title: A Phase II Study of Darbepoetin Alpha in Myelodysplastic Syndromes (MSD)

summary: This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS patients with an International Prognostic Scoring System (IPSS) score of low or intermediate 1.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Kelaidi C, Beyne-Rauzy O, Braun T, Sapena R, Cougoul P, Adès L, Pillard F, Lamberto C, Charniot JC, Guerci A, Choufi B, Stamatoullas A, Slama B, De Renzis B, Ame S, Damaj G, Boyer F, Chaury MP, Legros L, Cheze S, Testu A, Gyan E, Béné MC, Rose C, Dreyfus F, Fenaux P. High response rate and improved exercise capacity and quality of life with a new regimen of darbepoetin alfa with or without filgrastim in lower-risk myelodysplastic syndromes: a phase II study by the GFM. Ann Hematol. 2013 May;92(5):621-31. doi: 10.1007/s00277-013-1686-4. Epub 2013 Jan 29. Erratum in: Ann Hematol. 2013 May;92(5):633. Lambert, Christine [corrected to Lamberto, C].

family: Kelaidi

full_name: C. Kelaidi

given: C.

family: Beyne-Rauzy

full_name: O. Beyne-Rauzy

given: O.

family: Braun

full_name: T. Braun

given: T.

family: Sapena

full_name: R. Sapena

given: R.

family: Cougoul

full_name: P. Cougoul

given: P.

family: Adès

full_name: L. Adès

given: L.

family: Pillard

full_name: F. Pillard

given: F.

family: Lambert

full_name: C. Lambert

family: Charniot

full_name: J. C. Charniot

given: J. C.

family: Guerci

full_name: A. Guerci

given: A.

family: Choufi

full_name: B. Choufi

given: B.

family: Stamatoullas

full_name: A. Stamatoullas

family: Slama

full_name: B. Slama

family: De Renzis

full_name: B. De Renzis

family: Ame

full_name: S. Ame

given: S.

family: Damaj

full_name: G. Damaj

given: G.

family: Boyer

full_name: F. Boyer

family: Chaury

full_name: M. P. Chaury

given: M. P.

family: Legros

full_name: L. Legros

family: Cheze

full_name: S. Cheze

family: Testu

full_name: A. Testu

family: Gyan

full_name: E. Gyan

given: E.

family: Béné

full_name: M. C. Béné

given: M. C.

family: Rose

location_facility:
Hopital Henri Becquerel
CH de la Cote Basque
CHU d'Angers
Hopital Paoli Calmette
CHU d'Amiens
Hopital Henri Mondor
CHU d'Avignon
CHU Albert Michallon
Hopital Percy
Hopital Hautepierre
Hopital Bretonneau
Hopital St Louis
CHU Nancy-Brabois
CHU de Brest - Hopital Morvan
CHU de Caen
CHU Robert Debre
CHU de Dijon
Hopital Hotel Dieu
Hopital Purpan
CHU Pontchaillou
Hopital Edouard Herriot
Hopital Jean-Bernard
CHRU Hurriez
CHU Archet
Hopital Saint Antoine
Hopital Cochin
CHRU Limoges


title: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand

summary: Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relapse, with variable delay. Objective of this study was to compare efficacy between a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence. Addition of methotrexate (MTX)to infliximab was also tested.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Fautrel B, Benhamou M, Breban M, Roy C, Lenoir C, Trape G, Baleydier A, Ravaud P, Dougados M. Cost effectiveness of two therapeutic regimens of infliximab in ankylosing spondylitis: economic evaluation within a randomised controlled trial. Ann Rheum Dis. 2010 Feb;69(2):424-7. doi: 10.1136/ard.2008.103887. Epub 2009 Sep 9.

family: Fautrel

full_name: B Fautrel

given: B

sequence: first

family: Benhamou

full_name: M Benhamou

given: M

sequence: additional

family: Breban

full_name: M Breban

family: Roy

full_name: C Roy

given: C

family: Lenoir

full_name: C Lenoir

family: Trape

full_name: G Trape

given: G

family: Baleydier

full_name: A Baleydier

given: A

family: Ravaud

full_name: P Ravaud

given: P

family: Dougados

full_name: M Dougados

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Breban M, Ravaud P, Claudepierre P, Baron G, Henry YD, Hudry C, Euller-Ziegler L, Pham T, Solau-Gervais E, Chary-Valckenaere I, Marcelli C, Perdriger A, Le Loët X, Wendling D, Fautrel B, Fournié B, Combe B, Gaudin P, Jousse S, Mariette X, Baleydier A, Trape G, Dougados M; French Ankylosing Spondylitis Infliximab Network. Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment. Arthritis Rheum. 2008 Jan;58(1):88-97. doi: 10.1002/art.23167.

full_name: Maxime Breban

given: Maxime

full_name: Philippe Ravaud

given: Philippe

family: Claudepierre

full_name: Pascal Claudepierre

given: Pascal

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Henry

full_name: Yves-Dominique Henry

given: Yves-Dominique

family: Hudry

full_name: Christophe Hudry

given: Christophe

family: Euller-Ziegler

full_name: Liana Euller-Ziegler

given: Liana

family: Pham

full_name: Thao Pham

given: Thao

family: Solau-Gervais

full_name: Elisabeth Solau-Gervais

given: Elisabeth

family: Chary-Valckenaere

full_name: Isabelle Chary-Valckenaere

given: Isabelle

family: Marcelli

full_name: Christian Marcelli

given: Christian

family: Perdriger

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

title: Maintenance of infliximab treatment in ankylosing spondylitis: Results of a one-year randomized controlled trial comparing systematic versus on-demand treatment

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_facility:
Hôpital Henri Mondor
CHU Hôpital Minjoz
Hôpital Général
Hôpital de Purpan
Hôpital de la Conception
CHU Saint-Etienne
Groupe Hospitalier du Havre
CHU Amiens
CHU Hautepierre
Hôpital Lapeyronie
Hôpital Porte Madeleine
CHU de Poitiers
CHU A. Michallon
Hôpital Bicêtre
CHU Nancy-Brabois
CHRU Hôpital Roger Salengro
CHU Côte de Nacre
Centre Hospitalier Saint Philibert
CHU - Hôpital Sud
CHU Dupuytren
CHU - Hôpital de Bois Guillaume
Hôpital Cochin
CHU Hôpital Trousseau
Hôpital Avicenne
Hôpital de la Pitié
Hôpital Gilles de Corbeil
CH St Joseph - St Luc
CHU de la Cavale Blanche
CHU l'Archet 1
Hôpital Ambroise Paré
Hôpital Pellegrin


title: Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

summary:
The purpose of this study is

To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
To evaluate the tolerance of this treatment

design_allocation: Non-Randomized

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
Hopital Henri Becquerel
Hopital Necker
CHU d'Angers
HOPITAL Cochin
CHU d'Amiens
CHU d'Avignon
CHU Albert Michallon
Hopital Percy
CH de Cournouaille
Hopital Avicenne
Hopital Hautepierre
CHU Brabois
CHU Dijon
CHU Edouard Herriot
CH de la cote Basque
CHU de Caen
CHU Robert Debre
Hopital Hotel Dieu
Institut Paoli Calmette
CHU Bretoneau
CHU Archet
Hopital Saint Antoine
CHRU Limoges
Chu Purpan

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

title: A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.

summary:
Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA

study_completion_date_type: Actual

ReferenceCitation: Ferrera G, Gajdos V, Thomas S, Tran C, Fiquet A. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. Hum Vaccin. 2009 Jul;5(7):455-60. Epub 2009 Jul 23.

lead_sponsor: Merck Sharp & Dohme Corp.

location_country: Italy France

intervention_type: Biological

status_simplified: Completed


type: Other Grant/Funding Number

title: Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.

summary: Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Jover JA, Hernández-García C, Morado IC, Vargas E, Bañares A, Fernández-Gutiérrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Jan 16;134(2):106-14.

ReferenceCitation: Chevalet P, Barrier JH, Pottier P, Magadur-Joly G, Pottier MA, Hamidou M, Planchon B, El Kouri D, Connan L, Dupond JL, De Wazieres B, Dien G, Duhamel E, Grosbois B, Jego P, Le Strat A, Capdeville J, Letellier P, Agron L. A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients. J Rheumatol. 2000 Jun;27(6):1484-91.

ReferenceCitation: Mazlumzadeh M, Hunder GG, Easley KA, Calamia KT, Matteson EL, Griffing WL, Younge BR, Weyand CM, Goronzy JJ. Treatment of giant cell arteritis using induction therapy with high-dose glucocorticoids: a double-blind, placebo-controlled, randomized prospective clinical trial. Arthritis Rheum. 2006 Oct;54(10):3310-8.

ReferenceCitation: Le Guennec P, Dromer C, Sixou L, Marc V, Coustals P, Fournié B. [Treatment of Horton disease. Value of synthetic antimalarials. Apropos of a retrospective study of 36 patients]. Rev Rhum Ed Fr. 1994;61(7-8):485-90. Review. French.

ReferenceCitation: David-Chaussé J, Dehais J, Leman A. [Results of a regional survey on the treatment of rhizomelic pseudopolyarthritis and temporal arteritis. Apropos of 242 cases treated by various modalities with synthetic antimalarials, corticoids and non-steroidal anti-inflammatory agents]. Rev Rhum Mal Osteoartic. 1983 Jul-Sep;50(8-9):563-71. French.

ReferenceCitation: Hoffman GS, Cid MC, Hellmann DB, Guillevin L, Stone JH, Schousboe J, Cohen P, Calabrese LH, Dickler H, Merkel PA, Fortin P, Flynn JA, Locker GA, Easley KA, Schned E, Hunder GG, Sneller MC, Tuggle C, Swanson H, Hernández-Rodríguez J, Lopez-Soto A, Bork D, Hoffman DB, Kalunian K, Klashman D, Wilke WS, Scheetz RJ, Mandell BF, Fessler BJ, Kosmorsky G, Prayson R, Luqmani RA, Nuki G, McRorie E, Sherrer Y, Baca S, Walsh B, Ferland D, Soubrier M, Choi HK, Gross W, Segal AM, Ludivico C, Puechal X; International Network for the Study of Systemic Vasculitides. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum. 2002 May;46(5):1309-18.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hospital Béziers
University Hospital Bretonneau
University Hospital Bichat
Hospital
Saint Louis Hospital
University Hospital Côte de Nacre
University Hospital Toulouse
Hospital Auch
University Hospital
Hospital Suresnes
University Hospital Besançon
University Hospital Dupuytren
University Hospital Dijon
Hospital Avignon
University Hospital Saint Antoine

lead_sponsor_type: academique


title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

acronym: GRECCAR 2

summary: Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.

study_start_date_type: Actual

primary_purpose: Supportive Care

ReferenceCitation: Teste B, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sielezneff I, Prudhomme M, Marchal F, Dubois A, Capdepont M, Denost Q, Rullier E. Early and late morbidity of local excision after chemoradiotherapy for rectal cancer. BJS Open. 2021 May 7;5(3). pii: zrab043. doi: 10.1093/bjsopen/zrab043.

apc_source: doaj

name: Department of Colorectal Surgery, Magellan Centre, Haut-Leveque Hospital, University of Bordeaux, 33604 Pessac, France

family: Teste

full_name: B Teste

given: B

name: Département de Chirurgie Oncologique, ICM Val d’Aurelle, Montpellier, France

family: Rouanet

full_name: P Rouanet

name: Service de Chirurgie Digestive, CHU Charles Nicolle, Rouen, France

family: Tuech

full_name: J -J Tuech

given: J -J

name: Service de Chirurgie Digestive, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France

family: Valverde

full_name: A Valverde

name: Département de Chirurgie Oncologique, Institut Paoli Calmette, Marseille, France

family: Lelong

full_name: B Lelong

name: Département de Chirurgie Oncologique, Centre Léon Bérard, Lyon, France

family: Rivoire

full_name: M Rivoire

name: Service de Chirurgie Digestive, Hôpital A. Michallon, La Tronche, France

family: Faucheron

full_name: J -L Faucheron

given: J -L

name: Département de Chirurgie Oncologique, Centre Oscar Lambret, Lille, France

family: Jafari

full_name: M Jafari

name: Service de Chirurgie Digestive, Hôpital Purpan, Toulouse, France

family: Portier

full_name: G Portier

name: Service de Chirurgie Viscérale, CHU Pontchaillou, Rennes, France

family: Meunier

full_name: B Meunier

name: Service de Chirurgie Digestive, CHU Timone, Marseille, France

family: Sielezneff

full_name: I Sielezneff

given: I

name: Département de Chirurgie Digestive et de Cancérologie Digestive, Hôpital Universitaire Carémeau, Nimes, France

family: Prudhomme

full_name: M Prudhomme

name: Département de Chirurgie Oncologique, Institut de Cancérologie de Lorraine, Vandoeuvre les Nancy, France

family: Marchal

full_name: F Marchal

given: F

name: Service de Chirurgie Générale et Digestive, Hôtel Dieu, Clermont-Ferrand, France

family: Dubois

full_name: A Dubois

family: Capdepont

full_name: M Capdepont

family: Denost

full_name: Q Denost

given: Q

family: Rullier

full_name: E Rullier

given: E

currency_apc_doaj: GBP

journal_name: BJS Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Rullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7.

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.

location_facility: Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac

location_facility: Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale

location_facility: Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital

location_facility: Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne

location_facility: Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont

location_facility: Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt

location_facility: Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet

location_facility: Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux

location_facility: Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne

location_facility: Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle

location_facility: Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine

location_facility: Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne

location_facility: Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre

location_facility: Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming

location_facility: Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec

location_facility: Service de Chirurgie Digestive - Hôpital Hautepierre

location_facility: Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre

location_facility: Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet

location_facility: Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens

location_facility: Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne

location_facility: Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer

location_facility: Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose

location_facility: Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet

location_facility: Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux

location_facility: Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron

location_facility: Service de Chirurgie Générale - Hôpital Archet II

location_facility: Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc

location_facility: Service de Chirurgie Générale - Hôpitaux Civils de Lyon

location_facility: Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque

location_facility: Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot

location_facility: Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré

location_facility: Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod

location_facility: Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert

location_facility: Département de Chirurgie Oncologique - CRLC Val d'Aurelle

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine


title: Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.

ReferenceCitation: Carrie C, Magné N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16.

family: Carrie

full_name: Christian Carrie

family: Magné

full_name: Nicolas Magné

given: Nicolas

family: Burban-Provost

full_name: Patricia Burban-Provost

given: Patricia

family: Sargos

full_name: Paul Sargos

given: Paul

family: Latorzeff

full_name: Igor Latorzeff

given: Igor

family: Lagrange

full_name: Jean-Léon Lagrange

given: Jean-Léon

family: Supiot

full_name: Stéphane Supiot

given: Stéphane

family: Belkacemi

full_name: Yazid Belkacemi

given: Yazid

family: Peiffert

full_name: Didier Peiffert

given: Didier

family: Allouache

full_name: Nedla Allouache

given: Nedla

family: Dubray

full_name: Bernard M Dubray

given: Bernard M

family: Servagi-Vernat

full_name: Stéphanie Servagi-Vernat

given: Stéphanie

family: Suchaud

full_name: Jean-Philippe Suchaud

given: Jean-Philippe

family: Crehange

full_name: Gilles Crehange

given: Gilles

family: Guerif

full_name: Stéphane Guerif

family: Brihoum

full_name: Meryem Brihoum

given: Meryem

family: Barbier

full_name: Nicolas Barbier

family: Graff-Cailleaud

full_name: Pierre Graff-Cailleaud

given: Pierre

family: Ruffion

full_name: Alain Ruffion

given: Alain

family: Dussart

full_name: Sophie Dussart

given: Sophie

family: Ferlay

full_name: Céline Ferlay

given: Céline

family: Chabaud

full_name: Sylvie Chabaud

given: Sylvie

journal_name: The Lancet Oncology

ReferenceCitation: Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Créhange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6. Erratum in: Lancet Oncol. 2016 Jun;17 (6):e223. Erratum in: Lancet Oncol. 2019 Jun;20(6):e293.

ReferenceCitation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prisé E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.

summary: The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression

study_type: Observational

time_perspective: Prospective

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 32
Site 07
Site 11
Site 02
Site 00
Site 30
Site 41
Site 27
Site 12
Site 43
Site 05
Site 01
Site 06
Site 20
Site 33
Site 14
Site 42
Site 19
Site 22
Site 17
Site 26
Site 04
Site 25


title: A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.

summary: The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

enrollment_type: Anticipated

location_facility:
Site 32
Site 07
Site 11
Centre Hospitalier Lyon Sud
Site 27
Centre Hospitalier Régional
Centre Hospitalier du Morvan
Site 43
Centre Hospitalier Universitaire
Site 05
Site 01
Centre Hospitalier René Dubos
Site 06
Site 33
Hôpital Yves Le Foll
Site 14
Centre Hospitalier Les Oudairies
Site 22
Hospital du Cluzeau
Centre François Baclesse
Hospital Saint Antoine
Site 17
Site 04
Site 25


title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ Gemcitabine When Progression.

summary: The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.

location_facility:
Site 32
Site 07
Site 11
Site 02
Site 00
Site 30
Site 41
Site 27
Site 12
Site 48
Site 01
Site 06
Site 20
Site 33
Site 14
Site 19
Site 22
Site 18
Site 17
Site 26
Site 04
Site 25


title: Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy

summary: This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Chevaliez S, Hézode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-α and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24.

family: Chevaliez

full_name: Stéphane Chevaliez

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Soulier

full_name: Alexandre Soulier

given: Alexandre

family: Costes

full_name: Bruno Costes

given: Bruno

family: Bouvier–Alias

full_name: Magali Bouvier–Alias

given: Magali

family: Rouanet

full_name: Stéphanie Rouanet

family: Foucher

full_name: Juliette Foucher

given: Juliette

family: Bronowicki

full_name: Jean–Pierre Bronowicki

given: Jean–Pierre

family: Tran

full_name: Albert Tran

given: Albert

family: Rosa

full_name: Isabelle Rosa

given: Isabelle

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Alric

full_name: Laurent Alric

given: Laurent

family: Leroy

full_name: Vincent Leroy

given: Vincent

family: Couzigou

full_name: Patrice Couzigou

given: Patrice

family: Mallat

full_name: Ariane Mallat

given: Ariane

family: Charaf–Eddine

full_name: Mariem Charaf–Eddine

given: Mariem

family: Babany

full_name: Gérard Babany

given: Gérard

family: Pawlotsky

full_name: Jean–Michel Pawlotsky

given: Jean–Michel

journal_name: Gastroenterology

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

repository_normalized: HAL

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: High-Dose Pegylated Interferon-α and Ribavirin in Nonresponder Hepatitis C Patients and Relationship With IL-28B Genotype (SYREN Trial)

lead_sponsor: Hoffmann-La Roche


title: DEPISTORL - THANCS (Trial of Head And Neck Cancer Screening) Randomized Multicenter Trial to Assess the Impact of a Screening Program for Heavy Alcohol Drinkers and Smokers Treated in Alcohol Addiction Clinics on Upper Aerodigestive Tract Cancer Mortality.

summary: Randomized multicenter trial to assess the impact of a screening program for heavy alcohol drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer mortality.

primary_purpose: Prevention

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
CHU de Strasbourg - Hôpital Hautepierre
Centre ANPAA d'Orléans
Centre Hospitalier du Mans
Centre Hospitalier des Chanaux
Hopital de Saint Cloud
Centre Hospitalier MONTPERRIN
Centre de soins de suite Marienbronn
CHU de Nancy
Hôpitaux du Leman
Centre Hospitalier Louis Sevestre
CHBS Lorient
C.A.S.A.
CHU Hôpital Gabriel Montpied
CHR de la Réunion
Institut_Gustave-Roussy
Centre Paul Cézanne
CHU de Nantes
CHU de Lille
Chba Vannes
Centre ANPAA 51 de Reims
CHIAB Annemasse Bonneville
Centre Hospitalier du Centre Bretagne
CHU le Bocage
Chg Beziers
Hopital Paul Brousse
Centre Hospitalier de DIEPPE
Ch Saint-Egreve
Centre Hospitalier de LENS
Centre hospitalier Lyon sud
CHS de L'Yonne
Hôpital de la Source
CHU Hôpital Pontchaillou
Centre Hospitalier d'ARRAS
Clinique Philae
Hôpital ARCHET II

intervention_type: Procedure


title: Evaluation of the Efficacy of the Thermal Cure in the Prevention of the Post-Thrombotic Syndrome After a Deep Venous Thrombosis of Lower Limbs.

summary: The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

status: Terminated

ReferenceCitation: Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7.

ReferenceCitation: Kahn SR, Kearon C, Julian JA, Mackinnon B, Kovacs MJ, Wells P, Crowther MA, Anderson DR, Van Nguyen P, Demers C, Solymoss S, Kassis J, Geerts W, Rodger M, Hambleton J, Ginsberg JS; Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005 Apr;3(4):718-23. Epub 2005 Feb 23.

ReferenceCitation: Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. Review.

ReferenceCitation: Asbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005 Apr;24(4):475-82.

ReferenceCitation: Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Saint-Pierre
Chênes
Caliceo
Les thermes
Le miradour
Le Grand Hôtel
Bérot
Les écureuils
Christus
Les arènes
L'avenue
Etablissmeent thermal
Dax thermal
Etablissement thermal
Le Splendid
Foch
Le Regina
Sarrailh
Domaine d'heurteboise
Borda


title: An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin in Patients With Type 2 Diabetes and Dyslipidemia

summary: The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

lead_sponsor: Solvay Pharmaceuticals

location_facility:
Site 32
Site 2
Site 28
Site 11
Site 21
Site 30
Site 27
Site 4
Site 23
Site 10
Site 8
Site 12
Site 24
Site 20
Site 33
Site 7
Site 9
Site 29
Site 5
Site 17
Site 34
Site 1
Site 26
Site 13
Site 25


title: A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions

summary: To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.

lead_sponsor: Pfizer


title: A Prospective Randomised Single-Blinded Multicentric and Pivotal Phase III Study Comparing the Efficacy, Safety and Acceptability of a New 2 Litres Gut Lavage Solution NRL994 Versus a Sodium Phosphate Solution for Colonoscopy Preparation

summary: The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

ReferenceCitation: Fordtran JS, Santa Ana CA, Cleveland MvB. A low-sodium solution for gastrointestinal lavage. Gastroenterology. 1990 Jan;98(1):11-6.

lead_sponsor: Norgine

location_facility: Centre Hospitalier De Montpellier Hôpital St Eloi

location_facility: Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré


type: EudraCT Number

title: The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).

summary: The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

lead_sponsor: Bayer


title: Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer.

PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.

ReferenceType: result

ReferenceCitation: Phelip JM, Vendrely V, Rostain F, Subtil F, Jouve JL, Gasmi M, Michel P, Le Malicot K, Smith D, Seitz JF, Fauchart JP, Martin P, Bennouna J, Morin T, Bonnet I, Maingon P, Lepage C, Chauffert B. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Fédération Francophone de Cancérologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014 Nov;50(17):2975-82. doi: 10.1016/j.ejca.2014.08.013. Epub 2014 Sep 17.

family: Phelip

full_name: Jean-Marc Phelip

given: Jean-Marc

family: Vendrely

full_name: Véronique Vendrely

given: Véronique

family: Rostain

full_name: Florian Rostain

given: Florian

family: Subtil

full_name: Fabien Subtil

given: Fabien

family: Jouve

full_name: Jean-Louis Jouve

given: Jean-Louis

family: Gasmi

full_name: Mohamed Gasmi

given: Mohamed

family: Michel

full_name: Pierre Michel

given: Pierre

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Smith

full_name: Denis Smith

given: Denis

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Fauchart

full_name: Jean-Pierre Fauchart

given: Jean-Pierre

family: Martin

full_name: Philippe Martin

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Morin

full_name: Thierry Morin

given: Thierry

family: Bonnet

full_name: Isabelle Bonnet

family: Maingon

full_name: Philippe Maingon

family: Lepage

full_name: Côme Lepage

given: Côme

family: Chauffert

full_name: Bruno Chauffert

journal_name: European Journal of Cancer

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier General de Mont de Marsan

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


title: Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .

ReferenceCitation: Aparicio T, Jouve J, Teillet L, et al.: Geriatric factors to predict toxicity and dose-intensity reduction in FFCD 2001-02 phase III study comparing a first-line chemotherapy of LV5FU2 or FOLFIRI in treatment of metastatic colorectal cancer (mCRC) in elderly patients. [Abstract] J Clin Oncol 29 (Suppl 15): A-9111, 2011.

ReferenceCitation: Mitry E, Phelip JM, Bonnetain F, et al.: Phase III trial of chemotherapy with or without irinotecan in the front-line treatment of metastatic colorectal cancer in elderly patients (FFCD 2001-02 trial): results of a planned interim analysis. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-281, 2008.

ReferenceCitation: Aparicio T, Lavau-Denes S, Phelip JM, Maillard E, Jouve JL, Gargot D, Gasmi M, Locher C, Adhoute X, Michel P, Khemissa F, Lecomte T, Provençal J, Breysacher G, Legoux JL, Lepère C, Charneau J, Cretin J, Chone L, Azzedine A, Bouché O, Sobhani I, Bedenne L, Mitry E; FFCD investigators. Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001-02). Ann Oncol. 2016 Jan;27(1):121-7. doi: 10.1093/annonc/mdv491. Epub 2015 Oct 20.

family: Aparicio

full_name: T. Aparicio

given: T.

family: Lavau-Denes

full_name: S. Lavau-Denes

given: S.

family: Phelip

full_name: J.M. Phelip

family: Maillard

full_name: E. Maillard

given: E.

full_name: J.L. Jouve

family: Gargot

full_name: D. Gargot

given: D.

full_name: M. Gasmi

given: M.

family: Locher

full_name: C. Locher

given: C.

family: Adhoute

full_name: X. Adhoute

given: X.

full_name: P. Michel

given: P.

family: Khemissa

full_name: F. Khemissa

given: F.

family: Lecomte

full_name: T. Lecomte

family: Provençal

full_name: J. Provençal

given: J.

family: Breysacher

full_name: G. Breysacher

given: G.

family: Legoux

full_name: J.L. Legoux

family: Lepère

full_name: C. Lepère

family: Charneau

full_name: J. Charneau

family: Cretin

full_name: J. Cretin

family: Chone

full_name: L. Chone

given: L.

family: Azzedine

full_name: A. Azzedine

given: A.

family: Bouché

full_name: O. Bouché

given: O.

family: Sobhani

full_name: I. Sobhani

given: I.

family: Bedenne

full_name: L. Bedenne

family: Mitry

full_name: E. Mitry

title: Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001–02)

ReferenceCitation: Aparicio T, Jouve JL, Teillet L, Gargot D, Subtil F, Le Brun-Ly V, Cretin J, Locher C, Bouché O, Breysacher G, Charneau J, Seitz JF, Gasmi M, Stefani L, Ramdani M, Lecomte T, Mitry E. Geriatric factors predict chemotherapy feasibility: ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients. J Clin Oncol. 2013 Apr 10;31(11):1464-70. doi: 10.1200/JCO.2012.42.9894. Epub 2013 Mar 4.

name: Thomas Aparicio, Avicenne Hospital, Assistance Publique-Hopitaux de Paris (AP-HP), Université Paris 13, Sorbonne Paris Cité, Bobigny; Laurent Teillet, Sainte Perine Hospital, AP-HP; Emmanuel Mitry, Institut Curie, Versaille Saint Quentin University, Paris; Jean-Louis Jouve, Centre Hospitalier Universitaire (CHU) Dijon; Fabien Subtil, Fédération Francophone de Cancérologie Digestive, Dijon; Dany Gargot, Centre Hôspitalier (CH) Blois, Blois; Valérie Le Brun-Ly, CHU Limoges, Limoges; Jacques Cretin, CH Ales...

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

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

publisher: American Society of Clinical Oncology (ASCO)

title: Geriatric Factors Predict Chemotherapy Feasibility: Ancillary Results of FFCD 2001-02 Phase III Study in First-Line Chemotherapy for Metastatic Colorectal Cancer in Elderly Patients

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Pole Sante Sarthe et Loir Hopital Pierre Daguet

location_facility: Hopital d'Instruction des Armees du Val de Grace

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Intercommunal de la Haute-Saone

location_facility: Centre Hospitalier de Chalons-en-Champagne

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre hospitalier de Charleville Mezieres

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Fédération Francophone de Cancérologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135.

family: Dahan

full_name: L. Dahan

family: Bonnetain

full_name: F. Bonnetain

family: Ychou

full_name: M. Ychou

family: Gasmi

full_name: M. Gasmi

family: Raoul

full_name: J.-L. Raoul

family: Cattan

full_name: S. Cattan

family: Phelip

full_name: J.-M. Phelip

family: Hammel

full_name: P. Hammel

family: Chauffert

full_name: B. Chauffert

given: B.

family: Michel

full_name: J.-L. Legoux

family: Rougier

full_name: P. Rougier

family: Seitz

full_name: J.-F. Seitz

name: for the Federation Francophone de Cancerologie Digestive

journal_name: Gut

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Mitry E, Dahan L, Ychou M, et al.: LV5FU2-cisplatin followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: preliminary results of a randomized phase III trial (FFCD 0301). [Abstract] J Clin Oncol 26 (Suppl 15): A-4513, 2008.

location_facility: Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne


title: Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

location_facility: Centre Hospitalier General - St. Nicolas


title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

summary: The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.

ReferenceCitation: Guérin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384.

ReferenceCitation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

family: Papazian

full_name: Laurent Papazian

given: Laurent

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Penot-Ragon

full_name: Christine Penot-Ragon

given: Christine

family: Perrin

full_name: Gilles Perrin

given: Gilles

family: Loundou

full_name: Anderson Loundou

given: Anderson

family: Jaber

full_name: Samir Jaber

given: Samir

family: Arnal

full_name: Jean-Michel Arnal

given: Jean-Michel

family: Perez

full_name: Didier Perez

given: Didier

family: Seghboyan

full_name: Jean-Marie Seghboyan

family: Constantin

full_name: Jean-Michel Constantin

family: Courant

full_name: Pierre Courant

given: Pierre

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Guérin

full_name: Claude Guérin

given: Claude

family: Prat

full_name: Gwenaël Prat

given: Gwenaël

family: Morange

full_name: Sophie Morange

given: Sophie

family: Roch

full_name: Antoine Roch

given: Antoine

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Neuromuscular Blockers in Early Acute Respiratory Distress Syndrome

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Réanimation Polyvalente - Hôpital Sainte-Marguerite

location_facility: Hôpital Pontchaillou - Réanimation médicale

location_facility: Hôpital Jean Minjoz - Réanimation médicale

location_facility: Hôpital de la croix rousse - Réanimation médicale

location_facility: Hôpital Sainte-Marguerite - Réanimation médicale

location_facility: Hôpital Pellegrin - Réanimation médicale

location_facility: Hôpital de la Tronche - Réanimation médicale

location_facility: Hôpital Saint-Louis - Réanimation médicale


title: Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study

acronym: RIGHT

summary: Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.


title: Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

summary:
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.

However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.

The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

lead_sponsor: University Hospital, Rouen

location_facility:
Emergecy department
Emergency Department

intervention_type: Other


title: Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.

ReferenceCitation: Penel N, Le Cesne A, Bui BN, Perol D, Brain EG, Ray-Coquard I, Guillemet C, Chevreau C, Cupissol D, Chabaud S, Jimenez M, Duffaud F, Piperno-Neumann S, Mignot L, Blay JY. Imatinib for progressive and recurrent aggressive fibromatosis (desmoid tumors): an FNCLCC/French Sarcoma Group phase II trial with a long-term follow-up. Ann Oncol. 2011 Feb;22(2):452-7. doi: 10.1093/annonc/mdq341. Epub 2010 Jul 9.

family: Penel

full_name: N. Penel

given: N.

family: Le Cesne

full_name: A. Le Cesne

given: A.

family: Bui

full_name: B.N. Bui

family: Perol

full_name: D. Perol

given: D.

family: Brain

full_name: E.G. Brain

family: Ray-Coquard

full_name: I. Ray-Coquard

given: I.

family: Guillemet

full_name: C. Guillemet

given: C.

family: Chevreau

full_name: C. Chevreau

family: Cupissol

full_name: D. Cupissol

family: Chabaud

full_name: S. Chabaud

given: S.

family: Jimenez

full_name: M. Jimenez

given: M.

family: Duffaud

full_name: F. Duffaud

given: F.

family: Piperno-Neumann

full_name: S. Piperno-Neumann

family: Mignot

full_name: L. Mignot

given: L.

family: Blay

full_name: J.-Y. Blay

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Fayette J, Dufresne A, Penel N, et al.: Imatinib for the treatment of aggressive fibromatosis/desmoid tumors (AF/DT) failing local treatment: updated outcome and predictive factors for progression free survival: a FNCLCC French Sarcoma Group-GETO study. [Abstract] J Clin Oncol 25 (Suppl 18): A-10062, 560s, 2007.

ipd_sharing: No

ipd_sharing_description: Individual Participant data will not be shared at an individual level.

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: Clinical Observations of Automatic Algorithms for Cardiac Pacing

summary: This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

lead_sponsor: Boston Scientific Corporation

location_country: France Guadeloupe

location_facility:
CH d'Arles
CH de La Roche sur Yon
Hôpital Nord
CH Cherbourg
Clinique A. Brillard
Hôpital de Brabois
Polyclinique Sévigné
CHR la Source
Clinique Notre Dame
CH Maréchal Joffre
CHG de Pau
Polyclinique du Bois
CH DAX
Clinique Belledone
Clinique Pasteur
CHG de Dinan
CH Nevers
Clinique du Lac et d'Argonay
CHP de la Loire
CHU Nîmes
CH de Laval
Hôpital Fontenoy
CHRU- Hôpital Nord
Clinique de L'Ormeau
CH privé St. Martin
Polyclinique Bordeaux-Cauderan
CHG Saint Louis - SIH Eure Seine
Clinique Paulmy
CHI de Castres
Nouvelles Cliniques Nantaises
Casamance
Clinique St Hilaire
Clinique Ambroise Paré
CH Beauvais
CH Emile Muller
CHU de Point à pitre
Clinique Cardiologique Aressy
Polyclinique Louis Pasteur
CHU Albert Michalon
Clinique des Cèdres

intervention_type: Device


title: A Randomized Cost-minimization Trial Comparing Pemetrexed (Alimta®) Versus Docetaxel (Taxotere®) as Second Line Treatment in Advanced Non Small Cell Lung Cancer (NSCLC): Study 05-06 of Groupe Français de Pneumo-Cancérologie (GFPC).

summary:
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature.

Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities.

However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment.

As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).

lead_sponsor: University Hospital, Limoges

location_facility: Service de Pneumologie ; Hôpital saint Antoine, Paris

location_facility: Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay

location_facility: Clinique Pneumologique; Hôpital Charles Nicolle

location_facility: Service de pneumologie; Centre Hospitalier d'Annecy

location_facility: Service de Pathologie Respiratoire; Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Service de Pneumologie; Hôpital Bois Guillaume

location_facility: Service de Pneumologie ; Centre hospitalier

location_facility: Département des Maladies Respiratoires ; Hôpital Sainte Marguerite

location_facility: Service de Pneumologie et Réanimation ; Hôpital Hôtel Dieu - Paris

location_facility: Service de Pneumologie - Hôpital St Antoine, Paris

location_facility: Service de Pneumologie; Centre Hospitalier

location_facility: Service de Pneumologie; Hôpital de la Croix Rousse

location_facility: Service d'Oncologie Médicale; Clinique Sainte Marguerite

location_facility: Service de Pathologie Respiratoire; CHU de Limoges

location_facility: Service de Pneumologie-Allergologie; Centre Hospitalier Général


title: Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma

summary:
Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples.

The investigators propose a phase II protocol for patients with refractory or relapsing nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy.

Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma who have not received asparaginase before.

ReferenceCitation: Jaccard A, Gachard N, Marin B, Rogez S, Audrain M, Suarez F, Tilly H, Morschhauser F, Thieblemont C, Ysebaert L, Devidas A, Petit B, de Leval L, Gaulard P, Feuillard J, Bordessoule D, Hermine O; GELA and GOELAMS Intergroup. Efficacy of L-asparaginase with methotrexate and dexamethasone (AspaMetDex regimen) in patients with refractory or relapsing extranodal NK/T-cell lymphoma, a phase 2 study. Blood. 2011 Feb 10;117(6):1834-9. doi: 10.1182/blood-2010-09-307454. Epub 2010 Dec 1.

name: Centre Hospitalier Universitaire (CHU) Limoges, Université et Centre National de la Recherche Scientifique (CNRS), Unité Mixte de Recherche (UMR) 6101, Limoges, France;

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

family: Gachard

full_name: Nathalie Gachard

given: Nathalie

name: CHU Limoges, Unité Fonctionnelle de Recherche Clinique et Biostatistique, Limoges, France;

family: Marin

full_name: Benoit Marin

given: Benoit

name: CHU Limoges, Laboratoire de Virologie, Limoges, France;

family: Rogez

full_name: Sylvie Rogez

given: Sylvie

name: CHU Nantes, Laboratoire d'Immunologie, Nantes, France;

family: Audrain

full_name: Marie Audrain

given: Marie

name: Hôpital Necker, Paris, service d'Hématologie Clinique Université Paris Descartes, CNRS UMR 8147, Centre de Référence des Mastocytoses, Paris, France;

family: Suarez

full_name: Felipe Suarez

given: Felipe

family: Tilly

full_name: Hervé Tilly

given: Hervé

name: CHU Lille, Service Maladies du Sang, Lille, France;

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

name: Hôpital Saint Louis, service d'Hématologie Oncologie, Paris, France;

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

name: CHU Toulouse Purpan, service d'Hématologie, Toulouse, France;

family: Ysebaert

full_name: Loic Ysebaert

given: Loic

name: Hôpital du Sud-Francilien, Corbeil, France;

family: Devidas

full_name: Alain Devidas

given: Alain

family: Petit

full_name: Barbara Petit

given: Barbara

name: Institut de Pathologie, CHU V, Université de Lausanne, Lausanne, Switzerland; and

family: de Leval

full_name: Laurence de Leval

given: Laurence

name: Hôpital Henri-Mondor, Créteil, Département de Pathologie, Inserm U955, Créteil, France

family: Gaulard

full_name: Philippe Gaulard

given: Philippe

family: Feuillard

full_name: Jean Feuillard

given: Jean

family: Bordessoule

full_name: Dominique Bordessoule

given: Dominique

family: Hermine

full_name: Olivier Hermine

given: Olivier

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

location_facility: Service d'Hématologie et de Thérapie Cellulaire - CHU Limoges

location_facility: Service d'Hématologie Clinique, CHU Dijon

location_facility: Service de Radiothérapie, Polyclinique Bordeaux Nord

location_facility: Département d'Immuno-Hématologie, Hôpital Saint-Louis

location_facility: Département d'Oncologie - Institut Paoli Calmettes

location_facility: Service d'Immunologie Clinique 2, Hôpital Saint Louis

location_facility: Service d'Hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière

location_facility: Service d'Hématologie Clinique, CHU de Reims

location_facility: Service d'Hématologie Clinique - Hôpital Henri Mondor

location_facility: Service d'Hématologie Clinique, Groupe Hospitalier Necker


title: Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer

acronym: TEAM

summary:
To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

ReferenceCitation: Derks MGM, Bastiaannet E, van de Water W, de Glas NA, Seynaeve C, Putter H, Nortier JWR, Rea D, Hasenburg A, Markopoulos C, Dirix LY, Portielje JEA, van de Velde CJH, Liefers GJ. Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial. Eur J Cancer. 2018 Aug;99:1-8. doi: 10.1016/j.ejca.2018.04.009. Epub 2018 Jun 6.

family: Derks

full_name: M.G.M. Derks

family: Bastiaannet

full_name: E. Bastiaannet

given: E.

family: van de Water

full_name: W. van de Water

given: W.

family: de Glas

full_name: N.A. de Glas

family: Seynaeve

full_name: C. Seynaeve

given: C.

family: Putter

full_name: H. Putter

given: H.

family: Nortier

full_name: J.W.R. Nortier

family: Rea

full_name: D. Rea

given: D.

family: Hasenburg

full_name: A. Hasenburg

given: A.

family: Markopoulos

full_name: C. Markopoulos

family: Dirix

full_name: L.Y. Dirix

family: Portielje

full_name: J.E.A. Portielje

family: van de Velde

full_name: C.J.H. van de Velde

family: Liefers

full_name: G.J. Liefers

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

ReferenceCitation: Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM, Liefers GJ, Putter H, Kroep JR, Rea D, Hasenburg A, Markopoulos C, Paridaens R, Smeets JBE, Dirix LY, van de Velde CJH. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1211-1220. doi: 10.1016/S1470-2045(17)30419-9. Epub 2017 Jul 18.

full_name: Marloes G M Derks

given: Marloes G M

family: Blok

full_name: Erik J Blok

given: Erik J

full_name: Caroline Seynaeve

given: Caroline

full_name: Johan W R Nortier

given: Johan W R

family: Kranenbarg

full_name: Elma Meershoek-Klein Kranenbarg

given: Elma Meershoek-Klein

ReferenceCitation: Kalatskaya I, Trinh QM, Spears M, McPherson JD, Bartlett JMS, Stein L. ISOWN: accurate somatic mutation identification in the absence of normal tissue controls. Genome Med. 2017 Jun 29;9(1):59. doi: 10.1186/s13073-017-0446-9.

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ReferenceCitation: Bartlett JM, Brookes CL, Piper T, van de Velde CJ, Stocken D, Lyttle N, Hasenburg A, Quintayo MA, Kieback DG, Putter H, Markopoulos C, Kranenbarg EM, Mallon EA, Dirix LY, Seynaeve C, Rea DW. Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial. Br J Cancer. 2013 Oct 29;109(9):2453-61. doi: 10.1038/bjc.2013.609. Epub 2013 Oct 3.

ReferenceCitation: van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. doi: 10.1016/S0140-6736(10)62312-4.


title: Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.

summary: The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.

lead_sponsor: Ipsen

location_facility:
Hôpital Henri Mondor
Hôpital Civil de Colmar
Centre Hospitalier François
Hôpital Gui de Chauliac
CHU de Reims - Hôpital Maison Blanche
Hôpital Nord - CHU d'Amiens
Hôpital J. Minjoz
Hopital Nord
Hôpital Laënnec
Hôpital Pasteur
CHU de Bordeaux
Hôpital Central
Groupe Hospitalier Pellegrin
Hôpital Léopold Bellan
CHU Hôpital Gabriel Montpied
CHG Dijon
Centre Hospitalier René Dubos
Hôpital Charles Nicolle
Hôpital Saint Joseph
Hôpital Guillaume et Réne
Hôpital Neurologique
Centre Hospitalier du Pays d'Aix
Cabinet Médical
Centre Hospitalier
Hôpital Universitaire Dupuytren
Hôpital Delafontaine
CHU Hôpital de Pontchaillou
14 bis Rue du Chapeau Rouge
Hôpital de la cavale Blanche


title: Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX

acronym: MIROX

summary: PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.

ReferenceCitation: Hamidou Z, Chibaudel B, Hebbar M, Hug de Larauze M, André T, Louvet C, Brusquant D, Garcia-Larnicol ML, de Gramont A, Bonnetain F. Time to Definitive Health-Related Quality of Life Score Deterioration in Patients with Resectable Metastatic Colorectal Cancer Treated with FOLFOX4 versus Sequential Dose-Dense FOLFOX7 followed by FOLFIRI: The MIROX Randomized Phase III Trial. PLoS One. 2016 Jun 16;11(6):e0157067. doi: 10.1371/journal.pone.0157067. eCollection 2016.

family: Hamidou

full_name: Zeinab Hamidou

given: Zeinab

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: Hebbar

full_name: Mohamed Hebbar

given: Mohamed

family: Hug de Larauze

full_name: Marine Hug de Larauze

given: Marine

family: André

full_name: Thierry André

given: Thierry

family: Louvet

full_name: Christophe Louvet

given: Christophe

family: Brusquant

full_name: David Brusquant

given: David

family: Garcia-Larnicol

full_name: Marie-Line Garcia-Larnicol

given: Marie-Line

family: de Gramont

full_name: Aimery de Gramont

given: Aimery

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

currency_apc_doaj: USD

journal_name: PLOS ONE

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Hebbar M, Chibaudel B, André T, Mineur L, Smith D, Louvet C, Dutel JL, Ychou M, Legoux JL, Mabro M, Faroux R, Auby D, Brusquant D, Khalil A, Truant S, Hadengue A, Dalban C, Gayet B, Paye F, Pruvot FR, Bonnetain F, Landi B, Flesch M, Carola E, Martin P, Vaillant E, de Gramont A; Group Coopérateur Multidisciplinaire en Oncologie (GERCOR) Group. FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI in patients with resectable metastatic colorectal cancer (MIROX): a pragmatic approach to chemotherapy timing with perioperative or postoperative chemotherapy from an open-label, randomized phase III trial. Ann Oncol. 2015 Feb;26(2):340-7. doi: 10.1093/annonc/mdu539. Epub 2014 Nov 17. Erratum in: Ann Oncol. 2015 May;26(5):1040. Taieb, J [removed]; Brucker, P [removed].

full_name: M. Hebbar

given: M.

full_name: B. Chibaudel

given: B.

full_name: T. André

given: T.

family: Mineur

full_name: L. Mineur

given: L.

family: Smith

full_name: D. Smith

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Clinique Specialise du Littoral-Cote d'Opale


title: A Randomized, Double-Blind, Comparative Parallel Group Study of Analgesic Effectiveness and Safety of Three Different Doses of Lamaline® New Formulation vs Dafalgan® Codeine, After 10 Days Administration in Subjects With Painful Gonarthrosis.

summary: This study aims to assess the analgesic effectiveness and safety of three different doses of a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in subjects with painful gonarthrosis

location_facility:
Site 139
Site 28
Site 110
Site 109
Site 118
Site 35
Site 30
Site 15
Site 41
Site 50
Site 27
Site 414
Site 10
Site 62
Site 207
Site 39
Site 302
Site 126
Site 114
Site 102
Site 130
Site 74
Site 72
Site 40
Site 38
Site 459
Site 128
Site 453
Site 462
Site 119
Site 503
Site 51
Site 134
Site 106
Site 104
Site 461
Site 489
Site 410
Site 314
Site 58
Site 47
Site 107
Site 108
Site 306
Site 318
Site 494
Site 208
Site 69
Site 48
Site 458
Site 488
Site 124
Site 502
Site 46
Site 319
Site 64
Site 225
Site 320
Site 33
Site 113
Site 36
Site 121
Site 45
Site 19
Site 506
Site 22
Site 215
Site 71
Site 315
Site 52
Site 132
Site 401
Site 423
Site 5
Site 29
Site 127
Site 54
Site 125
Site 133
Site 495
Site 112
Site 32
Site 2
Site 55
Site 224
Site 131
Site 31
Site 57
Site 60
Site 136
Site 402
Site 101
Site 496
Site 105
Site 129
Site 454
Site 103
Site 115
Site 117
Site 4
Site 228
Site 135
Site 321
Site 8
Site 12
Site 79
Site 77
Site 24
Site 432
Site 67
Site 433
Site 68
Site 14
Site 63
Site 42
Site 7
Site 460
Site 201
Site 44
Site 123
Site 3
Site 59
Site 511
Site 17
Site 65
Site 457
Site 49
Site 13
Site 25
Site 120
Site 301
Site 137
Site 56
Site 78
Site 122
Site 204
Site 11
Site 21
Site 498
Site 313
Site 37
Site 53
Site 70
Site 23
Site 66
Site 6
Site 116
Site 43
Site 451
Site 138
Site 219
Site 405
Site 209
Site 316
Site 20
Site 413
Site 221
Site 449
Site 75
Site 73
Site 16
Site 9
Site 61
Site 76
Site 18
Site 202
Site 34
Site 26
Site 140
Site 507
Site 213


title: Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin

summary: The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

lead_sponsor: University Hospital, Angers

location_facility:
H Avignon
H Châteauroux
UH Tours
UH Angers
UH Lyon
UH Caen
UH Clermont Ferrand
UH Toulouse
UH Rennes
H Montauban
H Corbeil-Essonnes
H saint-Antoine
H Orléans
UH Dijon
H Freyming-Merlebach
H montélimar
UH Nantes
H Pau
H Creil
H Bourgoin-Jallieu
Arnault Tzanck Institute
UH Poitiers
UH Limoges
H Créteil
H Tenon
UH Rouen
H Grasse
UH Montpellier
UH Grenoble
H Le Mans
H La Roche sur Yon
H Aix en Provence
UH Brest
H Tourcoing
H Saint-Joseph
H Saint-Dizier
H Dreux


title: A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients With Metabolic Syndrome

summary:
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.

An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).

lead_sponsor: Boehringer Ingelheim

location_facility: 502.486 3301A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3316A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3303A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3309A Cabinet Médical Jean Charcot

location_facility: 502.486.3322A Boehringer Ingelheim Investigational Site


title: Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

ReferenceCitation: Gérard JP, Azria D, Gourgou-Bourgade S, Martel-Laffay I, Hennequin C, Etienne PL, Vendrely V, François E, de La Roche G, Bouché O, Mirabel X, Denis B, Mineur L, Berdah JF, Mahé MA, Bécouarn Y, Dupuis O, Lledo G, Montoto-Grillot C, Conroy T. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol. 2010 Apr 1;28(10):1638-44. doi: 10.1200/JCO.2009.25.8376. Epub 2010 Mar 1.

name: From the Centre Antoine-Lacassagne; Université Nice Sofia Antipolis, Nice; Centre Val d'Aurelle, Montpellier; Centre Léon Bérard; Hôpital privé Jean Mermoz, Lyon; Hôpital St Louis; Fédération Nationale des Centres de Lutte Contre le Cancer, Paris; Clinique Armoricaine de Radiologie, St Brieuc; Hôpital Saint André, Bordeaux; Institut de Cancérologie de La Loire, St Priest en Jarez; Centre Hospitalier Universitaire Robert Debré, Reims; Centre Oscar Lambret, Lille; Hôpital Pasteur, Colmar; Institut Ste...

family: Gérard

full_name: Jean-Pierre Gérard

given: Jean-Pierre

family: Azria

full_name: David Azria

family: Gourgou-Bourgade

full_name: Sophie Gourgou-Bourgade

given: Sophie

family: Martel-Laffay

full_name: Isabelle Martel-Laffay

given: Isabelle

family: Hennequin

full_name: Christophe Hennequin

family: Etienne

full_name: Pierre-Luc Etienne

given: Pierre-Luc

family: Vendrely

full_name: Véronique Vendrely

given: Véronique

family: François

full_name: Eric François

given: Eric

family: de La Roche

full_name: Guy de La Roche

given: Guy

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Mirabel

full_name: Xavier Mirabel

given: Xavier

family: Denis

full_name: Bernard Denis

given: Bernard

full_name: Laurent Mineur

given: Laurent

family: Berdah

full_name: Jean-François Berdah

given: Jean-François

family: Mahé

full_name: Marc André Mahé

given: Marc André

family: Bécouarn

full_name: Yves Bécouarn

given: Yves

family: Dupuis

full_name: Olivier Dupuis

family: Lledo

full_name: Gérard Lledo

given: Gérard

family: Montoto-Grillot

full_name: Christine Montoto-Grillot

given: Christine

family: Conroy

full_name: Thierry Conroy

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Comparison of Two Neoadjuvant Chemoradiotherapy Regimens for Locally Advanced Rectal Cancer: Results of the Phase III Trial ACCORD 12/0405-Prodige 2

ReferenceCitation: Azria D, Doyen J, Jarlier M, Martel-Lafay I, Hennequin C, Etienne P, Vendrely V, François E, de La Roche G, Bouché O, Mirabel X, Denis B, Mineur L, Berdah J, Mahé M, Bécouarn Y, Dupuis O, Lledo G, Seitz J, Bedenne L, Gourgou-Bourgade S, Juzyna B, Conroy T, Gérard J. Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer. Ann Oncol. 2017 Oct 1;28(10):2436-2442. doi: 10.1093/annonc/mdx351.

full_name: D. Azria

given: D.

family: Doyen

full_name: J. Doyen

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier General Andre Boulloche

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma.

PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.

ReferenceCitation: Duffaud F, Bui BN, Penel N, et al.: A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). [Abstract] J Clin Oncol 26 (Suppl 15): A-10511, 2008.

ipd_sharing_description: Individual participant data will not be shared at an individual level.

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.

ReferenceCitation: Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. doi: 10.1200/JCO.2008.17.3146. Epub 2008 Sep 22.

name: From the Département de Cancérologie Générale, Unité de Biostatistiques, and Département d’Imagerie Médicale, Centre Oscar Lambret; Equipe d’Accueil 2694, Santé Publique, Epidémiologie et modélisation des maladies chroniques, Université Lille II, Lille; Département d’Oncologie Médicale, Institut Bergonié, Bordeaux; Département d’Oncologie Médicale, Centre Jean Perrin, Clermont-Ferrand; Département d’Oncologie Médicale, Centre Val d’Aurelle, Montpellier; Département d’Oncologie Médicale, and Unité...

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Bui

full_name: Binh Nguyen Bui

given: Binh Nguyen

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

family: Cupissol

full_name: Didier Cupissol

given: Didier

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Fournier

full_name: Charles Fournier

given: Charles

family: Taieb

full_name: Sophie Taieb

family: Jimenez

full_name: Marta Jimenez

given: Marta

family: Isambert

full_name: Nicolas Isambert

family: Peyrade

full_name: Frédéric Peyrade

given: Frédéric

family: Chevreau

full_name: Christine Chevreau

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Brain

full_name: Etienne G.C. Brain

given: Etienne G.C.

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

publisher_group: American Society of Clinical Oncology (ASCO)

title: Phase II Trial of Weekly Paclitaxel for Unresectable Angiosarcoma: The ANGIOTAX Study

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

acronym: UFT RT Phase 3

summary:
RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancérologie et d'Hématologie

location_facility: Centre d'Oncologie-radiothérapie d'Eure et Loir


title: A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.

summary: The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).

location_facility: Service de Pneumologie, Hôpital de la Croix Rousse

location_facility: Service de Pneumologie, Hôpital Bois Guillaume

location_facility: Service de Pneumologie - Hôpital St Antoine

location_facility: Service de Pneumologie, Hôpital Pontchailloux

location_facility: Hôpital Charles Nicolle, Service de Pneumologie


title: Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment

summary: The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.

lead_sponsor: Eli Lilly and Company

location_facility: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician


title: OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

summary: This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.

location_facility:
CH St. Joseph
CH La Roche sur Yon
CH Amiens
CHU Clermont Ferrand
CHG Pau
CHG Albi
Hopital Antoine Beclere
GH La Timone
CHU Montpellier
CHU Nantes
CHU Toulon
Hopital Nord
CH Avignon
Hopital Cote de Nacre
CHG Martigues
CHU Michalon
CHU D'Orleans
CHG Chateauroux
CHU Dupuytren
CH Besancon
CHU Pontchaillou
CHG Aix en Provence
Hopital Neuro-cardiologique
Hôpital Princesse de Grâce
CMC Arnaud Tzanck
CHU Angers
CHU Hopital la Cavale Blanche
CHU Tours
CHU Rangueil
CHU Nice
CHRU Robert Debré
CHU Rouen
Hopital Angouleme


title: Short and Long Term Evaluation of Electrical Measurements and Defibrillation Energies, Results of ATP and Diagnostic Functions of Devices Connected to Endotak RELIANCE® Defibrillation Leads

summary: The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.

location_facility:
CH Amiens
CHG Pau
CHU La Timone
CHU Montpellier
CHU Nantes
Clinique St. Gatien
CH Avignon
Centre cardiologique du Nord
CHU Brabois
CHU du Morvan
CHU Michalon
Hôpital Côte de Nacre
CHU Henri Mondor
CHU D'Orleans
CHU Pontchaillou
Hôpital Angoulème
Nouvelle Clinique Nantaise
CMC Arnaud Tzanck
CHU Angers
CH Hôpital Nord
Clinique Cardiologique Aressy
CHU Rangueil
CHU Nice
CHU Rouen
Clinique Bizet


title: Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.

summary: To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.


title: Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.

summary: To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.


title: Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm

summary: To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

ReferenceCitation: Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4.

family: Basmaison

full_name: Odile Basmaison

given: Odile

family: Ranchin

full_name: Bruno Ranchin

given: Bruno

family: Zouater

full_name: Hichem Zouater

given: Hichem

family: Robertson

full_name: Anna Robertson

given: Anna

family: Gomez

full_name: Roy Gomez

given: Roy

family: Koppiker

full_name: Nandan Koppiker

given: Nandan

journal_name: Annales d'Endocrinologie

location_facility: Groupe hospitalier Est-Hôpital Femme, Mère, Enfant

location_facility: CHU Tours - Centre Pediatrique Gatien de Cocheville

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie

location_facility: Service de Pédiatrie- Centre Hospitalier Intercommunal

location_facility: Groupe hospitalier Est- Hôpital Femme, Mère, Enfant


title: Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts

summary: To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary


title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Forced Titration Study Of The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Compared To Fenofibrate In Subjects With Fredrickson Type IIB Dyslipidemia (Mixed Hyperlipidemia

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.


title: Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility

summary: Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

ReferenceCitation: Fernandez H, Gervaise A. Ectopic pregnancies after infertility treatment: modern diagnosis and therapeutic strategy. Hum Reprod Update. 2004 Nov-Dec;10(6):503-13. Epub 2004 Sep 23. Review.

ReferenceCitation: Bourel G, Pelletier-Fleury N, Bouyer J, Delbarre A, Fernandez H, Capmas P. Cost-effectiveness analysis of medical management versus conservative surgery for early tubal pregnancy. Hum Reprod. 2019 Feb 1;34(2):261-267. doi: 10.1093/humrep/dey352.

name: INSERM, Université Paris-Saclay, Univ. Paris-Sud, UVSQ, Centre de Recherche en Epidémiologie et Santé des Populations, Hôpital Paul Brousse, 16 av Paul Vaillant Couturier, Villejuif, France

name: Unité de recherche médico-économique, CHU de Montpellier, 191 Av. du Doyen Gaston Giraud, Montpellier, France

family: Bourel

full_name: G Bourel

given: G

family: Pelletier-Fleury

full_name: N Pelletier-Fleury

given: N

family: Bouyer

full_name: J Bouyer

given: J

family: Delbarre

full_name: A Delbarre

given: A

name: GHU Sud, AP-HP, Service de Gynécologie Obstétrique, Hôpital Bicêtre, 78 Rue du Général Leclerc, Le Kremlin Bicêtre, France

family: Fernandez

full_name: H Fernandez

given: H

family: Capmas

full_name: P Capmas

given: P

journal_name: Human Reproduction

evidence: open (via free pdf)

ReferenceCitation: Fernandez H, Capmas P, Lucot JP, Resch B, Panel P, Bouyer J; GROG. Fertility after ectopic pregnancy: the DEMETER randomized trial. Hum Reprod. 2013 May;28(5):1247-53. doi: 10.1093/humrep/det037. Epub 2013 Mar 12.

full_name: H. Fernandez

given: H.

full_name: P. Capmas

given: P.

family: Lucot

full_name: J. P. Lucot

given: J. P.

family: Resch

full_name: B. Resch

given: B.

family: Panel

full_name: P. Panel

full_name: J. Bouyer

given: J.

bso_classification: Biology (fond.)

lead_sponsor: Hopital Antoine Beclere

location_facility: Versailles Hospital ; Hôpital André Mignot

location_facility: Assistance Publique Hôpitaux de Marseille ; Hôpital Nord

location_facility: Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception


title: Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

family: Conroy

full_name: Thierry Conroy

given: Thierry

family: Desseigne

full_name: Françoise Desseigne

given: Françoise

family: Ychou

full_name: Marc Ychou

given: Marc

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Bécouarn

full_name: Yves Bécouarn

given: Yves

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Gourgou-Bourgade

full_name: Sophie Gourgou-Bourgade

given: Sophie

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Khemissa-Akouz

full_name: Faiza Khemissa-Akouz

given: Faiza

family: Péré-Vergé

full_name: Denis Péré-Vergé

given: Denis

family: Delbaldo

full_name: Catherine Delbaldo

given: Catherine

family: Assenat

full_name: Eric Assenat

given: Eric

family: Chauffert

full_name: Bruno Chauffert

family: Michel

full_name: Pierre Michel

given: Pierre

family: Montoto-Grillot

full_name: Christine Montoto-Grillot

given: Christine

family: Ducreux

full_name: Michel Ducreux

given: Michel

title: FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

ReferenceCitation: Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.

ReferenceCitation: Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017.

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

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

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire d'Amiens