title: Congestive Heart Failure Atrial Arrhythmia Monitoring and Pacing (CHAMP)

summary: The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.

ReferenceCitation: Remme WJ, Swedberg K; Task Force for the Diagnosis and Treatment of Chronic Heart Failure, European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2001 Sep;22(17):1527-60. Erratum in: Eur Heart J 2001 Dec;22(23):2217-8.

ReferenceCitation: Mosterd A, de Bruijne MC, Hoes AW, Deckers JW, Hofman A, Grobbee DE. Usefulness of echocardiography in detecting left ventricular dysfunction in population-based studies (The Rotterdam Study). Am J Cardiol. 1997 Jan 1;79(1):103-4.

ReferenceCitation: Rihal CS, Davis KB, Kennedy JW, Gersh BJ. The utility of clinical, electrocardiographic, and roentgenographic variables in the prediction of left ventricular function. Am J Cardiol. 1995 Feb 1;75(4):220-3.

ReferenceCitation: Wheeldon NM, MacDonald TM, Flucker CJ, McKendrick AD, McDevitt DG, Struthers AD. Echocardiography in chronic heart failure in the community. Q J Med. 1993 Jan;86(1):17-23.

ReferenceCitation: SOLVD Investigators, Yusuf S, Pitt B, Davis CE, Hood WB Jr, Cohn JN. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992 Sep 3;327(10):685-91. Erratum in: N Engl J Med 1992 Dec 10;327(24):1768.

ReferenceCitation: Køber L, Torp-Pedersen C, Carlsen JE, Bagger H, Eliasen P, Lyngborg K, Videbaek J, Cole DS, Auclert L, Pauly NC. A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. Trandolapril Cardiac Evaluation (TRACE) Study Group. N Engl J Med. 1995 Dec 21;333(25):1670-6.

ReferenceCitation: Flather MD, Yusuf S, Køber L, Pfeffer M, Hall A, Murray G, Torp-Pedersen C, Ball S, Pogue J, Moyé L, Braunwald E. Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction: a systematic overview of data from individual patients. ACE-Inhibitor Myocardial Infarction Collaborative Group. Lancet. 2000 May 6;355(9215):1575-81.

ReferenceCitation: Bayliss J, Norell M, Canepa-Anson R, Sutton G, Poole-Wilson P. Untreated heart failure: clinical and neuroendocrine effects of introducing diuretics. Br Heart J. 1987 Jan;57(1):17-22.

ReferenceCitation: Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90.

ReferenceCitation: Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55.

ReferenceCitation: Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17.

ReferenceCitation: Khand AU, Rankin AC, Kaye GC, Cleland JG. Systematic review of the management of atrial fibrillation in patients with heart failure. Eur Heart J. 2000 Apr;21(8):614-32. Review.

ReferenceCitation: Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997 Feb 20;336(8):525-33.

ReferenceCitation: Cazeau S, Ritter P, Lazarus A, Gras D, Backdach H, Mundler O, Mugica J. Multisite pacing for end-stage heart failure: early experience. Pacing Clin Electrophysiol. 1996 Nov;19(11 Pt 2):1748-57.

ReferenceCitation: Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001.

ReferenceCitation: Gras D, Mabo P, Tang T, Luttikuis O, Chatoor R, Pedersen AK, Tscheliessnigg HH, Deharo JC, Puglisi A, Silvestre J, Kimber S, Ross H, Ravazzi A, Paul V, Skehan D. Multisite pacing as a supplemental treatment of congestive heart failure: preliminary results of the Medtronic Inc. InSync Study. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 2):2249-55.

ReferenceCitation: Stellbrink C, Auricchio A, Diem B, Breithardt OA, Kloss M, Schöndube FA, Klein H, Messmer BJ, Hanrath P. Potential benefit of biventricular pacing in patients with congestive heart failure and ventricular tachyarrhythmia. Am J Cardiol. 1999 Mar 11;83(5B):143D-150D.

ReferenceCitation: Saxon LA, Boehmer JP, Hummel J, Kacet S, De Marco T, Naccarelli G, Daoud E. Biventricular pacing in patients with congestive heart failure: two prospective randomized trials. The VIGOR CHF and VENTAK CHF Investigators. Am J Cardiol. 1999 Mar 11;83(5B):120D-123D. Review.

ReferenceCitation: Cazeau S, Ritter P, Bakdach S, Lazarus A, Limousin M, Henao L, Mundler O, Daubert JC, Mugica J. Four chamber pacing in dilated cardiomyopathy. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 2):1974-9.

ReferenceCitation: Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.

ReferenceCitation: Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.

ReferenceCitation: Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45.

ReferenceCitation: Gurley J, Lamba S, Moulton K, Miller B, Mullin J, Hine D, MIRACLE and InSync III investigators. Does the availability of multiple left heart lead and delivery systems matter for cardiac resynchronization therapy? Eur Heart J 2002; 4:Abstr Suppl: 51

ReferenceCitation: Auricchio A, Sack S, Stellbrink C, Neuzner J, Tockman B, Hoersch W, Klein H. Transvenous left ventricular pacing using a new over the wire coronary venous lead. Pacing Clin Electrophysiol 1999; 22: 717

ReferenceCitation: Achtelik M, Bocchiardo M, Trappe HJ, Gaita F, Lozano I, Niazi I, Gold M, Yong P, Duby C; VENTAK CHF/CONTAK CD Clinical Investigation Study Group. Performance of a new steroid-eluting coronary sinus lead designed for left ventricular pacing. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1741-3.

ReferenceCitation: Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996 Dec 26;335(26):1933-40.

ReferenceCitation: Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90. Erratum in: N Engl J Med 2000 Apr 27;342(17):1300.

ReferenceCitation: Salukhe TV, Francis DP, Sutton R. Comparison of medical therapy, pacing and defibrillation in heart failure (COMPANION) trial terminated early; combined biventricular pacemaker-defibrillators reduce all-cause mortality and hospitalization. Int J Cardiol. 2003 Feb;87(2-3):119-20.

ReferenceCitation: Walker S, Levy TM, Rex S, Brant S, Allen J, Ilsley CJ, Paul VE. Usefulness of suppression of ventricular arrhythmia by biventricular pacing in severe congestive cardiac failure. Am J Cardiol. 2000 Jul 15;86(2):231-3.

ReferenceCitation: Higgins SL, Yong P, Sheck D, McDaniel M, Bollinger F, Vadecha M, Desai S, Meyer DB. Biventricular pacing diminishes the need for implantable cardioverter defibrillator therapy. Ventak CHF Investigators. J Am Coll Cardiol. 2000 Sep;36(3):824-7.

ReferenceCitation: Ehrlich JR, Nattel S, Hohnloser SH. Atrial fibrillation and congestive heart failure: specific considerations at the intersection of two common and important cardiac disease sets. J Cardiovasc Electrophysiol. 2002 Apr;13(4):399-405. Review.

ReferenceCitation: Li D, Fareh S, Leung TK, Nattel S. Promotion of atrial fibrillation by heart failure in dogs: atrial remodeling of a different sort. Circulation. 1999 Jul 6;100(1):87-95.

ReferenceCitation: Leclercq C, Walker S, Linde C, Clementy J, Marshall AJ, Ritter P, Djiane P, Mabo P, Levy T, Gadler F, Bailleul C, Daubert JC. Comparative effects of permanent biventricular and right-univentricular pacing in heart failure patients with chronic atrial fibrillation. Eur Heart J. 2002 Nov;23(22):1780-7.

ReferenceCitation: Hohnloser SH, Singh BN. Proarrhythmia with class III antiarrhythmic drugs: definition, electrophysiologic mechanisms, incidence, predisposing factors, and clinical implications. J Cardiovasc Electrophysiol. 1995 Oct;6(10 Pt 2):920-36. Review.

ReferenceCitation: Carson PE, Johnson GR, Dunkman WB, Fletcher RD, Farrell L, Cohn JN. The influence of atrial fibrillation on prognosis in mild to moderate heart failure. The V-HeFT Studies. The V-HeFT VA Cooperative Studies Group. Circulation. 1993 Jun;87(6 Suppl):VI102-10.

ReferenceCitation: Crijns HJ, Van den Berg MP, Van Gelder IC, Van Veldhuisen DJ. Management of atrial fibrillation in the setting of heart failure. Eur Heart J. 1997 May;18 Suppl C:C45-9. Review.

ReferenceCitation: Mahoney P, Kimmel S, DeNofrio D, Wahl P, Loh E. Prognostic significance of atrial fibrillation in patients at a tertiary medical center referred for heart transplantation because of severe heart failure. Am J Cardiol. 1999 Jun 1;83(11):1544-7.

ReferenceCitation: Dries DL, Exner DV, Gersh BJ, Domanski MJ, Waclawiw MA, Stevenson LW. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Sep;32(3):695-703.

ReferenceCitation: Middlekauff HR, Stevenson WG, Stevenson LW. Prognostic significance of atrial fibrillation in advanced heart failure. A study of 390 patients. Circulation. 1991 Jul;84(1):40-8.

ReferenceCitation: Opasich C, Tavazzi L, Lucci D, Gorini M, Albanese MC, Cacciatore G, Maggioni AP. Comparison of one-year outcome in women versus men with chronic congestive heart failure. Am J Cardiol. 2000 Aug 1;86(3):353-7.

ReferenceCitation: van den Berg MP, van Gelder IC, van Veldhuisen DJ. Impact of atrial fibrillation on mortality in patients with chronic heart failure. Eur J Heart Fail. 2002 Oct;4(5):571-5. Review.

ReferenceCitation: International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med. 1991 Feb 7;324(6):424-8.

ReferenceCitation: Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Laurenti A, Fedele F, Santini M. Doppler myocardial imaging in patients with heart failure receiving biventricular pacing treatment. Am Heart J. 2001 Nov;142(5):881-96.

ReferenceCitation: Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Fedele F, Santini M. Doppler myocardial imaging to evaluate the effectiveness of pacing sites in patients receiving biventricular pacing. J Am Coll Cardiol. 2002 Feb 6;39(3):489-99.

ReferenceCitation: Bax JJ, Molhoek SG, van Erven L, Voogd PJ, Somer S, Boersma E, Steendijk P, Schalij MJ, Van der Wall EE. Usefulness of myocardial tissue Doppler echocardiography to evaluate left ventricular dyssynchrony before and after biventricular pacing in patients with idiopathic dilated cardiomyopathy. Am J Cardiol. 2003 Jan 1;91(1):94-7.

ReferenceCitation: Garrigue S, Jaïs P, Espil G, Labeque JN, Hocini M, Shah DC, Haïssaguerre M, Clementy J. Comparison of chronic biventricular pacing between epicardial and endocardial left ventricular stimulation using Doppler tissue imaging in patients with heart failure. Am J Cardiol. 2001 Oct 15;88(8):858-62.

ReferenceCitation: Yu CM, Chau E, Sanderson JE, Fan K, Tang MO, Fung WH, Lin H, Kong SL, Lam YM, Hill MR, Lau CP. Tissue Doppler echocardiographic evidence of reverse remodeling and improved synchronicity by simultaneously delaying regional contraction after biventricular pacing therapy in heart failure. Circulation. 2002 Jan 29;105(4):438-45.

ReferenceCitation: Adamson PB, St John Sutton MG, Plappert TJ, Abraham WT, Hilpisch KE, Hill MR. Echo-Defined Ventricular Dysynchrony predicts magnitude of response o Cardiac Resynchronization Abstract presented during AHA Scientific Session 2002.

ReferenceCitation: St John Sutton MG, Plappert TJ, Hilpisch KE, Chinchoy E. Baseline Aortic Pre-Ejection Interval (bAPEI) as a predictor of response to Cardiac Resynchronization Therapy (CRT) Abstract presented during AHA Scientific Session 2002.

ReferenceCitation: Pitzalis MV, Iacoviello M, Romito R, Massari F, Rizzon B, Luzzi G, Guida P, Andriani A, Mastropasqua F, Rizzon P. Cardiac resynchronization therapy tailored by echocardiographic evaluation of ventricular asynchrony. J Am Coll Cardiol. 2002 Nov 6;40(9):1615-22.

lead_sponsor: Medtronic BRC

location_country:
Italy
Serbia
United Kingdom
Netherlands
France
Slovakia
Czech Republic

location_facility: Institut Klinické A Experimentální Medicíny

location_facility: Fakultní Nemocnice S Poliklinikou Ostrava

location_facility: Hôpital Cardiologique Du Haut-Levêque - Chu

location_facility: Slovenský Ústav Srdcových A Cievnych Chorôb


title: Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD

acronym: REHABSUP

summary: Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Beaumont M, Péran L, Berriet AC, Le Ber C, Le Mevel P, Courtois-Communier E, Couturaud F. Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22131. doi: 10.1097/MD.0000000000022131.

family: Beaumont

full_name: Marc Beaumont

given: Marc

sequence: first

family: Péran

full_name: Loic Péran

given: Loic

sequence: additional

family: Berriet

full_name: Anne Cécile Berriet

given: Anne Cécile

family: Le Ber

full_name: Catherine Le Ber

given: Catherine

family: Le Mevel

full_name: Patricia Le Mevel

given: Patricia

family: Courtois-Communier

full_name: Emmanuelle Courtois-Communier

given: Emmanuelle

family: Couturaud

full_name: Francis Couturaud

given: Francis

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Brest

location_facility:
CH Pays de Morlaix
CHRU de Brest

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Relieve the Patient's Thirst, Refresh the Mouth First

acronym: ICU-MIC

summary:
Thirst is considered as one of the most distressing symptoms experienced by patients hospitalized in the Intensive Care Unit (ICU). Whereas pain is a permanent concern for all caregivers, thirst is often ignored and its complications are poorly known. Mechanisms involved in thirst regulation are numerous and complex. To date, care of thirst is still non optimal. Critically ill patients are usually rehydrated intravenously or using a naso-gastric tube, thus shunting the mouth as a therapeutic target to relieve the patient's thirst.

Water, cold and mint applied in mouth were studied separately and were shown to decrease thirst significantly on animal models and healthy humans.

Therefore, the hypothesis of this study is that application of small mint ice cubes in mouth of very dehydrated ICU patients should allow decreasing quickly and significantly thirst for these patients, before the correction of their biological parameters, like natremia and osmolarity.

status: Completed

study_completion_date_type: Actual

primary_purpose: Basic Science

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Arras

location_facility:
Centre Hospitalier d'Arras
Centre Hospitalier de Lens

status_simplified: Completed


type: Other Identifier

title: Olfactory Training and Emotional State

acronym: ENOLFEA

summary:
During the past three decades, researchers have paid particular attention to the study of olfactory disorders in depression. Recent studies have shown that depression is characterized by a change in olfactory and emotional perception resulting in a decrease of the perception of positive stimuli (odors and facial expressions) and an increase in perception of negative stimuli (odors). Moreover, it has also been shown in healthy subjects that the presence of minor depressive symptoms leads to a decreasing of olfactory sensitivity. However, odor discrimination was not impaired in these subjects. This observation suggest the presence of a change in "targeted" olfactory perception in people with depressive symptoms without reporting major depression. In addition, studies in subjects with olfactory disorders (following respiratory tract infections or following Parkinson's disease) have shown an improvement in olfactory function after daily training with odors during 12 weeks.

From all these observations, the hypothesis is that an olfactory training could improve the overall olfactory functioning and the emotional perception of the subjects presenting minor depressive symptoms and of the depressed patients.

primary_purpose: Other

lead_sponsor: University Hospital, Tours

location_facility: University Psychiatric Clinic,University Hospital, Tours


title: Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting

acronym: HIPEOS

summary: The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no history of instability.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nimes
CHU Lapeyronie de Montpellier


title: Combination Chemotherapy (Methotrexate, L-asparaginase, Idarubicin and Dexamethasone) in Patients With Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

acronym: LpDessai

summary: Patients with suspected BPDCN and meeting eligibility criteria will be enrolled in the study. First, BPDCN diagnosis will be confirmed by anatomic pathology (Dr Petrella T, Montreal) and cytologic plus immunophenotyping analysis (Pr Garnache Ottou F, UMR1098 BESANCON). Patients will then receive three 21 days cycles of a combination of chemotherapy (Ida/Metho/L-asp/Dex), followed by an evaluation. Patients with complete response (CR) or complete response with incomplete bone marrow recovery (CRi) will undergo an allo- or auto-SCT and those who are not eligible to the transplantation will have successive 28 days cycles of chemotherapy (Metho/L-asp/Dex). Patients who did not respond to the treatment will be treated by physicians. All patients will be followed for 24 months.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Chu Besancon
Chu Amiens

intervention_type: Drug


title: Interest of Local Compression by Thoracic Bandage on the Management of Seroma in Patients Treated by Mastectomy With or Without Lymphadenectomy. Local Compression Seroma DIminution Objective

acronym: CLODIS

summary: This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.

status: Unknown status

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Françis Baclesse
TANQUEREL Julie

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: To Assess Hemodynamic Disturbances to the Ostia of the Renal Arteries Generated by the Implantation of EVAR With a Suprarenal Fixation

acronym: IFIXEAR

summary: The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.

primary_purpose: Diagnostic

ReferenceCitation: Salomon du Mont L, Parmentier AL, Puyraveau M, Mauny F, Guillon B, Rinckenbach S, Costa P. To assess hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of EVAR with a suprarenal fixation. Medicine (Baltimore). 2020 May;99(18):e19917. doi: 10.1097/MD.0000000000019917.

family: Salomon du Mont

full_name: Lucie Salomon du Mont

given: Lucie

family: Parmentier

full_name: Anne-Laure Parmentier

given: Anne-Laure

family: Puyraveau

full_name: Marc Puyraveau

family: Mauny

full_name: Frédéric Mauny

given: Frédéric

family: Guillon

full_name: Benoit Guillon

given: Benoit

family: Rinckenbach

full_name: Simon Rinckenbach

given: Simon

family: Costa

full_name: Patricia Costa

location_facility:
Centre Hospitalier Universitaire
Centre Hosptalier Universitaire


title: SPECT Myocardial Perfusion Reserve Using a Cadmium Zinc Telluride (CZT) Camera in Cardiovascular Risk Stratification and Ischemia

acronym: CFR-OR

summary: CFR has been studied for few years using 82 Rubidium PET (positron emission tomography) /CT. CFR has shown to be correlated with cardiovascular events occurring in the 10 following years. CFR also helps to identify multivessel coronary disease. Few studies have shown the possibility to calculate CFR during myocardial perfusion SPECT on new ultrafast CZT cameras.

ReferenceType: background

ReferenceCitation: Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32.

ReferenceCitation: Agostini D, Roule V, Nganoa C, Roth N, Baavour R, Parienti JJ, Beygui F, Manrique A. First validation of myocardial flow reserve assessed by dynamic (99m)Tc-sestamibi CZT-SPECT camera: head to head comparison with (15)O-water PET and fractional flow reserve in patients with suspected coronary artery disease. The WATERDAY study. Eur J Nucl Med Mol Imaging. 2018 Jul;45(7):1079-1090. doi: 10.1007/s00259-018-3958-7. Epub 2018 Mar 1.

ReferenceCitation: Assante R, Zampella E, Arumugam P, Acampa W, Imbriaco M, Tout D, Petretta M, Tonge C, Cuocolo A. Quantitative relationship between coronary artery calcium and myocardial blood flow by hybrid rubidium-82 PET/CT imaging in patients with suspected coronary artery disease. J Nucl Cardiol. 2017 Apr;24(2):494-501. doi: 10.1007/s12350-015-0359-1. Epub 2016 Jan 15.

ReferenceCitation: Ben Bouallègue F, Roubille F, Lattuca B, Cung TT, Macia JC, Gervasoni R, Leclercq F, Mariano-Goulart D. SPECT Myocardial Perfusion Reserve in Patients with Multivessel Coronary Disease: Correlation with Angiographic Findings and Invasive Fractional Flow Reserve Measurements. J Nucl Med. 2015 Nov;56(11):1712-7. doi: 10.2967/jnumed.114.143164. Epub 2015 Sep 3.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHR d'Orleans
CHRU de Tours

intervention_type: Diagnostic Test


title: Rehabilitation Program With Robotic Assistance for the Improvement of Motor Performance and Functional Use of the Upper Limb in Subacute Hemiparetic. Multicenter Randomized Controlled Trial

acronym: ROBOASSIST

summary:
Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb.

The use of robotic assistance provides intensive motor training through a large number of repetitive movements, usually oriented and interactive tasks (pointing tasks, tracking paths tasks...). These feature have been demonstrated to be critical to stimulate brain plasticity after a brain damage. The InMotion Arm 2.0 manipulator works with an adaptive algorithm that provide patients with real-time Assistance-as-Needed™ desgned to enhance motor performance.

Hypothesis: In the sub-acute phase of stroke, the structured practice of a large number of repeated movements will increase motor function of the upper limb compared to conventional rehabilitation. Secondly, this practice will be more effective in a free active mode (without assistance) than an active assisted mode (Assistance-as-Needed™).

Expected secondary benefits: Subjective impression of improved use of the upper limb in activities of daily living and reduction of spastic cocontractions affecting the agonist and antagonist muscles during movements of the upper limb.

Objectives: This randomized controlled trial will evaluate the effects of structured repetition programs of arm movements, on the function of the hemiparetic upper limb and motor control, between 4 and 10 weeks after the stroke, using a robotic device with or without assistance in partial substitution of conventional rehabilitation care, compared to a program with conventional care alone.

lead_sponsor: Clinique Les Trois Soleils

location_facility:
Clinique Les Trois Soleils
Hôpitaux Universitaires Henri Mondor


title: Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis

summary: Parkinson's disease (PD) is the second most common neurodegenerative disease. Multiple system atrophy (MSA) is a relentlessly progressing rare neurodegenerative disease of unknown etiology. In early stages of the disease, PD and MSA symptoms are very similar, particularly MSA-P where Parkinsonism predominates. The differential diagnosis between MSA-P and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. Voice disorders are a common early symptom in both diseases and of different origin. The ambition and the originality of this project are to develop a digital voice-based tool for objective discrimination between PD and MSA-P.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Toulouse

intervention_type: Procedure


title: Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra

acronym: PRESIUS

summary: This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder (IUD). The goal is to predict the severity of the IU by measuring new static and dynamic ultrasound parameters of the urethra.

lead_sponsor: CMC Ambroise Paré

location_facility:
Centre Echographie Obstétricale
CMC Hartmann


title: Comparison of Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones in Addition to Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation

acronym: ISOCHRONE-AF

summary: Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.

location_facility:
CHU Nimes
CHU Montpellier


title: Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map

acronym: Isochrone-AFAn

summary: This study is an ancillary study to Isochrone-AF. The investigators hypothesize that patients eligible but non-included in the primary study (patients classified as non-reducible or non-inducible) will have different prognosis and electro-physiclogical characteristics to the patients included and randomized into the Isochrone AF study.

study_type: Observational

time_perspective: Prospective


title: Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients

acronym: TC-DEG

summary: This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury.

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Rouen

location_facility:
UH Rouen
Centre les Herbiers


title: Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate

acronym: PERSEE II

summary: This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.

lead_sponsor: Mauna Kea Technologies

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


title: Pelvic Inclination Measurement by Navigated Ultrasound

acronym: MIPEN

summary:
Prospective, multicenter, non-randomized study.

Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls.

Secondary endpoint : to describe the values of pelvic inclination while standing, sitting and lying in patients with severe hip osteoarthritis before and after total hip arthroplasty

After signing the inform consent form:

For the first endpoint (, 3 healthy volunteers of different morphotypes will have one consultation comprising :

a medical examination
10 measurements of pelvic inclination in sitting position, 10 measurements of pelvic inclination in supine position and 10 measurements of pelvic inclination in standing position, each realized per three different operators. These measurements will be carried out with navigated ultrasound.

For the secondary endpoint, 30 patients awaiting for a hip replacement surgical intervention will realized one consultation the day before the intervention, and one consultation at 2 months after surgery, each comprising :

a medical examination
3 measurements of pelvic inclination (1 standing, 1 sitting and 1 supine). These measurements will be carried out with navigated ultrasound.

location_facility:
Clinique de Keraudren
Brest University Hospital


title: Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis

summary: It aims to demonstrate the superiority of a 6-week supplementation with Lactibiane Buccodental compared to placebo, as adjunctive therapy in chronic periodontitis in patients with generalized chronic periodontitis

lead_sponsor: PiLeJe

location_facility:
CHU Hôtel Dieu de Nantes
Hospices Civils de Lyon


title: Assessment of Sexual Health of Obese Men Before and After Paresis Bariatric Surgery. Prospective Multicentre Study.

acronym: BARIASSO

summary: Compare Male Health Sexual Questionnaire (MHSQ) before and after bariatric surgery to assess the sexual health of the obese men with a recommended and exhaustive tool. There are few data that evaluate the sexual health of this population.

status: Active, not recruiting

location_facility: Hôpital Haut-Lévêque - groupe hospitalier Sud


title: Pilot Study to Identify the Benefits CAREGIVERSPRO-MMD Platform Use Based on the Information and Communications Technology, Dedicated to the Support and Assistance of Dyads Living With Neurocognitive Diseases Including Persons Living With Mild Cognitive Impairment or Mild to Moderate Dementia and Their Primary Caregivers

acronym: CAREGIVERSPRO

summary:
Our main goal is to test a web platform accessible by computers, smartphones and tablets, addressed specifically to caregivers and people with mild cognitive deterioration or mild to moderate dementia providing added value services based on social networks, adapted interventions, clinic strategies and gamification to improve the quality of life of caregivers and people living with dementia (dyads) and permitting to leave in the community as long as possible.

To evaluate the platform effectiveness and impact in dementia type disease affected people and caregivers a randomized, controlled, parallel, longitudinal is proposed. The objective will be to assess during 18 months aspects related to health of individuals (general aspect of health, neuropsychological, daily living functionalities, quality of life, treatment adherence, comorbidities ...), social aspects (improving dyad relationship…) and economics (cost-effectiveness of platform utilization), as well as satisfaction degree and usability of platform.

primary_purpose: Supportive Care

location_facility: Centre Hospitalier Intercommunal Elbeuf Louviers


title: Excision and Reconstruction of the Natal Cleft With a Parasacral Perforator Flap Versus Open Excision With Secondary Healing, in the Management of Sacrococcygeal Pilonidal Disease. A Randomized Controlled Study.

acronym: PILOPERFO

summary:
Chronic sacrococcygeal pilonidal disease is a common acquired condition associated with hirsutism that predominantly affects young male patients. Morbidity from this disease results in pain, embarrassment and loss of normal activities, causing absenteeism from work and school.

Various surgical procedures have been described for the treatment of both primary and recurrent pilonidal disease counting: open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.

No single method has been accepted as the "gold standard", and none of them cancels the risk of recurrence.

The optimal therapy for pilonidal sinus disease should be simple, with good aesthetic outcomes and a low recurrence rate. It must allow the return to normal activities quickly.

The parasacral perforator flap seems to answer these entire requirements. No study compares this flap repair with the most common procedure, which is the open excision with secondary healing. The aim of this study is to assess the efficacy and the security of the reconstruction of the natal cleft with the perforator parasacral flap versus open excision with secondary healing in the treatment of sacrococcygeal pilonidal sinus.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital
University hospital


title: Semantic and Syntactic Computerized Analysis of Free Speech

acronym: ASESID

summary: Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques

location_facility:
CH de SAINT ANNE
CHRU de Brest


lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Israel
Romania
Hungary
Argentina
Portugal
Canada
United Kingdom

acronym: ADAGIO Follow-Up

location_facility:
Teva Investigational Site 7034
Teva Investigational Site 7600
Teva Investigational Site 7308
Teva Investigational Site 7201
Teva Investigational Site 7022
Teva Investigational Site 7020
Teva Investigational Site 7054
Teva Investigational Site 7029
Teva Investigational Site 7161
Teva Investigational Site 7043
Teva Investigational Site 7010
Teva Investigational Site 7806
Teva Investigational Site 7088
Teva Investigational Site 7050
Teva Investigational Site 7104
Teva Investigational Site 7602
Teva Investigational Site 7018
Teva Investigational Site 7102
Teva Investigational Site 7019
Teva Investigational Site 7704
Teva Investigational Site 7039
Teva Investigational Site 7081
Teva Investigational Site 7611
Teva Investigational Site 7900
Teva Investigational Site 7306
Teva Investigational Site 7089
Teva Investigational Site 7051
Teva Investigational Site 7016
Teva Investigational Site 7017
Teva Investigational Site 7164
Teva Investigational Site 7009
Teva Investigational Site 7200
Teva Investigational Site 7103
Teva Investigational Site 7004
Teva Investigational Site 7205
Teva Investigational Site 7162
Teva Investigational Site 7202
Teva Investigational Site 7203
Teva Investigational Site 7024
Teva Investigational Site 7053
Teva Investigational Site 7082
Teva Investigational Site 7801
Teva Investigational Site 7008
Teva Investigational Site 7101
Teva Investigational Site 7607
Teva Investigational Site 7300
Teva Investigational Site 7006
Teva Investigational Site 7302
Teva Investigational Site 7606
Teva Investigational Site 7052
Teva Investigational Site 7015
Teva Investigational Site 7507
Teva Investigational Site 7504
Teva Investigational Site 7100
Teva Investigational Site 7805
Teva Investigational Site 7044
Teva Investigational Site 7035
Teva Investigational Site 7800
Teva Investigational Site 7080
Teva Investigational Site 7087
Teva Investigational Site 7501
Teva Investigational Site 7056
Teva Investigational Site 7046
Teva Investigational Site 7803
Teva Investigational Site 7083
Teva Investigational Site 7150
Teva Investigational Site 7500
Teva Investigational Site 7160
Teva Investigational Site 7304
Teva Investigational Site 7045
Teva Investigational Site 7204
Teva Investigational Site 7802
Teva Investigational Site 7404
Teva Investigational Site 7002
Teva Investigational Site 7604
Teva Investigational Site 7206
Teva Investigational Site 7610
Teva Investigational Site 7902
Teva Investigational Site 7025
Teva Investigational Site 7401
Teva Investigational Site 7055
Teva Investigational Site 7001
Teva Investigational Site 7048
Teva Investigational Site 7503
Teva Investigational Site 7086
Teva Investigational Site 7085
Teva Investigational Site 7505
Teva Investigational Site 7011
Teva Investigational Site 7303
Teva Investigational Site 7506
Teva Investigational Site 7400
Teva Investigational Site 7037
Teva Investigational Site 7804
Teva Investigational Site 7023
Teva Investigational Site 7026
Teva Investigational Site 7307
Teva Investigational Site 7309
Teva Investigational Site 7601
Teva Investigational Site 7013
Teva Investigational Site 7163
Teva Investigational Site 7502
Teva Investigational Site 7615

type: EudraCT Number

source: euctr

title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects Who Participated in the ADAGIO Study

summary: Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).


title: Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients: a mulTi-centre, Randomized, Single Blind, Parallel Group studY (ETERNITY)

acronym: ETERNITY

summary: The purpose of this study is to assessed the efficacy of a combined solution of ethanol (4%) and low molecular weight heparins LMWH in preventing tunnelled dialysis catheter infection in chronic hemodialysis patients

primary_purpose: Prevention

ReferenceCitation: Aniort J, Piraud A, Adda M, Perreira B, Bouiller M, Fourcade J, Guerraoui A, Kalbacher E, Krumel T, Moragues HL, Thibaudin D, Vela CG, Vernin G, Weclawiak H, Bernard L, Heng AE, Souweine B. Evaluation of the efficacy of an interdialytic "ethanol 40% v/v - enoxaparin 1000 U/mL" lock solution to prevent tunnelled catheter infections in chronic hemodialysis patients: a multi-centre, randomized, single blind, parallel group study. BMC Nephrol. 2019 Apr 30;20(1):149. doi: 10.1186/s12882-019-1338-6.

family: Aniort

full_name: Julien Aniort

given: Julien

family: Piraud

full_name: Aurélien Piraud

given: Aurélien

family: Adda

full_name: Mireille Adda

given: Mireille

family: Perreira

full_name: Bruno Perreira

given: Bruno

family: Bouiller

full_name: Marc Bouiller

family: Fourcade

full_name: Jacques Fourcade

given: Jacques

family: Guerraoui

full_name: Abdallah Guerraoui

given: Abdallah

family: Kalbacher

full_name: Emilie Kalbacher

given: Emilie

family: Krumel

full_name: Thierry Krumel

given: Thierry

family: Moragues

full_name: Hélène Leray Moragues

given: Hélène Leray

family: Thibaudin

full_name: Damien Thibaudin

given: Damien

family: Vela

full_name: Carlos Gustavo Vela

given: Carlos Gustavo

family: Vernin

full_name: Guillaume Vernin

given: Guillaume

family: Weclawiak

full_name: Hugo Weclawiak

given: Hugo

family: Bernard

full_name: Lise Bernard

given: Lise

family: Heng

full_name: Anne Elisabeth Heng

given: Anne Elisabeth

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

currency_apc_doaj: GBP

journal_name: BMC Nephrology

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

repository_institution: PubMed Central - Europe PMC

title: Evaluation of the efficacy of an interdialytic “ethanol 40% v/v - enoxaparin 1000 U/mL” lock solution to prevent tunnelled catheter infections in chronic hemodialysis patients: a multi-centre, randomized, single blind, parallel group study


title: Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL): Analysis of Real-life Data: "Snapshot" at 3 Years From the End of Ibrutinib ATU. A National Study of the FILO-LLC Group

summary:
Assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib

This project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of BTK mutations and PLCg2 in the absence of clinical or biological criteria for scalability.

lead_sponsor: French Innovative Leukemia Organisation

location_facility: FILO French Innovative Leukemia Organization


title: Early Detection by Molecular Biology Technique of Pathogens Responsible for Respiratory Infections Associated With Drownings in Seawater: Pilot Study at the CHU de Nice

acronym: APIR-NOY

summary:
Little data is currently available on the type of pathogen responsible for respiratory infections following drowning. Many environmental germs present in seawater are described as difficult to culture on standard media but are potentially pathogenic. Even using specific culture media nearly 90% of the bacteria present in the water remain non-cultivable. The use of 16S and 18S rDNA amplification followed by high throughput sequencing on respiratory samples could allow us to objectify these bacteria potentially involved in the physiopathological process secondary to drowning and thus improve their overall management.

Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care with analysis on standard and specific culture media of environmental germs, carrying out antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these results with the same analyses performed on seawater samples taken near the drowning site and during a new AML at 72h for patients still intubated and showing signs of pneumonia in order to determine if the pathogens detected at the entrance persist and are present in the environment.

AML at the patient's entrance, on day 3 and environmental sampling in the drowning environment within 24 hours. Standard and specific bacteriological analyses with molecular biology techniques (amplification 16 and 18S rDNA) carried out at Pr RUIMY's laboratory (Nice University Hospital) sequencing on INRA's Toulouse genomics platform. Phylogenetic data capture and analysis at IRCAN (Bioinformatics, Croce Olivier). Patient follow-up until resuscitation discharge.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Frejus hospital
university hospital of Nice


title: Seroprevalence, Multi-center, Phase IV Cross-sectional Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine

summary: The study aims to assess antibody persistence induced by Spirolept® vaccination in subjects who received at least 4 doses (2 doses two weeks apart and 2 booster doses) and no more than a total of 8 doses (2 doses two weeks apart and 6 booster doses).

time_perspective: Cross-Sectional

lead_sponsor: Imaxio

location_facility:
SIAAP
Mairie de Paris


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ReferenceCitation: de Matteis A, Nuzzo F, D'Aiuto G, Labonia V, Landi G, Rossi E, Mastro AA, Botti G, De Maio E, Perrone F. Docetaxel plus epidoxorubicin as neoadjuvant treatment in patients with large operable or locally advanced carcinoma of the breast: a single-center, phase II study. Cancer. 2002 Feb 15;94(4):895-901.

ReferenceCitation: Gradishar WJ, Wedam SB, Jahanzeb M, Erban J, Limentani SA, Tsai KT, Olsen SR, Swain SM. Neoadjuvant docetaxel followed by adjuvant doxorubicin and cyclophosphamide in patients with stage III breast cancer. Ann Oncol. 2005 Aug;16(8):1297-304. Epub 2005 May 19.

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ReferenceCitation: Reitsamer R, Peintinger F, Prokop E, Hitzl W. Pathological complete response rates comparing 3 versus 6 cycles of epidoxorubicin and docetaxel in the neoadjuvant setting of patients with stage II and III breast cancer. Anticancer Drugs. 2005 Sep;16(8):867-70. Erratum in: Anticancer Drugs. 2006 Mar;17(3):363.

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ReferenceCitation: Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. Epub 2003 Oct 14.

ReferenceCitation: Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235. Erratum in: J Clin Oncol. 2008 Jun 1;26(16):2793.

ReferenceCitation: Gonçalves A, Pierga JY, Ferrero JM, Mouret-Reynier MA, Bachelot T, Delva R, Fabbro M, Lerebours F, Lotz JP, Linassier C, Dohollou N, Eymard JC, Leduc B, Lemonnier J, Martin AL, Boher JM, Viens P, Roché H. UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.

ReferenceCitation: Masuda H, Brewer TM, Liu DD, Iwamoto T, Shen Y, Hsu L, Willey JS, Gonzalez-Angulo AM, Chavez-MacGregor M, Fouad TM, Woodward WA, Reuben JM, Valero V, Alvarez RH, Hortobagyi GN, Ueno NT. Long-term treatment efficacy in primary inflammatory breast cancer by hormonal receptor- and HER2-defined subtypes. Ann Oncol. 2014 Feb;25(2):384-91. doi: 10.1093/annonc/mdt525. Epub 2013 Dec 18.

ReferenceCitation: Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, Zambetti M, Vazquez F, Byakhow M, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Baronio R, Feyereislova A, Barton C, Valagussa P, Baselga J. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010 Jan 30;375(9712):377-84. doi: 10.1016/S0140-6736(09)61964-4.

ReferenceCitation: Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. doi: 10.1016/S1470-2045(11)70336-9. Epub 2011 Dec 6.

ReferenceCitation: Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. doi: 10.1016/S0140-6736(11)61847-3. Epub 2012 Jan 17. Erratum in: Lancet. 2012 Feb 18;379(9816):616. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.

family: Baselga

full_name: José Baselga

given: José

family: Bradbury

full_name: Ian Bradbury

given: Ian

family: Eidtmann

full_name: Holger Eidtmann

given: Holger

family: Di Cosimo

full_name: Serena Di Cosimo

given: Serena

family: de Azambuja

full_name: Evandro de Azambuja

given: Evandro

family: Aura

full_name: Claudia Aura

given: Claudia

family: Gómez

full_name: Henry Gómez

given: Henry

family: Dinh

full_name: Phuong Dinh

given: Phuong

family: Fauria

full_name: Karine Fauria

given: Karine

family: Van Dooren

full_name: Veerle Van Dooren

given: Veerle

family: Aktan

full_name: Gursel Aktan

given: Gursel

family: Goldhirsch

full_name: Aron Goldhirsch

given: Aron

family: Chang

full_name: Tsai-Wang Chang

given: Tsai-Wang

family: Horváth

full_name: Zsolt Horváth

given: Zsolt

family: Coccia-Portugal

full_name: Maria Coccia-Portugal

given: Maria

family: Domont

full_name: Julien Domont

family: Tseng

full_name: Ling-Min Tseng

given: Ling-Min

family: Kunz

full_name: Georg Kunz

given: Georg

family: Sohn

full_name: Joo Hyuk Sohn

given: Joo Hyuk

title: Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial

ReferenceCitation: Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roché H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.

title: Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study

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ReferenceCitation: Bertucci A, Bertucci F, Zemmour C, Lerebours F, Pierga JY, Levy C, Dalenc F, Grenier J, Petit T, Berline M, Gonçalves A. PELICAN-IPC 2015-016/Oncodistinct-003: A Prospective, Multicenter, Open-Label, Randomized, Non-Comparative, Phase II Study of Pembrolizumab in Combination With Neo Adjuvant EC-Paclitaxel Regimen in HER2-Negative Inflammatory Breast Cancer. Front Oncol. 2020 Nov 25;10:575978. doi: 10.3389/fonc.2020.575978. eCollection 2020.

location_facility:
UZ Gand
Institut BERGONIE
Institut Sainte Catherine
Saint Elisabeth
Clinique de L'Europe
Centre Paul Strauss
Centre Leon Berard
Jules Bordet
UCL
Institut Curie
Institut Curie hopital rene huguenin
Institut de cancérologie de la loire
Sint-Augustinus Hospital
CENTRE Francois Baclesse
IUCT-Oncopole Institut Claudius Rigaud
Centre Henri Becquerel
CHU Ambroise Pare
Grand Hôpital de Charleroi

title: A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.

summary: This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.


title: A Phase II, Double-blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of ZD4054 (Zibotentan) in Combination With Pemetrexed (Alimta®) vs. Pemetrexed Alone in Patients With Non-small Cell Lung Cancer Who Have Failed One Prior Platinum-based Chemotherapy Regimen

summary: The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone

lead_sponsor: AstraZeneca

location_country:
France
Bulgaria
Romania
Czech Republic
Ukraine

location_facility:
Research Site
research Site


title: Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

summary:
Self-administered questionnaire survey to determine the presence or absence of joint pain during bevacizumab treatment for lung, ovarian, colorectal cancers.

The principal end-point is the frequency of arthralgia after 6 months of treatment with Bevacizumab.

ReferenceCitation: Vauléon E, Behal H, Lebellec L, Desbarbieux R, Baldacci S, Simon N, Pannier D, Vieillard MH, Turpin A. Does bevacizumab increase joint pain in patients with cancer? Results of the prospective observational BEVARTHRALGIA study. Cancer Chemother Pharmacol. 2021 Apr;87(4):533-541. doi: 10.1007/s00280-020-04226-6. Epub 2021 Jan 12.

family: Vauléon

full_name: Enora Vauléon

given: Enora

family: Behal

full_name: Hélène Behal

given: Hélène

family: Lebellec

full_name: Loïc Lebellec

given: Loïc

family: Desbarbieux

full_name: Renaud Desbarbieux

given: Renaud

family: Baldacci

full_name: Simon Baldacci

given: Simon

family: Simon

full_name: Nicolas Simon

given: Nicolas

family: Pannier

full_name: Diane Pannier

given: Diane

family: Vieillard

full_name: Marie-Hélène Vieillard

given: Marie-Hélène

family: Turpin

full_name: Anthony Turpin

given: Anthony

journal_name: Cancer Chemotherapy and Pharmacology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Lille

location_facility:
Hôpital Huriez. CHRU
Centre Oscar Lambret


title: A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) With or Without Ipilimumab (BMS-734016) in Patients With Advanced Renal Cell Carcinoma in Real Life Setting

acronym: WITNESS

summary: This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.

lead_sponsor: Bristol-Myers Squibb


title: Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps

summary:
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.

The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.

The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre Hospitalier Universitaire Nantes
Centre Hospitalier Départemental Vendée


title: Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

summary: The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.

lead_sponsor: Poitiers University Hospital

location_facility:
CHU Poitiers
CHG de Niort


title: Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer

acronym: NIVEAL

summary:
To assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration.

Collection of standard data prospectively.

lead_sponsor: University Hospital, Tours

location_facility: Medical oncology department, University Hospital, Tours

location_facility: Pneumology department, University Hospital, Tours


title: Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial

acronym: TECNAT

summary: The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nimes
CHU Arnaud de Villeneuve


title: Validation of the Dosage of Asymmetric Dimethylarginine (ADMA) Plasma in the Assessment of Endothelial Dysfunction During Growth Hormone Deficiency and Intrauterine Growth Retardation

acronym: GAMMA

summary:
Principal objective : Validation of a handy biochemical parameter, plasma concentration of Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation of the brachial artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone deficiency (GHD) and intrauterine growth retardation (IUGR)

Secondary objectives:

Comparison of ADMA plasma concentrations with dose of matched healthy control children
Investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress and insulin resistance.

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: Multicenter, Randomized, Pilot Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost (Stereotaxic External Radiotherapy or High Dose Rate Brachytherapy) in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk

acronym: SHORT

summary:
The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years.

Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments. This therapeutic scheme makes it possible to deliver a higher equivalent biological dose than during a treatment carried out with a conventional fractionation.

The results with a follow-up of 9 years are extremely encouraging and do not show any excess toxicity compared to other irradiation techniques. They confirm that urinary and digestive toxicities are acceptable. All these studies did not involve pelvic irradiation. Several trials have also demonstrated the feasibility of normofractionated pelvic irradiation associated with hypofractionated prostatic irradiation using an integrated boost technique.

The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:

a prostatic boost in brachytherapy with high dose rate (HDR) or
an integrated boost in stereotaxis (in case of contraindication to brachytherapy)

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Georges François Leclerc
CGFL

intervention_type: Radiation


title: Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure: Impact on Prognosis: A Monocentric Observational Before-after Study

acronym: CAREHEMA

summary:
Over the last two decades, the number of patients with hematological malignancies (HMs) admitted to the ICU increased and their mortality has dropped sharply. Patients with HMs increasingly require admission to the intensive care unit (ICU) for life-threatening events related to the malignancy and/or treatments, with immunosuppression being a major contributor. Whether the increase in ICU admissions is related to increased referrals by hematologists and/or to increased admissions by intensivists is unknown. The criteria used for ICU referral and admission decisions have not been extensively evaluated. Finally, the links between admission policies and treatment-limitation decisions are unclear, but ICUs with broad admission policies may change the treatment goals based on the response to several days of full-code management.

The aim of this study is to evaluate the impact of a systematic evaluation by an intensivist of HMs patients presenting with acute respiratory and/or hemodynamic failure.

lead_sponsor: University Hospital, Grenoble

location_facility: Hematologic unit - Hospital Grenoble Alpes

location_facility: Intensive Care Unit - Hospital Grenoble-Alpes


title: How Participants Perceive Biomedical Research in Pulmonology

summary: The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

ipd_sharing: Yes

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available on a not-for-profit, free platform that allows access control: zenodo.

A link on osf.io/pxnhc will point towards the zenodo upload.

lead_sponsor: University Hospital, Montpellier

location_facility: CHRU Montpellier - Hôpital Arnaud de Villeneuve


type: Registry Identifier

title: Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse

acronym: REVERSE-MR

summary:
Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve repair, an ongoing international controversy exists regarding the need to perform early surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the probability of successful and durable repair is very high. In this group of patients, differing views of the risks of uncorrected severe MR exist: considered as benign by those supporting medical "watchful waiting" or associated with significant excess mortality/morbidity by those advocating early surgery. This controversy can only be resolved by a randomized controlled trial which is still lacking.

The main objective is to demonstrate the superiority of early mitral valve repair in patients with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative management in terms of all-cause death and cardiovascular morbidity during five years follow-up.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Amiens-Picardie
Centre Cardiologique du Nord


title: Validation of the Rest Respiratory Function Monitoring of Pulmonary Transplants at Home to Anticipate Unplanned Hospitalizations

acronym: TRANSADOM

summary: Acute cellular and/or humoral rejection and early graft infections after pulmonary transplant (<2.5 years) are common and can lead to chronic dysfunction of the transplanted organ or Chronic Lung Allograft Dysfunction, CLAD. These complications increase the number of unplanned and life-threatening hospitalizations. Regular multi-weekly monitoring of respiratory function is necessary to detect these complications early and to make their management more effective and less costly. Monitoring by micro spirometers with forced expirations at home proved difficult to perform (patient and effort dependent), often poorly coordinated (transmission of data to practitioners) and not sensitive in the prediction of post-transplant complications. Aqsitania has developed an innovative analysis of resting respiratory signals. This innovative analysis is called "Anharmonic Morphological Analysis of Respiratory Signals (AMARS)". This automated analysis is based on a measurement of the respiration collected by a spirometry device communicating and allowing a remote home monitoring (Ventilotel®). We hypothesize that this Anharmonic Morphological Analysis of Respiratory Signals at rest could predict unplanned hospitalizations and allow for more reliable monitoring of pulmonary transplant patients. Inclusion visit: Explanation of the study and collection of consent, measurement of resting breath and explanation on the mode of use of the measuring device at home, clinical examination, respiratory functional exploration. Follow-up at home for 12 months with a resting breath measurement for 2 to 3 min, in the morning on waking and in the evening before bed, 2 days / week with automatic sending of data on the Aqsitania server. The first month, a visit at home can be made if the subject feels the need. At each measurement, Aqsitania transmits the data in the e-CRF, a report that gives the anonymised values of the markers and the current personal respiratory profile. In order to avoid "motivational" bias, patients will have instructions to use the device but no "coaching" call will be made during the study. Patients will have their monthly or quarterly follow-up visits, including clinical examination, respiratory functional exploration and an analysis of adverse events. No additional search-specific visits will be carried out.

location_facility:
Lyon University Hospital
Grenoble University Hospital


title: Family Therapy and Anorexia Nervosa : Which is the Best Approach? Family Therapy Multicenter Randomised Control Trial of Systemic Family Therapy Versus Multiple Family Therapy

acronym: THERAFAMBEST

summary: The aim of this study is to evaluate whether the implementation of Multiple Family Therapy (MFT) within a multi-disciplinary treatment program for Anorexia Nervosa (AN) in adolescence is at least as effective in terms of clinical Body Mass Index evolution as single Systemic Family Therapy (SyFT) after 12 months of treatment. We expect that these two techniques will not differ in terms of global efficacy, but that MFT could be more suitable for certain profiles who may be less responsive to SyFT.

ReferenceCitation: Carrot B, Duclos J, Barry C, Radon L, Maria AS, Kaganski I, Jeremic Z, Barton-Clegg V, Corcos M, Lasfar M, Gerardin P, Harf A, Moro MR, Blanchet C, Godart N. Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study. Trials. 2019 Apr 30;20(1):249. doi: 10.1186/s13063-019-3347-y. Erratum in: Trials. 2020 Feb 18;21(1):196.

family: Carrot

full_name: Benjamin Carrot

given: Benjamin

family: Duclos

full_name: Jeanne Duclos

given: Jeanne

family: Barry

full_name: Caroline Barry

given: Caroline

family: Radon

full_name: Leslie Radon

given: Leslie

family: Maria

full_name: Anne-Solène Maria

given: Anne-Solène

family: Kaganski

full_name: Irène Kaganski

given: Irène

family: Jeremic

full_name: Zorica Jeremic

given: Zorica

family: Barton-Clegg

full_name: Vesper Barton-Clegg

given: Vesper

family: Corcos

full_name: Maurice Corcos

given: Maurice

family: Lasfar

full_name: Malaïka Lasfar

given: Malaïka

family: Gerardin

full_name: Priscille Gerardin

given: Priscille

family: Harf

full_name: Aurélie Harf

given: Aurélie

family: Moro

full_name: Marie-Rose Moro

given: Marie-Rose

family: Blanchet

full_name: Corinne Blanchet

given: Corinne

family: Godart

full_name: Nathalie Godart

given: Nathalie

journal_name: Trials

ipd_sharing: Undecided

location_facility: Maison de Solenn - Maison des Adolescents Cochin


title: Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY

summary: ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Fecal Microbiota transfer and restoration is a promising strategy to achieve this purpose.

status: Terminated

lead_sponsor: MaaT Pharma

location_facility:
Salengro hospital
Bichat Hospital


title: MRI of Sacroiliac Joints: Evaluation of Accuracy of Dixon Sequences in the Diagnosis of Axial Spondyloarthritis

acronym: SPADIX

summary: The investigators hypothesize that the T1 Dixon post-Gadolinium and T2 Dixon sequences will show good diagnostic performances for active sacroiliitis compared to the reference test (Short tau inversion recovery) and clinical-biological criteria, which will allow a better diagnosis of active sacroiliitis

location_facility:
CHU Lapeyronie
CHU Nimes


title: Influence of Emotions on Decision-making in Parkinson's Disease

summary:
Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which project on the striatum. Neuronal death within this structure leads to a decrease in dopamine levels. Dopamine is a neurotransmitter essential to the proper functioning of the basal ganglia highly involved in the control of voluntary and involuntary movements.

It also leads to cognitive and behavioral changes. Among these changes, the investigators will mainly remember the idea of the emergence of difficulties to make the right decisions, for example at the financial, medical .... This disruption would be the result of executive dysfunction. By definition, executive functions allow us to evaluate, plan and organize our actions to achieve a goal.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint Etienne
CHU de Grenoble Alpes


title: Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T

acronym: SPARCKLING

summary: In kidney transplant patients, CMV infection remains the leading infectious cause of morbidity and mortality. Clinical and virological relapses are common and are involved in chronic graft dysfunction. To date, it is not certain that secondary prophylaxis allows reducing these relapses, although this prophylaxis is part of the current recommendations. Our team has recently shown that the expansion of γδ T cells in peripheral blood during CMV infection was correlated with the absence of virological and clinical relapses. Indeed, the absence of relapse was associated in 94.7% of cases with the presence of γδ T cells expansion while relapses occurred in about 90% of cases in the absence of γδ T cells expansion. These results suggest that the indication and duration of secondary prophylaxis after the curative treatment of CMV infection in kidney transplantation could be guided by the immune surveillance of γδ T cells.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon


title: National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.

summary: Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with HIV.

ipd_sharing_description: We need to make a concertation with PI and scientists.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

intervention_type: Behavioral