title: Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy

lead_sponsor: ANRS, Emerging Infectious Diseases

ReferenceCitation: Fischer M, Hafner R, Schneider C, Trkola A, Joos B, Joller H, Hirschel B, Weber R, Günthard HF; Swiss HIV Cohort Study. HIV RNA in plasma rebounds within days during structured treatment interruptions. AIDS. 2003 Jan 24;17(2):195-9.

ReferenceCitation: Vergis EN, Paterson DL, Wagener MM, Swindells S, Singh N. Dyslipidaemia in HIV-infected patients: association with adherence to potent antiretroviral therapy. Int J STD AIDS. 2001 Jul;12(7):463-8.

ReferenceCitation: Magalhães MG, Greenberg B, Hansen H, Glick M. Comorbidities in older patients with HIV: a retrospective study. J Am Dent Assoc. 2007 Nov;138(11):1468-75.

ReferenceCitation: Ananworanich J, Nuesch R, Côté HC, Kerr SJ, Hill A, Jupimai T, Laopraynak N, Saenawat S, Ruxrungtham K, Hirschel B. Changes in metabolic toxicity after switching from stavudine/didanosine to tenofovir/lamivudine--a Staccato trial substudy. J Antimicrob Chemother. 2008 Jun;61(6):1340-3. doi: 10.1093/jac/dkn097. Epub 2008 Mar 12.

ReferenceCitation: Ferry JA, Sohani AR, Longtine JA, Schwartz RA, Harris NL. HHV8-positive, EBV-positive Hodgkin lymphoma-like large B-cell lymphoma and HHV8-positive intravascular large B-cell lymphoma. Mod Pathol. 2009 May;22(5):618-26. doi: 10.1038/modpathol.2009.36. Epub 2009 Mar 13.

ReferenceCitation: Ho JE, Hsue PY. Cardiovascular manifestations of HIV infection. Heart. 2009 Jul;95(14):1193-202. doi: 10.1136/hrt.2008.161463. Review.

ReferenceCitation: Edelman EJ, Gordon KS, Glover J, McNicholl IR, Fiellin DA, Justice AC. The next therapeutic challenge in HIV: polypharmacy. Drugs Aging. 2013 Aug;30(8):613-28. doi: 10.1007/s40266-013-0093-9. Review.

ReferenceCitation: Flandre P, Raffi F, Descamps D, Calvez V, Peytavin G, Meiffredy V, Harel M, Hazebrouck S, Pialoux G, Aboulker JP, Brun Vezinet F. Final analysis of the Trilège induction-maintenance trial: results at 18 months. AIDS. 2002 Mar 8;16(4):561-8.

ReferenceCitation: Bowersox J. ACTG 343: three drugs better than two for maintaining HIV suppression. NIAID AIDS Agenda. 1998 Mar:1-2, 10-1.

ReferenceCitation: Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martínez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabié A, Weiss L, Gatell JM; OLE/RIS-EST13 Study Group. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):785-92. doi: 10.1016/S1473-3099(15)00096-1. Epub 2015 Jun 7. Erratum in: Lancet Infect Dis. 2015 Aug;15(8):875.

ReferenceCitation: Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suárez-Lozano I, Riera M, Estébanez M, Palacios R, Sanz-Moreno J, Troya J, Mariño A, Antela A, Navarro J, Esteban H, Moreno S; GeSIDA 7011 Study Group. Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study). J Antimicrob Chemother. 2017 Jan;72(1):246-253. Epub 2016 Sep 13.

ReferenceCitation: Di Giambenedetto S, Fabbiani M, Quiros Roldan E, Latini A, D'Ettorre G, Antinori A, Castagna A, Orofino G, Francisci D, Chinello P, Madeddu G, Grima P, Rusconi S, Di Pietro M, Mondi A, Ciccarelli N, Borghetti A, Focà E, Colafigli M, De Luca A, Cauda R; Atlas-M Study Group. Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M). J Antimicrob Chemother. 2017 Apr 1;72(4):1163-1171. doi: 10.1093/jac/dkw557.

ReferenceCitation: Pulido F, Ribera E, Lagarde M, Pérez-Valero I, Palacios R, Iribarren JA, Payeras A, Domingo P, Sanz J, Cervero M, Curran A, Rodríguez-Gómez FJ, Téllez MJ, Ryan P, Barrufet P, Knobel H, Rivero A, Alejos B, Yllescas M, Arribas JR; DUAL-GESIDA-8014-RIS-EST45 Study Group. Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial. Clin Infect Dis. 2017 Nov 29;65(12):2112-2118. doi: 10.1093/cid/cix734.

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum in: Lancet. 2018 Feb 1;:.

ReferenceCitation: Katlama C, Assoumou L, Valantin MA, Soulié C, Martinez E, Béniguel L, Bouchaud O, Raffi F, Molina JM, Fellahi S, Peytavin G, Marcelin AG, Kolta S, Capeau J, Gibowski S, Cardon F, Reynes J, Costagliola D; members of the ANRS 163 ETRAL study. Dual therapy combining raltegravir with etravirine maintains a high level of viral suppression over 96 weeks in long-term experienced HIV-infected individuals over 45 years on a PI-based regimen: results from the Phase II ANRS 163 ETRAL study. J Antimicrob Chemother. 2019 Sep 1;74(9):2742-2751. doi: 10.1093/jac/dkz224.

ReferenceCitation: Joly V, Burdet C, Landman R, Vigan M, Charpentier C, Katlama C, Cabié A, Benalycherif A, Peytavin G, Yeni P, Mentre F, Argoud AL, Amri I, Descamps D, Yazdanpanah Y; LAMIDOL Study Group. Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL). J Antimicrob Chemother. 2019 Mar 1;74(3):739-745. doi: 10.1093/jac/dky467.

ReferenceCitation: Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.

ReferenceCitation: van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

ReferenceCitation: Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9. Erratum in: Lancet. 2018 Nov 28;:.

ReferenceCitation: Dybul M, Chun TW, Yoder C, Hidalgo B, Belson M, Hertogs K, Larder B, Dewar RL, Fox CH, Hallahan CW, Justement JS, Migueles SA, Metcalf JA, Davey RT, Daucher M, Pandya P, Baseler M, Ward DJ, Fauci AS. Short-cycle structured intermittent treatment of chronic HIV infection with highly active antiretroviral therapy: effects on virologic, immunologic, and toxicity parameters. Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):15161-6. Epub 2001 Dec 4.

ReferenceCitation: Dybul M, Nies-Kraske E, Dewar R, Maldarelli F, Hallahan CW, Daucher M, Piscitelli SC, Ehler L, Weigand A, Palmer S, Metcalf JA, Davey RT, Rock Kress DM, Powers A, Beck I, Frenkel L, Baseler M, Coffin J, Fauci AS. A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection. J Infect Dis. 2004 Jun 1;189(11):1974-82. Epub 2004 May 10.

ReferenceCitation: Cohen CJ, Colson AE, Sheble-Hall AG, McLaughlin KA, Morse GD. Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study. HIV Clin Trials. 2007 Jan-Feb;8(1):19-23.

ReferenceCitation: Cohen C, Colson A, Pierone G. The FOTO study: Twenty-Four week results support the safety of a two day break on efavirenz-based antiretroviral therapy. Presented at: Ninth International Congress on Drug Therapy in HIV Infection; November 8-13, 2008; Glasgow, UK

ReferenceCitation: Cohen C, Colson A, Pierone G, et al. The FOTO study: The 48 week extension to assess durability of the strategy of taking efavirenz, tenofovir and emtricitabine Five days On, Two days Off (FOTO) each week in virologically suppressed patients. Presented at: Fifth International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention; July 19-22, 2009; Cape Town, South Africa

ReferenceCitation: Reynolds SJ, Kityo C, Hallahan CW, Kabuye G, Atwiine D, Mbamanya F, Ssali F, Dewar R, Daucher M, Davey RT Jr, Mugyenyi P, Fauci AS, Quinn TC, Dybul MR. A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One. 2010 Apr 22;5(4):e10307. doi: 10.1371/journal.pone.0010307.

ReferenceCitation: Leibowitch J, Mathez D, de Truchis P, Ledu D, Melchior JC, Carcelain G, Izopet J, Perronne C, David JR. Four days a week or less on appropriate anti-HIV drug combinations provided long-term optimal maintenance in 94 patients: the ICCARRE project. FASEB J. 2015 Jun;29(6):2223-34. doi: 10.1096/fj.14-260315. Epub 2015 Apr 1.

ReferenceCitation: BREATHER (PENTA 16) Trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial. Lancet HIV. 2016 Sep;3(9):e421-e430. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.

ReferenceCitation: de Truchis P, Assoumou L, Landman R, Mathez D, Le Dû D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

ReferenceCitation: Landman R, de Truchis P, Assoumou L, Lambert S, Bellet J, Amat K, Lefebvre B, Allavena C, Katlama C, Yazdanpanah Y, Molina JM, Petrov-Sanchez V, Gibowski S, Alvarez JC, Leibowitch J, Capeau J, Fellahi S, Duracinsky M, Morand-Joubert L, Costagliola D, Alvarez JC, Girard PM; ANRS 170 QUATUOR study group. A 4-days-on and 3-days-off maintenance treatment strategy for adults with HIV-1 (ANRS 170 QUATUOR): a randomised, open-label, multicentre, parallel, non-inferiority trial. Lancet HIV. 2022 Feb;9(2):e79-e90. doi: 10.1016/S2352-3018(21)00300-3. Erratum in: Lancet HIV. 2022 Feb 22;:.

ReferenceCitation: Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783.

ReferenceCitation: Pogány K, van Valkengoed IG, Prins JM, Nieuwkerk PT, van der Ende I, Kauffmann RH, Kroon FP, Verbon A, Nievaard MF, Lange JM, Brinkman K. Effects of active treatment discontinuation in patients with a CD4+ T-cell nadir greater than 350 cells/mm3: 48-week Treatment Interruption in Early Starters Netherlands Study (TRIESTAN). J Acquir Immune Defic Syndr. 2007 Apr 1;44(4):395-400. Erratum in: J Acquir Immune Defic Syndr. 2007 Apr 15;44(5):607. Vanvalkengoed, Irene G [corrected to van Valkengoed, Irene G M].

ReferenceCitation: Zehnacker L, Abe E, Mathez D, Alvarez JC, Leibowitch J, Azoulay S. Plasma and Intracellular Antiretroviral Concentrations in HIV-Infected Patients under Short Cycles of Antiretroviral Therapy. AIDS Res Treat. 2014;2014:724958. doi: 10.1155/2014/724958. Epub 2014 Nov 9.

location_country: France Martinique

location_facility: Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses

location_facility: Hôpital Lariboisière/Service de Médecine Interne

location_facility: Hôpital Foch/Service de Médecine Interne

location_facility: Hôpital Purpan/Service des Maladies Infectieuses

location_facility: Hôpital Tenon/Service des Maladies Infectieuses

location_facility: Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique

location_facility: Hôpital François Mitterrand/Service des Maladies Infectieuses

location_facility: Hôpital Civil/Service Le Trait D'union UF 2066

location_facility: Hôpital Delafontaine/Service des Maladies Infectieuses

location_facility: Hôpital Necker/Service des Maladies Infectieuses

location_facility: Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses

location_facility: Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie

location_facility: Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses

location_facility: Hôpital Gui de Chauliac/Service des Maladies Infectieuses

location_facility: Hôpital Côte de Nacre/Service des Maladies Infectieuses

location_facility: Hôpital Avicenne/Service des Maladies Infectieuses et tropicales

location_facility: Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales

location_facility: Hôpital Bretonneau/Service des Maladies Infectieuses

location_facility: Hôpital de l'Archet/Service des Maladies Infectieuses

location_facility: CHD de La Roche sur Yon/Service de Médecine Interne

location_facility: Centre hospitalier de Poissy/Service des Maladies Infectieuses

location_facility: Hôpital de la Croix Rousse/Service des Maladies Infectieuses

location_facility: Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse

location_facility: Hôpital Raymond Poincaré/Service des Maladies Infectieuses

location_facility: Hôpital Gustave Dron/Service des Maladies Infectieuses

location_facility: Centre Hospitalier René Dubos/Service de Dermatologie

location_facility: Centre Hospitalier Sud-Francilien/Service d'Hématologie

location_facility: Hôpital Louis Pasteur/Service des Maladies Infectieuses

location_facility: Hôpital Saint Louis/Service des Maladies Infectieuses

location_facility: CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales

location_facility: Hôpital Robert DEBRE/Service des maladies infectieuses

location_facility: Hôpital Bichat/Service des Maladies Infectieuses

location_facility: Hôpital Pierre Zobda-Quitman/Service de Médecine Interne

location_facility: Hôpital Saint André/Service HDJ Maladies Infectieuses

location_facility: Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine Interne

location_facility: Hôpital Saint Antoine/Service des Maladies Infectieuses

location_facility: Hôpital Hôtel Dieu/Service d'Immunologie Clinique

summary: The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy.


title: The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic

acronym: PROBIOC

summary: The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.

status: Withdrawn

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: BioGaia AB

intervention_type: Dietary Supplement

lead_sponsor_type: industriel

status_simplified: Unknown


title: Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study

acronym: ESSURE

summary: To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.

study_start_date_type: Actual

status: Completed

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Montpellier

location_facility:
Public Assistance - Marseille Hospitals
Montpellier University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


intervention_type: Drug

title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.

lead_sponsor: Genfit

type: EudraCT Number

source: euctr

ReferenceType: derived

ReferenceCitation: Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.

ReferenceCitation: Cariou B, Zaïr Y, Staels B, Bruckert E. Effects of the new dual PPAR α/δ agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.

location_facility:
Site n°12
Site n°17
Site n°10
Site n°31
Site n°32
Site n°13
Site n°15
Site n°39
Site n°11
Site n°1
Site n°2
Site n°35
Site n°30
Site n°18
Site n°14
Site n°19
Site n°16
Site n°37
Site n°36
Site n°34

summary: The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.


title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 28 Days in Atherogenic Dyslipidaemic Patients With Abdominal Obesity. A Double Blind, Placebo-controlled and Randomized Study.

location_country: France Tunisia Romania

location_facility:
Site n°17
Site n°38
Site n°79
Site n°82
Site n°75
Site n°60
Site n°50
Site n°51
Site n°18
Site n°55
Site n°40
Site n°10
Site n°13
Site n°80
Site n°91
Site n°42
Site n°65
Site n°19
Site n°16
Site n°34
Site n°52
Site n°32
Site n°45
Site n°77
Site n°30
Site n°33
Site n°41
Site n°53
Site n°74
Site n°37
Site n°11
Site n°12
Site n°31
Site n°63
Site n°39
Site n°62
Site n°1
Site n°61
Site n°35
Site n°64
Site n°78
Site n°14
Site n°26
Site n°23
Site n°20
Site n°36
Site n°21

summary: The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.


title: An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain

summary: Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.

ipd_sharing: No

location_country: France Belgium

location_facility:
Centre Oscar Lambert
ATC, CHU Sart Tilman
Cliniques Universitaires Saint Luc
Hôpital La Timone
Hôpital A. Mignot
Institut Bordet
Universitair Ziekenhuis Antwerpen
Institut Curie


type: Other Identifier

title: Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

acronym: CARTESIAN

summary: The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Européen Georges Pompidou - APHP

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo

acronym: CellspermVIH

summary: The objective of our project is to determine the infected seminal cell types and the molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa, using conditions as close as possible to real life, i.e. seminal leukocytes and seminal plasma from HIV-infected donors and tissue explants

status: Unknown status

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Roulet V, Satie AP, Ruffault A, Le Tortorec A, Denis H, Guist'hau O, Patard JJ, Rioux-Leclerq N, Gicquel J, Jégou B, Dejucq-Rainsford N. Susceptibility of human testis to human immunodeficiency virus-1 infection in situ and in vitro. Am J Pathol. 2006 Dec;169(6):2094-103.

ReferenceCitation: Le Tortorec A, Le Grand R, Denis H, Satie AP, Mannioui K, Roques P, Maillard A, Daniels S, Jégou B, Dejucq-Rainsford N. Infection of semen-producing organs by SIV during the acute and chronic stages of the disease. PLoS One. 2008 Mar 12;3(3):e1792. doi: 10.1371/journal.pone.0001792.

ReferenceCitation: Le Tortorec A, Satie AP, Denis H, Rioux-Leclercq N, Havard L, Ruffault A, Jégou B, Dejucq-Rainsford N. Human prostate supports more efficient replication of HIV-1 R5 than X4 strains ex vivo. Retrovirology. 2008 Dec 31;5:119. doi: 10.1186/1742-4690-5-119.

ReferenceCitation: Houzet L, Matusali G, Dejucq-Rainsford N. Origins of HIV-infected leukocytes and virions in semen. J Infect Dis. 2014 Dec 15;210 Suppl 3:S622-30. doi: 10.1093/infdis/jiu328. Review.

ReferenceCitation: Camus C, Matusali G, Bourry O, Mahe D, Aubry F, Bujan L, Pasquier C, Massip P, Ravel C, Zirafi O, Munch J, Roan NR, Pineau C, Dejucq-Rainsford N. Comparison of the effect of semen from HIV-infected and uninfected men on CD4+ T-cell infection. AIDS. 2016 May 15;30(8):1197-208. doi: 10.1097/QAD.0000000000001048.

ReferenceCitation: Anderson DJ, Politch JA, Nadolski AM, Blaskewicz CD, Pudney J, Mayer KH. Targeting Trojan Horse leukocytes for HIV prevention. AIDS. 2010 Jan 16;24(2):163-87. doi: 10.1097/QAD.0b013e32833424c8. Review.

ipd_sharing_description:
The duplicated part of the CRFs will then be sent to Mrs DEJUC at the IRST in Rennes, the remaining part will be kept in the investigating center.

All the data of the study transcribed by the investigator in the CRFs will be transmitted electronically to the person in charge of the data of the INSERM / IRSET 1085 unit. Upon receipt, the data will be entered simply by typing and re-reading on the Excel spreadsheet. The files will be locked by password and backed up daily with storage for 3 months on the server of the INSERM 1085 unit managed by the IT department of the University of Rennes 1. The set Data is saved every evening, with storage for 4 weeks, then archived monthly on tape.

lead_sponsor: University Hospital, Toulouse

location_facility:
CECOS Bretagne Rennes
CECOS Paris Bichat
CECOS Hôpital Paule de Viguier


title: Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke

acronym: ISIS

summary: The main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke (less than 6 weeks).

ReferenceCitation: Jaillard A, Hommel M, Moisan A, Zeffiro TA, Favre-Wiki IM, Barbieux-Guillot M, Vadot W, Marcel S, Lamalle L, Grand S, Detante O; (for the ISIS-HERMES Study Group). Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial. Transl Stroke Res. 2020 Oct;11(5):910-923. doi: 10.1007/s12975-020-00787-z. Epub 2020 May 27.

ReferenceCitation: Hannanu FF, Goundous I, Detante O, Naegele B, Jaillard A. Spatiotemporal patterns of sensorimotor fMRI activity influence hand motor recovery in subacute stroke: A longitudinal task-related fMRI study. Cortex. 2020 Aug;129:80-98. doi: 10.1016/j.cortex.2020.03.024. Epub 2020 Apr 17.

lead_sponsor: University Hospital, Grenoble

location_facility: Stroke Unit, University Hospital of Grenoble

location_facility: Neuroradiology/MRI, University Hospital of Grenoble

location_facility: Tissular and cell therapy unit, UniversityHospitalof Grenoble

intervention_type: Genetic


title: Predictability of the Clinical Global Impression Scale (CGI) in Post Immediate in Psychotraumatic Impact

acronym: PRECLIP

summary: The objective of this study is to evaluate correlation between Clinical Global Impression Scale (CGI) score immediately in patients who have experienced psychotrauma and occurrence of posttraumatic stress disorder at distance from traumatic event. This could allow, in future, implementation of a systematic telephone reminder of psychotraumatized patients when they have a high score on the CGI scale, and thus detect onset of a stress disorder as early as possible, post-traumatic and orientation of these patients on specialized care.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Vaiva G, Jehel L, Cottencin O, Ducrocq F, Duchet C, Omnes C, Genest P, Rouillon F, Roelandt JL. [Prevalence of trauma-related disorders in the French WHO study: Santé mentale en population générale (SMPG)]. Encephale. 2008 Dec;34(6):577-83. doi: 10.1016/j.encep.2007.11.006. Epub 2008 Apr 2. French.

ReferenceCitation: Kilpatrick DG. The DSM-5 got PTSD right: comment on Friedman (2013). J Trauma Stress. 2013 Oct;26(5):563-6. doi: 10.1002/jts.21844.

ReferenceCitation: Pietrzak RH, Goldstein RB, Southwick SM, Grant BF. Prevalence and Axis I comorbidity of full and partial posttraumatic stress disorder in the United States: results from Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions. J Anxiety Disord. 2011 Apr;25(3):456-65. doi: 10.1016/j.janxdis.2010.11.010. Epub 2010 Nov 26.

ReferenceCitation: Vance MC, Kovachy B, Dong M, Bui E. Peritraumatic distress: A review and synthesis of 15 years of research. J Clin Psychol. 2018 Sep;74(9):1457-1484. doi: 10.1002/jclp.22612. Epub 2018 Mar 15. Review.

ReferenceCitation: Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

lead_sponsor: Centre Hospitalier Arras

location_facility:
Lille University Hospital
Douai General Hospital
Arras General Hospital
Lens General Hospital


title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled Study

summary: This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of MOTREM versus placebo in adult patients with septic shock.

lead_sponsor: Inotrem

location_country: Netherlands France Spain Belgium

location_facility: Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country)

location_facility: Hospital Clínico San Carlos, Medicina Intensiva (there may be other sites in this country)

location_facility: Radboudumc (there may be other sites in this country)

location_facility: Cliniques Universitaires Saint-Luc (there may be other sites in this country)


title: VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

acronym: VANGUARD

summary: The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.

lead_sponsor: LivaNova

location_country: Norway France Serbia Belgium

location_facility:
CHU Rangueil
UCL St Luc
Dedinje Cardiovascular Institute
Hôpital Européen Georges Pompidou
Rikshospitalet
CHRU Hôpital Pontchaillou

intervention_type: Device


title: Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools

acronym: SOUTIEN-PC

summary: Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.

lead_sponsor: University Hospital, Brest

location_facility:
ESEAN Nantes
CHU Angers
Fondation Ildys Ty-Yann
CHRU Brest
AP-HP Hôpital Trousseau
Kerpape

intervention_type: Procedure


title: Phenotypic Characterization and Array CGH Analysis in Patients With Syndromic Obesity of Unknown Etiology

acronym: REMOB

summary: Comparative genomic hybridization (CGH) array technology has been used in numerous studies on mental retardation, and few chromosomal abnormalities have been identified in patients. Because chromosomal abnormalities have still been associated with obesity, we can expect that syndromic obesity is also associated with small deletions/duplications. Characterization of deleted or duplicated loci in these obese patients would mean that these loci include genes implicated in obesity. This will permit to propose new gene(s) involved in obesity. (In french: Caractérisation phénotypique et recherche de REManiements chromosomiques chez des patients présentant une OBésité syndromique de cause non identifiée : REMOB)

ReferenceCitation: Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3.

ReferenceCitation: Ichihara S, Yamada Y. Genetic factors for human obesity. Cell Mol Life Sci. 2008 Apr;65(7-8):1086-98. Review.

ReferenceCitation: Delrue MA, Michaud JL. Fat chance: genetic syndromes with obesity. Clin Genet. 2004 Aug;66(2):83-93. Review.

ReferenceCitation: Schoumans J, Ruivenkamp C, Holmberg E, Kyllerman M, Anderlid BM, Nordenskjöld M. Detection of chromosomal imbalances in children with idiopathic mental retardation by array based comparative genomic hybridisation (array-CGH). J Med Genet. 2005 Sep;42(9):699-705.

ReferenceCitation: Fan YS, Jayakar P, Zhu H, Barbouth D, Sacharow S, Morales A, Carver V, Benke P, Mundy P, Elsas LJ. Detection of pathogenic gene copy number variations in patients with mental retardation by genomewide oligonucleotide array comparative genomic hybridization. Hum Mutat. 2007 Nov;28(11):1124-32.

ReferenceCitation: Rosenberg C, Knijnenburg J, Bakker E, Vianna-Morgante AM, Sloos W, Otto PA, Kriek M, Hansson K, Krepischi-Santos AC, Fiegler H, Carter NP, Bijlsma EK, van Haeringen A, Szuhai K, Tanke HJ. Array-CGH detection of micro rearrangements in mentally retarded individuals: clinical significance of imbalances present both in affected children and normal parents. J Med Genet. 2006 Feb;43(2):180-6. Epub 2005 Jun 24.

ReferenceCitation: Stankiewicz P, Beaudet AL. Use of array CGH in the evaluation of dysmorphology, malformations, developmental delay, and idiopathic mental retardation. Curr Opin Genet Dev. 2007 Jun;17(3):182-92. Epub 2007 Apr 30. Review.

ReferenceCitation: Zung A, Rienstein S, Rosensaft J, Aviram-Goldring A, Zadik Z. Proximal 19q trisomy: a new syndrome of morbid obesity and mental retardation. Horm Res. 2007;67(3):105-10. Epub 2006 Oct 19.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre de Génétique Hôpital d'Enfants CHU de Dijon

location_facility: Département de Génétique Médicale Centre de référence anomalies du développement Centre de compétence maladies osseuses constitutionnelles Hôpital Arnaud de Villeneuve CHRU Montpellier

location_facility: Service de Génétique de médicale - Hopital des enfants - Pellegrin

location_facility: Département de Génétique Hôpital Robert DEBRE Centre de Référence Maladies Rares "Anomalies du Développement & Syndromes Malformatifs"

location_facility: Génétique Médicale HOPITAL DEBROUSSE HCL


title: Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)

acronym: FSHD

summary: On the basis of published data and the investigators' results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, the investigators propose a study to test whether or not an antioxidant supplementation has a therapeutic interest for patients with FSHD. Their results have important implications for the successful implementation of rational antioxidant therapy in FSHD in which cell loss could be linked to oxidative stress.

primary_purpose: Supportive Care

ReferenceCitation: Passerieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Böcker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.

location_facility: Montpellier University Hospital- Saint Eloi Hospital


title: Comparison of Standard Treatment by Continuous Positive Airway Pressure (CPAP) and CPAP Combined to a Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension: RAP Randomized Controlled Trial

acronym: RAP

summary: Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a physical activity program will optimize 24-hour blood pressure control in patients with OSA-related resistant hypertension.

lead_sponsor: AGIR à Dom

location_country: Canada Switzerland France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)


title: Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening, in First Degree Relatives of Patients With Colorectal Neoplasia: a Prospective Randomized Study.

acronym: FAMCAP

summary: Efficacy of colonoscopy, colon capsule and fecal immunological test for colorectal cancer screening, in first degree relatives of patients with colorectal neoplasia: a prospective randomized study.

ipd_sharing: Undecided

lead_sponsor: Hôpital Edouard Herriot

location_facility: Hôpital Edouard Herriot - Hospices civils de Lyon

location_facility: Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris

location_facility: CHU de Brest - Hôpital de la Cavale Blanche


title: Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS)

acronym: ICAPS

summary: Physical activity is thought to be a key element in preventing the obesity epidemic and the associated cardiovascular and metabolic diseases. However population-based studies directed at promoting physical activity in youth have shown limited success in obesity prevention. The aim of this study is to assess whether an intervention integrating socioecological changes, which has the potential to induce sustained changes in physical activity, prevents overweight and cardiovascular risk in adolescents.

primary_purpose: Prevention

lead_sponsor: Louis Pasteur University, Strasbourg

intervention_type: Behavioral


title: Economic and Medical Evaluation of Self-monitoring of Anticoagulation in a Population of Patients Recently Fitted With a Mechanical Heart Valve Compared to Conventional Anticoagulation Follow-up

summary: To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.

location_facility: Pôle Cardio-Thoracique - Hôpital Cardiologique du Haut-Lévêque - CHU de Bordeaux - Avenue de Magellan


title: Sequential High-Dose Chemotherapy Combining Two Mobilization and Cyto-Reductive Treatments Followed by Three High-Dose Chemotherapy Regimens Supported by Autologous Stem Cell Transplantation

summary:
High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New strategies are needed with new drugs and a sequential approach.

Patients with relapsed (but not absolutely refractory to Cisplatinum-based chemotherapy) poor-prognosis GCTs are scheduled to receive 2 cycles combining epirubicin and paclitaxel followed by 3 consecutive HD-CT supported by stem cell transplantation. One course will combine Taxol, 360 mg/m² + thiotepa, 720 mg/m², followed by two ICE regimens (Ifosfamide, 12 g/m², carboplatin, AUC 20, etoposide, 1500 mg/m²).

This phase II study is designed as a Gehan method. The main objective of the study is the complete response rate. With this aim in view, it is planned to enroll in its first step 14 patients to insure that if no complete response (CR) is noticed, study would be stopped for inefficacy (i.e., a CR rate lower than 20%). If one or more CR are noticed, protocol specified that up to 45 patients will be included in order to reduce the confidence interval (CI) of the CR rate. Secondary objectives are the overall response rate (RR), the overall survival (OS) and the progression-free survival (PFS) rates, toxicity and toxic death rate. The statistical analysis is done in terms of intent-to-treat.

ReferenceCitation: Lotz JP, Bui B, Gomez F, Théodore C, Caty A, Fizazi K, Gravis G, Delva R, Peny J, Viens P, Duclos B, De Revel T, Curé H, Gligorov J, Guillemaut S, Ségura C, Provent S, Droz JP, Culine S, Biron P; Groupe d'Etudes des Tumeurs Uro-Génitales (GETUG). Sequential high-dose chemotherapy protocol for relapsed poor prognosis germ cell tumors combining two mobilization and cytoreductive treatments followed by three high-dose chemotherapy regimens supported by autologous stem cell transplantation. Results of the phase II multicentric TAXIF trial. Ann Oncol. 2005 Mar;16(3):411-8. Epub 2005 Jan 19.

ReferenceCitation: Selle F, Wittnebel S, Biron P, Gravis G, Roubaud G, Bui BN, Delva R, Bay JO, Fléchon A, Geoffrois L, Caty A, Soares DG, de Revel T, Fizazi K, Gligorov J, Micléa JM, Dubot C, Provent S, Temby I, Gaulet M, Horn E, Brindel I, Lotz JP. A phase II trial of high-dose chemotherapy (HDCT) supported by hematopoietic stem-cell transplantation (HSCT) in germ-cell tumors (GCTs) patients failing cisplatin-based chemotherapy: the Multicentric TAXIF II study. Ann Oncol. 2014 Sep;25(9):1775-1782. doi: 10.1093/annonc/mdu198. Epub 2014 Jun 3.

location_facility: Hôpital TENON, Service d'Oncologie Médicale


title: An Open-label, Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia

summary: The trial is a multi-centre, open-label, safety and tolerability extension trial to the IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML) patients over the age of 60 years, in complete remission, and who are not eligible for allogeneic stem-cell transplantation. The dose given to the individual patient will be the same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for the 12 patients in an additional cohort.

lead_sponsor: Innate Pharma

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon


title: Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes

acronym: IDCLTraining

summary: A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.

status: Terminated


title: Prediction of Arterial Lactate and Blood Gas Values Through the Analysis of Central Venous Blood. A Human, Prospective, Multicenter Validation Study.

acronym: PREDIGAZ

summary: Predicting arterial lactate and blood gas values with sufficient accuracy by simply analyzing central venous blood would be interesting in intensive care unit patients in whom the insertion of an arterial catheter or arterial punctures could be avoided. This prospective study aims at externally validating published mathematical models built to predict arterial values from central venous blood analysis.

ReferenceCitation: Boulain T, Garot D, Vignon P, Lascarrou JB, Benzekri-Lefevre D, Dequin PF; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Predicting arterial blood gas and lactate from central venous blood analysis in critically ill patients: a multicentre, prospective, diagnostic accuracy study. Br J Anaesth. 2016 Sep;117(3):341-9. doi: 10.1093/bja/aew261.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHU de DIJON
Chu de Garches
CHU de NANTES
CHU d'ANGERS
CHU de STRASBOURG
CHRU de POITIERS
Ch de Versailles
Chr D'Orleans
Hopital de La Timone
Chu Limoges


title: Effect of a 9-month Treatment of SPIRIVA® on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease. Validation of a New HRQoL Questionnaire Appropriate to Common Daily Practice. (TIPHON Study)

summary: The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic Obstructive Pulmonary Disease.

lead_sponsor: Boehringer Ingelheim

location_facility: Boehringer Ingelheim Investigational Site


title: Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.

summary:
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

location_facility: Centre Hospitalier Universitaire Arnaud de Villeneuve


title: Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

acronym: AcSé

summary:
Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment.

To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.

status: Active, not recruiting

ReferenceCitation: Mazieres J, Cropet C, Montané L, Barlesi F, Souquet PJ, Quantin X, Dubos-Arvis C, Otto J, Favier L, Avrillon V, Cadranel J, Moro-Sibilot D, Monnet I, Westeel V, Le Treut J, Brain E, Trédaniel J, Jaffro M, Collot S, Ferretti GR, Tiffon C, Mahier-Ait Oukhatar C, Blay JY. Vemurafenib in non-small-cell lung cancer patients with BRAF(V600) and BRAF(nonV600) mutations. Ann Oncol. 2020 Feb;31(2):289-294. doi: 10.1016/j.annonc.2019.10.022. Epub 2020 Jan 3.

lead_sponsor: UNICANCER


title: Assessment by EPISPOT of Circulating Tumor Cells as an Early Predictive Marker of Response to Chemotherapy and Targeted Therapy in Patients With Metastatic Colorectal Cancer in First Line of Treatment

summary: Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients. However, the choice of the therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor of non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers to propose the best personalized 1rst line therapeutic sequence. One idea would be to enumerate and characterize the circulating tumor cells (CTC) which, as it has been described in a recent study realized by Cohen et al. in patients with metastatic colorectal cancer, would give us an early evaluation of the therapeutic efficiency. In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection & characterization of viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the breast and prostate cancer. Thus, the investigators would like to perform a prospective study on a cohort of patients with metastatic colorectal cancer to confirm, with this technology, the predictive value of CTC count for the efficacy of the treatment.

primary_purpose: Other

ReferenceCitation: Cayrefourcq L, Thomas F, Mazard T, Assenat E, Assou S, Alix-Panabieres C. Selective treatment pressure in colon cancer drives the molecular profile of resistant circulating tumor cell clones. Mol Cancer. 2021 Feb 8;20(1):30. doi: 10.1186/s12943-021-01326-6.

lead_sponsor: University Hospital, Montpellier


title: Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency

acronym: SCORPION

summary: Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and decreases pro-inflammatory process. There is an inverse relationship, at least in some epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence and / or activity of RA. The hypothesis of our study is that natural vitamin D supplementation in patients with RA and a vitamin D deficiency (vitamin D <30 ng / mL) improves functional disability.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prospective Non-comparative Study to Assess the Efficacy, the Safety and the Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea Syndrome in European Population

summary: This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.

lead_sponsor: Seven Dreamers Europe SAS

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Phase I/II Clinical Trial Randomized, Multicentric, Open Label, Standard of Care (Silver Sulfadiazine) Controlled Aiming at Assessing Tolerance and Efficacy of Local Bacteriophage Treatment of Wound Infections Due to E. Coli or P. Aeruginosa in Burned Patients Using Pherecydes Pharma Anti-Escherichia Coli and Anti-Pseudomonas Aeruginosa Bacteriophages GMP Produced Cocktails . This Project is a European Research & Development (R&D) Project Funded by the European Commission Under the 7th Framework Programme for Research and Development Involving 7 Clinical Sites in EU.

acronym: PHAGOBURN

summary: The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.

ReferenceCitation: Jault P, Leclerc T, Jennes S, Pirnay JP, Que YA, Resch G, Rousseau AF, Ravat F, Carsin H, Le Floch R, Schaal JV, Soler C, Fevre C, Arnaud I, Bretaudeau L, Gabard J. Efficacy and tolerability of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomised, controlled, double-blind phase 1/2 trial. Lancet Infect Dis. 2019 Jan;19(1):35-45. doi: 10.1016/S1473-3099(18)30482-1. Epub 2018 Oct 3.

lead_sponsor: Pherecydes Pharma

location_country: France Switzerland Belgium


title: A Randomised Phase III Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With Carcinoma of an Unknown Primary (CUP)

summary: This is a european randomised, phase III, multi-centric study comparing a diagnostic and therapeutic strategy based on molecular analysis followed by suspected primary cancer tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown primary. The purpose of this trial is to determine whether or not a strategy based on molecular analysis is effective in improving the progression free survival rates of patients with carcinoma of unknown primary (CUP).

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Denmark France Netherlands

location_facility:
Viecuri Medical Centre Venlo
Rigshospitalet
Institut Gustave Roussy


title: Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial

acronym: TOCOPROM

summary: The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.

ReferenceCitation: Mackeen AD, Seibel-Seamon J, Muhammad J, Baxter JK, Berghella V. Tocolytics for preterm premature rupture of membranes. Cochrane Database Syst Rev. 2014 Feb 27;(2):CD007062. doi: 10.1002/14651858.CD007062.pub3. Review.

ReferenceCitation: Lorthe E, Goffinet F, Marret S, Vayssiere C, Flamant C, Quere M, Benhammou V, Ancel PY, Kayem G. Tocolysis after preterm premature rupture of membranes and neonatal outcome: a propensity-score analysis. Am J Obstet Gynecol. 2017 Aug;217(2):212.e1-212.e12. doi: 10.1016/j.ajog.2017.04.015. Epub 2017 Apr 13.

ReferenceCitation: Couteau C, Haumonté JB, Bretelle F, Capelle M, D'Ercole C. [Management of preterm and prelabour rupture of membranes in France]. J Gynecol Obstet Biol Reprod (Paris). 2013 Feb;42(1):21-8. doi: 10.1016/j.jgyn.2012.10.008. Epub 2012 Nov 24. French.

ReferenceCitation: Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabédian C, Azria E, Tessier V, Sénat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2. Review.

ReferenceCitation: Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;(6):CD002255. doi: 10.1002/14651858.CD002255.pub2. Review.

ReferenceCitation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8:CD014978. doi: 10.1002/14651858.CD014978.pub2. Review.

ReferenceCitation: Lorthe E, Kayem G; TOCOPROM Study Group and the GROG (Groupe de Recherche en Obstétrique et Gynécologie). Tocolysis in the management of preterm prelabor rupture of membranes at 22-33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM). BMC Pregnancy Childbirth. 2021 Sep 8;21(1):614. doi: 10.1186/s12884-021-04047-2.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN

acronym: SATURN

summary: The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters, in CRT patients.

lead_sponsor: MicroPort CRM

location_facility:
CHU La Timone
CHU Brest
CHU Bordeaux
CHU Rennes
CHU Dijon
CHU St Etienne


title: Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging

acronym: FRAGIBIOTE

summary:
Human microbial flora transfer studies in rodent models have clearly identified that age-associated microbiota dysbiosis can play a decisive role with respect to pathologies or complications linked to aging: increased intestinal permeability, in place of systemic inflammation, dysfunction of immune cells and insulin resistance.

This trial therefore aims to validate the process of ex vivo transfer to the rat of human microbiota selected from three categories of male individuals: young adults, healthy older adults and frail older adults, with the evaluation of the bacterial population of stool by analysis of the 16S rRNA gene.


title: Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events

summary:
The ANRS EP66 SEPTAVIH Study aims to screen feasibility of evaluating frailty in people living with HIV aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events.

SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service de Maladies Infectieuses, CHU Hôtel-Dieu


title: Results at 10 Years of the RESOLVE Study (REverse Metabolic SyndrOme by Lifestyle and Various Exercise)

summary: 10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose tissue (primary endpoint of the RESOLVE study 10 years ago): influence of kinetics abdominal visceral adipose tissue loss in the first year of follow-up on abdominal visceral adipose tissue at 10 years


title: Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial

acronym: PERISAFE

summary: Perineal pain is common after vaginal birth. Thermotherapy might be effective to limit postpartum perineal pain, thanks to the effects of local heating or cooling application. This study aims to evaluate the impact of thermotherapy during childbirth on postpartum perineal pain.

location_facility:
Cochin Hospital
Louis Mourier Hospital


title: Validation of Therapeutic Efficacy Targeting the Splicing Variants in Cystic Fibrosis and CFTR Pathologies

acronym: ONB-CFTR

summary: Cystic Fibrosis, an inherited autosomal recessive disease, arises from mutations in the CFTR gene. For intronic mutations affecting splicing events, oligonucleotides therapy has the potential to restore the production of the full length CFTR protein. Recent scientific research has demonstrated the potential of this approach to restore full length mRNA CFTR in in vitro human airway cells. The study aims to validate the therapeutic efficacy of oligonucleotide blockers (ONB) that target splicing defects associated to splicing variants in epithelia obtained from patients with Cystic Fibrosis and CFTR-related disorders.


title: Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder

acronym: POLARIS

summary:
The study aims to evaluate:

the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent
the functional impact of these disorders, factors or symptom thresholds associated with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).

lead_sponsor: AstraZeneca


acronym: Cassiopeia

title: Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma

lead_sponsor: Intergroupe Francophone du Myelome

ReferenceType: result

ReferenceCitation: Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, Béné MC, Broijl A, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Garderet L, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Lenain P, Macro M, Mathiot C, Orsini-Piocelle F, Perrot A, Stoppa AM, van de Donk NW, Wuilleme S, Zweegman S, Kolb B, Touzeau C, Roussel M, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Fermand JP, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Zhuang S, Chiu C, Pei L, de Boer C, Smith E, Deraedt W, Kampfenkel T, Schecter J, Vermeulen J, Avet-Loiseau H, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019 Jul 6;394(10192):29-38. doi: 10.1016/S0140-6736(19)31240-1. Epub 2019 Jun 3. Erratum in: Lancet. 2019 Jun 14;:.

ReferenceCitation: Alberge JB, Kraeber-Bodéré F, Jamet B, Touzeau C, Caillon H, Wuilleme S, Béné MC, Kampfenkel T, Sonneveld P, van Duin M, Avet-Loiseau H, Corre J, Magrangeas F, Carlier T, Bodet-Milin C, Chérel M, Moreau P, Minvielle S, Bailly C. Molecular Signature of (18)F-FDG PET Biomarkers in Newly Diagnosed Multiple Myeloma Patients: A Genome-Wide Transcriptome Analysis from the CASSIOPET Study. J Nucl Med. 2022 Jul;63(7):1008-1013. doi: 10.2967/jnumed.121.262884. Epub 2022 Jan 27.

ReferenceCitation: Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Béné MC, Zweegman S, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Stoppa AM, van de Donk NWCJ, Wuillème S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Krevvata M, Zhang K, de Boer C, Vara S, Kampfenkel T, Vanquickelberghe V, Vermeulen J, Avet-Loiseau H, Sonneveld P. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Oct;22(10):1378-1390. doi: 10.1016/S1470-2045(21)00428-9. Epub 2021 Sep 13.

ReferenceCitation: Hulin C, Offner F, Moreau P, Roussel M, Belhadj K, Benboubker L, Caillot D, Facon T, Garderet L, Kuhnowski F, Stoppa AM, Kolb B, Tiab M, Jie KS, Westerman M, Lambert J, Pei L, Vanquickelberghe V, De Boer C, Vermeulen J, Kampfenkel T, Sonneveld P, Van de Donk NWCJ. Stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone in the phase 3 CASSIOPEIA study. Haematologica. 2021 Aug 1;106(8):2257-2260. doi: 10.3324/haematol.2020.261842.

ReferenceCitation: Roussel M, Moreau P, Hebraud B, Laribi K, Jaccard A, Dib M, Slama B, Dorvaux V, Royer B, Frenzel L, Zweegman S, Klein SK, Broijl A, Jie KS, Wang J, Vanquickelberghe V, de Boer C, Kampfenkel T, Gries KS, Fastenau J, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab for transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA): health-related quality of life outcomes of a randomised, open-label, phase 3 trial. Lancet Haematol. 2020 Dec;7(12):e874-e883. doi: 10.1016/S2352-3026(20)30356-2.

location_country: Netherlands France Belgium

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: GH de l'Institut Catholique Saint Vincent

location_facility: CHV André Mignot - Université de Versailles

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

summary: The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.


title: A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)

summary:
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.

Secondary objectives are:

to characterize the global safety profile
to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
to assess preliminary evidence of anti-lymphoma activity.

lead_sponsor: Sanofi

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 250001


title: Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program

acronym: ThermOs

summary:
Osteoporosis is an increasing public health problem. Involution of bone mass in women is due to a reduction in sensitivity of the bone to the mechanical stress due to the slow-down of the bone turnover after 35 years old. Osteoporosis is a silent disease combining a decrease in bone mass (quantity) and an impaired bone microarchitecture (quality) leading to an increased risk of fracture. Bone microarchitecture is an important element to be taken into account in assessing the bone properties, as demonstrated by numerous ex vivo studies.

Bone densitometry only identifies 50% of osteoporotic fractures. The other half of the fractures appears in osteopenic women. The measurement of bone mineral density is too limited to assess risk of fracture. Bone microarchitecture can be assessed through a peripheral quantitative computed tomography scan (computed tomography peripherical - pQCT). The microarchitecture data allow the calculation of bone strength index (BSI) and stress strength index (SSI) highly predictive of fracture risk. These qualitative determinants of bone fragility are the most relevant to evaluate effect of physical activity over a short period compared with bone mineral content and density, which requires several months of constraints. Biochemical markers of bone turnover, specifically those of bone resorption, are predictive of the risk of osteoporotic fracture.

Physical activity can reduce the risk of fracture up to 20-35% via direct effects on bone strength, at any age. However, response of bone varies with modalities of exercise. Repeated exercise produces greater bone adaptations than a single bout. Moreover, it has been well demonstrated since 1970 that bone responds to a dynamic stimulation, but not a static stimulation, with a dose response relationship. It has been confirmed in premenopausal women.

The effect of physical activity on microarchitectural bone parameters (porosity and density of cortical and trabecular) has not been investigated in primary prevention. This original study would highlight the effect of short-term specific physical activity on the prevention of bone fragility (qualitative) observed with age in premenopausal women.

The main hypothesis is that a spa residential program including physical activity will have greater benefits on bone cortical porosity than a spa residential program alone or physical activity alone, in premenopausal women.


title: Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon

acronym: COG AGE

summary: The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive function in patients aged over 65 and suffering from breast cancer or colon.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre François BACLESSE
Centre Henri BECQUEREL
Hopital TENON
CHU
Hôpital Charles FOIX
Hopital Pitié-Sapètrière
INSERM
CHU, Hôpital Bois Guillaume
Hopital gériatrique des Bateliers
Hôpital Saint-Louis
CHRU Hôpital Claude Huriez
Hopitaux universitaires
Université


title: Analysis of the Macro-microcirculatory Coupling in the Course of Using the Vasoactive Substances During Anesthesia-resuscitation of Brain-damaged Patients

acronym: MICRONOR

summary:
In patients with severe brain injury, maintenance and control of blood pressure is at the very first point in the management strategy, whether in anesthesia or in intensive care. In order to restore cerebral perfusion pressure (CPP) to appropriate levels (60-70 mmHg) while ensuring optimal perfusion of other vital organs, intravenous administration of vasodilator, inodilator or vasoconstrictor vasoactive agents is commonly used.

These vasoactive agents, widely used to correct hypotension or hypertension, have their own effects on the load conditions of the left ventricle and the tone of the arterial tree, but also have effects on the microcirculation.

The microcirculatory status of a tissue cannot be reliably predicted by considering only the macrocirculatory parameters usually measured.

Therefore, in situations where organ perfusion is inadequate or compromised, patient management that includes the integration of the impact of vasoactive agents on the microcirculation seems essential for comprehensive hemodynamic treatment.

The non-invasive study of microcirculatory perfusion and its interactions with the macrocirculatory network, using a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used.

For cerebral patients, routine management already includes very complete monitoring of all cardiopulmonary and cerebral systemic parameters.

It is therefore imperative to study and propose new minimally invasive modalities for monitoring the microcirculation in order to define new therapeutic targets that take into account the microcirculatory compartment.

location_facility: AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care


title: Continuous Monitoring of the P3a Response During General Anesthesia Using the Rough Auditory Stimuli Coupled to the Analysis of Frontal EEG Signal

summary:
The interest of perioperative cerebral monitoring and in particular electroencephalography (EEG) to reduce neurological and cognitive damage in surgery has been the subject of abundant research and corresponds to a crucial issue. There is increasing evidence to suggest that inadequate (overdosed) anesthesia for patient characteristics and intraoperative hemodynamic instability is associated with an increased risk of complications including postoperative cognitive dysfunction and postoperative mortality.

However, these devices have many limitations in use, in particular their consideration of the muscle component of the electrical signal collected.There are other identifiable EEG signals that can be used to assess the depth of anesthesia, in particular auditory evoked potentials (AEPs).

The so-called rough sound waves correspond to a formulation composed of the rapid repetition of acoustic segments, at a frequency of 30 to 150 Hz.This frequency (whether sound or light) induces a temporal activation that captures attention and provokes unpleasant sensations and avoidance strategies when perceived by a subject.

This project aims at overcoming the interaction of the muscular electrical signal by evaluating the electrophysiological response (auditory evoked potentials) to particular sound stimuli, called "rough", thus underpinning the understanding of the mechanisms of neurosensory integration and attention during a state of loss of consciousness or altered consciousness.

The hypothesis proposed for this study is the following: the P3a wave (positive wave collected on the EEG during auditory evoked potentials) is altered during general anesthesia, in frequency and amplitude, and thus is indicative of the depth of the anesthetic state.


title: Change in Brain Perfusion During Induction of General Anesthesia: Relationship Between Transcranial Doppler, Bispectral Index and Cerebral Oximetry : a Prospective Observational Study CERVO2

summary: Arterial hypotension during general anesthesia remains a factor of poor outcomes, increases the risk of myocardial infarction, acute kidney injury and 1-year mortality. Furthermore, arterial hypotension may also decrease cerebral perfusion contributing to worsen neurological outcome. It seems necessary to monitor cerebral perfusion during anesthesia and to define individual dynamic targets of blood pressure. The goal of this study is to evaluate cerebral perfusion change in adult patients with or without cardiovascular risk factors during a standardized propofol-remifentanil anesthesia induction. Cerebral perfusion will be evaluated and compared by simultaneous measurements of cerebral blood flow, cerebral oxygen saturation and neurological function with use of transcranial Doppler (TCD), Near infrared spectroscopy (NIRS) and the Bispectral index (BIS) monitoring, respectively. Those measurements will be also repeated during and after treatment of arterial hypotension episodes in both groups.


title: Evaluation of the Efficacy of Spa Treatment for Prevention of Leg Ulcers in Advanced Chronic Venous Insufficiency.

summary: The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the risk of leg ulcers in patients with advanced chronic venous insufficiency (C4a-b and C5 of the CEAP classification) at one year.

ReferenceCitation: Carpentier PH, Maricq HR, Biro C, Ponçot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg. 2004 Oct;40(4):650-9.

ReferenceCitation: Carpentier PH, Satger B. Randomized trial of balneotherapy associated with patient education in patients with advanced chronic venous insufficiency. J Vasc Surg. 2009 Jan;49(1):163-70. doi: 10.1016/j.jvs.2008.07.075. Epub 2008 Oct 1.

ReferenceCitation: Ernst E, Saradeth T, Resch KL. A single blind randomized, controlled trial of hydrotherapy for varicose veins. Vasa. 1991;20(2):147-52.

ReferenceCitation: Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec;40(6):1248-52. Review.

ReferenceCitation: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12.

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.

ReferenceCitation: Constant F, Collin JF, Guillemin F, Boulangé M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.

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

ReferenceCitation: Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56.

ReferenceCitation: Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Cabinet médical
University Hospital Grenoble
Hopital thermal


title: Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

summary: This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).

lead_sponsor: Theranexus

location_facility:
CHU Grenoble Alpes
Hôpital Raymond Poincaré
University Hospital
CHU Pellegrin
CHU Dijon Bourgogne
Groupe Hospitalier Pitié Salpêtrière
CHRU Lilles
RespiSom


title: Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy

acronym: MESAMI

summary: Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the all damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of injecting MSCs directly into the heart to repair and restore heart function in people who have had a heart attack and who have chronic myocardial ischemia with heart failure.

ReferenceCitation: Guijarro D, Lebrin M, Lairez O, Bourin P, Piriou N, Pozzo J, Lande G, Berry M, Le Tourneau T, Cussac D, Sensebe L, Gross F, Lamirault G, Huynh A, Manrique A, Ruidavet JB, Elbaz M, Trochu JN, Parini A, Kramer S, Galinier M, Lemarchand P, Roncalli J. Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial. Int J Cardiol. 2016 Apr 15;209:258-65. doi: 10.1016/j.ijcard.2016.02.016. Epub 2016 Feb 2.

lead_sponsor: University Hospital, Toulouse


title: Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress

summary:
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure.

Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel.

ReferenceCitation: L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1). pii: 1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.

lead_sponsor: University Hospital, Brest

location_country: Canada France

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Québec


title: Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis

acronym: NPT-MAR

summary: The aim of this clinical trial is to compare the positive predictive value of the combination rapid nasal provocation test (RNTP) + skin tests (TC) + specific immunoglobulins E (IgEs) to the combination of TC + IgEs (strategy currently used in clinical practice) concerning the efficacy of treatment with Allergen immunotherapy (ITA) at 1 year, in patients with symptoms suggesting allergic rhinitis to house dust mites.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


type: Other Grant/Funding Number

title: Does Intense Weight Loss Improve Physical Performance in Obese Patients Older Than 60 Yrs Undergoing Exercise Training? Comparison Between Surgery and Standard of Care.

acronym: ELDSURG

summary: The main objective of this study is to compare the efficacy of two weight losing strategies (obesity surgery with gastric banding, and standard of care) on physical performance in elderly obese persons submitted to a physical training. Our hypothesis is that a surgery-induced weight loss in the context of a physical training (which is recommended in people 60-75 yrs losing weight) improves physical performance as compared to standard of care (3-5% weight loss).

ReferenceCitation: Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728.

ReferenceCitation: Chevallier JM, Zinzindohoué F, Douard R, Blanche JP, Berta JL, Altman JJ, Cugnenc PH. Complications after laparoscopic adjustable gastric banding for morbid obesity: experience with 1,000 patients over 7 years. Obes Surg. 2004 Mar;14(3):407-14.

ReferenceCitation: O'Brien PE, MacDonald L, Anderson M, Brennan L, Brown WA. Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg. 2013 Jan;257(1):87-94. doi: 10.1097/SLA.0b013e31827b6c02. Review.

ReferenceCitation: Mittermair RP, Obermüller S, Perathoner A, Sieb M, Aigner F, Margreiter R. Results and complications after Swedish adjustable gastric banding-10 years experience. Obes Surg. 2009 Dec;19(12):1636-41. doi: 10.1007/s11695-009-9967-7.

ReferenceCitation: Chevallier JM, Paita M, Rodde-Dunet MH, Marty M, Nogues F, Slim K, Basdevant A. Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior. Ann Surg. 2007 Dec;246(6):1034-9.

ReferenceCitation: Gagner M, Milone L, Yung E, Broseus A, Gumbs AA. Causes of early mortality after laparoscopic adjustable gastric banding. J Am Coll Surg. 2008 Apr;206(4):664-9. doi: 10.1016/j.jamcollsurg.2007.11.014. Epub 2008 Jan 28. Review.

location_facility:
CHU de LILLE
CHU de Nantes
CHU de Toulouse
Hôpital louis Mourier
HEGP
Hospices Civils de LYON


title: A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)

summary: The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.

ReferenceCitation: Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T; ADVANS Study Group. Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study. Arch Neurol. 2008 May;65(5):577-83. doi: 10.1001/archneur.65.5.577.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
United Kingdom
Austria
Netherlands
France
Germany

location_facility: Centre Hospitalier Universitaire JB Miletrie

location_facility: Klinikum Großhadern der L.M.-Universität

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg

location_facility: Hospital Clínico Universitario Vírgen de la Macarena

location_facility: Hospital Clínico niversitario de Santiago de Compostela


title: A Randomized, Double-blind Phase II Trial to Assess the Efficacy and Safety of Bicalutamide (Casodex® ) Associated to ZD6474 (Zactima™ ) or to Placebo in Patients With Castration-refractory Metastatic Prostate Cancer Without Any Clinical Symptom Related to Disease Progression

lead_sponsor: Genzyme, a Sanofi Company

summary: This randomized, double-blind phase II trial is to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.


title: A 12 Week Double-blind, Randomised, Placebo-controlled, Modified Dose-escalation Trial to Investigate Safety, Efficacy, and Pharmacokinetics of BIRT 2584XX Tablets at Doses of 100, 300 and 500 mg Administered Once Daily in Patients With Moderate to Severe Psoriasis With a 12 Week Treatment Extension

summary: The purpose of this clinical study is to determine the effectiveness, pharmacokinetics and safety of several doses of BIRT 2584 XX (100mg, 300mg and 500mg) taken once daily in the treatment of moderate to severe plaque-type psoriasis. This new medicine will be compared to a so-called placebo medicine over 12 weeks with a 12 weeks treatment extension possible.

location_country:
Denmark
Spain
United Kingdom
Netherlands
Finland
Canada
Sweden
France
Belgium
Germany

location_facility: Western Infirmary, Department of Dermatology

location_facility: Royal Free Hospital, Dermatology Department,

location_facility: Cardiff University, Dermatology Department

location_facility: Aberdeen Royal Infirmary, Department of Dermatology

location_facility: George Eliot Hospital, Dermatology Department

location_facility: Eastern Canada Cutaneous Research Associates Ltd.

location_facility: Skin Therapy Research Unit, St John's Inst of Dermatolology

location_facility: Royal South Hants Hospital, Dept of Dermatology

location_facility: University Medical Centre Nijmegen St. Radboud West


title: Consequences of the COVID-19 Pandemic on Worldwide Organ Procurement and Transplantation

acronym: COVID

summary:
End-stage organ failure is estimated to affect more than 4 to 6 million persons worldwide. In 2018, transplant systems across the globe enabled around 150,000 patients to benefit from a kidney, heart, lung, liver, or other solid organ, a number that was far less than the demand. According to data from the World Health Organization, more than 1,500,000 persons live with a transplanted organ worldwide. In the US, approximately 40,000 patients receive an organ transplant every year, but 120,000 still remain waitlisted for transplantation today, with 7,600 dying annually while waiting for an organ transplant. A similar lack of organs and high death rates on the waiting list affect patients in Europe and many other countries.

As nations adjust to new realities driven by the coronavirus (COVID-19) outbreak, many health care providers, institutions and patients are concerned about the potential impact that COVID-19 will have on organ donation and transplantation. One concern is that transplant recipients may have a greater susceptibility to infection and greater viral burden. A second concern is that hospitals will lack the resources in terms of staff and equipment to care for recipients after transplantation, who often require intensive care and multispecialty management.

Because of the overwhelming healthcare system burden, a dramatic negative effect on worldwide organ donation and transplantation is anticipated, but has not been measured. Our objective was to quantify the worldwide impact of COVID-19 pandemic on organ donation and transplantation and consequences for waitlisted patients.

ReferenceCitation: Xu B, Kraemer MUG; Open COVID-19 Data Curation Group. Open access epidemiological data from the COVID-19 outbreak. Lancet Infect Dis. 2020 May;20(5):534. doi: 10.1016/S1473-3099(20)30119-5. Epub 2020 Feb 19.

ReferenceCitation: Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9.

ReferenceCitation: Ahn C, Amer H, Anglicheau D, Ascher NL, Baan CC, Battsetset G, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon RM, Cantarovich M, Chan A, Chen ZS, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond JC, Farrero M, Friend PJ, Geissler EK, Ha J, Haberal MA, Henderson ML, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre CM, Man K, Moulin B, Muller E, Munkhbat R, Od-Erdene L, Perrin P, Rela M, Tanabe K, Tedesco Silva H, Tinckam KT, Tullius SG, Wong G. Global Transplantation COVID Report March 2020. Transplantation. 2020 Oct;104(10):1974-1983. doi: 10.1097/TP.0000000000003258.

ReferenceCitation: Zhang X. Epidemiology of Covid-19. N Engl J Med. 2020 May 7;382(19):1869. doi: 10.1056/NEJMc2005157. Epub 2020 Mar 27.

ReferenceCitation: Martino F, Plebani M, Ronco C. Kidney transplant programmes during the COVID-19 pandemic. Lancet Respir Med. 2020 May;8(5):e39. doi: 10.1016/S2213-2600(20)30182-X. Epub 2020 Apr 16.

ReferenceCitation: Akalin E, Azzi Y, Bartash R, Seethamraju H, Parides M, Hemmige V, Ross M, Forest S, Goldstein YD, Ajaimy M, Liriano-Ward L, Pynadath C, Loarte-Campos P, Nandigam PB, Graham J, Le M, Rocca J, Kinkhabwala M. Covid-19 and Kidney Transplantation. N Engl J Med. 2020 Jun 18;382(25):2475-2477. doi: 10.1056/NEJMc2011117. Epub 2020 Apr 24.

ReferenceCitation: Coates PT, Wong G, Drueke T, Rovin B, Ronco P; Associate Editors, for the Entire Editorial Team. Early experience with COVID-19 in kidney transplantation. Kidney Int. 2020 Jun;97(6):1074-1075. doi: 10.1016/j.kint.2020.04.001. Epub 2020 Apr 9.

ReferenceCitation: Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344.

ReferenceCitation: Omer SB, Malani P, Del Rio C. The COVID-19 Pandemic in the US: A Clinical Update. JAMA. 2020 May 12;323(18):1767-1768. doi: 10.1001/jama.2020.5788.

ReferenceCitation: Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. Erratum in: Lancet Infect Dis. 2020 Sep;20(9):e215.

ReferenceCitation: Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Köttgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tuttle KR, Wheeler DC, Eckardt KU; ISN Global Kidney Health Summit participants. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017 Oct 21;390(10105):1888-1917. doi: 10.1016/S0140-6736(17)30788-2. Epub 2017 Apr 20. Review.

ReferenceCitation: Aubert O, Yoo D, Zielinski D, Cozzi E, Cardillo M, Dürr M, Domínguez-Gil B, Coll E, Da Silva MI, Sallinen V, Lemström K, Midtvedt K, Ulloa C, Immer F, Weissenbacher A, Vallant N, Basic-Jukic N, Tanabe K, Papatheodoridis G, Menoudakou G, Torres M, Soratti C, Hansen Krogh D, Lefaucheur C, Ferreira G, Silva HT Jr, Hartell D, Forsythe J, Mumford L, Reese PP, Kerbaul F, Jacquelinet C, Vogelaar S, Papalois V, Loupy A. COVID-19 pandemic and worldwide organ transplantation: a population-based study. Lancet Public Health. 2021 Oct;6(10):e709-e719. doi: 10.1016/S2468-2667(21)00200-0. Epub 2021 Aug 30.

lead_sponsor: Paris Translational Research Center for Organ Transplantation


title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®

acronym: Exten MenbVac

summary: This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Rouen

intervention_type: Biological


title: Assessment and Follow-up of Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Nivolumab Under the French Temporary Authorization for Use (ATU) Program

acronym: CLINIVO

summary: Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

time_perspective: Retrospective

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Centre d'Oncologie de Gentilly
CHU Grenoble Alpes
HIA Percy
CH de Pau
CHU Bretagne Atlantique
HIA Saint Anne
CHU Toulouse
HIA Val de Grâce
CHI Toulon La Seyne Sur Mer
CH Métropole Savoie
CHR d'Orléans
ICL Lucien Neuwirth
Hegp Aphp
CH de Saint-Brieuc
Nice CLCC
CH Briançon
Hôpital Pradel HCL
Hôpital Nord APHM
Hôpital Avicenne APHP
CHU de Caen
Clinique des Cèdres
Centre Jean Perrin
CH Argenteuil
CH du Pays d'Aix
Clinique du Rambot
CHU de Clermont-Ferrand
CHR Saint-Omer
CH de Versailles
Polyclinique de Limoges
Centre Léon Bérard
HP Robert Schumann
Hôpital Tenon APHP
HIA Begin
Hôpital Bicêtre APHP
CHRU de Tours
CHU d'Amiens-Picardie
GRH Mulhouse Sud-Alsace
HP Clairval
CH d'Avignon
Hôpital Saint Joseph
Hôpital Saint Louis APHP
CH Lyon-Sud HCL
CH de la Côte Basque
Centre Georges-François Leclerc
CHU Nîmes
CH Annecy Genevois
CHD Vendée
CH de Dax
CHU de Bordeaux
Hôpital Paul Brousse APHP
Institut Daniel Hollard
CH de Pontoise
ICO René Gauducheau
CHU de Besançon
Institut Sainte Catherine
CH de Mont-De-Masan
Hôpital Nord-Ouest
CH de Blois
CHU de Nantes
Hôpital Foch
CH de Valence
CHU d'Angers
CH Le Mans
CH de Belfort Montbéliard
NHC CHRU de Strasbourg
Caen CLCC
CHU de Limoges
CH Alpes Léman
Clinique Saint Joseph
CHRU de Lille
CHI de Créteil
Gustave Roussy


title: Study of R-ACVBP Regimen Supported by Pegfilgrastim in Previously Untreated Patients Aged From 18 to 60 Years With High-Risk Diffuse Large B-Cell Lymphoma (Age-adjusted Ipi >or= 2)

summary: Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).

ReferenceCitation: Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35.

ReferenceCitation: Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31.

ReferenceCitation: Vose JM, Crump M, Lazarus H, Emmanouilides C, Schenkein D, Moore J, Frankel S, Flinn I, Lovelace W, Hackett J, Liang BC. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol. 2003 Feb 1;21(3):514-9.

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

ReferenceCitation: Copie-Bergman C, Cuillière-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

lead_sponsor: Lymphoma Study Association

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud

location_facility: Service d'Hématologie Clinique - CHU Le Bocage


title: Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable

summary: To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

ReferenceCitation: Fournel P, Vergnenégre A, Robinet G, Léna H, Gervais R, Le Caer H, Souquet PJ, Chavaillon JM, Bozonnat MC, Daurès JP, Chouaid C, Martel-Lafay I; GFPC and IFCT Team. Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC - IFCT 02-01. Eur J Cancer. 2016 Jan;52:181-7. doi: 10.1016/j.ejca.2015.10.072. Epub 2015 Dec 12.