title: Effect of the Genetic Variant 2C19*2 on Clopidogrel Biological Response in Patients With Premature Coronary Artery Disease

summary: To evaluate the role of the genetic variant 2C19*2 on the pharmacodynamic response as assessed by optical aggregometry and on the pharmacokinetic response as assessed by measuring active metabolites following an oral administration of a loading dose of 300/900mg of clopidogrel in patients with established coronary artery disease.

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

name: From Université Pierre et Marie Curie-Paris 6, INSERM UMR S 956, Pharmacology Department, Pitié-Salpêtrière University Hospital, Paris, France (J.-S.H., F.A.); the Cardiovascular Research Center, Mount Sinai School of Medicine, New York, NY (J.-S.H.); Institut de Cardiologie, INSERM CMR937, Pitié-Salpêtrière Hospital (AP-HP) 75013, and Université Pierre et Marie Curie, Paris, France (J.-P.C., G.C., J.S., A.B.-A., G.M.); and the Department of Genetics and Genomics Sciences, Mount Sinai School of...

family: Hulot

full_name: Jean-Sébastien Hulot

given: Jean-Sébastien

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Allanic

full_name: Frédérick Allanic

given: Frédérick

family: Bellemain-Appaix

full_name: Anne Bellemain-Appaix

given: Anne

family: Scott

full_name: Stuart A. Scott

given: Stuart A.

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

title: CYP2C19But NotPON1Genetic Variants Influence Clopidogrel Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy in Post–Myocardial Infarction Patients

ReferenceCitation: Collet JP, Hulot JS, Anzaha G, Pena A, Chastre T, Caron C, Silvain J, Cayla G, Bellemain-Appaix A, Vignalou JB, Galier S, Barthélémy O, Beygui F, Gallois V, Montalescot G; CLOVIS-2 Investigators. High doses of clopidogrel to overcome genetic resistance: the randomized crossover CLOVIS-2 (Clopidogrel and Response Variability Investigation Study 2). JACC Cardiovasc Interv. 2011 Apr;4(4):392-402. doi: 10.1016/j.jcin.2011.03.002.

family: Anzaha

full_name: Ghalia Anzaha

given: Ghalia

family: Pena

full_name: Ana Pena

given: Ana

family: Chastre

full_name: Thomas Chastre

given: Thomas

family: Caron

full_name: Claire Caron

given: Claire

family: Vignalou

full_name: Jean-Baptiste Vignalou

given: Jean-Baptiste

family: Galier

full_name: Sophie Galier

given: Sophie

family: Barthélémy

full_name: Olivier Barthélémy

given: Olivier

title: High Doses of Clopidogrel to Overcome Genetic Resistance

location_facility: Hopital la Pitié-Salpétrière Institut de cardiologie


type: Other Identifier

title: Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome

acronym: biostroke

summary: In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.To answer to the question, we conduct a cohort study of stroke patients.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Colin O, Labreuche J, Deguil J, Mendyk AM, Deken V, Cordonnier C, Deplanque D, Leys D, Bordet R. Preadmission use of benzodiazepines and stroke outcomes: the Biostroke prospective cohort study. BMJ Open. 2019 Jan 15;9(1):e022720. doi: 10.1136/bmjopen-2018-022720.

family: Colin

full_name: Olivier Colin

sequence: first

family: Labreuche

full_name: Julien Labreuche

given: Julien

sequence: additional

family: Deguil

full_name: Julie Deguil

given: Julie

family: Mendyk

full_name: Anne-Marie Mendyk

given: Anne-Marie

family: Deken

full_name: Valérie Deken

given: Valérie

family: Cordonnier

full_name: Charlotte Cordonnier

given: Charlotte

family: Deplanque

full_name: Dominique Deplanque

given: Dominique

family: Leys

full_name: Didier Leys

given: Didier

family: Bordet

full_name: Régis Bordet

given: Régis

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_normalized: HAL

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

repository_normalized: LillOA (Lille Open Archive)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Moulin S, Leys D, Schraen-Maschke S, Bombois S, Mendyk AM, Muhr-Tailleux A, Cordonnier C, Buee L, Pasquier F, Bordet R. Aβ1-40 and Aβ1-42 Plasmatic Levels In Stroke: Influence of Pre-Existing Cognitive Status and Stroke Characteristics. Curr Alzheimer Res. 2017;14(6):686-694. doi: 10.2174/1567205012666151027141730. Review.

family: Moulin

full_name: Solene Moulin

title: Aβ1-40 and Aβ1-42 Plasmatic Levels In Stroke: Influence of Pre-Existing Cognitive Status and Stroke Characteristics#

location_facility: Lille University Hospital - Service de Neurologie vasculaire


title: Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.

acronym: Oestropec

summary: The purpose of this study is to determine whether the number of circulating EPC is different between healthy women and men.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hopitaux de Paris - Hopital Saint Antoine

lead_sponsor_type: academique

status_simplified: Completed


title: Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

acronym: GENERAC

summary: Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Perrot N, Thériault S, Dina C, Chen HY, Boekholdt SM, Rigade S, Després AA, Poulin A, Capoulade R, Le Tourneau T, Messika-Zeitoun D, Trottier M, Tessier M, Guimond J, Nadeau M, Engert JC, Khaw KT, Wareham NJ, Dweck MR, Mathieu P, Pibarot P, Schott JJ, Thanassoulis G, Clavel MA, Bossé Y, Arsenault BJ. Genetic Variation in LPA, Calcific Aortic Valve Stenosis in Patients Undergoing Cardiac Surgery, and Familial Risk of Aortic Valve Microcalcification. JAMA Cardiol. 2019 Jul 1;4(7):620-627. doi: 10.1001/jamacardio.2019.1581. Erratum in: JAMA Cardiol. 2019 Jul 1;4(7):714.

name: Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec City, Québec, Canada

name: Department of Medicine, Faculty of Medicine, Université Laval, Québec City, Québec, Canada

family: Perrot

full_name: Nicolas Perrot

given: Nicolas

name: Department of Molecular Biology, Medical Biochemistry and Pathology, Faculty of Medicine, Université Laval, Québec City, Québec, Canada

family: Thériault

full_name: Sébastien Thériault

given: Sébastien

name: L'Institut du Thorax, Institut National de la Santé et de la Recherche Médicale, Centre National de la Recherche Scientifique, Université de Nantes, Nantes, France

family: Dina

full_name: Christian Dina

given: Christian

name: McGill University Health Center Research Institute, Montreal, Québec, Canada

family: Chen

full_name: Hao Yu Chen

given: Hao Yu

name: Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands

family: Boekholdt

full_name: S. Matthijs Boekholdt

given: S. Matthijs

family: Rigade

full_name: Sidwell Rigade

given: Sidwell

family: Després

full_name: Audrey-Anne Després

given: Audrey-Anne

family: Poulin

full_name: Anthony Poulin

given: Anthony

family: Capoulade

full_name: Romain Capoulade

given: Romain

family: Le Tourneau

full_name: Thierry Le Tourneau

given: Thierry

name: Department of Cardiology, Assistance Publique–Hôpitaux de Paris, Bichat Hospital, Paris, France

name: University of Ottawa Heart Institute, Ottawa, Ontario, Canada

family: Messika-Zeitoun

full_name: David Messika-Zeitoun

given: David

family: Trottier

full_name: Mikaël Trottier

given: Mikaël

family: Tessier

full_name: Michel Tessier

given: Michel

family: Guimond

full_name: Jean Guimond

given: Jean

family: Nadeau

full_name: Maxime Nadeau

given: Maxime

family: Engert

full_name: James C. Engert

given: James C.

name: Medical Research Council Epidemiology Unit, Cambridge, United Kingdom

family: Khaw

full_name: Kay-Tee Khaw

given: Kay-Tee

name: Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom

family: Wareham

full_name: Nicholas J. Wareham

given: Nicholas J.

family: Dweck

full_name: Marc R. Dweck

given: Marc R.

name: Department of Surgery, Faculty of Medicine, Université Laval, Québec City, Québec, Canada

family: Mathieu

full_name: Patrick Mathieu

given: Patrick

family: Pibarot

full_name: Philippe Pibarot

given: Philippe

family: Schott

full_name: Jean-Jacques Schott

given: Jean-Jacques

family: Thanassoulis

full_name: George Thanassoulis

given: George

family: Clavel

name: Department of Molecular Medicine, Faculty of Medicine, Université Laval, Québec City, Québec, Canada

repository_institution: Université Laval - Corpus Université Laval

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

ReferenceCitation: Pawade T, Clavel MA, Tribouilloy C, Dreyfus J, Mathieu T, Tastet L, Renard C, Gun M, Jenkins WSA, Macron L, Sechrist JW, Lacomis JM, Nguyen V, Galian Gay L, Cuéllar Calabria H, Ntalas I, Cartlidge TRG, Prendergast B, Rajani R, Evangelista A, Cavalcante JL, Newby DE, Pibarot P, Messika Zeitoun D, Dweck MR. Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2018 Mar;11(3):e007146. doi: 10.1161/CIRCIMAGING.117.007146.

name: From the Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (T.P., W.S.A.J., T.R.G.C., D.E.N., M.R.D.); Institut Universitaire de Cardiology et de Pneumologie de Québec (Quebec Heart and Lung Institute), Laval University, Canada (M.-A.C., L.T., P.P.); Department of Cardiology, Centre Hospitalier Universitaire d’Amiens, Picardie, France (C.T., M.G.); Centre Cardiologique du Nord, Saint-Denis, France (J.D., L.M.); Department of Cardiology, Bichat Hospital, Paris, France (T.M.,...

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Arangalage D, Nguyen V, Robert T, Melissopoulou M, Mathieu T, Estellat C, Codogno I, Huart V, Duval X, Cimadevilla C, Vahanian A, Dehoux M, Messika-Zeitoun D. Determinants and prognostic value of Galectin-3 in patients with aortic valve stenosis. Heart. 2016 Jun 1;102(11):862-8. doi: 10.1136/heartjnl-2015-308873. Epub 2016 Feb 19.

ReferenceCitation: Guauque-Olarte S, Messika-Zeitoun D, Droit A, Lamontagne M, Tremblay-Marchand J, Lavoie-Charland E, Gaudreault N, Arsenault BJ, Dubé MP, Tardif JC, Body SC, Seidman JG, Boileau C, Mathieu P, Pibarot P, Bossé Y. Calcium Signaling Pathway Genes RUNX2 and CACNA1C Are Associated With Calcific Aortic Valve Disease. Circ Cardiovasc Genet. 2015 Dec;8(6):812-22. doi: 10.1161/CIRCGENETICS.115.001145. Epub 2015 Nov 9.

name: From the Centre de recherche Institut universitaire de cardiologie et de pneumologie de Québec, Quebec, Canada (S.G.-O., M.L., J.T.-M., E.L.-C., N.G., P.M., P.P., Y.B.); Departments of Molecular Medicine (A.D., Y.B.), Surgery (P.M.), and Medicine (P.P.), Laval University, Quebec, Canada; Cardiology Department, AP-HP, Bichat Hospital, Paris, France (D.M.-Z.); INSERM U698, Paris, France (D.M.-Z.); Département de Génétique, Hôpital Bichat, 75018 Paris, France (C.B.); Centre de Recherche du CHUQ, Quebec...

ReferenceCitation: Chin CW, Messika-Zeitoun D, Shah AS, Lefevre G, Bailleul S, Yeung EN, Koo M, Mirsadraee S, Mathieu T, Semple SI, Mills NL, Vahanian A, Newby DE, Dweck MR. A clinical risk score of myocardial fibrosis predicts adverse outcomes in aortic stenosis. Eur Heart J. 2016 Feb 21;37(8):713-23. doi: 10.1093/eurheartj/ehv525. Epub 2015 Oct 21.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Dreyfus J, Durand-Viel G, Raffoul R, Alkhoder S, Hvass U, Radu C, Al-Attar N, Ghodbhane W, Attias D, Nataf P, Vahanian A, Messika-Zeitoun D. Comparison of 2-Dimensional, 3-Dimensional, and Surgical Measurements of the Tricuspid Annulus Size: Clinical Implications. Circ Cardiovasc Imaging. 2015 Jul;8(7):e003241. doi: 10.1161/CIRCIMAGING.114.003241.

name: From the Department of Cardiology (J.D., G.D.-V., D.A., A.V., D.M.-Z.) and Department of Cardiac Surgery (R.R., S.A., U.H., C.R., N.A.-A., W.G., P.N.), AP-HP, Bichat Hospital, Paris, France; and INSERM U1148, Bichat Hospital and University Paris 7, Paris, France (P.N., A.V., D.M.-Z.).

ReferenceCitation: Nguyen V, Cimadevilla C, Estellat C, Codogno I, Huart V, Benessiano J, Duval X, Pibarot P, Clavel MA, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Haemodynamic and anatomic progression of aortic stenosis. Heart. 2015 Jun;101(12):943-7. doi: 10.1136/heartjnl-2014-307154. Epub 2015 Feb 5.

ReferenceCitation: Kochtebane N, Passefort S, Choqueux C, Ainoun F, Achour L, Michel JB, Bäck M, Jacob MP. Release of leukotriene B4, transforming growth factor-beta1 and microparticles in relation to aortic valve calcification. J Heart Valve Dis. 2013 Nov;22(6):782-8.

ReferenceCitation: Cimadevilla C, Cueff C, Hekimian G, Dehoux M, Lepage L, Iung B, Duval X, Huart V, Tubach F, Vahanian A, Messika-Zeitoun D. Prognostic value of B-type natriuretic peptide in elderly patients with aortic valve stenosis: the COFRASA-GENERAC study. Heart. 2013 Apr;99(7):461-7. doi: 10.1136/heartjnl-2012-303284. Epub 2013 Jan 24.

title: Prognostic value of B-type natriuretic peptide in elderly patients with aortic valve stenosis: the COFRASA–GENERAC study

location_facility: Assistance Publique - Hôpitaux de Paris, Bichat Hospital


title: Physiopathology of Sodium Retention in Acromegaly

acronym: AcromEnaC

summary: Acromegaly is a disease due to an excess of growth hormone that abnormally occurs in adulthood. It is due to a benign (non cancerous) tumor located in a particular part of the brain that secretes several hormones, the hypophysis. The excess of growth hormones in adults induces an increase in bone (resulting in large enlargement of extremities), and organs. The disease is complicated by the apparition of cardiovascular events including retention of water, salt in the tissues and increase in blood pressure, that altogether might major the mortality of the patients. The investigators recently got experimental data suggesting that the retention of water and salt is mainly due to the activation by the growth hormone of a renal transporter of sodium. Because this transporter is highly sensitive to amiloride, a well know diuretic, the investigators hypothesize that this drug will be very efficient in treating the hypertension in patients, as compared to another diuretic, furosemide.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Bihan H, Espinosa C, Valdes-Socin H, Salenave S, Young J, Levasseur S, Assayag P, Beckers A, Chanson P. Long-term outcome of patients with acromegaly and congestive heart failure. J Clin Endocrinol Metab. 2004 Nov;89(11):5308-13.

ReferenceCitation: Kamenický P, Blanchard A, Gauci C, Salenave S, Letierce A, Lombès M, Brailly-Tabard S, Azizi M, Prié D, Souberbielle JC, Chanson P. Pathophysiology of renal calcium handling in acromegaly: what lies behind hypercalciuria? J Clin Endocrinol Metab. 2012 Jun;97(6):2124-33. doi: 10.1210/jc.2011-3188. Epub 2012 Apr 10.

name: Assistance Publique-Hôpitaux de Paris (P.K., S.S., M.L., P.C.), Hôpital de Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction, F-94275 Le Kremlin Bicêtre, France

name: Université Paris-Sud (P.K., S.S., M.L., S.B.-T., P.C.), Faculté de Médecine Paris-Sud, Unité Mixte de Recherche-S693, F-94276 Le Kremlin Bicêtre, France

name: Institut National de la Santé et de la Recherche Médicale (INSERM) U693 (P.K., M.L., S.B.-T., P.C.), F-94276 Le Kremlin Bicêtre, France

family: Kamenický

full_name: Peter Kamenický

given: Peter

name: Assistance Publique-Hôpitaux de Paris (A.B., C.G., M.A.), Hôpital Européen George Pompidou, INSERM Centre d'Investigations Cliniques 9201, F-75015 Paris, France

name: Université Paris Descartes (A.B., M.A., D.P., J.-C.S.), Faculté de Médecine, F-75006 Paris, France

family: Blanchard

full_name: Anne Blanchard

given: Anne

family: Gauci

full_name: Cédric Gauci

given: Cédric

family: Salenave

full_name: Sylvie Salenave

given: Sylvie

name: Assistance Publique-Hôpitaux de Paris (A.L.), Hôpital de Bicêtre, Unité de Recherche Clinique, F-94275 Le Kremlin Bicêtre, France

family: Letierce

full_name: Alexia Letierce

given: Alexia

family: Lombès

full_name: Marc Lombès

given: Marc

name: Assistance Publique-Hôpitaux de Paris (S.B.-T.), Hôpital de Bicêtre, Service de Génétique Moléculaire, Pharmacogénétique et Hormonologie, F-94275 Le Kremlin Bicêtre, France

family: Brailly-Tabard

full_name: Sylvie Brailly-Tabard

family: Azizi

full_name: Michel Azizi

name: Assistance Publique-Hôpitaux de Paris (D.P., J.-C.S.), Hôpital Necker Enfants Malades, Service de Physiologie-Explorations Fonctionnelles, F-75015 Paris, France

name: INSERM U845 (D.P., J.-C.S.), F-75015 Paris, France

family: Prié

full_name: Dominique Prié

given: Dominique

family: Souberbielle

full_name: Jean-Claude Souberbielle

given: Jean-Claude

family: Chanson

full_name: Philippe Chanson

journal_name: The Journal of Clinical Endocrinology & Metabolism

oa_host_type: publisher

evidence: open (via free pdf)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Pathophysiology of Renal Calcium Handling in Acromegaly: What Lies behind Hypercalciuria?

ReferenceCitation: Kamenicky P, Blanchard A, Frank M, Salenave S, Letierce A, Azizi M, Lombès M, Chanson P. Body fluid expansion in acromegaly is related to enhanced epithelial sodium channel (ENaC) activity. J Clin Endocrinol Metab. 2011 Jul;96(7):2127-35. doi: 10.1210/jc.2011-0078. Epub 2011 Apr 20.

name: Assistance Publique-Hôpitaux de Paris, Hôpital de Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction (P.K., S.S., M.L., P.C.), Le Kremlin Bicêtre F-94275, France

name: Université Paris-Sud, Faculté de Médecine Paris-Sud, Unité Mixte de Recherche-S693 (P.K., S.S., M.L., P.C.), Le Kremlin Bicêtre F-94276, France

name: Institut National de la Santé et de la Recherche Médicale (INSERM) Unité 693 (P.K., M.L., P.C.), Le Kremlin Bicêtre F-94276, France

family: Kamenicky

full_name: Peter Kamenicky

name: Assistance Publique-Hôpitaux de Paris, Hôpital Européen George Pompidou, Centre d'Investigations Cliniques (A.B., M.F., M.A.), Paris F75015, France

name: Université Paris Descartes, Faculté de Médecine (A.B., M.A.), Paris F75015, France

name: INSERM Unité 652 (A.B.), Paris F75015, France

family: Frank

full_name: Michael Frank

given: Michael

name: Unité de Recherche Clinique (A.L.), Le Kremlin Bicêtre F-94275, France

name: INSERM, Center d'Investigation clinique 9201 (M.A.), Paris F75015, France

title: Body Fluid Expansion in Acromegaly Is Related to Enhanced Epithelial Sodium Channel (ENaC) Activity


title: Do Antidepressants Induce Metabolic Syndromes

acronym: METADAP

summary:
Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1 antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes is a matter of concern.

The main objective of this study is to assess the differential impact of antidepressants in terms of weight gain and metabolic syndromes.

design_allocation: Non-Randomized

ReferenceCitation: Loeb E, Becquemont L, Corruble E. Is the decrease in NO(x) due to a lack of substrate or a NOS inhibition in patients with major depression? : Commentary on Hess et al. 2017. Psychopharmacology (Berl). 2021 Feb;238(2):613-614. doi: 10.1007/s00213-020-05747-x. Epub 2021 Jan 9.

family: Loeb

full_name: E. Loeb

given: E.

family: Becquemont

full_name: L. Becquemont

given: L.

family: Corruble

full_name: E. Corruble

journal_name: Psychopharmacology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Is the decrease in NOx due to a lack of substrate or a NOS inhibition in patients with major depression?

intervention_type: Drug


title: Sequential Islet Transplantation With Steroid Free Immunosuppression for Type 1 Diabetes

summary:
The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in 2000 new standards for islet transplantation in patients with brittle T1D by achieving insulin independence in 80 percent of patients. These seminal results have however proved much more difficult to duplicate than initially expected.

This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D.

ReferenceCitation: Vantyghem MC, Chetboun M, Gmyr V, Jannin A, Espiard S, Le Mapihan K, Raverdy V, Delalleau N, Machuron F, Hubert T, Frimat M, Van Belle E, Hazzan M, Pigny P, Noel C, Caiazzo R, Kerr-Conte J, Pattou F; Members of the Spanish Back Pain Research Network Task Force for the Improvement of Inter-Disciplinary Management of Spinal Metastasis. Ten-Year Outcome of Islet Alone or Islet After Kidney Transplantation in Type 1 Diabetes: A Prospective Parallel-Arm Cohort Study. Diabetes Care. 2019 Nov;42(11):2042-2049. doi: 10.2337/dc19-0401. Erratum in: Diabetes Care. 2020 May;43(5):1164.

family: Vantyghem

full_name: Marie-Christine Vantyghem

given: Marie-Christine

family: Chetboun

full_name: Mikael Chetboun

given: Mikael

family: Gmyr

full_name: Valéry Gmyr

given: Valéry

family: Jannin

full_name: Arnaud Jannin

given: Arnaud

family: Espiard

full_name: Stéphanie Espiard

given: Stéphanie

family: Le Mapihan

full_name: Kristell Le Mapihan

given: Kristell

family: Raverdy

full_name: Violeta Raverdy

given: Violeta

family: Delalleau

full_name: Nathalie Delalleau

given: Nathalie

family: Machuron

full_name: François Machuron

given: François

family: Hubert

full_name: Thomas Hubert

given: Thomas

family: Frimat

full_name: Marie Frimat

given: Marie

family: Van Belle

full_name: Eric Van Belle

given: Eric

family: Hazzan

full_name: Marc Hazzan

family: Pigny

full_name: Pascal Pigny

given: Pascal

family: Noel

full_name: Christian Noel

given: Christian

family: Caiazzo

full_name: Robert Caiazzo

given: Robert

family: Kerr-Conte

full_name: Julie Kerr-Conte

given: Julie

family: Pattou

full_name: François Pattou

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Benomar K, Chetboun M, Espiard S, Jannin A, Le Mapihan K, Gmyr V, Caiazzo R, Torres F, Raverdy V, Bonner C, D'Herbomez M, Pigny P, Noel C, Kerr-Conte J, Pattou F, Vantyghem MC. Purity of islet preparations and 5-year metabolic outcome of allogenic islet transplantation. Am J Transplant. 2018 Apr;18(4):945-951. doi: 10.1111/ajt.14514. Epub 2017 Nov 11.

name: Department of Endocrinology and Metabolism; CHRU Lille; Lille France

name: UMR 1190; Translational Research in Diabetes INSERM; Lille France

name: EGID (European Genomic Institute for Diabetes); Univ Lille; Lille France

family: Benomar

full_name: K. Benomar

given: K.

name: Department of Endocrine Surgery; CHRU Lille; Lille France

name: Department of Biology; CHRU Lille; Lille France

name: Department of Nephrology and Transplantation; CHRU Lille; Lille France

ReferenceCitation: Caiazzo R, Vantyghem MC, Raverdi V, Bonner C, Gmyr V, Defrance F, Leroy C, Sergent G, Hubert T, Ernst O, Noel C, Kerr-Conte J, Pattou F. Impact of Procedure-Related Complications on Long-term Islet Transplantation Outcome. Transplantation. 2015 May;99(5):979-84. doi: 10.1097/TP.0000000000000458.

ReferenceCitation: Vantyghem MC, Raverdy V, Balavoine AS, Defrance F, Caiazzo R, Arnalsteen L, Gmyr V, Hazzan M, Noël C, Kerr-Conte J, Pattou F. Continuous glucose monitoring after islet transplantation in type 1 diabetes: an excellent graft function (β-score greater than 7) Is required to abrogate hyperglycemia, whereas a minimal function is necessary to suppress severe hypoglycemia (β-score greater than 3). J Clin Endocrinol Metab. 2012 Nov;97(11):E2078-83. doi: 10.1210/jc.2012-2115. Epub 2012 Sep 20.

title: Continuous Glucose Monitoring after Islet Transplantation in Type 1 Diabetes: An Excellent Graft Function (β-Score Greater Than 7) Is Required to Abrogate Hyperglycemia, Whereas a Minimal Function Is Necessary to Suppress Severe Hypoglycemia (β-Score Greater Than 3)


summary:
whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women.
n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.

status: Terminated

location_facility: Department of Diabetes-Hotel Dieu Hospital

status_simplified: Unknown


title: Characterization of Dystonia and Influence of Cognitive-attentional Factors

summary:
Dystonia is a rare disease leading to a severe handicap. It can be of primary or secondary origin. It is characterized by sustained muscle contractions, frequently causing twisting and repetitive movements or abnormal postures. These disorders are believed to be caused by some dysfunction of the basal ganglia (BG) circuitry, but the mechanisms are largely unknown.

A better understanding of the disorder requires significant improvements of its phenomenological description in relation to aetiology. We want to identify specific motor signatures of different forms of dystonia. To that aim, we will ask patients to perform movements of various complexities, while recording chronometric, kinematics and EMG data. The characteristics of the patients' movements will be compared to those of matched control subjects. We will examine abnormal co-activation in distal and proximal muscles to evaluate the characteristics of the loss of selectivity of the motor command in mobile vs. fixed dystonia. Consistency of the motor output patterns will be compared in three groups of patients. We will also study possible cognitive and limbic components of the disease, examining the influence of cognitive and emotional loads on movement production. Eventually we want to refine the criteria used to classify different forms of the disease, thus enabling clinicians to better predict the likely outcome of particular therapeutic procedures.

lead_sponsor: University Hospital, Grenoble

intervention_type: Other


title: Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation

acronym: ETOC

summary: This is a phase III clinical trial comparing early tracheostomy (day 4) versus prolonged endotracheal intubation in ICU patients needing prolonged ventilatory support after cardiovascular surgery.

ReferenceCitation: Trouillet JL, Luyt CE, Guiguet M, Ouattara A, Vaissier E, Makri R, Nieszkowska A, Leprince P, Pavie A, Chastre J, Combes A. Early percutaneous tracheotomy versus prolonged intubation of mechanically ventilated patients after cardiac surgery: a randomized trial. Ann Intern Med. 2011 Mar 15;154(6):373-83. doi: 10.7326/0003-4819-154-6-201103150-00002.

family: Trouillet

full_name: Jean-Louis Trouillet

given: Jean-Louis

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

family: Guiguet

full_name: Marguerite Guiguet

given: Marguerite

family: Ouattara

full_name: Alexandre Ouattara

given: Alexandre

family: Vaissier

full_name: Elisabeth Vaissier

given: Elisabeth

family: Makri

full_name: Ralouka Makri

given: Ralouka

family: Nieszkowska

full_name: Ania Nieszkowska

given: Ania

family: Leprince

full_name: Pascal Leprince

family: Pavie

full_name: Alain Pavie

given: Alain

family: Chastre

full_name: Jean Chastre

given: Jean

family: Combes

full_name: Alain Combes

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

title: Early Percutaneous Tracheotomy Versus Prolonged Intubation of Mechanically Ventilated Patients After Cardiac Surgery

location_facility: Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp

intervention_type: Procedure


title: Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin

summary: The purpose of this study is to determine whether patients with Parkinson's disease and treated with pergolide have a higher risk of heart valve disease compared to patients with Parkinson's disease not treated with pergolide.

ReferenceCitation: Corvol JC, Anzouan-Kacou JB, Fauveau E, Bonnet AM, Lebrun-Vignes B, Girault C, Agid Y, Lechat P, Isnard R, Lacomblez L. Heart valve regurgitation, pergolide use, and parkinson disease: an observational study and meta-analysis. Arch Neurol. 2007 Dec;64(12):1721-6. Review.

lead_sponsor: Société Française de Cardiologie

location_facility: Clinical Investigation Centre, Pitie-Salpetriere Hospital

lead_sponsor_type: industriel


title: Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

summary: The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in the occurrence of the distractibility in these patients. The aim of this study is to evaluate the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients, by using oculomotor and neuropsychological assessments.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE


title: Biomechanical Parameters of Gait in Patients With Parkinson's Disease and Parkinsonian Syndromes

summary: Gait disorders and falls are frequent in patients with parkinsonian syndromes. In patients with Parkinson's disease (PD), these signs occurred later during the course of the disease in comparison to patients with other degenerative parkinsonian disorders. The pathophysiology of these symptoms are still not fully understood. Gait initiation challenges the balance control system as the body moves from an upright stable static posture to a continuously unstable gait. The aim of this study is to analyse the gait initiation process in patients with parkinsonian disorders.

primary_purpose: Diagnostic

location_facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

intervention_type: Device


title: Pilot Study of Internal Globus Pallidus or Median Centre of the Thalamus High Frequency Stimulation for the Treatment of Patients With Severe Tourette's Syndrome

summary: Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.

ReferenceCitation: Welter ML, Mallet L, Houeto JL, Karachi C, Czernecki V, Cornu P, Navarro S, Pidoux B, Dormont D, Bardinet E, Yelnik J, Damier P, Agid Y. Internal pallidal and thalamic stimulation in patients with Tourette syndrome. Arch Neurol. 2008 Jul;65(7):952-7. doi: 10.1001/archneur.65.7.952.

family: Welter

full_name: Marie-Laure Welter

given: Marie-Laure

family: Mallet

full_name: Luc Mallet

given: Luc

family: Houeto

full_name: Jean-Luc Houeto

given: Jean-Luc

family: Karachi

full_name: Carine Karachi

given: Carine

family: Czernecki

full_name: Virginie Czernecki

given: Virginie

family: Cornu

full_name: Philippe Cornu

given: Philippe

family: Navarro

full_name: Soledad Navarro

given: Soledad

family: Pidoux

full_name: Bernard Pidoux

given: Bernard

family: Dormont

full_name: Didier Dormont

given: Didier

family: Bardinet

full_name: Eric Bardinet

family: Yelnik

full_name: Jérôme Yelnik

given: Jérôme

family: Damier

full_name: Philippe Damier

family: Agid

full_name: Yves Agid

given: Yves

journal_name: Archives of Neurology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Internal Pallidal and Thalamic Stimulation in Patients With Tourette Syndrome


title: Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis

summary: Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. The aim of this study is to determine the polysomnographic parameters in MS patients with fatigue in comparison to MS patients without fatigue.

time_perspective: Other

location_facility: Centre d'Investigation Clinique-Hopital Pitié-Salpêtrière


title: Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study

summary:
The study was designed to test the following hypotheses:

In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.

In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger) in addition to cycloergometer [cycloergometer + spirotiger] will be higher than cycloergometer training alone [cycloergometer] in term of functional and exercise capacities.

Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer + spirotiger]

ReferenceCitation: Vivodtzev I, Tamisier R, Croteau M, Borel JC, Grangier A, Wuyam B, Lévy P, Minville C, Sériès F, Maltais F, Pépin JL. Ventilatory support or respiratory muscle training as adjuncts to exercise in obese CPAP-treated patients with obstructive sleep apnoea: a randomised controlled trial. Thorax. 2018 Feb 20. pii: thoraxjnl-2017-211152. doi: 10.1136/thoraxjnl-2017-211152. [Epub ahead of print]

family: Vivodtzev

full_name: Isabelle Vivodtzev

given: Isabelle

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Croteau

full_name: Marilie Croteau

given: Marilie

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

family: Grangier

full_name: Angélique Grangier

given: Angélique

family: Wuyam

full_name: Bernard Wuyam

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Minville

full_name: Caroline Minville

given: Caroline

family: Sériès

full_name: Frédéric Sériès

given: Frédéric

family: Maltais

full_name: François Maltais

given: François

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

journal_name: Thorax

oa_colors: green hybrid

repository_institution: University of Oxford - Oxford Academic Notes & Queries

lead_sponsor: AGIR à Dom

location_country: Canada France

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)


title: Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation

summary: Tobacco is an addiction with serious consequences: somatic, psychiatric... The number of requests for treatment for tobacco addiction is gradually increasing from year to year, but conventional treatments have limited effectiveness. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations. The investigator will then evaluate the effect of this cybertherapy on patients' relapse time and their desire to smoke.

study_start_date_type: Actual

status: Recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral

status_simplified: Ongoing


title: Reliability Assessment of the HumaSens Plus Measurement of Uricemia in Capillary Blood

acronym: URICA

summary: Lowering the level of uric acid in the serum under 6mg/dL on the long term is a key factor of gout management success. Monitoring of uricemia in gout patients is therefore important and is presently done in the laboratory on serum samples obtained after venous puncture. This study aims at assessing the reliability of immediate uricemia measurement in a blood sample obtained by a mere fingertip puncture, by the HumaSensplus system, which is commercially available in the EU. Results obtained by the Humasens device will be compared to those of the standard measurement technique in serum and with a reference technique (liquid chromatography and mass spectroscopy). If the device appears reliable, it will allow self-measurement of uric acid by the gouty patient, in a similar way as diabetic patients measure their glycaemia following a fingertip puncture. This should improve patient monitoring and management effects.

status: Withdrawn

ipd_sharing: No

location_facility: Service de Rhumatologie, Hôpital Lariboisière


title: Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults: Randomized, Cross-over (Three Arms), Double-blind, Placebo-controlled Clinical Trial

summary: The prevalence of stress in daily human life increase in the investigator's modern life style. Short stress, could be benefit for memory, but prolonged stress may conduct to disturbance in cardiovascular, neuroendocrine and central nervous systems. Moreover, it is well established that stress is the most common risk factor for the development of mood and anxiety disorders, such as major depressive disorder (MDD) and generalized anxiety disorder. In response to stress, hypothalamic-pituitary-adrenocortical (HPA) axis is one of activated pathway, which induce the cortisol release. Certain natural products could increase resilience to stress. Indeed, several preclinical studies have already showed that botanical extracts inhibited the typical plasmatic corticosterone elevation induced by an acute stress challenge. Therefore, the aim of this clinical trial is to investigate the acute effects of a botanical extract and one of his major compound, both delivered as sublingual single dose, on cortisol level, cardiac parameters, and psychometric response, in healthy adults exposed to an acute psychological stress.

primary_purpose: Other

lead_sponsor: Activ'inside

intervention_type: Dietary Supplement


title: Innovation for Participation

summary:
Children with disabilities experience activities limitations and participation restrictions. Facilitating the children with disabilities' independence while performing tasks is a key stake to improve their successful participation and their development.

Products and technology can prevent, compensate, relieve or neutralize disability or handicap and help children and youth with disabilities to perform tasks that might otherwise be difficult or impossible.

The aim of this study was i) to identify the most frequent activity limitations and participation restrictions for which assistive products and technology may be useful for children and youth with disabilities, and ii) to highlight macroscopic trends related to encountered difficulties and wished products and technology.

We hypothesized that difficulties would be particularly expected for certain life situations, especially outside the home in an unfamiliar environment. We also hypothesized that products and technology would be whished for those situations which should be defined as priority subjects. Thanks to those results we wanted to highlight new processes to develop innovative solutions.

lead_sponsor: University Hospital, Brest


type: EudraCT Number

title: A Randomized, Open Label, Three-way Crossover Study to Evaluate the Pharmacodynamic Interactions Between Darexaban (YM150)/Darexaban Glucuronide (YM-222714) and Acetyl Salicylic Acid (ASA) in Healthy Male Subjects

summary: The primary objective of this study is to evaluate whether ASA and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.

lead_sponsor: Astellas Pharma Inc


title: A Randomized, Open-label, Two-period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Effect of Darexaban (YM150) on Acetyl Salicylic Acid (ASA) and of Darexaban on the Combination of ASA and Clopidogrel at Steady State

summary: The primary objective of this study is to evaluate whether ASA, the combination of ASA and clopidogrel, and darexaban, which have different effects on blood coagulation, influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.


title: A Phase I, Open-Label, Randomized 3-Period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Interactions Between YM150 on Naproxen at Steady-State

summary: The primary objective of this study is to evaluate whether naproxen and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.


title: An Open-label, One-sequence Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Pharmacokinetics of YM150 (Darexaban) and Metabolites in Young Healthy Male Subjects

summary: The primary objective of this study is to determine the effect of rifampicin on the way the body handles darexaban and its metabolites (drug degradation products). The secondary objective of the study is to evaluate the safety and tolerability of a single dose of darexaban alone and when administered together with rifampicin.

ReferenceType: background

ReferenceCitation: Groenendaal D, Strabach G, Garcia-Hernandez A, Kadokura T, Heeringa M, Mol R, Eltink C, Onkels H. The pharmacokinetics of darexaban are not affected to a clinically relevant degree by rifampicin, a strong inducer of P-glycoprotein and CYP3A4. Br J Clin Pharmacol. 2013 Feb;75(2):440-9. doi: 10.1111/j.1365-2125.2012.04346.x.


title: An Open-label, Randomized, Two-period Crossover Study to Evaluate the Effect of Multiple Doses of Ketoconazole on the Pharmacokinetics of Darexaban and Metabolites in Young Healthy Male Subjects

summary: The primary objective of this study is to determine the effect of ketoconazole on the blood concentrations of darexaban and its metabolites (drug degradation products). The secondary objective of the study is to evaluate the safety and tolerability of a single dose of darexaban alone and when administered together with ketoconazole.


title: Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia

summary: Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)

lead_sponsor: Hospital Ambroise Paré Paris


title: Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux

acronym: HEPCSEX

summary: The main objective of this study is to analyse sexual behavior of HIV + MSM in Bordeaux, who have sexually contracted hepatitis C between January 1st 2013, to January 31, 2017. These data will bring some improvement about prevention and maybe reduced the hepatitis C incidence.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin


title: Study on the Response to Tetanus Vaccination of People Living With HIV

acronym: VACTEVIH

summary:
The response to primary tetanus immunization of HIV-infected children is lower than that of uninfected children.

Response to tetanus toxoid (TT) booster doses in adults living with HIV who have received primary vaccination prior to infection is not known.

Currently, it is recommended to have a TT booster for people living with HIV (PLHIV) every 10 years. In general population, this recall is made only at 25, 45 and 65 years, then every 10 years.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier de Niort

intervention_type: Diagnostic Test


title: Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.

acronym: TAXI

summary: To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.

lead_sponsor: University Hospital, Lille


title: A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

summary:
The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients.

The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count.

This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.

24 patients will be included in the study.

ReferenceCitation: Zou W. Regulatory T cells, tumour immunity and immunotherapy. Nat Rev Immunol. 2006 Apr;6(4):295-307. Review.

ReferenceCitation: Treilleux I, Blay JY, Bendriss-Vermare N, Ray-Coquard I, Bachelot T, Guastalla JP, Bremond A, Goddard S, Pin JJ, Barthelemy-Dubois C, Lebecque S. Dendritic cell infiltration and prognosis of early stage breast cancer. Clin Cancer Res. 2004 Nov 15;10(22):7466-74.

ReferenceCitation: Bates GJ, Fox SB, Han C, Leek RD, Garcia JF, Harris AL, Banham AH. Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse. J Clin Oncol. 2006 Dec 1;24(34):5373-80.

ReferenceCitation: Gobert M, Treilleux I, Bendriss-Vermare N, Bachelot T, Goddard-Leon S, Arfi V, Biota C, Doffin AC, Durand I, Olive D, Perez S, Pasqual N, Faure C, Ray-Coquard I, Puisieux A, Caux C, Blay JY, Ménétrier-Caux C. Regulatory T cells recruited through CCL22/CCR4 are selectively activated in lymphoid infiltrates surrounding primary breast tumors and lead to an adverse clinical outcome. Cancer Res. 2009 Mar 1;69(5):2000-9. doi: 10.1158/0008-5472.CAN-08-2360. Epub 2009 Feb 24.

family: Gobert

full_name: Michael Gobert

given: Michael

family: Treilleux

full_name: Isabelle Treilleux

family: Bendriss-Vermare

full_name: Nathalie Bendriss-Vermare

given: Nathalie

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Goddard-Leon

full_name: Sophie Goddard-Leon

given: Sophie

family: Arfi

full_name: Vanessa Arfi

given: Vanessa

family: Biota

full_name: Cathy Biota

given: Cathy

family: Doffin

full_name: Anne Claire Doffin

given: Anne Claire

family: Durand

full_name: Isabelle Durand

family: Olive

full_name: Daniel Olive

given: Daniel

family: Perez

full_name: Solène Perez

given: Solène

family: Pasqual

full_name: Nicolas Pasqual

given: Nicolas

family: Faure

full_name: Christelle Faure

given: Christelle

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

family: Puisieux

full_name: Alain Puisieux

given: Alain

family: Caux

full_name: Christophe Caux

given: Christophe

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Ménétrier-Caux

full_name: Christine Ménétrier-Caux

given: Christine

journal_name: Cancer Research

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

title: Regulatory T Cells Recruited through CCL22/CCR4 Are Selectively Activated in Lymphoid Infiltrates Surrounding Primary Breast Tumors and Lead to an Adverse Clinical Outcome

ReferenceCitation: Blay JY, Chauvin F, Le Cesne A, Anglaret B, Bouhour D, Lasset C, Freyer G, Philip T, Biron P. Early lymphopenia after cytotoxic chemotherapy as a risk factor for febrile neutropenia. J Clin Oncol. 1996 Feb;14(2):636-43.

ReferenceCitation: Blay JY, Le Cesne A, Mermet C, Maugard C, Ravaud A, Chevreau C, Sebban C, Guastalla J, Biron P, Ray-Coquard I. A risk model for thrombocytopenia requiring platelet transfusion after cytotoxic chemotherapy. Blood. 1998 Jul 15;92(2):405-10.

ReferenceCitation: Ray-Coquard I, Le Cesne A, Rubio MT, Mermet J, Maugard C, Ravaud A, Chevreau C, Sebban C, Bachelot T, Biron P, Blay JY. Risk model for severe anemia requiring red blood cell transfusion after cytotoxic conventional chemotherapy regimens. The Elypse 1 Study Group. J Clin Oncol. 1999 Sep;17(9):2840-6.

ReferenceCitation: Ray-Coquard I, Borg C, Bachelot T, Sebban C, Philip I, Clapisson G, Le Cesne A, Biron P, Chauvin F, Blay JY; ELYPSE study group. Baseline and early lymphopenia predict for the risk of febrile neutropenia after chemotherapy. Br J Cancer. 2003 Jan 27;88(2):181-6.

ReferenceCitation: Marec-Berard P, Blay JY, Schell M, Buclon M, Demaret C, Ray-Coquard I. Risk model predictive of severe anemia requiring RBC transfusion after chemotherapy in pediatric solid tumor patients. J Clin Oncol. 2003 Nov 15;21(22):4235-8.

ReferenceCitation: Borg C, Ray-Coquard I, Philip I, Clapisson G, Bendriss-Vermare N, Menetrier-Caux C, Sebban C, Biron P, Blay JY. CD4 lymphopenia as a risk factor for febrile neutropenia and early death after cytotoxic chemotherapy in adult patients with cancer. Cancer. 2004 Dec 1;101(11):2675-80.

ReferenceCitation: Ray-Coquard I, Cropet C, Van Glabbeke M, Sebban C, Le Cesne A, Judson I, Tredan O, Verweij J, Biron P, Labidi I, Guastalla JP, Bachelot T, Perol D, Chabaud S, Hogendoorn PC, Cassier P, Dufresne A, Blay JY; European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/0008-5472.CAN-08-3845. Epub 2009 Jun 23.

title: Lymphopenia as a Prognostic Factor for Overall Survival in Advanced Carcinomas, Sarcomas, and Lymphomas

ReferenceCitation: Fry TJ, Mackall CL. The many faces of IL-7: from lymphopoiesis to peripheral T cell maintenance. J Immunol. 2005 Jun 1;174(11):6571-6. Review.

ReferenceCitation: Ménétrier-Caux C, Gobert M, Caux C. Differences in tumor regulatory T-cell localization and activation status impact patient outcome. Cancer Res. 2009 Oct 15;69(20):7895-8. doi: 10.1158/0008-5472.CAN-09-1642. Epub 2009 Oct 6. Review.

title: Differences in Tumor Regulatory T-Cell Localization and Activation Status Impact Patient Outcome: Figure 1.

ReferenceCitation: Fry TJ, Moniuszko M, Creekmore S, Donohue SJ, Douek DC, Giardina S, Hecht TT, Hill BJ, Komschlies K, Tomaszewski J, Franchini G, Mackall CL. IL-7 therapy dramatically alters peripheral T-cell homeostasis in normal and SIV-infected nonhuman primates. Blood. 2003 Mar 15;101(6):2294-9. Epub 2002 Oct 31.

ReferenceCitation: Fry TJ, Mackall CL. Interleukin-7: from bench to clinic. Blood. 2002 Jun 1;99(11):3892-904. Review.

ReferenceCitation: Rosenberg SA, Sportès C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9.

ReferenceCitation: Sportès C, Hakim FT, Memon SA, Zhang H, Chua KS, Brown MR, Fleisher TA, Krumlauf MC, Babb RR, Chow CK, Fry TJ, Engels J, Buffet R, Morre M, Amato RJ, Venzon DJ, Korngold R, Pecora A, Gress RE, Mackall CL. Administration of rhIL-7 in humans increases in vivo TCR repertoire diversity by preferential expansion of naive T cell subsets. J Exp Med. 2008 Jul 7;205(7):1701-14. doi: 10.1084/jem.20071681. Epub 2008 Jun 23.

name: Experimental Transplantation and Immunology Branch;

name: Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute;

name: Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD 20892

name: Methodist Hospital, Texas Medical Center, Houston, TX 77021

name: Biostatistics and Data Management Section, National Cancer Institute,

name: The Cancer Center at Hackensack University Medical Center, Hackensack, NJ 07601

ReferenceCitation: Akashi K, Kondo M, von Freeden-Jeffry U, Murray R, Weissman IL. Bcl-2 rescues T lymphopoiesis in interleukin-7 receptor-deficient mice. Cell. 1997 Jun 27;89(7):1033-41.

ReferenceCitation: Li WQ, Guszczynski T, Hixon JA, Durum SK. Interleukin-7 regulates Bim proapoptotic activity in peripheral T-cell survival. Mol Cell Biol. 2010 Feb;30(3):590-600. doi: 10.1128/MCB.01006-09. Epub 2009 Nov 23.

name: Laboratory of Molecular Immunoregulation, Cancer Inflammation Program, Center for Cancer Research

name: Protein Chemistry Core, Laboratory of Cell and Development Signaling, National Cancer Institute, Frederick, Maryland 21702

title: Interleukin-7 Regulates Bim Proapoptotic Activity in Peripheral T-Cell Survival

ReferenceCitation: McFarland RD, Douek DC, Koup RA, Picker LJ. Identification of a human recent thymic emigrant phenotype. Proc Natl Acad Sci U S A. 2000 Apr 11;97(8):4215-20.

ReferenceCitation: Alpdogan O, van den Brink MR. IL-7 and IL-15: therapeutic cytokines for immunodeficiency. Trends Immunol. 2005 Jan;26(1):56-64. Review.

ReferenceCitation: Melchionda F, Fry TJ, Milliron MJ, McKirdy MA, Tagaya Y, Mackall CL. Adjuvant IL-7 or IL-15 overcomes immunodominance and improves survival of the CD8+ memory cell pool. J Clin Invest. 2005 May;115(5):1177-87. Epub 2005 Apr 7.

ReferenceCitation: Jaleco S, Swainson L, Dardalhon V, Burjanadze M, Kinet S, Taylor N. Homeostasis of naive and memory CD4+ T cells: IL-2 and IL-7 differentially regulate the balance between proliferation and Fas-mediated apoptosis. J Immunol. 2003 Jul 1;171(1):61-8.

ReferenceCitation: Sereti I, Dunham RM, Spritzler J, Aga E, Proschan MA, Medvik K, Battaglia CA, Landay AL, Pahwa S, Fischl MA, Asmuth DM, Tenorio AR, Altman JD, Fox L, Moir S, Malaspina A, Morre M, Buffet R, Silvestri G, Lederman MM; ACTG 5214 Study Team. IL-7 administration drives T cell-cycle entry and expansion in HIV-1 infection. Blood. 2009 Jun 18;113(25):6304-14. doi: 10.1182/blood-2008-10-186601. Epub 2009 Apr 20.

name: National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD;

name: University of Pennsylvania, Philadelphia;

name: Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA;

name: Case Western Reserve University, University Hospitals/Case Medical Center, Cleveland, OH;

name: AIDS Clinical Trial Group Operations Center, Silver Spring, MD;

name: Rush University Medical Center, Chicago, IL;

name: University of Miami Miller School of Medicine, FL;

name: University of California, Davis Medical Center, Sacramento;

name: Emory Vaccine Center, Emory University, Atlanta, GA;

name: Division of AIDS, NIAID, Bethesda, MD; and

title: IL-7 administration drives T cell–cycle entry and expansion in HIV-1 infection

ReferenceCitation: Levy Y, Lacabaratz C, Weiss L, Viard JP, Goujard C, Lelièvre JD, Boué F, Molina JM, Rouzioux C, Avettand-Fénoêl V, Croughs T, Beq S, Thiébaut R, Chêne G, Morre M, Delfraissy JF. Enhanced T cell recovery in HIV-1-infected adults through IL-7 treatment. J Clin Invest. 2009 Apr;119(4):997-1007. doi: 10.1172/JCI38052. Epub 2009 Mar 16.

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

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

publisher: American Society for Clinical Investigation

publisher_dissemination: American Society for Clinical Investigation

publisher_group: American Society for Clinical Investigation

publisher_normalized: American Society for Clinical Investigation

title: Enhanced T cell recovery in HIV-1–infected adults through IL-7 treatment

ReferenceCitation: Lévy Y, Sereti I, Tambussi G, Routy JP, Lelièvre JD, Delfraissy JF, Molina JM, Fischl M, Goujard C, Rodriguez B, Rouzioux C, Avettand-Fenoël V, Croughs T, Beq S, Morre M, Poulin JF, Sekaly RP, Thiebaut R, Lederman MM. Effects of recombinant human interleukin 7 on T-cell recovery and thymic output in HIV-infected patients receiving antiretroviral therapy: results of a phase I/IIa randomized, placebo-controlled, multicenter study. Clin Infect Dis. 2012 Jul;55(2):291-300. doi: 10.1093/cid/cis383. Epub 2012 May 1.

title: Effects of Recombinant Human Interleukin 7 on T-Cell Recovery and Thymic Output in HIV-Infected Patients Receiving Antiretroviral Therapy: Results of a Phase I/IIa Randomized, Placebo-Controlled, Multicenter Study

ReferenceCitation: 27. Miguel-Angel Perales, Jenna D. Goldberg,, Leuren Lechner Jianda Yuan, Esperanza Papadopoulos, James W. Young, Ann A. Jakubowski, Guenther Koehne, Humilidad Gallardo, Ryan Kendle, Cailian Liu, Teresa Rasalan, Yinyan Xu, Bushra Zaidi, Jedd D Wolchok, Therese Croughs, Michel Morre, Molly Maloy, Glenn Heller and Marcel R.M. van den Brink. Recombinant Human Interleukin-7 (CYT107) Enhances CD4 and CD8 T Cell Recovery Following T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplant In Patients with Myeloid Malignancies Oral and Poster Abstracts Oral Session: ASH 2010 Meeting.

ReferenceCitation: Li B, VanRoey MJ, Jooss K. Recombinant IL-7 enhances the potency of GM-CSF-secreting tumor cell immunotherapy. Clin Immunol. 2007 May;123(2):155-65. Epub 2007 Feb 22.

ReferenceCitation: Pellegrini M, Calzascia T, Elford AR, Shahinian A, Lin AE, Dissanayake D, Dhanji S, Nguyen LT, Gronski MA, Morre M, Assouline B, Lahl K, Sparwasser T, Ohashi PS, Mak TW. Adjuvant IL-7 antagonizes multiple cellular and molecular inhibitory networks to enhance immunotherapies. Nat Med. 2009 May;15(5):528-36. doi: 10.1038/nm.1953. Epub 2009 Apr 26. Erratum in: Nat Med. 2009 Jul;15(7):819.

ReferenceCitation: McAlister FA, Straus SE, Sackett DL, Altman DG. Analysis and reporting of factorial trials: a systematic review. JAMA. 2003 May 21;289(19):2545-53. Review.

location_facility:
Centre Leon Berard
Institut Gustave Roussy
Institut Curie


title: Early Discontinuation of Empirical Antibacterial Therapy in Febrile Neutropenia: Prospective Observational Study (ANTIBIOSTOP)

acronym: ANTIBIOSTOP

summary: Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be responsible for side-effects and selection of resistance. This study demonstrates the safety of an early discontinuation of empirical treatments, in carefully selected patients presenting with fever of unknown origin.

ipd_sharing: Undecided


title: Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy

acronym: PREMEVA

summary:
Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester

Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.

ReferenceCitation: Subtil D, Brabant G, Tilloy E, Devos P, Canis F, Fruchart A, Bissinger MC, Dugimont JC, Nolf C, Hacot C, Gautier S, Chantrel J, Jousse M, Desseauve D, Plennevaux JL, Delaeter C, Deghilage S, Personne A, Joyez E, Guinard E, Kipnis E, Faure K, Grandbastien B, Ancel PY, Goffinet F, Dessein R. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018 Nov 17;392(10160):2171-2179. doi: 10.1016/S0140-6736(18)31617-9. Epub 2018 Oct 12.

family: Subtil

full_name: Damien Subtil

given: Damien

family: Brabant

full_name: Gilles Brabant

given: Gilles

family: Tilloy

full_name: Emma Tilloy

given: Emma

family: Devos

full_name: Patrick Devos

given: Patrick

family: Canis

full_name: Frédérique Canis

given: Frédérique

family: Fruchart

full_name: Annie Fruchart

given: Annie

family: Bissinger

full_name: Marie-Christine Bissinger

given: Marie-Christine

family: Dugimont

full_name: Jean-Charles Dugimont

given: Jean-Charles

family: Nolf

full_name: Catherine Nolf

given: Catherine

family: Hacot

full_name: Christophe Hacot

family: Gautier

full_name: Sophie Gautier

family: Chantrel

full_name: Jérôme Chantrel

given: Jérôme

family: Jousse

full_name: Marielle Jousse

given: Marielle

family: Desseauve

full_name: David Desseauve

given: David

family: Plennevaux

full_name: Jean Louis Plennevaux

given: Jean Louis

family: Delaeter

full_name: Christine Delaeter

family: Deghilage

full_name: Sylvie Deghilage

given: Sylvie

family: Personne

full_name: Anne Personne

given: Anne

family: Joyez

full_name: Emmanuelle Joyez

given: Emmanuelle

family: Guinard

full_name: Elisabeth Guinard

given: Elisabeth

family: Kipnis

full_name: Eric Kipnis

given: Eric

full_name: Karine Faure

given: Karine

family: Grandbastien

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

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

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


title: Long-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients

summary: After exiting the RACE trial (NCT02099747) patients will be invited to participate in this long term follow-up study

study_start_date_type: Anticipated

status: Enrolling by invitation

lead_sponsor: European Society for Blood and Marrow Transplantation


title: VERARE_2 Efficacy of the Observation of Virtual Motor Actions for the Improvement of Gait in Patients With ICU Weakness

summary:
After hospitalization in Intensive Care (Intensive Care Unit or Continuing Care Unit), approximately 50% of patients usually present with intensive ICU-weakness, i.e. damage to the nerves and muscles secondary to immobilization and to the treatments that must have been used. This condition will delay the resumption of walking in these patients, their discharge from hospital and impair their autonomy in the daily life.

The recent international literature is in favor of early rehabilitative management of these patients, which should ideally be started in the intensive care unit. However, this is not always possible, due to the possible lack of physiotherapists in the services on the one hand, due to the fatigue of the population concerned and the existence of unstable medical conditions which do not always allow the use of recommended rehabilitation techniques on the other hand.

Virtual Reality (VR) environments are widely used for the assessment and rehabilitation of patients with neurological pathology. VR allows the user to be active in simulated activities and offers many advantages for the rehabilitation of motor functions in patients with neurological diseases. VR tools used to create action observation, motor imagery and sensations or even the illusion of movement in particular, have already shown their effectiveness in recovering and improving walking in different populations, especially after a stroke, in patients with Parkinson's Disease or Multiple Sclerosis. The role of the embodiment in VR appears promising in immersing participants in a controlled environment and creating movement's illusions.

The Virtual Reality tool designed consists of virtual environments presented using a Virtual Reality headset where an avatar (double) of the hospitalized patient will be represented, who will perform a walking motor task (involving his lower limbs ) in several different virtual environments (sets). In the present study named VERARE_2, the patient will be asked to observe walking actions and imagine performing them as they will be performed by the avatar in the virtual environment.

This VERARE_2 protocol aims to assess the effectiveness of the Observation of Virtual Motor Actions on the speed of gait recovery in hospitalized patients with IUC-weakness and in the intensive care units and continuing care units of the Rennes University Hospital.

primary_purpose: Supportive Care

lead_sponsor: Rennes University Hospital


title: Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Contouring and Marionette Lines

acronym: VFORM

summary:
To collect post-marketing data on Juvéderm® VOLIFT™ with Lidocaine on the following indications:

Marionette lines (treatment skin depressions)
Forehead contouring (face contouring)

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: Allergan


title: Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane.

acronym: MYRE

summary: MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.

ReferenceCitation: Bridoux F, Carron PL, Pegourie B, Alamartine E, Augeul-Meunier K, Karras A, Joly B, Peraldi MN, Arnulf B, Vigneau C, Lamy T, Wynckel A, Kolb B, Royer B, Rabot N, Benboubker L, Combe C, Jaccard A, Moulin B, Knebelmann B, Chevret S, Fermand JP; MYRE Study Group. Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy: A Randomized Clinical Trial. JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924.

name: Department of Nephrology, Institut National de la Santé et de la Recherche Médicale, Centre d’Investigation Clinique 1402, Centre Hospitalier Universitaire, Poitiers, France2Centre de Référence Maladies Rares, Poitiers, France3Centre National de la Recherche Scientifique, Unite Mixte de Recherche 7276, Université de Limoges, Limoges, France

family: Bridoux

full_name: Frank Bridoux

given: Frank

name: Department of Nephrology, Centre Hospitalier Universitaire, Grenoble, France

family: Carron

full_name: Pierre-Louis Carron

given: Pierre-Louis

name: Department of Hematology, Centre Hospitalier Universitaire, Grenoble, France

family: Pegourie

full_name: Brigitte Pegourie

given: Brigitte

name: Department of Nephrology, Centre Hospitalier Universitaire, Saint-Etienne, France

family: Alamartine

full_name: Eric Alamartine

name: Department of Hematology, Centre Hospitalier Universitaire, Saint-Etienne, France

family: Augeul-Meunier

full_name: Karine Augeul-Meunier

name: Department of Nephrology, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France

family: Karras

full_name: Alexandre Karras

given: Alexandre

name: Department of Hematology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

family: Joly

full_name: Bertrand Joly

given: Bertrand

name: Department of Nephrology, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France

family: Peraldi

full_name: Marie-Noëlle Peraldi

given: Marie-Noëlle

name: Department of Hematology and Immunology, Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1126, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France

family: Arnulf

full_name: Bertrand Arnulf

name: Department of Nephrology, Centre Hospitalier Universitaire, Rennes, France

family: Vigneau

full_name: Cécile Vigneau

given: Cécile

name: Department of Hematology, Centre Hospitalier Universitaire, Rennes, France

family: Lamy

full_name: Thierry Lamy

given: Thierry

name: Department of Nephrology, Centre Hospitalier Universitaire, Reims, France

family: Wynckel

full_name: Alain Wynckel

given: Alain

name: Department of Hematology, Centre Hospitalier Universitaire, Reims, France

family: Kolb

full_name: Brigitte Kolb

name: Department of Hematology, Centre Hospitalier Universitaire, Amiens, France

family: Royer

full_name: Bruno Royer

given: Bruno

name: Department of Nephrology, Centre Hospitalier Universitaire, Tours, France

family: Rabot

full_name: Nolwenn Rabot

given: Nolwenn

name: Department of Hematology, Centre Hospitalier Universitaire, Tours, France

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

name: Department of Nephrology, Centre Hospitalier Universitaire, Bordeaux, France

family: Combe

full_name: Christian Combe

given: Christian

name: Centre de Référence Maladies Rares, Poitiers, France3Centre National de la Recherche Scientifique, Unite Mixte de Recherche 7276, Université de Limoges, Limoges, France20Department of Hematology, Centre Hospitalier Universitaire, Limoges, France

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

name: Department of Nephrology, Centre Hospitalier Universitaire, Strasbourg, France

family: Moulin

full_name: Bruno Moulin

name: Department of Nephrology, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France

family: Knebelmann

full_name: Bertrand Knebelmann

name: Department of Biostatistics and Medical Information, Institut National de la Santé et de la Recherche Médicale, Unite Mixte de Recherche 1153 (ECSTRA Team), Paris Diderot University, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France

family: Chevret

full_name: Sylvie Chevret

family: Fermand

full_name: Jean-Paul Fermand

given: Jean-Paul


title: Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Lenalidomide in Kaposi Disease Associated With HIV Infection (ANRS 154/LENAKAP)

acronym: LENAKAP

summary: Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.

ReferenceCitation: Pourcher V, Desnoyer A, Assoumou L, Lebbe C, Curjol A, Marcelin AG, Cardon F, Gibowski S, Salmon D, Chennebault JM, Poizot-Martin I, Peytavin G, Boué F, Costagliola D. Phase II Trial of Lenalidomide in HIV-Infected Patients with Previously Treated Kaposi's Sarcoma: Results of the ANRS 154 Lenakap Trial. AIDS Res Hum Retroviruses. 2017 Jan;33(1):1-10. doi: 10.1089/AID.2016.0069. Epub 2016 Sep 7.

name: Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Service de Maladies Infectieuses et Tropicales, Paris, France.

name: Sorbonne Universités, UPMC Paris Univ 06, Paris, France.

family: Pourcher

full_name: Valérie Pourcher

given: Valérie

name: Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, Département de Pharmaco-Toxicologie Clinique, Paris, France.

family: Desnoyer

full_name: Aude Desnoyer

given: Aude

name: INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP UMR 1136), Sorbonne Universités, UPMC Univ Paris 06, Paris, France.

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

name: Assistance Publique Hôpitaux de Paris, Hôpital Saint Louis, Service de Dermatologie, Paris, France.

name: INSERM U976, CIC et Dermatologie, Univ Paris Diderot, Paris, France.

family: Lebbe

full_name: Céleste Lebbe

given: Céleste

family: Curjol

full_name: Angélique Curjol

given: Angélique

name: Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Laboratoire de Virologie, Paris, France.

family: Marcelin

full_name: Anne-Geneviève Marcelin

given: Anne-Geneviève

name: ANRS (France REcherche Nord&Sud Sida-hiv Hépatites), Clinical and Therapeutic Research on HIV/AIDS Office, Paris, France.

family: Cardon

full_name: Fanny Cardon

given: Fanny

name: ANRS (France REcherche Nord&Sud Sida-hiv Hépatites), Clinical Research Safety Office, Paris, France.

family: Gibowski

full_name: Séverine Gibowski

given: Séverine

name: Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Cochin, Service des Maladies Infectieuses, Paris, France.

family: Salmon

full_name: Dominique Salmon

given: Dominique

name: CHU Angers, Service de Maladies Infectieuses et Tropicales, Angers, France.

family: Chennebault

full_name: Jean-Marie Chennebault

given: Jean-Marie

name: APHM Sainte-Marguerite, Service d'Immunohématologie Clinique, Marseille, France.

name: INSERM U912 (SESSTIM), Université Aix Marseille, Marseille, France.

family: Poizot-Martin

full_name: Isabelle Poizot-Martin

given: Isabelle

name: INSERM, IAME UMR 1137, Université Paris Diderot, Paris, France.

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

name: Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère, Service de Médecine Interne et Immunologie Clinique, Clamart, France.

family: Boué

full_name: François Boué

given: François

family: Costagliola

full_name: Dominique Costagliola

journal_name: AIDS Research and Human Retroviruses

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

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


title: Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study

acronym: GRECCAR 07

summary: The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.

ReferenceCitation: Prudhomme M, Rullier E, Lakkis Z, Cotte E, Panis Y, Meunier B, Rouanet P, Tuech JJ, Jafari M, Portier G, Dubois A, Sielezneff I, Parc Y, Faucheron JL, Meurette G, Lelong B, Piessen G, Karoui M, Fabbro-Peray P, Demattei C, Bertrand MM; GRECCAR research group. End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial. Ann Surg. 2021 Dec 1;274(6):928-934. doi: 10.1097/SLA.0000000000004371.

family: Prudhomme

full_name: Michel Prudhomme

given: Michel

family: Rullier

full_name: Eric Rullier

given: Eric

family: Lakkis

full_name: Zaher Lakkis

given: Zaher

family: Cotte

full_name: Eddy Cotte

given: Eddy

family: Panis

full_name: Yves Panis

given: Yves

family: Meunier

full_name: Bernard Meunier

given: Bernard

family: Rouanet

full_name: Philippe Rouanet

given: Philippe

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Jafari

full_name: Mehrdad Jafari

given: Mehrdad

family: Portier

full_name: Guillaume Portier

given: Guillaume

family: Dubois

full_name: Anne Dubois

given: Anne

family: Sielezneff

full_name: Igor Sielezneff

given: Igor

family: Parc

full_name: Yann Parc

given: Yann

family: Faucheron

full_name: Jean-Luc Faucheron

given: Jean-Luc

family: Meurette

full_name: Guillaume Meurette

family: Lelong

full_name: Bernard Lelong

family: Piessen

full_name: Guillaume Piessen

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

family: Fabbro-Peray

full_name: Pascale Fabbro-Peray

given: Pascale

family: Demattei

full_name: Christophe Demattei

given: Christophe

family: Bertrand

full_name: Martin M Bertrand

given: Martin M

journal_name: Annals of Surgery

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

ReferenceCitation: Prudhomme M, Alline M, Chauvat J, Fabbro-Perray P, Ripoche J, Bertrand MM; French Research Group of Rectal Cancer Surgery (GRECCAR). Primary prevention of peristomial hernias via parietal prostheses: A randomized, multicentric study (GRECCAR 7 trial). Dig Liver Dis. 2016 Jul;48(7):812-6. doi: 10.1016/j.dld.2016.03.020. Epub 2016 Apr 5.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre

location_facility: Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes

location_facility: Hôpital Albert Michallon, CHU de Grenoble

location_facility: Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque

location_facility: Centre Régional de Lutte contre le Cancer Centre Paul Strauss

location_facility: Centre de Lutte Contre le Cancer - Centre Oscar Lambret

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Prevention of Chikungunya Infection in Neonates: Clinical Evaluation of Anti-CHIKV Hyperimmune Intravenous Immunoglobulins

summary:
Chikungunya virus (CHIKV) has been detected in humans in the Caribbean area for the first time in November 2013 (St-Martin Island). By February 2014, the virus had spread to several other Caribbean islands as well as French Guyana, South America. During the outbreak of Chikungunya that affected the Reunion island in 2005/2006, it was observed that the neonatal forms of infections acquired by mother to child transmission during childbirth, were not the exception and were critical. Mother-to-child transmission occurs when the mother is viremic at the time of delivery. The mean duration of viremia after the onset of first clinical symptoms is six days. The rate of mother-to-child transmission is 50%. All neonates contaminated during labor and delivery present with a symptomatic disease and the rate of severe forms is about 50%, primarily due to damage of the central nervous system, often leaving permanent damage (seizures, cerebral palsy).Due to the severity of Chikungunya in neonates and the burden of cerebral palsy, it is imperative to identify a safe and effective preventive and/or curative intervention. Human polyvalent immunoglobulins purified from plasma samples obtained from Chikungunya-convalescent donors exhibit a potent neutralizing activity in vitro. They were evaluated for their preventive and curative effects in a neonatal mouse model of CHIKV infection. After administration of a lethal dose of CHIKV, all neonatal mice that had received immunoglobulins survived while all control animals that had received non hyperimmune immunoglobulins died. In humans, specific human immunoglobulins proved to be effective and safe in neonates born to hepatitis B viremic mothers.

Hypothesis : The investigators hypothesize that the administration of anti-CHIKV hyperimmune human intravenous immunoglobulins to neonates exposed to a high risk of severe form of Chikungunya infection is safe enough to justify its evaluation in an open non randomized trial aimed to confirm the safety and preliminary assess the efficacy of this intervention.

lead_sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre

location_facility: Centre Hospitalier de Cayenne "Andrée ROSEMON"

intervention_type: Biological


title: Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years : a Multicentre Controlled Cross-sectional Study

summary: Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. Nowadays, quality of life (QoL) assessment of this population is in the foreground. Our team is a reference center in the management of patient with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on health related QoL in pediatric and congenital heart disease. The investigators thus demonstrated the link between cardiopulmonary fitness and QoL in children with CHD aged 8 to 18 years, the correlation between functional class and QoL in adults with CHD, and the impact of therapeutic education on QoL in children under anticoagulants. Currently, no controlled cross-sectional quality of life study assessment has been leaded in the youngest children with CHD. This present study therefore extends our work in younger children aged 5 to 7 years.

ReferenceCitation: Abassi H, Huguet H, Picot MC, Vincenti M, Guillaumont S, Auer A, Werner O, De La Villeon G, Lavastre K, Gavotto A, Auquier P, Amedro P. Health-related quality of life in children with congenital heart disease aged 5 to 7 years: a multicentre controlled cross-sectional study. Health Qual Life Outcomes. 2020 Nov 12;18(1):366. doi: 10.1186/s12955-020-01615-6.

family: Abassi

full_name: Hamouda Abassi

given: Hamouda

family: Huguet

full_name: Helena Huguet

given: Helena

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Vincenti

full_name: Marie Vincenti

given: Marie

family: Guillaumont

full_name: Sophie Guillaumont

given: Sophie

family: Auer

full_name: Annie Auer

given: Annie

family: Werner

full_name: Oscar Werner

given: Oscar

family: De La Villeon

full_name: Gregoire De La Villeon

given: Gregoire

family: Lavastre

full_name: Kathleen Lavastre

given: Kathleen

family: Gavotto

full_name: Arthur Gavotto

given: Arthur

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Amedro

full_name: Pascal Amedro

journal_name: Health and Quality of Life Outcomes

license: cc-by

license_normalized: cc-by

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
HAL
PubMed Central
Research Square


title: Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases

acronym: DYSLIM

summary: The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre


title: Evaluation of Cardiological Tests Before Returning to Sport in Athletes After COVID-19 Infection (CADE Study)

acronym: CADE

summary:
COVID-19 infection coud induce cardiac injuries. Before returning to sport, cardiac evaluation is recommended by sports federations, based on the precautionary principle and the opinion of expert consensus.

The aim of this study is to to determine the prevalence of abnormalities in cardiological examinations realized in athletes who have suffered from COVID-19 infection, symptomatic or not.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


lead_sponsor: Bioprojet

source: euctr

title: Randomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD)

summary: The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of Parkinson's disease patients


title: Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. A Multicenter Randomised Phase II/III Open Label Study With a Group of 100 Pregnant Women Receiving Lopinavir/Ritonavir and a Group of 50 Receiving Lopinavir/Ritonavir Plus Zidovudine and Lamivudine. ANRS 135 Primeva

summary: In the pre-partum phase the use of antiretroviral therapy for the mother during the last trimester of pregnancy is mandatory. The use of HAART during pregnancy, usually two nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate toxicities related to both families. The aim of this study is to assess the use of a boosted protease inhibitor without nucleoside analogue during the pre-partum phase for women with no indication of antiretroviral therapy for their own.

ReferenceCitation: Sibiude J, Le Chenadec J, Bonnet D, Tubiana R, Faye A, Dollfus C, Mandelbrot L, Delmas S, Lelong N, Khoshnood B, Warszawski J, Blanche S; French National Agency for Research on AIDS and Viral Hepatitis French Perinatal Cohort/Protease Inhibitor Monotherapy Evaluation Trial. In utero exposure to zidovudine and heart anomalies in the ANRS French perinatal cohort and the nested PRIMEVA randomized trial. Clin Infect Dis. 2015 Jul 15;61(2):270-80. doi: 10.1093/cid/civ260. Epub 2015 Apr 1.

family: Sibiude

full_name: Jeanne Sibiude

given: Jeanne

family: Le Chenadec

full_name: Jérôme Le Chenadec

given: Jérôme

family: Bonnet

full_name: Damien Bonnet

given: Damien

family: Tubiana

full_name: Roland Tubiana

given: Roland

family: Faye

full_name: Albert Faye

given: Albert

family: Dollfus

full_name: Catherine Dollfus

given: Catherine

family: Mandelbrot

full_name: Laurent Mandelbrot

given: Laurent

family: Delmas

full_name: Sandrine Delmas

given: Sandrine

family: Lelong

full_name: Nathalie Lelong

given: Nathalie

family: Khoshnood

full_name: Babak Khoshnood

given: Babak

family: Warszawski

full_name: Josiane Warszawski

given: Josiane

family: Blanche

full_name: Stéphane Blanche

given: Stéphane

journal_name: Clinical Infectious Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: In Utero Exposure to Zidovudine and Heart Anomalies in the ANRS French Perinatal Cohort and the Nested PRIMEVA Randomized Trial

ReferenceCitation: Tubiana R, Mandelbrot L, Le Chenadec J, Delmas S, Rouzioux C, Hirt D, Treluyer JM, Ekoukou D, Bui E, Chaix ML, Blanche S, Warszawski J; ANRS 135 PRIMEVA (Protease Inhibitor Monotherapy Evaluation) Study Group. Lopinavir/ritonavir monotherapy as a nucleoside analogue-sparing strategy to prevent HIV-1 mother-to-child transmission: the ANRS 135 PRIMEVA phase 2/3 randomized trial. Clin Infect Dis. 2013 Sep;57(6):891-902. doi: 10.1093/cid/cit390. Epub 2013 Jun 12.

full_name: Jérome Le Chenadec

given: Jérome

family: Rouzioux

full_name: Christine Rouzioux

given: Christine

family: Hirt

full_name: Deborah Hirt

given: Deborah

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

family: Ekoukou

full_name: Dieudonné Ekoukou

title: Lopinavir/Ritonavir Monotherapy as a Nucleoside Analogue–Sparing Strategy to Prevent HIV-1 Mother-to-Child Transmission: The ANRS 135 PRIMEVA Phase 2/3 Randomized Trial


title: Pilot Study of A One-Step Procedure for the Use of Autologous Bone Marrow Mesenchymal Stem Cells Stimulated by Proteins Scaffold to Heal Under Arthroscopy Full-Thickness Defects Articular Cartilage and Osteoarthrosis of the Knee.

summary: The purpose of this pilot study is to investigate the efficacy and safety of autologous transplantation, under arthroscopy, of Bone Marrow Mesenchymal stem cells, using, with a cell separator, a fresh non-culture expanded Autologous Bone Marrow derived Mesenchymal Stem, mixed and activated with proteins scaffold in patient with Knee cartilage defects and osteoarthritis. Based on extensive preclinical investigations, the technology of using freshly isolated bone marrow mononuclear cells mixed with proteins seems safe and most effective for a one-step correction of cartilage defect and restoration of the osteochondral complex, because the same mixture can generate cartilage in the vasculature-free knee joint, and bone in the environment of bone defects.

lead_sponsor: Michel Assor, MD

location_facility: Knee and Lower Limb Institute, Dr Michel Assor


title: A Study to Evaluate the Efficacy and the Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers: a Randomized, Double-blind, Parallel Groups and Placebo Controlled Clinical Trial.

summary:
The prevalence of overweight and obesity is getting more and more important in developed as well as in emerging countries. It can be defined according to the degree of fat storage by measurement of fat mass.

No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a fungal chitosan from the mycelium of non-genetically modified Aspergillus niger. KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan.

The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body weight reduction after 3 months of intake in overweight and obese men and women. Furthermore, effects on anthropometric measurements, body fat mass percentage, serum lipids and safety parameters will be investigated.

lead_sponsor: Kitozyme

location_facility: Clinical Nutrition Center Naturalpha (CNCN)


title: SAFETIM Besoins: Suivi Des Adolescents Des Familles et Des Equipes Pour Une Transition Idéale en Mucoviscidose Etude Des Besoins Adolescents et Parent Avant après Transition

acronym: SAFETIM-needs

summary: prospective multicentric study protocol in french CF center, exploring adolescent avec parents needs during transition from pediatric CF center to adult CF center

ReferenceCitation: Bregnballe V, Schiøtz PO, Lomborg K. Parenting adolescents with cystic fibrosis: the adolescents' and young adults' perspectives. Patient Prefer Adherence. 2011;5:563-70. doi: 10.2147/PPA.S25870. Epub 2011 Nov 7.

ReferenceCitation: Kreindler JL, Miller VA. Cystic fibrosis: addressing the transition from pediatric to adult-oriented health care. Patient Prefer Adherence. 2013 Dec 11;7:1221-6. doi: 10.2147/PPA.S37710. Review.

ReferenceCitation: Blum RW, Garell D, Hodgman CH, Jorissen TW, Okinow NA, Orr DP, Slap GB. Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J Adolesc Health. 1993 Nov;14(7):570-6.

ReferenceCitation: Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.

ReferenceCitation: Davis AM, Brown RF, Taylor JL, Epstein RA, McPheeters ML. Transition care for children with special health care needs. Pediatrics. 2014 Nov;134(5):900-8. doi: 10.1542/peds.2014-1909. Epub 2014 Oct 6. Review.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital, Clermont-Ferrand
South Hospital of Lyon, HCL
UniversityHospitalGrenoble
Hôpital Femme Mère Enfant, HCL


lead_sponsor: Akcea Therapeutics

location_country:
Italy
Brazil
South Africa
Netherlands
Germany
France
Israel
Spain
United States
United Kingdom
Canada

title: ISIS 304801-CS7 The APPROACH Open Label Study Volanesorsen (ISIS 304801) An Open-Label Study of Volanesorsen Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

summary: An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.


title: Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab + CHOP Regimen in Patients With HIV Related Non-Hodgkin's Lymphomas. ANRS 085 Rituximab

summary: Most treatment procedures in AIDS-related lymphomas disclose a relatively poor outcome for patients with low response rates, high number of relapses and AIDS events. The addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients. The aim of the trial is to evaluate the safety and efficacy of rituximab when added to the CHOP regimen in patients with newly diagnosed AIDS-related non-Hodgkin lymphoma.

location_facility: Service de Medecine Interne Hopital Antoine Beclere