title: Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of the Medical Device VistaCare® Versus Dressings

summary:
Primary objective:

Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates the formation of a quality granulation tissue and reduces preparation time to a cover gesture.

Secondary objectives:

Evaluate the success of hedging gesture
Assess the quality of the bud by colorimetry
Assess tolerance
Collect medical and economic data on the care of patients included
Evaluate the quality of life of patients
Assess patient comfort
Evaluate the ease of use for the caregiver

lead_sponsor: Qualissima

location_facility:
Hôpital Saint Louis
Hopital Conception
CHU Nantes


title: Study of Impact of Adapted Physical Activity on Cognitive Functions and Quality of Life in Patients Treated for Locally Advanced Breast Cancer

acronym: COG-SPORTIF

summary:
Breast cancer is the most frequent cancer in women in western countries. The improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. But several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. To limit these damages, non therapeutic approaches such as Adapted Physical Activity (APA) have been developped.

The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
Centre François Baclesse
Centre Oscar Lambret

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


title: Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study

acronym: MITRAGISTER

summary: The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.

study_start_date_type: Actual

status: Recruiting

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11.

ReferenceCitation: Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Bärwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43.

ReferenceCitation: Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25.

ReferenceCitation: De Bonis M, Lapenna E, La Canna G, Ficarra E, Pagliaro M, Torracca L, Maisano F, Alfieri O. Mitral valve repair for functional mitral regurgitation in end-stage dilated cardiomyopathy: role of the "edge-to-edge" technique. Circulation. 2005 Aug 30;112(9 Suppl):I402-8.

ReferenceCitation: Alfieri O, Maisano F, De Bonis M, Stefano PL, Torracca L, Oppizzi M, La Canna G. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg. 2001 Oct;122(4):674-81.

ReferenceCitation: Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.

ReferenceCitation: Maisano F, Franzen O, Baldus S, Schäfer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013 Sep 17;62(12):1052-1061. doi: 10.1016/j.jacc.2013.02.094. Epub 2013 Jun 7.

ReferenceCitation: Baldus S, Schillinger W, Franzen O, Bekeredjian R, Sievert H, Schofer J, Kuck KH, Konorza T, Möllmann H, Hehrlein C, Ouarrak T, Senges J, Meinertz T; German Transcatheter Mitral Valve Interventions (TRAMI) investigators. MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail. 2012 Sep;14(9):1050-5. Epub 2012 Jun 8.

ReferenceCitation: Armoiry X, Brochet E, Lefevre T, Guerin P, Dumonteil N, Himbert D, Cormier B, Piriou N, Gautier M, Messika-Zeitoun D, Romano M, Rioufol G, Warin Fresse K, Boudou N, Leclercq F, Bedossa M, Obadia JF. Initial French experience of percutaneous mitral valve repair with the MitraClip: a multicentre national registry. Arch Cardiovasc Dis. 2013 May;106(5):287-94. doi: 10.1016/j.acvd.2013.03.059. Epub 2013 May 28.

ReferenceCitation: Obadia JF, Armoiry X, Iung B, Lefèvre T, Mewton N, Messika-Zeitoun D, Cormier B, Berthiller J, Maucort-Boulch D, Boutitie F, Vaz B, Trochu JN, Vahanian A. The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation. EuroIntervention. 2015 Mar;10(11):1354-60. doi: 10.4244/EIJV10I11A232.

lead_sponsor: French Cardiology Society

location_facility:
CHU Lyon
Bichat Hospital
CHU Nantes

status_simplified: Ongoing


title: Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination

summary:
Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments diagnosis in free tissue transfers is realized.

These measures are done after surgical reconstructions with free tissue flap, simultaneously with clinical examination. These biological data aren't available to make clinical diagnosis of complication; only clinical examination is allowed in this way.

A posteriori, clinical and biological parameters will be compared in order to determine if capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps monitoring.

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Narcisse Zwetyenga

location_facility: Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital

location_facility: Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens

location_facility: Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire

location_facility: Maxillo-Facial Surgery, Besancon Univestitary Hospital

intervention_type: Device

status_simplified: Completed


type: Registry Identifier

title: Evolution of Pain at Three Months by Oral Resveratrol in Primary Knee Osteoarthritis: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial

acronym: ARTHROL

summary: The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.

ReferenceType: result

ReferenceCitation: Nguyen C, Boutron I, Baron G, Coudeyre E, Berenbaum F, Poiraudeau S, Rannou F. Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial. BMJ Open. 2017 Sep 29;7(9):e017652. doi: 10.1136/bmjopen-2017-017652.

family: Nguyen

full_name: Christelle Nguyen

given: Christelle

sequence: first

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

sequence: additional

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

family: Berenbaum

full_name: Francis Berenbaum

given: Francis

family: Poiraudeau

full_name: Serge Poiraudeau

given: Serge

family: Rannou

full_name: François Rannou

given: François

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

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: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Rehabilitation department , CHU Clermont-Ferrand

location_facility: Rheumatology Department, Saint Antoine Hospital

location_facility: Rehabilitation Department, Cochin Hospital

intervention_type: Drug

lead_sponsor_type: academique


title: PREvention of Post-mastectomy LYMphoceles by PAdding. A Randomized Prospective Multicenter Study

acronym: PRELYMCA

summary:
Lymphoceles, or seromas, are the most frequent complication following mastectomy and are associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as the presence of a palpable post operative serous accumulation that is bothersome for the patient and requires a puncture and drainage or even several repeated punctures. The presence of seromas is therefore associated with discomfort and pain. Seromas could also be responsible for increased morbidity due to complications such as infection, suture separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as obesity, increased post operative drainage of J1 to J3, and arterial hypertension.

Different measures have demonstrated the benefits of limiting axillary lymphoceles after dissection : placement of a drain, padding and delay in shoulder mobility.

Studies have shown that axillary padding decreases lymphocele development and shortens the length of hospital stay. Some studies based on padding of the mastectomy site also have shown a decrease in post operative seromas; however no study has been done on the usefulness of padding in the mastectomy site alone because they include both padding and a drain or padding of the axillary area.

The padding technique the investigators employ is performed at the donor site in breast reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of seromas.

In this study, the classic technique will be compared to padding in the mastectomy site with short drainage (48h).

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CH Compiègne
CHU Amiens
CH Soissons

intervention_type: Procedure


title: Genetics of Aortic Stenosis: From Family Forms to the Common Forms

summary:
The association study will compare the allele frequencies of polymorphisms of a single nucleotide (SNP) in the population of individuals with aortic stenosis compared to a control population.

Patients will be included only if they are suffering from a typical form of tight and surgical tricuspid aortic stenosis. Patients will therefore only included if they are suffering from aortic stenosis, the surface is less than 1 cm² and if histological analysis or failing intraoperative findings of the surgeon showed a tricuspid aortic stenosis.

time_perspective: Retrospective

lead_sponsor: Nantes University Hospital

location_facility:
CHU Angers
CHU de Rennes
CHU de Nantes -


title: An Observatory for Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL) and Treated With the Combination of Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy.

summary:
The use of imatinib in combination with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over. 2. Dasatinib is indicated as first line therapy in Ph+ ALL. Results from the EWALLPH-01 are supporting the use of dasatinib in combination with low-intensity chemotherapy. A new EWALL-PH-02 study combining nilotinib in combination with low-intensity chemotherapy is currently initiated within the EWALL centers.

3. The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The activation of the EWALL-PH-02 trial is expected for Q1 2012. Based on the recruitment of the EWALL-PH-01 study it could be anticipated that 50 to 100 patients aged more than 55 years will be diagnosed during this 6 months period of time. In addition, all the EWALL centers are not participating to the EWALL-PH-02 study and thus these centers could be offered to treat patient following the EWALL backbone in addition to imatinib. 4. A minimum data set will be defined in order to collect the data of the patients treated following the EWALL-PH imatinib study. The main recommendation is to follow as close as possible the procedures of the EWALL-PH-01 trial (mutation analysis, MRD follow-up) in order to have a comparable data set. This imatinib treated cohort of patients would be of particular importance in order to better define the potential benefit of using one TKI compared to one other. From the end of the EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02 study, patients were treated following the common backbone schedule in combination with imatinib or others TKI. Patients not included in clinical trials for other reasons were also offered a treatment with the combination of TKIs and backbone low-intensity chemotherapy. The goal of this observatory retrospective and prospective is to describe the efficacy and the tolerance of the combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy (EWALL backbone) in patients with Ph+ ALL aged 55 years and over.

lead_sponsor: Versailles Hospital

location_facility:
CHU Nimes
CH Reims
CH Versailles


title: Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa in Women Older Than 38 Years Old Undergoing in Vitro Fertilization

acronym: PRESCORI

summary:
E2 given in late luteal phase can be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends .

Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort.

The objective of this study is to evaluate the impact on the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated.

The scheduling of IVF cycles represents a double benefit. On one hand, to enable a "synchronization" of the follicular cohort for a best response and a higher number of mature oocytes. On the other hand, a more efficient organization for both the center (avoiding retrievals on weekends and public holidays, organize and distribute equally the activity, reduce cost operations) and couples (personal and professional organization).

primary_purpose: Treatment

ReferenceCitation: Blockeel C, Engels S, De Vos M, Haentjens P, Polyzos NP, Stoop D, Camus M, Devroey P. Oestradiol valerate pretreatment in GnRH-antagonist cycles: a randomized controlled trial. Reprod Biomed Online. 2012 Mar;24(3):272-80. doi: 10.1016/j.rbmo.2011.11.012. Epub 2011 Nov 30.

ReferenceCitation: Boostanfar R, Shapiro B, Levy M, Rosenwaks Z, Witjes H, Stegmann BJ, Elbers J, Gordon K, Mannaerts B; Pursue investigators. Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertil Steril. 2015 Jul;104(1):94-103.e1. doi: 10.1016/j.fertnstert.2015.04.018. Epub 2015 May 21.

ReferenceCitation: Cédrin-Durnerin I, Bständig B, Parneix I, Bied-Damon V, Avril C, Decanter C, Hugues JN. Effects of oral contraceptive, synthetic progestogen or natural estrogen pre-treatments on the hormonal profile and the antral follicle cohort before GnRH antagonist protocol. Hum Reprod. 2007 Jan;22(1):109-16. Epub 2006 Aug 26.

ReferenceCitation: Cédrin-Durnerin I, Guivarc'h-Levêque A, Hugues JN; Groupe d'Etude en Médecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.

family: Cédrin-Durnerin

full_name: Isabelle Cédrin-Durnerin

family: Guivarc'h-Levêque

full_name: Anne Guivarc'h-Levêque

given: Anne

family: Hugues

full_name: Jean-Noël Hugues

given: Jean-Noël

journal_name: Fertility and Sterility

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Chang X, Wu J. Effects of luteal estradiol pre-treatment on the outcome of IVF in poor ovarian responders. Gynecol Endocrinol. 2013 Mar;29(3):196-200. doi: 10.3109/09513590.2012.736558. Epub 2012 Nov 30.

ReferenceCitation: Escriva AM, Diaz-Garcia C, Monterde M, Rubio JM, Pellicer A. Antral Follicle Priming Before Intracytoplasmic Sperm Injection in Previously Diagnosed Low Responders: A Randomized Controlled Trial (FOLLPRIM). J Clin Endocrinol Metab. 2015 Jul;100(7):2597-605. doi: 10.1210/jc.2015-1194. Epub 2015 May 8.

ReferenceCitation: Fanchin R, Salomon L, Castelo-Branco A, Olivennes F, Frydman N, Frydman R. Luteal estradiol pre-treatment coordinates follicular growth during controlled ovarian hyperstimulation with GnRH antagonists. Hum Reprod. 2003 Dec;18(12):2698-703.

ReferenceCitation: Guivarc'h-Levêque A, Homer L, Arvis P, Broux PL, Moy L, Priou G, Vialard J, Colleu D, Dewailly D. Programming in vitro fertilization retrievals during working days after a gonadotropin-releasing hormone antagonist protocol with estrogen pretreatment: does the length of exposure to estradiol impact on controlled ovarian hyperstimulation outcomes? Fertil Steril. 2011 Oct;96(4):872-6. doi: 10.1016/j.fertnstert.2011.07.1138. Epub 2011 Aug 24.

ReferenceCitation: Hauzman EE, Zapata A, Bermejo A, Iglesias C, Pellicer A, Garcia-Velasco JA. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial. Reprod Biol Endocrinol. 2013 Sep 28;11:96. doi: 10.1186/1477-7827-11-96.

ReferenceCitation: Nielsen AP, Korsholm AS, Lemmen JG, Sylvest R, Sopa N, Nyboe Andersen A. Selective use of corifollitropin for controlled ovarian stimulation for IVF in patients with low anti-Müllerian hormone. Gynecol Endocrinol. 2016 Aug;32(8):625-628. Epub 2016 Feb 18.

ReferenceCitation: Polyzos NP, De Vos M, Corona R, Vloeberghs V, Ortega-Hrepich C, Stoop D, Tournaye H. Addition of highly purified HMG after corifollitropin alfa in antagonist-treated poor ovarian responders: a pilot study. Hum Reprod. 2013 May;28(5):1254-60. doi: 10.1093/humrep/det045. Epub 2013 Feb 26.

ReferenceCitation: Reynolds KA, Omurtag KR, Jimenez PT, Rhee JS, Tuuli MG, Jungheim ES. Cycle cancellation and pregnancy after luteal estradiol priming in women defined as poor responders: a systematic review and meta-analysis. Hum Reprod. 2013 Nov;28(11):2981-9. doi: 10.1093/humrep/det306. Epub 2013 Jul 25. Review.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Hôpital Jean Verdier
CHI Creteil
Clinique de la Sagesse


title: VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

acronym: VASO-AM

summary: This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Recoquillon S, Pépin JL, Vielle B, Andriantsitohaina R, Bironneau V, Chouet-Girard F, Fleury B, Goupil F, Launois S, Martinez MC, Meslier N, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Gagnadoux F. Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial. Thorax. 2019 May;74(5):496-499. doi: 10.1136/thoraxjnl-2018-212609. Epub 2018 Oct 26.

family: Recoquillon

full_name: Sylvain Recoquillon

given: Sylvain

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

family: Vielle

full_name: Bruno Vielle

given: Bruno

family: Andriantsitohaina

full_name: Ramaroson Andriantsitohaina

given: Ramaroson

family: Bironneau

full_name: Vanessa Bironneau

given: Vanessa

family: Chouet-Girard

full_name: Frédérique Chouet-Girard

given: Frédérique

family: Fleury

full_name: Bernard Fleury

given: Bernard

family: Goupil

full_name: François Goupil

family: Launois

full_name: Sandrine Launois

given: Sandrine

family: Martinez

full_name: M Carmen Martinez

given: M Carmen

family: Meslier

full_name: Nicole Meslier

given: Nicole

full_name: Xuan-Lan Nguyen

given: Xuan-Lan

family: Paris

full_name: Audrey Paris

given: Audrey

family: Priou

full_name: Pascaline Priou

given: Pascaline

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Trzepizur

full_name: Wojciech Trzepizur

given: Wojciech

family: Gagnadoux

full_name: Frédéric Gagnadoux

given: Frédéric

journal_name: Thorax

oa_host_type: repository

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

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

ReferenceCitation: Gagnadoux F, Pépin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B. Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2017 May 1;195(9):1244-1252. doi: 10.1164/rccm.201609-1817OC.

name: Université Bretagne Loire, INSERM UMR 1063, Angers, France

name: Université Grenoble Alpes, HP2, INSERM UMR 1042, Grenoble, France

name: CHU de Grenoble, Laboratoire EFCR, Clinique Universitaire de Physiologie, Grenoble, France

name: Centre de Recherche Clinique, CHU d’Angers, Angers, France

name: Université de Poitiers, CHU, Service de Pneumologie, Poitiers, France

name: Service de Chirurgie Maxillo-faciale et Stomatologie and

name: Université Paris VI, Hopital Saint-Antoine, Unité de Sommeil, Paris, France

name: Service de Pneumologie, Centre Hospitalier, Le Mans, France; and

journal_name: American Journal of Respiratory and Critical Care Medicine

location_facility:
Hopital Saint Antoine
CHU Poitiers
CHU Grenoble
CH Le Mans


title: Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study

acronym: STIMAGNECT

summary: It's a prospective, multicentric, randomized, controlled study concerning 56 patients with treatment-resistant depression (TRD). The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before Electroconvulsive therapy (ECT) for treatment of TRD patients. The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.

ReferenceCitation: Rothärmel M, Quesada P, Husson T, Harika-Germaneau G, Nathou C, Guehl J, Dalmont M, Opolczynski G, Miréa-Grivel I, Millet B, Gérardin E, Compère V, Dollfus S, Jaafari N, Bénichou J, Thill C, Guillin O, Moulier V. The priming effect of repetitive transcranial magnetic stimulation on clinical response to electroconvulsive therapy in treatment-resistant depression: a randomized, double-blind, sham-controlled study. Psychol Med. 2021 Sep 28:1-12. doi: 10.1017/S0033291721003810. [Epub ahead of print]

family: Rothärmel

full_name: Maud Rothärmel

given: Maud

family: Quesada

full_name: Pierre Quesada

given: Pierre

family: Husson

full_name: Thomas Husson

given: Thomas

family: Harika-Germaneau

full_name: Ghina Harika-Germaneau

given: Ghina

family: Nathou

full_name: Clément Nathou

given: Clément

family: Guehl

full_name: Julien Guehl

given: Julien

family: Dalmont

full_name: Marine Dalmont

given: Marine

family: Opolczynski

full_name: Gaëlle Opolczynski

given: Gaëlle

family: Miréa-Grivel

full_name: Iris Miréa-Grivel

given: Iris

family: Millet

full_name: Bruno Millet

family: Gérardin

full_name: Emmanuel Gérardin

given: Emmanuel

family: Compère

full_name: Vincent Compère

given: Vincent

family: Dollfus

full_name: Sonia Dollfus

given: Sonia

family: Jaafari

full_name: Nemat Jaafari

given: Nemat

family: Bénichou

full_name: Jacques Bénichou

given: Jacques

family: Thill

full_name: Caroline Thill

given: Caroline

family: Guillin

full_name: Olivier Guillin

given: Olivier

family: Moulier

full_name: Virginie Moulier

given: Virginie

journal_name: Psychological Medicine

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

lead_sponsor: Centre Hospitalier du Rouvray

location_facility:
Centre Hospitalier Laborit
Centre Esquirol- CHU de Caen
Centre Hospitalier du Rouvray


title: Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy

acronym: CHIMIO ORALE

summary:
Therapeutic education is an effective way to support the prescription of oral chemotherapy in oncology. It aims to increase adherence to treatment, to better control the side effects and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education Program context of each of these institutions.

The objective of this study is to evaluate the implementation of the intervention in the 3 participating centers, over 1 year:

Assess the achievement of the target population
Evaluate the adaptation of intervention in context
Evaluate the effectiveness of the intervention (impact): effectiveness in real life, identification of interactions with the environment linked to the center, identification of unintended effects of the intervention.
Assessing the sustainability of the intervention

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth

intervention_type: Behavioral


ReferenceCitation: Dinh A, Hallouin-Bernard MC, Davido B, Lemaignen A, Bouchand F, Duran C, Even A, Denys P, Perrouin-Verbe B, Sotto A, Lavigne JP, Bruyère F, Grall N, Tavernier E, Bernard L. Weekly Sequential Antibioprophylaxis for Recurrent Urinary Tract Infections Among Patients With Neurogenic Bladder: A Randomized Controlled Trial. Clin Infect Dis. 2020 Dec 15;71(12):3128-3135. doi: 10.1093/cid/ciz1207.

name: Infectious Diseases Unit, Raymond Poincaré University Hospital, Assistance Publique Hôpitaux de Paris, Versailles Saint-Quentin University, Garches, France

family: Dinh

full_name: Aurélien Dinh

given: Aurélien

name: Department of Infectious Diseases, Bretonneau University Hospital, Tours, France

family: Hallouin-Bernard

full_name: Marie-Charlotte Hallouin-Bernard

given: Marie-Charlotte

family: Davido

full_name: Benjamin Davido

given: Benjamin

family: Lemaignen

full_name: Adrien Lemaignen

given: Adrien

name: Pharmacy Department, Raymond Poincaré University Hospital, Assistance Publique Hôpitaux de Paris, Versailles Saint-Quentin University, Garches, France

family: Bouchand

full_name: Frédérique Bouchand

given: Frédérique

family: Duran

full_name: Clara Duran

given: Clara

name: Department of Urology, Raymond Poincaré University Hospital, Assistance Publique Hôpitaux de Paris, Versailles Saint-Quentin University, Garches, France

family: Even

full_name: Alexia Even

given: Alexia

family: Denys

full_name: Pierre Denys

name: Department of Physical Medicine and Rehabilitation, Saint-Jacques Hospital, University Hospital of Nantes, Nantes, France

family: Perrouin-Verbe

full_name: Brigitte Perrouin-Verbe

given: Brigitte

name: Department of Infectious Diseases, Caremeau University Hospital, Nîmes, France

family: Sotto

full_name: Albert Sotto

given: Albert

name: Microbiology Laboratory, Caremeau University Hospital, Nîmes, France

family: Lavigne

full_name: Jean-Philippe Lavigne

given: Jean-Philippe

name: Department of Urology, Bretonneau University Hospital, Tours, France

family: Bruyère

full_name: Franck Bruyère

given: Franck

name: Microbiology Laboratory, Bichat-Claude Bernard University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France

family: Grall

full_name: Nathalie Grall

given: Nathalie

name: Clinical Investigation Centre INSERM 1415, Bretonneau University Hospital, Tours, France

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

family: Bernard

full_name: Louis Bernard

given: Louis

journal_name: Clinical Infectious Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Tours

acronym: PACHIU

location_facility: University Hospital, Pontchaillou / RENNES

location_facility: University Hospital, St Jacques / NANTES

location_facility: University Hospital, Raymond Poincaré / APHP

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Randomized, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder

summary:
Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic therapy increases the risk of multi-resistant bacterial infections, without reducing the rate of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral Cyclic Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and antibiotic Y on odd weeks) seem to drastically reduce both the number of symptomatic UTIs and the number of hospitalizations in patients with neurogenic bladder, without affecting bacterial ecology.

The objective of this study is to validate this preliminary work with a large-scale randomized, parallel-group, multicenter study.


title: Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human

acronym: HPVLichen

summary:
Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant peptide of Human Papilloma Virus (HPV) 16.

In line with this recent work which shows for the first time a link between HPV-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis that HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus.

status: Active, not recruiting

lead_sponsor: Institut Pasteur

location_facility: Service de Dermatologie de l'hôpital Saint Louis

location_facility: Service de Dermatologie du CHU de Besançon


title: Impact of a Bridge Device on the Loop Ileostomy

acronym: IBIP

summary:
During the creation of an ileostomy, a bridge device is systematically placed in an aim to reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to justify this issue.

Moreover the placement of a bridge device increases the difficulty of nurse cares and is associated with its own morbidity.

ReferenceCitation: Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14.

ReferenceCitation: Sagap I, Remzi FH, Hammel JP, Fazio VW. Factors associated with failure in managing pelvic sepsis after ileal pouch-anal anastomosis (IPAA)--a multivariate analysis. Surgery. 2006 Oct;140(4):691-703; discussion 703-4.

ReferenceCitation: Panis Y, Maggiori L, Caranhac G, Bretagnol F, Vicaut E. Mortality after colorectal cancer surgery: a French survey of more than 84,000 patients. Ann Surg. 2011 Nov;254(5):738-43; discussion 743-4. doi: 10.1097/SLA.0b013e31823604ac.

ReferenceCitation: Oberkofler CE, Rickenbacher A, Raptis DA, Lehmann K, Villiger P, Buchli C, Grieder F, Gelpke H, Decurtins M, Tempia-Caliera AA, Demartines N, Hahnloser D, Clavien PA, Breitenstein S. A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis. Ann Surg. 2012 Nov;256(5):819-26; discussion 826-7. doi: 10.1097/SLA.0b013e31827324ba.

ReferenceCitation: Cottam J, Richards K, Hasted A, Blackman A. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery. Colorectal Dis. 2007 Nov;9(9):834-8. Epub 2007 Aug 2.

location_facility:
Chu Rouen
Beauvais hospital
Amiens Universitary Hospital


title: Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma: a French Multicenter Prospective Study

summary: To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated prospectively in an independent population. Our goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French pediatric population in multiple clinical settings.

ReferenceCitation: Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14. Erratum in: Lancet. 2014 Jan 25;383(9914):308.

ReferenceCitation: Lorton F, Poullaouec C, Legallais E, Simon-Pimmel J, Chêne MA, Leroy H, Roy M, Launay E, Gras-Le Guen C. Validation of the PECARN clinical decision rule for children with minor head trauma: a French multicenter prospective study. Scand J Trauma Resusc Emerg Med. 2016 Aug 4;24:98. doi: 10.1186/s13049-016-0287-3.

family: Lorton

full_name: F. Lorton

given: F.

family: Poullaouec

full_name: C. Poullaouec

given: C.

family: Legallais

full_name: E. Legallais

given: E.

family: Simon-Pimmel

full_name: J. Simon-Pimmel

given: J.

family: Chêne

full_name: M. A. Chêne

given: M. A.

family: Leroy

full_name: H. Leroy

given: H.

family: Roy

full_name: M. Roy

given: M.

family: Launay

full_name: E. Launay

family: Gras-Le Guen

full_name: C. Gras-Le Guen

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility:
Nantes University Hospital
Hospital of Saint-Nazaire
Departmental Hospital of Vendée


title: Study of Prognostic Value of T Cell Receptor Diversity and CD4 Lymphopenia in First Relapse Breast or Lung Cancer Patients

summary: The T and B cells repertoire diversity represent one of the immune defence level which controls the integrity of the organism and determines its ability to recognize and control infectious attacks and development of tumours. The study of the lymphocytes TCR and BCR diversity could permit to better understand how lymphopenia act on overall survival and to improve detection of high risk patients who could benefit of adapted therapies for better care.

ReferenceCitation: Belbaraka R, Trédan O, Ray-Coquard I, Chvetzoff G, Bajard A, Pérol D, Ismaili N, Ismaili M, Errihani H, Bachelot T, Rebattu P. Factors of interrupting chemotherapy in patients with Advanced Non-Small-Cell Lung Cancer. BMC Res Notes. 2010 Jun 10;3:164. doi: 10.1186/1756-0500-3-164.

family: Belbaraka

full_name: Rhizlane Belbaraka

given: Rhizlane

family: Trédan

full_name: Olivier Trédan

given: Olivier

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Chvetzoff

full_name: Giselle Chvetzoff

given: Giselle

family: Bajard

full_name: Agathe Bajard

given: Agathe

family: Pérol

full_name: David Pérol

given: David

family: Ismaili

full_name: Nabil Ismaili

given: Nabil

full_name: Mohammed Ismaili

given: Mohammed

family: Errihani

full_name: Hassan Errihani

given: Hassan

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Rebattu

full_name: Paul Rebattu

given: Paul

journal_name: BMC Research Notes

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Ray-Coquard I, Cropet C, Van Glabbeke M, Sebban C, Le Cesne A, Judson I, Tredan O, Verweij J, Biron P, Labidi I, Guastalla JP, Bachelot T, Perol D, Chabaud S, Hogendoorn PC, Cassier P, Dufresne A, Blay JY; European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/0008-5472.CAN-08-3845. Epub 2009 Jun 23.

family: Cropet

full_name: Claire Cropet

given: Claire

family: Van Glabbeke

full_name: Martine Van Glabbeke

given: Martine

family: Sebban

full_name: Catherine Sebban

given: Catherine

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

publisher: American Association for Cancer Research (AACR)

title: Lymphopenia as a Prognostic Factor for Overall Survival in Advanced Carcinomas, Sarcomas, and Lymphomas

location_facility:
Hopital Privé Jean Mermoz
Centre Léon Bérard
CHLS
Hopital de la Croix Rousse


title: Immunomonitoring of Children With Neuroblastoma for the Development of Antitumor Immunotherapy Strategies

acronym: Immuneuro

summary:
Apart from brain tumors, Neuroblastoma is the most common solid tumor during childhood. About 50% of the cases present at diagnosis with factors of bad prognosis. During the last two decades, despite increased therapeutic intensity during induction and consolidation of high-risk neuroblastomas, the 5 year overall survival of high risk neuroblastoma remains in between 30 to 40% depending on studies.

Besides strategies of high-dose chemotherapy followed by autologous transplantation of hematopoietic stem cells, and differentiating molecules (retinoids), immunotherapy will become one of the leading anti-neuroblastoma targeted therapy. No therapeutic strategies or molecules obtained such gains of survival ever before.

Studying the immune system of children with neuroblastoma at diagnosis and during their treatment will help us to determine when we should test active or passive immunotherapy strategies. Moreover, this study would allow us to specify the cause of tumor immune tolerance in neuroblastoma, on which we have few data in comparison to adult tumors.

This will be a multicentric, pilot, prospective, open, study that will not require unusual diagnostic interventions. This study will be transversal (all neuroblastoma stages included) in order to determine comparative criteria between low and high risk neuroblastoma. It will also be longitudinal (from diagnosis to post-treatment follow-up) in order to specify evolutionary aspects of immunity under radio-chemotherapy and retinoic acid therapy.

Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis, and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These types of samples are routinely done during conventional neuroblastoma treatment.

primary_purpose: Screening

ReferenceCitation: Marabelle A, Merlin E, Halle P, Paillard C, Berger M, Tchirkov A, Rousseau R, Leverger G, Piguet C, Stephan JL, Demeocq F, Kanold J. CD34+ immunoselection of autologous grafts for the treatment of high-risk neuroblastoma. Pediatr Blood Cancer. 2011 Jan;56(1):134-42. doi: 10.1002/pbc.22840.

family: Marabelle

full_name: Aurélien Marabelle

given: Aurélien

family: Merlin

full_name: Etienne Merlin

given: Etienne

family: Halle

full_name: Pascale Halle

given: Pascale

family: Paillard

full_name: Catherine Paillard

family: Berger

full_name: Marc Berger

given: Marc

family: Tchirkov

full_name: Andrei Tchirkov

given: Andrei

family: Rousseau

full_name: Raphaël Rousseau

given: Raphaël

family: Leverger

full_name: Guy Leverger

given: Guy

family: Piguet

full_name: Christophe Piguet

given: Christophe

family: Stephan

full_name: Jean-Louis Stephan

given: Jean-Louis

family: Demeocq

full_name: François Demeocq

given: François

family: Kanold

full_name: Justyna Kanold

given: Justyna

journal_name: Pediatric Blood & Cancer

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Bertrand A, Marec-Berard P, Raverot G, Trouillas J, Marabelle A. Cabergoline therapy of paraneoplastic Cushing syndrome in children. Pediatr Blood Cancer. 2010 Sep;55(3):589-90. doi: 10.1002/pbc.22581.

family: Bertrand

full_name: Amandine Bertrand

given: Amandine

family: Marec-Berard

full_name: Perrine Marec-Berard

given: Perrine

family: Raverot

full_name: Gerald Raverot

given: Gerald

family: Trouillas

full_name: Jacqueline Trouillas

given: Jacqueline

title: Cabergoline therapy of paraneoplastic cushing syndrome in children

ReferenceCitation: Marabelle A, Bergeron C, Billaud G, Mekki Y, Girard S. Hemophagocytic syndrome revealing primary HHV-6 infection. J Pediatr. 2010 Sep;157(3):511. doi: 10.1016/j.jpeds.2010.02.064. Epub 2010 Apr 18.

title: Hemophagocytic Syndrome Revealing Primary HHV-6 Infection

ReferenceCitation: Marabelle A, Sapin V, Rousseau R, Periquet B, Demeocq F, Kanold J. Hypercalcemia and 13-cis-retinoic acid in post-consolidation therapy of neuroblastoma. Pediatr Blood Cancer. 2009 Feb;52(2):280-3. doi: 10.1002/pbc.21768.

ReferenceCitation: Marabelle A, Campagne D, Déchelotte P, Chipponi J, Deméocq F, Kanold J. Focal nodular hyperplasia of the liver in patients previously treated for pediatric neoplastic diseases. J Pediatr Hematol Oncol. 2008 Jul;30(7):546-9. doi: 10.1097/MPH.0b013e3181691709.

journal_name: Journal of Pediatric Hematology/Oncology

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Focal Nodular Hyperplasia of the Liver in Patients Previously Treated for Pediatric Neoplastic Diseases

ReferenceCitation: Kanold J, Paillard C, Tchirkov A, Merlin E, Marabelle A, Lutz P, Rousseau R, Baldomero H, Deméocq F. Allogeneic or haploidentical HSCT for refractory or relapsed solid tumors in children: toward a neuroblastoma model. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S25-30. doi: 10.1038/bmt.2008.279. Review.

ReferenceCitation: Kanold J, Merlin E, Halle P, Paillard C, Marabelle A, Rapatel C, Evrard B, Berger C, Stephan JL, Galambrun C, Piguet C, D'Incan M, Bordigoni P, Deméocq F. Photopheresis in pediatric graft-versus-host disease after allogeneic marrow transplantation: clinical practice guidelines based on field experience and review of the literature. Transfusion. 2007 Dec;47(12):2276-89. Epub 2007 Aug 30.

location_facility:
Chu Grenoble - Hopital Nord
Chu - Hopital Nord
Hopital D'Estaing
IHOP


acronym: Biofilm Plaie

summary: In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.

lead_sponsor: Institut Curie

location_facility:
Institut Curie
Chu Montpellier
Hopital Rothschild

intervention_type: Biological


title: Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.

acronym: EPIC-FOP

summary: The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

ReferenceCitation: Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.

name: Brest University Hospital, Western Brittany University, Brest, France (E.L., S.T., D.B., R.D., Y.J., R.L., C.H., A.D., G.L., K.L., C.L., D.M., F.C.)

family: Le Moigne

full_name: Emmanuelle Le Moigne

given: Emmanuelle

family: Timsit

full_name: Serge Timsit

given: Serge

family: Ben Salem

full_name: Douraied Ben Salem

given: Douraied

family: Didier

full_name: Romain Didier

given: Romain

family: Jobic

full_name: Yannick Jobic

given: Yannick

name: Toulon Military Hospital, Toulon, France (N.P.)

family: Paleiron

full_name: Nicolas Paleiron

given: Nicolas

family: Le Mao

full_name: Raphael Le Mao

given: Raphael

name: Cornouaille Hospital Center, Quimper, France (T.J.)

family: Joseph

full_name: Thierry Joseph

given: Thierry

family: Hoffmann

full_name: Clément Hoffmann

given: Clément

family: Dion

full_name: Angelina Dion

given: Angelina

name: Brest University Hospital, Brest, France (J.R.)

family: Rousset

full_name: Jean Rousset

given: Jean

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

family: Lacut

full_name: Karine Lacut

given: Karine

family: Leroyer

full_name: Christophe Leroyer

family: Mottier

full_name: Dominique Mottier

given: Dominique

family: Couturaud

full_name: Francis Couturaud

given: Francis

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

lead_sponsor: University Hospital, Brest

location_facility:
Centre Hospitalier de Cornouaille
Army Hospital
Brest University Hospital
CHU Dijon de Bocage


title: Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition

summary: The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Hôpital Guy de Chauliac, CHU de Montpellier


title: Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Care Cancer Patients Presenting Severe Refractory Lower Limbs Lymphedema

summary:
Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them.

Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure.

Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results.

Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Genetics of the Combined Pulmonary Fibrosis and Emphysema Syndrome

acronym: GENES-SEF

summary: The combined pulmonary fibrosis and emphysema syndrome (CPFE) individualized by our group in 2005 is characterized by an often severe dyspnea, almost exclusive male predominance, and often major, profound impairment of gas exchange contrasting with preserved lung volumes and absence of airflow obstruction, and a high risk of pre-capillary pulmonary hypertension responsible for increased mortality. Almost all patients are smokers or ex-smokers. There are some arguments in favor of genetic abnormalities in this syndrome of unknown etiology (other than smoking) including short telomeres and mutations in the telomerase complex genes. There are also emphysematous lesions, in patients with familial pulmonary fibrosis, with mutations in the SFTPC gene (surfactant protein C), and reported cases of CPFE syndrome with SFTPC mutation. No large genetic studies have been conducted to date in the CPFE syndrome. Our main hypothesis is that the proportion of subjects with short telomeres is higher among patients with CPFE syndrome than in subjects of similar age with idiopathic pulmonary fibrosis but without emphysema. It has previously been shown that mutations in the telomerase TERT or TERC genes are mostly found in people whose telomeres are abnormally short. The investigators propose to use that test to identify patients most likely carrying a mutation, and to seek, among them, the mutations in the TERT or TERC telomerase genes. The objective of the study is to compare the proportion of patients with short telomeres in the group of patients with CPFE syndrome to that of other patients (with idiopathic pulmonary fibrosis without emphysema, or with emphysema without fibrosis).

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital louis Pradel

intervention_type: Genetic


title: Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's

acronym: BeatPark

summary:
The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait characteristics in Parkinson's disease (PD) are attested by clinical research.

Nonetheless, it is still unclear which auditory information parameters (i.e. complexity, temporal regularity or adaptability to gait) maximize the effectiveness of RAS.

Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics in PD patients with gait disorders according to:

RAS complexity (i.e. metronome, amplitude modulated noise, music)
RAS variability (i.e fixed, random, semi-random)
RAS adapted in real-time to gait

Variability study:

To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.

Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.

ReferenceCitation: Arias P, Cudeiro J. Effects of rhythmic sensory stimulation (auditory, visual) on gait in Parkinson's disease patients. Exp Brain Res. 2008 Apr;186(4):589-601. doi: 10.1007/s00221-007-1263-y. Epub 2008 Jan 23.

family: Arias

full_name: Pablo Arias

given: Pablo

family: Cudeiro

full_name: Javier Cudeiro

given: Javier

bso_classification: Biology (fond.)

journal_name: Experimental Brain Research

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

title: Effects of rhythmic sensory stimulation (auditory, visual) on gait in Parkinson’s disease patients

ReferenceCitation: Arias P, Cudeiro J. Effect of rhythmic auditory stimulation on gait in Parkinsonian patients with and without freezing of gait. PLoS One. 2010 Mar 22;5(3):e9675. doi: 10.1371/journal.pone.0009675.

currency_apc_doaj: USD

journal_name: PLoS ONE

repository_institution: Universidade Da Coruña - RUC

evidence: oa repository (semantic scholar lookup)

repositories_institution:
PubMed Central - Europe PMC
Universidade Da Coruña - RUC

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Effect of Rhythmic Auditory Stimulation on Gait in Parkinsonian Patients with and without Freezing of Gait

ReferenceCitation: Blin O, Ferrandez AM, Pailhous J, Serratrice G. Dopa-sensitive and dopa-resistant gait parameters in Parkinson's disease. J Neurol Sci. 1991 May;103(1):51-4.

ReferenceCitation: Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. Review.

ReferenceCitation: Brown LA, de Bruin N, Doan JB, Suchowersky O, Hu B. Novel challenges to gait in Parkinson's disease: the effect of concurrent music in single- and dual-task contexts. Arch Phys Med Rehabil. 2009 Sep;90(9):1578-83. doi: 10.1016/j.apmr.2009.03.009.

family: Brown

full_name: Lesley A. Brown

given: Lesley A.

family: de Bruin

full_name: Natalie de Bruin

given: Natalie

family: Doan

full_name: Jon B. Doan

given: Jon B.

family: Suchowersky

full_name: Oksana Suchowersky

given: Oksana

family: Hu

full_name: Bin Hu

journal_name: Archives of Physical Medicine and Rehabilitation

title: Novel Challenges to Gait in Parkinson's Disease: The Effect of Concurrent Music in Single- and Dual-Task Contexts

ReferenceCitation: Delignières D, Torre K. Fractal dynamics of human gait: a reassessment of the 1996 data of Hausdorff et al. J Appl Physiol (1985). 2009 Apr;106(4):1272-9. doi: 10.1152/japplphysiol.90757.2008. Epub 2009 Feb 19.

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name: Laboratoire de Neurosciences Fonctionnelles et Pathologies; EA 4559; Université Lille; Lille France

name: Neurologie et Pathologie du Mouvement; Neurologie A; Hôpital Salengro; Centre Hospitalier Universitaire; Lille France

name: Laboratoire PSITEC; EA 4072; UDL3; Université Lille Nord de France; Lille France

ReferenceCitation: Ebersbach G, Heijmenberg M, Kindermann L, Trottenberg T, Wissel J, Poewe W. Interference of rhythmic constraint on gait in healthy subjects and patients with early Parkinson's disease: evidence for impaired locomotor pattern generation in early Parkinson's disease. Mov Disord. 1999 Jul;14(4):619-25.

ReferenceCitation: Elbers RG, van Wegen EE, Verhoef J, Kwakkel G. Is gait speed a valid measure to predict community ambulation in patients with Parkinson's disease? J Rehabil Med. 2013 Apr;45(4):370-5. doi: 10.2340/16501977-1123.

title: Is gait speed a valid measure to predict community ambulation in patients with Parkinsonâ€™s disease?

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ReferenceCitation: Hausdorff JM. Gait dynamics in Parkinson's disease: common and distinct behavior among stride length, gait variability, and fractal-like scaling. Chaos. 2009 Jun;19(2):026113. doi: 10.1063/1.3147408. Review.

journal_name: Chaos: An Interdisciplinary Journal of Nonlinear Science

title: Gait dynamics in Parkinson’s disease: Common and distinct behavior among stride length, gait variability, and fractal-like scaling

ReferenceCitation: Hove MJ, Suzuki K, Uchitomi H, Orimo S, Miyake Y. Interactive rhythmic auditory stimulation reinstates natural 1/f timing in gait of Parkinson's patients. PLoS One. 2012;7(3):e32600. doi: 10.1371/journal.pone.0032600. Epub 2012 Mar 2.

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

repositories_institution:
Max Planck Society - MPG.PuRe
PubMed Central - Europe PMC

title: Interactive Rhythmic Auditory Stimulation Reinstates Natural 1/f Timing in Gait of Parkinson's Patients

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repository_institution: Australian Catholic University - Research Bank

repositories_institution: Australian Catholic University - Research Bank

title: Predictors of future falls in Parkinson disease

ReferenceCitation: Kirschner S, Tomasello M. Joint drumming: social context facilitates synchronization in preschool children. J Exp Child Psychol. 2009 Mar;102(3):299-314. doi: 10.1016/j.jecp.2008.07.005. Epub 2008 Sep 12.

journal_name: Journal of Experimental Child Psychology

title: Joint drumming: Social context facilitates synchronization in preschool children

ReferenceCitation: Lehman DA, Toole T, Lofald D, Hirsch MA. Training with verbal instructional cues results in near-term improvement of gait in people with Parkinson disease. J Neurol Phys Ther. 2005 Mar;29(1):2-8.

ReferenceCitation: Lim I, van Wegen E, de Goede C, Deutekom M, Nieuwboer A, Willems A, Jones D, Rochester L, Kwakkel G. Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review. Clin Rehabil. 2005 Oct;19(7):695-713. Review.

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ReferenceCitation: Marmelat V, Delignières D. Strong anticipation: complexity matching in interpersonal coordination. Exp Brain Res. 2012 Oct;222(1-2):137-48. doi: 10.1007/s00221-012-3202-9. Epub 2012 Aug 4.

repository_institution: Chiba Institute of Technology - Springer Link

repository_institution: The Pennsylvania State University - CiteSeer X

repositories_institution: Chiba Institute of Technology - Springer Link

repositories_institution: The Pennsylvania State University - CiteSeer X

title: Strong anticipation: complexity matching in interpersonal coordination

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ReferenceCitation: McIntosh, G.C., Rice, R.R., Hurt, C.P., and Thaut, M.H. (1998). Long-term training effects of rhythmic auditory stimulation on gait in patients with Parkinson's disease. Mov. Disord. Off. J. Mov. Disord. Soc. 13 (supple2), 212.

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ReferenceCitation: Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991.

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title: Cueing for freezing of gait in patients with Parkinson's disease: A rehabilitation perspective

ReferenceCitation: Nieuwboer A, Kwakkel G, Rochester L, Jones D, van Wegen E, Willems AM, Chavret F, Hetherington V, Baker K, Lim I. Cueing training in the home improves gait-related mobility in Parkinson's disease: the RESCUE trial. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):134-40. Erratum in: J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1414. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):126.

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title: Into the groove: Can rhythm influence Parkinson's disease?

ReferenceCitation: del Olmo MF, Cudeiro J. Temporal variability of gait in Parkinson disease: effects of a rehabilitation programme based on rhythmic sound cues. Parkinsonism Relat Disord. 2005 Jan;11(1):25-33. Epub 2004 Dec 9.

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ReferenceCitation: Rascol O, Goetz C, Koller W, Poewe W, Sampaio C. Treatment interventions for Parkinson's disease: an evidence based assessment. Lancet. 2002 May 4;359(9317):1589-98. Review.

ReferenceCitation: Repp BH. Sensorimotor synchronization: a review of the tapping literature. Psychon Bull Rev. 2005 Dec;12(6):969-92. Review.

ReferenceCitation: Repp BH, Su YH. Sensorimotor synchronization: a review of recent research (2006-2012). Psychon Bull Rev. 2013 Jun;20(3):403-52. doi: 10.3758/s13423-012-0371-2. Review.

title: Sensorimotor synchronization: A review of recent research (2006–2012)

ReferenceCitation: Rizzolatti G, Fogassi L, Gallese V. Neurophysiological mechanisms underlying the understanding and imitation of action. Nat Rev Neurosci. 2001 Sep;2(9):661-70. Review.

ReferenceCitation: Schaafsma JD, Giladi N, Balash Y, Bartels AL, Gurevich T, Hausdorff JM. Gait dynamics in Parkinson's disease: relationship to Parkinsonian features, falls and response to levodopa. J Neurol Sci. 2003 Aug 15;212(1-2):47-53.

ReferenceCitation: Sowiński J, Dalla Bella S. Poor synchronization to the beat may result from deficient auditory-motor mapping. Neuropsychologia. 2013 Aug;51(10):1952-63. doi: 10.1016/j.neuropsychologia.2013.06.027. Epub 2013 Jul 6.

title: Poor synchronization to the beat may result from deficient auditory-motor mapping

ReferenceCitation: Spaulding SJ, Barber B, Colby M, Cormack B, Mick T, Jenkins ME. Cueing and gait improvement among people with Parkinson's disease: a meta-analysis. Arch Phys Med Rehabil. 2013 Mar;94(3):562-70. doi: 10.1016/j.apmr.2012.10.026. Epub 2012 Nov 2.

title: Cueing and Gait Improvement Among People With Parkinson's Disease: A Meta-Analysis

ReferenceCitation: Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

title: Gait Speed and Survival in Older Adults

ReferenceCitation: Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Mov Disord. 1996 Mar;11(2):193-200.

ReferenceCitation: Thaut MH, McIntosh KW, McIntosh GC, Hoemberg V. Auditory rhythmicity enhances movement and speech motor control in patients with Parkinson's disease. Funct Neurol. 2001 Apr-Jun;16(2):163-72.

ReferenceCitation: Vu TC, Nutt JG, Holford NH. Progression of motor and nonmotor features of Parkinson's disease and their response to treatment. Br J Clin Pharmacol. 2012 Aug;74(2):267-83. doi: 10.1111/j.1365-2125.2012.04192.x.

journal_name: British Journal of Clinical Pharmacology

ReferenceCitation: Willems AM, Nieuwboer A, Chavret F, Desloovere K, Dom R, Rochester L, Jones D, Kwakkel G, Van Wegen E. The use of rhythmic auditory cues to influence gait in patients with Parkinson's disease, the differential effect for freezers and non-freezers, an explorative study. Disabil Rehabil. 2006 Jun 15;28(11):721-8.

ReferenceCitation: Wright WG, Gurfinkel VS, King LA, Nutt JG, Cordo PJ, Horak FB. Axial kinesthesia is impaired in Parkinson's disease: effects of levodopa. Exp Neurol. 2010 Sep;225(1):202-9. doi: 10.1016/j.expneurol.2010.06.016. Epub 2010 Jul 1.

title: Axial kinesthesia is impaired in Parkinson's disease: Effects of levodopa

ReferenceCitation: Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9.

ReferenceCitation: Zatorre RJ, Chen JL, Penhune VB. When the brain plays music: auditory-motor interactions in music perception and production. Nat Rev Neurosci. 2007 Jul;8(7):547-58. Review.

ReferenceCitation: Zentner M, Eerola T. Rhythmic engagement with music in infancy. Proc Natl Acad Sci U S A. 2010 Mar 30;107(13):5768-73. doi: 10.1073/pnas.1000121107. Epub 2010 Mar 15.

journal_name: Proceedings of the National Academy of Sciences

publisher: Proceedings of the National Academy of Sciences

publisher_dissemination: Proceedings of the National Academy of Sciences

publisher_group: Proceedings of the National Academy of Sciences

publisher_normalized: Proceedings of the National Academy of Sciences

title: Rhythmic engagement with music in infancy

location_facility: Service de neurologie de la Clinique Beau Soleil

location_facility: Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du


title: Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients

summary:
Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation.

To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients

location_facility:
Angers University Hospital
Nantes University Hospital
Rennes University Hospital


title: Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence. Randomised, Prospective, Non-inferiority Study.

summary:
Inguinal incisions are the most frequent incisions used in children before the acquisition of continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU). However, healing of those wounds can be made hard because of soiling induced by urine and/or stool, which is unavoidable in case of wearing nappies.

Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery wound dressing is protected by the application of a waterproof band aid (like Tegaderm®) during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse changes it, causing unpleasantness in low age children (whose epidermal fragility is well known), and sometimes parents worry.

Moreover, those occlusive wound dressings avoid any control of the surgical wound during healing phase.

At the end of the wound-healing time, wound dressings are removed, causing discomfort for children and necessity of a qualified nurse staff at visit times.

Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture in children is made with 5/0) and has its own local antiseptic properties. It does not need to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age distinction) seem to be equivalent to conventional sutures. Finally, its application goes with time saving (in preoperative and during wound-healing phase) and increases comfort for patients.

The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond® (2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the acquisition of continence, by a non-inferiority randomized multicentric prospective study.

Two patient groups will be studied, the sutures of one control group will be made with a conventional technique (intradermic surjet surgical suture), and one patient group will be sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality (short- and long-term cosmetic aspect) evaluated by the surgeon.

Two secondary criteria will be studied :

Parental satisfaction
Ease of clinical nursing management Each studied criteria will be evaluated by a numeric score.

location_facility: Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie

location_facility: Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2


acronym: GenCInibs-Suni

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi

title: The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer: Searching for Pharmacogenetic Determinants

summary: The primary objective of this study is to determine the percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml (effective concentration according to the current literature).


title: Development and Validation of Fungal Extraction and Real -Time PCR Assay for the Diagnosis of Medically Important Fungal Infections in Blood Samples.

summary:
Invasive fungal infections have a major impact on the morbidity and mortality of immunocompromised patients, including patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted patients and patients admitted in an intensive care unit.

The survival of these patients depends on early diagnosis and prompt appropriate antifungal treatment. The early diagnosis of these infections is difficult because of the lack of sensitive test methods, notably blood cultures. For these reasons, the investigators decided to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should allow rapid response to establish a positive or negative diagnosis of invasive fungal infection, could contribute strongly to the decision of treating using antifungals, and should monitor the effectiveness and the optimization of antifungal prescriptions.

The investigators' objectives are: First, to validate an extraction method from blood infected by fungi species. Secondly, the investigators want to develop three real-time PCR: A fungal real-time PCR able to detect most fungal species; a real-time PCR targetting Candida albicans and Aspergillus fumigatus which are two clinically important pathogens. Then blood samples of patients (classified according to EORTC consensus) will be collected during the study in order to evaluate and validate our method on clinical samples. Results will allow the investigators to determine the sensitivity, specificity and reproducibility, negative and predictive values.

Overall, the investigators' work aims to evaluate the clinical impact of real-time PCR in the early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal therapy. The economic impact resulting from the use of this method will be evaluated.

location_facility:
CAL
CHU de Rennes
CHU de Nice - 4 avenue Reine Victoria
CHU de Touloluse - hôpital de Rangueil


title: Comparison of Two Tranexamic Acid Dose Regimens on Transfusion Needs During Cardiac Surgery With Cardiopulmonary Bypass

acronym: Exacylcardio

summary:
Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding, and may lead to allogenic blood transfusion re-intervention and many adverse outcomes. Prophylactic use of tranexamic Acid (TA) has been shown to decrease blood loss and blood transfusion during cardiac surgery.There currently are multiple dosing regimens for TA for cardiac surgery.Preliminary dose-response study has shown that low prophylactic dose of TA would be as accurate for haemostatic efficacy as higher dose.

The primary objective of this tri-center, prospective, double-blinded, randomised trial is to compare two administrations and dosing regimens of TA during cardiac surgery with CPB on the perioperative blood loss.

In addition to the clinical study, a pharmacokinétic/pharmacodynamic study will be conducted.

Patients are divided in two groups: low and high risk surgery. Methods: After written informed consent, patients are randomly assigned to one of the two treatment groups. The low dose TA group is: 10 mg/kg TA given over 15 min, followed by an infusion of 1 mg/kg/h throughout the operation, and 1 mg/kg into the CPB prime volume. The high dose group is :30 mg/kg TA given over 15 min, followed by an infusion of 16 mg/kg/h throughout the operation, and 2 mg/kg into the CPB prime volume. Hemodynamic and anaesthesia care will be as usual. A blood salvage device will be systematically used. The triggers for transfusion will be: red blood cells: haemoglobin less than 8 g/dl or 6 g/dl during CBP; Plasma: PT less than 50% or INR more than 1.5; platelets: platelets count less than 50/70 G/mm3; fibrinogen: fibrinogen less than 1g/l . All patients will receive standard anaesthesia and perioperative care.

In 60 consecutive patients in the principal investigator center, 5 blood samples will allow to assess the plasmatic concentration of tranexamic acid at different time of the surgery procedure:

Baseline
5 min after the loading dose
10 min after the beginning of bypass
at the discontinuation of the infusion
1 hour after the discontinuation Plasmatic dosage will be assessed using a high performance liquid chromatography technique.

Patients will be stratified in two groups for the statistical analysis; low and high risk surgery. Analysis will be in intention to treat. 300 patients should be recruited in each group to detect an absolute difference of respectively 10% (low risk cardiac surgery) and 20% (high risk cardiac surgery) in the number of patients exposed to allogenic blood transfusion between patients receiving high dose TA regimen and those receiving low dose TA regimen, assuming a power of 80% and a two-tailed value less than 0.05.

ReferenceCitation: Grassin-Delyle S, Tremey B, Abe E, Fischler M, Alvarez JC, Devillier P, Urien S. Population pharmacokinetics of tranexamic acid in adults undergoing cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2013 Dec;111(6):916-24. doi: 10.1093/bja/aet255. Epub 2013 Jul 23.

family: Grassin-Delyle

full_name: S. Grassin-Delyle

given: S.

family: Tremey

full_name: B. Tremey

given: B.

family: Abe

full_name: E. Abe

given: E.

family: Fischler

full_name: M. Fischler

given: M.

family: Alvarez

full_name: J.C. Alvarez

family: Devillier

full_name: P. Devillier

given: P.

family: Urien

full_name: S. Urien

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Hopital Foch

location_facility: department of anaesthesiology, CHU Jean Minjoz

location_facility: department of anesthesiology, Haut Leveque Hospital

location_facility: department of anesthesiology, Bichat Hospital


title: Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter

acronym: TOTEME

summary:
TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period.

Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.

ReferenceCitation: Kulkarni R, Bellamy E. Nickel-titanium shape memory alloy Memokath 051 ureteral stent for managing long-term ureteral obstruction: 4-year experience. J Urol. 2001 Nov;166(5):1750-4.

ReferenceCitation: Klarskov P, Nordling J, Nielsen JB. Experience with Memokath 051 ureteral stent. Scand J Urol Nephrol. 2005;39(2):169-72.

ReferenceCitation: Pariente JL, Conort P. [Biomaterials used in contact with the urinary tract for urine drainage: catheters and ureteric stents]. Prog Urol. 2005 Nov;15(5):897-906. Review. French.

ReferenceCitation: Ringel A, Richter S, Shalev M, Nissenkorn I. Late complications of ureteral stents. Eur Urol. 2000 Jul;38(1):41-4.

ReferenceCitation: Kehinde EO, Rotimi VO, Al-Awadi KA, Abdul-Halim H, Boland F, Al-Hunayan A, Pazhoor A. Factors predisposing to urinary tract infection after J ureteral stent insertion. J Urol. 2002 Mar;167(3):1334-7.

ReferenceCitation: Al-Kandari AM, Al-Shaiji TF, Shaaban H, Ibrahim HM, Elshebiny YH, Shokeir AA. Effects of proximal and distal ends of double-J ureteral stent position on postprocedural symptoms and quality of life: a randomized clinical trial. J Endourol. 2007 Jul;21(7):698-702.

ReferenceCitation: Hübner WA, Plas EG, Stoller ML. The double-J ureteral stent: in vivo and in vitro flow studies. J Urol. 1992 Aug;148(2 Pt 1):278-80.

ReferenceCitation: Poulsen AL, Schou J, Ovesen H, Nordling J. Memokath: a second generation of intraprostatic spirals. Br J Urol. 1993 Sep;72(3):331-4.

ReferenceCitation: Laaksovirta S, Välimaa T, Isotalo T, Törmälä P, Talja M, Tammela TL. Encrustation and strength retention properties of the self-expandable, biodegradable, self-reinforced L-lactide-glycolic acid co-polymer 80:20 spiral urethral stent in vitro. J Urol. 2003 Aug;170(2 Pt 1):468-71.

ReferenceCitation: Vaidyanathan S, Soni BM, Oo T, Sett P, Hughes PL, Singh G. Long-term result of Memokath urethral sphincter stent in spinal cord injury patients. BMC Urol. 2002 Nov 11;2:12. Epub 2002 Nov 11.

ReferenceCitation: Perry MJ, Roodhouse AJ, Gidlow AB, Spicer TG, Ellis BW. Thermo-expandable intraprostatic stents in bladder outlet obstruction: an 8-year study. BJU Int. 2002 Aug;90(3):216-23.

ReferenceCitation: Arya M, Mostafid H, Patel HR, Kellett MJ, Philp T. The self-expanding metallic ureteric stent in the long-term management of benign ureteric strictures. BJU Int. 2001 Sep;88(4):339-42.

lead_sponsor: University Hospital, Bordeaux

location_facility: Department of Urology, University Hospital, Toulouse

location_facility: Department of Urology, University Hospital, Bordeaux

location_facility: Department of Urology, Hospices Civils de Lyon

location_facility: Department of Urology, University Hospital, Limoges


title: Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

acronym: ROTEM

summary:
Cardiac surgery is bleeding requiring transfusion surgery .

The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.

All these changes contribute to increase the need for transfusions during heart surgery.

The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.

100 pateinst (50 in each arm) should be included in this trial.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Limoges

location_facility: Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale


title: Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors, Daily Physical Activity, Dietary Habits and Blood Glucose and Fatty Acids in Coronary Syndromes Patients

acronym: OLIMPIC

summary:
In secondary prevention, the beneficial role of cardiac rehabilitation programs after myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now well established. The large majority of patients don't benefit from cardiac rehabilitation but for those who do, they usually follow an inhospital short health educational program with a sensibilisation to different coronary risk factors like smoking, overweight and inactivity. The impact of these inhospital short health educational programs combined to cardiac rehabilitation has never been totally evaluated, especially the impact on smoking cessation, weight loss and daily physical activity.

Therefore, the present study aims to evaluate the impact at one year on 400 consecutive patients' coronary risk profile of:

an inhospital short health educational program alone
an inhospital short health educational program combined to cardiac rehabilitation
a cardiac rehabilitation program alone

ReferenceCitation: De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomér K, Perk J, Pyörälä K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10.

ReferenceCitation: AHA; ACC; National Heart, Lung, and Blood Institute, Smith SC Jr, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pearson T, Pfeffer MA, Taubert KA. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update endorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol. 2006 May 16;47(10):2130-9.

ReferenceCitation: Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Association of Cardiovascular and Pulmonary Rehabilitation. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007 May 22;115(20):2675-82. Epub 2007 May 18.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH de Firminy
Centre Médical de Chavanne
CHU de Saint-Etienne
CH de Feurs


title: Evaluation of a New Feedback Canceller Algorithm for Patient With Moderate to Severe Hearing Loss Implanted With a Fully Implantable Carina™ Medical Device

summary: The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.

lead_sponsor: Cochlear

location_facility:
Hôpital Nord
Hôpital Edouard Herriot
CHU Lyon Sud


title: Development and Evaluation of a Therapeutic Education Intervention Focused on the Accession of Patients Treated With Hormonal Therapy in the Management of Breast Cancer: PEPs Hormonotherapy

acronym: PEPs HORMONO

summary: The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.

ReferenceCitation: Golant M, Altman T, Martin C. Managing cancer side effects to improve quality of life: a cancer psychoeducation program. Cancer Nurs. 2003 Feb;26(1):37-44; quiz 45-6.

ReferenceCitation: Diefenbach MA, Butz BP. A multimedia interactive education system for prostate cancer patients: development and preliminary evaluation. J Med Internet Res. 2004 Jan 21;6(1):e3.

ReferenceCitation: Pérol D, Toutenu P, Lefranc A, Régnier V, Chvetzoff G, Saltel P, Chauvin F. [Therapeutic education in oncology: involving patient in the management of cancer]. Bull Cancer. 2007 Mar;94(3):267-74. Review. French.

ReferenceCitation: Persijn JP, Korsten CB, Engelsman E. Oestrogen and androgen receptors in breast cancer and response to endocrine therapy. Br Med J. 1975 Nov 29;4(5995):503.

ReferenceCitation: Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, Costantino J, Redmond C, Fisher ER, Bowman DM, Deschênes L, Dimitrov NV, Margolese RG, Robidoux A, Shibata H, Terz J, Paterson AH, Feldman MI, Farrar W, Evans J, Lickley HL. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996 Nov 6;88(21):1529-42.

ReferenceCitation: Rao RD, Cobleigh MA. Adjuvant endocrine therapy for breast cancer. Oncology (Williston Park). 2012 Jun;26(6):541-7, 550, 552 passim. Review.

ReferenceCitation: Lebovits AH, Strain JJ, Schleifer SJ, Tanaka JS, Bhardwaj S, Messe MR. Patient noncompliance with self-administered chemotherapy. Cancer. 1990 Jan 1;65(1):17-22.

ReferenceCitation: Love RR, Cameron L, Connell BL, Leventhal H. Symptoms associated with tamoxifen treatment in postmenopausal women. Arch Intern Med. 1991 Sep;151(9):1842-7.

ReferenceCitation: Waterhouse DM, Calzone KA, Mele C, Brenner DE. Adherence to oral tamoxifen: a comparison of patient self-report, pill counts, and microelectronic monitoring. J Clin Oncol. 1993 Jun;11(6):1189-97.

ReferenceCitation: Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002 May 1;94(9):652-61. Review.

ReferenceCitation: Horwitz RI, Horwitz SM. Adherence to treatment and health outcomes. Arch Intern Med. 1993 Aug 23;153(16):1863-8. Review.

ReferenceCitation: Banning M. Adherence to adjuvant therapy in post-menopausal breast cancer patients: a review. Eur J Cancer Care (Engl). 2012 Jan;21(1):10-9. doi: 10.1111/j.1365-2354.2011.01295.x. Epub 2011 Oct 18. Review.

ReferenceCitation: Henry NL, Azzouz F, Desta Z, Li L, Nguyen AT, Lemler S, Hayden J, Tarpinian K, Yakim E, Flockhart DA, Stearns V, Hayes DF, Storniolo AM. Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. J Clin Oncol. 2012 Mar 20;30(9):936-42. doi: 10.1200/JCO.2011.38.0261. Epub 2012 Feb 13.

ReferenceCitation: Atkins L, Fallowfield L. Intentional and non-intentional non-adherence to medication amongst breast cancer patients. Eur J Cancer. 2006 Sep;42(14):2271-6. Epub 2006 Apr 27.

ReferenceCitation: Sant M, Allemani C, Berrino F, Coleman MP, Aareleid T, Chaplain G, Coebergh JW, Colonna M, Crosignani P, Danzon A, Federico M, Gafà L, Grosclaude P, Hédelin G, Macè-Lesech J, Garcia CM, Møller H, Paci E, Raverdy N, Tretarre B, Williams EM; European Concerted Action on Survival and Care of Cancer Patients (EUROCARE) Working Group. Breast carcinoma survival in Europe and the United States. Cancer. 2004 Feb 15;100(4):715-22.

ReferenceCitation: Hohneker J, Shah-Mehta S, Brandt PS. Perspectives on adherence and persistence with oral medications for cancer treatment. J Oncol Pract. 2011 Jan;7(1):65-7. doi: 10.1200/JOP.2010.000076.

family: Hohneker

full_name: John Hohneker

given: John

family: Shah-Mehta

full_name: Shilpa Shah-Mehta

given: Shilpa

family: Brandt

full_name: Patricia S. Brandt

given: Patricia S.

journal_name: Journal of Oncology Practice

publisher: American Society of Clinical Oncology (ASCO)

title: Perspectives on Adherence and Persistence With Oral Medications for Cancer Treatment

location_facility:
Hôpital Privé de la Loire
Institut de Cancérologie de la Loire
CH Lyon Sud


acronym: SONOCAP

summary:
Background: Bracco has released the VueBoxTM-Prostate software, aimed at distinguishing prostate cancer from prostate benign peripheral zone (PZ) at contrast-enhanced ultrasound (CEUS) using SonoVue® as contrast agent.

The software analyses the ascending phase of enhancement (wash-in) and calculates the mode and the dispersion (sigma) of the wash-in rate in a given region of interest. The diagnosis of cancer is based on the combination of these two parameters.

The main objective of the study is to evaluate the diagnostic value of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal PZ at contrast-enhanced ultrasound (CEUS).

The secondary objective is to evaluate the diagnostic value of the wash-out rate, the time to peak, the transit time and the area under the enhancement curve (parameters not used by the VueBoxTM-Prostate software) in distinguishing prostate cancer from prostate benign peripheral zone at contrast-enhanced ultrasound (CEUS).

The study will enroll patients referred for prostate biopsy. The US transrectal probe will be inserted and the local anesthesia performed as per the institution's standard of care protocol. Then, the biopsy operator will choose an axial plane likely to contain cancer (e.g. based on MRI or Digital rectal examination results). Half a vial (2.4 ml) of SonoVue® will then be injected and the ultrasound enhancement of this plane will be recorded during 2 minutes while the biopsy gun is already in place. Then, the biopsy will be taken while the recording is still on, so that it will be possible to calculate quantitative enhancement parameters at the exact location of the biopsy.

Then, the operator will choose a plane that is likely not to contain cancer in the opposite prostate lobe and the same process will be repeated with injection of the second half of the vial.

The rest of the biopsies will be performed as per the institution's standard of care protocol.

The two recordings will be sent to Bracco's Research center in Geneva in order to:

Predict the biopsy result (cancer vs benign) based on the VueBoxTM-Prostate software results
Calculate the wash-out rate, the time to peak, the transit time and the area under the enhancement curve at the biopsy location.

The two biopsy samples performed after the injection of SonoVue® (as the rest of the biopsy samples) will be processed and analysed at the institution's department of Pathology and their results will be blinded to the Bracco's Research center.

The correlation between the biopsy results, the VueBoxTM-Prostate software results and the wash-out rate, time to peak, transit time and area under the enhancement curve will be performed by the study investigator.

In total, 130 patients will be included (hypotheses of 20% of malignant biopsy cores and of an area under the ROC curve of 0.85 for the VueBoxTM-Prostate software).

location_facility: CHU de Bordeaux - Hôpital Pellegrin - Service d'imagerie diagnostique et interventionnelle de l'adulte

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital Necker - Service de Radiologie adultes

location_facility: Hospices Civils de Lyon - Hopital Edouard Herriot


title: A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults

summary:
Primary objective:

To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.

Secondary objectives:

To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.

lead_sponsor: Sanofi Pasteur, a Sanofi Company