title: A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.

summary: Will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.

ReferenceCitation: Moreau-Gaudry A, Prince A, Demongeot J, Payan Y. A new health strategy to prevent pressure ulcer formation in paraplegics using computer and sensory substitution via the tongue. Stud Health Technol Inform. 2006;124:926-31.

lead_sponsor: University Hospital, Grenoble


title: Neuromuscular and Cognitive Fatigue During a 24h Treadmill Running Exercise.

summary: The main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Health Services Research

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Morin JB, Samozino P, Féasson L, Geyssant A, Millet G. Effects of muscular biopsy on the mechanics of running. Eur J Appl Physiol. 2009 Jan;105(2):185-90. doi: 10.1007/s00421-008-0888-2. Epub 2008 Oct 8.

family: Morin

full_name: Jean-Benoit Morin

given: Jean-Benoit

sequence: first

family: Samozino

full_name: Pierre Samozino

given: Pierre

sequence: additional

family: Féasson

full_name: Léonard Féasson

given: Léonard

family: Geyssant

full_name: André Geyssant

given: André

family: Millet

full_name: Guillaume Millet

given: Guillaume

bso_classification: Biology (fond.)

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Applied Physiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceType: derived

ReferenceCitation: Jamart C, Francaux M, Millet GY, Deldicque L, Frère D, Féasson L. Modulation of autophagy and ubiquitin-proteasome pathways during ultra-endurance running. J Appl Physiol (1985). 2012 May;112(9):1529-37. doi: 10.1152/japplphysiol.00952.2011. Epub 2012 Feb 16.

name: Institute of Neuroscience, Université Catholique de Louvain, Louvain-la-Neuve, Belgium;

family: Jamart

full_name: Cécile Jamart

given: Cécile

family: Francaux

full_name: Marc Francaux

given: Marc

name: Exercise Physiology Laboratory, Université de Lyon, Saint-Etienne, France;

full_name: Guillaume Y. Millet

given: Guillaume Y.

name: Research Centre for Exercise and Health, Leuven, Belgium;

family: Deldicque

full_name: Louise Deldicque

given: Louise

family: Frère

full_name: Delphine Frère

given: Delphine

name: Unit of Myology, University Hospital Center, Saint-Etienne, France

bso_classification: Medical research

journal_name: Journal of Applied Physiology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: publishedVersion

publisher: American Physiological Society

publisher_dissemination: American Physiological Society

publisher_group: American Physiological Society

publisher_normalized: American Physiological Society

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Phase 3 Trial of Systematic Versus Response-adapted Timed-Sequential Induction in Patients With Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

summary:
Core binding factor (CBF) acute myeloid leukemias (AML) include AMLs carrying the t(8;21) translocation as well as AMLs carrying either the inversion of chromosome 16 or translocation t(16;16). CBF-AMLs are characterized by their high sensitivity to standard chemotherapeutical agents, especially to cytarabine when administered as high-dose bolus infusions, and thus by a relative good prognosis. However, relapse rates are still comprised between 30 and 50% in these patients, even if overall survival may reach approximately 65% due to the potential salvage of late relapses.

The primary purpose of the protocol is to compare two modalities of timed-sequential induction in order to improve the results of the treatment of CBF-AML patients. This protocol also includes the biological characterization of the heterogeneity of these diseases (gene mutation and transcription profiles), as well as a centralized minimal residual disease monitoring and centralized evaluation of pharmacogenetic polymorphisms.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Appelbaum FR, Kopecky KJ, Tallman MS, Slovak ML, Gundacker HM, Kim HT, Dewald GW, Kantarjian HM, Pierce SR, Estey EH. The clinical spectrum of adult acute myeloid leukaemia associated with core binding factor translocations. Br J Haematol. 2006 Oct;135(2):165-73. Epub 2006 Aug 25.

ReferenceCitation: Willekens C, Blanchet O, Renneville A, Cornillet-Lefebvre P, Pautas C, Guieze R, Ifrah N, Dombret H, Jourdan E, Preudhomme C, Boissel N; French AML Intergroup. Prospective long-term minimal residual disease monitoring using RQ-PCR in RUNX1-RUNX1T1-positive acute myeloid leukemia: results of the French CBF-2006 trial. Haematologica. 2016 Mar;101(3):328-35. doi: 10.3324/haematol.2015.131946. Epub 2015 Dec 3.

family: Willekens

full_name: C. Willekens

given: C.

family: Blanchet

full_name: O. Blanchet

given: O.

family: Renneville

full_name: A. Renneville

given: A.

family: Cornillet-Lefebvre

full_name: P. Cornillet-Lefebvre

given: P.

family: Pautas

full_name: C. Pautas

family: Guieze

full_name: R. Guieze

given: R.

family: Ifrah

full_name: N. Ifrah

given: N.

family: Dombret

full_name: H. Dombret

given: H.

family: Jourdan

full_name: E. Jourdan

given: E.

family: Preudhomme

full_name: C. Preudhomme

family: Boissel

full_name: N. Boissel

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: publisher-specific license

license_normalized: publisher-specific

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Duployez N, Nibourel O, Marceau-Renaut A, Willekens C, Helevaut N, Caillault A, Villenet C, Celli-Lebras K, Boissel N, Jourdan E, Dombret H, Figeac M, Preudhomme C, Renneville A. Minimal residual disease monitoring in t(8;21) acute myeloid leukemia based on RUNX1-RUNX1T1 fusion quantification on genomic DNA. Am J Hematol. 2014 Jun;89(6):610-5. doi: 10.1002/ajh.23696. Epub 2014 Mar 8.

name: Laboratory of Hematology; Biology and Pathology Center; Lille France

family: Duployez

full_name: Nicolas Duployez

given: Nicolas

name: Inserm U-837, Team 3; Cancer Research Institute; Lille France

family: Nibourel

full_name: Olivier Nibourel

given: Olivier

family: Marceau-Renaut

full_name: Alice Marceau-Renaut

given: Alice

name: Department of Adult Hematology; Claude Huriez Hospital; Lille France

full_name: Christophe Willekens

given: Christophe

family: Helevaut

full_name: Nathalie Helevaut

given: Nathalie

family: Caillault

full_name: Aurélie Caillault

name: Functional Genomic Platform; Lille France

name: Department of Adult Hematology; St. Louis Hospital; Paris France

name: Department of Hematology and Oncology; Nîmes University Hospital; Nîmes France

title: Minimal residual disease monitoring int(8;21) acute myeloid leukemia based onRUNX1-RUNX1T1fusion quantification on genomic DNA

ReferenceCitation: Jourdan E, Boissel N, Chevret S, Delabesse E, Renneville A, Cornillet P, Blanchet O, Cayuela JM, Recher C, Raffoux E, Delaunay J, Pigneux A, Bulabois CE, Berthon C, Pautas C, Vey N, Lioure B, Thomas X, Luquet I, Terré C, Guardiola P, Béné MC, Preudhomme C, Ifrah N, Dombret H; French AML Intergroup. Prospective evaluation of gene mutations and minimal residual disease in patients with core binding factor acute myeloid leukemia. Blood. 2013 Mar 21;121(12):2213-23. doi: 10.1182/blood-2012-10-462879. Epub 2013 Jan 15.

name: Department of Hematology and Oncology, Centre Hospitalier Universitaire (CHU) de Nimes, University Montpellier-Nimes, Nimes, France;

name: Department of Hematology and Tumor Bank, Hôpital Saint-Louis, Assistance Publique – Hôpitaux de Paris (AP-HP), Institut Universitaire d’Hématologie (IUH), University Paris Diderot, Paris, France;

name: Department of Biostatistics, Hôpital Saint-Louis (AP-HP), University Paris Diderot, INSERM S 717, Paris, France;

name: Department of Hematology, CHU and Centre de Recherche de Cancérologie de Toulouse, University Paul-Sabatier, Toulouse, France;

name: Laboratory of Hematology and Tumor Bank, Biology and Pathology Center, INSERM U837 Team 3, Cancer Research Institute of Lille, CHRU of Lille, University Lille Nord de France, Lille, France;

name: Department of Hematology, CHU and Tumor Bank, Reims, France;

name: Department of Hematology, Tumor Bank and INSERM U892, CHU and Institut Angevin du Cancer Paul Papin, Angers, France;

name: Department of Hematology, Hotel Dieu, CHU, Nantes, France;

name: Department of Hematology, Hôpital Haut-Lévèque, CHU, Bordeaux, France;

name: Department of Hematology, CHU, Grenoble, France;

name: Department of Hematology, CHU, Lille, France;

name: Department of Hematology, Hôpital Henri Mondor (AP-HP), Créteil, France;

name: Department of Hematology, Institut Paoli-Calmettes, University Aix-Marseille, Marseille, France;

name: Department of Hematology, CHU, Strasbourg, France;

name: Department of Hematology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, University Lyon 1, Pierre Bénite, France;

name: Department of Hematology, Hôpital Mignot, University Versailles – Saint Quentin, Le Chesnay, France;

name: Department of Hematology, INSERM U892, CHU, Angers, France; and

name: Department of Hematology, CHU, University de Lorraine, Vandoeuvre les Nancy, France


title: PRO-STATE: Prognostic Interest of Serum Protein Profiles of Patients Undergoing a Prostate Biopsy: Search for a Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins.

summary: The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins.

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Stattin P, Hakama M. Correspondence re: B-L. Adam et al., Serum protein fingerprinting coupled with a pattern-matching algorithm distinguishes prostate cancer from benign prostate hyperplasia and healthy men. Cancer Res., 62: 3609-3614, 2002. Cancer Res. 2003 May 15;63(10):2701; author reply 2701-2.

ReferenceCitation: Conrads TP, Fusaro VA, Ross S, Johann D, Rajapakse V, Hitt BA, Steinberg SM, Kohn EC, Fishman DA, Whitely G, Barrett JC, Liotta LA, Petricoin EF 3rd, Veenstra TD. High-resolution serum proteomic features for ovarian cancer detection. Endocr Relat Cancer. 2004 Jun;11(2):163-78.

ReferenceCitation: Lehrer S, Roboz J, Ding H, Zhao S, Diamond EJ, Holland JF, Stone NN, Droller MJ, Stock RG. Putative protein markers in the sera of men with prostatic neoplasms. BJU Int. 2003 Aug;92(3):223-5.

ReferenceCitation: Ornstein DK, Rayford W, Fusaro VA, Conrads TP, Ross SJ, Hitt BA, Wiggins WW, Veenstra TD, Liotta LA, Petricoin EF 3rd. Serum proteomic profiling can discriminate prostate cancer from benign prostates in men with total prostate specific antigen levels between 2.5 and 15.0 ng/ml. J Urol. 2004 Oct;172(4 Pt 1):1302-5.

ReferenceCitation: Petricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro VA, Steinberg SM, Mills GB, Simone C, Fishman DA, Kohn EC, Liotta LA. Use of proteomic patterns in serum to identify ovarian cancer. Lancet. 2002 Feb 16;359(9306):572-7.

ReferenceCitation: Petricoin EF 3rd, Ornstein DK, Paweletz CP, Ardekani A, Hackett PS, Hitt BA, Velassco A, Trucco C, Wiegand L, Wood K, Simone CB, Levine PJ, Linehan WM, Emmert-Buck MR, Steinberg SM, Kohn EC, Liotta LA. Serum proteomic patterns for detection of prostate cancer. J Natl Cancer Inst. 2002 Oct 16;94(20):1576-8.

ReferenceCitation: Xiao Z, Prieto D, Conrads TP, Veenstra TD, Issaq HJ. Proteomic patterns: their potential for disease diagnosis. Mol Cell Endocrinol. 2005 Jan 31;230(1-2):95-106. Review.

ReferenceCitation: Ye B, Cramer DW, Skates SJ, Gygi SP, Pratomo V, Fu L, Horick NK, Licklider LJ, Schorge JO, Berkowitz RS, Mok SC. Haptoglobin-alpha subunit as potential serum biomarker in ovarian cancer: identification and characterization using proteomic profiling and mass spectrometry. Clin Cancer Res. 2003 Aug 1;9(8):2904-11.

ReferenceCitation: Zhang Z, Bast RC Jr, Yu Y, Li J, Sokoll LJ, Rai AJ, Rosenzweig JM, Cameron B, Wang YY, Meng XY, Berchuck A, Van Haaften-Day C, Hacker NF, de Bruijn HW, van der Zee AG, Jacobs IJ, Fung ET, Chan DW. Three biomarkers identified from serum proteomic analysis for the detection of early stage ovarian cancer. Cancer Res. 2004 Aug 15;64(16):5882-90.

location_facility: Urology Department - University Hospital of Grenoble


title: ADAMTS13-related Prognostic Factors in Adult and Pediatric Thrombotic Thrombocytopenic Purpura

summary:
Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy defined by the spontaneous formation of platelet thrombi in the microvessels. These platelet microthrombi are responsible for a mechanical hemolytic anemia, a thrombocytopenia and a multivisceral ischemia. TTP is a rare but life-threatening disease in the absence of appropriate treatment (PLASMATHERAPY). The onset of the disease usually occurs in adulthood (MOSCHCOVITZ syndrome) and rarely in childhood (UPSHAW-SCHULMAN syndrome). TTP is either sporadic or recurrent with multiple unpredictable relapses. TTP pathophysiology has remained obscure until a new metalloprotease, ADAMTS13, has been demonstrated to be involved in about 90% of all cases. Physiologically, ADAMTS13 function consists in limiting the size of von Willebrand factor (VWF) multimers and consequently, their hemostatic capacity. A large majority of TTP is associated with a severe deficiency of ADAMTS13. In most cases, ADAMTS13 severe deficiency is acquired via auto-antibodies to ADAMTS13; more rarely, ADAMTS13 deficiency is hereditary via ADAMTS13 gene mutations. ADAMTS13 auto-antibodies are either inhibitory of the catalytic activity or non inhibitory. ADAMTS13 mutations are spread all over the gene.

TTP prognosis is quite heterogeneous. Indeed, in about one third of the patients, TTP is refractory to PLASMATHERAPY and/or chronic relapsing. Until now, TTP prognosis factors are not known. Their identification is however crucial both to adapt the curative treatment of an acute episode (addition of first intention immunosuppressive agents to PLASMATHERAPY) and to prevent relapses.

In this context, the aim of the current project is to identify some ADAMTS13 related prognosis factors in TTP. A national prospective multicenter study including both adult and pediatric patients with TTP related to a severe ADAMTS13 deficiency will be designed over a three-year period. This study will involve our group as the French reference center for ADAMTS13 and 10 clinical departments from various French hospitals. Patients will be tested for ADAMTS13 activity and antigen, ADAMTS13 antibodies and ADAMTS13 gene sequencing. Our main hypothesis is that the inactivation of the ADAMTS13 domains crucial for its catalytic activity, either by inhibitory auto-antibodies (acquired TTP) or by genetic mutations (hereditary TTP) is a major bad prognosis factor.

ReferenceCitation: Veyradier A, Obert B, Houllier A, Meyer D, Girma JP. Specific von Willebrand factor-cleaving protease in thrombotic microangiopathies: a study of 111 cases. Blood. 2001 Sep 15;98(6):1765-72.

ReferenceCitation: Veyradier A, Obert B, Haddad E, Cloarec S, Nivet H, Foulard M, Lesure F, Delattre P, Lakhdari M, Meyer D, Girma JP, Loirat C. Severe deficiency of the specific von Willebrand factor-cleaving protease (ADAMTS 13) activity in a subgroup of children with atypical hemolytic uremic syndrome. J Pediatr. 2003 Mar;142(3):310-7. Erratum in: J Pediatr. 2003 Jun;142(6):616. Loriat, C [corrected to Loirat, C].

ReferenceCitation: Veyradier A, Lavergne JM, Ribba AS, Obert B, Loirat C, Meyer D, Girma JP. Ten candidate ADAMTS13 mutations in six French families with congenital thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome). J Thromb Haemost. 2004 Mar;2(3):424-9.

ReferenceCitation: Fakhouri F, Vernant JP, Veyradier A, Wolf M, Kaplanski G, Binaut R, Rieger M, Scheiflinger F, Poullin P, Deroure B, Delarue R, Lesavre P, Vanhille P, Hermine O, Remuzzi G, Grünfeld JP. Efficiency of curative and prophylactic treatment with rituximab in ADAMTS13-deficient thrombotic thrombocytopenic purpura: a study of 11 cases. Blood. 2005 Sep 15;106(6):1932-7. Epub 2005 Jun 2.

ReferenceCitation: Ferrari S, Scheiflinger F, Rieger M, Mudde G, Wolf M, Coppo P, Girma JP, Azoulay E, Brun-Buisson C, Fakhouri F, Mira JP, Oksenhendler E, Poullin P, Rondeau E, Schleinitz N, Schlemmer B, Teboul JL, Vanhille P, Vernant JP, Meyer D, Veyradier A; French Clinical and Biological Network on Adult Thrombotic Microangiopathies. Prognostic value of anti-ADAMTS 13 antibody features (Ig isotype, titer, and inhibitory effect) in a cohort of 35 adult French patients undergoing a first episode of thrombotic microangiopathy with undetectable ADAMTS 13 activity. Blood. 2007 Apr 1;109(7):2815-22.

ReferenceCitation: Malak S, Wolf M, Millot GA, Mariotte E, Veyradier A, Meynard JL, Korach JM, Malot S, Bussel A, Azoulay E, Boulanger E, Galicier L, Devaux E, Eschwège V, Gallien S, Adrie C, Schlemmer B, Rondeau E, Coppo P; Réseau d'Etude des Microangiopathies Thrombotiques (TMA-Rare Diseases Reference Center). Human immunodeficiency virus-associated thrombotic microangiopathies: clinical characteristics and outcome according to ADAMTS13 activity. Scand J Immunol. 2008 Sep;68(3):337-44. doi: 10.1111/j.1365-3083.2008.02143.x.

family: Malak

full_name: S. Malak

given: S.

family: Wolf

full_name: M. Wolf

given: M.

family: Millot

full_name: G. A. Millot

given: G. A.

family: Mariotte

full_name: E. Mariotte

family: Veyradier

full_name: A. Veyradier

family: Meynard

full_name: J.-L. Meynard

family: Korach

full_name: J.-M. Korach

family: Malot

full_name: S. Malot

family: Bussel

full_name: A. Bussel

family: Azoulay

full_name: E. Azoulay

family: Boulanger

full_name: E. Boulanger

family: Galicier

full_name: L. Galicier

given: L.

family: Devaux

full_name: E. Devaux

family: Eschwège

full_name: V. Eschwège

given: V.

family: Gallien

full_name: S. Gallien

family: Adrie

full_name: C. Adrie

family: Schlemmer

full_name: B. Schlemmer

given: B.

family: Rondeau

full_name: E. Rondeau

family: Coppo

full_name: P. Coppo

name: for the Réseau d’Etude des Microangiopathies Thrombotiques (TMA-Rare Diseases Reference Center)

journal_name: Scandinavian Journal of Immunology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Human Immunodeficiency Virus-Associated Thrombotic Microangiopathies: Clinical Characteristics and Outcome According to ADAMTS13 Activity

ReferenceCitation: Loirat C, Girma JP, Desconclois C, Coppo P, Veyradier A. Thrombotic thrombocytopenic purpura related to severe ADAMTS13 deficiency in children. Pediatr Nephrol. 2009 Jan;24(1):19-29. doi: 10.1007/s00467-008-0863-5. Epub 2008 Jun 24. Review.

ReferenceCitation: Hommais A, Rayes J, Houllier A, Obert B, Legendre P, Veyradier A, Girma JP, Ribba AS. Molecular characterization of four ADAMTS13 mutations responsible for congenital thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome). Thromb Haemost. 2007 Sep;98(3):593-9.

ReferenceCitation: Joly BS, Stepanian A, Leblanc T, Hajage D, Chambost H, Harambat J, Fouyssac F, Guigonis V, Leverger G, Ulinski T, Kwon T, Loirat C, Coppo P, Veyradier A; French Reference Center for Thrombotic Microangiopathies. Child-onset and adolescent-onset acquired thrombotic thrombocytopenic purpura with severe ADAMTS13 deficiency: a cohort study of the French national registry for thrombotic microangiopathy. Lancet Haematol. 2016 Nov;3(11):e537-e546. doi: 10.1016/S2352-3026(16)30125-9. Epub 2016 Oct 3.

ReferenceCitation: Mariotte E, Azoulay E, Galicier L, Rondeau E, Zouiti F, Boisseau P, Poullin P, de Maistre E, Provôt F, Delmas Y, Perez P, Benhamou Y, Stepanian A, Coppo P, Veyradier A; French Reference Center for Thrombotic Microangiopathies. Epidemiology and pathophysiology of adulthood-onset thrombotic microangiopathy with severe ADAMTS13 deficiency (thrombotic thrombocytopenic purpura): a cross-sectional analysis of the French national registry for thrombotic microangiopathy. Lancet Haematol. 2016 May;3(5):e237-45. doi: 10.1016/S2352-3026(16)30018-7. Epub 2016 Apr 16.

ReferenceCitation: Thouzeau S, Capdenat S, Stépanian A, Coppo P, Veyradier A. Evaluation of a commercial assay for ADAMTS13 activity measurement. Thromb Haemost. 2013 Oct;110(4):852-3. doi: 10.1160/TH13-05-0393. Epub 2013 Jul 11.

ReferenceCitation: Moatti-Cohen M, Garrec C, Wolf M, Boisseau P, Galicier L, Azoulay E, Stepanian A, Delmas Y, Rondeau E, Bezieau S, Coppo P, Veyradier A; French Reference Center for Thrombotic Microangiopathies. Unexpected frequency of Upshaw-Schulman syndrome in pregnancy-onset thrombotic thrombocytopenic purpura. Blood. 2012 Jun 14;119(24):5888-97. doi: 10.1182/blood-2012-02-408914. Epub 2012 Apr 30.

name: Service d'Hématologie Biologique, Hôpital Antoine Béclère, Assistance Publique–Hôpitaux de Paris (AP-HP), Clamart, France;

name: Inserm U770, Université Paris 11, Le Kremlin Bicêtre, France;

name: Service de Génétique Médicale, Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, France;

name: Service de Réanimation Médicale, Hôpital Saint Louis, AP-HP, Paris, France;

name: Service d'Hématologie Biologique, Hôpital Louis Mourier, AP-HP, Colombes, France;

name: Service de Néphrologie Transplantation Dialyse, CHU de Bordeaux, Bordeaux, France;

name: Service de Néphrologie, Hôpital Tenon, AP-HP, Paris, France; and

name: Département d'Hématologie Clinique, Hôpital Saint Antoine, AP-HP, Université Pierre et Marie Curie (Paris 6), Paris, France


title: A Prospective Multicenter Open-label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

summary: Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

lead_sponsor: Novartis Pharmaceuticals

intervention_type: Drug

lead_sponsor_type: industriel


type: EudraCT Number

title: Pharmacokinetics Study of Combined Treatment Lapatinib and Tamoxifen in Advanced/Metastatic Breast Cancer

acronym: LAPATAM

summary:
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer.

PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and tamoxifen in treating patients with advanced or metastatic breast cancer.

status: Unknown status

ReferenceCitation: Fumoleau P, Koch KM, Brain E, Lokiec F, Rezai K, Awada A, Hayward L, Werutsky G, Bogaerts J, Marréaud S, Cardoso F. A phase I pharmacokinetics study of lapatinib and tamoxifen in metastatic breast cancer (EORTC 10053 Lapatam study). Breast. 2014 Oct;23(5):663-9. doi: 10.1016/j.breast.2014.07.003. Epub 2014 Jul 24.

family: Fumoleau

full_name: Pierre Fumoleau

given: Pierre

family: Koch

full_name: Kevin M. Koch

given: Kevin M.

family: Brain

full_name: Etienne Brain

given: Etienne

family: Lokiec

full_name: François Lokiec

given: François

family: Rezai

full_name: Keyvan Rezai

given: Keyvan

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Hayward

full_name: Larry Hayward

given: Larry

family: Werutsky

full_name: Gustavo Werutsky

given: Gustavo

family: Bogaerts

full_name: Jan Bogaerts

given: Jan

family: Marréaud

full_name: Sandrine Marréaud

given: Sandrine

family: Cardoso

full_name: Fatima Cardoso

given: Fatima

bso_classification: Chemistry

journal_name: The Breast

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

status_simplified: Unknown


title: Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance

summary: Experimental results are strongly suggesting that PCSK9 and FXR could occur in the physiopathology of human joined dyslipidemia. But no data in the literature can validate the potential role of these two genes in the lipidic and glucidic metabolism control in physiopathological situations. This protocol is based on the hypothesis that the expression levels of PCSK 9 and FXR are modified for some patients suffering from insulin resistance and dyslipidemia.

primary_purpose: Diagnostic

ReferenceCitation: Blanchard C, Ledoux S, Verhaegen A, Wargny M, Letessier E, Stepanian A, Huten N, Jacobi D, Krempf M, Le Bras M, Perrocheau Guillouche M, Arnaud L, Pichelin M, Van Gaal L, Cariou B, Le May C. Roux-en-Y gastric bypass, but not sleeve gastrectomy, decreases plasma PCSK9 levels in morbidly obese patients. Diabetes Metab. 2020 Nov;46(6):480-487. doi: 10.1016/j.diabet.2020.01.003. Epub 2020 Feb 4.

family: Blanchard

full_name: C. Blanchard

given: C.

family: Ledoux

full_name: S. Ledoux

given: S.

family: Verhaegen

full_name: A. Verhaegen

given: A.

family: Wargny

full_name: M. Wargny

family: Letessier

full_name: E. Letessier

given: E.

family: Stepanian

full_name: A. Stepanian

family: Huten

full_name: N. Huten

given: N.

family: Jacobi

full_name: D. Jacobi

given: D.

family: Krempf

full_name: M. Krempf

family: Le Bras

full_name: M. Le Bras

family: Perrocheau Guillouche

full_name: M. Perrocheau Guillouche

family: Arnaud

full_name: L. Arnaud

family: Pichelin

full_name: M. Pichelin

family: Van Gaal

full_name: L. Van Gaal

family: Cariou

full_name: B. Cariou

family: Le May

full_name: C. Le May

journal_name: Diabetes & Metabolism

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

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

repository_normalized: HAL

version: submittedVersion

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

lead_sponsor: Nantes University Hospital


title: A Randomized Multicenter Study With Non-inferiority Hypothesis, Comparing the Availability to Maintain a Complete Viral Suppression by a Monotherapy of Darunavir/r to a NRTI Containing Regimen Including Darunavir/r, in HIV-1 Infected Patients With Previous Prolonged Complete Viral Suppression. ANRS 136 MONOI

summary: The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.

ReferenceCitation: Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.

name: INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique (IPLESP), Paris, France

name: AP-HP, Laboratoire de Virologie, Hôpital Saint-Antoine, Paris, France

family: Lambert-Niclot

full_name: Sidonie Lambert-Niclot

given: Sidonie

family: Grude

full_name: Maxime Grude

given: Maxime

name: Département de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France

family: Meynard

full_name: Jean-Luc Meynard

given: Jean-Luc

name: AP-HP, Laboratoire de Virologie, Hôpital Pitié Salpêtrière, Paris, France

family: Marcelin

full_name: Anne-Geneviève Marcelin

given: Anne-Geneviève

name: Département de Maladies Infectieuses, Hôpital Pitié Salpêtrière, Paris

family: Valantin

full_name: Marc-Antoine Valantin

given: Marc-Antoine

family: Flandre

full_name: Philippe Flandre

given: Philippe

name: Université Toulouse III Paul-Sabatier, Toulouse, France

name: CHU de Toulouse, Laboratoire de Virologie, Toulouse, France

family: Izopet

full_name: Jacques Izopet

given: Jacques

name: Inserm, Bordeaux Population Health Research Center, Université Bordeaux, ISPED, Bordeaux, France

name: CHU de Bordeaux, Pole de Sante Publique, Bordeaux, France

family: Moinot

full_name: Laetitia Moinot

given: Laetitia

family: Bouteloup

full_name: Vincent Bouteloup

given: Vincent

family: Calvez

full_name: Vincent Calvez

family: Katlama

full_name: Christine Katlama

given: Christine

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Morand-Joubert

full_name: Laurence Morand-Joubert

given: Laurence

journal_name: Clinical Infectious Diseases

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Lambert-Niclot S, Flandre P, Valantin MA, Soulie C, Fourati S, Wirden M, Sayon S, Pakianather S, Bocket L, Masquelier B, Dos Santos G, Katlama C, Calvez V, Marcelin AG. Similar evolution of cellular HIV-1 DNA level in darunavir/ritonavir monotherapy versus triple therapy in MONOI-ANRS136 trial over 96 weeks. PLoS One. 2012;7(7):e41390. doi: 10.1371/journal.pone.0041390. Epub 2012 Jul 25.

family: Soulie

full_name: Cathia Soulie

given: Cathia

family: Fourati

full_name: Slim Fourati

given: Slim

title: Similar Evolution of Cellular HIV-1 DNA Level in Darunavir/Ritonavir Monotherapy versus Triple Therapy in MONOI –ANRS136 Trial over 96 Weeks

ReferenceCitation: Katlama C, Valantin MA, Algarte-Genin M, Duvivier C, Lambert-Niclot S, Girard PM, Molina JM, Hoen B, Pakianather S, Peytavin G, Marcelin AG, Flandre P. Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS. 2010 Sep 24;24(15):2365-74. doi: 10.1097/QAD.0b013e32833dec20.

publisher: Ovid Technologies (Wolters Kluwer Health)

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

location_facility: Service des maladies infectieuses et tropicales Hopital Pitie salpetriere


title: Validation d'Une Stratégie de Programme Transfusionnel Par Erythraphérèse basée Sur un Algorithme d'Aide à la Prescription Transfusionnelle Chez Les Patients Adultes Drépanocytaires

acronym: ALGODREP

summary:
The main objective of this study is to prove the superiority of a procedure which calculates the volume of RBCs to transfuse and the time between apheresis based on this algorithm, compared to the current procedure. The primary endpoint would be the number of patients with individually achieved objectives in terms of % HbS before each apheresis (which reflects the effectiveness of the previous apheresis) over a period of 12 months. The secondary objectives would be to compare the volume differences of transfused RBCs in both groups over a period of 12 months, the occurrence of clinical events and the satisfaction of patients and physicians.

The investigators hope that this study would improve the efficiency and the performance of apheresis in sickle cell patients. The investigators also hope to facilitate the organization of procedures with the flexibility that would allow the use of this algorithm.

study_start_date_type: Anticipated

study_completion_date_type: Anticipated

primary_purpose: Supportive Care

ReferenceCitation: Quinn CT, Ahmad N. Clinical correlates of steady-state oxyhaemoglobin desaturation in children who have sickle cell disease. Br J Haematol. 2005 Oct;131(1):129-34.

ReferenceCitation: Quinn CT, Sargent JW. Daytime steady-state haemoglobin desaturation is a risk factor for overt stroke in children with sickle cell anaemia. Br J Haematol. 2008 Feb;140(3):336-9. Epub 2007 Nov 27.

ReferenceCitation: Setty BN, Stuart MJ, Dampier C, Brodecki D, Allen JL. Hypoxaemia in sickle cell disease: biomarker modulation and relevance to pathophysiology. Lancet. 2003 Nov 1;362(9394):1450-5.

ReferenceCitation: Nahavandi M, Nichols JP, Hassan M, Gandjbakhche A, Kato GJ. Near-infrared spectra absorbance of blood from sickle cell patients and normal individuals. Hematology. 2009 Feb;14(1):46-8. doi: 10.1179/102453309X385133.

ReferenceCitation: Nahavandi M, Tavakkoli F, Hasan SP, Wyche MQ, Castro O. Cerebral oximetry in patients with sickle cell disease. Eur J Clin Invest. 2004 Feb;34(2):143-8.

ReferenceCitation: Waltz X, Pichon A, Lemonne N, Mougenel D, Lalanne-Mistrih ML, Lamarre Y, Tarer V, Tressières B, Etienne-Julan M, Hardy-Dessources MD, Hue O, Connes P. Normal muscle oxygen consumption and fatigability in sickle cell patients despite reduced microvascular oxygenation and hemorheological abnormalities. PLoS One. 2012;7(12):e52471. doi: 10.1371/journal.pone.0052471. Epub 2012 Dec 20.

ReferenceCitation: Waltz X, Pichon A, Mougenel D, Lemonne N, Lalanne-Mistrih ML, Sinnapah S, Tarer V, Tressières B, Lamarre Y, Etienne-Julan M, Hue O, Hardy-Dessources MD, Connes P. Hemorheological alterations, decreased cerebral microvascular oxygenation and cerebral vasomotion compensation in sickle cell patients. Am J Hematol. 2012 Dec;87(12):1070-3. doi: 10.1002/ajh.23318. Epub 2012 Aug 22.

ReferenceCitation: Belcher JD, Chen C, Nguyen J, Milbauer L, Abdulla F, Alayash AI, Smith A, Nath KA, Hebbel RP, Vercellotti GM. Heme triggers TLR4 signaling leading to endothelial cell activation and vaso-occlusion in murine sickle cell disease. Blood. 2014 Jan 16;123(3):377-90. doi: 10.1182/blood-2013-04-495887. Epub 2013 Nov 25.

ReferenceCitation: Eltzschig HK, Carmeliet P. Hypoxia and inflammation. N Engl J Med. 2011 Feb 17;364(7):656-65. doi: 10.1056/NEJMra0910283. Review.

ReferenceCitation: Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507. Review.

ReferenceCitation: Lionnet F, Arlet JB, Bartolucci P, Habibi A, Ribeil JA, Stankovic K; groupe de recommandations et d'étude de la drépanocytose de l'adulte (GREDA). [Guidelines for management of adult sickle cell disease]. Rev Med Interne. 2009 Sep;30 Suppl 3:S162-223. doi: 10.1016/j.revmed.2009.07.001. Epub 2009 Aug 26. French.

ReferenceCitation: Adams RJ, McKie VC, Hsu L, Files B, Vichinsky E, Pegelow C, Abboud M, Gallagher D, Kutlar A, Nichols FT, Bonds DR, Brambilla D. Prevention of a first stroke by transfusions in children with sickle cell anemia and abnormal results on transcranial Doppler ultrasonography. N Engl J Med. 1998 Jul 2;339(1):5-11.

ReferenceCitation: Adams RJ, Brambilla D; Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) Trial Investigators. Discontinuing prophylactic transfusions used to prevent stroke in sickle cell disease. N Engl J Med. 2005 Dec 29;353(26):2769-78.

ReferenceCitation: Abboud MR, Yim E, Musallam KM, Adams RJ; STOP II Study Investigators. Discontinuing prophylactic transfusions increases the risk of silent brain infarction in children with sickle cell disease: data from STOP II. Blood. 2011 Jul 28;118(4):894-8. doi: 10.1182/blood-2010-12-326298. Epub 2011 Jun 1.

ReferenceCitation: Gueguen A, Mahevas M, Nzouakou R, Hosseini H, Habibi A, Bachir D, Brugière P, Lionnet F, Ribei JA, Godeau B, Girot R, Ibrahima V, Calvet D, Galactéros F, Bartolucci P. Sickle-cell disease stroke throughout life: a retrospective study in an adult referral center. Am J Hematol. 2014 Mar;89(3):267-72.

ipd_sharing: No

lead_sponsor: Etablissement Français du Sang

location_country: Martinique France

location_facility:
Hôpital Henri Mondor
CHU Kremlin Bicêtre
Centre de Santé EFS
CHU de Martinique
EFS Rhône-Alpes-Auvergne

intervention_type: Device


title: A Randomized Phase II Study to Evaluate the Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma

acronym: PENILANE

summary: The purpose of this study is to evaluate the efficacy and safety of Cetuximab in metastatic penile carcinoma

status: Withdrawn

ReferenceCitation: Bleeker MC, Heideman DA, Snijders PJ, Horenblas S, Dillner J, Meijer CJ. Penile cancer: epidemiology, pathogenesis and prevention. World J Urol. 2009 Apr;27(2):141-50. doi: 10.1007/s00345-008-0302-z. Epub 2008 Jul 8. Review.

ReferenceCitation: Barnholtz-Sloan JS, Maldonado JL, Pow-sang J, Giuliano AR. Incidence trends in primary malignant penile cancer. Urol Oncol. 2007 Sep-Oct;25(5):361-7. Erratum in: Urol Oncol. 2008 Jan-Feb;26(1):112. Guiliano, Anna R [corrected to Giuliano, Anna R].

ReferenceCitation: Curado M.P., Edwards B., Shin H.R. et al. Cancer Incidence in Five continents. Sci Publ. 2007. 160:570-573.

ReferenceCitation: Calmon MF, Tasso Mota M, Vassallo J, Rahal P. Penile carcinoma: risk factors and molecular alterations. ScientificWorldJournal. 2011 Feb 3;11:269-82. doi: 10.1100/tsw.2011.24. Review.

ReferenceCitation: Rigaud J, Avancès C, Camparo P, Culine S, Durand X, Iborra F, Mottet N, Sèbe P, Soulié M; Oncology Committee of the French Association of Urology (CCAFU). [Recommendations Onco-Urology 2010: Malignancies of the penis]. Prog Urol. 2010 Nov;20 Suppl 4:S279-89. doi: 10.1016/S1166-7087(10)70044-0. French.

ReferenceCitation: Philippou P, Shabbir M, Malone P, Nigam R, Muneer A, Ralph DJ, Minhas S. Conservative surgery for squamous cell carcinoma of the penis: resection margins and long-term oncological control. J Urol. 2012 Sep;188(3):803-8. doi: 10.1016/j.juro.2012.05.012. Epub 2012 Jul 19.

ReferenceCitation: Smith Y, Hadway P, Biedrzycki O, Perry MJ, Corbishley C, Watkin NA. Reconstructive surgery for invasive squamous carcinoma of the glans penis. Eur Urol. 2007 Oct;52(4):1179-85. Epub 2007 Feb 20.

ReferenceCitation: Di Lorenzo G, Buonerba C, Federico P, Perdonà S, Aieta M, Rescigno P, D'Aniello C, Puglia L, Petremolo A, Ferro M, Marinelli A, Palmieri G, Sonpavde G, Mirone V, De Placido S. Cisplatin and 5-fluorouracil in inoperable, stage IV squamous cell carcinoma of the penis. BJU Int. 2012 Dec;110(11 Pt B):E661-6. doi: 10.1111/j.1464-410X.2012.11453.x. Epub 2012 Sep 10.

ReferenceCitation: Haas GP, Blumenstein BA, Gagliano RG, Russell CA, Rivkin SE, Culkin DJ, Wolf M, Crawford ED. Cisplatin, methotrexate and bleomycin for the treatment of carcinoma of the penis: a Southwest Oncology Group study. J Urol. 1999 Jun;161(6):1823-5.

ReferenceCitation: Pagliaro LC, Williams DL, Daliani D, Williams MB, Osai W, Kincaid M, Wen S, Thall PF, Pettaway CA. Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study. J Clin Oncol. 2010 Aug 20;28(24):3851-7. doi: 10.1200/JCO.2010.29.5477. Epub 2010 Jul 12.

ReferenceCitation: Lavens N, Gupta R, Wood LA. EGFR overexpression in squamous cell carcinoma of the penis. Curr Oncol. 2010 Feb;17(1):4-6.

ReferenceCitation: Andersson P, Kolaric A, Windahl T, Kirrander P, Söderkvist P, Karlsson MG. PIK3CA, HRAS and KRAS gene mutations in human penile cancer. J Urol. 2008 May;179(5):2030-4. doi: 10.1016/j.juro.2007.12.040. Epub 2008 Mar 19.

ReferenceCitation: Dorff T. EGFR, TS and ERCC1 expression in penile squamous cancer. ASCO GU 2011. Not yet published.

ReferenceCitation: Valverde C.M. BRAF and KRAS mutations in penile cancer and their correlation with clinical features. ASCO GU 2011. Not yet published.

ReferenceCitation: Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78.

ReferenceCitation: Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45.

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.

family: Pirker

full_name: Robert Pirker

given: Robert

family: Pereira

full_name: Jose R Pereira

given: Jose R

family: Szczesna

full_name: Aleksandra Szczesna

given: Aleksandra

family: von Pawel

full_name: Joachim von Pawel

given: Joachim

family: Krzakowski

full_name: Maciej Krzakowski

given: Maciej

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Vynnychenko

full_name: Ihor Vynnychenko

given: Ihor

family: Park

full_name: Keunchil Park

given: Keunchil

family: Yu

full_name: Chih-Teng Yu

given: Chih-Teng

family: Ganul

full_name: Valentyn Ganul

given: Valentyn

family: Roh

full_name: Jae-Kyung Roh

given: Jae-Kyung

family: Bajetta

full_name: Emilio Bajetta

given: Emilio

family: O'Byrne

full_name: Kenneth O'Byrne

given: Kenneth

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

family: Eberhardt

full_name: Wilfried Eberhardt

given: Wilfried

family: Goddemeier

full_name: Thomas Goddemeier

given: Thomas

family: Emig

full_name: Michael Emig

given: Michael

family: Gatzemeier

full_name: Ulrich Gatzemeier

given: Ulrich

ReferenceCitation: Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D'Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. J Clin Oncol. 2000 Feb;18(4):904-14.

ReferenceCitation: Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10. Erratum in: Lancet Oncol. 2010 Jan;11(1):14.

ReferenceCitation: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

title: Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer

ReferenceCitation: Vermorken JB, Trigo J, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, Knecht R, Amellal N, Schueler A, Baselga J. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1;25(16):2171-7.

ReferenceCitation: Rescigno P, Matano E, Raimondo L, Mainolfi C, Federico P, Buonerba C, Di Trolio R, D'Aniello C, Damiano V, Palmieri G, De Placido S, Di Lorenzo G. Combination of docetaxel and cetuximab for penile cancer: a case report and literature review. Anticancer Drugs. 2012 Jun;23(5):573-7. doi: 10.1097/CAD.0b013e328350ead7.

ReferenceCitation: Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.

title: Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer

location_facility:
Centre Léon Bérard
Institut Claudius Regaud
CHRU Strasbourg
Institut Paoli Calmettes
Institut Curie
Institut Bergonié
APHP Hôpital Saint Louis


title: Clinical Randomized Study of Sublingual Midazolam in Association With Morphine by Oral Route in Arm Fracture in Children at the Emergency Children Care

acronym: MIDAZODOL

summary: It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

ReferenceCitation: Wille-Ledon C, Chappuy H, Giraud C, Tréluyer JM, Chéron G. Comparison of a morphine and midazolam combination with morphine alone for paediatric displaced fractures: a randomized study. Acta Paediatr. 2011 Nov;100(11):e203-7. doi: 10.1111/j.1651-2227.2011.02311.x. Epub 2011 May 11.

family: Wille-Ledon

full_name: Chrystèle Wille-Ledon

given: Chrystèle

family: Chappuy

full_name: Hélène Chappuy

given: Hélène

family: Giraud

full_name: Carole Giraud

given: Carole

family: Tréluyer

full_name: Jean-Marc Tréluyer

given: Jean-Marc

family: Chéron

full_name: Gérard Chéron

given: Gérard

journal_name: Acta Paediatrica

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hopital Necker enfants Malade - Department of Pediatric Emergency


title: Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions

acronym: SOTHIS

summary: This study assesses the long term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.

study_start_date_type: Actual

status: Active, not recruiting

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 151514

location_facility: CH Annecy Genevois Site Annecy /ID# 151131

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 151508

location_facility: Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 151181

location_facility: Hopital de la Cavale Blanche /ID# 152618

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 166807

location_facility: Ceentre Hepatologie Biliaire /ID# 151152

location_facility: GH Mutualiste Les Port Du Sud /ID# 159231

location_facility: Centre Hosp Intercommunal de Creteil /ID# 152361

location_facility: Hopital Louis Mourier,Colombes /ID# 152650

location_facility: Centre Hospitalier Cote Basque /ID# 163714

location_facility: CH Heut Anjou de Chateau Gonti /ID# 151151

location_facility: Centre Medical du Clos de Pacy /ID# 151129

location_facility: Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 151132

location_facility: Hopital Bichat Claude Bernard /ID# 151176

location_facility: Cabinet Medical, Dr. Constant, /ID# 151119

location_facility: Ctr Consultations La Sauvegard /ID# 151515

location_facility: CH Des Deux Vallees Longumeau /ID# 150977

location_facility: CHU la Reunion Site St. Denis /ID# 151556

location_facility: Fondation Maison Sante Bagatel /ID# 151497

location_facility: GH Mutualiste Les Port Du Sud /ID# 152374

location_facility: Centre Medical Alexandre Dumas /Id# 165857

location_facility: Hopital de la Cavale Blanche /ID# 153608

status_simplified: Ongoing


title: Study of the Effects of Nefopam on Hyperalgesia Following Sternotomy in Cardiac Surgery

acronym: NefalCard

summary: Postoperative pain after major surgery is consecutive not only to the nociceptive inputs coming from the surgical lesion, but also to peripheral and central neuronal sensitization. This lead to postoperative hyperalgesia and allodynia that are enhanced by the per operative use of high opioid doses. Anti-NMDA drugs have been reported as able to reduce this sensitization process and then to decrease acute morphine tolerance during the postoperative period. Nefopam has been lately shown to combine in experimental trials analgesic and anti hyperalgesic effects. The aim of this study is to compare anti-hyperalgesic effects of nefopam given either before incision and continuously for the following 48hours or starting from the end of the surgery and given for 48hours to a control group that would receive placebo for 48hours. Postoperative analgesia will be based on morphine PCA. Pain scores, hyperalgesia, allodynia, postoperative morphine consumption, and development of chronic pain will be the main criteria that will be evaluated during this study

ReferenceCitation: Richebé P, Picard W, Rivat C, Jelacic S, Branchard O, Leproust S, Cahana A, Janvier G. Effects of nefopam on early postoperative hyperalgesia after cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):427-35. doi: 10.1053/j.jvca.2012.08.015. Epub 2012 Oct 12.

family: Richebé

full_name: Philippe Richebé

given: Philippe

family: Picard

full_name: Walter Picard

given: Walter

family: Rivat

full_name: Cyril Rivat

given: Cyril

family: Jelacic

full_name: Srdjan Jelacic

given: Srdjan

family: Branchard

full_name: Olivier Branchard

given: Olivier

family: Leproust

full_name: Sandy Leproust

given: Sandy

family: Cahana

full_name: Alex Cahana

given: Alex

family: Janvier

full_name: Gérard Janvier

journal_name: Journal of Cardiothoracic and Vascular Anesthesia

title: Effects of Nefopam on Early Postoperative Hyperalgesia After Cardiac Surgery

lead_sponsor: University Hospital, Bordeaux

location_facility: Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan


type: Other Identifier

title: Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART]

acronym: LUNG ART

summary:
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.

ReferenceCitation: Verma V, Moreno AC, Haque W, Fang P, Lin SH. Sequential Versus Concurrent Chemoradiation Therapy by Surgical Margin Status in Resected Non-Small Cell Lung Cancer. J Natl Compr Canc Netw. 2018 May;16(5):508-516. doi: 10.6004/jnccn.2018.7007.

family: Verma

full_name: Vivek Verma

given: Vivek

family: Moreno

full_name: Amy C. Moreno

given: Amy C.

family: Haque

full_name: Waqar Haque

given: Waqar

family: Fang

full_name: Penny Fang

given: Penny

family: Lin

full_name: Steven H. Lin

given: Steven H.

journal_name: Journal of the National Comprehensive Cancer Network

publisher: Harborside Press, LLC

publisher_dissemination: Harborside Press, LLC

publisher_group: Harborside Press, LLC

publisher_normalized: Harborside Press, LLC

title: Sequential Versus Concurrent Chemoradiation Therapy by Surgical Margin Status in Resected Non–Small Cell Lung Cancer

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Comparative Study of Effect of Valsartan 160mg Treatment Versus Continuous Positive Airway Pressure on Arterial Blood Pressure in Patients Who Have an Obstructive Sleep Apnea Syndrome and a Weak or Moderate Hypertension.

acronym: VALSAS

summary: The main objective of the study is to compare the decrease of mean arterial blood pressure over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate hypertension, treated by Valsartan 160mg per day versus continuous Positive Airway Pressure.

ReferenceCitation: Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197.

ReferenceCitation: Baguet JP, Hammer L, Lévy P, Pierre H, Rossini E, Mouret S, Ormezzano O, Mallion JM, Pépin JL. Night-time and diastolic hypertension are common and underestimated conditions in newly diagnosed apnoeic patients. J Hypertens. 2005 Mar;23(3):521-7.

ReferenceCitation: Baguet JP, Narkiewicz K, Mallion JM. Update on Hypertension Management: obstructive sleep apnea and hypertension. J Hypertens. 2006 Jan;24(1):205-8.

ReferenceCitation: Pepperell JC, Ramdassingh-Dow S, Crosthwaite N, Mullins R, Jenkinson C, Stradling JR, Davies RJ. Ambulatory blood pressure after therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised parallel trial. Lancet. 2002 Jan 19;359(9302):204-10.

ReferenceCitation: Becker HF, Jerrentrup A, Ploch T, Grote L, Penzel T, Sullivan CE, Peter JH. Effect of nasal continuous positive airway pressure treatment on blood pressure in patients with obstructive sleep apnea. Circulation. 2003 Jan 7;107(1):68-73.

ReferenceCitation: Kraiczi H, Hedner J, Peker Y, Grote L. Comparison of atenolol, amlodipine, enalapril, hydrochlorothiazide, and losartan for antihypertensive treatment in patients with obstructive sleep apnea. Am J Respir Crit Care Med. 2000 May;161(5):1423-8.

ReferenceCitation: Jordan J, Engeli S, Boschmann M, Weidinger G, Luft FC, Sharma AM, Kreuzberg U. Hemodynamic and metabolic responses to valsartan and atenolol in obese hypertensive patients. J Hypertens. 2005 Dec;23(12):2313-8.

ReferenceCitation: Calvo C, Hermida RC, Ayala DE, Ruilope LM. Effects of telmisartan 80 mg and valsartan 160 mg on ambulatory blood pressure in patients with essential hypertension. J Hypertens. 2004 Apr;22(4):837-46.

ReferenceCitation: Baguet JP, Pépin JL, Hammer L, Lévy P, Mallion JM. [Cardiovascular consequences of obstructive sleep apnea syndrome]. Rev Med Interne. 2003 Aug;24(8):530-7. Review. French.

ReferenceCitation: Pépin JL, Tamisier R, Barone-Rochette G, Launois SH, Lévy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Barone-Rochette

full_name: Gilles Barone-Rochette

given: Gilles

family: Launois

full_name: Sandrine H. Launois

given: Sandrine H.

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Comparison of Continuous Positive Airway Pressure and Valsartan in Hypertensive Patients with Sleep Apnea


title: Multicenter International Observational Study to Build and Validate Multidimensional Risk Score in the Clinical Setting of Kidney Allograft Biopsies to Predict Long-term Allograft Survival

acronym: iBOX

summary:
To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, clinical trials and clinical decision-making.

Despite a clear pressing need, no population-scale prognostication system exists that will combine traditional factors and biomarker candidates to represent the complete spectrum of risk predicting parameters. To adequately predict transplant patients' individual risks of allograft loss, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, allograft precision phenotypes, ethnicity, immunosuppressive regimen monitoring, allograft infections, acute kidney injuries, and recipient immune profiles.

This project aims:

To develop a generalizable, transportable, mechanistically and data driven composite surrogate end point in kidney transplantation;
To validate several risk scores to predict kidney allograft survival and response to treatment of individual patients;

Eventually, it will provide an easily accessible tool to calculate individual patients' risk profiles after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

ReferenceCitation: Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.

family: Aubert

full_name: Olivier Aubert

family: Divard

full_name: Gillian Divard

given: Gillian

family: Pascual

full_name: Julio Pascual

given: Julio

family: Oppenheimer

full_name: Federico Oppenheimer

given: Federico

family: Sommerer

full_name: Claudia Sommerer

given: Claudia

family: Citterio

full_name: Franco Citterio

given: Franco

family: Tedesco

full_name: Helio Tedesco

given: Helio

family: Chadban

full_name: Steve Chadban

given: Steve

family: Henry

full_name: Mitchell Henry

given: Mitchell

family: Vincenti

full_name: Flavio Vincenti

given: Flavio

family: Srinivas

full_name: Titte Srinivas

given: Titte

family: Watarai

full_name: Yoshihiko Watarai

given: Yoshihiko

family: Legendre

full_name: Christophe Legendre

given: Christophe

family: Bernhardt

full_name: Peter Bernhardt

given: Peter

family: Loupy

full_name: Alexandre Loupy

given: Alexandre

currency_apc_doaj: GBP

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Böhmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.

apc_source: openAPC

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Department of Nephrology and Renal Transplantation, University Hospitals Leuven

location_facility: Virginia Commonwealth University School of Medicine

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon

location_facility: William J. von Liebig Center for Transplantation and Clinical Regeneration

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch, Suresnes, France

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France ;

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France;

location_facility: Department of Surgery, Johns Hopkins University School of Medicine

location_facility: Department of Nephrology and Organ Transplantation, CHU Rangueil


title: Impact of a Computerized Decision Support System, Based on EBM French Guidelines, on the Management of Hypertension and Diabetes: a Randomised Controlled Trial in Primary Care

acronym: ASTI

summary: The purpose is to determine wether an electronic decision support system based on national guidelines is effective to improve the follow-up and the treatment of two conditions: hypertension and diabetes, in primary care practices.

ReferenceCitation: Séroussi B, Bouaud J, Dréau H, Falcoff H, Riou C, Joubert M, Simon C, Simon G, Venot A. ASTI: a guideline-based drug-ordering system for primary care. Stud Health Technol Inform. 2001;84(Pt 1):528-32.

lead_sponsor: Société de Formation Thérapeutique du Généraliste


title: Multicentric Randomized Trial of the Impact of Hemodialysis With Polymethylmetacrylate Membrane on the Improvement of Humoral Immune Response in the Hemodialyzed Patients: Application to Hepatitis B Vaccination and Correlation to sCD40 Clearing

acronym: HEPADIAL

summary: The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination

ReferenceCitation: de Précigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13.

family: de Précigout

full_name: Valérie de Précigout

given: Valérie

family: Germain

full_name: Christine Germain

given: Christine

family: Benard

full_name: Antoine Benard

given: Antoine

family: Lacraz

full_name: Adeline Lacraz

given: Adeline

family: Chauveau

full_name: Philippe Chauveau

given: Philippe

family: Deprele

full_name: Carole Deprele

given: Carole

family: Seigneuric

full_name: Bruno Seigneuric

given: Bruno

family: Pommereau

full_name: Antoine Pommereau

family: Courivaud

full_name: Cécile Courivaud

given: Cécile

family: Douillet

full_name: Marine Douillet

given: Marine

family: Taton

full_name: Benjamin Taton

given: Benjamin

family: Combe

full_name: Christian Combe

given: Christian

family: Contin-Bordes

full_name: Cécile Contin-Bordes

journal_name: Blood Purification

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

location_facility:
Pellegrin Hospital, Nephrology Unit
CH Annonay
Larrey Hospital, Dialyze Unit
Saint-Augustin Clinic, Dialyze Unit
CH de la côte Basque
CHU de Besançon

intervention_type: Procedure


title: A Clinical Study to Investigate Interferon Gamma (IFNɣ) Signature in Patients Post HSCT and in Patients With Impaired HSC Proliferation Pre-transplant

summary: Clinical study designed to collect blood for research purposes in patients after hematopoietic stem cell transplantation (HSCT) or in patients with a medical condition where the blood cells production is impaired. The blood samples will be used to study the role of Interferon gamma (IFNɣ) in graft failure or impairment of hematopoietic stem cell proliferation. The IFNɣ signature will be assessed by measuring primarily IFNɣ and C-X-C Motif Chemokine Ligand 9 (CXCL9).

status: Recruiting

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Italy
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Cardiff and Vale University Health Board

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz

location_facility: Imperial College Healthcare NHS Trust NHS Trust

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo


title: Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders

acronym: VHYPER

summary: The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

ReferenceCitation: Vargas F, Clavel M, Sanchez-Verlan P, Garnier S, Boyer A, Bui HN, Clouzeau B, Sazio C, Kerchache A, Guisset O, Benard A, Asselineau J, Gauche B, Gruson D, Silva S, Vignon P, Hilbert G. Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER). Intensive Care Med. 2017 Nov;43(11):1626-1636. doi: 10.1007/s00134-017-4785-1. Epub 2017 Apr 9.

family: Vargas

full_name: Frédéric Vargas

given: Frédéric

family: Clavel

full_name: Marc Clavel

given: Marc

family: Sanchez-Verlan

full_name: Pascale Sanchez-Verlan

given: Pascale

family: Garnier

full_name: Sylvain Garnier

given: Sylvain

family: Boyer

full_name: Alexandre Boyer

family: Bui

full_name: Hoang-Nam Bui

given: Hoang-Nam

family: Clouzeau

full_name: Benjamin Clouzeau

family: Sazio

full_name: Charline Sazio

given: Charline

family: Kerchache

full_name: Aissa Kerchache

given: Aissa

family: Guisset

full_name: Olivier Guisset

given: Olivier

family: Asselineau

full_name: Julien Asselineau

given: Julien

family: Gauche

full_name: Bernard Gauche

given: Bernard

family: Gruson

full_name: Didier Gruson

given: Didier

family: Silva

full_name: Stein Silva

given: Stein

family: Vignon

full_name: Philippe Vignon

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

journal_name: Intensive Care Medicine

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

location_facility:
University Hospital
Hospital
Saint-André Hospital
Pellegrin Hospital, Recovery Unit


title: ORALIA Trial Randomized Controlled Trial of Medical Treatment Alone vs Medical Treatment Associated With Anoperineal Physiotherapy for Adult Anal Incontinence. Assessment of Incontinence Symptoms and Quality of Life.

summary:
The purpose of this study is to evaluate the impact of anoperineal physiotherapy in adjunction to standard medical treatment on symptoms and quality of life of adults with anal incontinence, in comparison with standard treatment alone.

A total of 443 patients will be randomized to 2 groups: standard care (medical treatment) alone or standard care associated with anoperineal physiotherapy. Outcome measures include the patient own view of the effectiveness of the treatment, the continence score, quality of life and psychological status. These outcomes are measured at the end of the 4 months treatment period.

Following this period, the non responders to standard medical treatment will be proposed to undergo a course of anoperineal physiotherapy and the non responders to anoperineal physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The outcomes will be measured at the end of the 4 months new treatment and again after 4 months follow-up.

status: Terminated

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral


title: mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

acronym: EVEROLD

summary: This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).

lead_sponsor: University Hospital, Brest

location_facility:
CHU Rennes
AP-HP Hopital Necker
CHU Limoges
CHU Rangueil - Toulouse
CHU Clermont Ferrand
CHU Poitiers
CHU Reims
CHU Pellegrin - Bordeaux
CHU Montpellier
Hopitaux Universitaires de Strasbourg
CHU Tours
CHRU de BREST
CHU Dijon
CHU Nice
CHU Rouen
CHU Lille
CHU Amiens
CHU Cote de Nacre


title: Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis

summary: TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.

ReferenceCitation: Nguyen C, Palazzo C, Grabar S, Feydy A, Sanchez K, Zee N, Quinquis L, Ben Boutieb M, Revel M, Lefèvre-Colau MM, Poiraudeau S, Rannou F. Tumor necrosis factor-α blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study. Arthritis Res Ther. 2015 Nov 19;17:330. doi: 10.1186/s13075-015-0838-4.

family: Nguyen

full_name: Christelle Nguyen

given: Christelle

family: Palazzo

full_name: Clémence Palazzo

given: Clémence

family: Grabar

full_name: Sophie Grabar

given: Sophie

family: Feydy

full_name: Antoine Feydy

given: Antoine

family: Sanchez

full_name: Katherine Sanchez

given: Katherine

family: Zee

full_name: Nathalie Zee

given: Nathalie

family: Quinquis

full_name: Laurent Quinquis

given: Laurent

family: Ben Boutieb

full_name: Myriam Ben Boutieb

given: Myriam

family: Revel

full_name: Michel Revel

given: Michel

family: Lefèvre-Colau

full_name: Marie-Martine Lefèvre-Colau

given: Marie-Martine

family: Poiraudeau

full_name: Serge Poiraudeau

given: Serge

family: Rannou

full_name: François Rannou

given: François

journal_name: Arthritis Research & Therapy

license: cc-by

license_normalized: cc-by

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

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

repositories:
HAL
PubMed Central


ReferenceCitation: Qin S, Finn RS, Kudo M, Meyer T, Vogel A, Ducreux M, Macarulla TM, Tomasello G, Boisserie F, Hou J, Li X, Song J, Zhu AX. RATIONALE 301 study: tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Future Oncol. 2019 Jun;15(16):1811-1822. doi: 10.2217/fon-2019-0097. Epub 2019 Apr 10.

name: People’s Liberation Army (PLA) 81 Hospital, Nanjing 210016, PR China

family: Qin

full_name: Shukui Qin

given: Shukui

name: University of California Los Angeles, Los Angeles, CA 90095, USA

family: Finn

full_name: Richard S Finn

given: Richard S

name: Department of Gastroenterology & Hepatology, Kindai University School of Medicine, Osaka 577-8502, Japan

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

name: University College London Cancer Institute, London WC1E 6AG, UK

family: Meyer

full_name: Tim Meyer

given: Tim

name: Medizinische Hochschule Hannover, Hannover 30625, Germany

family: Vogel

full_name: Arndt Vogel

given: Arndt

family: Ducreux

full_name: Michel Ducreux

name: Vall d’Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona 08035, Spain

family: Macarulla

full_name: Teresa Mercade Macarulla

given: Teresa Mercade

name: Azienda Istituti Ospitalieri di Cremona, Cremona 26100, Italy

family: Tomasello

full_name: Gianluca Tomasello

given: Gianluca

family: Boisserie

full_name: Frederic Boisserie

given: Frederic

family: Hou

full_name: Jeannie Hou

given: Jeannie

name: BeiGene Co., Ltd, Beijing 102206, PR China

family: Li

full_name: Xin Li

given: Xin

family: Song

full_name: James Song

given: James

name: Harvard Medical School, Massachusetts General Hospital Cancer Center, Boston, MA 02114, USA

family: Zhu

full_name: Andrew X Zhu

given: Andrew X

journal_name: Future Oncology

evidence: open (via page says license)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_institution: University College London - UCL Discovery

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: BeiGene

location_country:
Italy
United States
Spain
France
Czechia
Japan
Poland
China
Germany
United Kingdom
Taiwan

location_facility: CHU Cote De Nacre - Hepato-Gastro-Enterologie Et N

location_facility: China Medical University Hospital - Transplantology - Taichung

location_facility: The First Affiliated Hospital Of XI'AN Jiaotong University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hôpital Privé des Côtes d'Armor - Service oncologie

location_facility: Sun Yat-sen Memorial Hospital , Sun Yat-sen University

location_facility: Queen Elizabeth Hospital - Clinical Reasearch

location_facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

location_facility: Precision Cancer Research / Dayton Physicians Network

location_facility: Beijing YouAn Hospital, Capital Medical University

location_facility: National Center for Global Health and Medicine

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: The First Affiliated Hospital Of Anhui Medical University

location_facility: Hahnemann University Hospital - Gastroenterology Hepatology

location_facility: Cancer Hopital Chinese Academy of Medical Sciences

location_facility: Ehime Prefectural Central Hospital - Gastroenterology

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele di Catania

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Gastroenterology

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Kinki University Hospital, Faculty of Medicine - Hematology & Clinical Oncology

location_facility: The Affiliated Hospital Of Qingdao University

location_facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Sir Run Run Shaw Hospital, Zhejiang University

location_facility: Bichat-Beaujon Service Inter Hospitalier De Cancerologie

location_facility: Wojewodzki Szpital Specjalistyczny im. Gromkowskiego we Wroclawiu

location_facility: PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology

location_facility: Anhui Medical University - The Second Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Tri-Service General Hospital - Neihu Branch

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

location_facility: Cancer Treatment Centers of America - Oncology

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: IRCCS Saverio De Bellis, AO Gastroenterologia

location_facility: University Hospital, Kyoto Prefectural Univ of Medicine

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hokkaido University Hospital - Gastroenterology

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Nihon University Itabashi Hospital - Gastroenterological surgery

location_facility: University of California - Hematology and Oncology

location_facility: Hospital Universitario Madrid Sanchinarro Centro integral Oncologico Clara Campal (CIOCC)

location_facility: Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital

location_facility: Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: CHU Amiens-Hopital Nord - Hépato-Gastroentérologie

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: The Christie NHS Foundation Trust - Oak Road Treatment Centre

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Malattie

location_facility: Fujian Medical University Union Hospital

location_facility: Vanderbilt University Medical Center (VUMC)

location_facility: Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su

location_facility: Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncologia

location_facility: The First Affiliated Hospital of Guangxi Medical University

location_facility: White Plains Hospital Center for Cancer Care - Oncology

ipd_sharing: Yes

type: Registry Identifier

source: euctr

title: RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

summary: This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study.


title: ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome. Beneficial or Iatrogenic Effects.

summary:
Scientific Objectives Primary objective : Demonstrate that oral intake of tranexamic acid significantly reduces the risk of epistaxis occurrence, estimated by the average monthly duration of episodes of epistaxis.

Secondary objectives :

Document the benefit of tranexamic acid on the amount of haemoglobine and quality of life of patients.
Identify scalable and genetic factors of response to the treatment by tranexamic acid.
Describe compliance and tolerance of the treatment. Method Experimental Design We suggest the realisation of a randomised comparative clinical trial versus placebo, with a crossover of random alternated periods of three months over a total of six months.

Study Population 213 affected patients, displaying sufficiently invalidating epistaxis to require a basal treatment, will be recruited and followed every 3 months. Recruitment will lean on teams who are part of the national French network in close collaboration with the reference centre for the Rendu-Osler disorder, appointed to Lyon on the 19th of November 2004. Follow up of the study will be carried out by the Clinical Investigational Centre of the related towns.

Outcome measures The main criterion of efficacy is the average duration of epistaxis, the secondary criterion of efficacy is the average number of epistaxis measured per month. Tolerance will be analysed according to the occurrence of venal or arterial thrombosis and allergic accidents. Venal thrombosis will systematically be sought by an inferior limbs echodoppler. Response markers will be sought through modelisation incorporating environmental, phenotypic and genetic factors.

ReferenceCitation: Gaillard S, Dupuis-Girod S, Boutitie F, Rivière S, Morinière S, Hatron PY, Manfredi G, Kaminsky P, Capitaine AL, Roy P, Gueyffier F, Plauchu H; ATERO Study Group. Tranexamic acid for epistaxis in hereditary hemorrhagic telangiectasia patients: a European cross-over controlled trial in a rare disease. J Thromb Haemost. 2014 Sep;12(9):1494-502. doi: 10.1111/jth.12654. Epub 2014 Jul 29.

name: INSERM, CIC 1407 Lyon; Hospices Civils de Lyon; Service de Pharmacologie Clinique Lyon; Université de Lyon; Lyon France

name: CNRS, UMR5558; Laboratoire de Biométrie et Biologie Evolutive; Equipe Biotatistique-Santé; Villeurbanne France

family: Gaillard

full_name: S. Gaillard

given: S.

name: Hospices Civils de Lyon; Hôpital Louis Pradel, Service de Génétique et Centre de Référence National Maladie de Rendu-Osler; Service ORL; Bron France

name: Hôpital Edouard Herriot; Service ORL; Lyon France

name: Hôpital de la Croix Rousse; Service ORL; Lyon France

family: Dupuis-Girod

full_name: S. Dupuis-Girod

name: Hospices Civils de Lyon; Service de Biostatistique; Lyon France

family: Boutitie

full_name: F. Boutitie

given: F.

name: Centre Hospitalier et Universitaire de Montpellier; Service de Médecine Interne; Montpellier France

family: Rivière

full_name: S. Rivière

name: Centre Hospitalier et Universitaire de Tours; Hôpital Bretonneau, Service ORL; Service de Pneumologie; Tours France

family: Morinière

full_name: S. Morinière

name: Centre Hospitalier Régional et Universitaire de Lille; Hôpital Huriez, Service de Médecine Interne; Hôpital Jeanne de Flandre; Service de Génétique; Lille France

family: Hatron

full_name: P.-Y. Hatron

name: Gastroenterology Department; HHT Centre for the National Network of Rare Diseases; Maggiore Hospital; Crema Italy

family: Manfredi

full_name: G. Manfredi

given: G.

name: Centre Hospitalier et Universitaire de Nancy; Hôpital Brabois, Service de Médecine Interne; Hôpital Central; Service ORL; Nancy France

family: Kaminsky

full_name: P. Kaminsky

given: P.

name: Centre Hospitalier et Universitaire de Poitiers; Hôpital Jean Bernard, Service ORL; Service de Génétique; Poitiers France

family: Capitaine

full_name: A.-L. Capitaine

family: Roy

full_name: P. Roy

family: Gueyffier

full_name: F. Gueyffier

family: Plauchu

full_name: H. Plauchu

given: H.

journal_name: Journal of Thrombosis and Haemostasis


title: TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy

summary: The purpose of this study is to compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the PFS, with that of single-agent cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet chemotherapy.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Italy
United States
Netherlands
France
Australia
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: L'Assistance Publique - Hopitaux de Marseille

location_facility: University of California San Diego Moores Cancer Center

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion) (UAM -FJD)

location_facility: Seoul National University Bundang Hospital

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST

location_facility: The Catholic University of Korea Saint Vincent's Hospital

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Central Coast Medical Oncology Corporation

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Walter Reed National Military Medical Center

location_facility: University of Pittsburgh Cancer Institute (UPMC)

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: The Oncology Institute of Hope and Innovation

location_facility: University of California, San Francisco Helen Diller Family Comprehensive Cancer Center

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: Sylvester Comprehensive Cancer Center (UMHC)

location_facility: Oregon Health & Science University (OHSU) - Knight Cancer Institute

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Florida Health Science Center


title: IMP321 Phase 1 Study in Advanced or Metastatic Renal Cell Carcinoma Patients (P003)

summary: Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting

ReferenceCitation: Brignone C, Escudier B, Grygar C, Marcu M, Triebel F. A phase I pharmacokinetic and biological correlative study of IMP321, a novel MHC class II agonist, in patients with advanced renal cell carcinoma. Clin Cancer Res. 2009 Oct 1;15(19):6225-31. doi: 10.1158/1078-0432.CCR-09-0068. Epub 2009 Sep 15.

family: Brignone

full_name: Chrystelle Brignone

given: Chrystelle

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Grygar

full_name: Caroline Grygar

given: Caroline

family: Marcu

full_name: Manon Marcu

given: Manon

family: Triebel

full_name: Frédéric Triebel

given: Frédéric

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: A Phase I Pharmacokinetic and Biological Correlative Study of IMP321, a Novel MHC Class II Agonist, in Patients with Advanced Renal Cell Carcinoma

lead_sponsor: Immutep S.A.S.

intervention_type: Biological


title: Placebo-controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation

summary: A probiotic bacterial strain was tested in a randomized, double blind , placebo controlled clinical trial with 54 healthy male volunteers. Half the volunteers received the dietary supplement the other half placebo during 6 weeks prior to exposure to solar-simulated UV irradition (2x1,5MED). Blister roofs and skin biopsies were recovered 1, 4 and 10 days after UV exposure from unirradiated and irradiated skin and used for immunohistochemical analysis and mixed epidermal cell lymphocyte reaction

lead_sponsor: L'Oreal


title: Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

summary: Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.

ReferenceCitation: Tranquart F, Brunereau L, Cottier JP, Marret H, Gallas S, Lebrun JL, Body G, Herbreteau D, Pourcelot L. Prospective sonographic assessment of uterine artery embolization for the treatment of fibroids. Ultrasound Obstet Gynecol. 2002 Jan;19(1):81-7.

ReferenceCitation: Marret H, Cottier JP, Alonso AM, Giraudeau B, Body G, Herbreteau D. Predictive factors for fibroids recurrence after uterine artery embolisation. BJOG. 2005 Apr;112(4):461-5.

ReferenceCitation: Marret H, Tranquart F, Sauget S, Alonso AM, Cottier JP, Herbreteau D. Contrast-enhanced sonography during uterine artery embolization for the treatment of leiomyomas. Ultrasound Obstet Gynecol. 2004 Jan;23(1):77-9.

lead_sponsor: University Hospital, Tours


title: Treatment of ANCA-Associated Vasculitides : Corticosteroids and Pulse Cyclophosphamide Followed by Maintenance Therapy With Methotrexate or Azathioprine: a Prospective Multicenter Randomized Trial

summary: Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent. This point warrants the prescription of a maintenance treatment with a less toxic immunosuppressant for several months to years. The optimal drug in this indication is not determine. We decided therefore to compare the 2 most used drugs in this indication. Induction therapy consists in the combination of corticosteroids and intravenous cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks, then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3 weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2). At that time, patients are randomized for a maintenance treatment with azathioprine (2 mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of 25 mg/wk) for 12 months.

ReferenceCitation: Pagnoux C, Mahr A, Hamidou MA, Boffa JJ, Ruivard M, Ducroix JP, Kyndt X, Lifermann F, Papo T, Lambert M, Le Noach J, Khellaf M, Merrien D, Puéchal X, Vinzio S, Cohen P, Mouthon L, Cordier JF, Guillevin L; French Vasculitis Study Group. Azathioprine or methotrexate maintenance for ANCA-associated vasculitis. N Engl J Med. 2008 Dec 25;359(26):2790-803. doi: 10.1056/NEJMoa0802311.

family: Pagnoux

full_name: Christian Pagnoux

given: Christian

family: Mahr

full_name: Alfred Mahr

given: Alfred

family: Hamidou

full_name: Mohamed A. Hamidou

given: Mohamed A.

family: Boffa

full_name: Jean-Jacques Boffa

given: Jean-Jacques

family: Ruivard

full_name: Marc Ruivard

given: Marc

family: Ducroix

full_name: Jean-Pierre Ducroix

given: Jean-Pierre

family: Kyndt

full_name: Xavier Kyndt

given: Xavier

family: Lifermann

full_name: François Lifermann

given: François

family: Papo

full_name: Thomas Papo

given: Thomas

family: Lambert

full_name: Marc Lambert

family: Le Noach

full_name: José Le Noach

given: José

family: Khellaf

full_name: Mehdi Khellaf

given: Mehdi

family: Merrien

full_name: Dominique Merrien

given: Dominique

family: Puéchal

full_name: Xavier Puéchal

family: Vinzio

full_name: Stéphane Vinzio

given: Stéphane

family: Cohen

full_name: Pascal Cohen

given: Pascal

family: Mouthon

full_name: Luc Mouthon

given: Luc

family: Cordier

full_name: Jean-François Cordier

given: Jean-François

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Azathioprine or Methotrexate Maintenance for ANCA-Associated Vasculitis


title: Phase II Study of Intra-Peritoneal Hyper-Thermic Chemotherapy as Consolidation Therapy for Advanced Epithelial Ovarian Carcinoma

summary:
Phase II to study results and morbidity of intra peritoneal hyper-thermic chemotherapy as consolidation therapy in patients with FIGO stage IIIC epithelial ovarian carcinoma treated by surgery and a total of 6 cycles of platinum based chemotherapy.

A second look operation is performed after treatment; during this second look secondary cytoreductive surgery is accepted without bowel resection.If none or milimetric peritoneal disease is obseved an intraperitoneal chemotherapy is achieve


summary: This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.

lead_sponsor: Guerbet


title: A Phase II Study of Velcade® (Bortezomib) in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Chemotherapy

summary: The purpose of this study is to determine whether Bortezomib is effective in the treatment of patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen for advanced disease.


title: A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo

acronym: OSMAUSE

summary:
The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).

The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:

Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and

Bone turnover markers (BTMs) of:

fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
serum aminoterminal propeptide of type 1 procollagen (PINP); and
urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.

lead_sponsor: Sanofi


title: A Randomised, Double-blind, French Multi-centre Study, to Evaluate the Efficacy and Tolerance, in Comparison With Placebo, of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults

acronym: RhiCNANI

summary: To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious Rhinitis


title: Severe Post Partum Haemorrhage (PPH): A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks

summary:
Hypothesis A "multifaceted" intervention program aimed at increasing the responsiveness of care givers, the adequacy of care provided, and the efficacy of organisation of care, in presence of abnormal blood loss in the immediate post partum has more impact on the incidence of severe PPH and on the costs of care than the current methods of dissemination of clinical practice guidelines.

Intervention Intervention group. The intervention includes three components: (1) outreach visits with local presentation of evidence-based clinical practice guidelines for management of PPH, and discussion of their applicability in the context of local organisation; (2) during these educational visits, reminders - check list, "PPH emergency case" containing appropriate materials - to be used in case of PPH, will be proposed; (3) finally, cases of severe PPH will be reviewed during peer review sessions organized in each participating unit, to help identifying weaknesses in care provided, and needs for improvement.

Control group. The proposed guidelines for management of PPH will be disseminated through the participating perinatal networks; then each unit will be free to implement them at its own convenience.

Randomisation procedure The trial follows a cluster randomised trial design. Randomisation of maternity units will be stratified by region, status (public versus private) and size (annual number of deliveries). The stratified design will guarantee the comparability of the two arms of the trial at baseline.

Outcome measures The primary outcome is the incidence of severe PPH (number of severe PPH to number of deliveries). A severe PPH is defined as a PPH that was associated with one or more of the following: peripartum haemoglobin drop greater than 4g/dl, blood transfusion, arterial embolisation, surgical procedures such as hysterectomy or arterial ligation, transfer of the mother to intensive care unit, maternal death.

Secondary outcomes include the cost of care and the cost/efficacy ratio, and the incidence of adverse effects of uterotonic drugs.


title: Multi Centers, Open-trial Phase II Study Evaluating 5-azacytidine (Vidaza®) + Valproic Acid (Depakine ®) Before Administration of Retinoic Acid (Vesanoid®) in Patients With Acute Myelogenous Leukemia and High Risk Myelodysplasia.

summary: MULTICENTERS. Uncontrolled and open phase II study. Evaluation of the effectiveness of a treatment associating 5 Azacytidine,Valproic acid ,Retinoic Acid at subjects-reached of syndromes myelodysplasia and acute MYELOID leukaemia Hematological response at 6 months Uncontrolled prospective cohort.