title: Long Term Impact of a Physical Activity Intervention Combining Workshop During a Balneotherapy and a Web and Smartphone-based Physical Activity Program After Balneotherapy, on Physical Activity Level : a Randomized Control Trial

acronym: THERMACTIVE

summary:
The purpose of this study is to evaluate the impact of an intervention combining a workshop during a balneotherapy and the use after the end of the balneotherapy of a web and smartphone-based physical activity program using connected devices, on physical activity level among patients 12 months after they participated in a balneotherapy in thermal care center.

A multi center randomized controlled trial is setting to evaluate the impact of the intervention on physical activity recommendations achievement of the patients.

Investigators hypothesize that an intervention including a workshop during a balneotherapy and an automated physical activity program using web, mobile phone and connected devices will help patients to be engaged in more physical activities and to reach physical activity recommendations.

ReferenceCitation: van der Weegen S, Verwey R, Spreeuwenberg M, Tange H, van der Weijden T, de Witte L. It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Jul 24;17(7):e184. doi: 10.2196/jmir.4579.

ReferenceCitation: Aalbers T, Baars MA, Rikkert MG. Characteristics of effective Internet-mediated interventions to change lifestyle in people aged 50 and older: a systematic review. Ageing Res Rev. 2011 Sep;10(4):487-97. doi: 10.1016/j.arr.2011.05.001. Epub 2011 May 20. Review.

ReferenceCitation: Ammann R, Vandelanotte C, de Vries H, Mummery WK. Can a website-delivered computer-tailored physical activity intervention be acceptable, usable, and effective for older people? Health Educ Behav. 2013 Apr;40(2):160-70. doi: 10.1177/1090198112461791. Epub 2012 Oct 16.

ReferenceCitation: Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11). pii: e002239. doi: 10.1161/JAHA.115.002239.

ReferenceCitation: Krebs P, Prochaska JO, Rossi JS. A meta-analysis of computer-tailored interventions for health behavior change. Prev Med. 2010 Sep-Oct;51(3-4):214-21. doi: 10.1016/j.ypmed.2010.06.004. Epub 2010 Jun 15.

ReferenceCitation: Irvine AB, Gelatt VA, Seeley JR, Macfarlane P, Gau JM. Web-based intervention to promote physical activity by sedentary older adults: randomized controlled trial. J Med Internet Res. 2013 Feb 5;15(2):e19. doi: 10.2196/jmir.2158.

ReferenceCitation: Fillol F, Paris L, Pascal S, Mulliez A, Roques CF, Rousset S, Duclos M. Possible Impact of a 12-Month Web- and Smartphone-Based Program to Improve Long-term Physical Activity in Patients Attending Spa Therapy: Randomized Controlled Trial. J Med Internet Res. 2022 Jun 16;24(6):e29640. doi: 10.2196/29640.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Centre thermal d'Eugénie-les-Bains
Thermes du Boulou
Thermes de Brides-les-Bains
Thermes CHEVALLEY
Thermes de Bourbon-Lancy
Thermes de Vals-les-Bains
Thermes CALLOU
Caleden Complexe Thermal
Centre thermal d'Amélie-les-Bains


title: Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)

acronym: COSMIC

summary:
As ICU mortality is high, end-of-life is a subject of major concern for intensivists. With a mortality rate of 20%, end-of-life care has become a daily responsibility. Among those deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where physicians, nurses and relatives must work together towards the most consensual decision. In this context, patients' relatives feel vulnerable and, in the months that follow the death, they are most likely to present symptoms that negatively affect their quality of life (anxiety, depression, PTSD, prolonged grief). Many studies have shown that communication with caregivers is one of the most highly valued aspects of care that impacts on family members' experience during the patient's stay and after the patient's death. Improving communication during the end-of-life process in the ICU context is a necessity that has been put forward in palliative care and family-centered care guidelines.

This study aims to improve both communication skills and behaviour by giving precise recommendations to physicians (3 step strategy) in their direct contact with patients' relatives. A 3-step physician-driven support strategy is used, that consists in 3 meetings with the relative - one before, one during and one after the patient's death. The underlying hypothesis is that this strategy will improve communication in the end-of-life setting and thus should reduce post-ICU burden for family members, specifically the development of prolonged grief 6 months after the death.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Kentish-Barnes N, Chevret S, Valade S, Jaber S, Kerhuel L, Guisset O, Martin M, Mazaud A, Papazian L, Argaud L, Demoule A, Schnell D, Lebas E, Ethuin F, Hammad E, Merceron S, Audibert J, Blayau C, Delannoy PY, Lautrette A, Lesieur O, Renault A, Reuter D, Terzi N, Philippon-Jouve B, Fiancette M, Ramakers M, Rigaud JP, Souppart V, Asehnoune K, Champigneulle B, Goldgran-Toledano D, Dubost JL, Bollaert PE, Chouquer R, Pochard F, Cariou A, Azoulay E. A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial. Lancet. 2022 Feb 12;399(10325):656-664. doi: 10.1016/S0140-6736(21)02176-0. Epub 2022 Jan 19.

ReferenceCitation: Kentish-Barnes N, Chevret S, Azoulay E. Guiding intensive care physicians' communication and behavior towards bereaved relatives: study protocol for a cluster randomized controlled trial (COSMIC-EOL). Trials. 2018 Dec 22;19(1):698. doi: 10.1186/s13063-018-3084-7.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Réanimation médicale Bicetre
Réanimation médicale HEGP
Réanimation Médicale hôpital Cochin
Réanimation polyvalente René Dubos
Réanimation chirurgicale HEGP
Anesthésie Réanimation Beaujon
Réanimation polyvalente Sud Francilien
Réanimation médicale
Réanimation médico chirurgicale Tenon
Réanimation médicale Pitié Salpetriere

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: Prospective Multicenter Randomized Study Comparing Two Standard Treatments: SpineJack® System and Conservative Orthopedic Management in Acute Traumatic Vertebral Fractures Types A1 and A3.1 According to the Magerl Classification

summary:
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:

SpineJack® system
Conservative Orthopedic Management consisting of brace and pain medication.

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Vexim SA

location_facility:
CHU de Bordeaux - Hopital Pellegrin
CHU Brest
CHU de Dijon
Centre Hospitalier De Chambéry
APHM, Hopital Nord Marseille
Hopital Jean Minjoz Besancon
Centre Hospitalier Privé Saint Grégoire
CHU de Rouen-Hopital Charles Nicolle
CHU de Rennes

intervention_type: Device

lead_sponsor_type: industriel


title: Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty

acronym: FAVABED

summary:
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisationand morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA.

Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate but a poor 1-year patency rate.

These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital.

Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty.

For the past few years, angioplasty balloons delivering anticancer drugs have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer molecule through the different layers of the vessel wall confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy.

These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty.

These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising.

The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered. Patients that will be non-evaluable for the primary endpointwill be censored at the date of the latest news.

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de RENNES

status_simplified: Ongoing


title: Hepcicor Cohort : Clinical, Biological, Genetic and Fonctional charactérization of Rare Iron Overlaod phénotypes Associated With Hepcidin Deficiency Excluding C282Y Homozygosity

acronym: HEPCICOR

summary: The study explores the hepcidin deficiency causes of rare iron overload (excluding C282Y homozygosity), and aim to characterize this iron overload in term of clinical, biological, genetic and functional spacificities.

study_type: Observational

time_perspective: Prospective

location_facility:
Hopital E.Muller
CHU Purpan
CHR La Source
Hopital Paul Brousse
Centre Hospitalier Lyon-Sud
Hôpital Hasenrain
CHU Limoges - Médecine interne A
Bardou Jacquet
CHRU de Montpellier - Hôpital St Eloi

intervention_type: Other


title: A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)

acronym: STERIMGLI

summary:
This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part.

The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part.

Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms:

Arm A (control arm): Radiation therapy alone
Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Regional Du Cancer de Montpellier

intervention_type: Radiation


title: Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test

acronym: SCA-AAR

summary:
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.

the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm

status: Unknown status

ReferenceCitation: Leclerc B, Salomon Du Mont L, Parmentier AL, Besch G, Rinckenbach S. Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR). Medicine (Baltimore). 2018 Jun;97(25):e11066. doi: 10.1097/MD.0000000000011066.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU
CHU Strasbourg
CH

intervention_type: Procedure

status_simplified: Unknown


type: Other Identifier

title: APPLE Trial: Feasibility and Activity of AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR Mutant NSCLC Patients

acronym: APPLE

summary: The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial will examine the best strategy for delivering osimertinib (upfront versus sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial will also explore the mechanisms of acquired resistance to Osimertinib based on the results of an optional biopsy upon progression.

status: Active, not recruiting

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Poland Jordan Slovenia Spain France

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University Hospital A Coruna-Hospital Teresa Herrera

intervention_type: Drug


title: Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients: Benefits on Physical Ability and Skeletal Muscle. An Interventional Pilot, Multicentric, Prospective, Longitudinal Study

acronym: EXDRE

summary:
Sickle cell disease (SCD) is the most frequent inherited disease in the world. Literature reports that SCD patients display intolerance to exercise, important muscle weakness and profound remodeling of skeletal muscle including amyotrophy and rarefied microvascular network.

Because strenuous exercise induces acidosis, hemorheological alterations, endothelial activation and oxidative stress, it constitutes a potential triggering factor of sickling and vaso-occlusive crisis. As a consequence, physical activity is usually discouraged in patients with SCD. However, moderate and regular physical activity seems to be not only safe but also beneficial for SCD patients.

ReferenceCitation: Merlet AN, Féasson L, Bartolucci P, Hourdé C, Schwalm C, Gellen B, Galactéros F, Deldicque L, Francaux M, Messonnier LA; EXDRE Collaborative Study Group. Muscle structural, energetic and functional benefits of endurance exercise training in sickle cell disease. Am J Hematol. 2020 Nov;95(11):1257-1268. doi: 10.1002/ajh.25936. Epub 2020 Aug 1.

ReferenceCitation: Merlet AN, Messonnier LA, Coudy-Gandilhon C, Béchet D, Gellen B, Rupp T, Galactéros F, Bartolucci P, Féasson L. Beneficial effects of endurance exercise training on skeletal muscle microvasculature in sickle cell disease patients. Blood. 2019 Dec 19;134(25):2233-2241. doi: 10.1182/blood.2019001055.

ReferenceCitation: Gellen B, Messonnier LA, Galactéros F, Audureau E, Merlet AN, Rupp T, Peyrot S, Martin C, Féasson L, Bartolucci P; EXDRE collaborative study group. Moderate-intensity endurance-exercise training in patients with sickle-cell disease without severe chronic complications (EXDRE): an open-label randomised controlled trial. Lancet Haematol. 2018 Nov;5(11):e554-e562. doi: 10.1016/S2352-3026(18)30163-7.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hopital Avicenne
Centre hospitalier de Saint-Denis
Hopital Tenon
Hopital Necker
CHU Henri MONDOR
Hopital Europeen Georges POMPIDOU
CHU de SAINT-ETIENNE
CHU Kremlin-Bicêtre
Centre hospitalier sud francilien


acronym: EVA

summary:
Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention

Material and Methods:

Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile)

Sudy 1: passive recording.

Study 2: active recording (instruction of attentional control given to the subject).

Study 3: active recording with a feedback obtained after a processing of the brain activity.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Neurosciences de Lyon

location_facility: Hospices civils de Lyon, Hôpital Henry Gabrielle,


title: Cost Utility of Radical Surgery in Ovarian Cancer

acronym: CURSOC

summary: The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).

primary_purpose: Health Services Research

ReferenceCitation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

location_facility: Hopital Nord-Ouest - Villefranche Sur Saone


title: Impact of 3-week SPA Therapy on Sleep Apnea in Patients With Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency: A Randomized, Controlled Study

acronym: THERMA-SAS

summary: The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).

status: Withdrawn

ReferenceType: background

ReferenceCitation: Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG. Review.

ReferenceCitation: Caffo B, Diener-West M, Punjabi NM, Samet J. A novel approach to prediction of mild obstructive sleep disordered breathing in a population-based sample: the Sleep Heart Health Study. Sleep. 2010 Dec;33(12):1641-8.

ReferenceCitation: Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.

ReferenceCitation: Monahan K, Storfer-Isser A, Mehra R, Shahar E, Mittleman M, Rottman J, Punjabi N, Sanders M, Quan SF, Resnick H, Redline S. Triggering of nocturnal arrhythmias by sleep-disordered breathing events. J Am Coll Cardiol. 2009 Nov 3;54(19):1797-804. doi: 10.1016/j.jacc.2009.06.038.

ReferenceCitation: Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84.

ReferenceCitation: Terán-Santos J, Jiménez-Gómez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51.

ReferenceCitation: Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41.

ReferenceCitation: Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503.

ReferenceCitation: Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008. Review. Erratum in: Physiol Rev.2010 Apr;90(2):797-8.

ReferenceCitation: Lévy P, Pépin JL, Dematteis M. Pharyngeal neuropathy in obstructive sleep apnea: where are we going? Am J Respir Crit Care Med. 2012 Feb 1;185(3):241-3. doi: 10.1164/rccm.201111-1992ED.

ReferenceCitation: Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8.

ReferenceCitation: Yumino D, Wang H, Floras JS, Newton GE, Mak S, Ruttanaumpawan P, Parker JD, Bradley TD. Prevalence and physiological predictors of sleep apnea in patients with heart failure and systolic dysfunction. J Card Fail. 2009 May;15(4):279-85. doi: 10.1016/j.cardfail.2008.11.015. Epub 2009 Jan 21.

ReferenceCitation: de Oliveira Rodrigues CJ, Marson O, Tufic S, Kohlmann O Jr, Guimarães SM, Togeiro P, Ribeiro AB, Tavares A. Relationship among end-stage renal disease, hypertension, and sleep apnea in nondiabetic dialysis patients. Am J Hypertens. 2005 Feb;18(2 Pt 1):152-7.

ReferenceCitation: Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7.

ReferenceCitation: Yumino D, Redolfi S, Ruttanaumpawan P, Su MC, Smith S, Newton GE, Mak S, Bradley TD. Nocturnal rostral fluid shift: a unifying concept for the pathogenesis of obstructive and central sleep apnea in men with heart failure. Circulation. 2010 Apr 13;121(14):1598-605. doi: 10.1161/CIRCULATIONAHA.109.902452. Epub 2010 Mar 29.

ReferenceCitation: Friedman O, Bradley TD, Chan CT, Parkes R, Logan AG. Relationship between overnight rostral fluid shift and obstructive sleep apnea in drug-resistant hypertension. Hypertension. 2010 Dec;56(6):1077-82. doi: 10.1161/HYPERTENSIONAHA.110.154427. Epub 2010 Nov 8.

ReferenceCitation: Elias RM, Bradley TD, Kasai T, Motwani SS, Chan CT. Rostral overnight fluid shift in end-stage renal disease: relationship with obstructive sleep apnea. Nephrol Dial Transplant. 2012 Apr;27(4):1569-73. doi: 10.1093/ndt/gfr605. Epub 2011 Nov 5.

ReferenceCitation: Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.

ReferenceCitation: Rapoport DM, Garay SM, Epstein H, Goldring RM. Hypercapnia in the obstructive sleep apnea syndrome. A reevaluation of the "Pickwickian syndrome". Chest. 1986 May;89(5):627-35.

ReferenceCitation: Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet. 1981 Apr 18;1(8225):862-5.

ReferenceCitation: Giles TL, Lasserson TJ, Smith BH, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001106. Review.

ReferenceCitation: Haentjens P, Van Meerhaeghe A, Moscariello A, De Weerdt S, Poppe K, Dupont A, Velkeniers B. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med. 2007 Apr 23;167(8):757-64.

ReferenceCitation: Marin JM, Agusti A, Villar I, Forner M, Nieto D, Carrizo SJ, Barbé F, Vicente E, Wei Y, Nieto FJ, Jelic S. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA. 2012 May 23;307(20):2169-76. doi: 10.1001/jama.2012.3418.

ReferenceCitation: Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. CPAP for the metabolic syndrome in patients with obstructive sleep apnea. N Engl J Med. 2011 Dec 15;365(24):2277-86. doi: 10.1056/NEJMoa1103944. Retraction in: Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. N Engl J Med. 2013 Oct 31;369(18):1770.

ReferenceCitation: Papandreou C, Schiza SE, Bouloukaki I, Hatzis CM, Kafatos AG, Siafakas NM, Tzanakis NE. Effect of Mediterranean diet versus prudent diet combined with physical activity on OSAS: a randomised trial. Eur Respir J. 2012 Jun;39(6):1398-404. doi: 10.1183/09031936.00103411. Epub 2011 Oct 27.

ReferenceCitation: Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.

ReferenceCitation: Mirrakhimov AE. Physical exercise related improvement in obstructive sleep apnea. Look for the rostral fluid shift. Med Hypotheses. 2013 Feb;80(2):125-8. doi: 10.1016/j.mehy.2012.11.007. Epub 2012 Dec 3.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

ReferenceCitation: Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.

ReferenceCitation: Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.

ReferenceCitation: Chan AS, Sutherland K, Schwab RJ, Zeng B, Petocz P, Lee RW, Darendeliler MA, Cistulli PA. The effect of mandibular advancement on upper airway structure in obstructive sleep apnoea. Thorax. 2010 Aug;65(8):726-32. doi: 10.1136/thx.2009.131094.

ReferenceCitation: Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. Review.

ReferenceCitation: Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost. 2009 May;7(5):879-83. doi: 10.1111/j.1538-7836.2009.03294.x. Epub 2009 Jan 19.

location_facility:
Clinic Beau Soleil
University Hospital Grenoble
Medical pratice (angiology)
Medical practice (angiology)


title: Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis

acronym: DESTIN

summary: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

ReferenceCitation: Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panés J, Schölmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lémann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21.

ReferenceCitation: Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
IMM
Hopital Beaujon
CHU NICE
CHU Bordeaux - Pessac
Chu Clermont-Ferrand
Hopital Saint Louis
Hopital Saint-Antoine
Chu Toulouse
CHRU Lille


title: Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

acronym: iLOC

summary: The study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria.

ReferenceCitation: Soussain C, Choquet S, Blonski M, Leclercq D, Houillier C, Rezai K, Bijou F, Houot R, Boyle E, Gressin R, Nicolas-Virelizier E, Barrie M, Moluçon-Chabrot C, Lelez ML, Clavert A, Coisy S, Leruez S, Touitou V, Cassoux N, Daniau M, Ertault de la Bretonnière M, El Yamani A, Ghesquières H, Hoang-Xuan K. Ibrutinib monotherapy for relapse or refractory primary CNS lymphoma and primary vitreoretinal lymphoma: Final analysis of the phase II 'proof-of-concept' iLOC study by the Lymphoma study association (LYSA) and the French oculo-cerebral lymphoma (LOC) network. Eur J Cancer. 2019 Aug;117:121-130. doi: 10.1016/j.ejca.2019.05.024. Epub 2019 Jul 3.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHRU de LILLE - Claude Huriez
CHU Brabois
Hôpital René Huguenin Institut Curie
CHU de Grenoble
Centre Léon Bérard
CHU d'ESTAING
CHU de la Timone
CHU de la Pitié Salpêtrière
Centre Henri Becquerel
CHU de Rennes


title: Phase 3 Multicentric Randomized Study Assessing Self-reported Symptoms Transmitted Via an Internet Web-application " Sentinel " Versus Conventional Follow-up in Patients With High Risk Lung Cancer (SENTINEL)

acronym: SENTINEL

summary: This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients.

lead_sponsor: Weprom

location_facility: Institut de Cancerologie de l'Ouest - site René Gauducheau

location_facility: Institut de Cancerologie de l'Ouest - site Paul Papin


title: Multicenter Prospective Broad Validation of a Management Algorithm Mild Head Injury in Children

acronym: EVEACE

summary:
Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary exposure to radiation ionizing. This clinical decision rule constructed from a multicenter prospective cohort 42,412 American children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions.

Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. Indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established.

The investigators' work aims to conduct this broad validation study prospective multicenter way in a French pediatric population, as recommended by the French Emergency Medicine Society, in order to confirm or deny its predictive performance and allow its application and generalization. The investigators will check and if the Rule Clinical Decision is adapted or not to the management of mild head injuries in the French pediatric population.

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospiatlier Départemental de Vendée


title: A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).

acronym: EVERCMV

summary: Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.

ReferenceCitation: Kaminski H, Marseres G, Yared N, Nokin MJ, Pitard V, Zouine A, Garrigue I, Loizon S, Capone M, Gauthereau X, Mamani-Matsuda M, Coueron R, Durán RV, Pinson B, Pellegrin I, Thiébaut R, Couzi L, Merville P, Déchanet-Merville J. mTOR Inhibitors Prevent CMV Infection through the Restoration of Functional αβ and γδ T cells in Kidney Transplantation. J Am Soc Nephrol. 2022 Jan;33(1):121-137. doi: 10.1681/ASN.2020121753. Epub 2021 Nov 1.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Edouard Herriot
CHU de Toulouse - Hôpital Rangueil
CHU de Limoges - Hôpital Dupuytren
CHRU Caen - Hôpital de Caen
CHU La Cavale Blanche
CHU de Bordeaux
APHP - Hôpital Necker
APHP - Kremlin Bicetre
CHRU Strasbourg


title: Contribution of High-throughput Exome Sequencing in Fetopathology

acronym: FOETEX

summary:
This research concerns the contribution of a new examination, high-throughput exome sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. With currently available examinations, the causes of polyformative syndromes, which correspond to the association of several congenital malformations with varying degrees of severity in different organs, remain unknown in a large number of cases.

High-throughput exome sequencing (HTES) is a diagnostic tool that allows the simultaneous analysis of all of the coding parts of DNA. This examination has already shown its superior diagnostic capability in every post-natal diagnostic context, in particulier in infants with malformations associated or not with intellectual deficiency. Its contribution has not yet been studied in a large number of fetuses with polymalformations. To investigate the usefulness of HTES, we propose to carry out the examination in 100 fetuses with polymalformations, as well as the usual examinations including chromosomal microarray analysis and possibly the study of specific genes that may explain these malformations. A blood sample will be taken from both parents to allow interpretation of the results.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CH de Mulhouse (Hôpital Emile Muller)
CHU de DIJON
CHU de Rouen
CHU de NANCY
CHU Montpellier
CHU de STRASBOURG (Hôpital Hautepierre)
CHU de Clermont-Ferrand
CHRU de Reims (Hôpital Maison Blanche)
CHRU de Tours
CHU de Rennes


type: EudraCT Number

title: Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial

acronym: KETIS

summary: The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.

ReferenceCitation: Abbar M, Demattei C, El-Hage W, Llorca PM, Samalin L, Demaricourt P, Gaillard R, Courtet P, Vaiva G, Gorwood P, Fabbro P, Jollant F. Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial. BMJ. 2022 Feb 2;376:e067194. doi: 10.1136/bmj-2021-067194.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

location_facility: CHRU de Tours - Clinique Psychiatrique Universitaire


title: Determining Biomechanical and Morphological Factors That Affect Children With Duchenne Muscular Dystrophy (DMD) Who Loss of the Ability to Walk

acronym: MARCHE-DMD

summary: The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a pejorative event. Biomechanical and morphological unknowledge about the loss of the walk ability in children with DMD is an obstacle in reeducative, pharmacological or surgical therapeutic targets.

primary_purpose: Other

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Nantes
CHRU
CH Le Mans
CHU
CHBA


title: Does the Time Between the End of Vascular Filling and Evaluation of Its Effectiveness Modify Fluid Challenge Results in Septic Shock?

acronym: FC-Rev

summary: The main objective of this study is to evaluate in a population of patients with septic shock receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as "responders" to the fluid challenge (increase of at least 15% of ITV in aortic) at the end of vascular filling (T10) and becoming "non-responders" 20 minutes after the end of the fluid challenge (T30) and whether this proportion is greater than 10 points.

ReferenceCitation: Roger C, Zieleskiewicz L, Demattei C, Lakhal K, Piton G, Louart B, Constantin JM, Chabanne R, Faure JS, Mahjoub Y, Desmeulles I, Quintard H, Lefrant JY, Muller L; AzuRea Group. Time course of fluid responsiveness in sepsis: the fluid challenge revisiting (FCREV) study. Crit Care. 2019 May 16;23(1):179. doi: 10.1186/s13054-019-2448-z.

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

location_facility: CHU de Nantes - Hôpital Guillaume et René Laennec


intervention_type: Biological

title: Assessment of VAC-3S Therapeutic Properties When Combined With Standard Antiretroviral Therapy (ART) in the Course of HIV-1 Infection. A European, Randomized, Double Blind Placebo-controlled Phase II Study

lead_sponsor: InnaVirVax

source: euctr

location_country: Germany France Spain

location_facility:
Hôpital Bichat - Claude Bernard
Jürgen Rockstroh
Hôpital Gui de Chauliac
Hôpital Pitié Salpêtrière
Hospital Clinic University of Barcelona
Hôpital Sud Francilien
Hôpital Européen Georges Pompidou
Gerd Fätkenheuer
Hôpital Tenon
Hôpital de la Croix Rousse
Hôpital Cochin Saint Vincent de Paul
Hôpital Saint-Antoine

summary: The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.


title: Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.

acronym: BANQUISE

summary:
For the specific patient population studied receiving 5-Fluorouracil, epirubicin and cyclophosphamide - Docetaxel sequence (cumulative dose <300 mg / m2), using a cryoprotection has never been assessed.

The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well established in this population (breast cancer in the adjuvant setting) and is based solely on a publication (Scotté) that does not contain the same therapeutic modalities (dose significantly higher). The few studies available have heterogeneous populations, nonrandomized, retrospective or with a small sample.

By extension to what has been observed with higher cumulative doses of docetaxel, some teams offer mittens and booties chilled to their patients, a practice that is not the subject of a national consensus.

The investigators wish to accurately assess the effectiveness of mittens and slippers chilled, their tolerance and their observance because of weak data on this specific population in the literature.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Institut de cancérologie de l'Ouest - Angers

location_facility: Institut de cancérologie de l'Ouest - Nantes


title: Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase

acronym: EAP

summary: Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.

status: No longer available

study_type: Expanded Access

lead_sponsor: ERYtech Pharma

location_facility:
Hôpital Brabois Enfants
IHOP
CHRU Lille - Hôpital Claude-Huriez
Hôpital Saint Louis
CHU Saint Etienne Hôpital Nord
Institut Universitaire du Cancer
Hôpital de l'Archet 2
Hôpital Jean Minjoz - Batiment MEMCP
CHU Rouen - Hôpital des enfants
Hôpital BRETONNEAU


title: Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease

acronym: CHANCE

summary:
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies.

Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.

ReferenceCitation: Sands B.E. Crohn's Disease. Sleisenger and Fortran's Gastrointestinal and Liver Disease. 8th edition; Volume 2; Saunders Elsevier Publisher; Canada. 2006. pps 2459-2498.

ReferenceCitation: Lichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.

ReferenceCitation: Kornbluth A, Colombel JF, Leighton JA, Loftus E; ICCE. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005 Oct;37(10):1051-4.

ReferenceCitation: Engstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.

ReferenceCitation: Sipponen T, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Färkkilä M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008 Jan;14(1):40-6.

ReferenceCitation: Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. Review.

ReferenceCitation: Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005 Oct;37(10):960-5. Erratum in: Endoscopy. 2007 Mar;39(4):303.

ReferenceCitation: Mow WS, Lo SK, Targan SR, Dubinsky MC, Treyzon L, Abreu-Martin MT, Papadakis KA, Vasiliauskas EA. Initial experience with wireless capsule enteroscopy in the diagnosis and management of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2004 Jan;2(1):31-40.

ReferenceCitation: Dray X, Vahedi K, Valleur P, Marteau P. Is there any need for video capsule endoscopy evaluation in postduodenal small-bowel polyps detection in familial adenomatous polyposis? Gastrointest Endosc. 2007 Sep;66(3):634; author reply 634-5.

ReferenceCitation: Dionisio PM, Gurudu SR, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010 Jun;105(6):1240-8; quiz 1249. doi: 10.1038/ajg.2009.713. Epub 2009 Dec 22.

ReferenceCitation: van Assche G, Vermeire S, Rutgeerts P. Mucosal healing and anti TNFs in IBD. Curr Drug Targets. 2010 Feb;11(2):227-33.

ReferenceCitation: D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34.

ReferenceCitation: Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9.

ReferenceCitation: Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

ReferenceCitation: Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464.

ReferenceCitation: Dubcenco E, Jeejeebhoy KN, Petroniene R, Tang SJ, Zalev AH, Gardiner GW, Baker JP. Capsule endoscopy findings in patients with established and suspected small-bowel Crohn's disease: correlation with radiologic, endoscopic, and histologic findings. Gastrointest Endosc. 2005 Oct;62(4):538-44.

ReferenceCitation: Postgate AJ, Burling D, Gupta A, Fitzpatrick A, Fraser C. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci. 2008 Oct;53(10):2732-8. doi: 10.1007/s10620-008-0210-5. Epub 2008 Mar 5.

location_country: France Spain

location_facility:
CHU Kremlin Bicêtre
Hôpital Brabois
CHU Clermont Ferrand
Hôpital Huriez
Hôpital Beaujon
CHU CAEN
Hôpital Hôtel Dieu
Hôpital Archet 2
CHU Amiens
Hôpital St Louis
Hospital Clinic


title: Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

acronym: BestCuff

summary: The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

ReferenceCitation: Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z.

ReferenceCitation: Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoRéal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16.

lead_sponsor: University Hospital, Lille

location_facility: ICU, Salengro Hospital, University Hospital of Lille


acronym: CYCLIGIST

title: Efficacy and Safety of PD-0332991 in Patients With Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib: A Phase 2 Study

lead_sponsor: Institut Bergonié

ReferenceType: result

ReferenceCitation: Toulmonde M, Blay JY, Bouche O, Mir O, Penel N, Isambert N, Duffaud F, Bompas E, Esnaud T, Boidot R, Geneste D, Ghiringhelli F, Lucchesi C, Bellera CA, Le Loarer F, Italiano A. Activity and Safety of Palbociclib in Patients with Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib: A Biomarker-driven Phase II Study. Clin Cancer Res. 2019 Aug 1;25(15):4611-4615. doi: 10.1158/1078-0432.CCR-18-3127. Epub 2019 Apr 12. Erratum in: Clin Cancer Res. 2019 Aug 1;25(15):4859.

location_facility:
Institut Bergonié
Hôpital Saint-Antoine (AP-HP)
Centre René Gauducheau
Centre Léon Bérard
Centre Oscar Lambret
Institut Gustave Roussy
CHU de REIMS - Hôpital Robert Debré
Hôpital de la Timone - AP-HM
Centre Georges-Francois Leclerc

summary:
The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib is frequently short, and after failure with both imatinib and sunitinib, treatment remains controversial.

Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al. 2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A, CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005; Assamaki et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21 deletions target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are known to be under the transcriptional control of E2F. RB1 sequesters E2F, which is released from the complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a. Hence, we hypothesize that alteration of the restriction point via deletion of p16INK4a (and more rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads to the overexpression of CINSARC genes, which in turn induce chromosome instability and ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009). Considering our molecular data, we believed that PD-0332991 warrants clinical investigation in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is detectable by comparative genomic hybridization which is a technique highly manageable in the context of routine clinical care and clinical trial.

Main objective was to assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks (after centralized review) in patients with documented disease progression while on therapy with imatinib and sunitinib for unresectable and/or metastatic GIST.


title: Multicentric Evaluation of IMACTIS-CT Navigation System

summary: Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of interventional radiology under scan in the thoraco-abdominal level.

ReferenceCitation: Rouchy RC, Moreau-Gaudry A, Chipon E, Aubry S, Pazart L, Lapuyade B, Durand M, Hajjam M, Pottier S, Renard B, Logier R, Orry X, Cherifi A, Quehen E, Kervio G, Favelle O, Patat F, De Kerviler E, Hughes C, Medici M, Ghelfi J, Mounier A, Bricault I. Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. Trials. 2017 Jul 6;18(1):306. doi: 10.1186/s13063-017-2049-6.

lead_sponsor: University Hospital, Grenoble

location_facility:
Ambroise Paré University Hospital
University Hospital of Saint-Louis
University Hospital


title: WEB French Observatory

summary: An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.

lead_sponsor: Microvention-Terumo, Inc.

location_facility:
Hôpital Nord Laennec
CHU Pontchailloux
CHU Purpan
CHU Reims - Hôpital Maison-Blanche
CHU Pellegrin
CHU Côte de Nacre
CHU La Miletrie
CHU Bretonneau
CHU Beaujon
Hôpital Neurologique Pierre Wertheimer


title: Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.

summary: Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.

ReferenceCitation: Jacot W, Cottu P, Berger F, Dubot C, Venat-Bouvet L, Lortholary A, Bourgeois H, Bollet M, Servent V, Luporsi E, Espié M, Guiu S, D'Hondt V, Dieras V, Sablin MP, Brain E, Neffati S, Pierga JY, Bidard FC. Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial. Breast Cancer Res. 2019 Nov 14;21(1):121. doi: 10.1186/s13058-019-1215-z.

lead_sponsor: Institut Curie

location_facility:
Clinique Victor Hugo
Centre Val d'Aurelle - P. Lamarque
Chu de Limoges
Centre Catherine de Sienne
Chu Saint-Louis
Institut Curie - Hôpital René HUGENIN
Institut de Cancérologie de Lorraine
Centre Oscar Lambret
Institut Curie
Institut de Cancérologie HARTMANN


acronym: VESTOR

title: Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer

ReferenceCitation: Pulido M, Roubaud G, Cazeau AL, Mahammedi H, Vedrine L, Joly F, Mourey L, Pfister C, Goberna A, Lortal B, Bellera C, Pourquier P, Houédé N. Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer. BMC Cancer. 2018 Feb 17;18(1):194. doi: 10.1186/s12885-018-4059-5.

location_facility: Hôpital d'instruction des armées du Val-de-Grâce

summary: In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.


title: Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia

acronym: VISMOLY

summary: The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL).

status: Terminated

location_facility:
CHU Haut Lévèque
Hôpital René Huguenin _ Institut Curie
CHU de Nantes _ Hôtel Dieu
Hôpital Henri MONDOR
CHU Pontchaillou
CHRU de Lille _ Hôpital Huriez
CHU Dijon _ Hôpital d'Enfants
Centre Henri Becquerel
CH Lyon Sud
Hôpital Saint-Louis


title: Phase II Trial Studying the Efficacy of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone as Induction Prior to, and as Consolidation After High-dose Therapy With Peripheral Stem Cell Transplantation Followed by MLN9708 Maintenance in the Initial Management of Multiple Myeloma in Patients Younger Than 66 Years

location_facility:
Hôpital Saint-Antoine
CHRU - Hôpital Bretonneau
CHRU Dijon
Centre hospitalier départemental Vendée
CHRU - Hôpital Claude Huriez
CHRU - Hôpitaux de Brabois
Pole IUC Oncopole CHU
CHRU - Hôpital du Haut Lévêque
Centre Hospitalier Lyon sud
Nantes University Hospital

summary:
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.


title: Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled

acronym: DBMZol

summary:
Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.

Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.

No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.

location_facility:
CRMPR Les Herbiers
University hospital of Nantes
Institut Régional de Réadaptation Nancy
CHU
Hôpital Rangueil CHU
Centre Mutualiste Neurologique Propara
Hôpital R. Poincaré
Centre Bouffard - Vercelli CAP Cerbère
Centre de l'Arche


title: A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,

acronym: ASSESS

summary: This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Japan
Germany


title: Role of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Patients Wih Leptomeningeal Metastasis of Breast Cancer. A Randomized Phase III Study.

acronym: DEPOSEIN

summary: The purpose of this study is to evaluate the impact of Depocyte® IT combined with the systemic standard treatment in terms of clinical and/or radiological neuromeningeal progression free survival (SSPN)

ReferenceCitation: Le Rhun E, Wallet J, Mailliez A, Le Deley MC, Rodrigues I, Boulanger T, Lorgis V, Barrière J, Robin YM, Weller M, Bonneterre J. Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer. Neuro Oncol. 2020 Apr 15;22(4):524-538. doi: 10.1093/neuonc/noz201.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire Groupe Sud


title: Evaluation du Stent Multicouches Dans le Traitement Des anévrismes de l'Aorte Thoraco-abdominale

acronym: STRATO

summary:
Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm Repair.

The objectives of the study is to determine the efficacy, safety and performance of the MFM and its delivery system in patients at high surgical risk presenting with a type II, III thoracoabdominal aneurysm, below the left subclavian and above the iliac bifurcation, according to the Crawford classification.

ReferenceCitation: Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, Alsac JM, Leprince PN, Unterseeh T, Portocarrero E, Glock Y, Rousseau H; STRATO Investigators Group. One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial. J Endovasc Ther. 2014 Feb;21(1):85-95. doi: 10.1583/13-4553R.1.

ReferenceCitation: Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, Alsac JM, Leprince PN, Unterseeh T, Portocarrero E, Glock Y, Rousseau H; STRATO Investigators Group. Three-Year Outcomes With the Multilayer Flow Modulator for Repair of Thoracoabdominal Aneurysms: A Follow-up Report From the STRATO Trial. J Endovasc Ther. 2016 Oct;23(5):762-72. doi: 10.1177/1526602816653095. Epub 2016 Jun 8.

lead_sponsor: Cardiatis

location_facility: Institut Cardio-Vasculaire Paris Sud Hôpital Claude Galien À Quincy

location_facility: Centre Hospitalier de La Région D'Annecy


title: Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder

acronym: PRESTHYM

summary: Depression is a common, recurrent and disabling disorder. Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep brain stimulation (DBS) of nucleus accumbens is considered.

ReferenceCitation: Millet B, Jaafari N, Polosan M, Baup N, Giordana B, Haegelen C, Chabardes S, Fontaine D, Devaux B, Yelnik J, Fossati P, Aouizerate B, Krebs MO, Robert G, Jay T, Cornu P, Vérin M, Drapier S, Drapier D, Sauleau P, Peron J, Le Jeune F, Naudet F, Reymann JM. Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: accumbens more promising than caudate. Eur Neuropsychopharmacol. 2014 Aug;24(8):1229-39. doi: 10.1016/j.euroneuro.2014.05.006. Epub 2014 May 20.

lead_sponsor: Rennes University Hospital

location_facility: Grenoble University Hospital (Nord Hospital)


title: Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer

acronym: CEOLE

summary: The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.

primary_purpose: Supportive Care

ReferenceCitation: Poirier AL, Kwiatkowski F, Commer JM, D'Aillières B, Berger V, Mercier M, Bonnetain F. Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial. Trials. 2012 Apr 20;13:39. doi: 10.1186/1745-6215-13-39.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Institut Bergonié
Centre Val d'Aurelle Paul Lamarque
ICO Paul Papin
Centre Alexis Vautrin
CHU Minjoz
Centre Hospitalier
Centre Georges François Leclerc
Centre Antoine Lacassagne
CHU
Centre Oscar Lambret


title: Clinical, Biological, Genetic and Functional Characterization of Rare Iron Overload Phenotypes Associated With Hepcidin Deficiency Except C282Y Homozygosity.

acronym: HEPCIDEF

summary: Chronic iron overload is responsible for morbidity and mortality. There are many genetic and acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone for iron. The study explores this specific cause, and aim to characterize this iron overload in term of clinical, biological, genetic and functional specificities.

location_facility:
CHRU - Huriez Hospital
Saint Eloi Hospital - CHU
Limoges CHU
Lyon Sud Hospital
BP 86709
Hospital Center
Purpan CHU
Kremlin-Bicêtre Hospital
Emilie Muller Hospital
Hospital of conception


title: Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients in Terms of Mortality, Glycemic Control, and Cost Effectiveness - Prospective, Multicenter, Randomized Study

acronym: DIABSURG

summary: The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.

location_facility:
University Hospital of Lille
Ch Valenciennes
Hopital Jeanne D'Arc Chu Nancy
Hopital Lapeyronie Chu Montpellier
Hopital Larrey Chu Toulouse
Hopital de Bois-Guillaume Chu Rouen
Hu Pitie Salpetriere Aphp
Hu Ouest Site Ambroise Pare Aphp -
Centre Hospitalier Regional D' Angers
Hopital Lyon Sud - Hcl - Pierre Benite


ipd_sharing: Yes

acronym: HPV-071 PRI

title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Leung TF, Liu AP, Lim FS, Thollot F, Oh HM, Lee BW, Rombo L, Tan NC, Rouzier R, Friel D, De Muynck B, De Simoni S, Suryakiran P, Hezareh M, Folschweiller N, Thomas F, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689-702. doi: 10.1080/21645515.2015.1050570.

ReferenceCitation: Leung TF, Liu AP, Lim FS, Thollot F, Oh HML, Lee BW, Rombo L, Tan NC, Rouzier R, De Simoni S, Suryakiran P, Hezareh M, Thomas F, Folschweiller N, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9-14 years: Results to month 36 from a randomized trial. Vaccine. 2018 Jan 2;36(1):98-106. doi: 10.1016/j.vaccine.2017.11.034. Epub 2017 Nov 23.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below).

location_country:
Singapore
France
Hong Kong
Sweden

summary: The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.


title: Evaluation of the Protective Role of Beta-blockers Prescribed in a Chronic Way on the Arisen of a Severe Septic Syndrome or a Toxic Shock at Patients Having a Community Infection

summary: The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence on a community infection has never been studied. The objective of this study is to evaluate this role.

location_facility: Limoges University Hospital (Hospital Dupuytren)

location_facility: Grenoble University Hospital (A. Michallon)

location_facility: Nancy University Hospital (Jeanne d'Arc)

location_facility: Saint Etienne University Hospital (Bellevue)

location_facility: Rennes University Hospital (Pontchaillou)

location_facility: Groupe hospitalier Raymond Poincaré, AP-HP


summary:
Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in the brain of patients with AD.

The main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive decline in AD over a 2-year follow-up.

Secondary objectives include:

the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)
correlation between plasma cytokines levels and expression of the protein kinase PKR (involved in death cell) in blood mononuclear cells.

lead_sponsor: Poitiers University Hospital

location_facility: CHU DE NANTES - Centre ambulatoire de Gérontologie clinique

location_facility: CHU Angers - service Gérontologie clinique


title: Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial

summary: Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU Clermont Ferrand - Service of Thoracic Surgery

location_facility: Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery

location_facility: CHU Marseille - Department of Thoracic Surgery

location_facility: Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse

location_facility: CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital

location_facility: CHU Nice - Pasteur Hospital - Department of Thoracic Surgery

location_facility: CHU Strasbourg - Service of Thoracic Surgery

location_facility: CHU Grenoble - Department of Vascular and Thoracic Surgery


title: Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)

acronym: X-ACT

summary: The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).

lead_sponsor: Guerbet

location_country: Spain Italy Switzerland France Germany

location_facility: Ospedale civile Maggiore du Verona Borgo

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Ospedale A.Perrino U.O. di radiodiagnostica

location_facility: Institut für Radiologie Universitätsklinikum Charité


title: Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial

summary:
Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.

Objective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume.

Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.

Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.

ReferenceCitation: Meurin P, Lelay-Kubas S, Pierre B, Pereira H, Pavy B, Iliou MC, Bussière JL, Weber H, Beugin JP, Farrokhi T, Bellemain-Appaix A, Briota L, Tabet JY; French Society of Cardiology. Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial. Heart. 2015 Nov;101(21):1711-6. doi: 10.1136/heartjnl-2015-307827. Epub 2015 Jun 15.

lead_sponsor: French Cardiology Society

location_facility:
Maison du mineur
Hopital Corentin Celton
Clinique Iris
Centre Dieulefit Santé
Clinique de la mitterie
Bois Gibert
Centre Hospitalier Loire Vendée Océan
Clinique de Châtillon
Clinique les Grands Près
Centre Médical de Bligny


title: Cilengitide (EMD121974) in Combination With Irradiation in Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Glioma: Phase I Study

summary: The aim of the study is to determine the safety of Cilengitide in combination with radiation therapy.

location_facility: Centre Hospitalier Universitaire de Nantes


title: Open, Non-controlled, Multicentre, First-in-man Study Using Escalating Doses of LFB-R603 in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

summary: This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.

ReferenceCitation: de Romeuf C, Dutertre CA, Le Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Béliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Béral H. Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16. Br J Haematol. 2008 Mar;140(6):635-43. doi: 10.1111/j.1365-2141.2007.06974.x.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_facility:
Clinique Victor Hugo
Hôpital Hurriez
Hôpital de Brabois
Institut Paoli Calmettes
Institut Gustave Roussy
Hôpital Saint Eloi
Hôpital Pontchaillou
Centre Henri Becquerel
CH Lyon Sud


title: Randomised Phase II Study Evaluating the Anti-tumour Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy

acronym: REMYKIR

summary: This is an open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy.

lead_sponsor: Innate Pharma

location_facility:
C.H.R.U. de Tours
Institut Paoli Calmettes
Hôpital Saint Antoine
CHU Nancy
CHU Dijon
Hopital Saint Louis
C.H.R.U. de Caen - Hôpital Bretonneau
CHRU Lille
Hôpital Dupuytren


title: Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants

acronym: Rose

summary: The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.

lead_sponsor: Sodilac


title: Interest of Relaxation From Patients With Pain Due to Migraine

acronym: MIGREL

summary: The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.

location_facility: Consultation de la douleur du CHU d'Amiens

location_facility: Consultation de la douleur - CH Emile Roux


acronym: INFILTHERA

summary:
Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:

neuropathic pains treatment
specific kinesitherapy
Alcock's canal and sacrospinal ligament infiltrations under scan
with diagnostic block
local steroids injections
and surgical decompression of pudendal nerve with transrectal approach.

Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies.

The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament:

group A: only local anesthetic (control arm)
group B: local anesthetics associated with local steroids
group C: local anesthetics associated with local steroids and important volumes of physiological serum

lead_sponsor: Nantes University Hospital

location_facility:
Hôpital Rothschild
CHU Clermont-Ferrand
CHU de Nantes
Hôpital Charles Nicolle
Centre MARIENIA
CH de la Côte Basque
Hospices Civils de Lyon
Scanner Saint Hilaire
Catherine de Sienne


title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial

acronym: FLAME

summary: Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.

ReferenceCitation: Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29.

ReferenceCitation: Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4.

ReferenceCitation: Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7. Erratum in: Lancet Neurol. 2011 Mar;10(3):205.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital René Dubos
University Hospital
University Hospital Pitié Salpétrière
University Hospital Purpan
University Hospital Rangueil
University Hospital Sainte Anne


acronym: PIMABI

intervention_type: Genetic

title: An Open-label Phase II Trial of Panitumumab Plus Irinotecan for Patients With Advanced Metastatic Colorectal Cancer Without KRAS Mutation (Wild-type) in Third-line Chemotherapy (FOLFOX/XELOX ± Bevacizumab and Irinotecan Alone or FOLFIRI/CAPIRI ± Bevacizumab)

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

ReferenceCitation: André T, Blons H, Mabro M, Chibaudel B, Bachet JB, Tournigand C, Bennamoun M, Artru P, Nguyen S, Ebenezer C, Aissat N, Cayre A, Penault-Llorca F, Laurent-Puig P, de Gramont A; GERCOR. Panitumumab combined with irinotecan for patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy: a GERCOR efficacy, tolerance, and translational molecular study. Ann Oncol. 2013 Feb;24(2):412-419. doi: 10.1093/annonc/mds465. Epub 2012 Oct 5.

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

summary:
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan to see how well it works as third-line therapy in treating patients with metastatic colorectal cancer.


title: An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

acronym: IRISS

summary: The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.

ReferenceCitation: Sacco RL, Kargman DE, Gu Q, Zamanillo MC. Race-ethnicity and determinants of intracranial atherosclerotic cerebral infarction. The Northern Manhattan Stroke Study. Stroke. 1995 Jan;26(1):14-20.

ReferenceCitation: EC/IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med. 1985 Nov 7;313(19):1191-200.

ReferenceCitation: Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16.

ReferenceCitation: Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease Trial Investigators. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006 Jan 31;113(4):555-63. Epub 2006 Jan 23.

ReferenceCitation: Connors JJ 3rd, Wojak JC. Percutaneous transluminal angioplasty for intracranial atherosclerotic lesions: evolution of technique and short-term results. J Neurosurg. 1999 Sep;91(3):415-23.

ReferenceCitation: Marks MP, Wojak JC, Al-Ali F, Jayaraman M, Marcellus ML, Connors JJ, Do HM. Angioplasty for symptomatic intracranial stenosis: clinical outcome. Stroke. 2006 Apr;37(4):1016-20. Epub 2006 Feb 23.

ReferenceCitation: SSYLVIA Study Investigators. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke. 2004 Jun;35(6):1388-92. Epub 2004 Apr 22.

ReferenceCitation: Wojak JC, Dunlap DC, Hargrave KR, DeAlvare LA, Culbertson HS, Connors JJ 3rd. Intracranial angioplasty and stenting: long-term results from a single center. AJNR Am J Neuroradiol. 2006 Oct;27(9):1882-92.

ReferenceCitation: Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. Epub 2007 Mar 29.

ReferenceCitation: Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Pride L, Purdy P, Welch B, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG, Fiorella DJ. Wingspan in-stent restenosis and thrombosis: incidence, clinical presentation, and management. Neurosurgery. 2007 Sep;61(3):644-50; discussion 650-1.

ReferenceCitation: Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30.

ReferenceCitation: Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. Epub 2007 Jun 21. Review.

ReferenceCitation: Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Trial Investigators. Design, progress and challenges of a double-blind trial of warfarin versus aspirin for symptomatic intracranial arterial stenosis. Neuroepidemiology. 2003 Mar-Apr;22(2):106-17.

ReferenceCitation: Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000 Apr;21(4):643-6.

lead_sponsor: Stryker Neurovascular

location_country: Germany France

location_facility:
Hôpital Saint-Roch
Asklepios Klinik Altona
Fondation Rotschild
Universitätsklinikum Dresden
Universitätsklinikum Freiburg
Klinikum Augsburg
CHU Toulouse
Groupe Hospitalier Pellegrin
Universitätsklinikum Essen
CHU Limoges
CHU Dijon-Hopital General
Universitätsklinikum Erlangen
CHU Hôpital Guillaume et René Laënnec
Universitätsklinikum Heidelberg
Höpital Gui de Chauliac
CHU Reims
Hôpital Lariboisière
UKSH Campus Kiel
Universitätsklinikum Düsseldorf


acronym: DECAPUB

title: Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty

lead_sponsor: Ipsen

location_facility:
Hôpital de la Gespe
Hôpital Charles Nicolle
Medical Centre
American Memorial Hospital
Hôpital Robert Debré
Hôpital Archet II
Hôpital Hôtel Dieu (CHU)
Hôpital Flaubert
Hôpital des Enfants
Hôpital Hautepierre

summary: The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.


title: Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


acronym: KinéSEP

title: Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®

lead_sponsor: Bayer

summary: Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.


title: A Phase II Trial of Bevacizumab in Myelodysplastic Syndromes (Int-1, Int-2 and High Risk According to IPSS) With Excess of Marrow Blasts

summary:
The objectives of this phase II trial are to test the efficacy and tolerance of Bevacizumab in MDS patients with excess of marrow blasts and to evaluate the impact of Bevacizumab on angiogenesis and erythropoiesis.

To limit the myelotoxicity observed in the preliminary phase II study, Bevacizumab will be administrated at the initial dose of 5 mg/kg.

The primary endpoint will be response: Complete Remission (CR), Partial Remission (PR) and hematological improvement (HI) according to IWG criteria (see appendix 3).

The secondary endpoints will be survival, response duration, side effects, evaluation of angiogenesis (bone marrow microvessel density, VEGF plasma level, VEGF mRNA expression, HIF-1alpha expression).

The design of this study consists of three study periods: pre-treatment (screening), treatment (loading and maintenance), and follow-up. All patients will participate in the study for at least 12 weeks of therapy, a 4-week follow-up visit, and long-term follow-up unless the criteria for planned or unplanned early discontinuation are met.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Department of Onco-Hematology, Caremeau Hospital, CHU Nîmes

location_facility: Department of clinical hematology, Robert Debré Hospital

location_facility: Department of Clinical hematology, Archet Hospital, CHU de Nice

location_facility: Department of Hematology and Oncology, CHU de Strasbourg


title: Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated

summary: This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization ratio, escitalopram 2/placebo 1).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Brabois Hospital
Michallon Hospital
Rangueil Hospital
Hautepierre Hospital
Sainte Marguerite Hospital
Antoine Beclere Hospital
Henri Mondor Hospital
Haut Lévèque Hospital
Louis Pradel Hospital


title: Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.

summary: The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.

ReferenceCitation: Karam G, Compagnon P, Hourmant M, Despins P, Duveau D, Noury D, Boudjema K. A single solution for multiple organ procurement and preservation. Transpl Int. 2005 Jun;18(6):657-63.

ReferenceCitation: Adam R, Cailliez V, Majno P, Karam V, McMaster P, Caine RY, O'Grady J, Pichlmayr R, Neuhaus P, Otte JB, Hoeckerstedt K, Bismuth H. Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Lancet. 2000 Aug 19;356(9230):621-7. Erratum in: Lancet 2001 Apr 21;367(9264):1296.

lead_sponsor: Rennes University Hospital

location_facility: Service de Chirurgie Générale - Hôpital de la Conception

location_facility: Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren

location_facility: Service de Chirurgie Digestive - Hôpital de la Côte de Nacre

location_facility: Département de Chirurgie Viscérale - Hôpital Pontchaillou

location_facility: Service de Chirurgie Digestive - Hôpital Henri Mondor

location_facility: Service de Chirurgie Générale - Hôpital Edouard Herriot

location_facility: Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Cochin

location_facility: Chirurgie générale et digestive - Hôpital de la Croix Rousse


title: Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70

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

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

ReferenceCitation: Viret F, Bugat R, Ducreux M, et al.: XELOX regimen in elderly patients with metastatic colorectal cancer (MCRC), a FNCLCC French Collaborative Group GERICO 02 phase II study. [Abstract] J Clin Oncol 25 (Suppl 18): A-19513, 708s, 2007.

lead_sponsor: UNICANCER

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


title: Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders

summary: Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe OCD.

ReferenceCitation: Le Jeune F, Vérin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.

ReferenceCitation: Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chéreau I, Arbus C, Mallet L, du Montcel ST; French "Stimulation dans le Trouble Obsessionnel Compulsif (STOC)" Study Group. A video Clinical Global Impression (CGI) in obsessive compulsive disorder. Psychiatry Res. 2011 Mar 30;186(1):117-22. doi: 10.1016/j.psychres.2010.06.021. Epub 2011 Feb 12.

ReferenceCitation: Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Vérin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1027.

lead_sponsor: Marie-laure Welter

location_facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière


title: Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia

acronym: REG-HYPO

summary: The purpose of this study is to assess medical events during follow-up of adult patients having hypophosphatasia and consulting rheumatologists.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Other

location_facility: Les hôpitaux universitaires de Strasbourg