagnosis procedures during the study.

primary_purpose: Screening

lead_sponsor: ANRS, Emerging Infectious Diseases

intervention_type: Radiation


title: Randomised Controlled Clinical Trial of Cognitive Rehabilitation in Multiple Sclerosis and Assessment by Neuroimaging

acronym: REACTIV

summary:
Despite the need for cognitive rehabilitation, there is a paucity of well-designed research studies to investigate treatment approaches or their effectiveness in MS. Most of published studies suffer from significant methodological flaws including small sample size, short follow-up periods, and lack of specific outcome criteria to determine improvement. O'Brien et al. (2008) recently reviewed 16 studies of cognitive rehabilitation designed to persons with MS and found only 4 class I studies and only one class I study of rehabilitation of attention deficits. Methodologically rigorous research is needed to confirm the preliminary results reported by these studies and determine the effectiveness and efficacy of cognitive rehabilitation interventions in attention deficits in MS. O'Brien et al. listed limitations found in previous studies that must be addressed in future studies. The present study was designed according to these recommendations. It is a randomized, controlled study, in parallel groups, evaluator blinded.

Number of participants: 25 RRMS patients in the active group, 25 RRMS patients in the control group and 25 healthy subjects.

The protocol will be proposed to RRMS patients AFFILIATED TO FRENCH SOCIAL SECURITY referred to the investigators center by practicing neurologists and fulfilling the inclusion criteria for screening.

Patients will be randomised between two groups. The active group (25 patients) will be treated by rehabilitation. Individual rehabilitation procedures will be focused on attention, executive functions and IPS. The program will be tailored to each patient cognitive status depending on the impairments identified during the initial assessment while maintaining a systematic work on attention and executive functions. A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed. Patients randomized in the other group will participate to group session every week without specific cognitive rehabilitation. 25 healthy control subjects (group C), matched to patients for education, gender and age with patients of groups A/B will have the same evaluation procedures than patients.

Evaluation will be performed at baseline, after 4 months (end of treatment period) and after 8 months. Evaluation will include clinical testing, cognitive battery (paper/pencil and computer tests), cognitive ecological evaluation (Computer test of attention in a virtual reality environment and driving test on a driving simulator), questionnaires about daily life and MRI (fMRI and MRI). All patients and healthy subjects will undergo the fMRI protocol using a paradigm previously published by the investigators group (Bonnet et al., 2009): Go/No-go paradigm with increasing difficulty during four successive conditions (the Tonic Alertness task, Go/No-go (IG), reversal Go/No-go (RG), and complex Go/No-go (CG). In a previous study the investigators observed compensatory activation in MS patients as compared to healthy controls for the three first conditions and a saturation of compensatory processes for the more complex. In the present study, the investigators hypothesize that a similar pattern will occur at baseline and that cognitive rehabilitation will improve brain compensation at the fourth level of complexity.

ReferenceCitation: Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupe P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27.

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

publisher_dissemination: British Medical Journal

sponsor_collaborators:
University Hospital, Bordeaux
Merck Serono International SA
ARSEP foundation

location_facility: Service de Neurologie - Pôle des Neurosciences Cliniques, CHU de Bordeaux.


title: Study of Prognostic Factors of Acute Splenic Sequestration in a Cohort of Sickle Cell Disease (SCD) Children Diagnosed at Birth

acronym: SSADREPA

summary:
Acute splenic sequestration is a frequent and life threatening complication occurring in approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months.

The investigators formulate the hypothesis that there are clinical, biological and genetic markers predictive of severe complications notably acute splenic sequestration in SCD children. The present research project thus aims at analyzing in a forward-looking way the profile of severity by analysing clinical, biological and genetic characteristics in a multicentric cohort of 60 SCD children

ReferenceCitation: Brousse V, El Hoss S, Bouazza N, Arnaud C, Bernaudin F, Pellegrino B, Guitton C, Odievre-Montanie MH, Mames D, Brouzes C, Picard V, Nguyen-Khoa T, Pereira C, Lapoumeroulie C, Pissard S, Gardner K, Menzel S, Le Van Kim C, Colin-Aronovicz Y, Buffet P, Mohandas N, Elie C, Maier-Redelsperger M, El Nemer W, de Montalembert M. Prognostic factors of disease severity in infants with sickle cell anemia: A comprehensive longitudinal cohort study. Am J Hematol. 2018 Nov;93(11):1411-1419. doi: 10.1002/ajh.25260. Epub 2018 Sep 21.

publisher_dissemination: Wiley


title: Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.

acronym: BASIK

summary:
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.

Knee MRI is not currently part of the investigations preceding bariatric surgery.


title: Pharmacodynamic Study of 125 mg of Paracetamol Permucosal Administered by Sublingual and Buccal Route

summary:
Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous and rectal.

The per-oral mucosal route is not used for the administration of paracetamol. It is a very interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV administration and faster than oral administration, seek a single medical procedure unattended after dosing, will entail no pain or risk for infections the patient (in contrast to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the only dosage form of reference used by the IV route in the protocol "Pilot study Pharmacology paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by half permucosal to assess how changing the pharmacodynamics of the form permucosal to 125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual (under the pillar of the language) and compared with paracetamol in IV.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Unither SA


acronym: GATE 1

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

summary:
GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients.

The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest.

Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions.

Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.

The patients will be subjected to research for the EGFR, HER2 and KRAS status.

ReferenceCitation: Assenat E, Mineur L, Mollevi C, Lopez-Crapez E, Lombard-Bohas C, Samalin E, Portales F, Walter T, de Forges H, Dupuy M, Boissiere-Michot F, Ho-Pun-Cheung A, Ychou M, Mazard T. Phase II study evaluating the association of gemcitabine, trastuzumab and erlotinib as first-line treatment in patients with metastatic pancreatic adenocarcinoma (GATE 1). Int J Cancer. 2021 Feb 1;148(3):682-691. doi: 10.1002/ijc.33225. Epub 2020 Sep 2.

title: Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma


title: Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial

summary: The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.

lead_sponsor: Phythea

location_facility: Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux


title: Prospective Observational Study to Asses the Insulin Resistance (IR) and Its Impact on Sustained Virological Response in a Cohort of HCV-infected Patients Treated With Pegasys and Copegus

summary: This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.


title: Hypoxia Diagnosis and Evaluation Using F-MISO PET and Biomarkers in Brain Tumors

acronym: HYPONCO

summary:
Background :

In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression. This multidisciplinary preclinical and clinical project aims to validate the use of 18F-FMISO as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas. Indeed, non-invasive methods of imagery such as Positron Emission Tomography (PET) and biological methods (after surgical resection) to detect the endogenous expression of factors induced by the hypoxia would allow to identify hypoxic areas. Identifying, with accuracy, the hypoxic areas could allow the clinicians to evaluate the response to the anti-angiogenic agents (preliminary validation in the preclinical project) and to optimize the combination of the anti-VEGF treatments with other conventional therapeutic approaches (radiotherapy, chemotherapy or other molecules).

Research project :

This research project includes 3 steps : first the investigators will establish the 18F-FMISO production technique for clinical application at CYCERON PET center. The second step consists in the preclinical validation of 18F-FMISO as a hypoxic marker and as a powerful tool for evaluating the therapeutical efficiency of anti-angiogenic treatment (sutent) in experimental rat gliomas. The third step is the clinical trial HypOnco. This research proposal aims to develop and use non invasive imaging methods (18F-FMISO with PET) and biological methods (after surgical resection) to detect hypoxic (HIF1 and HIF2) and angiogenic (VEGF and EPO) regions in different malignant gliomas with different degrees of vascularization (15 patients with grade III gliomas and 15 patients with grade IV glioblastomas). Within the same patient 18F-FMISO as a hypoxic index will be performed. A magnetic resonance imaging examination (MRI) including perfusion sequences and MR spectroscopy will also be assessed for each patient. Following this imaging protocol, surgical resection will be performed allowing us to study expression of endogenous factors induced by hypoxia and angiogenic factors by real time RT-PCR and in immunohistochemistry.

The data obtained will enable us to establish :

a hypoxic index (18F-FMISO with PET).
an index of hypoxic factor expression (HIFs)
an angiogenic index (VEGF, EPO, vascular markers)

The investigators will characterize the links between these data and also with the following parameters:

clinical (age, Karnofsky performance status, survival)
MR parameters included perfusion and spectroscopy
histological (necrosis, cellular proliferation, atypical cell abnormalities, vascularization).

Expected results and clinical advantages

To establish the 18F-FMISO production technique
To propose the 18F-FMISO as a non-invasive marker for efficacy of antiangiogenic treatment in a preclinical study.
To define the relationship between the 18F-FMISO uptake and tumour grade, patient survival, tumour recurrence, expression of hypoxic and angiogenic factors and tumour vascularisation.
To provide a hypoxic index in cerebral tumours from 18F-FMISO PET, allowing diagnosis and prognosis improvement for optimal treatment orientation and strategy.

In the field of the clinical applications, this tool will allow to :

Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the most hypoxic areas which are also the most radio resistant.
Evaluate antiangiogenic therapy efficacy

lead_sponsor: University Hospital, Caen


title: Search for the Presence of Genetic Alteration in the Plasma of Patients With Stage II-III Colorectal Cancers: Prognosis Impact

acronym: ALGECOLS

summary:
Cancer is a DNA disease characterized by the presence of genetics alterations in cancer cells.

The recent studies underline that these recurring alterations must be considered as a good molecular marker. In fact, they could use for tumor DNA detection in different biological fluids.

So, the main purpose is to define the presence of circulating tumor DNA in the patients plasma with colorectal cancer, by the presence of mutation (KRAS, NRAS, BRAF, APC, TP53 and MIRCOSATELLIE instability).

These molecular analysis will be done both in tumor and plasma samples,

This trial allows to characterize the prognostic value of circulating tumoral DNA presence in colorectal cancer.


title: Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma

acronym: EFAPRE

summary:
Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.

The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassess criteria for liver transplantation.


title: Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial

summary: This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.

lead_sponsor: Centre Oscar Lambret


acronym: ARACHILD

summary: This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
DBV Technologies

title: ARACHILD: A Multicentric, Double Blind Placebo-controlled Pilot Protocol to Study the Efficacy and Safety of an Epicutaneous Immunotherapy in Children Allergic to Peanut


acronym: MSN

summary:
A multicenter, randomized, study will be performed to evaluate the efficacy of low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in inducing remission in adults with minimal change nephrotic syndrome (MCNS). One hundred and fourteen patients (CPP decision 2009-04-02-a5) will be included in this study. They will be randomly assigned to an open label treatment with either prednisone

1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The outcome will be compared during one-year follow up

ReferenceCitation: Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.

ReferenceCitation: Remy P, Audard V, Natella PA, Pelle G, Dussol B, Leray-Moragues H, Vigneau C, Bouachi K, Dantal J, Vrigneaud L, Karras A, Pourcine F, Gatault P, Grimbert P, Ait Sahlia N, Moktefi A, Daugas E, Rigothier C, Bastuji-Garin S, Sahali D; MSN Trial Investigators. An open-label randomized controlled trial of low-dose corticosteroid plus enteric-coated mycophenolate sodium versus standard corticosteroid treatment for minimal change nephrotic syndrome in adults (MSN Study). Kidney Int. 2018 Dec;94(6):1217-1226. doi: 10.1016/j.kint.2018.07.021. Epub 2018 Oct 29.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Novartis

title: Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome


title: Inflammation and Oxidative Stress of Adipose Tissue in Obese and Non-obese Patients Having Sleep Apnea Syndrome

acronym: ADISAS

summary:
The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP).

An interim analysis will be performed when 40 patients will be included.

ReferenceCitation: Baguet JP, Hammer L, Levy P, Pierre H, Launois S, Mallion JM, Pepin JL. The severity of oxygen desaturation is predictive of carotid wall thickening and plaque occurrence. Chest. 2005 Nov;128(5):3407-12. doi: 10.1378/chest.128.5.3407.

ReferenceCitation: Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.

ReferenceCitation: Hosogai N, Fukuhara A, Oshima K, Miyata Y, Tanaka S, Segawa K, Furukawa S, Tochino Y, Komuro R, Matsuda M, Shimomura I. Adipose tissue hypoxia in obesity and its impact on adipocytokine dysregulation. Diabetes. 2007 Apr;56(4):901-11. doi: 10.2337/db06-0911.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.

ReferenceCitation: Coughlin SR, Mawdsley L, Mugarza JA, Wilding JP, Calverley PM. Cardiovascular and metabolic effects of CPAP in obese males with OSA. Eur Respir J. 2007 Apr;29(4):720-7. doi: 10.1183/09031936.00043306. Epub 2007 Jan 24.

ReferenceCitation: Lavie L. Obstructive sleep apnoea syndrome--an oxidative stress disorder. Sleep Med Rev. 2003 Feb;7(1):35-51. doi: 10.1053/smrv.2002.0261.

ReferenceCitation: Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.

collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters

summary: This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.

ReferenceCitation: Eljezi V, Duale C, Azarnoush K, Skrzypczak Y, Sautou V, Pereira B, Tsokanis I, Schoeffler P. The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):166-74. doi: 10.1097/AAP.0b013e318240957f.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®

acronym: Anaconda

summary: This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
University Hospital, Estaing


title: A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of Memantine on Pharmacokinetics, Safety and Tolerability of RO5313534 After Single Dose Administration in Healthy Volunteers and the Effect of RO5313534 on Safety and Tolerability of Steady State Memantine

summary: This open-label, fixed sequence, two-period study will assess the effect of memantine on the pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.


title: Effect of RAS Inhibitors on Albuminuria, Hyperfiltration and Endothelial Dysfunction in a Sickle Cell Disease Population.

acronym: RAND

summary: The prevalence of Sickle Cell Associated Nephropathy (SCAN) is increasing and is a growing concern. Microalbuminuria is detected in the early onset of SCAN. Noteworthy, as in diabetic nephropathy, hyperfiltration seems to be a frequent finding, with, in our series, an overall incidence of 57 % and suggests a pathological links between glomerular hyperpressure and glomerulosclerosis which occurs several years after. Nitric oxide (NO) deficiency and the renin angiotensin system (RAS) are likely to be involved in the glomerular hyperpressure leading to hyperfiltration. Renin angiotensin antagonists are currently given for NEPHROPROTECTION in numerous nephropathy including SCAN despite few available reports. The percentage of decrease of albuminuria or the percentage of responders (ie patient normalizing albuminuria) has never been reported to our knowledge in SCAN patients at the time of hyperfiltration. The focus of our study is therefore to 1) Quantify albuminuria reduction after 6 months RAS treatment (primary end point); 2) Quantify glomerular filtration rate (GFR) reduction after 6 months of RAS treatment, and to test the hypothesis of a beneficial effect of RAS inhibitors on several biomarkers assessing hemolysis, NO inhibition and the endothelial damages (secondary end points). The ultimate aim of our study is to identify relevant (new) biomarkers associated to hyperfiltration and/or albuminuria decrease (/normalization).

ReferenceCitation: Dharnidharka VR, Dabbagh S, Atiyeh B, Simpson P, Sarnaik S. Prevalence of microalbuminuria in children with sickle cell disease. Pediatr Nephrol. 1998 Aug;12(6):475-8. doi: 10.1007/s004670050491.

ReferenceCitation: Guasch A, Navarrete J, Nass K, Zayas CF. Glomerular involvement in adults with sickle cell hemoglobinopathies: Prevalence and clinical correlates of progressive renal failure. J Am Soc Nephrol. 2006 Aug;17(8):2228-35. doi: 10.1681/ASN.2002010084. Epub 2006 Jul 12.

ReferenceCitation: Falk RJ, Scheinman J, Phillips G, Orringer E, Johnson A, Jennette JC. Prevalence and pathologic features of sickle cell nephropathy and response to inhibition of angiotensin-converting enzyme. N Engl J Med. 1992 Apr 2;326(14):910-5. doi: 10.1056/NEJM199204023261402.

ReferenceCitation: Olson JL, Hostetter TH, Rennke HG, Brenner BM, Venkatachalam MA. Altered glomerular permselectivity and progressive sclerosis following extreme ablation of renal mass. Kidney Int. 1982 Aug;22(2):112-26. doi: 10.1038/ki.1982.143. No abstract available.

ReferenceCitation: Serjeant GR, Higgs DR, Hambleton IR. Elderly survivors with homozygous sickle cell disease. N Engl J Med. 2007 Feb 8;356(6):642-3. doi: 10.1056/NEJMc066547. No abstract available.

ReferenceCitation: Manci EA, Culberson DE, Yang YM, Gardner TM, Powell R, Haynes J Jr, Shah AK, Mankad VN; Investigators of the Cooperative Study of Sickle Cell Disease. Causes of death in sickle cell disease: an autopsy study. Br J Haematol. 2003 Oct;123(2):359-65. doi: 10.1046/j.1365-2141.2003.04594.x.

ReferenceCitation: Powars DR, Elliott-Mills DD, Chan L, Niland J, Hiti AL, Opas LM, Johnson C. Chronic renal failure in sickle cell disease: risk factors, clinical course, and mortality. Ann Intern Med. 1991 Oct 15;115(8):614-20. doi: 10.7326/0003-4819-115-8-614.

ReferenceCitation: Barros FB, Lima CS, Santos AO, Mazo-Ruiz MF, Lima MC, Etchebehere EC, Costa FF, Saad ST, Camargo EE, Ramos CD. 51Cr-EDTA measurements of the glomerular filtration rate in patients with sickle cell anaemia and minor renal damage. Nucl Med Commun. 2006 Dec;27(12):959-62. doi: 10.1097/01.mnm.0000243373.03636.6e.

ReferenceCitation: Marouf R, Mojiminiyi O, Abdella N, Kortom M, Al Wazzan H. Comparison of renal function markers in Kuwaiti patients with sickle cell disease. J Clin Pathol. 2006 Apr;59(4):345-51. doi: 10.1136/jcp.2005.026799.

ReferenceCitation: Vedel P, Obel J, Nielsen FS, Bang LE, Svendsen TL, Pedersen OB, Parving HH. Glomerular hyperfiltration in microalbuminuric NIDDM patients. Diabetologia. 1996 Dec;39(12):1584-9. doi: 10.1007/s001250050618.

ReferenceCitation: Berg UB. Differences in decline in GFR with age between males and females. Reference data on clearances of inulin and PAH in potential kidney donors. Nephrol Dial Transplant. 2006 Sep;21(9):2577-82. doi: 10.1093/ndt/gfl227. Epub 2006 May 23.

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location_facility: Centre de la Drépanocytose, Service de Médecine Interne. Hôpital Tenon, 4 Rue de la Chine