title: Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer : a Multicenter Non-randomized Prospective Cohort Study

acronym: StoRM

summary:
This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer.

1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study.

Patients will be treated and followed according to the standards of their treating center.

They will be followed during at least 5 years every 6 months for 3 years then every year.

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ReferenceCitation: Thomas G, Jacobs KB, Kraft P, Yeager M, Wacholder S, Cox DG, Hankinson SE, Hutchinson A, Wang Z, Yu K, Chatterjee N, Garcia-Closas M, Gonzalez-Bosquet J, Prokunina-Olsson L, Orr N, Willett WC, Colditz GA, Ziegler RG, Berg CD, Buys SS, McCarty CA, Feigelson HS, Calle EE, Thun MJ, Diver R, Prentice R, Jackson R, Kooperberg C, Chlebowski R, Lissowska J, Peplonska B, Brinton LA, Sigurdson A, Doody M, Bhatti P, Alexander BH, Buring J, Lee IM, Vatten LJ, Hveem K, Kumle M, Hayes RB, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover RN, Chanock SJ, Hunter DJ. A multistage genome-wide association study in breast cancer identifies two new risk alleles at 1p11.2 and 14q24.1 (RAD51L1). Nat Genet. 2009 May;41(5):579-84. doi: 10.1038/ng.353. Epub 2009 Mar 29.

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ReferenceCitation: Azzato EM, Pharoah PD, Harrington P, Easton DF, Greenberg D, Caporaso NE, Chanock SJ, Hoover RN, Thomas G, Hunter DJ, Kraft P. A genome-wide association study of prognosis in breast cancer. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1140-3. doi: 10.1158/1055-9965.EPI-10-0085. Epub 2010 Mar 23.

ReferenceCitation: Purcell S, Neale B, Todd-Brown K, Thomas L, Ferreira MA, Bender D, Maller J, Sklar P, de Bakker PI, Daly MJ, Sham PC. PLINK: a tool set for whole-genome association and population-based linkage analyses. Am J Hum Genet. 2007 Sep;81(3):559-75. Epub 2007 Jul 25.

lead_sponsor: Centre Leon Berard

location_facility:
Institut Bergonié
Centre Alexis Vautrin
Centre René Gauducheau
Centre Georges François Leclerc
Institut Jean Godinot
Centre Paul Strauss
Hôpital Jean Minjoz - CHU Besançon
Institut Paoli Calmettes
Centre Antoine Lacassagne
Val d'Aurelle
Centre Léon Bérard
Institut Gustave Roussy
Institut Claudius Regaud
Institut Daniel Hollard
Institut Curie
Centre François Baclesse
Hôpital Dupuytren


title: Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.

acronym: FRETEP

summary:
Background : Numerous studies have outlined the cellular pleiotropic effects of erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology.

Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Limoges

location_facility: CHU de TOULOUSE - Service de Néphrologie

location_facility: CHU de BORDEAUX - Service de Néphrologie

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

acronym: PROTECT

summary:
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..

Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Provention Bio, Inc.

location_country:
Poland
United Kingdom
Canada
Hungary
France
United States
Belgium
Germany
Czechia

location_facility: University of South Florida Diabetes and Endocrinology Center (Site 011)

location_facility: University of Chicago Medical Center (Site 017)

location_facility: University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005)

location_facility: Kinderkrankenhaus Auf Der Bult (Site 604)

location_facility: CHU UCL Namur, site Clinique Sainte-Elisabeth (Site 205)

location_facility: Hopitaux Pediatriques de Nice CHU-Lenval service de diabetologie et d'endocrinologia (Site 508)

location_facility: Children's Medical Center Dallas (Site 033)

location_facility: U. Minnesota Health Clinical Research Unit (Site 031)

location_facility: Childrens Hospital of Philadelphia - Endocrinology (Site 021)

location_facility: Universitätsklinikum Heidelberg (Site 608)

location_facility: Cardiff and Vale NHS Trust - University Hospital of Wales (Site 902)

location_facility: Endocrinology Service Northwest, LLC (Site 034)

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu (Site 804)

location_facility: Vanderbilt University Medical Center (Site 024)

location_facility: Centre Hospitalier Regional (CHR) d'Orleans-Service de pediatrie (Site 513)

location_facility: Instytut Diabetologii Sp. z o.o. (Site 802)

location_facility: Universitatsklinikum Carl Gustav Carus (Site 601)

location_facility: UNC Hospitals Children's Specialty Clinic (Site 038)

location_facility: Rady Children's Hospital-San Diego (Site 004)

location_facility: CHU Hopital de la Timone-Hopital d'Enfants (Site 512)

location_facility: Rocky Mountain Diabetes and Osteoporosis Center (Site 007)

location_facility: Alberta Diabetes Institute Clinical Research Unit Li Ka Shing Centre for Health Research Innovation (Site 103)

location_facility: Groupe Hospitalier Necker Enfants Malades (site 502)

location_facility: Evangelisches Klinikum Bethel Kinderklinik (Site 602)

location_facility: Baystate Pediatric Endocrinology & Diabetes (Site 040)

location_facility: Sheffield Children's NHS Foundation Trust Western Bank (Site 903)

location_facility: Capital Diabetes & Endocrine Associates (Site 029)

location_facility: St. Luke's Children's Endocrinology (Site 052)

location_facility: MultiCare Institute for Research & Innovation (Site 003)

location_facility: Rainbow Babies & Children's Hospital (Site 049)

location_facility: Benaroya Research Institute at Virginia Mason (Site 016)

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház ( Site 705)

location_facility: Nemours Children's Specialty Care-Endocrinology (Site 047)

location_facility: Universitätsklinikum Augsburg (Site 606)

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka" (Site 801)

location_facility: UF Clinical and Translation Research Building (Site 015)

location_facility: Groupe hospitalier Est-Hopital Femme, Mere, Enfant (Site 509)

location_facility: Montreal Children's Hospital-McGill (Site 101)

location_facility: All Children's Hospital-Johns Hopkins Medicine (Site 048)

location_facility: Columbus Regional Research Institute (Site 006)

location_facility: Indiana University Hospital and Riley Hospital for Children (Site 014)

location_facility: Sanford Diabetes and Thyroiid Clinical (Site 013)

location_facility: Women and Children's Hospital of Buffalo (Site 010)

location_facility: AM Diabetes & Endocrinology Center (Site 008)

location_facility: University of Miami Health System (Site 028)

location_facility: Universitätsklinikum Freiburg (Site 603)

location_facility: Children's Mercy Hospitals & Clinics (Site 026)

location_facility: Uniwersyteckie Centrum Kliniczne (Site 803)

location_facility: Northwick Park Hospital - Paediatrics (site 904)

location_facility: Diablo Clinical Research, Inc. (Site 002)

location_facility: Washington University School of Medicine (Site 018)

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Completed

title: Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

ReferenceType: derived

ReferenceCitation: Pautier P, Penel N, Ray-Coquard I, Italiano A, Bompas E, Delcambre C, Bay JO, Bertucci F, Delaye J, Chevreau C, Cupissol D, Bozec L, Eymard JC, Saada E, Isambert N, Guillemet C, Rios M, Piperno-Neumann S, Chenuc G, Duffaud F. A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study). Eur J Cancer. 2020 Jan;125:31-37. doi: 10.1016/j.ejca.2019.10.028. Epub 2019 Dec 10.

ipd_sharing_description: PD will not be shared at an individual level, they will be part of the study database including all enrolled patients

location_facility: Institut Curie - Hôpital Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest/Centre René Gauducheau

summary: The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.

status_simplified: Completed


acronym: FER

title: A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

ReferenceType: background

ReferenceCitation: Oldenburg B, Koningsberger JC, Van Berge Henegouwen GP, Van Asbeck BS, Marx JJ. Iron and inflammatory bowel disease. Aliment Pharmacol Ther. 2001 Apr;15(4):429-38. Review.

ReferenceCitation: Vijverman A, Piront P, Belaiche J, Louis E. Evolution of the prevalence and characteristics of anemia in inflammatory bowel diseases between 1993 and 2003. Acta Gastroenterol Belg. 2006 Jan-Mar;69(1):1-4.

ReferenceCitation: Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14.

ReferenceType: result

ReferenceCitation: Wilson A, Reyes E, Ofman J. Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:44S-49S. Review.

ReferenceCitation: Gasche C, Berstad A, Befrits R, Beglinger C, Dignass A, Erichsen K, Gomollon F, Hjortswang H, Koutroubakis I, Kulnigg S, Oldenburg B, Rampton D, Schroeder O, Stein J, Travis S, Van Assche G. Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases. Inflamm Bowel Dis. 2007 Dec;13(12):1545-53.

ReferenceCitation: Gisbert JP, Gomollón F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. doi: 10.1111/j.1572-0241.2008.01846.x. Review.

location_facility:
Chu Amiens
Chu Rennes
Hopital Cochin
Chu Marseille - Hopital Nord
Hopital St Antoine
Hopital Beaujon
CHU LYON
CHU Bordeaux - Pessac
Chu Saint Etienne
Chu Rouen
CHU CAEN
Chu Nantes
Chu Tours
Chu Clermont-Ferrand
Hopital Saint Louis
Chu Toulouse
CHRU Lille
Hopital Bicetre

summary:
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.

Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.

The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.


title: A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy of Afatinib (BIBW2992) in Maintenance Therapy After Post- Operative Radio-chemotherapy in Squamous-cell Carcinoma of the Head and Neck: GORTEC 2010-02

ReferenceCitation: Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52.

ReferenceCitation: Seiwert, TC, clement, P. M, Del Campo, J, de Mont-Serrat, H., Thurm, H. C., Blackman, A. S., and Cohen, E. E. BIBW 2992 versus cetuximab in patients with metastatic or recurrent head and neck cancer (SCCHN) after failure of platinum-containing therapy with a cross-over period for progressing patients: Preliminary results of a randomized, open-label phase II study. Journal of Clinical Oncology 28(15 suppl). 2010.

ReferenceCitation: Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44.

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ReferenceCitation: Mendelsohn J. Epidermal growth factor receptor inhibition by a monoclonal antibody as anticancer therapy. Clin Cancer Res. 1997 Dec;3(12 Pt 2):2703-7. Review.

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ReferenceCitation: Grandis JR, Tweardy DJ. TGF-alpha and EGFR in head and neck cancer. J Cell Biochem Suppl. 1993;17F:188-91. Review.

ReferenceCitation: Baselga J. New therapeutic agents targeting the epidermal growth factor receptor. J Clin Oncol. 2000 Nov 1;18(21 Suppl):54S-9S. Review.

ReferenceCitation: Fan Z, Mendelsohn J. Therapeutic application of anti-growth factor receptor antibodies. Curr Opin Oncol. 1998 Jan;10(1):67-73. Review.

ReferenceCitation: Milas L, Mason K, Hunter N, Petersen S, Yamakawa M, Ang K, Mendelsohn J, Fan Z. In vivo enhancement of tumor radioresponse by C225 antiepidermal growth factor receptor antibody. Clin Cancer Res. 2000 Feb;6(2):701-8.

ReferenceCitation: Kaplan EL and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81. 2006.

ReferenceCitation: Grégoire V, Eisbruch A, Hamoir M, Levendag P. Proposal for the delineation of the nodal CTV in the node-positive and the post-operative neck. Radiother Oncol. 2006 Apr;79(1):15-20. Epub 2006 Apr 17.

ReferenceCitation: Lapeyre M, Henrot P, Alfonsi M, Bardet E, Bensadoun RJ, Dolivet G, Favrel V, Gallocher O, Giraud P, Graff P, Guerif S, Lagarde P, Lartigau E, Marchesi V, Pommier P, Rives M, Tortochaux J, Toussaint B, Verrelle P, Bourhis J, Calais G; Groupe Oncologie Radiothérapie Tête et Cou. [Propositions for the selection and the delineation of peritumoral microscopic disease volumes in oral cavity and oropharyngeal cancers (lymph nodes excluded)]. Cancer Radiother. 2005 Jun;9(4):261-70. Epub 2005 Apr 25. Review. French.

ReferenceCitation: Grégoire V, Levendag P, Ang KK, Bernier J, Braaksma M, Budach V, Chao C, Coche E, Cooper JS, Cosnard G, Eisbruch A, El-Sayed S, Emami B, Grau C, Hamoir M, Lee N, Maingon P, Muller K, Reychler H. CT-based delineation of lymph node levels and related CTVs in the node-negative neck: DAHANCA, EORTC, GORTEC, NCIC,RTOG consensus guidelines. Radiother Oncol. 2003 Dec;69(3):227-36.

ReferenceCitation: Prescribing, Recording, and Reporting Intensity-Modulated Photon-Beam Therapy (IMRT)(ICRU Report 83) ICRU Report 83, Journal of the ICRU Vol. 10 No. 1. 2011.

ReferenceCitation: Chao KS, Majhail N, Huang CJ, Simpson JR, Perez CA, Haughey B, Spector G. Intensity-modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: a comparison with conventional techniques. Radiother Oncol. 2001 Dec;61(3):275-80.

location_facility: Institut de Cancérologie de lorraine (ICL)

location_facility: Pôle Hospitalier Mutualiste- Centre Etienne Dolet

summary: The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck.


title: Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs

summary: The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

location_facility:
Rehabilitation
Vascular investigation
Vascular Medicine

intervention_type: Other


title: Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.

acronym: PIL

summary: To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in primary care.

primary_purpose: Supportive Care

ReferenceCitation: Stewart M, Brown JB, Donner A, McWhinney IR, Oates J, Weston WW, Jordan J. The impact of patient-centered care on outcomes. J Fam Pract. 2000 Sep;49(9):796-804.

ReferenceCitation: Kitching JB. Patient information leaflets--the state of the art. J R Soc Med. 1990 May;83(5):298-300.

ReferenceCitation: Kenny T, Wilson RG, Purves IN, Clark J Sr, Newton LD, Newton DP, Moseley DV. A PIL for every ill? Patient information leaflets (PILs): a review of past, present and future use. Fam Pract. 1998 Oct;15(5):471-9. Review.

ReferenceCitation: Little P, Griffin S, Kelly J, Dickson N, Sadler C. Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial. BMJ. 1998 Jun 27;316(7149):1948-52.

ReferenceCitation: Little P, Dorward M, Warner G, Moore M, Stephens K, Senior J, Kendrick T. Randomised controlled trial of effect of leaflets to empower patients in consultations in primary care. BMJ. 2004 Feb 21;328(7437):441. Epub 2004 Feb 13.

ReferenceCitation: Coudeyre E, Givron P, Vanbiervliet W, Benaïm C, Hérisson C, Pelissier J, Poiraudeau S. [The role of an information booklet or oral information about back pain in reducing disability and fear-avoidance beliefs among patients with subacute and chronic low back pain. A randomized controlled trial in a rehabilitation unit]. Ann Readapt Med Phys. 2006 Nov;49(8):600-8. Epub 2006 May 26. French.

ReferenceCitation: Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drapé JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603.

ReferenceCitation: McIntosh A, Shaw CF. Barriers to patient information provision in primary care: patients' and general practitioners' experiences and expectations of information for low back pain. Health Expect. 2003 Mar;6(1):19-29.

ReferenceCitation: Watkins CJ, Papacosta AO, Chinn S, Martin J. A randomized controlled trial of an information booklet for hypertensive patients in general practice. J R Coll Gen Pract. 1987 Dec;37(305):548-50.

ReferenceCitation: Roberts L, Little P, Chapman J, Cantrell T, Pickering R, Langridge J. The back home trial: general practitioner-supported leaflets may change back pain behavior. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1821-8.

ReferenceCitation: Johnson LK, Edelman A, Jensen J. Patient satisfaction and the impact of written material about postpartum contraceptive decisions. Am J Obstet Gynecol. 2003 May;188(5):1202-4.

ReferenceCitation: Mancini J, Noguès C, Adenis C, Berthet P, Bonadona V, Chompret A, Coupier I, Eisinger F, Fricker JP, Gauthier-Villars M, Lasset C, Lortholary A, N'Guyen TD, Vennin P, Sobol H, Stoppa-Lyonnet D, Julian-Reynier C. Impact of an information booklet on satisfaction and decision-making about BRCA genetic testing. Eur J Cancer. 2006 May;42(7):871-81. Epub 2006 Mar 23.

ReferenceCitation: Al-Asfour A, Andersson L. The effect of a leaflet given to parents for first aid measures after tooth avulsion. Dent Traumatol. 2008 Oct;24(5):515-21. doi: 10.1111/j.1600-9657.2008.00651.x.

ReferenceCitation: Carré PC, Roche N, Neukirch F, Radeau T, Perez T, Terrioux P, Ostinelli J, Pouchain D, Huchon G. The effect of an information leaflet upon knowledge and awareness of COPD in potential sufferers. A randomized controlled study. Respiration. 2008;76(1):53-60. doi: 10.1159/000115947. Epub 2008 Feb 5.

ReferenceCitation: Scala D, Cozzolino S, D'Amato G, Cocco G, Sena A, Martucci P, Ferraro E, Mancini AA. Sharing knowledge is the key to success in a patient-physician relationship: how to produce a patient information leaflet on COPD. Monaldi Arch Chest Dis. 2008 Jun;69(2):50-4.

ReferenceCitation: Vetto JT, Dubois PM, Vetto IP. The impact of distribution of a patient-education pamphlet in a multidisciplinary breast clinic. J Cancer Educ. 1996 Fall;11(3):148-52.

ReferenceCitation: Leichtnam-Dugarin L, Carretier J, Delavigne V, Brusco S, Hoarau H, Philip T, Fervers B; Comité d'Organisation des Standards, Options et Recommentations SAVOIR; Fédération Nationale des Centres de lutte contre le cancer; Ligue contre le Cancer; Fédération Hospitalière de France; Fédération Nationale de Cancérologie des CHRU; Fédération Française de Cancérologie. [The SOR SAVOIR Patient, a project of patient information and education]. Cancer Radiother. 2003 Jun;7(3):210-2. French.

ReferenceCitation: Roland M, Dixon M. Randomized controlled trial of an educational booklet for patients presenting with back pain in general practice. J R Coll Gen Pract. 1989 Jun;39(323):244-6.

ReferenceCitation: Macfarlane JT, Holmes WF, Macfarlane RM. Reducing reconsultations for acute lower respiratory tract illness with an information leaflet: a randomized controlled study of patients in primary care. Br J Gen Pract. 1997 Nov;47(424):719-22.

ReferenceCitation: Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4.

ReferenceCitation: Vuorma S, Rissanen P, Aalto AM, Hurskainen R, Kujansuu E, Teperi J. Impact of patient information booklet on treatment decision--a randomized trial among women with heavy menstruation. Health Expect. 2003 Dec;6(4):290-7.

ReferenceCitation: Dedianne MC, Hauzanneau P, Labarere J, Moreau A. Relation médecin-malade en soins primaires: qu'attendent les patients? Investigation par la méthode qualitative des focus groups. La revue du praticien Médecine générale. 2003;17 (612):653-6.

ReferenceCitation: Paul F, Jones MC, Hendry C, Adair PM. The quality of written information for parents regarding the management of a febrile convulsion: a randomized controlled trial. J Clin Nurs. 2007 Dec;16(12):2308-22.

ReferenceCitation: Sustersic M, Voorhoeve M, Menuret H, Baudrant M, Meneau A, Bosson JL. Fiches d'information pour les patients: quel intérêt? L'étude EDIMAP. La Revue de la médecine générale. 2010;276:332-9.

ReferenceCitation: Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J. Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009 Jul 29;339:b2885. doi: 10.1136/bmj.b2885.

ReferenceCitation: Lerman C, Ross E, Boyce A, Gorchov PM, McLaughlin R, Rimer B, Engstrom P. The impact of mailing psychoeducational materials to women with abnormal mammograms. Am J Public Health. 1992 May;82(5):729-30.

ReferenceCitation: Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, Bosson JL. [Developing patient information sheets in general practice. Proposal for a methodology]. Rev Prat. 2008 Dec 15;58(19 Suppl):17-24. French.

ReferenceCitation: Sustersic M, Meneau A, Dremont R, Bosson JL. Fiches d'information patient: quelle méthodologie? La revue du praticien Médecine générale. 2007;790:1167-8.

ReferenceCitation: Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, Bosson JL. Elaboration d'un outil d'aide à l'éducation du patient pas la réalisation de 125 fiches d'information et de conseil concernant des motifs de consultation les plus fréquents en médecin générale. Université Joseph Fourier, faculté de médecine de Grenoble. juillet 2007.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital Grenoble
General practitioner office

intervention_type: Procedure


title: Phase 2 Multicenter Study to Assess the Safety and Efficacy of BKM120 as Monotherapy in Treatment of Initial or Recurrent Metastatic Endometrial Cancer After 1st Line Therapy in Patients Who Cannot Undergo Local Surgery and/or Radiotherapy

acronym: ENDOPIK

summary:
This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.

Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending on the group of patients. The primary endpoint is the non-progression rate at 3 months (12 weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive disease (high grade tumor = stratum 2).

Disease progression is defined by the RECIST 1.1 criteria

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Group Hospitalier Mutualiste de Grenoble


title: A Phase Ib/II Study of Escalating Doses of Revlimid in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

summary: The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.

ReferenceCitation: Tilly H, Morschhauser F, Casasnovas O, Molina TJ, Feugier P, Gouill SL, Haioun C, Tournilhac O, Bouabdallah R, Gabarre J, Lamy T, Cabeçadas J, Becker S, Jardin F, Mounier N, Salles G; Lymphoma Study Association. Lenalidomide in combination with R-CHOP (R2-CHOP) as first-line treatment of patients with high tumour burden follicular lymphoma: a single-arm, open-label, phase 2 study. Lancet Haematol. 2018 Sep;5(9):e403-e410. doi: 10.1016/S2352-3026(18)30131-5.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
Chu Lyon Sud
Hôpital Pontchaillou
Hôpital René Huguenin
Chu Brabois
Centre Léon Bérard
Hôpital Robert Debré
Polyclinique Bordeaux Nord Aquitaine
Institut Gustave Roussy
Hôpital Necker
CHU de NANTES
Institut Bergonié
CHU de DIJON
Hôpital Saint Antoine
Chru Lille
Hôpital Notre Dame de Bon Secours
CHU Estaing
Institut Curie
Hôpital St Louis
Institut Paoli Calmettes
Centre Henri BECQUEREL
Hôpital de la Pitié Salpétrière
CHU de Poitiers
Hôpital Saint Eloi
Hôpital Henri Mondor


title: Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.

summary: This observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 months .

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche


title: Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée

acronym: OPTIMUM

summary: The primary objective of this study is to confirm the long-term efficacy (remission and maintenance in remission) of current validated treatments. Each patient will be followed during 3 years in this non-interventional trial.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Centre Hospitalier du Haut Anjou Hospital St Julien

location_facility: Centre Hospitalier de Tourcoing-Hôpital DRON

location_facility: CH de Bourg-en Bresse Hopital de Fleyriart (Viriat)

location_facility: Groupe Hospitalier Mutualiste "Les Portes du Sud"

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud


title: Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

summary: GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).

location_facility: Centre Hospitalier Régional Universitaire Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire Jean Bernard

location_facility: Centre Hospitalier Régional Universitaire La Timone

location_facility: Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve

location_facility: Centre Universitaire Hospitalier- Hôpital Sud

location_facility: Clinique Sainte Thérèse de l'enfant Jésus


title: National Evaluation of the Adherence to Recommendations of VTE Treatment in Cancer Patients

acronym: CARMEN

summary: Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.

ReferenceCitation: Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Frequency, risk factors, and trends for venous thromboembolism among hospitalized cancer patients. Cancer. 2007 Nov 15;110(10):2339-46.

ReferenceCitation: Levitan N, Dowlati A, Remick SC, Tahsildar HI, Sivinski LD, Beyth R, Rimm AA. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimore). 1999 Sep;78(5):285-91.

ReferenceCitation: Khorana AA, Francis CW, Culakova E, Lyman GH. Risk factors for chemotherapy-associated venous thromboembolism in a prospective observational study. Cancer. 2005 Dec 15;104(12):2822-9.

ReferenceCitation: Blom JW, Vanderschoot JP, Oostindiër MJ, Osanto S, van der Meer FJ, Rosendaal FR. Incidence of venous thrombosis in a large cohort of 66,329 cancer patients: results of a record linkage study. J Thromb Haemost. 2006 Mar;4(3):529-35.

ReferenceCitation: Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64.

ReferenceCitation: Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15.

ReferenceCitation: Lee AY, Levine MN, Butler G, Webb C, Costantini L, Gu C, Julian JA. Incidence, risk factors, and outcomes of catheter-related thrombosis in adult patients with cancer. J Clin Oncol. 2006 Mar 20;24(9):1404-8.

lead_sponsor: Floralis

location_facility: Centre Hospitalier de Villefranche sur Saône

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

location_facility: Centre Hospitalier Mutualiste Site Etienne Dolet

location_facility: Centre de Lutte contre le Cancer (Centre René Gauducheau)


title: Patients Presenting With Acute STEMI Treated With Primary PCI : Comparison of the Impact of the MIMI Approach With a Conventional Strategy of Immediate Stenting

acronym: MIMI

summary: In the setting of primary Percutaneous Coronary Intervention (PCI), the investigators hypothesize that a 24-48 hour delay strategy of stenting after successful thrombus aspiration and establishment of Thrombolysis In Myocardial Infarction (TIMI)-3 flow with optimal antithrombotic therapy may decrease the risk of MicroVascular Obstruction (MVO) as assessed by Cardiac Magnetic Resonance Imaging (CMRI).

ReferenceCitation: Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991 Aug 15;115(4):256-65.

ReferenceCitation: Brodie BR, Stuckey TD, Hansen C, VerSteeg DS, Muncy DB, Moore S, Gupta N, Downey WE. Relation between electrocardiographic ST-segment resolution and early and late outcomes after primary percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2005 Feb 1;95(3):343-8.

ReferenceCitation: Bruder O, Breuckmann F, Jensen C, Jochims M, Naber CK, Barkhausen J, Erbel R, Sabin GV; Herzinfarktverbund Essen. Prognostic impact of contrast-enhanced CMR early after acute ST segment elevation myocardial infarction (STEMI) in a regional STEMI network: results of the "Herzinfarktverbund Essen". Herz. 2008 Mar;33(2):136-42. doi: 10.1007/s00059-008-3102-8.

ReferenceCitation: Hombach V, Grebe O, Merkle N, Waldenmaier S, Höher M, Kochs M, Wöhrle J, Kestler HA. Sequelae of acute myocardial infarction regarding cardiac structure and function and their prognostic significance as assessed by magnetic resonance imaging. Eur Heart J. 2005 Mar;26(6):549-57. Epub 2005 Feb 15.

ReferenceCitation: Isaaz K, Robin C, Cerisier A, Lamaud M, Richard L, Da Costa A, Sabry MH, Gerenton C, Blanc JL. A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention. Coron Artery Dis. 2006 May;17(3):261-9.

ReferenceCitation: Kushner FG, Hand M, Smith SC Jr, King SB 3rd, Anderson JL, Antman EM, Bailey SR, Bates ER, Blankenship JC, Casey DE Jr, Green LA, Hochman JS, Jacobs AK, Krumholz HM, Morrison DA, Ornato JP, Pearle DL, Peterson ED, Sloan MA, Whitlow PL, Williams DO; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009 Dec 1;120(22):2271-306. doi: 10.1161/CIRCULATIONAHA.109.192663. Epub 2009 Nov 18. Erratum in: Circulation. 2010 Mar 30;121(12):e257. Dosage error in article text.

ReferenceCitation: Meneveau N, Séronde MF, Descotes-Genon V, Dutheil J, Chopard R, Ecarnot F, Briand F, Bernard Y, Schiele F, Bassand JP. Immediate versus delayed angioplasty in infarct-related arteries with TIMI III flow and ST segment recovery: a matched comparison in acute myocardial infarction patients. Clin Res Cardiol. 2009 Apr;98(4):257-64. doi: 10.1007/s00392-009-0756-z. Epub 2009 Feb 9.

ReferenceCitation: Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.

ReferenceCitation: Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017.

ReferenceCitation: Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. Epub 2007 Jul 30.

ReferenceCitation: Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.

ReferenceCitation: Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, Erbs S, Linke A, Möbius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.

ReferenceCitation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12.

ReferenceCitation: Wu KC, Zerhouni EA, Judd RM, Lugo-Olivieri CH, Barouch LA, Schulman SP, Blumenthal RS, Lima JA. Prognostic significance of microvascular obstruction by magnetic resonance imaging in patients with acute myocardial infarction. Circulation. 1998 Mar 3;97(8):765-72.

ReferenceCitation: Belle L, Motreff P, Mangin L, Rangé G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility:
CHU Nord
Clinique Convert
Hopital Privé
Clinique St Hilaire
Ch Bastia
CH St Luc St Joseph
CHU Croix Rousse
Clinique du Tonkin
CHU
CHI
Clinique St Gatien
Clinique Mutualiste
Clinique Marie Lannelongue
CH
CHRA
Clinique de Courlancy


title: Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)

acronym: TECCO

summary: Even though the indication for endovascular therapy has been enlarged, open repair of common femoral artery is still considered as the treatment of choice. A recent pilot study showed that endovascular repair of the CFA seems to be a safe technique of revascularization with acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in press). TECCO, a French randomized and controlled trial, has been set up to compare open and endovascular procedures for the treatment of CFA atherosclerotic lesions.

ReferenceCitation: Gouëffic Y, Della Schiava N, Thaveau F, Rosset E, Favre JP, Salomon du Mont L, Alsac JM, Hassen-Khodja R, Reix T, Allaire E, Ducasse E, Soler R, Guyomarc'h B, Nasr B. Stenting or Surgery for De Novo Common Femoral Artery Stenosis. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1344-1354. doi: 10.1016/j.jcin.2017.03.046.

lead_sponsor: Nantes University Hospital

location_facility:
St Augustin Clinic
University Hospital
NCN Clinic
Tonkin Clinic
University Hospital, HEGP
University Hospital, Henri Mondor

intervention_type: Device


title: Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation

acronym: RITUX-ERAH

summary: Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"

lead_sponsor: University Hospital, Tours

location_facility:
Hospital Pitié-Salpêtrière
Hospital Edouard Herriot
Hospital Nord
Hospital Bicêtre
Hospital Bocage
Hospital Tenon
Hospital Sud
Hospital Gabriel Montpied
Hospital Saint Louis
Hospital Bois-Guillaume
Hospital Pellegrin
Hospital Calmette
Hospital
Hospital Saint-Jacques
Hospital Bretonneau
Hospital Milétrie Jean Bernard
Hospital Necker
Hospital Dupuytren
Hospital Civil
Hospital Pasteur
Hospital Conception
Hospital Hôtel Dieu
Hospital Lapeyronie
Hospital Henri Mondor
Hospital Maison Blanche
Hospital Lyon Sud


title: Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

acronym: TARSEQ

summary:
This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.

The anticipated time on study treatment is until disease progression. Target sample size is 156.

The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .

location_facility: Service de Pneumologie; Centre Hospitalier

location_facility: Service de Pneumologie ; Centre hospitalier

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

location_facility: Hôpital Charles Nicolle, Service de Pneumologie

location_facility: Service de Pneumologie-Allergologie; Centre Hospitalier Général

location_facility: Service de pneumologie; Centre Hospitalier d'Annecy

location_facility: Département des Maladies Respiratoires ; Hôpital Sainte Marguerite

location_facility: Service de Pneumologie - Hôpital St Antoine, Paris

location_facility: Service de Pneumologie; Hôpital Bois Guillaume

location_facility: Clinique Pneumologique; Hôpital Charles Nicolle

location_facility: Département de Pathologie Respiratoire du CHU de Limoges

location_facility: Service de Pneumologie, Hôpital Pontchailloux

location_facility: Service de Pneumologie, Hôpital de la Croix Rousse


title: A Cohort Study of First-line Treatment of Patients With Unresectable Advanced (Stage IIIB), Metastatic (Stage IV) or Recurrent Non Squamous Non-small Cell Lung Cancer (NSCLC), Starting a Treatment With Bevacizumab (Avastin®) in Combination With Chemotherapy.

summary: This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 18 months from initiation of Avastin therapy.


type: Registry Identifier

title: ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH

acronym: ORCADES

summary: The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to Continuous Positive Airway Pressure (CPAP) treatment.

ReferenceCitation: Vecchierini MF, Attali V, Collet JM, d'Ortho MP, El Chater P, Kerbrat JB, Leger D, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Meurice JC; ORCADES investigators. A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study. Sleep Med. 2016 Mar;19:131-40. doi: 10.1016/j.sleep.2015.05.020. Epub 2015 Jun 29.

ReferenceCitation: Attali V, Vecchierini MF, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Martin F, Tordjman F, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators. Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data. Sleep Med. 2019 Nov;63:64-74. doi: 10.1016/j.sleep.2019.04.021. Epub 2019 Jun 12.

ReferenceCitation: Vecchierini MF, Attali V, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Martin F, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators, Abedipour D, Allard-Redon A, Aranda A, Attali V, Bavozet F, Becu M, Beruben W, Bessard J, Bonafe I, Boukhana M, Chabrol B, Chatte G, Lebret C, Collet JM, Coste O, Dumont N, Durand-Amat S, D'ortho MP, Elbaum JM, De Santerre OG, Goutorbes F, Grandjean T, Guyot W, Hammer D, Havasi C, Huet P, Kerbrat JB, Khemliche H, Koltes C, Leger D, Lacassagne L, Laur X, Lerousseau L, Liard O, Loisel C, Longuet M, Mallart A, Martin F, Merle Beral F, Meurice JC, Mokhtari Z, Monaca C, Monteyrol PJ, Muir JF, Mullens E, Muller D, Paoli C, Petit FX, Pigearias B, Pradines M, Prigent A, Putterman G, Rey M, Samama M, Tamisier R, Tiberge M, Tison C, Tordjman F, Triolet B, Vacher C, Vecchierini MF, Verain A. Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome. Sleep Breath. 2019 Sep;23(3):837-848. doi: 10.1007/s11325-018-1766-8. Epub 2018 Dec 22.

lead_sponsor: ResMed

location_facility: CHRU Rennes / polyclinique St Laurent / cabinet dentaire

location_facility: Fondation Bon Sauveur / cabinet médical / cabinet dentaire

location_facility: CH Compiègne Senlis / cabinets dentaires

location_facility: CHRU Montpellier / Clinique Beau Soleil / Faculté d'Odontologie / cabinet dentaire

location_facility: Polyclinique du Tondu / cabinet dentaire

location_facility: Maison de la Mutualité / polyclinique de l'Atlantique

location_facility: Centre Médical Plateau de Haye / cabinet médical / cabinet dentaire


type: Other Identifier

title: Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

acronym: RoboLaps

summary:
The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques.

The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


acronym: LUDIC

title: An Open-label, Multicenter, Phase IV Study of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema in Current Medical Practice

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.


acronym: PRODIGE 12

title: Phase III Multicenter Randomized Study Comparing the Effect of Adjuvant Chemotherapy for Six Months With Gemcitabine-Oxaliplatin 85 mg/m2 (GEMOX 85) to Observation in Patients Who Underwent Surgery for Cancer of the Bile Ducts

location_facility:
Centre Hospitalier Saint Eloi
CHU Saint Louis
Hôpital Edouard Herriot
Centre Paul Strauss
CHU de Rouen - Hôpital Ch. Nicolle
Hôpital Nord
Hôpital Privé Jean Mermoz
CHU Timone Adulte
CHU Côte de Nacre
Hôpital Avicenne
Institut Mutualiste Montsouris
CHU Sainte-Etienne - Hopital Nord
Hôpital de Hautepierre / Hôpital Civil
CHU Brabois
Centre Léon Bérard
Hôpital Beaujon
CHU - Hôpital Nord
Hôpital La Source
Institut Gustave Roussy
Centre René Gauducheau
Hôpital Saint Antoine
Hôpital Saint Joseph
Hôpital Européen Georges Pompidou
CHD Vendée
CHU Estaing
CHU Brest - Hôpital Morvan
Institut Sainte Catherine
Institut Paoli Calmettes
Hôpital Jean Minjoz
Centre Eugene Marquis
Hôpital de la Pitié Salpétrière
CHU de Poitiers
Hôpital Trousseau
Centre Paul Papin
Hôpital Bocage
Hôpital Henri Mondor
Centre hospitalier de la Côte Basque

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient's condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery.


title: Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective

acronym: ZOMAJET

summary:
The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients.

Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution.

The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training.

In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device.

The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum.

The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.


title: A Phase I/II Study of the Efficacy and Safety of an Intensified Schedule of Azacitidine (Vidaza®) in Intermediate-2 and High Risk MDS Patients

summary: A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hopital Saint Louis - AP-HP, Hematology Dpt

location_facility: Hopital Purpan Service d'Hématologie Clinique

location_facility: CHU Albert Michallon - Service d'Hématologie Clinique


title: A Phase I-II Study of the Efficacy and Safety of Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

summary:
Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing.

For the Phase I study :

Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS.

For the phase II study:

Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS

location_country: France Tunisia

location_facility: Hôpital saint louis - Hématologie Clinique

location_facility: Hôpital Saint Louis - Hématologie Séniors


title: Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort.

summary: The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.

ReferenceCitation: Motykie GD, Zebala LP, Caprini JA, Lee CE, Arcelus JI, Reyna JJ, Cohen EB. A guide to venous thromboembolism risk factor assessment. J Thromb Thrombolysis. 2000 Apr;9(3):253-62. Review.

ReferenceCitation: Edelsberg J, Ollendorf D, Oster G. Venous thromboembolism following major orthopedic surgery: review of epidemiology and economics. Am J Health Syst Pharm. 2001 Nov 1;58 Suppl 2:S4-13. Review.

ReferenceCitation: Lijfering WM, Rosendaal FR, Cannegieter SC. Risk factors for venous thrombosis - current understanding from an epidemiological point of view. Br J Haematol. 2010 Jun;149(6):824-33. doi: 10.1111/j.1365-2141.2010.08206.x. Epub 2010 Apr 29. Review.

ReferenceCitation: Gensini GF, Prisco D, Falciani M, Comeglio M, Colella A. Identification of candidates for prevention of venous thromboembolism. Semin Thromb Hemost. 1997;23(1):55-67. Review.

ReferenceCitation: Eschwège V, Robert A. Strikes in French public transport and resistance to activated protein C. Lancet. 1996 Jan 20;347(8995):206.

ReferenceCitation: Vaitkus PT, Leizorovicz A, Goldhaber SZ; PREVENT Investigator Group. Rationale and design of a clinical trial of a low-molecular-weight heparin in preventing clinically important venous thromboembolism in medical patients: the prospective evaluation of dalteparin efficacy for prevention of venous thromboembolism in immobilized patients trial (the PREVENT study). Vasc Med. 2002;7(4):269-73.

ReferenceCitation: Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. Epub 2006 Jan 26.

ReferenceCitation: Kujath P, Spannagel U, Habscheid W. Incidence and prophylaxis of deep venous thrombosis in outpatients with injury of the lower limb. Haemostasis. 1993 Mar;23 Suppl 1:20-6.

ReferenceCitation: Jørgensen PS, Warming T, Hansen K, Paltved C, Vibeke Berg H, Jensen R, Kirchhoff-Jensen R, Kjaer L, Kerbouche N, Leth-Espensen P, Narvestad E, Rasmussen SW, Sloth C, Tørholm C, Wille-Jørgensen P. Low molecular weight heparin (Innohep) as thromboprophylaxis in outpatients with a plaster cast: a venografic controlled study. Thromb Res. 2002 Mar 15;105(6):477-80.

ReferenceCitation: Lassen MR, Borris LC, Nakov RL. Use of the low-molecular-weight heparin reviparin to prevent deep-vein thrombosis after leg injury requiring immobilization. N Engl J Med. 2002 Sep 5;347(10):726-30.

ReferenceCitation: Riou B, Rothmann C, Lecoules N, Bouvat E, Bosson JL, Ravaud P, Samama CM, Hamadouche M. Incidence and risk factors for venous thromboembolism in patients with nonsurgical isolated lower limb injuries. Am J Emerg Med. 2007 Jun;25(5):502-8.

location_facility: Medical group "SELARL Sports médecine montagne"

location_facility: Medical center of Beauregard - "les cyclamens"


title: Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

acronym: TACERTE

summary: Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).

location_facility:
CHU Nantes
CH Avignon
AP-HP Paul Brousse Villejuif
CHR Orléans
CHD les Oudairies
CHU de Lyon
La Pitié-Salpétrière
CHU d'Angers
Centre Eugene Marquis
CHU de Nancy Hôpital Brabois
Hôpital Tenon
CHR de Lille Hôpital Claude Huriez
CHU de Bordeaux
CHU de Reims
CHU Amiens
AP-HP Henri Mondor
CHU Dijon
Institut Sainte Catherine


title: A Multi Centre, Double Blind, Placebo-controlled Study to Evaluate the Non Steroidal Anti-inflamatory Drugs (NSAIDS) Sparing Effect of Etanercept in Adult Subjects With Axial Involvement of Spondyloarthritis

acronym: SPARSE

summary: This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.

ReferenceCitation: Dougados M, Wood E, Gossec L, Dubanchet A, Logeart I, van der Heijde D. Discriminant Capacity of Clinical Efficacy and Nonsteroidal Antiinflammatory Drug-sparing Endpoints, Alone or in Combination, in Axial Spondyloarthritis. J Rheumatol. 2015 Dec;42(12):2361-8. doi: 10.3899/jrheum.150378. Epub 2015 Nov 15.

ReferenceCitation: Dougados M, Wood E, Combe B, Schaeverbeke T, Miceli-Richard C, Berenbaum F, Koppiker N, Dubanchet A, Logeart I. Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study. Arthritis Res Ther. 2014 Nov 27;16(6):481. doi: 10.1186/s13075-014-0481-5.

lead_sponsor: Pfizer

location_facility: Chu Dupuytren, Rhumatologie et Therapeutique

location_facility: Hopital Saint Joseph - Service de Rhumatologie

location_facility: Centre Hospitalier, Service de Rhumatologie

location_facility: CHU Bois Guillaume - Service de Rhumatologie


title: Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi

acronym: CAMOMY

summary: The purpose of this study is to determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary infection.

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ReferenceCitation: Jenkins PA, Campbell IA; Research Committee of The British Thoracic Society. Pulmonary disease caused by Mycobacterium xenopi in HIV-negative patients: five year follow-up of patients receiving standardised treatment. Respir Med. 2003 Apr;97(4):439-44.

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ReferenceCitation: Martín-Casabona N, Bahrmand AR, Bennedsen J, Thomsen VO, Curcio M, Fauville-Dufaux M, Feldman K, Havelkova M, Katila ML, Köksalan K, Pereira MF, Rodrigues F, Pfyffer GE, Portaels F, Urgell JR, Rüsch-Gerdes S, Tortoli E, Vincent V, Watt B; Spanish Group for Non-Tuberculosis Mycobacteria. Non-tuberculous mycobacteria: patterns of isolation. A multi-country retrospective survey. Int J Tuberc Lung Dis. 2004 Oct;8(10):1186-93.

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ReferenceCitation: Andréjak C, Lescure FX, Pukenyte E, Douadi Y, Yazdanpanah Y, Laurans G, Schmit JL, Jounieaux V; Xenopi Group. Mycobacterium xenopi pulmonary infections: a multicentric retrospective study of 136 cases in north-east France. Thorax. 2009 Apr;64(4):291-6. doi: 10.1136/thx.2008.096842. Epub 2008 Dec 3.

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ReferenceCitation: Andréjak C, Thomsen VØ, Johansen IS, Riis A, Benfield TL, Duhaut P, Sørensen HT, Lescure FX, Thomsen RW. Nontuberculous pulmonary mycobacteriosis in Denmark: incidence and prognostic factors. Am J Respir Crit Care Med. 2010 Mar 1;181(5):514-21. doi: 10.1164/rccm.200905-0778OC. Epub 2009 Dec 10.

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ReferenceCitation: Varadi RG, Marras TK. Pulmonary Mycobacterium xenopi infection in non-HIV-infected patients: a systematic review. Int J Tuberc Lung Dis. 2009 Oct;13(10):1210-8. Review.

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ReferenceCitation: Wallace RJ Jr, Brown BA, Griffith DE. Drug intolerance to high-dose clarithromycin among elderly patients. Diagn Microbiol Infect Dis. 1993 Mar-Apr;16(3):215-21.

ReferenceCitation: Gillespie SH, Billington O. Activity of moxifloxacin against mycobacteria. J Antimicrob Chemother. 1999 Sep;44(3):393-5.

ReferenceCitation: Alcaide F, Calatayud L, Santín M, Martín R. Comparative in vitro activities of linezolid, telithromycin, clarithromycin, levofloxacin, moxifloxacin, and four conventional antimycobacterial drugs against Mycobacterium kansasii. Antimicrob Agents Chemother. 2004 Dec;48(12):4562-5.

ReferenceCitation: Rodriguez Díaz JC, López M, Ruiz M, Royo G. In vitro activity of new fluoroquinolones and linezolid against non-tuberculous mycobacteria. Int J Antimicrob Agents. 2003 Jun;21(6):585-8.

ReferenceCitation: Gosling RD, Uiso LO, Sam NE, Bongard E, Kanduma EG, Nyindo M, Morris RW, Gillespie SH. The bactericidal activity of moxifloxacin in patients with pulmonary tuberculosis. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1342-5. Epub 2003 Aug 13.

ReferenceCitation: Bermudez LE, Kolonoski P, Petrofsky M, Wu M, Inderlied CB, Young LS. Mefloquine, moxifloxacin, and ethambutol are a triple-drug alternative to macrolide-containing regimens for treatment of Mycobacterium avium disease. J Infect Dis. 2003 Jun 15;187(12):1977-80. Epub 2003 Jun 4.

ReferenceCitation: Bermudez LE, Inderlied CB, Kolonoski P, Petrofsky M, Aralar P, Wu M, Young LS. Activity of moxifloxacin by itself and in combination with ethambutol, rifabutin, and azithromycin in vitro and in vivo against Mycobacterium avium. Antimicrob Agents Chemother. 2001 Jan;45(1):217-22.

ReferenceCitation: Veziris N, Truffot-Pernot C, Aubry A, Jarlier V, Lounis N. Fluoroquinolone-containing third-line regimen against Mycobacterium tuberculosis in vivo. Antimicrob Agents Chemother. 2003 Oct;47(10):3117-22.

ReferenceCitation: Valerio G, Bracciale P, Manisco V, Quitadamo M, Legari G, Bellanova S. Long-term tolerance and effectiveness of moxifloxacin therapy for tuberculosis: preliminary results. J Chemother. 2003 Feb;15(1):66-70.

ReferenceCitation: Moadebi S, Harder CK, Fitzgerald MJ, Elwood KR, Marra F. Fluoroquinolones for the treatment of pulmonary tuberculosis. Drugs. 2007;67(14):2077-99. Review.

ReferenceCitation: Shandil RK, Jayaram R, Kaur P, Gaonkar S, Suresh BL, Mahesh BN, Jayashree R, Nandi V, Bharath S, Balasubramanian V. Moxifloxacin, ofloxacin, sparfloxacin, and ciprofloxacin against Mycobacterium tuberculosis: evaluation of in vitro and pharmacodynamic indices that best predict in vivo efficacy. Antimicrob Agents Chemother. 2007 Feb;51(2):576-82. Epub 2006 Dec 4.

ReferenceCitation: Teeter JG, Bleecker ER. Relationship between airway obstruction and respiratory symptoms in adult asthmatics. Chest. 1998 Feb;113(2):272-7.

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ReferenceCitation: Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: CHU Clermont Ferrand Hôpital Gabriel Mont pied

location_facility: Centre National de Reference Des Mycobactéries

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Bicetre

location_facility: Assistance Publique Hôpitaux de Paris, hôpital TENON

location_facility: Assistance Publique Hôpitaux de Paris Hôpital BICHAT

location_facility: CHU Montpellier Hôpital Arnaud de Villeneuve

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Saint Louis

location_facility: Assistance Publique Hôpitaux de Paris CHU Avicenne


type: Other Grant/Funding Number

title: Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?

summary: The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth hormone (GHD).

ReferenceCitation: Cadoudal T, Buléon M, Sengenès C, Diene G, Desneulin F, Molinas C, Eddiry S, Conte-Auriol F, Daviaud D, Martin PG, Bouloumié A, Salles JP, Tauber M, Valet P. Impairment of adipose tissue in Prader-Willi syndrome rescued by growth hormone treatment. Int J Obes (Lond). 2014 Sep;38(9):1234-40. doi: 10.1038/ijo.2014.3. Epub 2014 Jan 10.

ReferenceCitation: Eddiry S, Diene G, Molinas C, Salles J, Auriol FC, Gennero I, Bieth E, Skryabin BV, Rozhdestvensky TS, Burnett LC, Leibel RL, Tauber M, Salles JP. SNORD116 and growth hormone therapy impact IGFBP7 in Prader-Willi syndrome. Genet Med. 2021 Sep;23(9):1664-1672. doi: 10.1038/s41436-021-01185-y. Epub 2021 May 26.

ReferenceCitation: Bieth E, Eddiry S, Gaston V, Lorenzini F, Buffet A, Conte Auriol F, Molinas C, Cailley D, Rooryck C, Arveiler B, Cavaillé J, Salles JP, Tauber M. Highly restricted deletion of the SNORD116 region is implicated in Prader-Willi Syndrome. Eur J Hum Genet. 2015 Feb;23(2):252-5. doi: 10.1038/ejhg.2014.103. Epub 2014 Jun 11.

lead_sponsor: University Hospital, Toulouse

location_facility: CHU Limoges Hôpital Mère Enfant Service Pédiatrie - 8, ave du Larrey

location_facility: AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres

location_facility: CHU Saint-Etienne Hôpital Nord Service de Pédiatrie

location_facility: CHU Nice Hôpital Archet 2 - 151 route Saint Antoine de Ginestière

location_facility: CHU Bordeaux Hôpital Pellegrin Service endocrinologie de l'enfant - Place Amélie Raba Léon

location_facility: CHU Strasbourg Hôpital Haute-Pierre - Avenue Molière

location_facility: CHU Rouen Hôpital Nicolle - 1, rue de Germont

location_facility: CHU Nantes Hôpital Mère Enfant Service de Pédiatrie

location_facility: CHU Poitiers Service de Pédiatrie - Rue de la Miléterie

location_facility: CHU Besançon Hôpital Saint Jacques - 2 Place Saint Jacques

location_facility: AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire

location_facility: CHU Montpellier Hôpital Arnaud de Villeneuve - 371 ave du doyen Gaston Giraud

location_facility: CHU Brest Département de Pédiatrie - 5, ave Foch

location_facility: CHU La Rochelle Service de Pédiatrie - Rue du Dr Schweitzer

location_facility: CHU Amiens Hôpital Nord Service Pédiatrie - Place Victor Pauchet

location_facility: CHU Reims Service de Pédiatrie - 47, rue Cognacq-Jay

location_facility: CHU Dijon Service de pédiatrie - 2, Bd Maréchal de lattre de Tassigny

location_facility: CHU Toulouse Hôpital des Enfants Service d'endocrinologie - 330 ave de Grande Bretagne

location_facility: CHRU Tours Centre de Pédiatrie Gatien de Clocheville

location_facility: CHU Lorient Hôpital du Scorff Pôle Femme Mère Enfant - Rue Guiguen

location_facility: CHRU Lille Hôpital Jeanne de Flandre service de Pédiatrie

location_facility: CHU Lyon Hôpital Debrousse service Pédiatrie

location_facility: CHU Grenoble Service de pédiatrie - BP 217


title: Phase II Trial Evaluating the Efficacy and Safety of Carboplatin Plus Pemetrexed in Human Immunodeficiency Virus Positive (HIV+) Patients With Stage III (Not Amenable to Radiation or Inoperable) or Stage IV Nonsquamous Non Small Cell Lung Cancer

acronym: CHIVA

summary: This is a phase II, multicenter, non-randomized, open-label study evaluating the combination of pemetrexed plus carboplatin in HIV-positive patients with lung cancer.

ReferenceCitation: Lavolé A, Chouaïd C, Baudrin L, Wislez M, Raguin G, Pialoux G, Girard PM, Milleron B, Cadranel J. Effect of highly active antiretroviral therapy on survival of HIV infected patients with non-small-cell lung cancer. Lung Cancer. 2009 Sep;65(3):345-50. doi: 10.1016/j.lungcan.2008.11.018. Epub 2009 Jan 9.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Centre François Magendie - hôpital du Haut-Lévèque


title: Prospective, Multicentre, Observational Study

acronym: TCD

summary: Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary neurological deterioration. Their outcome within the first week after injury could be predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma Data Bank, TCDB classification II. The principal outcome measure is the negative predictive value of TCD.

ReferenceCitation: Thornhill S, Teasdale GM, Murray GD, McEwen J, Roy CW, Penny KI. Disability in young people and adults one year after head injury: prospective cohort study. BMJ. 2000 Jun 17;320(7250):1631-5.

ReferenceCitation: Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81.

ReferenceCitation: Livingston DH, Lavery RF, Passannante MR, Skurnick JH, Baker S, Fabian TC, Fry DE, Malangoni MA. Emergency department discharge of patients with a negative cranial computed tomography scan after minimal head injury. Ann Surg. 2000 Jul;232(1):126-32.

ReferenceCitation: Marshall LF, Marshall SB, Klauber MR, van Berkum Clark M, Eisenberg HM, Jane JA, et al. A new classification of head injury based on computerized tomography. J Neurosurg 1991; 75: S14-S20.

ReferenceCitation: Wardlaw JM, Easton VJ, Statham P. Which CT features help predict outcome after head injury? J Neurol Neurosurg Psychiatry. 2002 Feb;72(2):188-92; discussion 151.

ReferenceCitation: Sifri ZC, Homnick AT, Vaynman A, Lavery R, Liao W, Mohr A, Hauser CJ, Manniker A, Livingston D. A prospective evaluation of the value of repeat cranial computed tomography in patients with minimal head injury and an intracranial bleed. J Trauma. 2006 Oct;61(4):862-7.

ReferenceCitation: af Geijerstam JL, Oredsson S, Britton M; OCTOPUS Study Investigators. Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial. BMJ. 2006 Sep 2;333(7566):465. Epub 2006 Aug 8.

ReferenceCitation: Stein SC, Burnett MG, Glick HA. Indications for CT scanning in mild traumatic brain injury: A cost-effectiveness study. J Trauma. 2006 Sep;61(3):558-66. Review. Erratum in: J Trauma. 2007 May;62(5):1309.

ReferenceCitation: White H, Venkatesh B. Applications of transcranial Doppler in the ICU: a review. Intensive Care Med. 2006 Jul;32(7):981-94. Epub 2006 May 10. Review.

ReferenceCitation: McQuire JC, Sutcliffe JC, Coats TJ. Early changes in middle cerebral artery blood flow velocity after head injury. J Neurosurg. 1998 Oct;89(4):526-32.

ReferenceCitation: Jaffres P, Brun J, Declety P, Bosson JL, Fauvage B, Schleiermacher A, Kaddour A, Anglade D, Jacquot C, Payen JF. Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. Intensive Care Med. 2005 Jun;31(6):785-90. Epub 2005 Apr 16.

lead_sponsor: University Hospital, Grenoble

location_facility:
Ch Briancon
Ch Cannes
CHU Lyon
Hopitaux Du Pays Du Mont Blanc
Ch Belley
Chu Edouard Herriot
Ch Saint Jean de Maurienne
Ch Grasse
CHU
CHU Grenoble
CH Nantes
Ch Chambery
CHU Pierre Benite
Ch Thonon Les Bains
Ch Voiron
Ch Saint Julien En Genevois
Chu Nimes
CHRA Annecy
CH Valence


summary: The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.

lead_sponsor: Poitiers University Hospital

location_facility:
Chu Amiens
Chu de Poitiers
Chu de Limoges
Chu de Lyon
Chu de Rennes
Chu Bordeaux
Chu de Nice
Chu de Nimes
Ch Saint Antoine
Chu de Rouen
Chu de Nantes
CH d'Aix en Provence
Chu de Marseille
Ch La Pitie Salpetriere
Chu Saint Etienne
Chu Clermont-Ferrand
Chu de Toulouse
Chu de Strasbourg
Hôpital Henri Mondor
Chu Lille


title: EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

status: Recruiting

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
Ukraine
United States
Belgium
Japan
Czechia
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Brazil
China
Germany
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: The First Afflilated Hospital of Bengbu Medical College

location_facility: Evangelisches Krankenhaus Bethesda Mönchengladbach

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of California, Davis - Health Systems

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: University of North Carolina Medical Center

location_facility: Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: The Fifth Medical Center of PLA General Hospital

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Christus Muguerza Clinica Vidriera (Christus Muguerza Sistemas Hospitalarios S.A. de C.V.)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Volgograd Regional Clinical Cancer Clinic No.1

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Harbin Medical University Cancer Hospital

location_facility: Centro de Investigación Clínica de Alta Especialidad

location_facility: Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council

location_facility: The University of Louisville, James Graham Brown Cancer Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hwa Mei Hospital University of Chinese Academy of Sciences

location_facility: Willamette Valley Cancer Institute & Research Ctr.

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen

location_facility: COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F.

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Texas Oncology - Methodist Charlton Cancer Center

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

location_facility: Banner MD Anderson Cancer Center at McKee Medical Center

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Instituto Argentino de Diagnóstico y Tratamiento (IADT)

location_facility: The First People's Hospital of Changde City

location_facility: Aultman Hospital - Timken Family Cancer Center

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Jining Medical University - Affiliated Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Gynäkologisch-Onkologische Praxis am Pelikanplatz

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Xiangya Hospital Central South University

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi

location_facility: University General Hospital of Heraklion

location_facility: Government Medical College And Hospital - Nagpur

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: University of Health Sciences,Gulhane School of Medicine

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department


title: Hematologic Toxicity Observation of the TPF Medical Protocol. Description of the Impact of Febrile Neutropenia in Patients Who Receive the Chemotherapy of the TPF Medical Protocol in Head and Neck Cell Carcinoma

acronym: OTOHTPF

summary: The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Clinique Armoricaine
Centre René Gauducheau
Centre Hospitalier Bretonneau
Polyclinique de Bordeaux Nord
Centre Hospitalier
Institut Jean Godinot
Centre Jean Perrin
Centre Hospitalier de Vendée
Centre Antoine Lacassagne
Groupe Hospitalier Pitié Salpétrière
Centre Eugene Marquis
Centre Oscar Lambret
Centre Guillaume le Conquerant
Institut Sainte Catherine
Centre Leon Berard
Centre Hospitalier Universitaire


title: PHASE II STUDY Evaluating the Toxicity and Activity of the Combination Lapatinib + Capecitabine in Elderly Patients Aged 70 and Over With Metastatic Breast Cancer Over Expressing HER2

lead_sponsor: UNICANCER

location_facility: Institut Cancérologie- CENTRE HOSPITALIER BREST

summary:
GERICO 09/0907 is a Phase II multicentric trial evaluating the toxicity and activity of the combination of lapatinib and capecitabine in locally advanced or metastatic breast cancer over expressing HER2 for patients aged ≥ 70 who have failed after one line of chemotherapy in combination with trastuzumab.

Due to the minimal participation of older people in clinical trials, there is a lack of data to make evidence-based decisions regarding chemotherapy in this indication.

The study is designed to investigate whether elderly patients with locally advanced or metastatic breast cancer over-expressing HER2 could take advantage of the combination lapatinib and capecitabine in term of clinical benefit, and with no adverse effects and no detrimental impact on functional status (part of geriatric assessment).

The main objective is to assess clinical benefit (defined at 4 months as complete response, partial response or stable disease), safety and preserved geriatric independence (main objective is a "bi-criteria" or composite criteria).


acronym: ESOGIA

summary:
This is a phase III randomized multicenter study involving subjects over 70 years of age with non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously received chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS) as a screening tool. If the SGS results are normal, the patient will be treated with dual-agent therapy based on platinum (carboplatin + pemetrexed if the histology is non epidermoid, carboplatin + gemcitabin if the histology is epidermoid), with no further geriatric assessment. When the SGS reveals abnormalities, a comprehensive geriatric evaluation (CGE) will be used to define two subpopulations on Balducci's fragility scale, who will receive either monotherapy (docetaxel) or best supportive care.

The strategy based on the SGS will be compared with a treatment algorithm based on standard criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified cognitive assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression scale (GDS 5), and screening for a geriatric syndrome defined by the existence of dementia, repeated falls, and urinary and fecal incontinence. The SGS will be validated by comparison with the CGE, that will be administered systematically at enrollment. All the SGS items are included in the CGE.

Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL questionnaires), overall survival, the objective response rate, and toxicity. The investigators will also study the predictive power of nutritional indices such as the PINI and the Buzby score with respect to survival, the treatment response, and tolerability.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Général de la Fontonne Antibes

location_facility: Centre Hospitalier De Villefranche sur Saone

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universaitaire de Brest

location_facility: Centre Hospitalier Général Salon de Provence