title: Safety and Efficacy of Ibritumomab Tiuxetan (Zevalin®) in Association With a Fludarabine Based Reduced Conditioning Regimen and Allogenic Stem Cell Support in Chemo-sensitive Relapsed CD20 Positive Aggressive Non-Hodgkin's Lymphoma Patients.

acronym: ZEVALLO

summary: The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen.

ReferenceCitation: Cheson BD. The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma. BioDrugs. 2005;19(5):309-22. Review.

ReferenceCitation: Chopra R, Goldstone AH, Pearce R, Philip T, Petersen F, Appelbaum F, De Vol E, Ernst P. Autologous versus allogeneic bone marrow transplantation for non-Hodgkin's lymphoma: a case-controlled analysis of the European Bone Marrow Transplant Group Registry data. J Clin Oncol. 1992 Nov;10(11):1690-5.

ReferenceCitation: Dean RM, Fowler DH, Wilson WH, Odom J, Steinberg SM, Chow C, Kasten-Sportes C, Gress RE, Bishop MR. Efficacy of reduced-intensity allogeneic stem cell transplantation in chemotherapy-refractory non-hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Aug;11(8):593-9.

ReferenceCitation: Escalón MP, Champlin RE, Saliba RM, Acholonu SA, Hosing C, Fayad L, Giralt S, Ueno NT, Maadani F, Pro B, Donato M, McLaughlin P, Khouri IF. Nonmyeloablative allogeneic hematopoietic transplantation: a promising salvage therapy for patients with non-Hodgkin's lymphoma whose disease has failed a prior autologous transplantation. J Clin Oncol. 2004 Jun 15;22(12):2419-23.

ReferenceCitation: Fietz T, Uharek L, Gentilini C, Muessig A, Rieger K, Marinets O, Sandrock D, Munz DL, Glass B, Thiel E, Blau IW. Allogeneic hematopoietic cell transplantation following conditioning with 90Y-ibritumomab-tiuxetan. Leuk Lymphoma. 2006 Jan;47(1):59-63.

ReferenceCitation: Frater JL, Hsi ED. Properties of the mantle cell and mantle cell lymphoma. Curr Opin Hematol. 2002 Jan;9(1):56-62. Review.

ReferenceCitation: Freytes CO, Loberiza FR, Rizzo JD, Bashey A, Bredeson CN, Cairo MS, Gale RP, Horowitz MM, Klumpp TR, Martino R, McCarthy PL, Molina A, Pavlovsky S, Pecora AL, Serna DS, Tsai T, Zhang MJ, Vose JM, Lazarus HM, van Besien K; Lymphoma Working Committee of the International Bone Marrow Transplant Registry. Myeloablative allogeneic hematopoietic stem cell transplantation in patients who experience relapse after autologous stem cell transplantation for lymphoma: a report of the International Bone Marrow Transplant Registry. Blood. 2004 Dec 1;104(12):3797-803. Epub 2004 Jul 27.

ReferenceCitation: Gianni AM, Cortelazzo S, Magni M, Martelli M; Michelangelo Cooperative. Rituximab: enhancing stem cell transplantation in mantle cell lymphoma. Bone Marrow Transplant. 2002 Feb;29 Suppl 1:S10-3. Review.

ReferenceCitation: Gopal AK, Pagel JM, Rajendran JG, Maloney DG, Appelbaum FR, Sorror ML, Sandmaier BM, Storb R, Press OW. Improving the efficacy of reduced intensity allogeneic transplantation for lymphoma using radioimmunotherapy. Biol Blood Marrow Transplant. 2006 Jul;12(7):697-702. Review.

ReferenceCitation: Grigg A, Ritchie D. Graft-versus-lymphoma effects: clinical review, policy proposals, and immunobiology. Biol Blood Marrow Transplant. 2004 Sep;10(9):579-90. Review.

ReferenceCitation: Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Brière J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30.

ReferenceCitation: Johnson TA, Press OW. Synergistic cytotoxicity of iodine-131-anti-CD20 monoclonal antibodies and chemotherapy for treatment of B-cell lymphomas. Int J Cancer. 2000 Jan 1;85(1):104-12.

ReferenceCitation: Jones RJ, Ambinder RF, Piantadosi S, Santos GW. Evidence of a graft-versus-lymphoma effect associated with allogeneic bone marrow transplantation. Blood. 1991 Feb 1;77(3):649-53.

ReferenceCitation: Khouri IF, Keating M, Körbling M, Przepiorka D, Anderlini P, O'Brien S, Giralt S, Ippoliti C, von Wolff B, Gajewski J, Donato M, Claxton D, Ueno N, Andersson B, Gee A, Champlin R. Transplant-lite: induction of graft-versus-malignancy using fludarabine-based nonablative chemotherapy and allogeneic blood progenitor-cell transplantation as treatment for lymphoid malignancies. J Clin Oncol. 1998 Aug;16(8):2817-24.

ReferenceCitation: Khouri IF, Lee MS, Romaguera J, Mirza N, Kantarjian H, Korbling M, Albitar M, Giralt S, Samuels B, Anderlini P, Rodriguez J, von Wolff B, Gajewski J, Cabanillas F, Champlin R. Allogeneic hematopoietic transplantation for mantle-cell lymphoma: molecular remissions and evidence of graft-versus-malignancy. Ann Oncol. 1999 Nov;10(11):1293-9.

ReferenceCitation: Khouri IF, Lee MS, Saliba RM, Jun G, Fayad L, Younes A, Pro B, Acholonu S, McLaughlin P, Katz RL, Champlin RE. Nonablative allogeneic stem-cell transplantation for advanced/recurrent mantle-cell lymphoma. J Clin Oncol. 2003 Dec 1;21(23):4407-12.

ReferenceCitation: Maris MB, Sandmaier BM, Storer BE, Chauncey T, Stuart MJ, Maziarz RT, Agura E, Langston AA, Pulsipher M, Storb R, Maloney DG. Allogeneic hematopoietic cell transplantation after fludarabine and 2 Gy total body irradiation for relapsed and refractory mantle cell lymphoma. Blood. 2004 Dec 1;104(12):3535-42. Epub 2004 Aug 10.

ReferenceCitation: Milpied N, Deconinck E, Gaillard F, Delwail V, Foussard C, Berthou C, Gressin R, Lucas V, Colombat P, Harousseau JL; Groupe Ouest-Est des Leucémies et des Autres Maladies du Sang. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004 Mar 25;350(13):1287-95.

ReferenceCitation: Morris E, Thomson K, Craddock C, Mahendra P, Milligan D, Cook G, Smith GM, Parker A, Schey S, Chopra R, Hatton C, Tighe J, Hunter A, Peggs K, Linch D, Goldstone A, Mackinnon S. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. 2004 Dec 15;104(13):3865-71. Epub 2004 Aug 10.

ReferenceCitation: Nademanee A, Forman SJ. Role of hematopoietic stem cell transplantation for advanced-stage diffuse large cell B-cell lymphoma-B. Semin Hematol. 2006 Oct;43(4):240-50. Review.

ReferenceCitation: Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, Sonneveld P, Gisselbrecht C, Cahn JY, Harousseau JL, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995 Dec 7;333(23):1540-5.

ReferenceCitation: Ratanatharathorn V, Uberti J, Karanes C, Abella E, Lum LG, Momin F, Cummings G, Sensenbrenner LL. Prospective comparative trial of autologous versus allogeneic bone marrow transplantation in patients with non-Hodgkin's lymphoma. Blood. 1994 Aug 15;84(4):1050-5.

ReferenceCitation: Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205.

ReferenceCitation: Rodriguez R, Nademanee A, Ruel N, Smith E, Krishnan A, Popplewell L, Zain J, Patane K, Kogut N, Nakamura R, Sarkodee-Adoo C, Forman SJ. Comparison of reduced-intensity and conventional myeloablative regimens for allogeneic transplantation in non-Hodgkin's lymphoma. Biol Blood Marrow Transplant. 2006 Dec;12(12):1326-34.

ReferenceCitation: Schimmer AD, Jamal S, Messner H, Keating A, Meharchand J, Huebsch L, Walker I, Benger A, Gluck S, Smith A. Allogeneic or autologous bone marrow transplantation (BMT) for non-Hodgkin's lymphoma (NHL): results of a provincial strategy. Ontario BMT Network, Canada. Bone Marrow Transplant. 2000 Oct;26(8):859-64.

ReferenceCitation: Shenkier TN, Voss N, Fairey R, Gascoyne RD, Hoskins P, Klasa R, Klimo P, O'Reilly SE, Sutcliffe S, Connors JM. Brief chemotherapy and involved-region irradiation for limited-stage diffuse large-cell lymphoma: an 18-year experience from the British Columbia Cancer Agency. J Clin Oncol. 2002 Jan 1;20(1):197-204.

ReferenceCitation: Slavin S, Nagler A, Naparstek E, Kapelushnik Y, Aker M, Cividalli G, Varadi G, Kirschbaum M, Ackerstein A, Samuel S, Amar A, Brautbar C, Ben-Tal O, Eldor A, Or R. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood. 1998 Feb 1;91(3):756-63.

ReferenceCitation: Vandenberghe E, Ruiz de Elvira C, Loberiza FR, Conde E, López-Guillermo A, Gisselbrecht C, Guilhot F, Vose JM, van Biesen K, Rizzo JD, Weisenburger DD, Isaacson P, Horowitz MM, Goldstone AH, Lazarus HM, Schmitz N. Outcome of autologous transplantation for mantle cell lymphoma: a study by the European Blood and Bone Marrow Transplant and Autologous Blood and Marrow Transplant Registries. Br J Haematol. 2003 Mar;120(5):793-800.

ReferenceCitation: Winter JN. Combining yttrium 90-labeled ibritumomab tiuxetan with high-dose chemotherapy and stem cell support in patients with relapsed non-Hodgkin's lymphoma. Clin Lymphoma. 2004 Oct;5 Suppl 1:S22-6. Review.

ReferenceCitation: Bouabdallah K, Furst S, Asselineau J, Chevalier P, Tournilhac O, Ceballos P, Vigouroux S, Tabrizi R, Doussau A, Bouabdallah R, Mohty M, Le Gouill S, Blaise D, Milpied N. 90Y-ibritumomab tiuxetan, fludarabine, busulfan and antithymocyte globulin reduced-intensity allogeneic transplant conditioning for patients with advanced and high-risk B-cell lymphomas. Ann Oncol. 2015 Jan;26(1):193-198. doi: 10.1093/annonc/mdu503. Epub 2014 Oct 30.

family: Bouabdallah

full_name: K. Bouabdallah

given: K.

family: Furst

full_name: S. Furst

given: S.

family: Asselineau

full_name: J. Asselineau

given: J.

family: Chevalier

full_name: P. Chevalier

given: P.

family: Tournilhac

full_name: O. Tournilhac

given: O.

family: Ceballos

full_name: P. Ceballos

family: Vigouroux

full_name: S. Vigouroux

family: Tabrizi

full_name: R. Tabrizi

given: R.

family: Doussau

full_name: A. Doussau

given: A.

full_name: R. Bouabdallah

family: Mohty

full_name: M. Mohty

given: M.

family: Le Gouill

full_name: S. Le Gouill

family: Blaise

full_name: D. Blaise

family: Milpied

full_name: N. Milpied

given: N.

journal_name: Annals of Oncology

evidence: open (via crossref license)

location_facility: Service d'hématologie clinique - Hôpital l'Archet 1

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan

location_facility: Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand

location_facility: Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade

location_facility: Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin

location_facility: Pôle hématologie et immunologie clinique - Hôpital Saint-Louis

location_facility: Hématologie et Oncologie médicale - CHU Lapeyronie

location_facility: Département d'hématologie et d'Oncologie - CHRU Hautepierre

location_facility: Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau

location_facility: Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite


title: Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD

acronym: START

summary: Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5.

ReferenceCitation: Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73.

ReferenceCitation: Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31.

ReferenceCitation: Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6.

ReferenceCitation: Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020. Erratum in: Ophthalmology. 2011 Sep;118(9):1700.

ReferenceType: derived

ReferenceCitation: Korobelnik JF, Souied EH, Oubraham H, Razavi S, Mauget-Faÿsse M, Savel H, Chene G, Wolf S. ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START). Retina. 2021 Mar 1;41(3):588-594. doi: 10.1097/IAE.0000000000002910.

family: Korobelnik

full_name: Jean-François Korobelnik

given: Jean-François

sequence: first

family: Souied

full_name: Eric H. Souied

given: Eric H.

sequence: additional

family: Oubraham

full_name: Hassiba Oubraham

given: Hassiba

family: Razavi

full_name: Sam Razavi

given: Sam

family: Mauget-Faÿsse

full_name: Martine Mauget-Faÿsse

given: Martine

family: Savel

full_name: Helene Savel

given: Helene

family: Chene

full_name: Genevieve Chene

given: Genevieve

family: Wolf

full_name: Sebastian Wolf

given: Sebastian

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Retina

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun

location_facility: Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau

location_facility: Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve

location_facility: Centre Ophtalmologie Transparence 30 Boulevard Heurteloup

location_facility: Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard

location_facility: Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré

location_facility: Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle

location_facility: Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908

location_facility: Service d'Ophtalmologie Hôpital de la croix rousse

location_facility: Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

summary:
Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes.

The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Supportive Care

ipd_sharing: No

location_facility: Service de Chirurgie Digestive, Centre Léon Bérard - Lyon

location_facility: Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble

location_facility: Service de Chirurgie Digestive, CHU Amiens Picardie

location_facility: Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse

location_facility: Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille

location_facility: Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon

location_facility: Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen

location_facility: Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois

location_facility: Service de Chirurgie Digestive, Hôpital Saint-André - CHU de Bordeaux

location_facility: Service de Chirurgie Digestive, CHU Carémeau - Nîmes

location_facility: Service de Chirurgie Digestive, Hôpital Pontchaillou - CHU Rennes

location_facility: Service de Chirurgie Digestive, Institut du Cancer de Montpellier

location_facility: Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand

location_facility: Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP

location_facility: Département de chirurgie digestive, Institut Gustave Roussy

location_facility: Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon

location_facility: Service de Chirurgie Digestive, Hôpital Saint-Louis - APHP Paris

location_facility: Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie

location_facility: Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine

location_facility: Service de Chirurgie Digestive, Hôpital les Diaconnesses

location_facility: Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes

location_facility: Service de Chirurgie Digestive, CHU de Besançon

location_facility: Service de Chirurgie Digestive, Institut Bergonié

location_facility: Service de Chirurgie Digestive, CHU de la Timone - Marseille

location_facility: Service de Chirurgie Digestive, Centre Oscar Lambret - Lille

location_facility: Service de Chirurgie Digestive, Hôpital Beaujon - APHP

location_facility: Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP

location_facility: Service de Chirurgie Digestives, Hôpital Européen de Marseille

intervention_type: Radiation

status_simplified: Ongoing


title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib

acronym: STIM 2

summary:
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials.

Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.

enrollment_type: Anticipated

location_facility: University Hospital Bordeaux, Hôpital du Haut Lévêque

location_facility: CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: University Hospital Poitiers - Hôpital Jean Bernard

location_facility: Lille University hospital - Hôpital Claude Huriez

intervention_type: Drug


title: Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old

acronym: LAM-SA 2007

summary: A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

ReferenceCitation: Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. Epub 2006 Feb 2.

ReferenceCitation: Sekeres MA, Stone R. Older adults with acute myeloid leukemia. Curr Oncol Rep. 2002 Sep;4(5):403-9. Review.

ReferenceCitation: Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903.

ReferenceCitation: Stone RM, Berg DT, George SL, Dodge RK, Paciucci PA, Schulman P, Lee EJ, Moore JO, Powell BL, Schiffer CA. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. Cancer and Leukemia Group B. N Engl J Med. 1995 Jun 22;332(25):1671-7.

ReferenceCitation: Witz F, Sadoun A, Perrin MC, Berthou C, Brière J, Cahn JY, Lioure B, Witz B, François S, Desablens B, Pignon B, Le Prisé PY, Audhuy B, Caillot D, Casassus P, Delain M, Christian B, Tellier Z, Polin V, Hurteloup P, Harousseau JL. A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction treatment for de novo acute myelogenous leukemia in elderly patients. Groupe Ouest Est Leucémies Aiguës Myéloblastiques (GOELAM). Blood. 1998 Apr 15;91(8):2722-30.

ReferenceCitation: Pigneux A, Perreau V, Jourdan E, Vey N, Dastugue N, Huguet F, Sotto JJ, Salmi LR, Ifrah N, Reiffers J. Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. Haematologica. 2007 Oct;92(10):1327-34.

ReferenceCitation: Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction]. Nihon Seirigaku Zasshi. 1972 May;34(5):257-61. Japanese.

ReferenceCitation: Gardin C, Turlure P, Fagot T, Thomas X, Terre C, Contentin N, Raffoux E, de Botton S, Pautas C, Reman O, Bourhis JH, Fenaux P, Castaigne S, Michallet M, Preudhomme C, de Revel T, Bordessoule D, Dombret H. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial. Blood. 2007 Jun 15;109(12):5129-35. Epub 2007 Mar 6.

ReferenceCitation: Hegenbart U, Niederwieser D, Sandmaier BM, Maris MB, Shizuru JA, Greinix H, Cordonnier C, Rio B, Gratwohl A, Lange T, Al-Ali H, Storer B, Maloney D, McSweeney P, Chauncey T, Agura E, Bruno B, Maziarz RT, Petersen F, Storb R. Treatment for acute myelogenous leukemia by low-dose, total-body, irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors. J Clin Oncol. 2006 Jan 20;24(3):444-53. Epub 2005 Dec 12.

ReferenceCitation: Largeaud L, Cornillet-Lefebvre P, Hamel JF, Dumas PY, Prade N, Dufrechou S, Plenecassagnes J, Luquet I, Blanchet O, Banos A, Béné MC, Bernard M, Bertoli S, Bonmati C, Fornecker LM, Guièze R, Haddaoui L, Hunault M, Ianotto JC, Jourdan E, Ojeda M, Peterlin P, Vey N, Zerazhi H, Yosr H, Mineur A, Cahn JY, Ifrah N, Récher C, Pigneux A, Delabesse E; French Innovative Leukemia Organization (FILO). Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study. Leukemia. 2021 May;35(5):1291-1300. doi: 10.1038/s41375-020-01031-1. Epub 2020 Sep 18.

family: Largeaud

full_name: Laetitia Largeaud

given: Laetitia

name: on behalf of the French Innovative Leukemia Organization (FILO)

family: Cornillet-Lefebvre

full_name: Pascale Cornillet-Lefebvre

given: Pascale

family: Hamel

full_name: Jean-François Hamel

family: Dumas

full_name: Pierre-Yves Dumas

given: Pierre-Yves

family: Prade

full_name: Naïs Prade

given: Naïs

family: Dufrechou

full_name: Stéphanie Dufrechou

given: Stéphanie

family: Plenecassagnes

full_name: Julien Plenecassagnes

given: Julien

family: Luquet

full_name: Isabelle Luquet

given: Isabelle

family: Blanchet

full_name: Odile Blanchet

given: Odile

family: Banos

full_name: Anne Banos

given: Anne

family: Béné

full_name: Marie C. Béné

given: Marie C.

family: Bernard

full_name: Marc Bernard

given: Marc

family: Bertoli

full_name: Sarah Bertoli

given: Sarah

family: Bonmati

full_name: Caroline Bonmati

given: Caroline

family: Fornecker

full_name: Luc Matthieu Fornecker

given: Luc Matthieu

family: Guièze

full_name: Romain Guièze

given: Romain

family: Haddaoui

full_name: Lamya Haddaoui

given: Lamya

family: Hunault

full_name: Mathilde Hunault

given: Mathilde

family: Ianotto

full_name: Jean Christophe Ianotto

given: Jean Christophe

family: Jourdan

full_name: Eric Jourdan

given: Eric

family: Ojeda

full_name: Mario Ojeda

location_facility: Service Hématologie, Centre Hospitalier Annecy

location_facility: Unité Hématologie, Centre Hospitalier Blois

location_facility: Service Hématologie Clinique, Hôpital Bretonneau

location_facility: Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse

location_facility: Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque

location_facility: Service Hématologie Clinique, Hôpital Archet 1

location_facility: Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon

location_facility: Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand

location_facility: Service Hématologie Oncologie, CHR Metz-Thionville

location_facility: Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

location_facility: Service Hématologie, Centre Hospitalier de la Côte Basque

location_facility: Service Médecine B - Unité Onco-hématologique, CHU Caremeau

location_facility: Service Hématologie Clinique, CHU Dijon Hôpital des enfants

location_facility: Service Hématologie, Hôpital Augustin Morvan

location_facility: Service d'Hématologie, Institut de Cancérologhie de la Loire

location_facility: Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre

location_facility: Service des maladies du sang, Centre Hospitalier Universitaire d'Angers

location_facility: Service Hématologie Clinique, Hôpital Pontchaillou

location_facility: Service Hématologie - Médecine Interne, Hôpitaux de Brabois

location_facility: Service Onco-Hématologie 3, Institut Paoli Calmettes

location_facility: Service Hématologie Clinique, CHU -Hôtel Dieu

location_facility: Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar

location_facility: Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble

location_facility: Service Hématologie, Hôpital Dr Duchenne

location_facility: Service Hématologie Clinique, Hôpital Robert Debre

location_facility: Service Oncologie Médicale, Hôpital de la Source


title: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)

acronym: STIM

summary: The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.

design_allocation: Non-Randomized

ReferenceCitation: Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18.

family: Rea

full_name: Delphine Rea

given: Delphine

family: Henry

full_name: Guylaine Henry

given: Guylaine

family: Khaznadar

full_name: Zena Khaznadar

given: Zena

family: Etienne

full_name: Gabriel Etienne

given: Gabriel

family: Guilhot

full_name: François Guilhot

given: François

family: Nicolini

full_name: Franck Nicolini

given: Franck

full_name: Joelle Guilhot

given: Joelle

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

family: Huguet

full_name: Françoise Huguet

given: Françoise

family: Legros

full_name: Laurence Legros

given: Laurence

family: Gardembas

full_name: Martine Gardembas

given: Martine

family: Dubruille

full_name: Viviane Dubruille

given: Viviane

family: Guerci-Bresler

full_name: Agnès Guerci-Bresler

given: Agnès

family: Charbonnier

full_name: Aude Charbonnier

given: Aude

family: Maloisel

full_name: Frédéric Maloisel

given: Frédéric

full_name: Jean-Christophe Ianotto

given: Jean-Christophe

family: Villemagne

full_name: Bruno Villemagne

given: Bruno

family: Mahon

full_name: François-Xavier Mahon

given: François-Xavier

family: Moins-Teisserenc

full_name: Hélène Moins-Teisserenc

given: Hélène

family: Dulphy

full_name: Nicolas Dulphy

given: Nicolas

family: Toubert

full_name: Antoine Toubert

given: Antoine

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

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

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Français des Leucémies Myéloïdes Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.

location_facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin

location_facility: University Hospital Strasbourg, Hôpital Civil

location_facility: Centre hospitalier-service de médecine interne Onco-Hématologique


title: Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)

acronym: PHARMA-A

summary: The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.

ReferenceCitation: Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.

name: Centre d’Investigation Clinique (CIC1401), Centre de Ressources et de Compétences de la Mucoviscidose (CRCM), Centre de Recherche Cardio-thoracique de Bordeaux (U1045), Université de Bordeaux, Centre Hospitalier Universitaire de Bordeaux Groupe hospitalier Pellegrin, Bordeaux, France

family: Bui

full_name: S Bui

given: S

name: Département de Pharmacologie Pédiatrique et Pharmacogénétique, Centre Hospitalier Universitaire Robert Debré APHP, Paris, France

name: Service de Pharmacie, Centre hospitalier Intercommunal Robert Ballanger, Aulnay-sous-Bois, France

family: Facchin

full_name: A Facchin

given: A

family: Ha

full_name: P Ha

given: P

name: Département de Pharmacologie et de toxicologie, Centre Hospitalier Universitaire de Bordeaux, Groupe hospitalier Pellegrin, Bordeaux, France

family: Bouchet

full_name: S Bouchet

family: Leroux

full_name: S Leroux

family: Nacka

full_name: F Nacka

given: F

family: Fayon

full_name: M Fayon

given: M

name: Centre d’Investigation Clinique (CIC1426), Centre Hospitalier Universitaire Robert Debré APHP, Paris, France

family: Jacqz-Aigrain

full_name: E Jacqz-Aigrain

given: E

family: M Fayon

full_name: Bordeaux M Fayon

given: Bordeaux

family: E Jacqz-Aigrain

full_name: Paris E Jacqz-Aigrain

given: Paris

family: J Kanold

full_name: Clermont-Ferrand J Kanold

given: Clermont-Ferrand

family: H Chevassus

full_name: Montpellier H Chevassus

given: Montpellier

family: R Hankard

full_name: Tours R Hankard

given: Tours

family: B Kassai

full_name: Lyon B Kassai

given: Lyon

family: Marc Bardou

full_name: Dijon Marc Bardou

given: Dijon

name: network of Paediatric Clinical Investigation Centres

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_facility:
APHP - Hôpital NEcker
CHRU Lille
Hospices Civils de Lyon
CHU Toulouse
CHU de Dijon
CHU Clermont Ferrand
CHU Poitiers
CHU de Bordeaux, Hôpital Pellegrin
AP-HP - Hôpital Robert Debré
CHU de Grenoble
CHU Montpellier
CHU tours
CHU Rouen
AP-HM, Hôpital La Timone


title: Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study

acronym: DOCTORS

summary:
Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - To date, no study has evaluated whether optical coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI) and stenting.

The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. In particular, we will evaluate the impact of changes in procedural strategy resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute coronary syndromes.

ReferenceCitation: Meneveau N, Ecarnot F, Souteyrand G, Motreff P, Caussin C, Van Belle E, Ohlmann P, Morel O, Grentzinger A, Angioi M, Chopard R, Schiele F. Does optical coherence tomography optimize results of stenting? Rationale and study design. Am Heart J. 2014 Aug;168(2):175-81.e1-2. doi: 10.1016/j.ahj.2014.05.007. Epub 2014 May 24.

ReferenceType: result

ReferenceCitation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrançois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

name: From Department of Cardiology, EA3920, University Hospital Jean Minjoz, Besançon, France (N.M., N.B., R.C., M.C., F.E., H.T., F.S.); University Hospital Gabriel Montpied, and Université d’Auvergne UMR 6284, Clermont Ferrand, France (G.S., P.M.); Institut Mutualiste Montsouris, Paris, France (C.C., N.A.); Nouvel Hôpital Civil, Strasbourg, France (P.O., O.M.); Centre Hospitalier, Belfort, France (Y.L.); Centre Hospitalier, Chambéry, France (V.D.-G.); Sorbonne Université - Univ Paris 06 (UPMC), ACTION...

family: Meneveau

full_name: Nicolas Meneveau

family: Souteyrand

full_name: Geraud Souteyrand

given: Geraud

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Caussin

full_name: Christophe Caussin

given: Christophe

family: Amabile

full_name: Nicolas Amabile

family: Ohlmann

full_name: Patrick Ohlmann

given: Patrick

family: Morel

full_name: Olivier Morel

given: Olivier

family: Lefrançois

full_name: Yoann Lefrançois

given: Yoann

family: Descotes-Genon

full_name: Vincent Descotes-Genon

given: Vincent

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Braik

full_name: Nassim Braik

given: Nassim

family: Chopard

full_name: Romain Chopard

given: Romain

family: Chatot

full_name: Marion Chatot

given: Marion

family: Ecarnot

full_name: Fiona Ecarnot

given: Fiona

family: Tauzin

full_name: Hélène Tauzin

family: Van Belle

full_name: Eric Van Belle

given: Eric

family: Belle

full_name: Loïc Belle

given: Loïc

family: Schiele

full_name: François Schiele

given: François

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

title: Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non–ST-Elevation Acute Coronary Syndrome

ReferenceCitation: Meneveau N, Ecarnot F. Response by Meneveau and Ecarnot to Letter Regarding Article, "Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting)". Circulation. 2017 Feb 28;135(9):e142-e143. doi: 10.1161/CIRCULATIONAHA.116.026277.

name: From Department of Cardiology, University Hospital Jean Minjoz, and EA3920, University of Burgundy - Franche-Comté, Besançon, France.

title: Response by Meneveau and Ecarnot to Letter Regarding Article, “Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting)”

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire Régional


type: Other Identifier

title: On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

acronym: IPERGAY

summary: This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed recent studies have reported a higher incidence of new HIV infection in MSM as compared to the general population, new approaches to the prevention of HIV infection are, therefore, necessary in order to consider the limits of current strategies.

primary_purpose: Prevention

ReferenceCitation: Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.

family: Antoni

full_name: Guillemette Antoni

given: Guillemette

family: Tremblay

full_name: Cécile Tremblay

given: Cécile

family: Delaugerre

full_name: Constance Delaugerre

given: Constance

family: Charreau

full_name: Isabelle Charreau

given: Isabelle

family: Cua

full_name: Eric Cua

family: Rojas Castro

full_name: Daniela Rojas Castro

given: Daniela

family: Raffi

full_name: François Raffi

family: Chas

full_name: Julie Chas

given: Julie

family: Huleux

full_name: Thomas Huleux

given: Thomas

family: Spire

full_name: Bruno Spire

given: Bruno

family: Capitant

full_name: Catherine Capitant

given: Catherine

family: Cotte

full_name: Laurent Cotte

given: Laurent

family: Meyer

full_name: Laurence Meyer

given: Laurence

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Aboulker

full_name: Jean-Pierre Aboulker

given: Jean-Pierre

family: Bajos

full_name: Nathalie Bajos

given: Nathalie

family: Baril

full_name: Jean-Guy Baril

given: Jean-Guy

family: Besnier

full_name: Michel Besnier

given: Michel

family: Binesse

full_name: Johan Binesse

given: Johan

family: Carette

full_name: Diane Carette

given: Diane

family: Cattin

full_name: Grégoire Cattin

given: Grégoire

family: Chéret

full_name: Antoine Chéret

given: Antoine

family: Chidiac

full_name: Christian Chidiac

given: Christian

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

ReferenceCitation: Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bébéar C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Doré V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.

ReferenceCitation: Molina JM, Charreau I, Spire B, Cotte L, Chas J, Capitant C, Tremblay C, Rojas-Castro D, Cua E, Pasquet A, Bernaud C, Pintado C, Delaugerre C, Sagaon-Teyssier L, Mestre SL, Chidiac C, Pialoux G, Ponscarme D, Fonsart J, Thompson D, Wainberg MA, Doré V, Meyer L; ANRS IPERGAY Study Group. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017 Sep;4(9):e402-e410. doi: 10.1016/S2352-3018(17)30089-9. Epub 2017 Jul 23.

evidence: open (via crossref license, author manuscript)

ReferenceCitation: Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Préau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Doré V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.

location_facility:
Hôpital de l'Archet
CHU Hôtel Dieu
Hôpital Tenon
Hôpital Gustave Dron
Hôpital de La Croix Rousse
CHUM - Hôpital Hôtel Dieu
Hôpital Saint-Louis


title: Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer

summary:
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.

Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.

Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen

status: Unknown status

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

lead_sponsor_type: industriel

status_simplified: Unknown


title: LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable Hepacellular Carcinoma

summary: The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: de Baere T, Guiu B, Ronot M, Chevallier P, Sergent G, Tancredi I, Tselikas L, Dioguardi Burgio M, Raynaud L, Deschamps F, Verset G. Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry. Cancers (Basel). 2020 Nov 17;12(11). pii: E3405. doi: 10.3390/cancers12113405.

family: de Baere

full_name: Thierry de Baere

given: Thierry

family: Guiu

full_name: Boris Guiu

given: Boris

family: Ronot

full_name: Maxime Ronot

given: Maxime

family: Chevallier

full_name: Patrick Chevallier

given: Patrick

family: Sergent

full_name: Géraldine Sergent

given: Géraldine

family: Tancredi

full_name: Illario Tancredi

given: Illario

family: Tselikas

full_name: Lambros Tselikas

given: Lambros

family: Dioguardi Burgio

full_name: Marco Dioguardi Burgio

given: Marco

family: Raynaud

full_name: Lucas Raynaud

given: Lucas

family: Deschamps

full_name: Frederic Deschamps

given: Frederic

family: Verset

full_name: Gontran Verset

given: Gontran

currency_apc_doaj: CHF

journal_name: Cancers

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

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

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central
dipot.ulb.ac.be

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

ipd_sharing: Undecided

lead_sponsor: Terumo Europe N.V.

location_country: Belgium France

location_facility:
CHRU Lille
Institut Gustave Roussy
Cliniques Universitaires Saint Luc
Hôpital Universitaire Saint-Eloi
Hôpital L'Archet II
Hôpital Erasme
Hôpital Beaujon

intervention_type: Device


status: Recruiting

lead_sponsor: AB Science

location_facility: CHU Clermont-Ferrand: Site Gabriel-Montpied

location_facility: Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux

type: EudraCT Number

source: euctr

title: Randomized, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib Combined With Isoquercetin, and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

summary: Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.


title: BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

acronym: BioCONTINUE

summary:
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.

80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.

So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

lead_sponsor: Biotronik SE & Co. KG

location_country: Italy Spain France Israel Hungary Belgium Portugal Germany

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Cliniques du Tonkin, de la Sauvegarde et Protestante

location_facility: Hospital Clinico Universitario de Valladolid


lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

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

acronym: PNET 5 MB

location_facility: Klinikum Schwabing, Pediatric Hospital of Technical University

location_facility: Barncancercentrum Drottning Silvias Barnochungdomssjukhus

location_facility: The Children's Memorial Health Institute

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Vestische Kinder- und Jugendklinik, University Witten/Herdecke

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: University Hospital München, Dr. von Haunersches Kinderspital

title: An International Prospective Study on Clinically Standard-risk Medulloblastoma in Children Older Than 3 to 5 Years With Low-risk Biological Profile (PNET 5 MB-LR) or Average-risk Biological Profile (PNET 5 MB-SR)

summary: The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms.


title: Assessment of the Numen Stent With Evaluation in a Randomized Study

acronym: ANSWERS

summary: The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent

lead_sponsor: International Biomedical Systems S.p.A.

location_facility:
Clinique Saint Gatien
Clinique Valmente
Clinique Vert Coteau
Clinique Alleray-Labrouste
CMC De Parly II
Centre Hospitalier Privé Beauregard
Clinique Turin
CHU Cote de Nacre


title: During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease

acronym: AIRVO-PHYSIO

summary:
Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease.

Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device.

Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease.

Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.

lead_sponsor: ADIR Association

intervention_type: Other


title: Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study

acronym: PPR-NHF

summary:
Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.

Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.

Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.


title: Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort

acronym: TRAKR

summary: The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born from type 1 diabetic parents.

primary_purpose: Screening

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

acronym: TRAUMAX

summary: The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX

lead_sponsor: Integra LifeSciences Services

location_facility: Nouvelle Clinique de l'Union et du Vaurais

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Hôpital d'Instruction des Armées R. Picqué


title: Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.

summary: The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).

lead_sponsor: Terumo BCTbio

location_facility: Centre Hospitalier Univesrsitaire A Michallon

location_facility: Centre Hospitalier Universitaire Jean Minjoz

location_facility: Centre Hospitalier Universitaire Hôtel Dieu

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Régional Universitaire Hautepierre


title: Alterations in Total Red Blood Cell Volume and Plasma Volume During a One-year Confinement in Antarctica: Effect of Hypoxia

acronym: ANTARCV

summary: This study evaluates the effect of hypoxia on blood volumes during Antarctic winter-over confinement. Half of the participants will be evaluated during sea-level winter-over confinement, while the other half will be examined during high-altitude hypoxia winter-over confinement.

status: Enrolling by invitation

primary_purpose: Basic Science

lead_sponsor: Ecole Nationale des Sports de Montagne

location_facility: Ecole nationale des sports de montagne, site de l'Ecole nationale de ski et d'alpinisme


title: A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

summary: This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

ReferenceCitation: Ribrag V, Caballero D, Fermé C, Zucca E, Arranz R, Briones J, Gisselbrecht C, Salles G, Gianni AM, Gomez H, Kahatt C, Corrado C, Szyldergemajn S, Extremera S, de Miguel B, Cullell-Young M, Cavalli F. Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin's lymphoma. Haematologica. 2013 Mar;98(3):357-63. doi: 10.3324/haematol.2012.069757. Epub 2012 Oct 12.

family: Ribrag

full_name: V. Ribrag

given: V.

family: Caballero

full_name: D. Caballero

given: D.

family: Ferme

full_name: C. Ferme

given: C.

family: Zucca

full_name: E. Zucca

given: E.

family: Arranz

full_name: R. Arranz

given: R.

family: Briones

full_name: J. Briones

given: J.

family: Gisselbrecht

full_name: C. Gisselbrecht

family: Salles

full_name: G. Salles

given: G.

family: Gianni

full_name: A. M. Gianni

given: A. M.

family: Gomez

full_name: H. Gomez

given: H.

family: Kahatt

full_name: C. Kahatt

family: Corrado

full_name: C. Corrado

family: Szyldergemajn

full_name: S. Szyldergemajn

given: S.

family: Extremera

full_name: S. Extremera

family: de Miguel

full_name: B. de Miguel

given: B.

family: Cullell-Young

full_name: M. Cullell-Young

given: M.

family: Cavalli

full_name: F. Cavalli

given: F.

license: publisher-specific license

license_normalized: publisher-specific

repository_institution: PubMed Central - Europe PMC

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_country:
Italy
Peru
Switzerland
France
Puerto Rico
Spain

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Instituto Nacional de Enfermedades Neoplásicas (INEN)

location_facility: Istituto di ematologia e oncologia medica "L. e. A. Seragnoli"

location_facility: Hospital Español Auxilio Mutuo de Puerto Rico Inc.


title: A Randomized Phase II Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

summary: A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

location_facility: Service des Maladies Infectieuses et Tropicales, Hopital Tenon

location_facility: Hopital du Kremlin Bicêtre Service de médecine interne

location_facility: CIC de Vaccinologie Cochin Pasteur, hôpital Cochin

location_facility: Hôpital Gustave Dron, Service Maladies Infectieuses

intervention_type: Biological


lead_sponsor: MedDay Pharmaceuticals SA

acronym: MS-SPI

location_facility: Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

title: Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study

summary: The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.


title: A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence

summary: The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

lead_sponsor: Coloplast A/S

location_country: Italy France Belgium Spain Germany

location_facility: Clinique Mutualiste de la Porte de l'Orient


title: Recombinant Human Activated Factor VII as Salvage Therapy in Women With Severe Postpartum Hemorrhage

summary: The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments. We are going to compare its early use, before elective surgery or arterial embolization, to its late use, after embolization or surgery, before salvage hysterectomy.

ReferenceCitation: Lavigne-Lissalde G, Aya AG, Mercier FJ, Roger-Christoph S, Chauleur C, Morau E, Ducloy-Bouthors AS, Mignon A, Raucoules M, Bongain A, Boehlen F, de Moerloose P, Bouvet S, Fabbro-Peray P, Gris JC. Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial. J Thromb Haemost. 2015 Apr;13(4):520-9. doi: 10.1111/jth.12844. Epub 2015 Mar 11.

name: Laboratory of Hematology; Carémeau University Hospital; Nîmes France

name: Research group EA2992; Montpellier University; Nîmes France

family: Lavigne-Lissalde

full_name: G. Lavigne-Lissalde

name: Department of Anesthesiology and Intensive Care; Carémeau University Hospital; Nîmes France

family: Aya

full_name: A. G. Aya

given: A. G.

name: Department of Anesthesiology and Intensive Care; APHP - A. Béclère Hospital; South-University of Paris; Clamart Paris France

family: Mercier

full_name: F. J. Mercier

given: F. J.

name: Department of Anesthesiology; Private Hospital Antony of Paris; Paris France

family: Roger-Christoph

full_name: S. Roger-Christoph

name: Department of Obstetrics and Gynecology; University Hospital, and Thrombosis Research Group EA3065; Saint-Etienne France

family: Chauleur

full_name: C. Chauleur

name: Department of Anaesthesiology and Intensive Care; University Hospital Arnaud de Villeneuve; Montpellier France

family: Morau

full_name: E. Morau

name: Department of Anesthesiology and Intensive Care; Jeanne de Flandre Hospital; University Hospital of Lille; Lille France

family: Ducloy-Bouthors

full_name: A. S. Ducloy-Bouthors

given: A. S.

name: Department of Anesthesiology and Intensive Care; Cochin University Hospital; Paris France

family: Mignon

full_name: A. Mignon

given: A.

name: Department of Anesthesiology and Intensive Care; University Hospital; Nice France

family: Raucoules

full_name: M. Raucoules

name: Department of Obstetrics and Gynecology; University Hospital; Nice France

family: Bongain

full_name: A. Bongain

name: Division of Angiology and Hemostasis; University Hospital and Faculty of Medicine of Geneva; Geneva Switzerland

family: Boehlen

full_name: F. Boehlen

family: de Moerloose

full_name: P. de Moerloose

given: P.

name: Department of Medical Information, Biostatistics, Epidemiology and Public Health; Carémeau University Hospital; Nîmes France

family: Bouvet

full_name: S. Bouvet

family: Fabbro-Peray

full_name: P. Fabbro-Peray

family: Gris

full_name: J.-C. Gris

journal_name: Journal of Thrombosis and Haemostasis

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country: France Switzerland

location_facility: Laboratoire d'hématologie, Groupe Hospitalo-Universitaire Caremeau


ReferenceCitation: Arock M. A new therapeutic advance for symptomatic systemic mastocytosis? Lancet. 2017 Feb 11;389(10069):576-578. doi: 10.1016/S0140-6736(16)31655-5. Epub 2017 Jan 7.

ReferenceCitation: Lortholary O, Chandesris MO, Bulai Livideanu C, Paul C, Guillet G, Jassem E, Niedoszytko M, Barete S, Verstovsek S, Grattan C, Damaj G, Canioni D, Fraitag S, Lhermitte L, Georgin Lavialle S, Frenzel L, Afrin LB, Hanssens K, Agopian J, Gaillard R, Kinet JP, Auclair C, Mansfield C, Moussy A, Dubreuil P, Hermine O. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017 Feb 11;389(10069):612-620. doi: 10.1016/S0140-6736(16)31403-9. Epub 2017 Jan 7.

family: Lortholary

full_name: Olivier Lortholary

given: Olivier

family: Chandesris

full_name: Marie Olivia Chandesris

given: Marie Olivia

family: Livideanu

full_name: Cristina Bulai Livideanu

given: Cristina Bulai

family: Paul

full_name: Carle Paul

given: Carle

family: Guillet

full_name: Gérard Guillet

given: Gérard

family: Jassem

full_name: Ewa Jassem

given: Ewa

family: Niedoszytko

full_name: Marek Niedoszytko

given: Marek

family: Barete

full_name: Stéphane Barete

given: Stéphane

family: Verstovsek

full_name: Srdan Verstovsek

given: Srdan

family: Grattan

full_name: Clive Grattan

given: Clive

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

family: Canioni

full_name: Danielle Canioni

given: Danielle

family: Fraitag

full_name: Sylvie Fraitag

given: Sylvie

family: Lhermitte

full_name: Ludovic Lhermitte

given: Ludovic

family: Lavialle

full_name: Sophie Georgin Lavialle

given: Sophie Georgin

family: Frenzel

full_name: Laurent Frenzel

given: Laurent

family: Afrin

full_name: Lawrence B Afrin

given: Lawrence B

family: Hanssens

full_name: Katia Hanssens

given: Katia

family: Agopian

full_name: Julie Agopian

given: Julie

family: Gaillard

full_name: Raphael Gaillard

given: Raphael

family: Kinet

full_name: Jean-Pierre Kinet

given: Jean-Pierre

family: Auclair

full_name: Christian Auclair

given: Christian

family: Mansfield

full_name: Colin Mansfield

given: Colin

family: Moussy

full_name: Alain Moussy

given: Alain

family: Dubreuil

full_name: Patrice Dubreuil

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

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

location_facility: UC Davis Health System , Department of Dermatology

title: Randomized, Placebo-controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib at 6 mg/kg/Day to Placebo in Treatment of Patients With Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis With Handicap

summary: The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.


title: Multicentric Study of the Clinical Interest of the TcPO2 Technique

acronym: CINEYSOFT

summary:
The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.

The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital
Hospital


title: Phase 2 of Sunitinib (Sutent) in Patients With Locally Advanced or Metastatic Anaplastic, Differentiated or Medullar Thyroid Cancer

acronym: THYSU

summary:
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during previous studies with sunitinib (an angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment despite some use of chemotherapy.

The objective of the trial is to determine the objective tumor response rate (efficacy) in patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of sunitinib in these patients.

The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75 patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid carcinoma.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Léon Bérard - Département de Médecine - 28 rue Laennec

location_facility: Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André - 1 rue Jean Burguet

location_facility: Service des Maladies Endocriniennes - Hôpital Lapeyronie - 191 avenue du Doyen Gaston Giraud

location_facility: Centre Paul Lamarque - Va d'Aurelle - CRLC Val d'Aurelle - 208 rue des Apothicaires

location_facility: Service d'Endocrinologie, CHU Timone, AP-HM - 254 rue St Pierre

location_facility: Service de Cancérologie Médicale - HEGP - 20 rue Leblanc

location_facility: Fédération Endocrinologie - Groupe Hospitalier Est - Hôpital neurologique - CHU Lyon - 59 Boulevard Pinel

location_facility: Service d'Endocrinologie - Hôpital de l'Archet I - Route Saint Antoine de Jinestière

location_facility: Centre Antoine Lacassagne - 33 avenue de Valombrose

location_facility: Service d'Oncologie Médicale, Institut Claudius Regaud - 20-24 rue du Pont Saint Pierre

location_facility: Service d'endocrinologie et Maladies Métaboliques, Groupe Hospitalier Rangueil-Larrey CHU Toulouse - avenue Prof Jean Poulhes

location_facility: Service d'Endocrinologie - CHU de Nancy, Hôpital de Brabois - rue du Morvan

location_facility: Département Endocrinolo-Diabéto-Nutrition - CHU d'Angers - 4 rue de Larray

location_facility: Service d'Endocrinologie et maladies métaboliques, Clinique Marc Linquette - rue du Pr Laguesse


acronym: CAPADOGE

summary: The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.

location_facility:
CH Mont de Marsan
CHRU Lille
CHU de Limoges, Hôpital Dupuytren
Institut jean Godinot, CLCC Reims
Centre Oscar Lambret, CLCC Lille
CH de Dax
CHU Bordeaux - hôpital Xavier Arnozan
Centre Alexis Vautrin CLCC Nancy
Centre hospitalier de Senlis
CHU de Bordeaux - Hôpital Saint André
CHU Nancy hôpital adulte du brabois
Institut Bergonié


summary: The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population

lead_sponsor: Pierre Fabre Medical Devices


title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.

acronym: COMET

summary:
The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

primary_purpose: Health Services Research

ReferenceCitation: Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9:CD009437. doi: 10.1002/14651858.CD009437.pub3. Review.

name: Department of Public Health and Primary Care; Leiden University Medical Center (LUMC); Leiden Netherlands

family: Poot

full_name: Charlotte C Poot

given: Charlotte C

family: Meijer

full_name: Eline Meijer

given: Eline

family: Kruis

full_name: Annemarije L Kruis

given: Annemarije L

name: Department of Epidemiology; University Medical Center Groningen, University of Groningen; Groningen Netherlands

family: Smidt

full_name: Nynke Smidt

given: Nynke

family: Chavannes

full_name: Niels H Chavannes

given: Niels H

family: Honkoop

full_name: Persijn J Honkoop

given: Persijn J

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Kessler R, Casan-Clara P, Koehler D, Tognella S, Viejo JL, Dal Negro RW, Díaz-Lobato S, Reissig K, Rodríguez González-Moro JM, Devouassoux G, Chavaillon JM, Botrus P, Arnal JM, Ancochea J, Bergeron-Lafaurie A, De Abajo C, Randerath WJ, Bastian A, Cornelissen CG, Nilius G, Texereau JB, Bourbeau J. COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD. Eur Respir J. 2018 Jan 11;51(1). pii: 1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.

family: Kessler

full_name: Romain Kessler

given: Romain

family: Casan-Clara

full_name: Pere Casan-Clara

given: Pere

family: Koehler

full_name: Dieter Koehler

given: Dieter

family: Tognella

full_name: Silvia Tognella

given: Silvia

family: Viejo

full_name: Jose Luis Viejo

given: Jose Luis

family: Dal Negro

full_name: Roberto W. Dal Negro

given: Roberto W.

family: Díaz-Lobato

full_name: Salvador Díaz-Lobato

given: Salvador

family: Reissig

full_name: Karina Reissig

given: Karina

family: Rodríguez González-Moro

full_name: José Miguel Rodríguez González-Moro

given: José Miguel

family: Devouassoux

full_name: Gilles Devouassoux

given: Gilles

family: Chavaillon

full_name: Jean-Michel Chavaillon

given: Jean-Michel

family: Botrus

full_name: Pierre Botrus

given: Pierre

family: Arnal

full_name: Jean-Michel Arnal

family: Ancochea

full_name: Julio Ancochea

given: Julio

family: Bergeron-Lafaurie

full_name: Anne Bergeron-Lafaurie

location_facility: Azienda ULSS 22 - Ospedale di Bussolengo

location_facility: Azienda Ospedaliera, "Ospedale San Carlo Borromeo"

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

location_facility: Hôpitaux Civils de Colmar - Hôpital Pasteur

location_facility: Universitätsklinikum Ulm, - Klinik Innere Medizin II

location_facility: Centre Hospitalier d Antibes Juans-les-pins


title: Randomized Clinical Trial Evaluating the Efficacy of Methotrexate in Addition to Anti-H1 Versus Placebo and Anti-H1 in the Treatment of Severe Chronic Idiopathic Urticaria

acronym: MUCIS

summary: Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic alternatives exist. Methotrexate, which is not expensive and often prescribed by dermatologists, has been efficiently tried in an open study on severe chronic idiopathic urticaria, and also in few case reports.

lead_sponsor: University Hospital, Tours

location_facility:
Ch Le Mans
Hopital TENON
Chru Reims
Chru Nantes
Chu Mondor
CHRU BREST Morvan
CHRU LILLE Huriez
CHRU POITIERS La Miléterie
Chru Tours
CHRU NANCY Brabois
CHRU RENNES Pontchaillou


title: Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial

summary: To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.

ReferenceCitation: Nuytens F, Dabakuyo-Yonli TS, Meunier B, Gagnière J, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrère N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Markar SR, Piessen G; Fédération de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Groups. Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer: Results of the MIRO Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):323-332. doi: 10.1001/jamasurg.2020.7081.

name: Department of Digestive and Oncological Surgery, Hôpital Claude Huriez, Centre Hospitalier Universitaire (CHU) de Lille, Lille, France

family: Nuytens

full_name: Frederiek Nuytens

given: Frederiek

name: Epidemiology and Quality of Life Unit, Institut National de la Santé et de la Recherche Médicale (INSERM) Unité 1231, Centre Georges François Leclerc, Dijon, France

family: Dabakuyo-Yonli

full_name: Tienhan Sandrine Dabakuyo-Yonli

given: Tienhan Sandrine

name: Department of Hepatobiliary and Digestive Surgery, CHU Rennes, University of Rennes 1, Rennes, France

family: Meunier

full_name: Bernard Meunier

given: Bernard

name: Université Clermont Auvergne, INSERM, CHU Clermont-Ferrand, Service de Chirurgie Digestive, Clermont-Ferrand, France

family: Gagnière

full_name: Johan Gagnière

given: Johan

name: Department of Digestive Surgery, Haut Lévèque University Hospital, Bordeaux, France

family: Collet

full_name: Denis Collet

given: Denis

name: Department of Thoracic Surgery, Hôpital Nord, Aix-Marseille Université, Assistance Publique–Hôpitaux de Marseille, Marseille, France

family: D’Journo

full_name: Xavier B. D’Journo

given: Xavier B.

name: Department of Digestive Surgery, Strasbourg University, Strasbourg, France

family: Brigand

full_name: Cécile Brigand

given: Cécile

name: Department of Digestive Surgery, Institut Mutualiste Montsouris, Paris, France

family: Perniceni

full_name: Thierry Perniceni

given: Thierry

name: Department of Digestive Surgery, Purpan Hospital, CHU Toulouse, Université Toulouse III, Toulouse, France

family: Carrère

full_name: Nicolas Carrère

given: Nicolas

name: Department of General Surgery and Liver Transplantation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Equipe Mixte de Recherche 3738, Université Lyon 1, Lyon, France

family: Mabrut

full_name: Jean-Yves Mabrut

given: Jean-Yves

name: Department of Digestive and General Surgery, CHU Louis Mourier, Assistance Publique–Hôpitaux de Paris (AP-HP), Université Paris 7, Denis Diderot, Pôle de Recherche et d'Enseignement Supérieur (PRES) Sorbonne Paris Cité, Colombes, France

family: Msika

full_name: Simon Msika

given: Simon

name: Department of Surgery and Oncology, CHU Ambroise Paré, AP-HP, Université de Versailles, Boulogne-Billancourt, France

family: Peschaud

full_name: Frédérique Peschaud

given: Frédérique

name: Department of Digestive Surgery, CHU Nîmes, Nîmes, France

family: Prudhomme

full_name: Michel Prudhomme

given: Michel

name: Department of Surgery and Cancer, Imperial College, London, United Kingdom

name: Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

family: Markar

full_name: Sheraz R. Markar

given: Sheraz R.

name: Université de Lille, Centre National de la Recherche Scientifique, INSERM, CHU Lille, UMR9020-U1277—CANTHER—Cancer Heterogeneity, Plasticity and Resistance to Therapies, Lille, France

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

journal_name: JAMA Surgery

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Mariette C, Markar SR, Dabakuyo-Yonli TS, Meunier B, Pezet D, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrère N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Bonnetain F, Piessen G; Fédération de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. N Engl J Med. 2019 Jan 10;380(2):152-162. doi: 10.1056/NEJMoa1805101.

name: From the Department of Digestive and Oncologic Surgery, Claude Huriez University Hospital, and INSERM, Centre Hospitalier Universitaire (CHU) Lille, Unité Mixte de Recherche 1172-JPARC Jean-Pierre Aubert Research Center, Team “Mucins, epithelial differentiation, and carcinogenesis,” Université de Lille, Lille (C.M., G.P.), the Epidemiology and Quality of Life Unit, INSERM Unité 1231, Centre Georges François Leclerc, Dijon (T.S.D.-Y.), the Department of Hepatobiliary and Digestive Surgery, CHU Rennes,...

family: Mariette

full_name: Christophe Mariette

given: Christophe

full_name: Tienhan S. Dabakuyo-Yonli

given: Tienhan S.

family: Pezet

full_name: Denis Pezet

ReferenceCitation: Briez N, Piessen G, Bonnetain F, Brigand C, Carrere N, Collet D, Doddoli C, Flamein R, Mabrut JY, Meunier B, Msika S, Perniceni T, Peschaud F, Prudhomme M, Triboulet JP, Mariette C. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial. BMC Cancer. 2011 Jul 23;11:310. doi: 10.1186/1471-2407-11-310.

location_facility:
Hopitalpontchaillou
Institut Mutualiste Montsouris
Hopital de La Croix Rousse
Hopital Purpan
Hopital St Louis Ap-Hp
Hotel Dieu
Hopital Du Haut Leveque
Hopital Ambroise Pare Ap-Hp
Hopitaux Universitaires de Strasbourg
Hopital St Marguerite Ap-Hm
Hopital Louis Mourier


title: Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.

summary: The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle

primary_purpose: Other

lead_sponsor: Boston Scientific Corporation

location_facility:
CHU Angers
CH St. Joseph
CHU Lariboisière
CHU Pitié Salpitrière
CH Amiens
CHU Clermont Ferrand
CHU Henri Mandor
Hôpital Pontchaillou
CH Besancon
CHU Rouen
CHU La Timone
CHU Montpellier
CHU Rangueil
HEGP
CHU Nantes
CHU Tours
Nouvelle Clinique Nantaise
CHU Michalon


title: Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

acronym: MVP

summary: Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Brest University Hospital
Rennes University Hospital


title: A Phase I/II Study of Eltrombopag in Patients With Chronic Myelomonocytic Leukemia and Thrombocytopenia

summary: Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital Saint Louis - Service d'hématologie AJA

location_facility: IUCT Oncopole - Service d'Hématologie Clinique

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Hôpital Saint Louis - Service d'hématologie séniors


title: A Phase I-II Trial of Acadesine in IPSS High and Int-2 SMD, LAM With 20-30% Marrow Blasts and CMML Type 2 Not Responding to Azacitidine or Decitabine for at Least 6 Courses or Relapsing After a Response

acronym: Acadesine

summary:
A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response:

Patients will receive 6 treatment cycles unless disease progression, transformation, or unacceptable toxicity occurs, or the patient refuses to continue participating in the study.

Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until progression.

status: Terminated

location_facility:
Centre Antoine Lacassagne
Hôpital Saint Antoine
Hôpital Saint Louis
CHU de Limoges
Hôpital Bretonneau de Tours
Hôpital Saint-Louis
CHU de Haut-Lévèque
CHU de nantes
Centre hospitalier de la côte Basque
centre hospitalier de Meaux
CHU de Grenoble
Hôpital Cochin
Hôpital Avicenne
Centre henri Becquerel
Hôpital L'archet 1, Nice
Institut paoli calmettes
Centre henri Mondor


title: Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

acronym: RYTHMODIAL

summary: The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with hemodialysis parameters.

ReferenceCitation: Sacher F, Jesel L, Borni-Duval C, De Precigout V, Lavainne F, Bourdenx JP, Haddj-Elmrabet A, Seigneuric B, Keller A, Ott J, Savel H, Delmas Y, Bazin-Kara D, Klotz N, Ploux S, Buffler S, Ritter P, Rondeau V, Bordachar P, Martin C, Deplagne A, Reuter S, Haissaguerre M, Gourraud JB, Vigneau C, Mabo P, Maury P, Hannedouche T, Benard A, Combe C. Cardiac Rhythm Disturbances in Hemodialysis Patients: Early Detection Using an Implantable Loop Recorder and Correlation With Biological and Dialysis Parameters. JACC Clin Electrophysiol. 2018 Mar;4(3):397-408. doi: 10.1016/j.jacep.2017.08.002. Epub 2017 Sep 27.

family: Sacher

full_name: Frederic Sacher

given: Frederic

family: Jesel

full_name: Laurence Jesel

given: Laurence

family: Borni-Duval

full_name: Claire Borni-Duval

given: Claire

family: De Precigout

full_name: Valerie De Precigout

given: Valerie

family: Lavainne

full_name: Frédéric Lavainne

given: Frédéric

family: Bourdenx

full_name: Jean-Philippe Bourdenx

given: Jean-Philippe

family: Haddj-Elmrabet

full_name: Atman Haddj-Elmrabet

given: Atman

family: Seigneuric

full_name: Bruno Seigneuric

given: Bruno

family: Keller

full_name: Adrien Keller

given: Adrien

family: Ott

full_name: Julien Ott

given: Julien

family: Savel

full_name: Helene Savel

given: Helene

family: Delmas

full_name: Yahsou Delmas

given: Yahsou

family: Bazin-kara

full_name: Dorothée Bazin-kara

given: Dorothée

family: Klotz

full_name: Nicolas Klotz

family: Ploux

full_name: Sylvain Ploux

given: Sylvain

family: Buffler

full_name: Sébastien Buffler

given: Sébastien

family: Ritter

full_name: Philippe Ritter

given: Philippe

family: Rondeau

full_name: Virginie Rondeau

given: Virginie

family: Bordachar

full_name: Pierre Bordachar

given: Pierre

family: Martin

full_name: Claire Martin

family: Deplagne

full_name: Antoine Deplagne

given: Antoine

family: Reuter

full_name: Sylvain Reuter

family: Haissaguerre

full_name: Michel Haissaguerre

location_facility:
Polyclinique Bordeaux-Nord Aquitaine
University Hospital of Bordeaux
CHU de Nantes
CHU de Strasbourg
CH de Haguenau
CH de Libourne
Clinique Saint Augustin
CHU de Toulouse
CHU de Rennes


title: A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR

acronym: FLARE

summary:
The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.

However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance.

It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment.

lead_sponsor: Centre Francois Baclesse

location_facility: Hôpital d'instruction des Armées Sainte-Anne


title: Triple-site Biventricular Stimulation in the Optimization of Cardiac Resynchronization Therapy (CRT)

acronym: TRIUMPH-CRT

summary:
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation.

Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation.

Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.

lead_sponsor: MicroPort CRM

location_country: Italy Netherlands Spain France Portugal Germany


title: A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

summary: The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Oscar Lambret
Hopital de La Timone
Hopital Trousseau
Hopital Felix Guyon
Chu Estaing
Institut Curie
Chu Morvan
CHRU
CHU
Institut Gustave Roussy