ReferenceCitation: Frank M, Albuisson J, Ranque B, Golmard L, Mazzella JM, Bal-Theoleyre L, Fauret AL, Mirault T, Denarié N, Mousseaux E, Boutouyrie P, Fiessinger JN, Emmerich J, Messas E, Jeunemaitre X. The type of variants at the COL3A1 gene associates with the phenotype and severity of vascular Ehlers-Danlos syndrome. Eur J Hum Genet. 2015 Dec;23(12):1657-64. doi: 10.1038/ejhg.2015.32. Epub 2015 Mar 11.

ReferenceCitation: Faugeroux J, Nematalla H, Li W, Clement M, Robidel E, Frank M, Curis E, Ait-Oufella H, Caligiuri G, Nicoletti A, Hagege A, Messas E, Bruneval P, Jeunemaitre X, Bergaya S. Angiotensin II promotes thoracic aortic dissections and ruptures in Col3a1 haploinsufficient mice. Hypertension. 2013 Jul;62(1):203-8. doi: 10.1161/HYPERTENSIONAHA.111.00974. Epub 2013 Apr 29.

name: From the INSERM, U970, Paris Cardiovascular Research Center, Paris, France (J.F., W.L., E.R., H.A., P.B., X.J., S.B.); Université Paris Descartes, Paris, France (J.F., W.L., E.R., H.A., P.B., X.J., S.B.); Service de Cardiologie (H.N., A.H.), Service d’Anatomopathologie (P.B.), Centre de Référence des Maladies Vasculaires Rares (M.F., E.M., X.J.), Assistance Publique-Hôpitaux de Paris, and Centre d’Investigation Clinique (E.C.), Hôpital Européen Georges-Pompidou, Paris, France; INSERM, U698, Paris,...

family: Faugeroux

full_name: Julie Faugeroux

given: Julie

family: Nematalla

full_name: Hany Nematalla

given: Hany

family: Li

full_name: Weiwei Li

given: Weiwei

family: Clement

full_name: Marc Clement

given: Marc

family: Robidel

full_name: Estelle Robidel

given: Estelle

family: Frank

full_name: Michael Frank

given: Michael

family: Curis

full_name: Emmanuel Curis

given: Emmanuel

family: Ait-Oufella

full_name: Hafid Ait-Oufella

given: Hafid

family: Caligiuri

full_name: Giuseppina Caligiuri

given: Giuseppina

family: Nicoletti

full_name: Antonino Nicoletti

given: Antonino

family: Hagege

full_name: Albert Hagege

given: Albert

family: Messas

full_name: Emmanuel Messas

family: Bruneval

full_name: Patrick Bruneval

given: Patrick

family: Jeunemaitre

full_name: Xavier Jeunemaitre

given: Xavier

family: Bergaya

full_name: Sonia Bergaya

given: Sonia

journal_name: Hypertension

title: Angiotensin II Promotes Thoracic Aortic Dissections and Ruptures in Col3a1 Haploinsufficient Mice

ReferenceCitation: Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7. Erratum in: Lancet. 2016 Aug 6;388(10044):564. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.

family: Ong

full_name: Kim-Thanh Ong

given: Kim-Thanh

family: Perdu

full_name: Jérôme Perdu

given: Jérôme

family: De Backer

full_name: Julie De Backer

family: Bozec

full_name: Erwan Bozec

given: Erwan

family: Collignon

full_name: Patrick Collignon

family: Emmerich

full_name: Joseph Emmerich

given: Joseph

location_facility: CHU DE GRENOBLE - Hopital Albert Michallon

location_facility: CHRU DE NANCY - Institut Lorrain du Coeur et des Vaisseaux

location_facility: AP-HP - Hopital Europeen Georges-Pompidou

title: Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome: a Double Blind, Randomized, Placebo Controlled, Multicenter Trial.

summary: This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their vasculature affected by a defect in type III collagen in addition to the effects celiprolol. This randomized, double blind, placebo controlled trial compares the administration of the Ang II type I receptor blocker (ARB) - irbesartan- to placebo over a 2-year period in vEDS patients with the main objective to reduce the incidence of both symptomatic and asymptomatic vascular events.


type: Other Identifier

title: Optimum and Stepped Care Standardised Antihypertensive Treatment With or Without Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis. ANDORRA TRIAL

acronym: ANDORRA

summary: The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting + standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration in patients with confirmed resistant hypertension (RH) and angiographically proven grade III unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hopital Europeen Georges Pompidou (HEGP)

location_facility: Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease

acronym: PREDI-STIM

summary:
This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .

The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Besse-Pinot E, Pereira B, Durif F, Fantini ML, Durand E, Debilly B, Derost P, Moreau C, Hainque E, Rouaud T, Eusebio A, Benatru I, Drapier S, Guehl D, Rascol O, Maltête D, Lagha-Boukbiza O, Giordana C, Tir M, Thobois S, Hopes L, Hubsch C, Jarraya B, Rolland AS, Corvol JC, Devos D, Marques A; Predistim study group. Preoperative REM Sleep Behavior Disorder and Subthalamic Deep Brain Stimulation Outcome in Parkinson Disease 1 Year After Surgery. Neurology. 2021 Oct 19. pii: 10.1212/WNL.0000000000012862. doi: 10.1212/WNL.0000000000012862. [Epub ahead of print]

ReferenceCitation: Betrouni N, Moreau C, Rolland AS, Carrière N, Chupin M, Kuchcinski G, Lopes R, Viard R, Defebvre L, Devos D. Texture-based markers from structural imaging correlate with motor handicap in Parkinson's disease. Sci Rep. 2021 Feb 1;11(1):2724. doi: 10.1038/s41598-021-81209-4.

family: Betrouni

full_name: Nacim Betrouni

given: Nacim

sequence: first

family: Moreau

full_name: Caroline Moreau

given: Caroline

sequence: additional

family: Rolland

full_name: Anne-Sophie Rolland

given: Anne-Sophie

family: Carrière

full_name: Nicolas Carrière

given: Nicolas

family: Chupin

full_name: Marie Chupin

given: Marie

family: Kuchcinski

full_name: Gregory Kuchcinski

given: Gregory

family: Lopes

full_name: Renaud Lopes

given: Renaud

family: Viard

full_name: Romain Viard

given: Romain

family: Defebvre

full_name: Luc Defebvre

given: Luc

family: Devos

full_name: David Devos

given: David

bso_classification: Biology (fond.)

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Scientific Reports

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

version: submittedVersion

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Texture-based markers from structural imaging correlate with motor handicap in Parkinson’s disease

ReferenceCitation: Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Croiset A, Ory-Magne F, Rascol O, Moreau C, Rolland AS, Maltête D, Rouaud T, Meyer M, Drapier S, Giordana B, Anheim M, Hainque E, Jarraya B, Benatru I, Auzou N, Belamri L, Tir M, Marques AR, Thobois S, Eusebio A, Corvol JC, Devos D, Brefel-Courbon C; PREDI-STIM study group. Personality dimensions of patients can change during the course of parkinson's disease. PLoS One. 2021 Jan 7;16(1):e0245142. doi: 10.1371/journal.pone.0245142. eCollection 2021.

family: Boussac

full_name: Mathilde Boussac

given: Mathilde

family: Arbus

full_name: Christophe Arbus

given: Christophe

family: Dupouy

full_name: Julia Dupouy

given: Julia

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

title: Personality dimensions of patients can change during the course of parkinson’s disease

ReferenceCitation: Santin MDN, Voulleminot P, Vrillon A, Hainque E, Béreau M, Lagha-Boukbiza O, Wirth T, Montaut S, Bardinet E, Kyheng M, Rolland AS, Voirin J, Drapier S, Durif F, Eusebio A, Giordana C, Auzou N, Houeto JL, Hubsch C, Jarraya B, Laurencin C, Maltete D, Meyer M, Rascol O, Rouaud T, Tir M, Moreau C, Corvol JC, Proust F, Grabli D, Devos D, Tranchant C, Anheim M; Predistim Study Group. Impact of Subthalamic Deep Brain Stimulation on Impulse Control Disorders in Parkinson's Disease: A Prospective Study. Mov Disord. 2021 Mar;36(3):750-757. doi: 10.1002/mds.28320. Epub 2020 Oct 6.

name: Department of Neurosurgery, NS‐PARK/F‐CRIN Strasbourg University Hospital  Strasbourg France

name: Department of Neurology NS‐PARK/F‐CRIN, Strasbourg University Hospital, Fédération de Médecine Translationnelle de Médecine de Strasbourg  Strasbourg France

name: Department of Neurology NS‐PARK/F‐CRIN, Assistance Publique ‐ Hôpitaux de Paris (APHP), Pitié‐Salpêtrière Hospital  Paris France

name: Sorbonne Universités, Assistance Publique ‐ Hôpitaux de Paris (APHP), Inserm, CNRS, Institut du Cerveau et de la Moelle (ICM)  Paris France

name: Department of Neurology NS‐PARK/F‐CRIN, University Hospital of Besançon  Besançon France

name: Centre de Neuroimagerie de Recherche, Institut du Cerveau et de la Moelle (ICM)  Paris France

name: Department of Clinical Research Lille University Hospital  Lille France

name: Department of Medical Pharmacology University Hospital, NS‐PARK/F‐CRIN, University of Lille, Lille Neuroscience & Cognition, Inserm, UMR‐S1172  Lille France

name: Department of Neurology NS‐PARK/F‐CRIN, University Hospital of Rennes  Rennes France

name: Department of Neurology NS‐PARK/F‐CRIN, CHU Clermont‐Ferrand  Clermont‐Ferrand France

name: Department of Neurology NS‐PARK/F‐CRIN, Assistance Publique ‐ Hôpitaux de Marseille (APHM), Timone University Hospital and Institut de Neurosciences de la Timone  Marseille France

name: Department of Neurology NS‐PARK/F‐CRIN, Centre Hospitalier Universitaire de Nice  Nice France

name: Institute of Neurodegenerative Disorders NS‐PARK/F‐CRIN, University Hospital of Bordeaux  Bordeaux France

name: Department of Neurology NS‐PARK/F‐CRIN, University Hospital of Poitiers  Poitiers France

name: Department of Neurology NS‐PARK/F‐CRIN, Fondation Ophtalmologique Adolphe de Rothschild  Paris France

name: Neuroscience Pole NS‐PARK/F‐CRIN, Hôpital Foch, Suresnes, University of Versailles Paris‐Saclay, INSERM‐CEA NeuroSpin  Saclay France

name: Department of Neurology NS‐PARK/F‐CRIN, University Hospital of Lyon  Lyon France

name: Department of Neurology NS‐PARK/F‐CRIN, Rouen University Hospital and University of Rouen, France; INSERM U1239, Laboratory of Neuronal and Neuroendocrine Differentiation and Communication  Mont‐Saint‐Aignan France

name: Department of Neurology NS‐PARK/F‐CRIN, University Hospital of Nancy  Nancy France

name: Department of Clinical Pharmacology and Neuroscience NS‐Park/F‐CRIN, Toulouse University Hospital  Toulouse France

name: Department of Neurology NS‐PARK/F‐CRIN, Nantes University Hospital  Nantes France

name: Department of Neurology NS‐PARK/FCRIN, Amiens University Hospital  Amiens France

name: Department of Neurology University Hospital, NS‐PARK/F‐CRIN, University of Lille, Lille Neuroscience & Cognition, INSERM, UMR‐S1172  Lille France

ReferenceCitation: Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Ory-Magne F, Rascol O, Moreau C, Maltête D, Rouaud T, Meyer M, Houvenaghel JF, Marsé C, Tranchant C, Hainque E, Jarraya B, Ansquer S, Bonnet M, Belamri L, Tir M, Marques AR, Danaila T, Eusebio A, Devos D, Brefel-Courbon C; PREDI-STIM study group*. Personality Dimensions Are Associated with Quality of Life in Fluctuating Parkinson's Disease Patients (PSYCHO-STIM). J Parkinsons Dis. 2020;10(3):1057-1066. doi: 10.3233/JPD-191903.

name: ToNIC, Toulouse NeuroImaging Center, University of Toulouse, Inserm, UPS, Toulouse, France

name: Psychiatry Department of the University Hospital of Toulouse, CHU Purpan, Toulouse, France

name: Department of Clinical Pharmacology and Neurosciences, Centre d’Investigation Clinique CIC1436, University Hospital of Toulouse, Toulouse, France

name: CHU of Lille, Univ. Lille, Inserm UMRS_1171, Licend, Department of Medical Pharmacology, Neurology and Movement Disorders Department, Referent Center of Parkinson’s Disease, Lille, France

name: Department of Neurology, Rouen University Hospital and University of Rouen, France; INSERM U1239, Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan, France

name: Clinique Neurologique, Hôpital Guillaume et René Laennec, Boulevard Jacques Monod, Nantes Cedex

name: Neurology Department, Nancy University Hospital, Nancy, France

name: Behavior and Basal Ganglia” Research Unit (EA 4712), University of Rennes 1, Rennes, France; Department of Neurology, Rennes University Hospital, Rennes Cedex, France

name: CHU Nice, Centre Expert Parkinson, Service de Neurologie, Nice, France

name: Service de Neurologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; Institut de Génétique et de Biologie Moléculaire et Cellulaire (IGBMC), INSERM-U964/CNRS-UMR7104/Université de Strasbourg, Illkirch, France; Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg, Strasbourg, France

name: Département de Neurologie, Hôpital Pitié-Salpêtrière, AP-HP, Faculté de Médecine de Sorbonne Université, UMR S 1127, Inserm U 1127, and CNRS UMR 7225, and Institut du Cerveau et de la Moëlle épinière, Paris, France

name: Pôle Neurosciences, Foch Hospital, Suresnes, France; Université de Versailles Paris-Saclay, INSERM U992, CEA Neurospin, Paris, France

name: Service de Neurologie, Centre Expert Parkinson, CIC-INSERM 1402, CHU Poitiers, Poitiers, France

name: CHU de Bordeaux, Centre Expert Parkinson, Institut des maladies neuro-dégénératives, Bordeaux, France

name: Fondation Ophtalmologique A de Rothschild, Unité James Parkinson, Paris, France

name: Department of Neurology, Department of Neurosurgery, Expert Centre for Parkinson’s Disease, Amiens University Hospital, EA 4559 Laboratoire de Neurosciences Fonctionnelles et Pathologie (LNFP) Université de Picardie Jules Verne, University of Picardy Jules Verne (UPJV), Amiens, France

name: Université Clermont Auvergne, EA7280, Clermont-Ferrand University Hospital, Neurology Department, Clermont-Ferrand, France

name: Centre Expert Parkinson, Hôpital Neurologique “Pierre Wertheimer”, Hospices Civils de Lyon, Bron, France

name: Aix Marseille Université, AP-HM, Hôpital de La Timone, Service de Neurologie et Pathologie du Mouvement, and UMR CNRS 7289, Institut de Neuroscience de La Timone, Marseille, France

title: Personality Dimensions Are Associated with Quality of Life in Fluctuating Parkinson’s Disease Patients (PSYCHO-STIM)


title: Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery

acronym: préOVNI

summary:
Surgical treatment is the standard treatment for localized forms of lung cancer non-small cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing this procedure is a major public health issue. The non-invasive ventilation is a technique commonly used postoperatively in acute respiratory distress and in the treatment of sleep apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the non-invasive ventilation achieved during 7 days minimum before the intervention could significantly reduce postoperative complications in patients with an obstructive or restrictive disorder, obesity or chronic heart failure.

The aim of the study is to demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.

status: Completed

lead_sponsor: University Hospital, Brest

location_facility: Hôpital Nord Ouest Villefranche Sur Saône

status_simplified: Completed


title: Tolerance and Efficacy of Rituximab in Sjogren's Disease

acronym: TEARS

summary:
CLINICAL PHASE II INDICATION Sjogren's syndrome RATIONALE Sjögren's syndrome (SS) is an autoimmune disorder affecting 0.2% to 3% of the general population. Pharmacological treatment can improve the sicca symptoms, often transiently, but they are unable to modify the course of the disease.Open label studies suggested that low-dose rituximab produced acute and complete CD20 depletion in blood and tissue; was well tolerated without corticosteroid use; and significantly improved glandular and extra-glandular manifestations of pSS. Larger controlled studies are now warranted. Our hypothesis is that two infusions of 1000 mg of Rituximab may be better than placebo to treat patients suffering from pSS. To test this hypothesis, we propose to compare patients with recent and/or severe pSS treated with either Rituximab or placebo.

OBJECTIVES Primary objective : Evaluation of the efficacy defined as a 30% improvement between Day 1 and Week 24 in the values on 2 of the 4 VAS measuring global scores of the disease (activity of the disease including extra glandular manifestations), joint pain, fatigue, and the most disturbing dryness.Secondary objectives : Variations from baseline to week 24 of:

The 0-100-mm VAS scores for dry mouth, dry eyes, dry trachea, dry vagina, and dry skin; fatigue; pain; Tender and swollen joint counts; Tender points; Other systemic manifestation; Unstimulated salivary flow rate; Schirmer and van Bijsterveld scores (2-3); C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR); rheumatoid factor (RF); ANA; serum IgG, IgA, and IgM; complement; cryoglobulinemia; and counts of B and T cells; Evaluation of the safety of Rituximab during the study Evaluation of the improvement evaluated on VAS by the physician Evaluation of the disease activity scores as suggested by Bowman and Vitali Evaluation of Chisholm score, B cells characteristics and DNA microarray on labial accessory salivary gland (SG) biopsy samples, and salivary gland echography at inclusion and at week 24.

TRIAL DESIGN Multicenter, randomized, double-blind, placebo-controlled trial NUMBER OF SUBJECTS : 120

ReferenceType: background

ReferenceCitation: Devauchelle-Pensec V, Pennec Y, Morvan J, Pers JO, Daridon C, Jousse-Joulin S, Roudaut A, Jamin C, Renaudineau Y, Roué IQ, Cochener B, Youinou P, Saraux A. Improvement of Sjögren's syndrome after two infusions of rituximab (anti-CD20). Arthritis Rheum. 2007 Mar 15;57(2):310-7.

ReferenceCitation: Cornec D, Devauchelle-Pensec V, Mariette X, Jousse-Joulin S, Berthelot JM, Perdriger A, Puéchal X, Le Guern V, Sibilia J, Gottenberg JE, Chiche L, Hachulla E, Yves Hatron P, Goeb V, Hayem G, Morel J, Zarnitsky C, Dubost JJ, Saliou P, Pers JO, Seror R, Saraux A. Severe Health-Related Quality of Life Impairment in Active Primary Sjögren's Syndrome and Patient-Reported Outcomes: Data From a Large Therapeutic Trial. Arthritis Care Res (Hoboken). 2017 Apr;69(4):528-535. doi: 10.1002/acr.22974.

name: Centre Hospitalier Universitaire de la Cavale Blanche, and EA 2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGOBrest France

family: Cornec

full_name: Divi Cornec

given: Divi

family: Devauchelle‐Pensec

full_name: Valérie Devauchelle‐Pensec

given: Valérie

name: Assistance Publique‐Hôpitaux de Paris, Hôpitaux Universitaires Paris‐Sud, INSERM U1184, Université Paris‐SudLe Kremlin Bicêtre France

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Jousse‐Joulin

full_name: Sandrine Jousse‐Joulin

given: Sandrine

name: Hôtel‐Dieu, Centre Hospitalier Universitaire NantesNantes France

family: Berthelot

full_name: Jean‐Marie Berthelot

given: Jean‐Marie

name: Centre Hospitalier Universitaire, Hôpital SudRennes France

family: Perdriger

full_name: Aleth Perdriger

given: Aleth

family: Puéchal

full_name: Xavier Puéchal

family: Le Guern

full_name: Véronique Le Guern

given: Véronique

name: Hôpitaux Universitaires de Strasbourg and Université de StrasbourgStrasbourg France

family: Sibilia

full_name: Jean Sibilia

given: Jean

family: Gottenberg

full_name: Jacques‐Eric Gottenberg

given: Jacques‐Eric

family: Chiche

full_name: Laurent Chiche

given: Laurent

name: Hôpital Claude Huriez and Université Lille Nord‐de‐FranceLille France

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Yves Hatron

full_name: Pierre Yves Hatron

given: Pierre

name: Centres Hospitaliers Régionaux Universitaires de AmiensAmiens France

family: Goeb

full_name: Vincent Goeb

given: Vincent

name: Centre Hospitalier Universitaire Ambroise ParéBoulogne France

family: Hayem

full_name: Gilles Hayem

given: Gilles

name: Centre Hospitalier Universitaire LapeyronieMontpellier France

family: Morel

full_name: Jacques Morel

given: Jacques

name: Centre Hospitalier J. MonodMontivilliers France

family: Zarnitsky

full_name: Charles Zarnitsky

given: Charles

name: Hôpital Gabriel MontpiedClermont‐Ferrand France

family: Dubost

full_name: Jean Jacques Dubost

given: Jean Jacques

name: Centres Hospitaliers Régionaux Universitaires MorvanBrest France

family: Saliou

full_name: Philippe Saliou

given: Philippe

name: EA 2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGO, and Centre Hospitalier Universitaire Morvan, and EA 2216, Université Bretagne OccidentaleBrest France

family: Pers

full_name: Jacques Olivier Pers

given: Jacques Olivier

family: Seror

full_name: Raphaèle Seror

given: Raphaèle

family: Saraux

full_name: Alain Saraux

given: Alain

bso_classification: Medical research

title: Severe Health‐Related Quality of Life Impairment in Active Primary Sjögren's Syndrome and Patient‐Reported Outcomes: Data From a Large Therapeutic Trial

ReferenceCitation: Costa S, Schutz S, Cornec D, Uguen A, Quintin-Roué I, Lesourd A, Berthelot JM, Hachulla E, Hatron PY, Goeb V, Vittecoq O, Pers JO, Marcorelles P, Saraux A, Devauchelle-Pensec V. B-cell and T-cell quantification in minor salivary glands in primary Sjögren's syndrome: development and validation of a pixel-based digital procedure. Arthritis Res Ther. 2016 Jan 20;18:21. doi: 10.1186/s13075-016-0924-2.

title: B-cell and T-cell quantification in minor salivary glands in primary Sjögren’s syndrome: development and validation of a pixel-based digital procedure

ReferenceCitation: Jousse-Joulin S, Devauchelle-Pensec V, Cornec D, Marhadour T, Bressollette L, Gestin S, Pers JO, Nowak E, Saraux A. Brief Report: Ultrasonographic Assessment of Salivary Gland Response to Rituximab in Primary Sjögren's Syndrome. Arthritis Rheumatol. 2015 Jun;67(6):1623-8. doi: 10.1002/art.39088.

name: CHU de la Cavale Blanche and EA 2216, INSERM ESPRI, ERI29 Université Bretagne Occidentale; Brest France

name: INSERM CIC 0502, CHU de la Cavale Blanche; Brest France

ReferenceCitation: Devauchelle-Pensec V, Mariette X, Jousse-Joulin S, Berthelot JM, Perdriger A, Puéchal X, Le Guern V, Sibilia J, Gottenberg JE, Chiche L, Hachulla E, Hatron PY, Goeb V, Hayem G, Morel J, Zarnitsky C, Dubost JJ, Pers JO, Nowak E, Saraux A. Treatment of primary Sjögren syndrome with rituximab: a randomized trial. Ann Intern Med. 2014 Feb 18;160(4):233-42.

location_facility:
Ch Le Mans
CHRU de LILLE
GH Le Havre
CHU de Nantes
CHU de Marseille
CHU Bichat
Hôpital SUD CHU Rennes
CHU Rouen
CHU de Strasbourg
CHU Clermont-Ferrand
Hopital LAPEYRONIE
AP-HP Bicêtre
Hôpital Cochin APHP
CHU de Brest


title: Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection

acronym: METASYNC

summary: The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

ReferenceCitation: Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2.

ReferenceCitation: Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62.

lead_sponsor: Rennes University Hospital

location_facility: Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz

location_facility: Chirurgie digestive, thoracique et cancérologie

location_facility: Département de Chirurgie - CRLCC Léon Bérard

location_facility: Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine

location_facility: Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine

location_facility: Centre Hépato-biliaire - Hôpital Paul Brousse

location_facility: Service de Chirurgie - Hôpital Jean Bernard

location_facility: Département de Chirurgie Viscérale - Hôpital Pontchaillou

location_facility: Chirurgie Viscérale Digestive - CH Chubert

location_facility: Service d'Oncologie Digestive- CRLCC Eugène Marquis

location_facility: Chirurgie générale viscérale et digestive - Hôpital Nord

location_facility: Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre

intervention_type: Procedure


title: Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

summary:
The conventional sonography is frequently used to detect incidental focal liver lesions because of its availability, innocuity and low cost. Nevertheless, sensibility and specificity of conventional sonography does not exceed 70% for tumoral affections. Consequently the interest of this practice must be reconsidered by studying its ratio cost/diagnosis contribution.

These limitations of conventional sonography have led to the use of other imaging modalities and invasive or costly procedures such as computed tomography (CT), magnetic resonance imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or cirrhotic liver in a neoplastic context or not, without inconvenience for the patient.

The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance and catch of load cost, in the characterization of focal liver lesions detected but not characterized by CT or conventional sonography.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Kim TK, Choi BI, Hong HS, Choi BY, Han JK. Improved imaging of hepatic metastases with delayed pulse inversion harmonic imaging using a contrast agent SH U 508A: preliminary study. Ultrasound Med Biol. 2000 Nov;26(9):1439-44.

ReferenceCitation: Albrecht T, Blomley MJ, Burns PN, Wilson S, Harvey CJ, Leen E, Claudon M, Calliada F, Correas JM, LaFortune M, Campani R, Hoffmann CW, Cosgrove DO, LeFevre F. Improved detection of hepatic metastases with pulse-inversion US during the liver-specific phase of SHU 508A: multicenter study. Radiology. 2003 May;227(2):361-70. Epub 2003 Mar 20.

ReferenceCitation: Quaia E, Bertolotto M, Forgács B, Rimondini A, Locatelli M, Mucelli RP. Detection of liver metastases by pulse inversion harmonic imaging during Levovist late phase: comparison with conventional ultrasound and helical CT in 160 patients. Eur Radiol. 2003 Mar;13(3):475-83. Epub 2002 Sep 26.

ReferenceCitation: Bernatik T, Becker D, Neureiter D, Hänsler J, Frieser M, Schaber S, Hahn EG, Strobel D. [Detection of liver metastases--comparison of contrast--enhanced ultrasound using first versus second generation contrast agents]. Ultraschall Med. 2003 Jun;24(3):175-9. German.

ReferenceCitation: Basilico R, Blomley MJ, Harvey CJ, Filippone A, Heckemann RA, Eckersley RJ, Cosgrove DO. Which continuous US scanning mode is optimal for the detection of vascularity in liver lesions when enhanced with a second generation contrast agent? Eur J Radiol. 2002 Mar;41(3):184-91.

ReferenceCitation: Leen E, Angerson WJ, Yarmenitis S, Bongartz G, Blomley M, Del Maschio A, Summaria V, Maresca G, Pezzoli C, Llull JB. Multi-centre clinical study evaluating the efficacy of SonoVue (BR1), a new ultrasound contrast agent in Doppler investigation of focal hepatic lesions. Eur J Radiol. 2002 Mar;41(3):200-6.

ReferenceCitation: Tranquart F, Bleuzen A, Tchuenbou J. [Contrast ultrasound imaging in focal liver lesions: diagnostic value and guidelines]. J Radiol. 2004 May;85(5 Pt 2):680-9. Review. French.

lead_sponsor: University Hospital, Tours

location_facility: Hôpital Necker, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Beaujon, Assistance Publique Hôpitaux de Paris

location_facility: Service de Radiologie, Hôpital d'Enfants de Brabois

location_facility: Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris


title: Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.

acronym: PACKING

summary:
Severe injurious behaviors in children with autism spectrum disorder are challenging. First line treatment approaches include behavioral techniques but pharmacotherapy is frequently required despite frequent adverse effects in youths.

Therapeutic body wraps has been reported in small series or case reports, but has never been assessed in the context of a randomized controlled trial.

The present study is an exploratory, multicenter, randomized, controlled, open label with blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic body wraps in children presenting with autism spectrum disorder and severe injurious behavior.

primary_purpose: Supportive Care

ReferenceCitation: Delion P, Labreuche J, Deplanque D, Cohen D, Duhamel A, Lallié C, Ravary M, Goeb JL, Medjkane F, Xavier J; Therapeutic Body Wrap Study group. Therapeutic body wraps (TBW) for treatment of severe injurious behaviour in children with autism spectrum disorder (ASD): A 3-month randomized controlled feasibility study. PLoS One. 2018 Jun 29;13(6):e0198726. doi: 10.1371/journal.pone.0198726. eCollection 2018.

family: Delion

full_name: Pierre Delion

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Deplanque

full_name: Dominique Deplanque

given: Dominique

family: Cohen

full_name: David Cohen

given: David

family: Duhamel

full_name: Alain Duhamel

family: Lallié

full_name: Céline Lallié

given: Céline

family: Ravary

full_name: Maud Ravary

given: Maud

full_name: Jean-Louis Goeb

given: Jean-Louis

family: Medjkane

full_name: François Medjkane

given: François

family: Xavier

full_name: Jean Xavier

name: on behalf of The Therapeutic Body Wrap Study group

journal_name: PLOS ONE

repository_institution: PubMed Central - Europe PMC

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

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
pdfs.semanticscholar.org

repositories_institution: Université de Lille (University Of Lille) - LillOA

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

ReferenceCitation: Huang HF, Tian JL, Yang XT, Sun L, Hu RY, Yan ZH, Li SS, Xie Q, Tian XB. Efficacy and safety of low-molecular-weight heparin after knee arthroscopy: A meta-analysis. PLoS One. 2018 Jun 21;13(6):e0197868. doi: 10.1371/journal.pone.0197868. eCollection 2018.

location_facility: Etablissement Public de Santé Mentale Val de Lys-Artois

location_facility: Etablissement Public de Santé Roger Prévot


title: Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection SINBIOSE-H.

acronym: SINBIOSE-H

summary:
Each year, around 1500 infected Total Hip Arthroplasties (THA) need non-conservative surgery, remaining an issue for patients and healthcare units. The recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. This protocol implies a first surgery to remove all infected implants and at least 6 weeks of antibiotic treatment without implant, then usually an antibiotic-free period and only then a second surgery to put back new implants and start the rehabilitation protocol, with usually more than a week of a second hospital stay. Between both surgeries, full-weight bearing is prohibited and joint stiffness and/or pain are rather usual complications. Failure rate is estimated at 10% in this two-stage strategy. The single-stage procedure (i.e. implanting back a new prosthesis during the same surgery after implant removal, synovectomy and lavage) is thought to be less susceptible to late functional complications (i.e. pain, stiffness and muscle deficiency) with a shorter, single hospital stay.

Although, with single-stage surgery, infection control could be less efficient because most pathogens produce during the first hours of infection an antibiotic-resistant layer called biofilm, allowing them to colonize and adhere to foreign objects like implants. This single-surgery protocol thus highly relies on antibiotics and has a list of contra-indications (based on experts' consensus): the presence of damaged soft tissues or a sinus tract, unknown pathogens, difficult to treat micro-organisms, severe immunosuppression and for many surgeons, each time a bone graft is necessary. Most of these contra-indications are directly related to the biofilm.

As no randomized control trial has ever compared single-stage versus two-stage surgery, the level of evidence for recommending one procedure over the other is low.

We conducted a survey that showed that most of the French reference centers have already switched to single stage surgery for single-stage non contra-indicated cases.

An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating®, Novagenit SRL), has been proven to mechanically prevent the biofilm formation, while allowing a prolonged intraarticular antibiotic release, in a randomized controlled trial in primary prevention of infection in THA.

The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for secondary prevention of peri-prosthetic hip joint infection. Moreover, using this device to prevent biofilm formation could expand one stage surgery to patients that are "normally" contra-indicated to one stage surgery.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Marseille
CHU Toulouse
CHU Caen
CHU Clermont-Ferrand
CHU Bordeaux
Chu Saint-Etienne
CHU Dijon
CHU Lille
CHU Nantes
CHU Nancy
CHU Nice
CHU Amiens

status_simplified: Ongoing


title: MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis

acronym: CFMR-lung

summary: The aim of the study is to assess the diagnostic sensitivity of MRI to detect changes in Helbich-Bhalla scoring over time in patients with cystic fibrosis

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Armand-Trousseau
Hôpital Henri Mondor
University Hospital of Bordeaux
CHRU de Lille
Hopital Universitaire de la Timone
Fondation Lenval
Hôpital Foch
CHRU Bretonneau-Tours
CHRU de Grenoble
Hopital Nord
Hôpital Necker Enfant Malades


title: Predictive Value of Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies Stretches of 4 or More Segments on Non-cirrhotic Liver

acronym: SCINTIVOL

summary: Extended hepatectomies of 4 or more segments are complicated by high rates of morbidity and mortality, mainly related to hepatic liver failure. Nowadays, preoperative assessment of the future remnant liver is just performed through its volumetric measurement by computed tomography. Nevertheless, this volumetric assessment does not reflect the hepatocellular function of the future remnant liver that can be disturbed in case of vascular and/or biliary obstruction, chemotherapy-induced liver injuries or steatosis in overweight patients. Literature data (albeit originating from a single centre in Europe) have suggested that (99m)Tc-mebrofenin hepatobiliary scintigraphy could be useful in evaluating the function of the future remnant liver. The aim of this prospective multicentric study is to determine the predictive value of hepatobiliary scintigraphy in assessing the risk of postoperative liver failure of extended hepatectomies of 4 or more segments in noncirrhotic liver.

primary_purpose: Screening

ReferenceType: result

ReferenceCitation: Bennink RJ, Tulchinsky M, de Graaf W, Kadry Z, van Gulik TM. Liver function testing with nuclear medicine techniques is coming of age. Semin Nucl Med. 2012 Mar;42(2):124-37. doi: 10.1053/j.semnuclmed.2011.10.003. Review.

family: Bennink

full_name: Roelof J. Bennink

given: Roelof J.

family: Tulchinsky

full_name: Mark Tulchinsky

given: Mark

family: de Graaf

full_name: Wilmar de Graaf

given: Wilmar

family: Kadry

full_name: Zakiyah Kadry

given: Zakiyah

family: van Gulik

full_name: Thomas M. van Gulik

given: Thomas M.

journal_name: Seminars in Nuclear Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Liver Function Testing with Nuclear Medicine Techniques Is Coming of Age

ReferenceCitation: de Graaf W, Heger M, Spruijt O, Maas A, de Bruin K, Hoekstra R, Bennink RJ, van Gulik TM. Quantitative assessment of liver function after ischemia-reperfusion injury and partial hepatectomy in rats. J Surg Res. 2012 Jan;172(1):85-94. doi: 10.1016/j.jss.2010.06.038. Epub 2010 Jul 21.

family: Heger

full_name: Michal Heger

given: Michal

family: Spruijt

full_name: Onno Spruijt

given: Onno

family: Maas

full_name: Adrie Maas

given: Adrie

family: de Bruin

full_name: Kora de Bruin

given: Kora

family: Hoekstra

full_name: Ruurdtje Hoekstra

given: Ruurdtje

journal_name: Journal of Surgical Research

title: Quantitative Assessment of Liver Function after Ischemia-Reperfusion Injury and Partial Hepatectomy in Rats

ReferenceCitation: de Graaf W, Bennink RJ, Veteläinen R, van Gulik TM. Nuclear imaging techniques for the assessment of hepatic function in liver surgery and transplantation. J Nucl Med. 2010 May;51(5):742-52. doi: 10.2967/jnumed.109.069435. Epub 2010 Apr 15. Review.

family: Veteläinen

full_name: Reeta Veteläinen

given: Reeta

title: Nuclear Imaging Techniques for the Assessment of Hepatic Function in Liver Surgery and Transplantation

ReferenceCitation: de Graaf W, Häusler S, Heger M, van Ginhoven TM, van Cappellen G, Bennink RJ, Kullak-Ublick GA, Hesselmann R, van Gulik TM, Stieger B. Transporters involved in the hepatic uptake of (99m)Tc-mebrofenin and indocyanine green. J Hepatol. 2011 Apr;54(4):738-45. doi: 10.1016/j.jhep.2010.07.047. Epub 2010 Oct 1.

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Transporters involved in the hepatic uptake of 99mTc-mebrofenin and indocyanine green

ReferenceCitation: de Graaf W, van Lienden KP, van den Esschert JW, Bennink RJ, van Gulik TM. Increase in future remnant liver function after preoperative portal vein embolization. Br J Surg. 2011 Jun;98(6):825-34. doi: 10.1002/bjs.7456. Epub 2011 Apr 11.

name: Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands

name: Department of Radiology, Academic Medical Centre, Amsterdam, The Netherlands

name: Department of Nuclear Medicine, Academic Medical Centre, Amsterdam, The Netherlands

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand


title: Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial

acronym: pericardite

summary:
Treatment of pericarditis largely remains empirical due to the relative lack of randomized controlled trials. Nevertheless, some recommendations have been formulated to guide management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages is the mainstay of treatment. Optimal length of treatment is not established.

PERICARDITE is a French multicentric placebo controlled double blind randomized trial assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non inferiority trial.

Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction, autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis, neoplastic disease).

Primary endpoint is: 30 days recovery defined as the normalization of all clinical and paraclinical initial abnormalities.

Secondary endpoint is: 6-month recurrence.

ReferenceCitation: Maisch B, Seferović PM, Ristić AD, Erbel R, Rienmüller R, Adler Y, Tomkowski WZ, Thiene G, Yacoub MH; Grupo de Trabajo para el Diagnóstico y Tratamiento de las Enfermedades del Pericardio de la Sociedad Europea de Cardiología. [Guidelines on the diagnosis and management of pericardial diseases. Executive summary]. Rev Esp Cardiol. 2004 Nov;57(11):1090-114. Spanish.

ReferenceCitation: Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6.

location_facility: Centre Hospitalier Intercommunal de Cornouaille

intervention_type: Drug


title: Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients

summary: Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.

location_facility: Rééducation Fonctionnelle - Hôpital Raymond Poincaré

location_facility: Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi

location_facility: Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger

location_facility: Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

location_facility: Service de Rééducation Neuro-orthopédique - Hôpital Rothschild

location_facility: Service de Médecine Physique et Réadaptation - Hôpital de l'Archet


title: Virtual Reality Exposure Therapy for Gambling Disorder: Randomized Controlled Trial

acronym: VIRET-GAD

summary:
Gambling disorder (GD) is recognized as an addictive disorder in the DSM-5. Craving is a core phenomenon in addiction that can lead to relapse in problem gambling for pathological gamblers. Exposure Therapy (ET) focuses on craving in addiction treatment. ET in Cognitive-Behavioral Therapy (CBT) is based on classical conditioning that addresses the association between contextual cues and the craving response. ET helps the patient to reduce craving when faced with cues triggering craving. ET includes in vivo exposure and imaginal exposure. The literature recommends being as close as possible to the context of addiction to facilitate the extinction of craving but in vivo ET is complicated to perform. For GD, in outpatient consultation, bringing a patient to a casino presents obstacles (e.g., time, human and financial cost, agreement with casino for therapy).

The study will be to assess the effectiveness of Virtual Reality Exposure Therapy (VRET) in a virtual gambling environment. Various trials show that VRET is no more or less effective than classical ET in CBT but has other advantages for motivation to treatment. This research aims to compare efficacy between CBT with VRET and CBT with imaginal exposure for treatment of GD in a multicenter, randomized, controlled, non-inferiority clinical trial.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

lead_sponsor: University Hospital, Lille

location_facility: CH de l'arrondissement de Montreuil / CSAPA

intervention_type: Other


title: ENDOBARRIER® vs Conventional Therapy in the Management of Metabolic Syndrome in Obese Patients. Medico-economic Analysis as Part of a Randomized Controlled Multicenter Trial - ENDOMETAB

acronym: ENDOMETAB

summary: Obesity and metabolic syndrome (MS) are closely interrelated leading to increased mortality, mainly due to cardiovascular disease. In addition, some cancers are much higher when obesity is associated with metabolic syndrome. Bariatric surgery allows significant and sustained weight loss with marked improvement of MS. Considered too invasive, surgery is proposed to a small proportion of patients who could theoretically benefit. The ENDOBARRIER® device implanted endoscopically is an innovative approach developed for management of obesity in the non-surgical manner with benefits for improvement in MS already reported in literature.

location_facility: Assistance Publique des Hôpitaux de Marseille


title: Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse

acronym: LAPREM

summary:
Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%).

The benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 LS with double-mesh (anterior & posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p<0,01), and total recurrence rates 16.2 vs. 43.8% (p<0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since).

On the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.

location_facility:
Chu de Nice Hopital de L'Archet
Hopital Saint Vincent - Saint Antoine
Hopital Estaing
Clinique Du Pre
Ch Dunkerque
Chu Nimes - Nimes
Chi Poissy St Germain Site de Poissy
Hop Jeanne de Flandre Chu Lille
Hopital Saint-Louis - La Rochelle


title: Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National

summary: Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.

ReferenceCitation: Palussière J, Chomy F, Savina M, Deschamps F, Gaubert JY, Renault A, Bonnefoy O, Laurent F, Meunier C, Bellera C, Mathoulin-Pelissier S, de Baere T. Radiofrequency ablation of stage IA non-small cell lung cancer in patients ineligible for surgery: results of a prospective multicenter phase II trial. J Cardiothorac Surg. 2018 Aug 24;13(1):91. doi: 10.1186/s13019-018-0773-y.

family: Palussière

full_name: J. Palussière

given: J.

family: Chomy

full_name: F. Chomy

given: F.

family: Savina

full_name: M. Savina

given: M.

family: Deschamps

full_name: F. Deschamps

family: Gaubert

full_name: J. Y. Gaubert

given: J. Y.

family: Renault

full_name: A. Renault

given: A.

family: Bonnefoy

full_name: O. Bonnefoy

given: O.

family: Laurent

full_name: F. Laurent

family: Meunier

full_name: C. Meunier

given: C.

family: Bellera

full_name: C. Bellera

family: Mathoulin-Pelissier

full_name: S. Mathoulin-Pelissier

given: S.

family: de Baere

full_name: T. de Baere

given: T.

currency_apc_doaj: GBP

journal_name: Journal of Cardiothoracic Surgery

title: Radiofrequency ablation of stage IA non–small cell lung cancer in patients ineligible for surgery: results of a prospective multicenter phase II trial

lead_sponsor: Institut Bergonié

location_facility:
CHU de Strasbourg
CHU de Bordeaux
CH de Pau
CHU Rangueil-Larrey
Hôpital Cochin
Hôpital de Tenon
Hôpital Européen Georges Pompidou
Institut Gustave Roussy
CHU de Rennes

lead_sponsor_type: industriel


title: Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence

acronym: SURFER

summary: Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. The aim of the study is to use a simplified magnetic resonance imaging (MRI) technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically.

location_country: France Spain

location_facility:
CHU Angers
Hôpital Edouard Herriot
Hôpital de Pontchaillou
Hopital Donostia-San Sebastian
Hôpital Tenon
Hôpital de la Timone
Hôpital Huriez
Hôpital Saint Eloi
Hôpital du Brabois
Hôpital Beaujon


acronym: CYTOVEDO

location_facility:
CHU de Nice
CHU de Clermont-Ferrand
CHU de Montpellier
CHU de Grenoble
CH d'Annecy
APHP - Hôpital Saint-Antoine
CHU de Saint Etienne
CHU de Lyon Sud

type: EudraCT Number

source: euctr

title: Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy.

summary:
Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs 25.5% with placebo.

CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). A recent meta-analysis supports the use of valganciclovir in case of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC).

Moreover, a study showed that the risk of CMV reactivation seems to be more important with vedolizumab than with anti TNF, and the risk of colectomy is higher in case of CytoMegaloVirus (CMV) reactivation (p<0.05).


title: Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity

acronym: I GET DRY

summary: Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index/Eular Sjogren's Syndrome Patient Reported Index).

location_facility:
CHU Grenoble Alpes
CHU Estaing - Clermont Ferrand
CHU Reims
Hôpital Edouard Herriot - CHU Lyon
Chu Saint-Etienne
CH Pierre Oudot
Hôpital de la Croix Rousse
CH Lyon Sud


title: Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs

acronym: STEPH

summary: To date, the investigators still do not know the annual incidence of Superficial Vein Thrombosis in the legs, although the investigators do know that this pathology is frequent and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so it is important to re-evaluate this rate on an unselected population from general practice.

time_perspective: Cross-Sectional

location_facility: Clinique Mutualiste CHirurgicale de St-Etienne


ReferenceCitation: Mendenhall WM, Mendenhall CM, Reith JD, Scarborough MT, Gibbs CP, Mendenhall NP. Pigmented villonodular synovitis. Am J Clin Oncol. 2006 Dec;29(6):548-50. Review.

ReferenceCitation: Martin RC 2nd, Osborne DL, Edwards MJ, Wrightson W, McMasters KM. Giant cell tumor of tendon sheath, tenosynovial giant cell tumor, and pigmented villonodular synovitis: defining the presentation, surgical therapy and recurrence. Oncol Rep. 2000 Mar-Apr;7(2):413-9. Review.

ReferenceCitation: West RB, Rubin BP, Miller MA, Subramanian S, Kaygusuz G, Montgomery K, Zhu S, Marinelli RJ, De Luca A, Downs-Kelly E, Goldblum JR, Corless CL, Brown PO, Gilks CB, Nielsen TO, Huntsman D, van de Rijn M. A landscape effect in tenosynovial giant-cell tumor from activation of CSF1 expression by a translocation in a minority of tumor cells. Proc Natl Acad Sci U S A. 2006 Jan 17;103(3):690-5. Epub 2006 Jan 6.

ReferenceCitation: Cupp JS, Miller MA, Montgomery KD, Nielsen TO, O'Connell JX, Huntsman D, van de Rijn M, Gilks CB, West RB. Translocation and expression of CSF1 in pigmented villonodular synovitis, tenosynovial giant cell tumor, rheumatoid arthritis and other reactive synovitides. Am J Surg Pathol. 2007 Jun;31(6):970-6.

ReferenceCitation: Dewar AL, Cambareri AC, Zannettino AC, Miller BL, Doherty KV, Hughes TP, Lyons AB. Macrophage colony-stimulating factor receptor c-fms is a novel target of imatinib. Blood. 2005 Apr 15;105(8):3127-32. Epub 2005 Jan 6.

ReferenceCitation: Blay JY, El Sayadi H, Thiesse P, Garret J, Ray-Coquard I. Complete response to imatinib in relapsing pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT). Ann Oncol. 2008 Apr;19(4):821-2. doi: 10.1093/annonc/mdn033. Epub 2008 Feb 21.

ReferenceCitation: Brownlow N, Russell AE, Saravanapavan H, Wiesmann M, Murray JM, Manley PW, Dibb NJ. Comparison of nilotinib and imatinib inhibition of FMS receptor signaling, macrophage production and osteoclastogenesis. Leukemia. 2008 Mar;22(3):649-52. Epub 2007 Sep 13.

ReferenceCitation: P. A. Cassier, S. Stacchiotti, H. Gelderblom, D. M. Thomas, W. Van Der Graaf, B. M. Seddon, D. Julien, A. J. Wagner, J. Blay. Imatinib mesylate for the treatment of locally advanced and/or metastatic pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT). J Clin Oncol. 2010 (suppl; abstr 10012); 28:15s. Meeting: 2010 ASCO Annual Meeting Abstract No: 10012

ReferenceCitation: V. Ravi, W. Wang, D. M. Araujo, J. A. Ludwig, R. J. Luke, V. O. Lewis, J. C. Trent, R. S. Benjamin, S. Patel. Imatinib in the treatment of tenosynovial giant-cell tumor and pigmented villonodular synovitis. J Clin Oncol. 2010 (suppl; abstr 10011); 28:15s. Meeting: 2010 ASCO Annual Meeting Abstract No: 10011

ReferenceCitation: Gelderblom H, Cropet C, Chevreau C, Boyle R, Tattersall M, Stacchiotti S, Italiano A, Piperno-Neumann S, Le Cesne A, Ferraresi V, Penel N, Duffaud F, Cassier P, Toulmonde M, Casali P, Taieb S, Guillemaut S, Metzger S, Pérol D, Blay JY. Nilotinib in locally advanced pigmented villonodular synovitis: a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2018 May;19(5):639-648. doi: 10.1016/S1470-2045(18)30143-8. Epub 2018 Mar 20.

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

family: Cropet

full_name: Claire Cropet

given: Claire

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Boyle

full_name: Richard Boyle

given: Richard

family: Tattersall

full_name: Martin Tattersall

given: Martin

family: Stacchiotti

full_name: Silvia Stacchiotti

given: Silvia

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Ferraresi

full_name: Virginia Ferraresi

given: Virginia

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Duffaud

full_name: Florence Duffaud

given: Florence

family: Cassier

full_name: Philippe Cassier

given: Philippe

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Casali

full_name: Paolo Casali

given: Paolo

family: Taieb

full_name: Sophie Taieb

family: Guillemaut

full_name: Séverine Guillemaut

given: Séverine

family: Metzger

full_name: Séverine Metzger

family: Pérol

full_name: David Pérol

given: David

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

journal_name: The Lancet Oncology

location_country:
Italy
Netherlands
Poland
France
United Kingdom

location_facility: Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: University College Hospital UCL Hospitals NHS Foundation Trust

location_facility: Radboud University Nijmegen Medical Centre

title: Phase II Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)

summary:
The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell tumour (PVNS/TGCT) who cannot be treated by surgery.

The primary objective of the study will be to determine the efficacy of 12 weeks (3 months) of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation Criteria In Solid Tumours - RECIST version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by surgery.

this study is an international, multicentre, non-randomized, open-label phase II clinical trial with a Bayesian design.

A maximum sample size of 50 patients will be included in the study


title: Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers

acronym: LOBOTENS

summary:
Prior studies showed contradictory results about the best type of TENS in chronic pain pathology.

Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia.

The functional ability score is evaluated by the Roland scale at 6 weeks.

ReferenceCitation: Buchmuller A, Navez M, Milletre-Bernardin M, Pouplin S, Presles E, Lantéri-Minet M, Tardy B, Laurent B, Camdessanché JP; Lombotens Trial Group. Value of TENS for relief of chronic low back pain with or without radicular pain. Eur J Pain. 2012 May;16(5):656-65. doi: 10.1002/j.1532-2149.2011.00061.x. Epub 2011 Dec 20.

name: Centre d'investigation Clinique - Epidémiologie Clinique/Essais Cliniques (CIE3); CHU de Saint-Etienne; 42055; Saint-Etienne Cedex 02; France

family: Buchmuller

full_name: A. Buchmuller

given: A.

name: Centre d'Évaluation et de Traitement de la Douleur (CETD); CHU de Saint-Etienne; 42055; Saint-Etienne Cedex 02; France

family: Navez

full_name: M. Navez

given: M.

name: Département d'Évaluation et de Traitement de la Douleur; Médecine Palliative; Pôle Neurosciences Cliniques; CHU de Nice; 06002; Nice; France

family: Milletre-Bernardin

full_name: M. Milletre-Bernardin

name: Centre d'Évaluation et de Traitement de la Douleur; CHU de Rouen; 76031; Rouen; France

family: Pouplin

full_name: S. Pouplin

given: S.

family: Presles

full_name: E. Presles

given: E.

family: Lantéri-Minet

full_name: M. Lantéri-Minet

family: Tardy

full_name: B. Tardy

given: B.

family: Laurent

full_name: B. Laurent

family: Camdessanché

full_name: J.P. Camdessanché

journal_name: European Journal of Pain

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Fondation Hôpital Saint Joseph - MARSEILLE


title: Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .

summary: AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem organ failure and death. The prognosis for AL amyloidosis with conventional treatment remains poor, Autologous stem cell transplantation (ASCT) for AL amyloidosis produces high hematologic and organ responses. However, treatment-related mortality remains high and reported series are subject to selection bias.

ReferenceCitation: Jaccard A, Moreau P, Leblond V, Leleu X, Benboubker L, Hermine O, Recher C, Asli B, Lioure B, Royer B, Jardin F, Bridoux F, Grosbois B, Jaubert J, Piette JC, Ronco P, Quet F, Cogne M, Fermand JP; Myélome Autogreffe (MAG) and Intergroupe Francophone du Myélome (IFM) Intergroup. High-dose melphalan versus melphalan plus dexamethasone for AL amyloidosis. N Engl J Med. 2007 Sep 13;357(11):1083-93.

lead_sponsor: University Hospital, Limoges

location_facility: Service d'immuno-hématologie, Hôpital Saint-Louis

location_facility: Service d'Hématologie et de Thérapie cellulaire

location_facility: Service d'hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière

location_facility: Service d'hématologie clinique, Hôpital Necker


title: Evaluation of the Benefit/Risk Ratio of a Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil on the Prevention of Complications in Adult Liver Transplantation

acronym: MMF-FK

summary: The prevention of graft rejection after liver transplantation benefits nowadays from a variety of newly developed immunosuppressive agents. This allows more flexible and individualized immunoprophylaxis and gives an opportunity to reduce the long-term side effects (hypertension, renal failure, diabetes, etc.) of immunosuppression. The purpose of this study is to evaluate, in liver transplanted patients, if low doses of tacrolimus, given in combination with mycophenolate mofetil, can result in a lower rate of long-term side effects without increasing the rate of graft rejection.

ReferenceCitation: Jain AB, Hamad I, Rakela J, Dodson F, Kramer D, Demetris J, McMichael J, Starzl TE, Fung JJ. A prospective randomized trial of tacrolimus and prednisone versus tacrolimus, prednisone, and mycophenolate mofetil in primary adult liver transplant recipients: an interim report. Transplantation. 1998 Nov 27;66(10):1395-8.

ReferenceCitation: Klupp J, Glanemann M, Bechstein WO, Platz KP, Langrehr JM, Keck H, Settmacher U, Radtke C, Neuhaus R, Neuhaus P. Mycophenolate mofetil in combination with tacrolimus versus Neoral after liver transplantation. Transplant Proc. 1999 Feb-Mar;31(1-2):1113-4.

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

location_facility: Centre Hépato-biliaire - Hôpital Paul Brousse

location_facility: Service de Chirurgie Générale - Hôpital Cochin

location_facility: Service d'Hépatogastroentérologie - Hôpital Henri Mondor

location_facility: Service d'Hépatogastroentérologie - Hôpital Beaujon

location_facility: Département de Chirurgie Viscérale - Hôpital Pontchaillou

location_facility: Chirurgie Générale et Digestive - Hôpital de La Croix Rousse

location_facility: Service d'Hépaogastroentérologie - Hôpital Saint Eloi


title: Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs

acronym: REHABDO

summary:
The aim of this clinical trial is to establish the non-inferiority of home-based respiratory rehabilitation compared to respiratory rehabilitation in center in terms of exercise tolerance as evaluated by the 6 minutes Stepper test..

This trial will also 1°) evaluate the Medico-economic aspects of the home-based Respiratory rehabilitation versus respiratory Rehabilitation in center; 2°) analyse the patient preferences between home-based respiratory rehabilitation and respiratory rehabilitation in center and 3°) Compare home-based respiratory rehabilitation vs respiratory rehabilitation in center in terms of dyspnea, quality of life, anxiety and depression.

location_facility:
CH Victor Provot, Roubaix
Hôpital Calmette, CHU
CH de Béthune
CH de Loos
CH de Tourcoing
Centre hospitalier de béthune
CH de Wattrelos


title: Impact of Applying a Bandage Skin Hydrogel on the Pains of the Head and Neck in Patients With Cancer of Head and Neck Treated With Radiotherapy

acronym: IPAC

summary: The investigators hope to get by reduced and delayed acute radiodermatitis following the application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and improved quality of life of patients with head and neck cancer treated with concomitant radiotherapy.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Guillaume Le Conquérant
Centre de la Baie
Centre Maurice TUBIANA
Clinique Leonard de Vinci
centre hospitalier du Cotentin
CHU
Centre François BACLESSE


title: Study Evaluating the Interest of Cytology-molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors

acronym: CMM

summary:
Renal cancer is frequent and its diagnosis mainly dependant on imaging. More than 50% of renal tumors are currently diagnosed without symptoms. However, 20% of small solid tumors are benign and this percentage is much higher in atypical cystic tumors Bosniak II and III, where 76% and 59% are benign respectively. Determining the malignancy by imaging in these cases is difficult and sometimes impossible. The fine needle aspiration (FNA) cytology or biopsy is necessary. The diagnostic sensitivity and specificity with biopsy are high, but the potential tumor contamination is a major risk. The FNA cytology is simple and safe, but its sensitivity is about 50%. We are conducting a multicentric prospective study to add the molecular markers in FNA cytology as a new diagnostic method in imaging-indeterminate renal tumors.

Four molecular markers including MN/CA9, vimentin, KIT, and S100A1 will be studied. These four markers have been reported to have a differential diagnostic value in renal tumors. MN/CA9 and vimentin are often found in conventional renal cancers. KIT is frequently expressed in renal oncocytomas and chromophobe renal cancers. S100A1 may further distinguish renal oncocytoma from chromophobe renal cancer. These markers will be analyzed by real time polymerase chain reaction (RT-PCR).

The aim of this study is to evaluate the diagnostic performance of the association cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.

The expected results will improve the preoperative diagnostic accuracy in renal tumors.

ReferenceCitation: Li G, Cuilleron M, Cottier M, Gentil-Perret A, Lambert C, Genin C, Tostain J. The use of MN/CA9 gene expression in identifying malignant solid renal tumors. Eur Urol. 2006 Feb;49(2):401-5. Epub 2005 Dec 19.

ReferenceCitation: Li G, Cuilleron M, Gentil-Perret A, Cottier M, Passebosc-Faure K, Lambert C, Genin C, Tostain J. Rapid and sensitive detection of messenger RNA expression for molecular differential diagnosis of renal cell carcinoma. Clin Cancer Res. 2003 Dec 15;9(17):6441-6.

ReferenceCitation: Li G, Barthelemy A, Feng G, Gentil-Perret A, Peoc'h M, Genin C, Tostain J. S100A1: a powerful marker to differentiate chromophobe renal cell carcinoma from renal oncocytoma. Histopathology. 2007 Apr;50(5):642-7.

ReferenceCitation: Li G, Feng G, Gentil-Perret A, Genin C, Tostain J. CA9 gene expression in conventional renal cell carcinoma: a potential marker for prediction of early metastasis after nephrectomy. Clin Exp Metastasis. 2007;24(3):149-55. Epub 2007 Mar 28.

ReferenceCitation: Li G, Gentil-Perret A, Lambert C, Genin C, Tostain J. S100A1 and KIT gene expressions in common subtypes of renal tumours. Eur J Surg Oncol. 2005 Apr;31(3):299-303.

location_facility: Hospices Civils de Lyon - Edouard Herriot


title: Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy

summary:
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.

Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.

The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.

Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.

The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.

ReferenceCitation: Arpin D, Perol D, Blay JY, Falchero L, Claude L, Vuillermoz-Blas S, Martel-Lafay I, Ginestet C, Alberti L, Nosov D, Etienne-Mastroianni B, Cottin V, Perol M, Guerin JC, Cordier JF, Carrie C. Early variations of circulating interleukin-6 and interleukin-10 levels during thoracic radiotherapy are predictive for radiation pneumonitis. J Clin Oncol. 2005 Dec 1;23(34):8748-56.

ReferenceCitation: Claude L, Pérol D, Ginestet C, Falchero L, Arpin D, Vincent M, Martel I, Hominal S, Cordier JF, Carrie C. A prospective study on radiation pneumonitis following conformal radiation therapy in non-small-cell lung cancer: clinical and dosimetric factors analysis. Radiother Oncol. 2004 May;71(2):175-81.

ReferenceCitation: L. Falchero, D. Perol, D. Arpin, M. Vincent, M. Perol, JF. Cordier, D. Boutry, I. Martel-Lafay, C. Carrie.- Conséquences fonctionnelles de la radiothérapie thoracique conformationnelle (r3d) et facteurs prédictifs de pneumopathie radique aiguë (PRA) chez des patients atteints de cancer bronchique non à petites cellules (CNPC). Rev. Mal. Resp., 2001 ; 18 (suppl) : 1S102

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
Centre Oscar Lambret
Hôpital de la Pitié Salpêtrière
Institut Curie
Centre René Gauducheau
Hôpital Européen Georges Pompidou
Centre Catalan d'Oncologie

intervention_type: Radiation


title: Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura (ITP) : a Prospective Study in Pays De La Loire

summary:
The objective of this study is to describe a paediatric population presenting an acute idiopathic thrombocytopenic purpura (ITP) and their evolution during their therapy in the region Pays de la Loire. The study will particularly evaluate the quality of life of these patients and their parents.

The secondary objectives are to identify the predictive factors of the complications, the repetitions and the chronicity of the ITP, to estimate the principal parameters of the economic cost of therapy of the children suffering from ITP according to the protocol of therapy, set up in the region Pays de la Loire and the constitution of a blood sample collection which allow a better understanding of the physiopathology of this disease.

It is about a prospective, multicentric clinical epidemiologic study of a paediatric cohort. Patients: 100 children from 0 to 17,99 years suffering from a first discovered ITP. The patients are not included if they present a serious, intercurrent, stabilized chronic pathology or not likely to modify the quality of life of the child and if they present a pathology other than the thrombopenia bringing into play the vital prognosis within a time lower than one year. These patients will be followed for 6 months according to the diagnosis of their ITP.

During the 6 months follow-up of each patient, the study will not carry out more consultations, nor more blood tests than the usual follow-up of a child suffering from ITP. On the other hand, in addition to the J0 questionnaire, it will be requested to the patient and to his family to fill in the questionnaires of quality of life and way of life during the consultations of J8, 1 month, 3 months and 6 months. A check-up of autoimmunity at 6 months will be carried out if the thrombopenia persists (this check-up is usual and not-specific to the study). At the time of the blood test for the control of the platelets at J0 and 6 months, an additional blood sample will be carried out: 5 ml are taken for the children of an age ≤ at 2 years, 10 ml from 2 to 4 years and 15 ml of blood for the children of an age > at 4 years. These blood samples are intended for the constitution of a blood sample collection.

The protocol of therapy of the children suffering from ITP is homogeneous in all centers, this protocol being a consensus established by the network of Oncopaediatrics of the Pays de la Loire. The instituted treatment will be in function of the gravity of the ITP expressed in 4 stages:

Stage I: Platelets > 20 gigas/L and absence of clinical signs. Stage II: Platelets > 10 gigas/L and hemorrhagic signs: haematomas, petechias or occasional epistaxis without repercussion on the daily life.

Stage III: moderate. Platelets > 10.000/mm3 and epistaxis with gauze pluggings or mucous lesions.

Stage IV: severe. Platelets ≤ 10.000/mm3 or fall of 2 grs/dl of haemoglobin with bleedings: epistaxis, melaena or haemorrhages requiring a blood transfusion or an hospitalization and important changes in the activities of the daily life.

Stages I and II do not receive any treatment and benefit from a simple monitoring.

Stages III benefit from either a corticosteroid treatment (Méthylprednisolone or Prednisone) at the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/day) or a monitoring according to the appreciation of the clinician.

Stages IV profit in first intention from a treatment by Méthylprednisolone or Prednisone at the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/jour).

The therapeutic attitude and the stadification belong to a regional consensus, established before the study, but each one can decide to apply a treatment according to the gravity of the clinical state of the child.

status: Unknown status

ReferenceCitation: Strullu M, Rakotonjanahary J, Tarral E, Savagner C, Thomas C, Méchinaud F, Reguerre Y, Poignant S, Boutet A, Bassil J, Médinger D, Quemener E, Young NL, Rachieru P, Klaassen RJ, Pellier I. Evaluation of health related quality of life in children with immune thrombocytopenia with the PedsQL™ 4.0 Generic Core Scales: a study on behalf of the pays de Loire pediatric hematology network. Health Qual Life Outcomes. 2013 Nov 13;11:193. doi: 10.1186/1477-7525-11-193.

family: Strullu

full_name: Marion Strullu

given: Marion

family: Rakotonjanahary

full_name: Josué Rakotonjanahary

given: Josué

family: Tarral

full_name: Eliane Tarral

given: Eliane

family: Savagner

full_name: Christophe Savagner

given: Christophe

family: Thomas

full_name: Caroline Thomas

given: Caroline

family: Méchinaud

full_name: Françoise Méchinaud

given: Françoise

family: Reguerre

full_name: Yves Reguerre

given: Yves

family: Poignant

full_name: Sylvaine Poignant

given: Sylvaine

family: Boutet

full_name: Arnaud Boutet

given: Arnaud

family: Bassil

full_name: Joachim Bassil

given: Joachim

family: Médinger

full_name: Dominique Médinger

given: Dominique

family: Quemener

full_name: Emmanuel Quemener

given: Emmanuel

family: Young

full_name: Nancy L Young

given: Nancy L

family: Rachieru

full_name: Petronela Rachieru

given: Petronela

family: Klaassen

full_name: Robert J Klaassen

given: Robert J

family: Pellier

full_name: Isabelle Pellier

given: Isabelle

journal_name: Health and Quality of Life Outcomes

repository_institution: University of Ottawa - uO Research

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

location_facility:
UH of Nantes
Hosptal of Saint Nazaire
UH of Angers
Hospital of La Roche Sur Yon
Hospital of Laval
Hospital of Le Mans
Hospital of Cholet


title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of a Therapeutic Administration of Selenium, as Selenite, in Septic Shock Patients.

summary: Septic shock is a frequent syndrome with a 45% mortality rate despite intensive care unit (ICU) care, where free radicals may play a key role, and a >40% decrease in plasma selenium concentration is observed. Selenium is a trace element with both indirect enzymatic anti-oxidant, and direct oxidant properties. High dose of sodium selenite administration could increase antioxidant cells capacities, and reduce inflammation by a direct paradoxical pro-oxidative effect. We conduct a study to evaluate the effects of selenium treatment in comparison to placebo, in septic shock patients. Efficacy will be evaluated by the weaning time of catecholamines.

ReferenceCitation: Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Régnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.

ReferenceCitation: Forceville X, Vitoux D, Gauzit R, Combes A, Lahilaire P, Chappuis P. Selenium, systemic immune response syndrome, sepsis, and outcome in critically ill patients. Crit Care Med. 1998 Sep;26(9):1536-44.

ReferenceCitation: Goode HF, Webster NR. Free radicals and antioxidants in sepsis. Crit Care Med. 1993 Nov;21(11):1770-6. Review.

ReferenceCitation: Novelli GP. Role of free radicals in septic shock. J Physiol Pharmacol. 1997 Dec;48(4):517-27. Review.

ReferenceCitation: Forceville X, Laviolle B, Annane D, Vitoux D, Bleichner G, Korach JM, Cantais E, Georges H, Soubirou JL, Combes A, Bellissant E. Effects of high doses of selenium, as sodium selenite, in septic shock: a placebo-controlled, randomized, double-blind, phase II study. Crit Care. 2007;11(4):R73.

lead_sponsor: Centre Hospitalier de Meaux

location_facility: Service de Réanimation - Centre Hospitalier G. Dron

location_facility: Service de Réanimation Polyvalente - CH de Châlons

location_facility: Service de Réanimation - HIA Desgenettes

location_facility: Service de Réanimation - Centre Hospitalier Victor Dupouy

location_facility: Service de Réanimation Polyvalente - Hôpital Saint Faron

location_facility: Service de Réanimation Médicale - Hôpital Raymond Poincaré


title: Impact of Incretin-mimetic Hypoglycaemic Drugs on Diabetic Retinopathy in Type 2 Diabetic Patients and Study of Biomarkers in the Development of Severe Retinopathy: Angiosafe-T2D Study 2

summary: Experimental data suggest that GLP-1 promote endothelial cell growth and angiogenesis which may have beneficial effects on the cardiovascular system but harmful effects on the retina . This project investigate the possible link between incretin therapy and Severe Diabetic Retinopathy. The prevalence of severe DR in patients exposed to incretin therapy (GLP-1 analogs or DPP4 inhibitors) is compared to that in non-exposed patients to these antidiabetic classes.

ReferenceCitation: Gaborit B, Julla JB, Besbes S, Proust M, Vincentelli C, Alos B, Ancel P, Alzaid F, Garcia R, Mailly P, Sabatier F, Righini M, Gascon P, Matonti F, Houssays M, Goumidi L, Vignaud L, Guillonneau X, Erginay A, Dupas B, Marie-Louise J, Autié M, Vidal-Trecan T, Riveline JP, Venteclef N, Massin P, Muller L, Dutour A, Gautier JF, Germain S. Glucagon-like Peptide 1 Receptor Agonists, Diabetic Retinopathy and Angiogenesis: The AngioSafe Type 2 Diabetes Study. J Clin Endocrinol Metab. 2020 Apr 1;105(4). pii: dgz069. doi: 10.1210/clinem/dgz069.

name: Aix Marseille University, INSERM, INRA, C2VN, Marseille, France

name: Endocrinology, Metabolic Diseases and Nutrition Department, Assistance Publique Hôpitaux de Marseille, France

family: Gaborit

full_name: Bénédicte Gaborit

given: Bénédicte

name: Department of Diabetes and Endocrinology, Assistance Publique - Hôpitaux de Paris, Lariboisière Hospital, University Paris-Diderot Paris-7, Paris, France

name: Centre de Recherche des Cordeliers, INSERM, Sorbonne Université, USPC, Université Paris Descartes, Université Paris Diderot, Paris, France

family: Julla

full_name: Jean-Baptiste Julla

given: Jean-Baptiste

name: Center for Interdisciplinary Research in Biology (CIRB), College de France – Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Paris Sciences et Lettres (PSL) Research University, Paris, France

family: Besbes

full_name: Samaher Besbes

given: Samaher

family: Proust

full_name: Matthieu Proust

given: Matthieu

family: Vincentelli

full_name: Clara Vincentelli

given: Clara

family: Alos

full_name: Benjamin Alos

given: Benjamin

family: Ancel

full_name: Patricia Ancel

given: Patricia

family: Alzaid

full_name: Fawaz Alzaid

given: Fawaz

family: Garcia

full_name: Rodrigue Garcia

given: Rodrigue

family: Mailly

full_name: Philippe Mailly

given: Philippe

family: Sabatier

full_name: Florence Sabatier

given: Florence

name: Department of Ophtalmology, AP HM, Marseille, France

family: Righini

full_name: Maud Righini

given: Maud

name: Aix Marseille University, CNRS, INT, Inst Neurosci Timone, Marseille, France

family: Gascon

full_name: Pierre Gascon

given: Pierre

family: Matonti

full_name: Frédéric Matonti

given: Frédéric

name: Aix Marseille University, APHM, INSERM, CIC1409, Hôpital de la Conception, Marseille, France

family: Houssays

full_name: Marie Houssays

given: Marie

family: Goumidi

full_name: Louisa Goumidi

given: Louisa

name: Sorbonne Université, INSERM, CNRS, Institut de la Vision, Paris, France

family: Vignaud

full_name: Lucile Vignaud

given: Lucile

family: Guillonneau

full_name: Xavier Guillonneau

given: Xavier

name: Department of Ophthalmology, Lariboisière Hospital, AP HP, University Paris-Diderot Paris-7, Paris, France

family: Erginay

full_name: Ali Erginay

given: Ali

family: Dupas

full_name: Bénédicte Dupas

family: Marie-Louise

full_name: Jennifer Marie-Louise

given: Jennifer

family: Autié

full_name: Marianne Autié

given: Marianne

family: Vidal-Trecan

full_name: Tiphaine Vidal-Trecan

given: Tiphaine

journal_name: The Journal of Clinical Endocrinology & Metabolism

location_facility: Département de Diabétologie - Hopital Lariboisière