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name: From the Institutions Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia, Modena; Azienda Universitaria Ospedaliera S. Giovanni Battista, Torino; Istituto Seràgnoli, Unità Operativa di Emolinfopatologia, Bologna; Ematologia, Università “La Sapienza”, Roma; Ematologia e Centro Trapianto di Midollo Osseo Ospedale Centrale di Bolzano, Bolzano; Istituto Europeo di Oncologia, Milano; Cattedra di Ematologia, Università di Firenze e Azienda Ospedaliera Careggi, Firenze; Divisione di...

family: Federico

full_name: Massimo Federico

given: Massimo

family: Bellei

full_name: Monica Bellei

given: Monica

family: Marcheselli

full_name: Luigi Marcheselli

given: Luigi

family: Luminari

full_name: Stefano Luminari

given: Stefano

family: Lopez-Guillermo

full_name: Armando Lopez-Guillermo

given: Armando

family: Vitolo

full_name: Umberto Vitolo

given: Umberto

family: Pro

full_name: Barbara Pro

given: Barbara

family: Pileri

full_name: Stefano Pileri

family: Pulsoni

full_name: Alessandro Pulsoni

given: Alessandro

family: Soubeyran

full_name: Pierre Soubeyran

given: Pierre

family: Cortelazzo

full_name: Sergio Cortelazzo

given: Sergio

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

family: Martelli

full_name: Maurizio Martelli

given: Maurizio

family: Rigacci

full_name: Luigi Rigacci

family: Arcaini

full_name: Luca Arcaini

given: Luca

family: Di Raimondo

full_name: Francesco Di Raimondo

given: Francesco

family: Merli

full_name: Francesco Merli

family: Sabattini

full_name: Elena Sabattini

given: Elena

family: McLaughlin

full_name: Peter McLaughlin

given: Peter

family: Solal-Céligny

full_name: Philippe Solal-Céligny

given: Philippe

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Follicular Lymphoma International Prognostic Index 2: A New Prognostic Index for Follicular Lymphoma Developed by the International Follicular Lymphoma Prognostic Factor Project

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name: Hospices Civils de Lyon and Université Lyon 1, Lyon, France;

name: Centre Hospitalier Universitaire de Nice, Nice, France;

name: Centre Hospitalier Universitaire de Rennes, Rennes, France;

name: Centre Hospitalier Universitaire de Lille, Lille, France;

name: Cliniques Universitaires (UCL) de Mont-Godinne, Yvoir, Belgium;

name: Centre Hospitalier Universitaire de Montpellier, Montpellier, France;

name: Hôpital Henri-Mondor, Assistance Publique-Hopitaux de Paris and Université Paris XII, Paris, France;

name: Hôpital Saint-Louis, Assistance Publique-Hopitaux de Paris, Paris, France;

name: Centre Hospitalier Universitaire de Nantes, Nantes, France;

name: Institut Paoli Calmettes, Marseille, Marseille, France;

name: Centre Hospitalier (CH) de Colmar, Colmar, France;

name: Institut Gustave Roussy, Villejuif, France;

name: Centre Hospitalier Universitaire de Tours, Tours, France;

name: Centre Hospitalier Universitaire de Nancy, Nancy, France;

name: Centre Hospitalier Universitaire d'Angers, d'Angers, France

title: Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study

ReferenceCitation: Salles G, Seymour JF, Offner F, López-Guillermo A, Belada D, Xerri L, Feugier P, Bouabdallah R, Catalano JV, Brice P, Caballero D, Haioun C, Pedersen LM, Delmer A, Simpson D, Leppa S, Soubeyran P, Hagenbeek A, Casasnovas O, Intragumtornchai T, Fermé C, da Silva MG, Sebban C, Lister A, Estell JA, Milone G, Sonet A, Mendila M, Coiffier B, Tilly H. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7. Epub 2010 Dec 20. Erratum in: Lancet. 2011 Apr 2;377(9772):1154.

ReferenceCitation: Deconinck E, Foussard C, Milpied N, Bertrand P, Michenet P, Cornillet-LeFebvre P, Escoffre-Barbe M, Maisonneuve H, Delwail V, Gressin R, Legouffe E, Vilque JP, Desablens B, Jaubert J, Ramee JF, Jenabian A, Thyss A, Le Pourhiet-Le Mevel A, Travade P, Delepine R, Colombat P; GOELAMS. High-dose therapy followed by autologous purged stem-cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by GOELAMS. Blood. 2005 May 15;105(10):3817-23. Epub 2005 Feb 1.

ReferenceCitation: Gyan E, Foussard C, Bertrand P, Michenet P, Le Gouill S, Berthou C, Maisonneuve H, Delwail V, Gressin R, Quittet P, Vilque JP, Desablens B, Jaubert J, Ramée JF, Arakelyan N, Thyss A, Moluçon-Chabrot C, Delépine R, Milpied N, Colombat P, Deconinck E; Groupe Ouest-Est des Leucémies et des Autres Maladies du Sang (GOELAMS). High-dose therapy followed by autologous purged stem cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by the GOELAMS with final results after a median follow-up of 9 years. Blood. 2009 Jan 29;113(5):995-1001. doi: 10.1182/blood-2008-05-160200. Epub 2008 Oct 27.

name: Department of Hematology, Bretonneau University Hospital, Tours;

name: Department of Hematology, University Hospital, Angers;

name: Department of Biostatistics, Faculty of Medicine, Tours;

name: Department of Pathology, Centre Hospitalier, Orléans;

name: Department of Hematology, University Hospital of Nantes, Nantes;

name: Department of Hematology, University Hospital, Brest;

name: Department of Hematology, Centre Hospitalier, La Roche-sur-Yon;

name: Department of Hematology, University Hospital of Poitiers, Jean Bernard Hospital, Poitiers;

name: Department of Hematology, University Hospital, Grenoble;

name: Department of Hematology, University Hospital of Montpellier, Montpellier;

name: François Baclesse Anticancer Center, Caen;

name: Department of Hematology, University Hospital, Amiens;

name: Department of Hematology, University Hospital, Saint-Etienne;

name: Department of Hematology, Catherine de Sienne Clinic, Nantes;

name: Department of Hematology, Georges Pompidou European Hospital, Paris;

name: Antoine Lacassagne Anticancer Center, Nice;

name: Department of Hematology, University Hospital, Clermont-Ferrand;

name: Department of Hematology, University Hospital of Bordeaux, Bordeaux; and

name: Inserm, U645, Franche-Comté University and Department of Hematology, Jean Minjoz Hospital, Besançon, France

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ReferenceCitation: Lenz G, Dreyling M, Schiegnitz E, Forstpointner R, Wandt H, Freund M, Hess G, Truemper L, Diehl V, Kropff M, Kneba M, Schmitz N, Metzner B, Pfirrmann M, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission prolongs progression-free survival in follicular lymphoma: results of a prospective, randomized trial of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 1;104(9):2667-74. Epub 2004 Jul 6.

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ReferenceCitation: van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3.

name: From the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group, Hovon, Belgium; EORTC Data Center, National Cancer Institute Canada, Clinical Trials Group, Hematology Group, Vancouver, British Columbia, Canada; British National Lymphoma Investigation, London, United Kingdom; Australasian Leukemia and Lymphoma Group, Melbourne, Victoria, Australia; and Nordic Lymphoma Group, Oslo, Norway.

title: Rituximab Maintenance Treatment of Relapsed/Resistant Follicular Non-Hodgkin's Lymphoma: Long-Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study

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ReferenceCitation: Rohatiner AZ, Nadler L, Davies AJ, Apostolidis J, Neuberg D, Matthews J, Gribben JG, Mauch PM, Lister TA, Freedman AS. Myeloablative therapy with autologous bone marrow transplantation for follicular lymphoma at the time of second or subsequent remission: long-term follow-up. J Clin Oncol. 2007 Jun 20;25(18):2554-9. Epub 2007 May 21.

ReferenceCitation: Vose JM, Bierman PJ, Loberiza FR, Lynch JC, Bociek GR, Weisenburger DD, Armitage JO. Long-term outcomes of autologous stem cell transplantation for follicular non-Hodgkin lymphoma: effect of histological grade and Follicular International Prognostic Index. Biol Blood Marrow Transplant. 2008 Jan;14(1):36-42. Epub 2007 Dec 3.

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ReferenceCitation: Witzens-Harig M, Dreger P. Autologous transplant of follicular lymphoma in the era of rituximab. Leuk Lymphoma. 2010 Jun;51(6):967-74. doi: 10.3109/10428191003793341. Review.

ReferenceCitation: Sebban C, Brice P, Delarue R, Haioun C, Souleau B, Mounier N, Brousse N, Feugier P, Tilly H, Solal-Céligny P, Coiffier B. Impact of rituximab and/or high-dose therapy with autotransplant at time of relapse in patients with follicular lymphoma: a GELA study. J Clin Oncol. 2008 Jul 20;26(21):3614-20. doi: 10.1200/JCO.2007.15.5358. Epub 2008 Jun 16.

ReferenceCitation: Le Gouill S, De Guibert S, Planche L, Brice P, Dupuis J, Cartron G, Van Hoof A, Casasnovas O, Gyan E, Tilly H, Fruchart C, Deconinck E, Fitoussi O, Gastaud L, Delwail V, Gabarre J, Gressin R, Blanc M, Foussard C, Salles G; GELA and GOELAMS. Impact of the use of autologous stem cell transplantation at first relapse both in naive and previously rituximab exposed follicular lymphoma patients treated in the GELA/GOELAMS FL2000 study. Haematologica. 2011 Aug;96(8):1128-35. doi: 10.3324/haematol.2010.030320. Epub 2011 Apr 12.

ReferenceCitation: Decaudin D, Mounier N, Tilly H, Ribrag V, Ghesquières H, Bouabdallah K, Morschhauser F, Coiffier B, Le Gouill S, Bologna S, Delarue R, Huynh A, Bosly A, Brière J, Gisselbrecht C. (90)Y ibritumomab tiuxetan (Zevalin) combined with BEAM (Z -BEAM) conditioning regimen plus autologous stem cell transplantation in relapsed or refractory low-grade CD20-positive B-cell lymphoma. A GELA phase II prospective study. Clin Lymphoma Myeloma Leuk. 2011 Apr;11(2):212-8. doi: 10.1016/j.clml.2011.03.007. Epub 2011 Apr 9.

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ReferenceCitation: Chow KU, Boehrer S, Napieralski S, Nowak D, Knau A, Hoelzer D, Mitrou PS, Weidmann E. In AML cell lines Ara-C combined with purine analogues is able to exert synergistic as well as antagonistic effects on proliferation, apoptosis and disruption of mitochondrial membrane potential. Leuk Lymphoma. 2003 Jan;44(1):165-73.

ReferenceCitation: Leoni LM, Bailey B, Reifert J, Bendall HH, Zeller RW, Corbeil J, Elliott G, Niemeyer CC. Bendamustine (Treanda) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res. 2008 Jan 1;14(1):309-17. doi: 10.1158/1078-0432.CCR-07-1061.

ReferenceCitation: Fischer K, Stilgenbauer S, Schweighofer CD, et al.: Bendamustine in combination with rituximab (BR) for patients with relapsed chronic lymphocitic leukemia (CLL): a multicenter phase II trial of the German CLL study group. Blood 112, 2008 (abstr)

ReferenceCitation: Robinson KS, Williams ME, van der Jagt RH, Cohen P, Herst JA, Tulpule A, Schwartzberg LS, Lemieux B, Cheson BD. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol. 2008 Sep 20;26(27):4473-9. doi: 10.1200/JCO.2008.17.0001. Epub 2008 Jul 14.

ReferenceCitation: Rummel M, iederle N, aschmeyer G, et al.: Bendamustine plus rituximab is superior in respect of progression-free survival and CR rate when compared to CHOP plus rituximab as first-line treatment of patients with advanced follicular, indolent, and mantle cell lymphomas: Final results of a randomized phase III study of the StiL (Study Group Indolent Lymphomas, Germany). Lancet. 2013 Feb 19 (In press)

ReferenceCitation: Rummel MJ, Al-Batran SE, Kim SZ, Welslau M, Hecker R, Kofahl-Krause D, Josten KM, Dürk H, Rost A, Neise M, von Grünhagen U, Chow KU, Hansmann ML, Hoelzer D, Mitrou PS. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol. 2005 May 20;23(15):3383-9.

ReferenceCitation: Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008 Jan 10;26(2):204-10. doi: 10.1200/JCO.2007.12.5070. Erratum in: J Clin Oncol. 2008 Apr 10;26(11) 1911.

ReferenceCitation: Herold M, Schulze A, Niederwieser D, Franke A, Fricke HJ, Richter P, Freund M, Ismer B, Dachselt K, Boewer C, Schirmer V, Weniger J, Pasold R, Winkelmann C, Klinkenstein C, Schulze M, Arzberger H, Bremer K, Hahnfeld S, Schwarzer A, Müller C, Müller C; East German Study Group Hematology and Oncology (OSHO). Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19). J Cancer Res Clin Oncol. 2006 Feb;132(2):105-12. Epub 2005 Aug 9.

ReferenceCitation: Rasschaert M, Schrijvers D, Van den Brande J, Dyck J, Bosmans J, Merkle K, Vermorken JB. A phase I study of bendamustine hydrochloride administered once every 3 weeks in patients with solid tumors. Anticancer Drugs. 2007 Jun;18(5):587-95.

ReferenceCitation: Rasschaert M, Schrijvers D, Van den Brande J, Dyck J, Bosmans J, Merkle K, Vermorken JB. A phase I study of bendamustine hydrochloride administered day 1+2 every 3 weeks in patients with solid tumours. Br J Cancer. 2007 Jun 4;96(11):1692-8. Epub 2007 May 8.

ReferenceCitation: Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3.

ReferenceCitation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.

ReferenceCitation: Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-López A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. Review. Erratum in: J Clin Oncol 2000 Jun;18(11):2351.

ReferenceCitation: Boellaard R, O'Doherty MJ, Weber WA, Mottaghy FM, Lonsdale MN, Stroobants SG, Oyen WJ, Kotzerke J, Hoekstra OS, Pruim J, Marsden PK, Tatsch K, Hoekstra CJ, Visser EP, Arends B, Verzijlbergen FJ, Zijlstra JM, Comans EF, Lammertsma AA, Paans AM, Willemsen AT, Beyer T, Bockisch A, Schaefer-Prokop C, Delbeke D, Baum RP, Chiti A, Krause BJ. FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0. Eur J Nucl Med Mol Imaging. 2010 Jan;37(1):181-200. doi: 10.1007/s00259-009-1297-4.

location_facility:
Centre Léon Bérard
CHU de Rennes - Hôpital Pontchaillou
CHU Henri Mondor
CHU Grenoble - Hôpital Michallon
CHRU de Montpellier, Hôpital Saint-Eloi
CHU de Nancy
CHU de Dijon - Hôpital Le Bocage
Centre Henri Becquerel
CHU de Nantes Hôtel Dieu
APHP Hôpital Necker
AP-HP Hôpital Saint-Louis
CHU Lyon Sud
CHRU de Lille Hôpital Claude Huriez

title: A Multicenter Phase II Study Evaluating BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Prior to Autologous Stem Cell Transplant for First and Second Chemosensitive Relapses in Patients With Follicular Lymphoma

summary: The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine, etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for first and second chemosensitive relapses in patients with follicular lymphoma (World Health Organisation (WHO) grade 1, 2, 3a).


title: Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours

acronym: PRECOCE

summary:
Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma.

In the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia. To this end, the investigators realize a national multicenter prospective study including 300 patients. The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU Limoges -Urologie - Hôpital Dupuytren

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Tolerance of Long Term Administration of Forlax® 10g in Elderly Ambulatory or Institutionalized Patients Suffering From Chronic Constipation. Single Blind Randomised Lactulose-controlled Study With Individual Expected Benefit.

summary: The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Ipsen

location_facility: Hôpital Charles Nicolle - Service de Gastroentérologie et Nutrition

location_facility: Centre Hospitalier Sud Hôpital Xavier Arnozan

location_facility: Hôpital Charles Nicolle - Service de Biochimie Médicale

intervention_type: Drug

lead_sponsor_type: industriel


title: Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)

acronym: PRECIS

summary:
Purpose of the study :

To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Moluçon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20.

name: Groupe Hospitalier Universitaire Pitié-Salpétrière, Paris, France

family: Houillier

full_name: Caroline Houillier

given: Caroline

sequence: first

name: Centre Hospitalier Universitaire de Nancy, Nancy, France

family: Taillandier

full_name: Luc Taillandier

given: Luc

sequence: additional

name: Institut Curie, Site Saint-Cloud, Saint-Cloud, France

family: Dureau

full_name: Sylvain Dureau

given: Sylvain

name: Centre Hospitalier Universitaire de Rennes, Rennes, France

family: Lamy

full_name: Thierry Lamy

given: Thierry

family: Laadhari

full_name: Mouna Laadhari

given: Mouna

name: Centre Hospitalier Universitaire de la Timone, Marseille, France

family: Chinot

full_name: Olivier Chinot

given: Olivier

name: Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

family: Moluçon-Chabrot

full_name: Cecile Moluçon-Chabrot

given: Cecile

name: Centre Hospitalier Universitaire de Grenoble, La Tronche, France

family: Gressin

full_name: Remy Gressin

given: Remy

family: Choquet

full_name: Sylvain Choquet

name: Centre Hospitalier Universitaire d’Amiens, Salouël, France

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

family: Thyss

full_name: Antoine Thyss

given: Antoine

name: Centre Hospitalier Universitaire de Limoges, Limoges, France

family: Abraham

full_name: Julie Abraham

given: Julie

name: Centre Hospitalier Universitaire de Poitiers, Poitiers, France

family: Delwail

full_name: Vincent Delwail

given: Vincent

name: Centre Hospitalier Regional Universitaire de Tours, Tours, France

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

name: Centre Hospitalier de Perpignan, Perpignan, France

family: Sanhes

full_name: Laurence Sanhes

given: Laurence

name: Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez, France

family: Cornillon

full_name: Jérôme Cornillon

given: Jérôme

name: Centre Hospitalier de Saint Quentin, Saint Quentin, France

family: Garidi

full_name: Reda Garidi

given: Reda

name: Centre Hospitalier Universitaire de Reims, Reims, France

family: Delmer

full_name: Alain Delmer

given: Alain

family: Tanguy

full_name: Marie-Laure Tanguy

given: Marie-Laure

name: Centre Hospitalier d’Argenteuil, Argenteuil, France

family: Al Jijakli

full_name: Ahmad Al Jijakli

given: Ahmad

name: Centre Hospitalier de Lens, Lens, France

family: Morel

full_name: Pierre Morel

name: Centre Hospitalier Universitaire de Nîmes, Nîmes, France

family: Bourquard

full_name: Pascal Bourquard

given: Pascal

name: Centre Hospitalier Universitaire d’Angers, Angers, France

name: Centre Hospitalier Universitaire de Besançon, Besançon, France

name: Centre Hospitalier Universitaire de Nantes, Nantes, France

name: Hôpital d’Instruction des Armées Percy, Clamart, France

name: on behalf of the Intergroupe GOELAMS–ANOCEF and the LOC Network for CNS Lymphoma

location_facility:
CHG Saint Jean
Hôtel Dieu Nantes
CHU de la Timone
Chu D'Angers
Cancérologie Hôpital Sud
Centre Hospitalier Lens
Institut de Cancérologie
Centre Antoine Lacassagne
CHU Hôtel Dieu
CHU Nancy - Hôpital Neurologique
CHU de Besancon
CH de Saint-Quentin
GH Pitié-Salpétrière
CHU Michalon
Chu Reims
Centre René Huguenin
Institut Bergonié
CHU Hôpital Bernard
CHR Argenteuil
CHU de Limoges
Hôpital Pontchaillou
CHU de Nimes
Hôpital Bretonneau


title: A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.

summary: This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

ReferenceType: result

ReferenceCitation: Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.

name: Division of Nephrology; Hospital do Rim e Hipertensão - UNIFESP; São Paulo; Brazil

family: Tedesco-Silva

full_name: H. Tedesco-Silva

given: H.

name: Erasmus University Medical Center Rotterdam; Rotterdam; The Netherlands

family: Kho

full_name: M. M. L. Kho

given: M. M. L.

name: Oslo Universitetssykehus HF; Rikshospitalet; Oslo; Norway

family: Hartmann

full_name: A. Hartmann

given: A.

name: Institute for Clinical and Experimental Medicine; Praha; Czech Republic

family: Vitko

full_name: S. Vitko

given: S.

name: Royal Adelaide Hospital; Adelaide; Australia

family: Russ

full_name: G. Russ

given: G.

family: Rostaing

full_name: L. Rostaing

given: L.

name: Department of Nephrology; Charité Universitätsmedizin Berlin; Berlin; Germany

family: Budde

full_name: K. Budde

given: K.

name: Department of Nephrology and Renal Transplantation; University of Barcelona; Barcelona; Spain

family: Campistol

full_name: J. M. Campistol

given: J. M.

name: Royal Prince Alfred Hospital; Camperdown; NSW; Australia

family: Eris

full_name: J. Eris

given: J.

family: Krishnan

full_name: I. Krishnan

given: I.

name: Novartis Healthcare Pvt. Ltd.; Hyderabad; India

family: Gopalakrishnan

full_name: U. Gopalakrishnan

given: U.

family: Klupp

full_name: J. Klupp

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Transplantation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Sotrastaurin in Calcineurin Inhibitor-Free Regimen Using Everolimus inDe NovoKidney Transplant Recipients

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Brazil
Switzerland
Netherlands
France
Slovakia
Norway
Singapore
Argentina
Australia
Belgium
Spain
Germany
Czech Republic
Taiwan
Colombia

location_facility:
Italy
Austria
Brazil
Netherlands
Spain
France
Norway
Australia
Argentina
Novartis Investigative Site
Belgium
Czech Republic


title: Interest of Using the Sevoflurane in the Prevention of Newborns Pain

summary: The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.

enrollment_type: Anticipated

ReferenceCitation: Michel F, Vialet R, Hassid S, Nicaise C, Garbi A, Thomachot L, DI Marco JN, Lagier P, Martin C. Sevoflurane for central catheter placement in neonatal intensive care: a randomized trial. Paediatr Anaesth. 2010 Aug;20(8):712-9. doi: 10.1111/j.1460-9592.2010.03334.x.

family: MICHEL

full_name: FABRICE MICHEL

given: FABRICE

family: VIALET

full_name: RENAUD VIALET

given: RENAUD

family: HASSID

full_name: SOPHIE HASSID

given: SOPHIE

family: NICAISE

full_name: CLAIRE NICAISE

given: CLAIRE

family: GARBI

full_name: AURÉLIE GARBI

given: AURÉLIE

family: THOMACHOT

full_name: LAURENT THOMACHOT

given: LAURENT

family: DI MARCO

full_name: JEAN N. DI MARCO

given: JEAN N.

family: LAGIER

full_name: PIERRE LAGIER

given: PIERRE

family: MARTIN

full_name: CLAUDE MARTIN

given: CLAUDE

journal_name: Pediatric Anesthesia

oa_host_type: repository

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille CHU Nord


title: Postconditioning and Functional Recovery After Acute Myocardial Infarction

summary: We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

primary_purpose: Diagnostic

ReferenceCitation: Thibault H, Piot C, Staat P, Bontemps L, Sportouch C, Rioufol G, Cung TT, Bonnefoy E, Angoulvant D, Aupetit JF, Finet G, André-Fouët X, Macia JC, Raczka F, Rossi R, Itti R, Kirkorian G, Derumeaux G, Ovize M. Long-term benefit of postconditioning. Circulation. 2008 Feb 26;117(8):1037-44. doi: 10.1161/CIRCULATIONAHA.107.729780. Epub 2008 Feb 11.

name: From the Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France (H.T., P.S., L.B., G.R., E.B., D.A., G.F., X.A.-F., R.R., R.I., G.K., G.D., M.O.); Hôpital Arnaud de Villeneuve, Montpellier, France (C.P., C.S., T.T.C., J.C.M., F.R.); Hôpital Saint Luc–Saint Joseph, Lyon, France (J.A.); and INSERM U886, Lyon, France (H.T., G.R., D.A., G.F., G.D., M.O.).

family: Thibault

full_name: Hélène Thibault

given: Hélène

family: Piot

full_name: Christophe Piot

given: Christophe

family: Staat

full_name: Patrick Staat

given: Patrick

family: Bontemps

full_name: Laurence Bontemps

given: Laurence

family: Sportouch

full_name: Catherine Sportouch

given: Catherine

family: Rioufol

full_name: Gilles Rioufol

given: Gilles

family: Cung

full_name: Thien Tri Cung

given: Thien Tri

family: Bonnefoy

full_name: Eric Bonnefoy

given: Eric

family: Angoulvant

full_name: Denis Angoulvant

given: Denis

family: Aupetit

full_name: Jean-François Aupetit

given: Jean-François

family: Finet

full_name: Gérard Finet

given: Gérard

family: André-Fouët

full_name: Xavier André-Fouët

given: Xavier

family: Macia

full_name: Jean Christophe Macia

given: Jean Christophe

family: Raczka

full_name: Franck Raczka

given: Franck

family: Rossi

full_name: Rolland Rossi

given: Rolland

family: Itti

full_name: Rolland Itti

family: Kirkorian

full_name: Gilbert Kirkorian

given: Gilbert

family: Derumeaux

full_name: Geneviève Derumeaux

given: Geneviève

family: Ovize

full_name: Michel Ovize

given: Michel

journal_name: Circulation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Long-Term Benefit of Postconditioning

lead_sponsor: Hospices Civils de Lyon

intervention_type: Procedure


title: Phase I Studies of TarcevaTM (Erlotinib Hydrochloride, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma

summary: The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy

design_allocation: Non-Randomized

ReferenceCitation: White-Koning M, Civade E, Geoerger B, Thomas F, Le Deley MC, Hennebelle I, Delord JP, Chatelut E, Vassal G. Population analysis of erlotinib in adults and children reveals pharmacokinetic characteristics as the main factor explaining tolerance particularities in children. Clin Cancer Res. 2011 Jul 15;17(14):4862-71. doi: 10.1158/1078-0432.CCR-10-3278. Epub 2011 Jun 8.

family: White-Koning

full_name: Melanie White-Koning

given: Melanie

family: Civade

full_name: Elodie Civade

given: Elodie

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Thomas

full_name: Fabienne Thomas

given: Fabienne

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

family: Hennebelle

full_name: Isabelle Hennebelle

given: Isabelle

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Chatelut

full_name: Etienne Chatelut

given: Etienne

family: Vassal

full_name: Gilles Vassal

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: Population Analysis of Erlotinib in Adults and Children Reveals Pharmacokinetic Characteristics as the Main Factor Explaining Tolerance Particularities in Children

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID)

acronym: CAMOVID

summary:
The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines.

Camostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.

status: Recruiting

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Sud Ile de France - Melun

status_simplified: Ongoing


title: A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Microemulsion, in de Novo Adult Renal Transplant Recipients

summary: This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.

lead_sponsor: Novartis


title: Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects

summary: To test pharmacodynamic response to clopidogrel 150mg once daily during 7 days in healthy subjects carriers of a mutated allele (*2) associated with CYP2C19 deficiency and non responders to the usual regimen of 75 mg once daily

ReferenceCitation: Hulot JS, Bura A, Villard E, Azizi M, Remones V, Goyenvalle C, Aiach M, Lechat P, Gaussem P. Cytochrome P450 2C19 loss-of-function polymorphism is a major determinant of clopidogrel responsiveness in healthy subjects. Blood. 2006 Oct 1;108(7):2244-7. Epub 2006 Jun 13.


title: Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

acronym: MindCOVID

summary: The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Żelazna Medical Centre, LLC

location_country:
Italy
Sweden
Hong Kong
Lebanon
Germany
France
Czechia
Albania
Israel
Poland
Norway
Australia
Spain
United States
Taiwan

location_facility: Centre of Postgraduate Medical Education

location_facility: 11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"

location_facility: Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz


title: Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing

summary: This study aims at investigating handwashing behavior during COVID-19 pandemic. It was hypothesized that social-cognitive and emotional predictors as well as COVID-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.

ReferenceType: background

ReferenceCitation: World Health Organization. Coronavirus disease (COVID-19) advice for the public. 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public

ReferenceCitation: Centers for Disease Control and Prevention. When and how to wash your hands. 2020. https://www.cdc.gov/handwashing/when-how-handwashing.html

ReferenceCitation: Reyes Fernández B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26.

ReferenceCitation: Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.

ReferenceCitation: Ruiter RAC, Abraham C, Kok G. Scary warnings and rational precautions: A review of the psychology of fear appeals. Psychol Health. 2011;11(1): 613-630. doi: 10.1080/08870440108405863

ReferenceCitation: Szczuka Z, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, de Matos MG, Griva K, Jongenelis M, Keller J, Knoll N, Ma J, Miah MAA, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Siwa M, Szymanski K, Taut D, Tomaino SCM, Vilchinsky N, Wolf H, Luszczynska A. The trajectory of COVID-19 pandemic and handwashing adherence: findings from 14 countries. BMC Public Health. 2021 Oct 5;21(1):1791. doi: 10.1186/s12889-021-11822-5.

family: Szczuka

full_name: Zofia Szczuka

given: Zofia

family: Abraham

full_name: Charles Abraham

given: Charles

family: Baban

full_name: Adriana Baban

given: Adriana

family: Brooks

full_name: Sydney Brooks

given: Sydney

family: Cipolletta

full_name: Sabrina Cipolletta

given: Sabrina

family: Danso

full_name: Ebrima Danso

given: Ebrima

family: Dombrowski

full_name: Stephan U. Dombrowski

given: Stephan U.

family: Gan

full_name: Yiqun Gan

given: Yiqun

family: Gaspar

full_name: Tania Gaspar

given: Tania

family: de Matos

full_name: Margarida Gaspar de Matos

given: Margarida Gaspar

family: Griva

full_name: Konstadina Griva

given: Konstadina

family: Jongenelis

full_name: Michelle Jongenelis

given: Michelle

family: Keller

full_name: Jan Keller

given: Jan

family: Knoll

full_name: Nina Knoll

given: Nina

family: Ma

full_name: Jinjin Ma

given: Jinjin

family: Miah

full_name: Mohammad Abdul Awal Miah

given: Mohammad Abdul Awal

family: Morgan

full_name: Karen Morgan

given: Karen

family: Peraud

full_name: William Peraud

given: William

family: Quintard

full_name: Bruno Quintard

given: Bruno

family: Shah

full_name: Vishna Shah

given: Vishna

family: Schenkel

full_name: Konstantin Schenkel

given: Konstantin

family: Scholz

full_name: Urte Scholz

given: Urte

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

ipd_sharing_description:
The lead researchers in 14 countries will have full access to data collected across the countries.

In line with the Consortium Agreement (v2, 16th Jul 2020) data will be openly available under following conditions:

De-identified individual participant data that underline the results reported in publications; individual-level aggregated data (e.g., sum scores for scales) used for main analyses in respective publications; available following the publication, no end date of availability; available for analyses that are conducted to achieve aims in the approved proposal.

Due to local regulations, there are exceptions in terms of data sharing rules (stated above):

AUSTRALIA: Data from Australia will be available for 5 years after collection.
GERMANY, SWITZERLAND: Instead of individual-level sum scores, variance-covariance matrices will be shared.
MALAYSIA: Data will not be shared.

lead_sponsor: University of Social Sciences and Humanities, Warsaw

location_country: Italy Switzerland Gambia Germany France Malaysia Poland Israel Romania Singapore Australia China Canada Portugal

location_facility: London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)

location_facility: SWPS University of Social Sciences and Humanities


title: Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors

summary: These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors.


title: Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study

summary: To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation

ReferenceCitation: Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33.

lead_sponsor: Alcon Research


title: Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study

summary: Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.

ReferenceCitation: Parienti JJ, Peytavin G, Reliquet V, Verdon R, Coquerel A. Pharmacokinetics of the treatment switch from efavirenz to nevirapine. Clin Infect Dis. 2010 Jun 1;50(11):1547-8. doi: 10.1086/652718.

ReferenceCitation: Parienti JJ, Massari V, Rey D, Poubeau P, Verdon R; SIROCCO study team. Efavirenz to nevirapine switch in HIV-1-infected patients with dyslipidemia: a randomized, controlled study. Clin Infect Dis. 2007 Jul 15;45(2):263-6. Epub 2007 Jun 6.

lead_sponsor: University Hospital, Caen


title: Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.

summary: Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.

status: Unknown status

ReferenceCitation: Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, André-Fouët X, Derumeaux G, Piot C, Vernhet H, Revel D, Ovize M. Effect of cyclosporine on left ventricular remodeling after reperfused myocardial infarction. J Am Coll Cardiol. 2010 Mar 23;55(12):1200-1205. doi: 10.1016/j.jacc.2009.10.052.

family: Mewton

full_name: Nathan Mewton

given: Nathan

family: Croisille

full_name: Pierre Croisille

given: Pierre

family: Gahide

full_name: Gerald Gahide

given: Gerald

family: Rioufol

full_name: Gilles Rioufol

given: Gilles

family: Bonnefoy

full_name: Eric Bonnefoy

given: Eric

family: Sanchez

full_name: Ingrid Sanchez

given: Ingrid

family: Cung

full_name: Thien Tri Cung

given: Thien Tri

family: Sportouch

full_name: Catherine Sportouch

given: Catherine

family: Angoulvant

full_name: Denis Angoulvant

given: Denis

family: Finet

full_name: Gérard Finet

given: Gérard

family: André-Fouët

full_name: Xavier André-Fouët

given: Xavier

family: Derumeaux

full_name: Geneviève Derumeaux

given: Geneviève

family: Piot

full_name: Christophe Piot

given: Christophe

family: Vernhet

full_name: Hélène Vernhet

given: Hélène

family: Revel

full_name: Didier Revel

given: Didier

family: Ovize

full_name: Michel Ovize

given: Michel

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Effect of Cyclosporine on Left Ventricular Remodeling After Reperfused Myocardial Infarction

status_simplified: Unknown


summary: Several milk proteins are precursors of peptides, released during fermentation, which possess various biochemical and physiological properties. Among them, some peptides have been reported to inhibit angiotensin-converting enzyme (ACE) in vitro (an enzyme implicated in blood pressure regulation) and to lower blood pressure (BP). in hypertensive rats and in a small sample of patients with hypertension. One possible mechanism for the BP lowering effect is inhibition of ACE. Prior investigating BP lowering effect of these peptides in a large cohort of hypertensive patients, it is necessary to assess in depth their potency to inhibit ACE in vivo in humans and to compare it to that induced by a well-known ACE inhibitor.

status: Terminated

ReferenceCitation: FitzGerald RJ, Murray BA, Walsh DJ. Hypotensive peptides from milk proteins. J Nutr. 2004 Apr;134(4):980S-8S. Review.

location_facility: Clinical Investigation Center 920, Hôpital Européen Georges Pompidou


title: Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients

acronym: Morphee

summary: The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.

ReferenceCitation: Resta O, Barbaro MP, Giliberti T, Caratozzolo G, Cagnazzo MG, Scarpelli F, Nocerino MC. Sleep related breathing disorders in adults with Down syndrome. Downs Syndr Res Pract. 2003 Aug;8(3):115-9.

lead_sponsor: Institut Jerome Lejeune

intervention_type: Device


title: A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years.

acronym: PRI-angine

summary: The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.

lead_sponsor: Sanofi


title: Effect of Continuous Positive Airway Pressure as a First Line Therapy in Out-of-Hospital Management of Severe Cardiogenic Pulmonary Edema

summary: In cardiogenic pulmonary edema, Continuous Positive Airway Pressure (CPAP) added to medical treatment improves outcome. The present study was designed to assess the benefit of CPAP as a first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment.

lead_sponsor: Hopital Lariboisière


title: Effect of Metformin on Lactate Metabolism in Healthy Subjects

summary:
The main objective of this study is to evaluate the influence of metformin on lactate metabolism.

The main outcome is the lactate production following an exogenous lactate overload in healthy male subjects without metformin and one week later with metformin.

lead_sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe

location_facility: Centre Hospitalier Universitaire de Grenoble


title: Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

summary:
Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely frequent pathology, leading to a high rate of hospital admissions and money expense.

Management of small bowel obstruction is based on 2 options: either a surgical approach where all patients are operating on, or a conservative treatment in which surgery is proposed in case of failure of medical treatment. The surgical approach leads to operate on an excessive rate of patients while the medical approach increases the risk of increased small bowel resection, morbidity rate or hospitalization duration.

In order to improve the management of small bowel obstruction, it seems necessary to better distinguish patients that need an emergency surgical procedure from patients in which medical treatment will be useful. Many studies have been performed to investigate the value of imaging in the management of small bowel obstruction, using abdominal X-ray, oral gastrografin administration or CT-Scan.

The aim of this study is to analyse the effect of a systematic performance of imaging investigation on the management of patients presenting with a postoperative small bowel obstruction.

All patients suffering from a postoperative small bowel obstruction will be included in this study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral water administration while in group SG, Patients will have CT-Scan and oral gastrografin administration The major end point of this study is to analyse whether imaging examination can reduce the need for a surgical approach or the rate of small bowel resection and to determine its influence on fasting time or hospitalization duration

ReferenceCitation: Cosse C, Regimbeau JM, Fuks D, Mauvais F, Scotte M. Serum procalcitonin for predicting the failure of conservative management and the need for bowel resection in patients with small bowel obstruction. J Am Coll Surg. 2013 May;216(5):997-1004. doi: 10.1016/j.jamcollsurg.2012.12.051. Epub 2013 Mar 19.

family: Cosse

full_name: Cyril Cosse

given: Cyril

family: Regimbeau

full_name: Jean Marc Regimbeau

given: Jean Marc

family: Fuks

full_name: David Fuks

given: David

family: Mauvais

full_name: François Mauvais

given: François

family: Scotte

full_name: Michel Scotte

journal_name: Journal of the American College of Surgeons

title: Serum Procalcitonin for Predicting the Failure of Conservative Management and the Need for Bowel Resection in Patients with Small Bowel Obstruction

lead_sponsor: University Hospital, Rouen


title: Life Experience of People Aged 60 and Over Living With HIV: Quantitative Sociological Study

acronym: PVVIH

summary: The purpose of this study is to Assess the impact of HIV on the life course of patients aged 60 and over.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Hospital Delafontaine, Saint-Denis / Maladie infectieuse

location_facility: Hôpital Bichat Claude-Bernard -COREVIH Ile de France Nord

location_facility: Hôpital Bichat Claude-Bernard - Service de Maladies Infectieuses et Tropicales

location_facility: Hospital Beaujon, Clichy / Médecine Interne


title: A Randomized, Open-Label, Cross-Over Study, to Compare the Bioavailability of the Fixed Combination of Amodiaquine and Artesunate (COARSUCAM™) After Single Oral Administration Under Fed and Fasted Conditions in Healthy Subjects

summary:
Primary Objective: to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male subjects
Secondary Objective: to assess the clinical and biological safety and tolerability of Coarsucam™


title: Therapeutic Follow-up Observational Study and Population Kinetics Ancillary Study of Valproate Microgranules (Micropakine® SR) in Patients Aged Between 6 Months and 15 Years Suffering From Epilepsy.

acronym: VAPOP

summary:
Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.

Secondary objectives: Ancillary population kinetics study

Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data.
Evaluate the influence of individual characteristics on the pharmacokinetic parameters.
Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.


type: EudraCT Number

type: Other Identifier

title: An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma

acronym: SIOP-EP-II

summary:
The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving and harmonising the staging and the standard of care of this patient population and to improve the investigators understanding of the underlying biology thereby informing future treatment.

The program will evaluate new strategies for diagnosis (centralized reviews of pathology and imaging) and new therapeutic strategies in order to develop treatment recommendations.

Patients will be stratified into different treatment subgroups according to their age, the tumour location and the outcome of the initial surgery. Each subgroup will be studied in a specific randomised study to evaluate the proposed therapeutic strategies.

Stratum 1:

The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression free survival in patients who are > 12 months and < 22 years at diagnosis, with completely removed intra cranial Ependymoma.

Stratum 2:

This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving to all patients the benefit of VEC chemotherapy whilst randomising half of patients to receive additional HD-MTX.

Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the residual tumour will be delivered immediately after the end of the cRT.

Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of postoperative dose intense chemotherapy administered alone or in combination with valproate in children <12 months of age or those not eligible to receive radiotherapy .

lead_sponsor: Centre Leon Berard

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
United Kingdom
France
Czechia
Norway
Ireland
Belgium
Spain
Denmark
Germany
Slovenia

location_facility: CHU de Bordeaux-Hôpital des enfants Pellegrin

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Medical University of Graz-Department of Pediatrics and Adolescent Medicine

location_facility: CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve

location_facility: CHRU STRASBOURG - Hôpital de Hautepierre

location_facility: Department of Paediatric, Haukeland University Hospital

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Hospitales Universitarios Virgen Macarena y Virgen del Rocío Avda

location_facility: Princess Maxima Center for pediatric oncology

intervention_type: Radiation


type: Other Grant/Funding Number

title: Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study

acronym: EduStra-HF

summary:
The EduStra-HF study will examine the impact of an intensive therapeutic education on patients discharged from hospital after an episode of acute heart failure (HF).

Patients will be randomized into two groups: one will receive "usual care" monitoring and one will receive a specific educational monitoring programme for 1 year.

All patients will meet with a specialized therapeutic education nurse before discharge.

The effect of the intensive education on HF rehospitalization and quality of life will be examined.

primary_purpose: Supportive Care

ipd_sharing_description: Sharing Individual Participant Data requires a specific authorization from the French Board CNIL (Commission Nationale de l'Informatique et des Libertés) which chooses whether to allow the research team to share patient data. A specific request is needed and will be sent to that authority.

lead_sponsor: Resicard

location_facility:
Clinique Ambroise Paré
Hôpital AP-HP Pitié-Salpêtrière
Centre Cardiologique du Nord
Centre Hospitalier André Mignot
Clinique du Mont Louis
Institut Mutualiste Montsouris
Hopital AP-HP Saint-Antoine

intervention_type: Behavioral


title: Randomized, Comparative, Multicenter, Patient-blinded Trial of the Safety and Efficacy of Intradermal Injections of Polylactic Acid (Newfill TM) Versus Polyacrylamid Gel (Eutrophill) in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE

summary: Treatment of facial lipoatrophy with dermal injections polylactic acid (Newfill TM) is a safe procedure and has been now widely used with a good efficacy. However, this therapy is not effective in all treated patients and the benefit of the injections may decrease with time necessitating re-injections several months after the first sets of injections. In this study we would like to compare the efficacy and safety of Eutrophill(polyacrylamid gel), a resorbable filler compound versus Newfill in a comparative, randomised, multicenter trial. Primary endpoint will be the self-perception by the patient with a visual analogue scale (VAS index). Secondary endpoints are a quality of life questionnaire (MOS-HIV), the a-NBC questionnaire (perception by the patient and by the doctor of the severity of the lipoatrophy), the measure of the dermal thickness and cheek skin fold as assessed by the Skinfold Caliper, the ordering of digital photographs and the evaluation of the dermal thickness by CT scan.

ReferenceCitation: Lafaurie M, Dolivo M, Girard PM, May T, Bouchaud O, Carbonnel E, Madelaine I, Loze B, Porcher R, Molina JM; ANRS 132 SMILE study group. Polylactic acid vs. polyacrylamide hydrogel for treatment of facial lipoatrophy: a randomized controlled trial [Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) 132 SMILE]. HIV Med. 2013 Aug;14(7):410-20. doi: 10.1111/hiv.12021. Epub 2013 Feb 24.

family: Lafaurie

full_name: M Lafaurie

given: M

family: Dolivo

full_name: M Dolivo

family: Girard

full_name: P-M Girard

given: P-M

name: Department of Infectious Diseases; Brabois Hospital; Vandoeuvre les Nancy; Paris; France

family: May

full_name: T May

given: T

name: Department of Infectious Diseases; Avicenne Hospital; Bobigny Cedex; France

family: Bouchaud

full_name: O Bouchaud

given: O

name: Department of Dermatology; E. Herriot Hospital; Lyon Cedex; France

family: Carbonnel

full_name: E Carbonnel

given: E

name: Pharmacy; Saint-Louis Hospital; Paris; France

family: Madelaine

full_name: I Madelaine

given: I

family: Loze

full_name: B Loze

given: B

name: Department of Biostatistics; Saint-Louis Hospital; Paris; France

family: Porcher

full_name: R Porcher

given: R

family: Molina

full_name: J-M Molina

given: J-M

journal_name: HIV Medicine

title: Polylactic acidvs.polyacrylamide hydrogel for treatment of facial lipoatrophy: a randomized controlled trial [Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) 132 SMILE]

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

location_facility: Hôpital Saint-Louis Service des Maladies Infectieuses


title: TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers

summary:
Tissue factor is the main activator of coagulation cascades. Excessive tissue factor expression is made responsible of thrombosis in a number of clinical situations including thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor gene expression in adipose tissue was significantly increased in obese versus lean mice.

The main objective of this study is to show that tissue factor expression is increased in human adipose tissue obtained from obese subjects and to identify its main tissular origin by comparing abdominal and subcutaneous adipose tissue.

The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue factor expressed by adipose tissue, (ii) the amount of subcutaneous and profound adipose tissue, and (iii) coagulation activation markers.

ReferenceCitation: Samad F, Pandey M, Loskutoff DJ. Regulation of tissue factor gene expression in obesity. Blood. 2001 Dec 1;98(12):3353-8.


title: Multicenter Trial to Investigate the Safety and Efficacy of Vitrectomy With Radial Optic Neurotomy for the Preservation of Visual Function in Subjects With Central Retinal Vein Occlusion (CRVO)

acronym: OVCR

summary: Natural evolution of severe central retinal vein occlusion with low visual acuity is very poor. A randomized clinical trial will compare troxerutin and platelet anti-aggregating agents (drug treatment) versus surgery and drug treatment. Surgery will include vitrectomy and radial optic neurotomy. The primary outcome will be vision measured 6 months after surgery.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon


title: A Randomized Trial Assessing the Role of Arsenic Trioxide and/or ATRA During Consolidation Course in Newly Diagnosed Acute Promyelocytic Leukemia (APL)

summary: To assess the role of Arsenic trioxide and/or ATRA during consolidation course in APL. It is hoped that the investigational arms will further increase the event-free survival at 2 years, with reduced toxicity and without increasing the relapse rate by comparison with a classical anthracycline-AraC consolidation regimen.

ReferenceCitation: Adès L, Thomas X, Bresler AG, Raffoux E, Spertini O, Vey N, Marchand T, Récher C, Pigneux A, Girault S, Deconinck E, Gardin C, Tournilhac O, Lambert JF, Chevallier P, de Botton S, Lejeune J, Dombret H, Chevret S, Fenaux P. Arsenic trioxide is required in the treatment of newly diagnosed acute promyelocytic leukemia. Analysis of a randomized trial (APL 2006) by the French Belgian Swiss APL group. Haematologica. 2018 Dec;103(12):2033-2039. doi: 10.3324/haematol.2018.198614. Epub 2018 Jul 19.

family: Adès

full_name: Lionel Adès

given: Lionel

family: Thomas

full_name: Xavier Thomas

given: Xavier

family: Bresler

full_name: Agnes Guerci Bresler

given: Agnes Guerci

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

family: Spertini

full_name: Olivier Spertini

given: Olivier

family: Vey

full_name: Norbert Vey

given: Norbert

family: Marchand

full_name: Tony Marchand

given: Tony

family: Récher

full_name: Christian Récher

given: Christian

family: Pigneux

full_name: Arnaud Pigneux

given: Arnaud

family: Girault

full_name: Stephane Girault

given: Stephane

family: Deconinck

full_name: Eric Deconinck

given: Eric

family: Gardin

full_name: Claude Gardin

given: Claude

family: Tournilhac

full_name: Olivier Tournilhac

family: Lambert

full_name: Jean Francois Lambert

given: Jean Francois

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

family: de Botton

full_name: Stephane de Botton

family: Lejeune

full_name: Julie Lejeune

given: Julie

family: Dombret

full_name: Hervé Dombret

given: Hervé

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

publisher: Ferrata Storti Foundation (Haematologica)


title: Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose

summary: This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

ReferenceCitation: HoWangYin KY, Loinard C, Bakker W, Guérin CL, Vilar J, d'Audigier C, Mauge L, Bruneval P, Emmerich J, Lévy BI, Pouysségur J, Smadja DM, Silvestre JS. HIF-prolyl hydroxylase 2 inhibition enhances the efficiency of mesenchymal stem cell-based therapies for the treatment of critical limb ischemia. Stem Cells. 2014 Jan;32(1):231-43. doi: 10.1002/stem.1540. Erratum in: Stem Cells. 2014 Apr;32(4):1055-7. D'Audigier, Clément [corrected to d'Audigier, Clément].

name: INSERM UMRS 970; Fontenay aux Roses France

family: HoWangYin

full_name: Kiave-Yune HoWangYin

given: Kiave-Yune

name: Institut de Radioprotection et de Sureté Nucléaire; Fontenay aux Roses France

family: Loinard

full_name: Céline Loinard

given: Céline

family: Bakker

full_name: Wineke Bakker

given: Wineke

family: Guérin

full_name: Coralie L. Guérin

given: Coralie L.

family: Vilar

full_name: José Vilar

given: José

name: INSERM UMRS 765; Université Paris Descartes; Sorbonne Paris Cité Paris France

name: AP-HP; Hôpital Européen Georges Pompidou; Service d'hématologie Biologique Paris France

family: D'Audigier

full_name: Clément D'Audigier

given: Clément

family: Mauge

full_name: Laetitia Mauge

given: Laetitia

name: AP-HP; Hôpital Européen Georges Pompidou; Service d'anatomie Pathologique Paris France

family: Bruneval

full_name: Patrick Bruneval

given: Patrick

family: Emmerich

full_name: Joseph Emmerich

given: Joseph

family: Lévy

full_name: Bernard I. Lévy

given: Bernard I.

name: University of Nice, Institute of Research on Cancer & Aging (IRCAN)Centre A. Lacassagne, Nice, France and Centre Scientifique de Monaco

family: Pouysségur

full_name: Jacques Pouysségur

given: Jacques

family: Smadja

full_name: David M. Smadja

given: David M.

family: Silvestre

full_name: Jean-Sébastien Silvestre

given: Jean-Sébastien

bso_classification: Biology (fond.)

journal_name: STEM CELLS

title: HIF-Prolyl Hydroxylase 2 Inhibition Enhances the Efficiency of Mesenchymal Stem Cell-Based Therapies for the Treatment of Critical Limb Ischemia

ReferenceCitation: Smadja DM, Duong-van-Huyen JP, Dal Cortivo L, Blanchard A, Bruneval P, Emmerich J, Gaussem P. Early endothelial progenitor cells in bone marrow are a biomarker of cell therapy success in patients with critical limb ischemia. Cytotherapy. 2012 Feb;14(2):232-9. doi: 10.3109/14653249.2011.627917. Epub 2011 Oct 31.

family: Duong-van-Huyen

full_name: Jean-Paul Duong-van-Huyen

given: Jean-Paul

family: Dal Cortivo

full_name: Liliane Dal Cortivo

given: Liliane

family: Blanchard

full_name: Anne Blanchard

given: Anne

family: Gaussem

full_name: Pascale Gaussem

ReferenceCitation: Smadja DM, d'Audigier C, Guerin CL, Mauge L, Dizier B, Silvestre JS, Dal Cortivo L, Gaussem P, Emmerich J. Angiogenic potential of BM MSCs derived from patients with critical leg ischemia. Bone Marrow Transplant. 2012 Jul;47(7):997-1000. doi: 10.1038/bmt.2011.196. Epub 2011 Oct 10.

ReferenceCitation: Smadja DM, d'Audigier C, Bièche I, Evrard S, Mauge L, Dias JV, Labreuche J, Laurendeau I, Marsac B, Dizier B, Wagner-Ballon O, Boisson-Vidal C, Morandi V, Duong-Van-Huyen JP, Bruneval P, Dignat-George F, Emmerich J, Gaussem P. Thrombospondin-1 is a plasmatic marker of peripheral arterial disease that modulates endothelial progenitor cell angiogenic properties. Arterioscler Thromb Vasc Biol. 2011 Mar;31(3):551-9. doi: 10.1161/ATVBAHA.110.220624. Epub 2010 Dec 9.

name: From the Université Paris Descartes (D.M.S., C.d'A., I.B., S.E., L.M., I.L., B.M., J.-P.D.-V.-H., P.B., J.E., P.G.), Paris, France; INSERM UMRS 765 (D.M.S., C.d'A., S.E., L.M., J.-V.D., B.M., B.D., C.B.-V., J.E., P.G.), Paris, France; AP-HP (D.M.S., C.d'A., S.E., L.M., J.-P.D.-V.-H., P.B., J.E., P.G.), Hôpital Européen Georges Pompidou, Paris, France; INSERM UMRS 745 (I.B., I.L.), Paris, France; Departamento de Biologia Celular (J.-V.D., V.M.), Universidade do Estado do Rio de Janeiro, Brazil;...

journal_name: Arteriosclerosis, Thrombosis, and Vascular Biology

title: Thrombospondin-1 Is a Plasmatic Marker of Peripheral Arterial Disease That Modulates Endothelial Progenitor Cell Angiogenic Properties


title: Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

acronym: TRAPEZE

summary: This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.

lead_sponsor: Novartis Pharmaceuticals


title: Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes : a Double Blind Sham Controlled Study

summary:
Objectives : To investigate the analgesic effects of repeated sessions of unilateral rTMS in patients with chronic pain syndrome due to fibromyalgia, IBS or burning mouth syndrome. Primary outcome will be numerical pain scores.

Methods : The study will be randomized and performed in parallel groups and double blind versus sham stimulation, and will include 90 patients (45 patients per treatment arm). The randomization will be computerized and performed for each aetiological group separately. The rTMS will be performed on the left motor cortex, 5 consecutive days , then once a week during 3 weeks then twice a month during 2 months, then once a month during 6 months. Clinical assessment will include an assessment of pain, quality of life, sleep, depression and anxiety, catastrophizing, and a neuropsychological evaluation.

Conclusion : this study should allow to determine for the first time the long term efficacy and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes which are often refractory to conventional treatments.

lead_sponsor: Hospital Ambroise Paré Paris


title: Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach

summary: The purpose of this study is to compare the effectiveness of 2 different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.

ReferenceCitation: Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, André T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouché O. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study. J Clin Oncol. 2014 Nov 1;32(31):3520-6. doi: 10.1200/JCO.2013.54.1011. Epub 2014 Oct 6. Erratum in: J Clin Oncol. 2015 Apr 20;33(12):1416.

name: Rosine Guimbaud, Centre Hospitalier Universitaire Toulouse, Toulouse; Christophe Louvet, Institut Mutualiste Montsouris; Thierry André, Hôpital Saint Antoine; Jean-Marc Gornet, Centre Hospitalier Universitaire Saint Louis (Assistance Publique-Hôpitaux de Paris); Pascal Hammel, Hôpital Beaujon; Philippe Rougier, Hôpital Européen Georges Pompidou, Paris; Pauline Ries, Institut Paoli Calmettes, Marseille; Marc Ychou, Institut Régional du Cancer Val d'Aurelle, Montpellier; Emilie Maillard, Fédération...

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Louvet

full_name: Christophe Louvet

given: Christophe

family: Ries

full_name: Pauline Ries

given: Pauline

family: Ychou

full_name: Marc Ychou

given: Marc

family: Maillard

full_name: Emilie Maillard

given: Emilie

family: André

full_name: Thierry André

given: Thierry

family: Gornet

full_name: Jean-Marc Gornet

given: Jean-Marc

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

family: Nguyen

full_name: Suzanne Nguyen

given: Suzanne

family: Azzedine

full_name: Ahmed Azzedine

given: Ahmed

family: Etienne

full_name: Pierre-Luc Etienne

given: Pierre-Luc

family: Boucher

full_name: Eveline Boucher

given: Eveline

family: Rebischung

full_name: Christine Rebischung

given: Christine

family: Hammel

full_name: Pascal Hammel

given: Pascal

family: Rougier

full_name: Philippe Rougier

given: Philippe

family: Bedenne

full_name: Laurent Bedenne

given: Laurent

family: Bouché

full_name: Olivier Bouché

given: Olivier

title: Prospective, Randomized, Multicenter, Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Versus Epirubicin, Cisplatin, and Capecitabine in Advanced Gastric Adenocarcinoma: A French Intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) Study

lead_sponsor: University Hospital, Toulouse


title: Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease

acronym: COMT

summary: Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity determined by a genetic polymorphism. The aim of this study is to investigate whether the genetic variability influences entacapone efficacy in Parkinson's disease.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,


title: Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?

summary: To evaluate the effect of the threat of an aversive reaction on the response during alcohol cue exposure in alcohol dependent patients : (1) the subjective response (craving) and (2) the physiological response (heart rate and blood pressure).

ReferenceCitation: Skinner MD, Coudert M, Berlin I, Passeri E, Michel L, Aubin HJ. Effect of the threat of a disulfiram-ethanol reaction on cue reactivity in alcoholics. Drug Alcohol Depend. 2010 Dec 1;112(3):239-46. doi: 10.1016/j.drugalcdep.2010.06.011. Epub 2010 Aug 13.

family: Skinner

full_name: Marilyn D. Skinner

given: Marilyn D.

family: Coudert

full_name: Mathieu Coudert

given: Mathieu

family: Berlin

full_name: Ivan Berlin

given: Ivan

family: Passeri

full_name: Elodie Passeri

given: Elodie

family: Michel

full_name: Laurent Michel

family: Aubin

full_name: Henri-Jean Aubin

given: Henri-Jean

journal_name: Drug and Alcohol Dependence

title: Effect of the threat of a disulfiram–ethanol reaction on cue reactivity in alcoholics


title: Prevention of Endoleaks Using Autologous Platelet Gel During Endovascular Procedures on Unruptured Abdominal Aortic Aneurysms: Pilot Study

summary: The main risk of aortic aneurysms is rupture that leads to a high risk of death. A preventive surgical treatment is thus needed. In order to reduce the morbidity and mortality associated with conventional surgery, an endovascular approach (insertion of an endovascular stent graft)is now widely favored. The main problem of this procedure is the occurrence of endoleaks (persistence of a communication between the aneurysm and the aorta). A new approach is proposed to prevent these endoleaks. The principle is to draw blood from the patient, separate the blood from the platelets, and reinject both platelet rich plasma (PRP) and autologous thrombin, in order to form a platelet gel (PRP + autologous thrombin). Before studying the efficacy of this technique, its safety of use and feasibility must be evaluated.

lead_sponsor: Rennes University Hospital

location_facility: Service de Chirurgie Vasculaire - Hôpital de Pontchaillou


title: An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.

summary: The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

intervention_type: Biological


title: Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia

summary: This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome loading dose regimen, in a weekly administration schedule, during the aplastic phase following induction or consolidation chemotherapy for acute leukaemia, and during the initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe fungal infections development is concerned.

lead_sponsor: Gilead Sciences


lead_sponsor: Eisai Limited

source: euctr

title: A Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

summary:
Randomised, double-blind, double dummy, parallel group design. Following the screening period patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm from 2 mg up to the maintenance dose of 4 mg. Patients randomised to entacapone or placebo will have dummy up titrations to maintain the blind. Following this titration phase, patients will remain on the maintenance dose for a further 14 weeks.

Patients will have visits at 2, 4, 6, 10, 14 and 18 weeks after baseline. A follow up visit will be performed at Week 22.

A home diary will be completed in which patients rate themselves as either:

"OFF"
"ON" without dyskinesias
"ON" with non-troublesome dyskinesias
"ON" with troublesome dyskinesias
Asleep

These entries will be completed every 30 minutes during the waking day and will be completed for three consecutive days immediately prior to visits at Baseline, Weeks 6, 10, 18 and 22.

At Baseline (Day 0), week 10 and 18 the Unified Parkinson's Disease Rating Scale (UPDRS - Parts I, II , III and IV) will be performed.

At the end of the treatment period (Week 18), patients will undergo final efficacy and safety assessments and will stop taking the study medication they were receiving. They will be seen 4 weeks later for a follow up visit.


title: VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.

summary: The objective of this study is to demonstrate that influenza vaccination of nursing home workers is an effective intervention for reducing mortality of elderly people.

ReferenceCitation: Carman WF, Elder AG, Wallace LA, McAulay K, Walker A, Murray GD, Stott DJ. Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial. Lancet. 2000 Jan 8;355(9198):93-7.

ReferenceCitation: Potter J, Stott DJ, Roberts MA, Elder AG, O'Donnell B, Knight PV, Carman WF. Influenza vaccination of health care workers in long-term-care hospitals reduces the mortality of elderly patients. J Infect Dis. 1997 Jan;175(1):1-6.

ReferenceCitation: Thomas RE, Jefferson TO, Demicheli V, Rivetti D. Influenza vaccination for health-care workers who work with elderly people in institutions: a systematic review. Lancet Infect Dis. 2006 May;6(5):273-9. Review.


title: A Study to Investigate the Irritation Potential on Healthy Intact Skin and Effect on Psoriatic Skin of Topical Applications of GW786034

summary: This study is an exploratory study to evaluate the effectiveness, safety and tolerability of three concentrations of GW786034 ointment following treatment to small areas of stable psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of ointment will be applied under full occlusion to representative psoriatic plaques. The effectiveness of topical GW786034 treatments and controls will be explored using visual intensity assessments in addition to dermal imaging and histological surrogates of disease activity.

lead_sponsor: GlaxoSmithKline


title: Development of a Noninvasive Method of Evaluation of the Pulmonary Inflammation in the Condensates of Exhaled Air

summary: The aim of the study is identify biological parameters reflecting proteolytic activity in the exhaled condenstaes which might be useful to follow up pulmonary inflammation in various conditions including cystic fibrosis, COPD, asthma, tobacco exposure. Three proteases will be analyzed, i.e. elastase, proteinase 3 and cathepsin G. Results in the condensates will be compared to those obtained in sputum.

ReferenceCitation: Attucci S, Gauthier A, Korkmaz B, Delépine P, Martino MF, Saudubray F, Diot P, Gauthier F. EPI-hNE4, a proteolysis-resistant inhibitor of human neutrophil elastase and potential anti-inflammatory drug for treating cystic fibrosis. J Pharmacol Exp Ther. 2006 Aug;318(2):803-9. Epub 2006 Apr 20.

ReferenceCitation: Grimbert D, Vecellio L, Delépine P, Attucci S, Boissinot E, Poncin A, Gauthier F, Valat C, Saudubray F, Antonioz P, Diot P. Characteristics of EPI-hNE4 aerosol: a new elastase inhibitor for treatment of cystic fibrosis. J Aerosol Med. 2003 Summer;16(2):121-9.

lead_sponsor: University Hospital, Tours

location_facility: Service de Pneumologie et EFR CHRU Tours