title: A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.

summary:
The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose.

Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT.

Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.

ReferenceCitation: Sun XS, Tao Y, Le Tourneau C, Pointreau Y, Sire C, Kaminsky MC, Coutte A, Alfonsi M, Boisselier P, Martin L, Miroir J, Ramee JF, Delord JP, Clatot F, Rolland F, Villa J, Magne N, Elicin O, Gherga E, Nguyen F, Lafond C, Bera G, Calugaru V, Geoffrois L, Chauffert B, Zubel A, Zanna C, Brienza S, Crompton P, Rouits E, Gollmer K, Szyldergemajn S, Bourhis J. Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study. Lancet Oncol. 2020 Sep;21(9):1173-1187. doi: 10.1016/S1470-2045(20)30327-2. Epub 2020 Aug 3.

family: Sun

full_name: Xu-Shan Sun

given: Xu-Shan

family: Tao

full_name: Yungan Tao

given: Yungan

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

family: Pointreau

full_name: Yoann Pointreau

given: Yoann

family: Sire

full_name: Christian Sire

given: Christian

family: Kaminsky

full_name: Marie-Christine Kaminsky

given: Marie-Christine

family: Coutte

full_name: Alexandre Coutte

given: Alexandre

family: Alfonsi

full_name: Marc Alfonsi

given: Marc

family: Boisselier

full_name: Pierre Boisselier

given: Pierre

family: Martin

full_name: Laurent Martin

given: Laurent

family: Miroir

full_name: Jessica Miroir

given: Jessica

family: Ramee

full_name: Jean-Francois Ramee

given: Jean-Francois

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Clatot

full_name: Florian Clatot

given: Florian

family: Rolland

full_name: Frederic Rolland

given: Frederic

family: Villa

full_name: Julie Villa

given: Julie

family: Magne

full_name: Nicolas Magne

given: Nicolas

family: Elicin

full_name: Olgun Elicin

given: Olgun

family: Gherga

full_name: Elisabeta Gherga

given: Elisabeta

family: Nguyen

full_name: France Nguyen

given: France

family: Lafond

full_name: Cedrick Lafond

given: Cedrick

family: Bera

full_name: Guillaume Bera

given: Guillaume

family: Calugaru

full_name: Valentin Calugaru

given: Valentin

family: Geoffrois

location_facility: Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4

location_facility: L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin

location_facility: Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF

location_facility: Institut de Cancérologie de l'Ouest (ICO) René Gauducheau

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)


type: EudraCT Number

title: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

acronym: CURASMUR

summary: All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Guihard B, Chollet-Xémard C, Lakhnati P, Vivien B, Broche C, Savary D, Ricard-Hibon A, Marianne Dit Cassou PJ, Adnet F, Wiel E, Deutsch J, Tissier C, Loeb T, Bounes V, Rousseau E, Jabre P, Huiart L, Ferdynus C, Combes X. Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial. JAMA. 2019 Dec 17;322(23):2303-2312. doi: 10.1001/jama.2019.18254.

name: Department of Emergency, CHU de la Réunion, Allée des Topazes, Saint Denis, Réunion, France

family: Guihard

full_name: Bertrand Guihard

given: Bertrand

sequence: first

name: Groupe Hospitalo-Universitaire Henri Mondor, SAMU 94, Assistance Publique-Hôpitaux de Paris, Créteil, France

family: Chollet-Xémard

full_name: Charlotte Chollet-Xémard

given: Charlotte

sequence: additional

name: SMUR 95, Centre Hospitalier de Gonesse, Gonesse, France

family: Lakhnati

full_name: Philippe Lakhnati

given: Philippe

name: Department of Anesthesia & Critical Care - SAMU, Assistance Publique - Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Université Paris Descartes, Paris, France

family: Vivien

full_name: Benoit Vivien

given: Benoit

name: Département d'Anesthésie-Réanimation-SMUR, Hôpital Universitaire Lariboisière, AP-HP, Paris, France

family: Broche

full_name: Claire Broche

given: Claire

name: Emergency Department, General Hospital of Annecy, Annecy, France

family: Savary

full_name: Dominique Savary

given: Dominique

name: SMUR de l'hôpital Beaujon, Clichy, France

family: Ricard-Hibon

full_name: Agnes Ricard-Hibon

given: Agnes

name: Department of Emergency, CHU de la Réunion, Réunion, France

family: Marianne dit Cassou

full_name: Pierre-Jean Marianne dit Cassou

given: Pierre-Jean

name: AP-HP, Urgences-SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne, Bobigny, France

family: Adnet

full_name: Frédéric Adnet

given: Frédéric

name: Univ Lille, EA 2694 - Santé Publique: Epidémiologie et Qualité des Soins, Lille, France

name: French National Out-of-Hospital Cardiac Arrest Registry Research Group - Registre électronique des Arrêts Cardiaques, Lille, France

name: Emergency Medicine Department and SAMU 59, Lille University Hospital, Lille, France

family: Wiel

full_name: Eric Wiel

given: Eric

name: Department of Emergency Medicine, Groupe Hospitalier Broca Cochin Hôtel-Dieu, Paris, France

family: Deutsch

full_name: Juliette Deutsch

given: Juliette

name: Department of Emergency Medicine, University Hospital Dijon, Dijon, France

family: Tissier

full_name: Cindy Tissier

given: Cindy

name: Raymond Poincaré Hospital (APHP), SAMU 92, Paris, France

family: Loeb

full_name: Thomas Loeb

given: Thomas

name: Pôle Médecine d'Urgence, Hôpital Universitaire de Purpan, Toulouse, France

name: INSERM UMR 1027, Université Paul Sabatier, Toulouse, France

family: Bounes

full_name: Vincent Bounes

given: Vincent

name: Services de Médecine d’Urgence et de Réanimation, Pôle Urgence Réanimation, SAMU 77, Melun, France

family: Rousseau

full_name: Emmanuel Rousseau

given: Emmanuel

name: AP-HP, Service d'Aide Médicale d'Urgence (SAMU) de Paris and Paris Sudden Death Expertise Center, Université Paris Descartes, Paris, France

family: Jabre

full_name: Patricia Jabre

given: Patricia

name: INSERM CIC 1410 Clinical and Epidemiology/ CHU Réunion/Université de la Réunion, Saint-Pierre, Reunion, France

name: Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg

family: Huiart

full_name: Laetitia Huiart

given: Laetitia

name: Departement d'Informatique Clinique, Centre Hospitalier Universitaire de La Réunion Site Félix Guyon, Saint-Denis, France

family: Ferdynus

full_name: Cyril Ferdynus

given: Cyril

name: Department of Emergency, CHU de la Réunion, Université de la Réunion, Réunion, France

family: Combes

full_name: Xavier Combes

given: Xavier

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
CHU Lariboisière
CHU de Nîmes
CH Annecy
CHU Henri Mondor
CHU de Dijon
CHU Raymond Poincaré
CHRU de Lille
CHU Hôtel-Dieu
CHU Avicenne
CHU Toulouse - Hôpital PURPAN
CHU de La Réunion
CH Gonesse
CHU Pitié-Salpêtrière
CH Marc Jacquet
CHU de la Réunion
CH René Dubos
CHU Necker


title: A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older Patients With Type 2 Diabetes Insufficiently Controlled by Metformin Monotherapy.

acronym: GLYCEMIA

summary: The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin

ReferenceType: result

ReferenceCitation: Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.

family: Penfornis

full_name: A. Penfornis

given: A.

family: Bourdel-Marchasson

full_name: I. Bourdel-Marchasson

given: I.

family: Quere

full_name: S. Quere

given: S.

family: Dejager

full_name: S. Dejager

journal_name: Diabetes & Metabolism

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: The HYPOCRAS study

lead_sponsor: Novartis

location_facility:
Novartis Investigative Site #2
Novartis Investigative Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase IIIb Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids.

summary:
This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid.

Principal objective is to compare the clinical effects (success/failure) of two methods of methadone titration in patients with cancer-related pain inadequately relieved or with intolerable side effects after treatment with level 3 opioid.

Secondary objectives are : Overall safety of methadone during the study, to describe the patients' characteristics, to describe the effects of methadone on pain relief, to describe the methadone administration, to evaluate patient's quality of life, to evaluate the prescriber's opinion regarding the handling of methadone initiation.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Laboratoires Bouchara-Recordati

location_facility:
Investigational Site 16
Investigational Site 05
Investigational Site 07
Investigational site 08
Investigational Site 06
Investigational Site 10
Investigational Site 12
Investigational Site 17
Investigational Site 02
Investigational Site 03
Investigational Site 15
Investigational Site 01
Investigational Site 04
Investigational Site 14
Investigational Site 11
Investigational Site 13

status_simplified: Unknown


ReferenceType: background

ReferenceCitation: Voormolen N, Noordzij M, Grootendorst DC, Beetz I, Sijpkens YW, van Manen JG, Boeschoten EW, Huisman RM, Krediet RT, Dekker FW; PREPARE study group. High plasma phosphate as a risk factor for decline in renal function and mortality in pre-dialysis patients. Nephrol Dial Transplant. 2007 Oct;22(10):2909-16. Epub 2007 May 21.

ReferenceCitation: Levin A, Djurdjev O, Beaulieu M, Er L. Variability and risk factors for kidney disease progression and death following attainment of stage 4 CKD in a referred cohort. Am J Kidney Dis. 2008 Oct;52(4):661-71. doi: 10.1053/j.ajkd.2008.06.023.

ReferenceCitation: Kestenbaum B, Sampson JN, Rudser KD, Patterson DJ, Seliger SL, Young B, Sherrard DJ, Andress DL. Serum phosphate levels and mortality risk among people with chronic kidney disease. J Am Soc Nephrol. 2005 Feb;16(2):520-8. Epub 2004 Dec 22.

ReferenceCitation: Vassalotti JA, Uribarri J, Chen SC, Li S, Wang C, Collins AJ, Calvo MS, Whaley-Connell AT, McCullough PA, Norris KC; Kidney Early Evaluation Program Investigators. Trends in mineral metabolism: Kidney Early Evaluation Program (KEEP) and the National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S56-68. doi: 10.1053/j.ajkd.2007.12.018.

ReferenceCitation: Danziger J. The bone-renal axis in early chronic kidney disease: an emerging paradigm. Nephrol Dial Transplant. 2008 Sep;23(9):2733-7. doi: 10.1093/ndt/gfn260. Epub 2008 May 9.

ReferenceCitation: Inaba M, Okuno S, Imanishi Y, Yamada S, Shioi A, Yamakawa T, Ishimura E, Nishizawa Y. Role of fibroblast growth factor-23 in peripheral vascular calcification in non-diabetic and diabetic hemodialysis patients. Osteoporos Int. 2006 Oct;17(10):1506-13. Epub 2006 Aug 5.

ReferenceCitation: Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group, Kuen E, König P, Kraatz G, Mann JF, Müller GA, Köhler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. Epub 2007 Jul 26.

ReferenceCitation: Gutiérrez OM, Mannstadt M, Isakova T, Rauh-Hain JA, Tamez H, Shah A, Smith K, Lee H, Thadhani R, Jüppner H, Wolf M. Fibroblast growth factor 23 and mortality among patients undergoing hemodialysis. N Engl J Med. 2008 Aug 7;359(6):584-92. doi: 10.1056/NEJMoa0706130.

ReferenceCitation: Jean G, Terrat JC, Vanel T, Hurot JM, Lorriaux C, Mayor B, Chazot C. High levels of serum fibroblast growth factor (FGF)-23 are associated with increased mortality in long haemodialysis patients. Nephrol Dial Transplant. 2009 Sep;24(9):2792-6. doi: 10.1093/ndt/gfp191. Epub 2009 Apr 25.

ReferenceCitation: Peiskerová M, Kalousová M, Kratochvílová M, Dusilová-Sulková S, Uhrová J, Bandúr S, Malbohan IM, Zima T, Tesar V. Fibroblast growth factor 23 and matrix-metalloproteinases in patients with chronic kidney disease: are they associated with cardiovascular disease? Kidney Blood Press Res. 2009;32(4):276-83. doi: 10.1159/000243050. Epub 2009 Oct 1.

ReferenceCitation: JP Cristol, AS Bargnoux, AM Dupuy, M Morena, A Avignon and B Canaud. Biological markers of vascular calcifications in uremia. Médecine Nucléaire 2009; 33, 53-61.

ReferenceCitation: Stubbs JR, Quarles LD. Fibroblast growth factor 23: uremic toxin or innocent bystander in chronic kidney disease? Nephrol News Issues. 2009 May;23(6):33-4, 36-7. Review.

ReferenceCitation: Westerberg PA, Linde T, Wikström B, Ljunggren O, Stridsberg M, Larsson TE. Regulation of fibroblast growth factor-23 in chronic kidney disease. Nephrol Dial Transplant. 2007 Nov;22(11):3202-7. Epub 2007 Jun 13.

ReferenceCitation: Shigematsu T, Kazama JJ, Yamashita T, Fukumoto S, Hosoya T, Gejyo F, Fukagawa M. Possible involvement of circulating fibroblast growth factor 23 in the development of secondary hyperparathyroidism associated with renal insufficiency. Am J Kidney Dis. 2004 Aug;44(2):250-6.

ReferenceCitation: Tanaka H, Hamano T, Fujii N, Tomida K, Matsui I, Mikami S, Nagasawa Y, Ito T, Moriyama T, Horio M, Imai E, Isaka Y, Rakugi H. The impact of diabetes mellitus on vitamin D metabolism in predialysis patients. Bone. 2009 Nov;45(5):949-55. doi: 10.1016/j.bone.2009.07.016. Epub 2009 Jul 23.

ReferenceCitation: Urena Torres P, Friedlander G, de Vernejoul MC, Silve C, Prié D. Bone mass does not correlate with the serum fibroblast growth factor 23 in hemodialysis patients. Kidney Int. 2008 Jan;73(1):102-7. Epub 2007 Oct 17.

ReferenceCitation: Nagano N, Miyata S, Abe M, Kobayashi N, Wakita S, Yamashita T, Wada M. Effect of manipulating serum phosphorus with phosphate binder on circulating PTH and FGF23 in renal failure rats. Kidney Int. 2006 Feb;69(3):531-7.

ReferenceCitation: Oliveira RB, Cancela AL, Graciolli FG, Dos Reis LM, Draibe SA, Cuppari L, Carvalho AB, Jorgetti V, Canziani ME, Moysés RM. Early control of PTH and FGF23 in normophosphatemic CKD patients: a new target in CKD-MBD therapy? Clin J Am Soc Nephrol. 2010 Feb;5(2):286-91. doi: 10.2215/CJN.05420709. Epub 2009 Nov 12.

ReferenceCitation: Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009 Aug;(113):S1-130. doi: 10.1038/ki.2009.188.

ReferenceCitation: National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266.

ReferenceCitation: Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. Erratum in: Ann Intern Med. 2008 Oct 7;149(7):519. Erratum in: Ann Intern Med. 2021 Apr;174(4):584.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

acronym: FRENCH

location_facility: Néphrologie - Dialyse Centre de Rein Artificiel

location_facility: CHU de Montpellier Hôpital Lapeyronie Service de Néphrologie

location_facility: Hôpital Européen Georges Pompidou Service de Nephrologie

location_facility: CHU St Etienne Hopital Nord Service de néphrologie

source: euctr

title: Randomized Placebo Controlled Double-blind Trial in CKD Patients Not on Dialysis to Evaluate the Effect of Sevelamer Carbonate in the Control of FGF-23 Serum Levels and Its Consequences in the Evolution of PTH, Calcitriol and Mineral Metabolism Parameters Levels

summary: The purpose of this study is to evaluate in Chronic Kidney Disease (CKD) patients not on dialysis and who have an Fibroblast growth factor 23 (FGF23) serum levels elevated, the effect of non calcic phosphate binder: sevelamer carbonate. This treatment could lead to a diminution of FGF23 serum levels due to the diminution of intestinal absorption of dietary phosphate. In addition, the investigators will describe the impact of the FGF23 level monitoring on the main phosphocalcium metabolism markers as phosphatemia, intact parathyroid hormone (iPTH), serum calcitriol and phosphaturia.

lead_sponsor_type: academique


title: Endoscopic Detection of Small Bowel Dysplasia and Cancer in Patients With Jejuna or Ileal Crohn Disease : Prospective Study in a Cohort of High Risk Patients

acronym: DYDJI

summary:
Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and natural history remains unknown but progression of inflammation to dysplasia and then to adenocarcinoma is suspected.

As for surveillance recommendations for colorectal carcinoma in long standing inflammatory colonic disease, endoscopic screening of SB could be proposed in CD patients with risk factors of SBA. No study can be found in literature.

The investigators propose a multicenter exploratory open study on prospective cohort of CD patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population

primary_purpose: Diagnostic

ReferenceCitation: Abrahams NA, Halverson A, Fazio VW, Rybicki LA, Goldblum JR. Adenocarcinoma of the small bowel: a study of 37 cases with emphasis on histologic prognostic factors. Dis Colon Rectum. 2002 Nov;45(11):1496-502.

ReferenceCitation: von Roon AC, Reese G, Teare J, Constantinides V, Darzi AW, Tekkis PP. The risk of cancer in patients with Crohn's disease. Dis Colon Rectum. 2007 Jun;50(6):839-55. Review.

ReferenceCitation: Jess T, Gamborg M, Matzen P, Munkholm P, Sørensen TI. Increased risk of intestinal cancer in Crohn's disease: a meta-analysis of population-based cohort studies. Am J Gastroenterol. 2005 Dec;100(12):2724-9. Review.

ReferenceCitation: Canavan C, Abrams KR, Mayberry J. Meta-analysis: colorectal and small bowel cancer risk in patients with Crohn's disease. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1097-104.

ReferenceCitation: Palascak-Juif V, Bouvier AM, Cosnes J, Flourié B, Bouché O, Cadiot G, Lémann M, Bonaz B, Denet C, Marteau P, Gambiez L, Beaugerie L, Faivre J, Carbonnel F. Small bowel adenocarcinoma in patients with Crohn's disease compared with small bowel adenocarcinoma de novo. Inflamm Bowel Dis. 2005 Sep;11(9):828-32.

ReferenceCitation: Lashner BA. Risk factors for small bowel cancer in Crohn's disease. Dig Dis Sci. 1992 Aug;37(8):1179-84.

ReferenceCitation: Solem CA, Harmsen WS, Zinsmeister AR, Loftus EV Jr. Small intestinal adenocarcinoma in Crohn's disease: a case-control study. Inflamm Bowel Dis. 2004 Jan;10(1):32-5.

ReferenceCitation: Piton G, Cosnes J, Monnet E, Beaugerie L, Seksik P, Savoye G, Cadiot G, Flourie B, Capelle P, Marteau P, Lemann M, Colombel JF, Khouri E, Bonaz B, Carbonnel F. Risk factors associated with small bowel adenocarcinoma in Crohn's disease: a case-control study. Am J Gastroenterol. 2008 Jul;103(7):1730-6. doi: 10.1111/j.1572-0241.2008.01847.x. Epub 2008 Jun 28.

family: Piton

full_name: Gal Piton

given: Gal

family: Cosnes

full_name: Jacques Cosnes

given: Jacques

family: Monnet

full_name: Elisabeth Monnet

given: Elisabeth

family: Beaugerie

full_name: Laurent Beaugerie

given: Laurent

family: Seksik

full_name: Philippe Seksik

given: Philippe

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Cadiot

full_name: Guillaume Cadiot

family: Flourie

full_name: Bernard Flourie

given: Bernard

family: Capelle

full_name: Philippe Capelle

family: Marteau

full_name: Philippe Marteau

family: Lemann

full_name: Marc Lemann

given: Marc

family: Colombel

full_name: Jean Frdric Colombel

given: Jean Frdric

family: Khouri

full_name: Elie Khouri

given: Elie

family: Bonaz

full_name: Bruno Bonaz

given: Bruno

family: Carbonnel

full_name: Franck Carbonnel

given: Franck

journal_name: The American Journal of Gastroenterology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Risk Factors Associated With Small Bowel Adenocarcinoma in Crohn's Disease: A CaseControl Study

ReferenceCitation: Yamamoto T, Fazio VW, Tekkis PP. Safety and efficacy of strictureplasty for Crohn's disease: a systematic review and meta-analysis. Dis Colon Rectum. 2007 Nov;50(11):1968-86. Review.

ReferenceCitation: Greenstein AJ, Sachar D, Pucillo A, Kreel I, Geller S, Janowitz HD, Aufses A Jr. Cancer in Crohn's disease after diversionary surgery. A report of seven carcinomas occurring in excluded bowel. Am J Surg. 1978 Jan;135(1):86-90.

ReferenceCitation: Ribeiro MB, Greenstein AJ, Heimann TM, Yamazaki Y, Aufses AH Jr. Adenocarcinoma of the small intestine in Crohn's disease. Surg Gynecol Obstet. 1991 Nov;173(5):343-9.

ReferenceCitation: Watermeyer G, Locketz M, Govender D, Mall A. Crohn's disease-associated small bowel adenocarcinoma with pre-existing low-grade dysplasia: a case report. Am J Gastroenterol. 2007 Jul;102(7):1545-6.

ReferenceCitation: Riddell RH, Goldman H, Ransohoff DF, Appelman HD, Fenoglio CM, Haggitt RC, Ahren C, Correa P, Hamilton SR, Morson BC, et al. Dysplasia in inflammatory bowel disease: standardized classification with provisional clinical applications. Hum Pathol. 1983 Nov;14(11):931-68.

ReferenceCitation: Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Fléjou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Besancon
Chu Nancy
Hopital Saint Louis
Hopital Haut Leveque
Chu Rouen
Chu Tours
Chu Amiens
Hopital Beaujon
CHU NICE
Chu Saint Etienne
Chu Toulouse
Institut Mutualiste Montsouris (Imm)
Chru Lille
Hopital Bicetre
CHU LYON

intervention_type: Procedure


title: Analysis of Psychosocial Determinants of Observance of Monitoring Neuro-urological in Spina-bifida Adult Patients and in Spinal Cord Injury Patients: a Prospective, Comparative, Multicenter With Parallel Groups Study

acronym: ESTIME

summary:
With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder.

The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.

status: Terminated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

location_facility: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE

location_facility: APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale

location_facility: Neuro-urologie et explorations périnéales, APHP Tenon

location_facility: Urologie CH Lyon Sud et Hôpital Henry Gabrielle


title: Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.

acronym: SURACAP

summary:
This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages:

patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or = 6) are registered if they accept a second prostate biopsy in a 3 months delay
after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.

If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.

lead_sponsor: Clinique Mutualiste Chirurgicale de la Loire

location_facility:
Eric LECHEVALLIER
Xavier REBILLARD
René GASCHIGNARD
Clinique Mutualiste Chirurgicale
SALOMON
R Azzouzi
Christophe AVANCES
SOULIE Michel
RIGAUD Jérôme
Jean-Louis DAVIN
P. ROSSI
IRANI Jacques
P Colloby
RUFFION
Henri BENSADOUN


title: Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery

acronym: C-MUST

summary: This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

ReferenceCitation: Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.

family: Berdah

full_name: Stéphane V. Berdah

given: Stéphane V.

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Denet

full_name: Christine Denet

given: Christine

family: Panis

full_name: Yves Panis

given: Yves

family: Laurent

full_name: Christophe Laurent

family: Cotte

full_name: Eddy Cotte

given: Eddy

family: Huten

full_name: Nöel Huten

given: Nöel

family: Le Peillet Feuillet

full_name: Eliane Le Peillet Feuillet

given: Eliane

family: Duron

full_name: Jean-Jacques Duron

given: Jean-Jacques

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Genzyme, a Sanofi Company

location_facility: Centre Hospitalier Intercommunal de Poissy Saint-German

intervention_type: Device


type: Other Identifier

title: Prospective, Randomized, Double-blind Study Assessing the Effects of Levetiracetam Compared to Placebo in the Prevention of Early Epileptic Seizures and Late Epilepsy in Patients With Severe Traumatic Brain Injury

acronym: TRACK

summary: Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.

primary_purpose: Prevention

location_facility: Neurologie - CHU Tours Hopital Trousseau

location_facility: Beurophysiologie clinique - CHU Marseille

location_facility: Explorations Fonctionnelles Neurologiques - CHU Nantes

location_facility: Neurophysiologie clinique - CHU Lyon (Hôpital neurologique)


title: An Open-label, Multicentre, Nonrandomized, Dose-escalating Phase I/II Study, With a Randomized Phase II Part, to Investigate the Safety and Tolerability of RO5072759 Given as Monotherapy in Patients With CD20+ Malignant Disease.

summary:
The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL).

It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used.

Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.

design_allocation: Non-Randomized

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

family: Gibiansky

full_name: Ekaterina Gibiansky

given: Ekaterina

full_name: Leonid Gibiansky

given: Leonid

name: Pharma Research and Early DevelopmentRoche Innovation Center Basel Basel Switzerland

family: Buchheit

full_name: Vincent Buchheit

given: Vincent

family: Frey

full_name: Nicolas Frey

given: Nicolas

name: Clinical DevelopmentRoche Innovation Center Welwyn Welwyn Garden City UK

family: Brewster

full_name: Michael Brewster

given: Michael

name: Pharma Development Clinical OncologyF. Hoffmann‐La Roche Ltd Basel Switzerland

family: Fingerle‐Rowson

full_name: Günter Fingerle‐Rowson

given: Günter

family: Jamois

full_name: Candice Jamois

given: Candice

journal_name: British Journal of Clinical Pharmacology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab‐refractory follicular lymphoma patients in the GADOLIN phase III study

ReferenceCitation: Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ. Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma. Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11.

family: Cartron

full_name: G. Cartron

given: G.

family: Hourcade-Potelleret

full_name: F. Hourcade-Potelleret

given: F.

family: Morschhauser

full_name: F. Morschhauser

family: Salles

full_name: G. Salles

family: Wenger

full_name: M. Wenger

given: M.

family: Truppel-Hartmann

full_name: A. Truppel-Hartmann

given: A.

family: Carlile

full_name: D. J. Carlile

given: D. J.

currency_apc_doaj: EUR

journal_name: Haematologica

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Cartron G, de Guibert S, Dilhuydy MS, Morschhauser F, Leblond V, Dupuis J, Mahe B, Bouabdallah R, Lei G, Wenger M, Wassner-Fritsch E, Hallek M. Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study. Blood. 2014 Oct 2;124(14):2196-202. doi: 10.1182/blood-2014-07-586610. Epub 2014 Aug 20.

name: Département d’Hématologie, Unités Mixtes de Recherche–Centre National de la Recherche Scientifique 5235, Centre Hospitalier Universitaire de Montpellier, Montpellier, France;

name: Service d’Hematologie Clinique, Unité d’Investigation Clinique, Institut National de la Santé et de la Recherche Médicale 1414, Centre Hospitalier Universitaire Pontchaillou, Rennes, France;

name: Service d’Hématologie Clinique et Thérapie Cellulaire, Hôpital du Haut-Lévèque, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France;

name: Service d’Hématologie, Centre Hospitalier Universitaire de Lille, Lille, France;

name: Service d’Hématologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France;

name: Unité Hémopathies Lymphoïdes, Centre Hospitalier Universitaire Henri Mondor, Creteil, France;

name: Département d’Hématologie, Centre Hospitalier Universitaire Nantes, Nantes, France;

name: Centre de Lutte Contre le Cancer Paoli-Calmettes, Marseille, France;

name: Pharma Development Biostatistics, Roche Products, Welwyn Garden City, United Kingdom;

name: Pharma Development Oncology, F. Hoffmann–La Roche, Basel, Switzerland; and

name: First Department of Internal Medicine, University of Cologne, Cologne, Germany

ReferenceCitation: Morschhauser FA, Cartron G, Thieblemont C, Solal-Céligny P, Haioun C, Bouabdallah R, Feugier P, Bouabdallah K, Asikanius E, Lei G, Wenger M, Wassner-Fritsch E, Salles GA. Obinutuzumab (GA101) monotherapy in relapsed/refractory diffuse large b-cell lymphoma or mantle-cell lymphoma: results from the phase II GAUGUIN study. J Clin Oncol. 2013 Aug 10;31(23):2912-9. doi: 10.1200/JCO.2012.46.9585. Epub 2013 Jul 8.

name: Franck Morschhauser, Centre Hospitalier Régional Universitaire de Lille, Lille; Guillaume Cartron, Centre Hospitalier Régional Universitaire de Montpellier, Montpellier; Catherine Thieblemont, Hôpital Saint-Louis, Paris; Philippe Solal-Céligny, Institut de Cancérologie de l'Ouest, Nantes; Corinne Haioun, Hôpital Henri Mondor, Créteil; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille; Pierre Feugier, Centre Hospitalier Universitaire de Nancy, Nancy; Krimo Bouabdallah, Centre Hospitalier Universitaire...

publisher: American Society of Clinical Oncology (ASCO)

title: Obinutuzumab (GA101) Monotherapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma or Mantle-Cell Lymphoma: Results From the Phase II GAUGUIN Study

ReferenceCitation: Salles GA, Morschhauser F, Solal-Céligny P, Thieblemont C, Lamy T, Tilly H, Gyan E, Lei G, Wenger M, Wassner-Fritsch E, Cartron G. Obinutuzumab (GA101) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: results from the phase II GAUGUIN study. J Clin Oncol. 2013 Aug 10;31(23):2920-6. doi: 10.1200/JCO.2012.46.9718. Epub 2013 Jul 8.

name: Gilles A. Salles, Hospices Civils de Lyon-Université de Lyon, Pierre-Bénite; Franck Morschhauser, EA 4481 GRIIOT, Centre Hospitalier Régional Universitaire de Lille, Lille; Philippe Solal-Céligny, Institut de Cancérologie de l'Ouest, Nantes; Catherine Thieblemont, Hôpital Saint-Louis, Paris; Thierry Lamy, Centre Hospitalier Universitaire (CHU) de Rennes, Rennes; Hervé Tilly, Centre Henri-Becquerel, Université de Rouen, Rouen; Emmanuel Gyan, CHU de Tours, Clinical Investigation Center, Institut National...

title: Obinutuzumab (GA101) in Patients With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: Results From the Phase II GAUGUIN Study

ReferenceCitation: Salles G, Morschhauser F, Lamy T, Milpied N, Thieblemont C, Tilly H, Bieska G, Asikanius E, Carlile D, Birkett J, Pisa P, Cartron G. Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients. Blood. 2012 May 31;119(22):5126-32. doi: 10.1182/blood-2012-01-404368. Epub 2012 Mar 19.

name: Hospices Civils de Lyon, Hematologie, Université de Lyon, Unité Mixte de Recherche (UMR) 5239, Centre National de la Recherche Scientifique (CNRS), Pierre-Bénite, France;

name: Hématologie, Centre Hospitalier Universitaire (CHU), Université de Lille, Equipe d'Accueil 4481, Lille, France;

name: Service d'Hématologie Clinique, CHU, Université de Rennes, UMR 917, Rennes, France;

name: Assistance Publique des Hôpitaux de Paris Hôpital Saint-Louis, Hémato-Oncologie-Université Paris Diderot, Sorbonne Paris Cité, UMR 728, Paris, France;

name: Hématologie, UMR 918, Centre Henri Becquerel, Université de Rouen, Rouen, France;

name: Roche Products, Welwyn Garden City, United Kingdom; and

name: Département d'Hématologie, CHU, UMR 5235, CNRS, Montpellier, France


title: Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801

acronym: ALFA 9801

summary: Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2

ReferenceCitation: Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terré C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.

family: Sarkozy

full_name: Clémentine Sarkozy

given: Clémentine

name: Hematology Department, Hôpital Avicenne, AP-HP; University Paris 13; Bobigny; France

family: Gardin

full_name: Claude Gardin

given: Claude

name: Hematology Department, Hôpital Dupuytren; University Limoges; Limoges; France

family: Gachard

full_name: Nathalie Gachard

given: Nathalie

name: Hematology Department, Hôpital Mignot; University Versailles - Saint Quentin; Le Chesnay; France

family: Merabet

full_name: Fathia Merabet

given: Fathia

family: Turlure

full_name: Pascal Turlure

given: Pascal

name: Hematology Department; Hôpital d'Instruction des Armées; Clamart; France

family: Malfuson

full_name: Jean-Valère Malfuson

given: Jean-Valère

name: Hematology Department, Hôpital Henri Mondor, AP-HP; University Paris 12; Créteil; France

family: Pautas

full_name: Cécile Pautas

given: Cécile

name: Hematology Department, Hôpital Saint-Louis, Assistance Publique - Hôpitaux de Paris (AP-HP); University Paris 7; EA 3518; Paris; France

family: Micol

full_name: Jean-Baptiste Micol

given: Jean-Baptiste

name: Hematology Department; Hôpital Lyon Sud; Pierre-Bénite; France

family: Thomas

full_name: Xavier Thomas

given: Xavier

name: Hematology Department, Hôpital Claude Huriez; University Lille; Lille; France

family: Quesnel

full_name: Bruno Quesnel

given: Bruno

family: Celli-Lebras

full_name: Karine Celli-Lebras

given: Karine

family: Preudhomme

full_name: Claude Preudhomme

family: Terré

full_name: Christine Terré

given: Christine

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

name: Department of Biostatistics, Hôpital Saint-Louis, AP-HP; University Paris 7; Paris; France

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Castaigne

full_name: Sylvie Castaigne

family: Dombret

full_name: Hervé Dombret

given: Hervé

journal_name: American Journal of Hematology

oa_host_type: publisher

ReferenceCitation: Gardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terré C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.

name: Claude Gardin and Pierre Fenaux, Hôpital Avicenne, Assistance Publique–Hôpitaux de Paris (AP-HP), Université Paris 13, Bobigny; Sylvie Chevret, Emmanuel Raffoux, Nicolas Boissel, Karine Celli-Lebras, and Hervé Dombret, Hôpital Saint-Louis, AP-HP, Université Paris 7, Paris; Cécile Pautas, Hôpital Henri Mondor, AP-HP, Université Paris 12, Créteil; Pascal Turlure, Nathalie Gachard, and Dominique Bordessoule, Hôpital Dupuytren, Université de Limoges, Limoges; Xavier Thomas, Hôpital Edouard Herriot,...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Superior Long-Term Outcome With Idarubicin Compared With High-Dose Daunorubicin in Patients With Acute Myeloid Leukemia Age 50 Years and Older

ReferenceCitation: Itzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terré C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.

name: for the Acute Leukemia French Association (ALFA)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Boissel N, Nibourel O, Renneville A, Gardin C, Reman O, Contentin N, Bordessoule D, Pautas C, de Revel T, Quesnel B, Huchette P, Philippe N, Geffroy S, Terre C, Thomas X, Castaigne S, Dombret H, Preudhomme C. Prognostic impact of isocitrate dehydrogenase enzyme isoforms 1 and 2 mutations in acute myeloid leukemia: a study by the Acute Leukemia French Association group. J Clin Oncol. 2010 Aug 10;28(23):3717-23. doi: 10.1200/JCO.2010.28.2285. Epub 2010 Jul 12.

name: From the University of Paris 7; Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris; Laboratoire d'hématologie, Centre Hospitalier Universitaire de Lille; L'Institut National de la Santé et de la Recherche Médicale, U837; Université Lille Nord de France; Institut de Recherche sur le Cancer de Lille, Lille; Avicenne Hospital, APHP, Bobigny; Clemenceau Hospital, Caen; Henri Becquerel Center, Rouen; Dupuytren Hospital, Limoges; Henri Mondor Hospital, APHP, Créteil; Hôpital des Armées,...

title: Prognostic Impact of Isocitrate Dehydrogenase Enzyme Isoforms 1 and 2 Mutations in Acute Myeloid Leukemia: A Study by the Acute Leukemia French Association Group

location_facility:
CH
Hopital Pitie-Salpetriere
Hopital Edouard Herriot
CNLCC
Hopital Saint-Louis
St Antoine Hospital
CHU
Hopital Percy
IGR


summary: The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Assistance Publique des Hopitaux de Paris, Hopital Necker

location_facility: Assistance Publique des Hopitaux de Paris, Hopital Robert Debré

location_facility: Assistance Publique des Hopitaux de Paris, Hopital Cochin

location_facility: Assistance Publique des hopitaux de paris, Hopital Trousseau


title: Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation.

acronym: VAPRED

summary:
The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation.

The patients are included in the study from the anticoagulant treatment cessation. An ED score and a blood sample are performed at this time and one month later. Then, the patients are followed up by phone for 2 years.

ReferenceCitation: Agnelli G, Prandoni P, Santamaria MG, Bagatella P, Iorio A, Bazzan M, Moia M, Guazzaloca G, Bertoldi A, Tomasi C, Scannapieco G, Ageno W; Warfarin Optimal Duration Italian Trial Investigators. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. Warfarin Optimal Duration Italian Trial Investigators. N Engl J Med. 2001 Jul 19;345(3):165-9.

ReferenceCitation: Agnelli G, Prandoni P, Becattini C, Silingardi M, Taliani MR, Miccio M, Imberti D, Poggio R, Ageno W, Pogliani E, Porro F, Zonzin P; Warfarin Optimal Duration Italian Trial Investigators. Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med. 2003 Jul 1;139(1):19-25.

ReferenceCitation: Bosson JL, Riachi M, Pichot O, Michoud E, Carpentier PH, Franco A. Diameters of acute proximal and distal deep venous thrombosis of the lower limbs. Int Angiol. 1998 Dec;17(4):260-7.

ReferenceCitation: Cushman M, Folsom AR, Wang L, Aleksic N, Rosamond WD, Tracy RP, Heckbert SR. Fibrin fragment D-dimer and the risk of future venous thrombosis. Blood. 2003 Feb 15;101(4):1243-8. Epub 2002 Sep 26.

ReferenceCitation: Eichinger S, Minar E, Bialonczyk C, Hirschl M, Quehenberger P, Schneider B, Weltermann A, Wagner O, Kyrle PA. D-dimer levels and risk of recurrent venous thromboembolism. JAMA. 2003 Aug 27;290(8):1071-4.

ReferenceCitation: Emmerich J, Fiessinger JN. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304.

ReferenceCitation: Fattorini A, Crippa L, Vigano' D'Angelo S, Pattarini E, D'Angelo A. Risk of deep vein thrombosis recurrence: high negative predictive value of D-dimer performed during oral anticoagulation. Thromb Haemost. 2002 Jul;88(1):162-3.

ReferenceCitation: Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, Turpie AG, Green D, Ginsberg JS, Wells P, MacKinnon B, Julian JA. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med. 1999 Mar 25;340(12):901-7. Erratum in: N Engl J Med 1999 Jul 22;341(4):298.

ReferenceCitation: Kuruvilla J, Wells PS, Morrow B, MacKinnon K, Keeney M, Kovacs MJ. Prospective assessment of the natural history of positive D-dimer results in persons with acute venous thromboembolism (DVT or PE). Thromb Haemost. 2003 Feb;89(2):284-7.

ReferenceCitation: Palareti G, Legnani C, Cosmi B, Guazzaloca G, Pancani C, Coccheri S. Risk of venous thromboembolism recurrence: high negative predictive value of D-dimer performed after oral anticoagulation is stopped. Thromb Haemost. 2002 Jan;87(1):7-12.

ReferenceCitation: Palareti G, Legnani C, Cosmi B, Valdré L, Lunghi B, Bernardi F, Coccheri S. Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia. Circulation. 2003 Jul 22;108(3):313-8. Epub 2003 Jul 7.

ReferenceCitation: Pernod G, Mossuz P, Polack B. Optimized factor V gene mutation detection using buffy-coat direct PCR. Biotechniques. 1997 May;22(5):837, 840, 841.

ReferenceCitation: Piovella F, Crippa L, Barone M, Viganò D'Angelo S, Serafini S, Galli L, Beltrametti C, D'Angelo A. Normalization rates of compression ultrasonography in patients with a first episode of deep vein thrombosis of the lower limbs: association with recurrence and new thrombosis. Haematologica. 2002 May;87(5):515-22.

ReferenceCitation: Prandoni P, Lensing AW, Prins MH, Bernardi E, Marchiori A, Bagatella P, Frulla M, Mosena L, Tormene D, Piccioli A, Simioni P, Girolami A. Residual venous thrombosis as a predictive factor of recurrent venous thromboembolism. Ann Intern Med. 2002 Dec 17;137(12):955-60.

ReferenceCitation: Schulman S, Rhedin AS, Lindmarker P, Carlsson A, Lärfars G, Nicol P, Loogna E, Svensson E, Ljungberg B, Walter H. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group. N Engl J Med. 1995 Jun 22;332(25):1661-5.

ReferenceCitation: Schulman S, Granqvist S, Holmström M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Lärfars G, Leijd B, Linder O, Loogna E. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Trial Study Group. N Engl J Med. 1997 Feb 6;336(6):393-8.

ReferenceCitation: Schulman S. Clinical practice. Care of patients receiving long-term anticoagulant therapy. N Engl J Med. 2003 Aug 14;349(7):675-83. Review.

ReferenceCitation: Sebastian JL, Torre DM. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304.

lead_sponsor: University Hospital, Grenoble

location_facility: Vascular Medecine Departement - University Hospital of Grenoble

intervention_type: Other


title: Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.

summary: Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in adult ICU patients and have led to discrepant results. These discrepancies may be related to the time lag separating the administration of the corticosteroids and the planned extubation. Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12 hours before a planned extubation may efficiently prevent the occurrence of postextubation laryngeal edema in critically-ill adults who have been mechanically ventilated for more than 36 hours in the ICU.

ReferenceCitation: Kastanos N, Estopá Miró R, Marín Perez A, Xaubet Mir A, Agustí-Vidal A. Laryngotracheal injury due to endotracheal intubation: incidence, evolution, and predisposing factors. A prospective long-term study. Crit Care Med. 1983 May;11(5):362-7.

ReferenceCitation: Darmon JY, Rauss A, Dreyfuss D, Bleichner G, Elkharrat D, Schlemmer B, Tenaillon A, Brun-Buisson C, Huet Y. Evaluation of risk factors for laryngeal edema after tracheal extubation in adults and its prevention by dexamethasone. A placebo-controlled, double-blind, multicenter study. Anesthesiology. 1992 Aug;77(2):245-51.

ReferenceCitation: Ho LI, Harn HJ, Lien TC, Hu PY, Wang JH. Postextubation laryngeal edema in adults. Risk factor evaluation and prevention by hydrocortisone. Intensive Care Med. 1996 Sep;22(9):933-6.

ReferenceCitation: François B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Réanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9.

lead_sponsor: University Hospital, Limoges

location_facility: Réanimation médicale et chirurgicale - Hôpital d'Angoulême

location_facility: Réanimation polyvalente - Hôpital d'Orléans

location_facility: Service de Réanimation - CH de Chateauroux

location_facility: Réanimation Médicale - Hôpital Bretonneau

location_facility: Service de Réanimation Polyvalente - Hôpital Dupuytren

location_facility: Service de Réanimation - CH de Saint Nazaire

location_facility: Réanimation polyvalente - Hôpital de Cholet


title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

acronym: Neo-PDGF

summary: Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

ReferenceCitation: Martinez F, Kamar N, Pallet N, Lang P, Durrbach A, Lebranchu Y, Adem A, Barbier S, Cassuto-Viguier E, Glowaki F, Le Meur Y, Rostaing L, Legendre C, Hermine O, Choukroun G; NeoPDGF Study Investigators. High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study. Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x.

family: Martinez

full_name: F. Martinez

given: F.

family: Kamar

full_name: N. Kamar

given: N.

family: Pallet

full_name: N. Pallet

family: Lang

full_name: P. Lang

given: P.

family: Durrbach

full_name: A. Durrbach

given: A.

family: Lebranchu

full_name: Y. Lebranchu

given: Y.

family: Adem

full_name: A. Adem

family: Barbier

full_name: S. Barbier

given: S.

family: Cassuto-Viguier

full_name: E. Cassuto-Viguier

given: E.

family: Glowaki

full_name: F. Glowaki

family: Le Meur

full_name: Y. Le Meur

family: Rostaing

full_name: L. Rostaing

given: L.

family: Legendre

full_name: C. Legendre

given: C.

family: Hermine

full_name: O. Hermine

given: O.

family: Choukroun

full_name: G. Choukroun

given: G.

journal_name: American Journal of Transplantation

title: High Dose Epoetin Beta in the First Weeks Following Renal Transplantation and Delayed Graft Function: Results of the Neo-PDGF Study

location_facility:
Amiens hospital
CHU Nantes, Hotel-Dieu Hospital
Bois Guillaume Hospital
LA CAVALE BLANCHE Hospital
Kremlin Bicêtre Hospital
CHU Nice, Pasteur Hospital
MICHALLON Hospital
LA MILETRIE Hospital
Georges Pompidou European Hospital
Necker Hospital
RANGUEIL Hospital
MONDOR Hospital
FOCH Hospital
BRETONNEAU Hospital
ALBERT CALMETTE Hospital
MAISON BLANCHE Hospital
TENON Hospital


title: Open-Label Study To Evaluate The EULAR-RAID Score, Rheumatoid Arthritis Impact Of Disease Score, In Rheumatoid Arthritis Patients Eligible To Etanercept And Who Will Receive Etanercept

acronym: Rainbow

summary: The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses certain criteria, including joint counts and patient perceived disease activity, to measure disease activity in people with Rheumatoid Arthritis . More recently, the European League against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite score based on patient reported outcomes, and includes such criteria as pain, functional disability, fatigue, sleep disturbances, coping, overall assessment of physical well being and overall assessment of psychological well being. The objective of this study is to evaluate the practical modalities and performance of the EULAR- RAID score in patients with rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.

ReferenceCitation: Duarte C, Santos EJF, Ferreira RJO, Kvien TK, Dougados M, de Wit M, da Silva JAP, Gossec L. Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients. RMD Open. 2021 Feb;7(1). pii: e001539. doi: 10.1136/rmdopen-2020-001539.

family: Duarte

full_name: Catia Duarte

given: Catia

family: Santos

full_name: Eduardo José Ferreira Santos

given: Eduardo José Ferreira

family: Ferreira

full_name: Ricardo J O Ferreira

given: Ricardo J O

family: Kvien

full_name: Tore K Kvien

given: Tore K

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: de Wit

full_name: Maarten de Wit

given: Maarten

family: da Silva

full_name: Jose Antonio Pereira da Silva

given: Jose Antonio Pereira

family: Gossec

full_name: Laure Gossec

given: Laure

journal_name: RMD Open

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T. Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis Res Ther. 2012 May 30;14(3):R129. doi: 10.1186/ar3859.

family: Brault

full_name: Yves Brault

given: Yves

family: Logeart

full_name: Isabelle Logeart

given: Isabelle

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

full_name: Tore Kvien

given: Tore

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Dougados M, Ripert M, Hilliquin P, Brocq O, Brault Y, Logeart I. Onset of action of etanercept in rheumatoid arthritis based on patient-reported outcomes. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):266-8. Epub 2012 Apr 13.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer


title: A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae

summary: The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

ReferenceCitation: Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7.

lead_sponsor: Ipsen

location_country:
Russian Federation
France

location_facility: Institute of Surgery n.a. A.V. Vishnevsky


ReferenceCitation: Sargos P, Chabaud S, Latorzeff I, Magné N, Benyoucef A, Supiot S, Pasquier D, Abdiche MS, Gilliot O, Graff-Cailleaud P, Silva M, Bergerot P, Baumann P, Belkacemi Y, Azria D, Brihoum M, Soulié M, Richaud P. Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X.

family: Sargos

full_name: Paul Sargos

given: Paul

family: Chabaud

full_name: Sylvie Chabaud

given: Sylvie

family: Latorzeff

full_name: Igor Latorzeff

given: Igor

family: Magné

full_name: Nicolas Magné

given: Nicolas

family: Benyoucef

full_name: Ahmed Benyoucef

given: Ahmed

family: Supiot

full_name: Stéphane Supiot

given: Stéphane

family: Pasquier

full_name: David Pasquier

given: David

family: Abdiche

full_name: Menouar Samir Abdiche

given: Menouar Samir

family: Gilliot

full_name: Olivier Gilliot

given: Olivier

family: Graff-Cailleaud

full_name: Pierre Graff-Cailleaud

given: Pierre

family: Silva

full_name: Marlon Silva

given: Marlon

family: Bergerot

full_name: Philippe Bergerot

given: Philippe

family: Baumann

full_name: Pierre Baumann

family: Belkacemi

full_name: Yazid Belkacemi

given: Yazid

family: Azria

full_name: David Azria

family: Brihoum

full_name: Meryem Brihoum

given: Meryem

family: Soulié

full_name: Michel Soulié

given: Michel

family: Richaud

full_name: Pierre Richaud

journal_name: The Lancet Oncology

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

family: Campillo-Gimenez

full_name: Boris Campillo-Gimenez

given: Boris

family: Buscail

full_name: Camille Buscail

given: Camille

family: Zekri

full_name: Oussama Zekri

given: Oussama

family: Laguerre

full_name: Brigitte Laguerre

given: Brigitte

family: Le Prisé

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

location_facility: Centre Hospitalier Universitaire Henri Mondor

title: Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.


title: Validation d'Une Solution Digitale intégrée (SUNrise®) d'Analyse Automatique Des Mouvements Mandibulaires Par Intelligence Artificielle Versus Polysomnographie Pour le Diagnostic du Syndrome d'Apnées Obstructives du Sommeil

acronym: SUNSAS

summary: Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm, open-label, multicenter, national, controlled study.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Sunrise

location_facility: Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),

location_facility: CHU Montpellier - Hôpital Gui-de-Chauliac

status_simplified: Ongoing


title: Interruption of the Calcineurine Inhibitors (ICN) and Introduction of Mycophenolate Mofetil (MMF) in Liver Transplant Patients With Side Effects Due to ICN: Study of the Reduction of the Risks of Rejection by Mycophenolate Mofetil Therapeutic Drug Monitoring

acronym: MONOCEPT

summary:
The aim of this project is to determine whether, in liver transplant patients with side effects due to ICN, the use of MMF in monotherapy can be optimised by dose adjustment based on the area under the curve (AUC) of mycophenolic acid (MPA). It involves a multicentre phase IV trial with direct individual benefit.

A population of 130 liver transplant patients at 2 to 10 years post-transplant, showing significant clinical ICN side effects and being given bitherapy by ICN +MMF will be included and randomised 1:1 in two arms:

Arm 1: progressive interruption of ICN after obtaining an AUC of MPA of 50 mg.h/l, followed by MMF monotherapy with dose adjustment based on the AUC of MPA,
Arm 2: continuation of the ICN+MMF bitherapy without MMF therapeutic drug monitoring.

The main judgement criterion will be the incidence of acute rejection in the 2 groups at 6 months. The secondary judgment criterion will be the evaluation of the benefit of stopping ICN on the side effects caused by these drugs.

location_facility:
Hôpital Edouard Herriot
CHU de Caen
Hôpital Henri Mondor
Hôpital Saint Antoine
CHU de Marseille
CHU de Strasbourg
CHU de Bordeaux
CHU de Lille
CHU de Nice
Hôpital Paul Brousse
CHU de Montpellier
CHU de Grenoble
Hôpital Cochin
CHU de Rennes
CHU de Besançon
CHU de Toulouse
Hôpital Beaujon


title: A Phase II Prospective Study "GFM-DACORAL-DLI" ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients

summary: Study of early administration of ASTX727 associated with late Donor Lymphocyte Infusions after allogenic stem cell transplantation in very high risk MDS or AML patients

status: Recruiting

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Institut de Cancérologie Lucien Neuwirth - Hématologie clinique et thérapie cellulaire

location_facility: CHU d'Angers - Service des maladies du sang

location_facility: Hôpital Saint Louis - Service hématologie-greffe

location_facility: IUCT Oncopole - Département d'hématologie - Service de greffe de cellules souches hématopoïétiques

location_facility: CHU Brabois - Service hématologie clinique

location_facility: CHU de Grenoble - Clinique Universitaire d'hématologie

location_facility: Hôpital Pitié-Salpêtrière - Service hématologie clinique

location_facility: CHU Hôtel Dieu - Service hématologie clinique

location_facility: Hôpital Necker - Service hématologie adulte

location_facility: CHU de Haut-Lévèque de Bordeaux - Service des maladies du sang

location_facility: Centre Henri Becquerel - Département d'hématologie

location_facility: CHRU de Limoges - Hôpital Dupuytren - Service hématologie clinique et thérapie cellulaire

location_facility: CHU Estaing - Service hématologie clinique et thérapie cellulaire


title: An Eight-Week, Randomized, Double Blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 Per Day in Patients Hospitalized for Severe Depression

summary: An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.

ReferenceCitation: Brecht S, Desaiah D, Marechal ES, Santini AM, Podhorna J, Guelfi JD. Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. J Clin Psychiatry. 2011 Aug;72(8):1086-94. doi: 10.4088/JCP.09m05723blu. Epub 2010 Sep 21.

family: Brecht

full_name: Stephan Brecht

given: Stephan

family: Desaiah

full_name: Durisala Desaiah

given: Durisala

family: Marechal

full_name: Elisete S. Marechal

given: Elisete S.

family: Santini

full_name: Ambra M. Santini

given: Ambra M.

family: Podhorna

full_name: Jana Podhorna

given: Jana

family: Guelfi

full_name: Julien D. Guelfi

given: Julien D.

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

title: Efficacy and Safety of Duloxetine 60 mg and 120 mg Daily in Patients Hospitalized for Severe Depression

ReferenceCitation: Demyttenaere K, Desaiah D, Raskin J, Cairns V, Brecht S. Suicidal thoughts and reasons for living in hospitalized patients with severe depression: post-hoc analyses of a double-blind randomized trial of duloxetine. Prim Care Companion CNS Disord. 2014;16(3). pii: PCC.13m01591. doi: 10.4088/PCC.13m01591. Epub 2014 May 1.

family: Demyttenaere

full_name: Koen Demyttenaere

given: Koen

family: Raskin

full_name: Joel Raskin

given: Joel

family: Cairns

full_name: Victoria Cairns

given: Victoria

journal_name: The Primary Care Companion For CNS Disorders

oa_host_type: repository

title: Suicidal Thoughts and Reasons for Living in Hospitalized Patients With Severe Depression

lead_sponsor: Eli Lilly and Company

location_country:
Italy
South Africa
Russian Federation
France

location_facility: For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician


title: Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire

acronym: Q-MIGAL

summary: Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). The goal of the present study is to validate a new questionnaire made of 4 parts evaluating the presence of these 4 types of hypersensitivity, both during or between migraine attacks. It will allow to look for associations of these 4 symptoms and association of hypersensitivity with patients' or migraine's characteristics.

time_perspective: Cross-Sectional

ReferenceCitation: Choi JY, Oh K, Kim BJ, Chung CS, Koh SB, Park KW. Usefulness of a photophobia questionnaire in patients with migraine. Cephalalgia. 2009 Sep;29(9):953-9. doi: 10.1111/j.1468-2982.2008.01822.x. Epub 2009 Feb 27.

ReferenceCitation: Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, Serrano D, Stewart WF; American Migraine Prevalence Prevention Advisory Group. Cutaneous allodynia in the migraine population. Ann Neurol. 2008 Feb;63(2):148-58.

ReferenceCitation: Khalfa S, Dubal S, Veuillet E, Perez-Diaz F, Jouvent R, Collet L. Psychometric normalization of a hyperacusis questionnaire. ORL J Otorhinolaryngol Relat Spec. 2002 Nov-Dec;64(6):436-42.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: CH d'Annecy, Centre d'Etude et de Traitement de la Douleur

location_facility: CHU de Montpellier, Service de Neurologie

location_facility: CHU de Clermont-Ferrand, Service de Neurologie

location_facility: CHU de Nice, Département Evaluation et Traitement de la Douleur

location_facility: CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur

location_facility: Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie

location_facility: CH Emile Roux Le Puy en Velay, Service de Neurologie

location_facility: Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur

location_facility: CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie


title: Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

acronym: GATA

summary: The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.

ReferenceCitation: Renaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupré PF, Fritel X, Ngô C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20.

family: Renaudeau

full_name: C. Renaudeau

given: C.

family: Lefebvre-Lacoeuille

full_name: C. Lefebvre-Lacoeuille

family: Campion

full_name: L. Campion

given: L.

family: Dravet

full_name: F. Dravet

given: F.

family: Descamps

full_name: P. Descamps

given: P.

family: Ferron

full_name: G. Ferron

given: G.

family: Houvenaeghel

full_name: G. Houvenaeghel

family: Giard

full_name: S. Giard

given: S.

family: Tunon de Lara

full_name: C. Tunon de Lara

family: Dupré

full_name: P.F. Dupré

family: Fritel

full_name: X. Fritel

given: X.

family: Ngô

full_name: C. Ngô

family: Verhaeghe

full_name: J.L. Verhaeghe

family: Faure

full_name: C. Faure

family: Mezzadri

full_name: M. Mezzadri

given: M.

family: Damey

full_name: C. Damey

family: Classe

full_name: J.M. Classe

journal_name: The Breast

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Eugène Marquis
Centre Alexis Vautrin
Hopital Lariboisière
Centre Oscar Lambret
Hôpital Tenon
Centre Hospitalier
Hospital
Centre Claudius Regaud
Institut Jean Godinot
Hopital Européen Georges Pompidou
Institut Paoli Calmette
centre Léon Berard
Centre René Gauducheau
Institut Bergonié
Hospîtal


title: Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2

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

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

ReferenceCitation: Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, André T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.

name: From the Hôpital Saint-Antoine and Hôpital La Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Paris VI; L'Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche S 893, Paris; Hôpital Privé Jean Mermoz, Lyon; Institut Sainte-Catherine, Avignon; Hôpital Montfermeil, Montfermeil; Hôpital Foch, Suresnes; Hôpital de Senlis, Senlis; Hôpital Drevon, Dijon; Clinique Victor-Hugo, Le Mans; and Clinique de Courlancy, Reims, France.

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: Maindrault-Goebel

full_name: Frédérique Maindrault-Goebel

given: Frédérique

family: Lledo

full_name: Gérard Lledo

given: Gérard

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: André

full_name: Thierry André

given: Thierry

family: Bennamoun

full_name: Mostepha Bennamoun

given: Mostepha

family: Mabro

full_name: May Mabro

given: May

family: Artru

full_name: Pascal Artru

given: Pascal

family: Carola

full_name: Elisabeth Carola

given: Elisabeth

family: Flesch

full_name: Michel Flesch

given: Michel

family: Dupuis

full_name: Olivier Dupuis

given: Olivier

family: Colin

full_name: Philippe Colin

given: Philippe

family: Larsen

full_name: Annette K. Larsen

given: Annette K.

family: Afchain

full_name: Pauline Afchain

given: Pauline

family: Tournigand

full_name: Christophe Tournigand

given: Christophe

family: Louvet

full_name: Christophe Louvet

family: de Gramont

full_name: Aimery de Gramont

given: Aimery

journal_name: Journal of Clinical Oncology

publisher_group: American Society of Clinical Oncology (ASCO)

title: Can Chemotherapy Be Discontinued in Unresectable Metastatic Colorectal Cancer? The GERCOR OPTIMOX2 Study

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Polyclinique De Courlancy
Centre Medico-Chirurgical Foch
Hopital Louis Pasteur - Le Coudray
Centre Hospitalier de Dreux
C.H. Senlis
Clinique des Jockeys
Hopital Europeen Georges Pompidou
Hopital Saint Antoine
Hopital Drevon
Infirmerie Protestante
Intercommunal Hospital
Hopital Tenon
Hopital Duffaut
Institut Sainte Catherine
Clinique Saint Jean
Clinique Victor Hugo
Hopital Robert Boulin


title: Phase IIIb, Multicenter, Single-Arm Open-Label Study, Supporting the Development and the Validation of the MATHYS Scale (Multidimensional Assessment of THYmic States) in a Population of Bipolar Patients Treated With Olanzapine, Either in-Label (Manic and Mixed Patients) and Off-Label (Hypomanic and Bipolar Depression)

summary: A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b

summary: The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.

location_country: Italy France

location_facility: Clinica Neurologica Università di Torino

location_facility: Psichiatriche dell'Università di Bari, Policlinico

location_facility: Dipartimento di Scienze Neurologiche e Psichiatriche


type: Other Grant/Funding Number

title: Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed

summary: hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.

status: Active, not recruiting

lead_sponsor: The Netherlands Cancer Institute

location_country: France Netherlands

location_facility:
Centre Eugène Marquis
Centre Antoine Lacassagne
CHU Henri Mondor
Centre Val d'Aurelle
Centre Oscar Lambret
Hôpital J-Minjoz
Hôpital Saint Louis
Centre Hospitalier Lyon Sud
Centre René Huguenin
Centre Paul Strauss
CHU de Tours
Institut Paoli Calmettes
Institut Curie
Centre René Gauducheau
The Netherlands Cancer Institute
Institut Bergonié
Centre Henri Becquerel
Institut Gustave Roussy

intervention_type: Radiation


title: Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

summary: To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

ReferenceCitation: Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31.

family: Chanson

full_name: Philippe Chanson

family: Borson-Chazot

full_name: Franoise Borson-Chazot

given: Franoise

family: Kuhn

full_name: Jean-Marc Kuhn

given: Jean-Marc

family: Blumberg

full_name: Jolle Blumberg

given: Jolle

family: Maisonobe

full_name: Pascal Maisonobe

family: Delemer

full_name: Brigitte Delemer

given: Brigitte

journal_name: Clinical Endocrinology

title: Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48weeks in patients with acromegaly

location_country: France Switzerland

location_facility:
Hôpital du Cluzeau
Hôpital de Rangueil
Chu de Bicêtre
Hôpital Lapeyronie
Hôpital du Haut-Levêque
Hôpital Sud
Hôpital de Hautepierre
Hôpital Bellevue
Centre Hospitalier Vaudois
Hôpital de Bois Guillaume
Hôpital du Bocage
Chu de la Cote de Nacre
Chu d'Angers
Hôpital Maison Blanche
Hôpital de l'Archet 1
Hôpital Neurologique


title: A Post Marketing Surveillance Study of Dysport Formulated With a Batch of Bulk Active Substance From a New Primary Manufacturing Facility at the Centre for Applied Microbiology & Research (CAMR)

summary: The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

location_country:
Germany
Russian Federation
France

location_facility: Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences

location_facility: Institute of Medical Aestetic "Vallex-M"

location_facility: Klinikum der Stadt Villingen-Schwenningen

location_facility: Scientific Research Institute of Neurology

location_facility: Alma-Ata State Institute of Postgraduate Education

location_facility: Federal Centre "Pediatric Rehabilitology"

location_facility: Centre of plastic surgery "Reconstruction and Recreation"


title: Phase 2 Study of Ponatinib (Iclusig) for Prevention of Relapse After Allogeneic Stem Cell Transplantation (Allo-SCT) in FLT3-ITD AML Patients: the PONALLO Trial."

acronym: PONALLO

summary:
Recent advances in acute myeloid leukemia (AML) have been characterized by a better understanding of disease biology. As such, FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) have been recognized as conferring a poor prognosis. The FLT3-ITD molecular mutation is observed in about one-quarter of patients diagnosed with AML. Patients presenting with this abnormality are referred for early allogeneic stem-cell transplantation (allo-SCT). However, some data suggest that FLT3-ITD remains associated with a poor prognosis even after allo-SCT because of higher risk of relapse and strategies for preventing relapse in the post-transplant setting are required (Hu et al, Expert Rev Hematol, 2014). For example, in a large cohort of patients (Brunet et al, JCO, 2012), the incidence of relapse for FLT3-ITD AML patients after allo-SCT was 30% at 2-years, significantly higher compared to FLT3-ITD negative patients (p=0.006).

Ponatinib (Iclusig®) is an orally available, tyrosine kinase inhibitor with a unique binding mechanism allowing inhibition of BCR-ABL kinases, including those with the T315I point mutation. Ponatinib also has in vitro inhibitory activity against a discrete set of kinases implicated in the pathogenesis of other hematologic malignancies, including FLT3, KIT, fibroblast growth factor receptor 1 (FGFR1), and platelet derived growth factor receptor α (PDGFRα). In vitro activity of ponatinib in AML has been already demonstrated (Gozgit et al, Mol Cancer Ther, 2011; Smith et al, Blood 2013). If some trials are on-going to test ponatinib alone or in combination with chemotherapy in FLT3-ITD AML (Clinical.trials.gov), no study is dedicated to the use of ponatinib in the post-transplant setting in order to prevent relapse in these patients.

The main goal of this study will be to determine the maximal tolerated dose (MDT) of ponatinib after allo-SCT in FLT3-ITD AML patients, then to investigate the efficacy of ponatinib in a larger cohort of patients

lead_sponsor: Versailles Hospital

location_facility:
CHU Angers
CHu Lyon
CHu Brest
CHU Limoges
CHU Clermont Ferrand
CHU Poitiers
CRLC Toulouse
Hopital St Antoine
CHU Caen
Hopital St Louis
CHU Grenoble
CHU Lille
CHU Nancy
Chevallier


title: An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Activity and Safety of a Combination of Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma.

summary: This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients aged 18 to 75 years with relapsed/refractory follicular non-Hodgkin's lymphoma (NHL).

ReferenceCitation: Horning SJ. Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin Oncol. 1993 Oct;20(5 Suppl 5):75-88. Review.

ReferenceCitation: McLaughlin P, Hagemeister FB, Romaguera JE, Sarris AH, Pate O, Younes A, Swan F, Keating M, Cabanillas F. Fludarabine, mitoxantrone, and dexamethasone: an effective new regimen for indolent lymphoma. J Clin Oncol. 1996 Apr;14(4):1262-8.

ReferenceCitation: Maloney DG, Grillo-López AJ, White CA, Bodkin D, Schilder RJ, Neidhart JA, Janakiraman N, Foon KA, Liles TM, Dallaire BK, Wey K, Royston I, Davis T, Levy R. IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood. 1997 Sep 15;90(6):2188-95.

ReferenceCitation: McLaughlin P, Grillo-Lopez AJ, Maloney DG, Link BK, Levy R, Czuczman MS, Cabanillas F, Dallaire BK, White CA: Efficacy controls and long-term follow-up of patients treated with rituximab for relapsed or refractory, low-grade or follicular NHL. Blood 92:414a, 1998

lead_sponsor: Lymphoma Study Association

location_facility: Centre régional de lutte contre le cancer Léon Bérard

location_facility: Hôpital Claude Huriez - Sce des Maladies du Sang - Place Verdun

location_facility: Service d'hématologie Institut Paoli Calmette

location_facility: Service d'hématologie clinique - Hôpital de Pontchaillou

location_facility: Service d'hématologie Institut Gustave Roussy

location_facility: Service d'hématologie clinique - Centre Hospitalier du Dr Schaffner

location_facility: Service de médecine D - Maladies du Sang CHU Angers

location_facility: Service d'Hématologie Hôpital Jean Minjoz


title: Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.

acronym: TOPTACOS

summary:
Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients.

The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care.

This series of questionnaires will aim to identify:

the gradient of compliance of the patient with his treatment,
all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic,
the evolution of patient compliance during their treatment course,
a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3).
These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.

location_facility:
Centre Eugène Marquis
Clinique Mutualiste de l'Estuaire
Institut de Cancérologie de l'Ouest
Centre Catherine de Sienne
Centre Hospitalier
CHP Océane
CHIC Quimper
CHU Morvan
CHD Vendée
CHU
Clinique Pasteur Saint Esprit
Clinique Victor Hugo
CHP


title: Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy With Relapsed or Refractory Acute Myeloid Leukemia or HR-MDS .

summary: To assess the efficacy, and safety of BST-236 in patients unfit for intensive chemotherapy with AML or HR MDS that failed or relapsed following first line therapy

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Multicentre Observational Study on Community Acquired Intraabdominal Infections Management: the PERICOM Study

acronym: PERICOM

summary: Intraabdominal infection require rapid care management including antibiotic therapy and source control. Morbidity and mortality associated with Intraabdominal infections remain high. French recommendations have been edited in 2000 further updated in 2014. Delay in diagnosis and surgery can lead to worsened outcomes. However, little data are available on early community-acquired intraabdominal infections management to identify risk factors of inadequate management.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Angers
Hôpital Henri Mondor
CHRU Lille
CHU Strasbourg
CHU d'Amiens
CHU Bichat Claude Bernard
CHU Clermont-Ferrand
Ap Hm La Timone
Hia Percy
Le Kremlin-Bicêtre
CHU Nimes
AP HM La Timone
Lyon-Sud Pierre Bénite
CHU Grenoble La Tronche


title: Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer

acronym: HIFUSA

summary:
The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.

The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.

lead_sponsor: Hospices Civils de Lyon

location_country: Sweden France

location_facility: Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,

location_facility: Département d'Urologie, Institut Montsouris

location_facility: Service d'Urologie, Clinique Tivoli Ducos

location_facility: Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

location_facility: Service d'Urologie CHRU de Lille, Hôpital HURIEZ

location_facility: Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

location_facility: Clinique Générale Beaulieu - Swiss International Prostate Center

location_facility: Service d'Urologie, CHU de Guebwiller Colmar


title: A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

summary:
This study is a multicenter phase II trial including 2 cohorts of patients in Refractory/Relapse disease at least 1 month after CAR T-cells therapy:

cohort 1: DLBCL patients
cohort 2: PMBL, mantle cell lymphoma, transformed indolent NHL (t-iNHL) or iNHL CAR T-cells Refractory/Relapse status will be determined by PET-CT central review allowing inclusion in this trial.

Patients enrolled will then receive a pre-phase of obinutuzumab followed by experimental treatment:11 cycle of glofitamab.

The primary objective of the study is to assess the anti-lymphoma activity of glofitamab, a bispecific CD3xCD20 monoclonal antibody in patients with relapse/refractory DLBCL (cohort 1) disease after anti-CD19 CAR T-cells therapy

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHU de Brabois
CHU de Rennes - Hôpital Pontchaillou
CHU de Clermont Ferrand
Hôpital Saint Louis
Hopital Henri Mondor
CHRU Lille - Hôpital Claude Huriez
CHU de Bordeaux - Hôpital Haut Leveque
CHU Montpellier
APHP - Hôpital Saint Antoine
IUCT Oncopole
CHU Nantes
Centre Henri Becquerel
CHU Lyon Sud
APHP - Hôpital de la Pitiè Salpetrière
CHU de Dijon - Hôpital le Bocage


title: Observational, Real-life Study of the Use of octaplasLG®.

summary: This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.

lead_sponsor: Octapharma

location_facility: Hospices Civils de Lyon Hôpital Edouard Herriot


lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

title: An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients

summary: This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.


title: Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score

acronym: Biper

summary: The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.

primary_purpose: Supportive Care

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Pasteur 2 Hospital - University Hospital


title: Peri-operative Association of Immunotherapy (Pre-operative Association of Nivolumab and Ipilimumab, Post-operative Nivolumab Alone) in Localized Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR) Oeso-gastric Adenocarcinoma: An Open-label GERCOR Phase II Study

acronym: NEONIPIGA

summary: This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate the complete pathologic response rate (cPRR) with neoadjuvant nivolumab and ipilimumab combination in patients with MSI and/or dMMR localized oeso-gastric cancer.

location_facility:
Hôpital Henri Mondor
Centre Léon Bérard
CHRU Lille
Hôpital Européen Geroges Pompidou
Hôpital Saint Antoine
CHU Toulouse
CHRU Jean Minjoz
Hôpital Saint Louis
CHU Poitiers
Institut Hospitalier Franco-Britannique
ICM Val d'Aurelle
CHU Nantes
Hôpital Privé Jean Mermoz
CHU Pontchaillou Rennes
Institut Mutualiste Montsouris


title: Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

acronym: ShareD-BD

summary: The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses

ReferenceCitation: Samalin L, Honciuc M, Boyer L, de Chazeron I, Blanc O, Abbar M, Llorca PM. Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD). BMC Psychiatry. 2018 Apr 13;18(1):103. doi: 10.1186/s12888-018-1686-y.

family: Samalin

full_name: L. Samalin

given: L.

family: Honciuc

full_name: M. Honciuc

given: M.

family: Boyer

full_name: L. Boyer

family: de Chazeron

full_name: I. de Chazeron

given: I.

family: Blanc

full_name: O. Blanc

given: O.

family: Abbar

full_name: M. Abbar

family: Llorca

full_name: P. M. Llorca

given: P. M.

journal_name: BMC Psychiatry

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

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

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied