title: Epidemiology and Prognostic Impact of Social Deprivation Features in Intensive Care Unit Patients

acronym: PRECAREA

summary:
Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. The epidemiology and impact of SED on the specific population of ICU patients has been insufficiently investigated.

In this prospective multicenter study of patients admitted to 9 ICUs of the Paris area, the investigators aim to explore the epidemiology of SED features, and its impact on mortality and length of stay.

ReferenceCitation: Marmot M, Allen J, Bell R, Bloomer E, Goldblatt P; Consortium for the European Review of Social Determinants of Health and the Health Divide. WHO European review of social determinants of health and the health divide. Lancet. 2012 Sep 15;380(9846):1011-29. doi: 10.1016/S0140-6736(12)61228-8. Epub 2012 Sep 8.

ReferenceCitation: Welch CA, Harrison DA, Hutchings A, Rowan K. The association between deprivation and hospital mortality for admissions to critical care units in England. J Crit Care. 2010 Sep;25(3):382-90. doi: 10.1016/j.jcrc.2009.11.003. Epub 2010 Jan 15.

ReferenceCitation: Zager S, Mendu ML, Chang D, Bazick HS, Braun AB, Gibbons FK, Christopher KB. Neighborhood poverty rate and mortality in patients receiving critical care in the academic medical center setting. Chest. 2011 Jun;139(6):1368-1379. doi: 10.1378/chest.10-2594. Epub 2011 Mar 31.

ReferenceCitation: Latour J, Lopez V, Rodriguez M, Nolasco A, Alvarez-Dardet C. Inequalities in health in intensive care patients. J Clin Epidemiol. 1991;44(9):889-94. doi: 10.1016/0895-4356(91)90051-a.

ReferenceCitation: Bein T, Hackner K, Zou T, Schultes S, Bosch T, Schlitt HJ, Graf BM, Olden M, Leitzmann M. Socioeconomic status, severity of disease and level of family members' care in adult surgical intensive care patients: the prospective ECSSTASI study. Intensive Care Med. 2012 Apr;38(4):612-9. doi: 10.1007/s00134-012-2463-x. Epub 2012 Jan 25.

ReferenceCitation: Bige N, Hejblum G, Baudel JL, Carron A, Chevalier S, Pichereau C, Maury E, Guidet B. Homeless Patients in the ICU: An Observational Propensity-Matched Cohort Study. Crit Care Med. 2015 Jun;43(6):1246-54. doi: 10.1097/CCM.0000000000000944.

lead_sponsor: Centre Hospitalier de Saint-Denis

location_facility: Centre Hospitalier Universitaire Lariboisière

location_facility: Centre Hospitalier Universitaire Louis Mourier

location_facility: Centre Hospitalier Intercommunal André Grégoire

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire Ambroise Paré


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Centre Leon Berard

summary: First preclinical data suggest that pegfilgrastim could constitute a potent adjuvant for immunotherapy with mAb possessing ADCC/ADCP properties as trastuzumab. Combined treatment of pegfilgrastim and trastuzumab should translate into an increased rate of pathological clinical response. Therefore the investigators' proposal is to evaluate the clinical and biological impact of pegfilgrastim in combination with trastuzumab + paclitaxel in HER2-positive early stage breast cancer patients. Breastimmune02 is a multicenter, randomized, open-label, Phase II trial. Operable HER2+ breast cancer patients previously treated with 4 cycles of standard adriamycine/cyclophosphamide (AC) chemotherapy will be randomized (1:1) to receive in the neoadjuvant setting:Arm A: weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) + pegfilgrastim (Q3W) versus Arm B: weekly paclitaxel + trastuzumab (Q3W).Stratification criteria will be: cN0 versus cN1.

ReferenceType: background

ReferenceCitation: Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

ReferenceCitation: Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.

ReferenceCitation: Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF; American Society of Clinical Oncology/College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131(1):18-43. doi: 10.5858/2007-131-18-ASOCCO.

ReferenceCitation: Zhou BP, Hung MC. Dysregulation of cellular signaling by HER2/neu in breast cancer. Semin Oncol. 2003 Oct;30(5 Suppl 16):38-48. doi: 10.1053/j.seminoncol.2003.08.006.

ReferenceCitation: Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

ReferenceCitation: Untch M, Rezai M, Loibl S, Fasching PA, Huober J, Tesch H, Bauerfeind I, Hilfrich J, Eidtmann H, Gerber B, Hanusch C, Kuhn T, du Bois A, Blohmer JU, Thomssen C, Dan Costa S, Jackisch C, Kaufmann M, Mehta K, von Minckwitz G. Neoadjuvant treatment with trastuzumab in HER2-positive breast cancer: results from the GeparQuattro study. J Clin Oncol. 2010 Apr 20;28(12):2024-31. doi: 10.1200/JCO.2009.23.8451. Epub 2010 Mar 22.

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

ReferenceCitation: Gianni L, Eiermann W, Semiglazov V, Lluch A, Tjulandin S, Zambetti M, Moliterni A, Vazquez F, Byakhov MJ, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Magazzu D, Heinzmann D, Steinseifer J, Valagussa P, Baselga J. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014 May;15(6):640-7. doi: 10.1016/S1470-2045(14)70080-4. Epub 2014 Mar 20. Erratum In: Lancet Oncol. 2018 Dec;19(12):e667.

ReferenceCitation: Kute T, Stehle JR Jr, Ornelles D, Walker N, Delbono O, Vaughn JP. Understanding key assay parameters that affect measurements of trastuzumab-mediated ADCC against Her2 positive breast cancer cells. Oncoimmunology. 2012 Sep 1;1(6):810-821. doi: 10.4161/onci.20447.

ReferenceCitation: Deauvieau F, Ollion V, Doffin AC, Achard C, Fonteneau JF, Verronese E, Durand I, Ghittoni R, Marvel J, Dezutter-Dambuyant C, Walzer T, Vie H, Perrot I, Goutagny N, Caux C, Valladeau-Guilemond J. Human natural killer cells promote cross-presentation of tumor cell-derived antigens by dendritic cells. Int J Cancer. 2015 Mar 1;136(5):1085-94. doi: 10.1002/ijc.29087. Epub 2014 Aug 6.

ReferenceCitation: Hernandez-Ilizaliturri FJ, Jupudy V, Ostberg J, Oflazoglu E, Huberman A, Repasky E, Czuczman MS. Neutrophils contribute to the biological antitumor activity of rituximab in a non-Hodgkin's lymphoma severe combined immunodeficiency mouse model. Clin Cancer Res. 2003 Dec 1;9(16 Pt 1):5866-73.

ReferenceCitation: Cornet S, Mathe D, Chettab K, Evesque A, Matera EL, Tredan O, Dumontet C. Pegfilgrastim Enhances the Antitumor Effect of Therapeutic Monoclonal Antibodies. Mol Cancer Ther. 2016 Jun;15(6):1238-47. doi: 10.1158/1535-7163.MCT-15-0759. Epub 2016 Mar 17.

ReferenceCitation: Cartron G, Zhao-Yang L, Baudard M, Kanouni T, Rouille V, Quittet P, Klein B, Rossi JF. Granulocyte-macrophage colony-stimulating factor potentiates rituximab in patients with relapsed follicular lymphoma: results of a phase II study. J Clin Oncol. 2008 Jun 1;26(16):2725-31. doi: 10.1200/JCO.2007.13.7729. Epub 2008 Apr 21.

ReferenceCitation: Bossuyt V, Provenzano E, Symmans WF, Boughey JC, Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration. Ann Oncol. 2015 Jul;26(7):1280-91. doi: 10.1093/annonc/mdv161. Epub 2015 May 27.

ReferenceCitation: Lin Y, Kikuchi S, Obata Y, Yagyu K; Tokyo Research Group on Prevention of Gastric Cancer. Serum levels of transforming growth factor beta1 are significantly correlated with venous invasion in patients with gastric cancer. J Gastroenterol Hepatol. 2006 Feb;21(2):432-7. doi: 10.1111/j.1440-1746.2005.03939.x.

ReferenceCitation: Tas F, Yasasever CT, Karabulut S, Tastekin D, Duranyildiz D. Serum transforming growth factor-beta1 levels may have predictive and prognostic roles in patients with gastric cancer. Tumour Biol. 2015 Mar;36(3):2097-103. doi: 10.1007/s13277-014-2817-9. Epub 2014 Nov 13.

ReferenceCitation: Lin Y, Kikuchi S, Tamakoshi A, Obata Y, Yagyu K, Inaba Y, Kurosawa M, Kawamura T, Motohashi Y, Ishibashi T; JACC Study Group. Serum transforming growth factor-beta1 levels and pancreatic cancer risk: a nested case-control study (Japan). Cancer Causes Control. 2006 Oct;17(8):1077-82. doi: 10.1007/s10552-006-0048-0.

ReferenceCitation: Zhao J, Liang Y, Yin Q, Liu S, Wang Q, Tang Y, Cao C. Clinical and prognostic significance of serum transforming growth factor-beta1 levels in patients with pancreatic ductal adenocarcinoma. Braz J Med Biol Res. 2016 Jul 25;49(8):e5485. doi: 10.1590/1414-431X20165485.

ReferenceCitation: Tas F, Karabulut S, Yasasever CT, Duranyildiz D. Serum transforming growth factor-beta 1 (TGF-beta1) levels have diagnostic, predictive, and possible prognostic roles in patients with melanoma. Tumour Biol. 2014 Jul;35(7):7233-7. doi: 10.1007/s13277-014-1984-z. Epub 2014 Apr 27.

ReferenceCitation: Xu S, Yang S, Sun G, Huang W, Zhang Y. Transforming growth factor-beta polymorphisms and serum level in the development of osteosarcoma. DNA Cell Biol. 2014 Nov;33(11):802-6. doi: 10.1089/dna.2014.2527. Epub 2014 Aug 6.

sponsor_collaborators:
Centre Leon Berard
Amgen

location_facility: Centre de Lutte contre le Cancer Jean Perrin

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Groupe Hospitalier Mutualiste de Grenoble

status: Recruiting

title: A Multicenter, Randomized, Open-label, Phase II Trial Aiming to Evaluate the Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2 Positive Breast Cancer Patients

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

study_type: Interventional

lead_sponsor_type: academique

status_simplified: Ongoing


title: Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

acronym: ARIAPUMP

summary:
The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately

Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.

ReferenceCitation: Bellot P, Welker MW, Soriano G, von Schaewen M, Appenrodt B, Wiest R, Whittaker S, Tzonev R, Handshiev S, Verslype C, Moench C, Zeuzem S, Sauerbruch T, Guarner C, Schott E, Johnson N, Petrov A, Katzarov K, Nevens F, Zapater P, Such J. Automated low flow pump system for the treatment of refractory ascites: a multi-center safety and efficacy study. J Hepatol. 2013 May;58(5):922-7. doi: 10.1016/j.jhep.2012.12.020. Epub 2013 Jan 11.

ReferenceCitation: Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump(R) system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. Erratum In: J Hepatol. 2018 Jan 29;: J Hepatol. 2020 Mar;72(3):595-596.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: acceptedVersion

repositories_concat: UCL Discovery

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.

ReferenceCitation: Sola E, Sole C, Gines P. Management of uninfected and infected ascites in cirrhosis. Liver Int. 2016 Jan;36 Suppl 1:109-15. doi: 10.1111/liv.13015.

ReferenceCitation: Thomas MN, Sauter GH, Gerbes AL, Stangl M, Schiergens TS, Angele M, Werner J, Guba M. Automated low flow pump system for the treatment of refractory ascites: a single-center experience. Langenbecks Arch Surg. 2015 Dec;400(8):979-83. doi: 10.1007/s00423-015-1356-1. Epub 2015 Nov 13.

ReferenceCitation: Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump(R) system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.

version: submittedVersion

publisher_dissemination: Springer-Nature

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

location_facility:
Jean MINJOZ Univesity Hospital
Chu Angers
LA PITIE SALPETRIERE Univesity Hospital
Toulouse University Hospital
Grenoble University Hospital
Beaujon Hospital
Amiens-Picardie University Hospital
Haut-Lévêque Hospital
Chu Pontchaillou

intervention_type: Device

appel_a_projets: PRME

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

type_etablissement: CH

acronyme: ARIA-PUMP

titre: Evaluation médico-économique de la prise en charge de l'Ascite Réfractaire par Implantation d'un dispositif Alfapump® chez les patients cirrhotiques

discipline_principale: hépatologie

nom_porteur: Hilleret

prenom_porteur: Marie-Noelle


title: Dexmedetomidine After Cardiac Surgery for Prevention of Delirium: The Exactum Study a Randomised Double Blind Controlled Trial

acronym: EXACTUM

summary: We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gargadennec T, Oilleau JF, Rozec B, Nesseler N, Lasocki S, Futier E, Amour J, Durand M, Bougle A, Kerforne T, Consigny M, Eddi D, Huet O. Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial. BMJ Open. 2022 Apr 8;12(4):e058968. doi: 10.1136/bmjopen-2021-058968.

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 pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Direction Générale de l'Offre de Soins
Baxter Healthcare Corporation

location_facility:
CHRU de Brest
Clermont Ferrand university hospital
Angers university hospital
Hôpital Privé Jacques Cartier
CHU de Grenoble
CHU Poitiers
CHU de Rennes
CHU de Nantes
CHU la Pitié Salpétrière

status_simplified: Completed

appel_a_projets: PHRCI

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: EXACTUM

titre: Utilisation de la Dexmédétomidine pour la prévention du délirium après chirurgie cardiaque (DEXmedetomidine After Cardiac surgery for prevenTion of deliriUM)

discipline_principale: autre

nom_porteur: OILLEAU

prenom_porteur: Jean-Ferreol


title: Observational Study : Minimal Intensity of Stimulation During Ultrasound Guided Peripheral Nerve Block According to Anatomic Needle Type Position

summary: The purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade

primary_purpose: Supportive Care

ReferenceCitation: Varobieff M, Choquet O, Swisser F, Coudray A, Menace C, Molinari N, Bringuier S, Capdevila X. Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial. Anesth Analg. 2021 Feb 1;132(2):556-565. doi: 10.1213/ANE.0000000000005308.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Capdevila M, Choquet O, Saporito A, Djanikian F, Swisser F, Marques M, Bringuier S, Capdevila X. Injection pressure monitoring during peripheral nerve blocks: from bench to operating theatre. Anaesth Crit Care Pain Med. 2020 Oct;39(5):603-610. doi: 10.1016/j.accpm.2020.03.022. Epub 2020 Aug 10.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

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

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

repository_normalized: HAL

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospital of Montpellier
University Hospital of Annecy
University hospital of Bordeaux
University hospital of Nice
University Hospital of Reims
University hospital of Clermont-Ferrand
University hospital of Marseille
University Hospital of Colmar
University hospital of limoges

intervention_type: Procedure


title: Diagnostic Value of the CardioSecur Connected EcG in General Care: The Connected EGG-study.

acronym: CARDIOSECUR

summary: Heart disease symptoms are a frequent reason of consultation in general medical practice. Only a few general practitioners are equipped with a 12 lead Electrocardiography (ECG) whereas this test is extremely useful for diagnosis orientation in cases of cardiac diseases.Cardiosecur allows the realization of a 15 or 22 leads ECG with only 4 electrodes connected to a smartphone or a tablet with an automatic interpretation function. The goal of the study is to evaluate the diagnostic value of Cardiosecur device regarding cardiac symptoms in family practice.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Lille Catholic University

intervention_type: Diagnostic Test


title: Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

acronym: FASCE

summary:
Acne vulgaris of adult woman has increased over the past 10 years; it affects currently 20% to 30% of adult women.

The physiopathology of adult woman acne is distinguished from the teenager one by essentially 2 factors:

hormonal factor with a peripheral hyperandrogenism coupled with an hypersensibility of cutaneous androgens receptors of these women. But this point is still at the stage of hypothesis.
inflammatory factor linked with Propionibacterium Aces ; indeed these women received most of the time many cures of local and systematic antibiotics at the origin of resistant Propionibacterium Aces strains which lead to a chronical activation of cutaneous innate immunity.

On a therapeutic plan, four types of systemic treatment, approved in this indication are:

Tetracyclines which are problematic for the bacterial resistance and consequently constant relapse when they are stopped.
Zinc salts which target only the inflammatory lesions and were shown less effective than cycline
Antiandrogens, with acetate of cyproterone associated with risks of phlebitis and pulmonary embolism, and increase risk of triglycerides, cholesterol and hepatic balance.
The last alternative is represented by isotretinoin but the use in women of childbearing potential is binding because of the teratogen risks and the hyperandrogenism represents an identified risk of relapse.

In this context, the spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at sebaceous gland and inhibits Luteinizing hormone (LH) production at the pituitary level. It is not submitted to isotretinoin constraints, does not lead to bacterial resistance and targets the peripheral hyperandrogenism.

Currently, very few studies have been performed and on a weak number of patients but they showed that at low doses (lower than 200mg/day), spironolactone can be effective against acne.

In that context, it seemed clearly interesting to perform the first double-blind randomized study spironolactone vs cyclines which remains the moderate acne reference treatment and to demonstrate the superiority of spironolactone's efficacy in order to establish it as alternative way to cycline.

ReferenceCitation: Poinas A, Lemoigne M, Le Naour S, Nguyen JM, Schirr-Bonnans S, Riche VP, Vrignaud F, Machet L, Claudel JP, Leccia MT, Hainaut E, Beneton N, Dert C, Boisrobert A, Flet L, Chiffoleau A, Corvec S, Khammari A, Dreno B. FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial. Trials. 2020 Jun 25;21(1):571. doi: 10.1186/s13063-020-04432-w.

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

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

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

evidence: oa repository (via page says license)

repository_normalized: Research Square

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square

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

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

lead_sponsor: Nantes University Hospital

location_facility:
CH Le Mans
Chru Brest
CHU Grenoble
CH La Rochelle
CHU de Nantes - Dermatologie
CHU Poitiers
CHU Caen
Cabinet du Dr Jean-Paul Claudel
CHRU Tours

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: FASCE

titre: Etude randomisée en double aveugle de l'intérêt de la spironolactone pour le traitement de l'acné de la femme adulte

discipline_principale: dermatologie

nom_porteur: DRÉNO

prenom_porteur: Brigitte


title: ADOPT-PRESTAGE: Randomized Controlled Trial on Acceptability, Diffusion and Impact on Treatment Adherence and Persistence of the PRESTAGE Program (Program for Education and Support for Oral Cancer Treatments in the Elderly) - Randomized Controlled Study Evaluating the Impact of the Program PRESTAGE

acronym: ADOPT-PRESTAGE

summary:
As the proportion of oral anticancer treatments is continuously increasing, adherence appears as a major issue for patients' outcomes. Poor adherence affects particularly geriatric patients due among others to polypharmacy or cognitive impairment. Thus, the need for educational programs in this population has been regularly emphasized.

PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being.

ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)

location_facility: Service de Gériatrie, Centre Hospitalier de Givors

location_facility: Service d'oncologie médicale, Cnetre Léon Bérard

location_facility: Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL

location_facility: Service d'oncologie, Centre Hospitalier Annecy Genevois

location_facility: Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL

location_facility: Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole

location_facility: service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne

location_facility: Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL

intervention_type: Behavioral

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: ADOPT-PRESTAGE

titre: Etude de l'Acceptabilité, de la Diffusion et de l'impact sur l'Observance et sur la Persistance Thérapeutique du programme PRESTAGE (PRogramme d'Education et de Soutien aux Traitements oraux du cancer chez le sujet ÂGÉ) - Essai Clinique Randomisé évaluant l'impact du programme PRESTAGE

discipline_principale: cancer

nom_porteur: CASTEL-KREMER

prenom_porteur: Elisabeth


title: Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors

summary: The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.

design_allocation: Non-Randomized

lead_sponsor: Oticon Medical

location_facility: CHU Nice - Institut Universitaire de la Face et du Cou

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

intervention_type: Other

lead_sponsor_type: industriel


title: Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis

acronym: COMPO-CLOT

summary:
The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology.

The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.

ReferenceCitation: Di Meglio L, Desilles JP, Solonomenjanahary M, Labreuche J, Ollivier V, Dupont S, Deschildre C, Maacha MB, Consoli A, Lapergue B, Piotin M, Blanc R, Ho-Tin-Noe B, Mazighi M; compoCLOT study groupdagger. DNA Content in Ischemic Stroke Thrombi Can Help Identify Cardioembolic Strokes Among Strokes of Undetermined Cause. Stroke. 2020 Sep;51(9):2810-2816. doi: 10.1161/STROKEAHA.120.029134. Epub 2020 Aug 19.

evidence: open (via free pdf)

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

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

unpaywall_oa_status: bronze

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non-Alcoholic Fatty Liver Disease (NAFLD)

acronym: FibroMR

summary: The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

location_facility:
Groupe Hospitalier Bretagne Sud
CHU de Toulouse
CHD Vendée
Centre Hospitalier Bretagne Atlantique
CHU d'Angers
CH de Saint Brieuc
CHU de Rennes
CHU de Nantes
CHU de Bordeaux

nom_etablissement: CHRU RENNES

acronyme: FibroMR

titre: Combinaison de la stéatose déterminée par l'IRM à l'élastométrie impulsionnelle pour le diagnostic de la fibrose hépatique dans la NAFLD

nom_porteur: BARDOU-JACQUET

prenom_porteur: Edouard


title: Study of cardiovAscular Contrasted Phenotypes in Patients With FamIliaI hypercholesteRolemia

acronym: SAFIR

summary: The main objective of SAFIR is to identify the atherosclerotic genetic factors in these patients, which will identify new therapeutic targets for the treatment of CV and Familial Hypercholesterolemia diseases. In addition, SAFIR will allow the identification of new CV protection biomarkers, which will be useful tools for the development of a personalized medicine for the management of dyslipidemias.

primary_purpose: Other

ipd_sharing: Undecided

location_facility:
Toulouse Hospital
Le Bocage Hospital
Nantes University Hospital
Pitié-Salpêtrière Hospital
CHRU de Lille
Louis Pradel Cardiovascular Hospital
Rennes University Hospital
Saint-Antoine Hospital
La Conception Hospital

intervention_type: Genetic


title: Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association

summary:
The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage.

The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack of information justify a modality of use and tolerence evaluation of this new association, commonly used.

status: Terminated

lead_sponsor: Poitiers University Hospital

sponsor_collaborators:
Poitiers University Hospital
Chiesi Farmaceutici S.p.A.

location_facility: Centre Hospitalier Universitaire de Poitiers

intervention_type: Combination Product

status_simplified: Unknown


title: Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score

acronym: SAS

summary:
A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...

The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).

We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.

status: Unknown status

location_facility: Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE

location_facility: Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble

location_facility: Service SSRS Enfants et Adolescents, Fondation Ildys

location_facility: Service de Médecine Physique et de Réadaptation - F.Widal - APHP

location_facility: Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle

location_facility: Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP


title: Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease

acronym: APOMORPHEE

summary: The purpose of the study is to demonstrate that continuous apomorphine treatment during the night compared with placebo improves sleep quality in insomniac patient with Parkinson's disease.

ReferenceCitation: De Cock VC, Dodet P, Leu-Semenescu S, Aerts C, Castelnovo G, Abril B, Drapier S, Olivet H, Corbille AG, Leclair-Visonneau L, Sallansonnet-Froment M, Lebouteux M, Anheim M, Ruppert E, Vitello N, Eusebio A, Lambert I, Marques A, Fantini ML, Devos D, Monaca C, Benard-Serre N, Lacombe S, Vidailhet M, Arnulf I, Doulazmi M, Roze E. Safety and efficacy of subcutaneous night-time only apomorphine infusion to treat insomnia in patients with Parkinson's disease (APOMORPHEE): a multicentre, randomised, controlled, double-blind crossover study. Lancet Neurol. 2022 May;21(5):428-437. doi: 10.1016/S1474-4422(22)00085-0.

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories_concat: univOAK

lead_sponsor: Clinique Beau Soleil

location_facility:
CHU de NIMES
Clinique Beau Soleil
CHU de NANTES - HOPITAL NORD
Chu Ponchaillou
Chu Gabriel Montpied
Hôpital CIVIL
Hôpital de HAUTEPIERRE
Hôpital de la TIMONE
Centre hospitalier JACQUES LACARIN


type: Registry Identifier

title: Written Advice to Improve Compliance With Early Detection of Melanoma in First-degree Relatives: a Multicenter, Cluster-randomized Intervention Trial to Evaluate the Impact of Specific Incentives and Study Psychological Determinants of Early Melanoma Detection Behavior in First-degree Relatives

acronym: FADEMELA

summary: First-degree relatives of patients with melanoma have a greater risk of developing melanoma. Patients are advised orally to inform their first-degree relatives that they should protect their skin from UV radiation and ask for a skin examination from a general practitioner or dermatologist. The study will evaluate the effectiveness of a written sheet in addition to the usual oral counselling to increase acceptance of skin examination by the first-degree relatives. If effective, written counselling provided to the patient for relatives should be recommended and generalized.

primary_purpose: Screening

lead_sponsor: University Hospital, Tours

collaborators: Institut national de la santé et de la recherche médicale, CIC 1415, TOURS

collaborators: Institut national de la santé et de la recherche médicale, U930,TOURS

collaborators: Institut d'Enseignement à Distance,University Paris - 8

location_facility: CHU -RENNES -Service de Dermatologie-CHU Pontchaillou

location_facility: Centre Eugène Marquis -Service d'Oncologie médicale

location_facility: CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie

location_facility: University Hospital of Tours, Service de Dermatologie

location_facility: GH La Rochelle Ré Aunis-Service de Dermatologie

location_facility: CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE


title: Aspirin for Uncontrolled Asthma : a Randomized Controlled Study

acronym: ASTHMIRINE

summary:
Asthma is characterized by changes in eicosanoids metabolism, especially high production of bronchoconstrictive cysteinyl leukotrienes (CystLTBs) and leukotriene B4 (LTB4). Recent studies have also demonstrated a relative low production of lipoxin A4, an endogenous lipid mediator resulting from lipo-oxygenase action, distinct from CystLTBs, with anti-inflammatory properties, in bronchial epithelial cells and lung macrophages of severe asthma patients, leading to imbalance between pro-resolving and pro-inflammatory eicosanoids production in airways. Such data suggest that aspirin, that induces lipoxins production, could restore lipoxins deficit in severe asthma. Interest for aspirin is also supported by data obtained in asthma patients with aspirin intolerance (Aspirin induced asthma, AIA) : in this particular group of patients, aspirin treatment significantly improves nasal symptoms, quality of life, asthma and rhinitis scores, and reduces need for hospitalizations, nasal surgery and oral steroids use. Potential effect of aspirin in patients with uncontrolled asthma without aspirin intolerance, who presented changes in arachidonic acid pathway close to those observed in AIA, is not established.

The aim of the study is to assess whether long term aspirin treatment could improve asthma control, compared to placebo, in patients with uncontrolled disease and nasal polyposis, whatever their aspirin tolerance level.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de pneumologie - Nouvel Hopital Civil - CHU strasbourg

location_facility: Service de Pneumologie - La Croix Rousse

location_facility: Service de Pneumologie - Hôpital François Mitterrand - CHU Dijon

location_facility: Service de Pneumologie - Hôpital Bicêtre

location_facility: Service de pneumologie - Hôpital Charles Nicolle - CHU Rouen

location_facility: Service de pneumologie - Hôpital Calmette - CHRU Lille

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: ASTHMIRINE

titre: Intérêt d'un traitement prolongé par aspirine dans l'asthme non contrôlé

discipline_principale: pneumologie

nom_porteur: TAILLE

prenom_porteur: Camille


title: A Study to Assess Efficacy and Safety of Pioglitazone as Add-On Therapy to Imatinib Mesylate in CP-CML Patients in Major Molecular Response

acronym: ACTIM

summary:
This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e. a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European Leukemia Net recommendations) after at least 2 years of therapy with imatinib.

Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not eradicated by imatinib alone in almost any of the patients.

Treatment discontinuation in patients treated by imatinib and in complete molecular remission for more than 2 years yield molecular relapses within 6 months in half of the patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the dysregulated activity of BCR-ABL in CML.

Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical studies, we went ahead and administered pioglitazone to one patient who suffered from both diabetes type II and CML with residual disease after continuous treatment with Gleevec. The amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3 months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months post-treatment, the latest time point assessed. This striking anecdotal result now forms the rationale for filing this formal Phase II clinical trial application.

lead_sponsor: Versailles Hospital

location_facility:
CHU Purpan
Institut Bergonié
CH Versailles
CHR Annecy
IPC
CHU Poitiers
St Louis
CHU Lille
CHU archet 1


title: Pharmacokinetic Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®)

acronym: ENVARSWITCH

summary:
Tools have been developed in our unit to calculate the inter-dose AUC (Area Under Curve) of immunosuppressive drugs (ISD) based on a limited number of blood concentrations (i.e., blood samples) using Bayesian methods. Since 2005, we have implemented these tools in an expert system and made them available to the transplant community through our very successful ISBA (Immunosuppressive drugs Bayesian dose Adjustment) website.

Briefly, we first need to develop a population pharmacokinetic model using rich pharmacokinetic (PK) profiles (about 10 samples per patient over the dosing interval). The model developed can then be used for inference of ISD PK parameters in new patients using Bayesian estimation. Bayes' theorem is based on conditional probability: individual PK parameters are estimated based on the known PK parameters in the population (mean and distribution), given the dose and concentrations observed in a patient. Our previous studies have shown that a limited sampling strategy (LSS) based on 3 samples collected within the first 3 hours after drug intake can estimate adequately the interdose AUC of ISD. In the present study, the AUC0-24h and the recommended dose will be calculated using Bayesian estimators previously developed using PK data from the clinical trials run by Veloxis, and proposed to the clinicians via a dedicated website comparable with ISBA.

lead_sponsor: University Hospital, Limoges

location_facility:
University Hospital of Bordeaux
University Hospital of Lille
University Hospital of Rouen
AP-HP
University Hospital of Tours
University Hospital of Reims
Limoges Hospital
University Hospital of Poitiers
University Hospital of Amiens


title: A Prospective Open Label Phase II Study to Optimize the Dose in 3D Pulsed Dose Rate Brachytherapy in Patients With Locally Advanced Cervical Cancer

acronym: TRIDICOL

summary: This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Institut de Cancérologie de Lorraine
Institut Bergonié
Centre Léon Bérard
Centre Claudius Regaud
CHRU Tours - Hôpital Bretonneau
CHU de Besançon
Centre Georges-François Leclerc
Centre Val d'Aurelle
Centre Paul Strauss


title: Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia

acronym: Grecco

summary:
Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention.

Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.

collaborators: Assistance Publique Hopitaux De Marseille

collaborators: Centre Hospitalier Charles Perrens, Bordeaux

location_facility:
Montpellier University Hospital
Le Vinatier Hospital
Charles Perrens Hospital
Chenevier Hospital
Louis Mourier Hospital
Gabriel-Montpied Univesity Hospital
Strasbourg University Hospital
Alpes Isère Hospital
La Conception Hospital

region: Occitanie

nom_etablissement: CHU MONTPELLIER

acronyme: GReCCo

titre: Etude coût-efficacité d'un groupe de remédiation cognitive compensatoire dans la schizophrénie

discipline_principale: psychiatrie / addictologie

nom_porteur: Capdevielle

prenom_porteur: Delphine


title: Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera

acronym: RETICERA

summary: Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to reach this target depends on numerous and imbricated factors such as age, associated pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO response and Hemoglobin (Hb) level is currently the only and late tool to assess the efficacy.

location_facility:
CH Cornouaille
CH Bretagne Sud
CH Yves LE FOLL
Ch Broussais
AUB Brest
CHRU La Cavale Blanche
CHU Pontchaillou
CHRU de Poitiers
CHU Angers

intervention_type: Biological


title: Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

summary:
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data).

Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.

ReferenceCitation: Kroemer M, Turco C, Spehner L, Viot J, Idirene I, Bouard A, Renaude E, Deschamps M, Godet Y, Adotevi O, Limat S, Heyd B, Jary M, Loyon R, Borg C. Investigation of the prognostic value of CD4 T cell subsets expanded from tumor-infiltrating lymphocytes of colorectal cancer liver metastases. J Immunother Cancer. 2020 Nov;8(2):e001478. doi: 10.1136/jitc-2020-001478.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Régional Universitaire de Besançon

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

titre: Etude prospective pour la validation de biomarqueurs immunologiques chez les patients atteints de cancer du colon métastatique

nom_porteur: KIM

prenom_porteur: Stéfano


acronym: AMYDARA

summary:
This is a Phase II, single-arm, multicentre study of Daratumumab (16mg/kg IV route) in adult patients with Light-Chain (AL) Amyloidosis who are not in VGPR or better after previous treatment. A sample size of 40 patients who meet all eligibility criteria will be enrolled to receive study treatment. Patients will receive treatment until either disease progression or toxicity has occurred with a maximum planned of six 28-day cycles.

Daratumumab will be administrated every week for the first 2 cycles then. every 2 weeks from cycle 3 through cycle 6.

Patients will also receive best supportive care (BSC) to mitigate Daratumumab side-effects, and to address underlying Amyloidosis, including blood product transfusions, antimicrobials, and (as appropriate) growth factors including granulocyte colony-stimulating factors for neutropenia, erythropoietin for anaemia, and/or transfusions for thrombocytopenia

location_facility: Amyloidosis Research and Treatment Center

title: A Multicentre Open Label Phase II Study of Daratumumab in AL Amyloidosis Patients Not in VGPR or Better

location_country: Italy France

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: AmyDara

titre: Etude Multicentrique En Ouvert de Phase 2 du Daratumumab chez les patients avec une amylose AL n'ayant pas atteint au moins une très bonne réponse partielle après traitement

discipline_principale: hématologie / vigilance et thérapeutique transfusionnelles

nom_porteur: JACCARD

prenom_porteur: Arnaud


title: Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer

summary: This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.

ReferenceCitation: Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Hequet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276.

lead_sponsor: Institut Curie

location_facility:
Louis Mourier Hospital
Bichat Beaujon University Hospital
Antoine Béclère Hospital
Institut Curie - René Huguenin Hospital
André Mignot Hospital - Versailles
Victor Dupouy Hospital
Poissy Interegional Hospital Center
René Dubos Hospital
Institut Curie

appel_a_projets: PRMEK

nom_etablissement: CLCC  INSTITUT CURIE

type_etablissement: CLCC

titre: Optimisation du parcours de santé des patientes traitées pour un cancer du sein opérable

discipline_principale: breast cancer

nom_porteur: ROUZIER

prenom_porteur: Roman


title: Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1

acronym: VARDIA

summary: Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of 5 questionnaires including fear of hypoglycemia-2 questionnaire.

ReferenceCitation: Saulnier PJ, Briet C, Gand E, Chaillous L, Dubois S, Bonnet F, Leguerrier AM, Fradet G, Delcourt Crespin I, Kerlan V, Gouet D, Perlemoine C, Ducluzeau PH, Pichelin M, Wargny M, Gonder-Frederick L, Ragot S, Hadjadj S, Cariou B; VARDIA study group. No association between fear of hypoglycemia and blood glucose variability in type 1 diabetes: The cross-sectional VARDIA study. J Diabetes Complications. 2019 Aug;33(8):554-560. doi: 10.1016/j.jdiacomp.2019.05.003. Epub 2019 May 10.

repositories_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

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

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

location_facility:
La Roche sur Yon Hospital
Chu de Nantes
Chu de Rennes
CH Bretagne sud
Angers University Hospital
Poitiers University Hospital
University Hospital of Tours
Brest University Hospital
La Rochelle Hospital


type: Other Identifier

title: Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease

acronym: KETAPAL

summary: KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination.

ReferenceCitation: Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.

ReferenceCitation: Lepine JP, Gasquet I, Kovess V, Arbabzadeh-Bouchez S, Negre-Pages L, Nachbaur G, Gaudin AF. [Prevalence and comorbidity of psychiatric disorders in the French general population]. Encephale. 2005 Mar-Apr;31(2):182-94. doi: 10.1016/s0013-7006(05)82385-1. French.

ReferenceCitation: Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.

ReferenceCitation: Atassi N, Cook A, Pineda CM, Yerramilli-Rao P, Pulley D, Cudkowicz M. Depression in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2011 Mar;12(2):109-12. doi: 10.3109/17482968.2010.536839. Epub 2010 Nov 24.

ReferenceCitation: Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26.

ReferenceCitation: Araujo SM, de Bruin VM, Daher Ede F, Almeida GH, Medeiros CA, de Bruin PF. Risk factors for depressive symptoms in a large population on chronic hemodialysis. Int Urol Nephrol. 2012 Aug;44(4):1229-35. doi: 10.1007/s11255-011-0032-9. Epub 2011 Jul 22.

ReferenceCitation: Koenig HG, George LK, Peterson BL, Pieper CF. Depression in medically ill hospitalized older adults: prevalence, characteristics, and course of symptoms according to six diagnostic schemes. Am J Psychiatry. 1997 Oct;154(10):1376-83. doi: 10.1176/ajp.154.10.1376.

ReferenceCitation: Lloyd-Williams M, Friedman T, Rudd N. A survey of antidepressant prescribing in the terminally ill. Palliat Med. 1999 May;13(3):243-8. doi: 10.1191/026921699676753309.

ReferenceCitation: Goldberg RJ, Mor V. A survey of psychotropic use in terminal cancer patients. Psychosomatics. 1985 Sep;26(9):745-8, 751. doi: 10.1016/S0033-3182(85)72803-4. No abstract available.

ReferenceCitation: Rumsfeld JS, Havranek E, Masoudi FA, Peterson ED, Jones P, Tooley JF, Krumholz HM, Spertus JA; Cardiovascular Outcomes Research Consortium. Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol. 2003 Nov 19;42(10):1811-7. doi: 10.1016/j.jacc.2003.07.013.

ReferenceCitation: Cubo E, Bernard B, Leurgans S, Raman R. Cognitive and motor function in patients with Parkinson's disease with and without depression. Clin Neuropharmacol. 2000 Nov-Dec;23(6):331-4. doi: 10.1097/00002826-200011000-00006.

ReferenceCitation: Lyketsos CG, Steele C, Baker L, Galik E, Kopunek S, Steinberg M, Warren A. Major and minor depression in Alzheimer's disease: prevalence and impact. J Neuropsychiatry Clin Neurosci. 1997 Fall;9(4):556-61. doi: 10.1176/jnp.9.4.556.

ReferenceCitation: Aimonino N, Tibaldi V, Barale S, Bardelli B, Pilon S, Marchetto C, Zanocchi M, Molaschi M. Depressive symptoms and quality of life in elderly patients with exacerbation of chronic obstructive pulmonary disease or cardiac heart failure: preliminary data of a randomized controlled trial. Arch Gerontol Geriatr. 2007;44 Suppl 1:7-12. doi: 10.1016/j.archger.2007.01.002.

ReferenceCitation: Newport DJ, Nemeroff CB. Assessment and treatment of depression in the cancer patient. J Psychosom Res. 1998 Sep;45(3):215-37. doi: 10.1016/s0022-3999(98)00011-7.

ReferenceCitation: Rhondali W, Perceau E, Berthiller J, Saltel P, Trillet-Lenoir V, Tredan O, Coulon JP, Bruera E, Filbet M. Frequency of depression among oncology outpatients and association with other symptoms. Support Care Cancer. 2012 Nov;20(11):2795-802. doi: 10.1007/s00520-012-1401-3. Epub 2012 Feb 17.

ReferenceCitation: Onitilo AA, Nietert PJ, Egede LE. Effect of depression on all-cause mortality in adults with cancer and differential effects by cancer site. Gen Hosp Psychiatry. 2006 Sep-Oct;28(5):396-402. doi: 10.1016/j.genhosppsych.2006.05.006.

ReferenceCitation: Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561.

ReferenceCitation: Lloyd-Williams M, Shiels C, Taylor F, Dennis M. Depression--an independent predictor of early death in patients with advanced cancer. J Affect Disord. 2009 Feb;113(1-2):127-32. doi: 10.1016/j.jad.2008.04.002. Epub 2008 Jun 16.

ReferenceCitation: DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7. doi: 10.1001/archinte.160.14.2101.

ReferenceCitation: Blank K, Robison J, Doherty E, Prigerson H, Duffy J, Schwartz HI. Life-sustaining treatment and assisted death choices in depressed older patients. J Am Geriatr Soc. 2001 Feb;49(2):153-61. doi: 10.1046/j.1532-5415.2001.49036.x.

ReferenceCitation: Rosenfeld KE, Wenger NS, Phillips RS, Connors AF, Dawson NV, Layde P, Califf RM, Liu H, Lynn J, Oye RK. Factors associated with change in resuscitation preference of seriously ill patients. The SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Arch Intern Med. 1996 Jul 22;156(14):1558-64.

ReferenceCitation: Breitbart W, Rosenfeld B, Pessin H, Kaim M, Funesti-Esch J, Galietta M, Nelson CJ, Brescia R. Depression, hopelessness, and desire for hastened death in terminally ill patients with cancer. JAMA. 2000 Dec 13;284(22):2907-11. doi: 10.1001/jama.284.22.2907.

ReferenceCitation: Haverkate I, Onwuteaka-Philipsen BD, van Der Heide A, Kostense PJ, van Der Wal G, van Der Maas PJ. Refused and granted requests for euthanasia and assisted suicide in the Netherlands: interview study with structured questionnaire. BMJ. 2000 Oct 7;321(7265):865-6. doi: 10.1136/bmj.321.7265.865. No abstract available.

ReferenceCitation: Meier DE, Emmons CA, Litke A, Wallenstein S, Morrison RS. Characteristics of patients requesting and receiving physician-assisted death. Arch Intern Med. 2003 Jul 14;163(13):1537-42. doi: 10.1001/archinte.163.13.1537.

ReferenceCitation: Buiting HM, Gevers JK, Rietjens JA, Onwuteaka-Philipsen BD, van der Maas PJ, van der Heide A, van Delden JJ. Dutch criteria of due care for physician-assisted dying in medical practice: a physician perspective. J Med Ethics. 2008 Sep;34(9):e12. doi: 10.1136/jme.2008.024976.

ReferenceCitation: Rietjens JA, van der Maas PJ, Onwuteaka-Philipsen BD, van Delden JJ, van der Heide A. Two Decades of Research on Euthanasia from the Netherlands. What Have We Learnt and What Questions Remain? J Bioeth Inq. 2009 Sep;6(3):271-283. doi: 10.1007/s11673-009-9172-3. Epub 2009 Jul 28.

ReferenceCitation: Emanuel LL. Facing requests for physician-assisted suicide: toward a practical and principled clinical skill set. JAMA. 1998 Aug 19;280(7):643-7. doi: 10.1001/jama.280.7.643.

ReferenceCitation: Rayner L, Price A, Hotopf M, Higginson IJ. The development of evidence-based European guidelines on the management of depression in palliative cancer care. Eur J Cancer. 2011 Mar;47(5):702-12. doi: 10.1016/j.ejca.2010.11.027. Epub 2011 Jan 4.

ReferenceCitation: Rayner L, Price A, Evans A, Valsraj K, Hotopf M, Higginson IJ. Antidepressants for the treatment of depression in palliative care: systematic review and meta-analysis. Palliat Med. 2011 Jan;25(1):36-51. doi: 10.1177/0269216310380764. Epub 2010 Oct 8.

ReferenceCitation: Ujeyl M, Muller-Oerlinghausen B. [Antidepressants for treatment of depression in palliative patients : a systematic literature review]. Schmerz. 2012 Sep;26(5):523-36. doi: 10.1007/s00482-012-1221-x. German.

ReferenceCitation: Willner P, Scheel-Kruger J, Belzung C. The neurobiology of depression and antidepressant action. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 1):2331-71. doi: 10.1016/j.neubiorev.2012.12.007. Epub 2012 Dec 19.

ReferenceCitation: Mion G, Villevieille T. Ketamine pharmacology: an update (pharmacodynamics and molecular aspects, recent findings). CNS Neurosci Ther. 2013 Jun;19(6):370-80. doi: 10.1111/cns.12099. Epub 2013 Apr 10.

ReferenceCitation: Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.

ReferenceCitation: Li N, Lee B, Liu RJ, Banasr M, Dwyer JM, Iwata M, Li XY, Aghajanian G, Duman RS. mTOR-dependent synapse formation underlies the rapid antidepressant effects of NMDA antagonists. Science. 2010 Aug 20;329(5994):959-64. doi: 10.1126/science.1190287.

ReferenceCitation: Li N, Liu RJ, Dwyer JM, Banasr M, Lee B, Son H, Li XY, Aghajanian G, Duman RS. Glutamate N-methyl-D-aspartate receptor antagonists rapidly reverse behavioral and synaptic deficits caused by chronic stress exposure. Biol Psychiatry. 2011 Apr 15;69(8):754-61. doi: 10.1016/j.biopsych.2010.12.015. Epub 2011 Feb 3.

ReferenceCitation: Monteggia LM, Gideons E, Kavalali ET. The role of eukaryotic elongation factor 2 kinase in rapid antidepressant action of ketamine. Biol Psychiatry. 2013 Jun 15;73(12):1199-203. doi: 10.1016/j.biopsych.2012.09.006. Epub 2012 Oct 11.

ReferenceCitation: Beurel E, Song L, Jope RS. Inhibition of glycogen synthase kinase-3 is necessary for the rapid antidepressant effect of ketamine in mice. Mol Psychiatry. 2011 Nov;16(11):1068-70. doi: 10.1038/mp.2011.47. Epub 2011 Apr 19. No abstract available.

ReferenceCitation: Li X, Jope RS. Is glycogen synthase kinase-3 a central modulator in mood regulation? Neuropsychopharmacology. 2010 Oct;35(11):2143-54. doi: 10.1038/npp.2010.105. Epub 2010 Jul 28.

ReferenceCitation: Akinfiresoye L, Tizabi Y. Antidepressant effects of AMPA and ketamine combination: role of hippocampal BDNF, synapsin, and mTOR. Psychopharmacology (Berl). 2013 Nov;230(2):291-8. doi: 10.1007/s00213-013-3153-2. Epub 2013 Jun 4.

ReferenceCitation: Autry AE, Adachi M, Nosyreva E, Na ES, Los MF, Cheng PF, Kavalali ET, Monteggia LM. NMDA receptor blockade at rest triggers rapid behavioural antidepressant responses. Nature. 2011 Jun 15;475(7354):91-5. doi: 10.1038/nature10130.

ReferenceCitation: Koike H, Iijima M, Chaki S. Involvement of AMPA receptor in both the rapid and sustained antidepressant-like effects of ketamine in animal models of depression. Behav Brain Res. 2011 Oct 10;224(1):107-11. doi: 10.1016/j.bbr.2011.05.035. Epub 2011 Jun 6.

ReferenceCitation: Rasmussen KG, Lineberry TW, Galardy CW, Kung S, Lapid MI, Palmer BA, Ritter MJ, Schak KM, Sola CL, Hanson AJ, Frye MA. Serial infusions of low-dose ketamine for major depression. J Psychopharmacol. 2013 May;27(5):444-50. doi: 10.1177/0269881113478283. Epub 2013 Feb 20.

ReferenceCitation: Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. doi: 10.1016/j.biopsych.2009.04.029. Epub 2009 Jul 9.

ReferenceCitation: Thakurta RG, Das R, Bhattacharya AK, Saha D, Sen S, Singh OP, Bisui B. Rapid response with ketamine on suicidal cognition in resistant depression. Indian J Psychol Med. 2012 Apr;34(2):170-5. doi: 10.4103/0253-7176.101793.

ReferenceCitation: Glue P, Gulati A, Le Nedelec M, Duffull S. Dose- and exposure-response to ketamine in depression. Biol Psychiatry. 2011 Aug 15;70(4):e9-10; author reply e11-2. doi: 10.1016/j.biopsych.2010.11.031. Epub 2011 Apr 8. No abstract available.

ReferenceCitation: Loo CK, Katalinic N, Garfield JB, Sainsbury K, Hadzi-Pavlovic D, Mac-Pherson R. Neuropsychological and mood effects of ketamine in electroconvulsive therapy: a randomised controlled trial. J Affect Disord. 2012 Dec 15;142(1-3):233-40. doi: 10.1016/j.jad.2012.04.032. Epub 2012 Aug 2.

ReferenceCitation: Thakurta RG, Ray P, Kanji D, Das R, Bisui B, Singh OP. Rapid Antidepressant Response with Ketamine: Is it the Solution to Resistant Depression? Indian J Psychol Med. 2012 Jan;34(1):56-60. doi: 10.4103/0253-7176.96161.

ReferenceCitation: Murrough JW, Perez AM, Pillemer S, Stern J, Parides MK, aan het Rot M, Collins KA, Mathew SJ, Charney DS, Iosifescu DV. Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. Biol Psychiatry. 2013 Aug 15;74(4):250-6. doi: 10.1016/j.biopsych.2012.06.022. Epub 2012 Jul 27.

ReferenceCitation: Cusin C, Hilton GQ, Nierenberg AA, Fava M. Long-term maintenance with intramuscular ketamine for treatment-resistant bipolar II depression. Am J Psychiatry. 2012 Aug;169(8):868-9. doi: 10.1176/appi.ajp.2012.12020219. No abstract available.

ReferenceCitation: Paslakis G, Gilles M, Meyer-Lindenberg A, Deuschle M. Oral administration of the NMDA receptor antagonist S-ketamine as add-on therapy of depression: a case series. Pharmacopsychiatry. 2010 Jan;43(1):33-5. doi: 10.1055/s-0029-1237375. Epub 2009 Dec 11. No abstract available.

ReferenceCitation: Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.

ReferenceCitation: Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.

ipd_sharing_description: Undecided yet

lead_sponsor: University Hospital, Lille

location_facility: Groupt Hopitaux Instit Catho de Lille - Lomme

region: Hauts-de-France

nom_etablissement: CH DE  VALENCIENNES

acronyme: KetaPAL

titre: Evaluation de l'impact de l'utilisation de la kétamine dans la dépression en situation palliative

discipline_principale: soins palliatifs , depression , psychiatrie ,

nom_porteur: LEMAIRE

prenom_porteur: Antoine


acronym: LUX-Bladder 1

lead_sponsor: Boehringer Ingelheim

summary:
The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis.

The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

title: LUX-Bladder 1: Phase II Open Label Single Arm Exploratory Trial of Oral Afatinib Monotherapy Following Platinum Failure for Patients With Advanced/Metastatic Urothelial Tract Carcinoma With Genetic Alterations in ERBB Receptors.

location_country: Italy Spain France


title: STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia (SCH)

acronym: STIM'ZO

summary:
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers.

This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 144 patients with persistent symptoms in schizophrenia. Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen.

Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.

ReferenceCitation: Brunelin J, Mondino M, Haesebaert J, Attal J, Benoit M, Chupin M, Dollfus S, El-Hage W, Galvao F, Jardri R, Llorca PM, Magaud L, Plaze M, Schott-Pethelaz AM, Suaud-Chagny MF, Szekely D, Fakra E, Poulet E. Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM'Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial. Trials. 2021 Dec 28;22(1):964. doi: 10.1186/s13063-021-05928-9.

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

location_country: Monaco France

location_facility: Centre Hospitalier Le Vinatier - Service de Psychiatrie Adulte

location_facility: Hôpital de la Colombière - CHU Montpellier - Service de Psychiatrie Adulte

location_facility: CHRU de Tours - Clinique Psychiatrique Universitaire

location_facility: Centre Hospitalier Princesse Grace - Service de Psychiatrie

location_facility: Centre Esquirol - CHU de Caen - Service de Psychiatrie Adulte,

location_facility: CHU de Clermont-Ferrand - Pôle de Psychiatrie B

location_facility: Hôpital Edouard Herriot - Service d'Urgences Psychiatriques

location_facility: Centre Hospitalier Saint-Anne - Service de Psychiatrie Adultes

location_facility: Hôpital Fontan - CHRU de Lille - Pôle de Psychiatrie

location_facility: CHU de St-Etienne - Service d'Urgences Psychiatriques

acronyme: STIMZO

titre: Étude des effets de la tDCS (stimulation électrique transcranienne en courant continu) délivrée en complément d'un traitement antipsychotique chez les patients schizophrènes présentant des symptômes persistants

nom_porteur: POULET

prenom_porteur: Emmanuel


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

acronym: THERMACTIVE

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

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

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

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

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

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

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

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

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

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

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

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

publisher_dissemination: JMIR Publications

lead_sponsor: Association Francaise pour la Recherche Thermale

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


title: Comparison of the Efficacy of Standard Treatment Associated With Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus Aureus: a Randomized, Multi-centre, Controlled, 2-parallel-group, Double-blind, Superiority Trial

acronym: PhagoPied

summary: The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

location_facility: CH Intercommunal de Villeneuve-Saint-Georges

nom_etablissement: CHU NIMES

acronyme: PhagoPied

titre: Comparaison de l'efficacité du traitement standard associé à la phagothérapie versus le traitement standard plus placebo sur les plaies du pied monoinfectées par Staphylococcus aureus chez le patient diabétique: essai de supériorité entre deux groupes parallèles, randomisé, multicentrique, en double-aveugle

nom_porteur: SOTTO

prenom_porteur: Albert


title: Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts: a Multicentre, Assessor-blinded, 2-parallel-group, Randomised, Superiority Trial

acronym: G-PACTS

summary: The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.

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

repository_institution: University of Bristol - Bristol Research

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Nottingham - Repository@Nottingham

publisher_dissemination: Wiley

ReferenceCitation: Chaib LS, Lopez-Castroman J, Abbar M. Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy for the prevention of repeat suicide attempts: a randomized controlled trial. Trials. 2020 Oct 27;21(1):889. doi: 10.1186/s13063-020-04816-y.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Research Square - Research Square

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

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

location_facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

acronyme: G PACTS

titre: La thérapie cognitive-comportementale de groupe versus la thérapie de soutien individuelle pour la prévention de la récidive de tentative de suicide: étude de supériorité, multicentrique, randomisée avec les évaluateurs en aveugle

nom_porteur: ABBAR

prenom_porteur: Mocrane


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

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

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

lead_sponsor: Vexim SA

sponsor_collaborators:
Vexim SA
Statitec

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


title: Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life

summary: Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life

lead_sponsor: Société des Produits Nestlé (SPN)

location_facility: Hospices Civils de LYON - Hopital de La Croix Rousse

location_facility: Assistance Publique-Hôpitaux de Marseille, Hôpital NORD

location_facility: Assistance Publique-Hôpitaux de Marseille, Hôpital de la Conception

location_facility: Hospices Civils de LYON - Hôpital Femme Mère Enfant de Bron

location_facility: Centre Hospitalier Régional Universitaire de Lille

intervention_type: Dietary Supplement


title: DIABELOOP WP6.2 : Crossover Evaluation of Glycemic Control Provided for Three Days by the Artificial Pancreas Diabeloop Compared to Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes in Sedentary Position, Outstanding Meals and Physical Activity .

summary:
The study will be conducted in crossover trial, with two 72-hour hospitalization separated by a period Wash-out of at least one week. Each hospitalization is a period of treatment. According to randomization, patients will be provided with either Diabeloop system or the usual system.

In both treatment periods:

patients in a situation of sedentarity or physical activity, will be equipped with ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate)
meals and physical activities will be similar in both periods
the same blood glucose meter will be used throughout the duration of the study.
the capillary blood glucose will be performed : before bolus and 2 hours after a meal, before exercise, in case of hypo or hyper-glycemic episodes and when the patient and / or investigator deem it necessary.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
Centre Hospitalier Sud-Francilien
Hôpital Jean Minjoz
Centre Hospitalier Universitaire


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

acronym: HEPCICOR

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

lead_sponsor: Rennes University Hospital

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


title: Assistance Médicale à la Procréation et Risque Thrombotique

acronym: AMPERT

summary:
This study aims at evaluating clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation.

Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the incidence and risk factors for ovarian hyperstimulation syndrome in these women

lead_sponsor: University Hospital, Brest

location_facility:
SELARL Gynecologia
Medicentre- Clinique du Val d'Ouest
AP-HP - Hôpital Bichat
CHU de Strasbourg - CMCO
Clinique Mathilde
Clinique Multualiste La sagesse
Hôpital Saint Joseph
Clinique Pasteur
CHU de Nice - Hôpital de l'Archet


title: Randomized Clinical Trial to Evaluate the Efficacy of a Dolutegravir Monotherapy (Tivicay®) Versus the Maintenance of a Successful Triple Therapy Using Abacavir + Lamivudine + Dolutegravir (Triumeq®) in HIV-1- Infected Patients

acronym: MONCAY

summary:
Triple antiretroviral regimens have greatly improved the prognosis of patients living with HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have a life expectancy close or equal to that of people not infected with HIV.[1] However, this is under the condition of a "lifetime" maintenance of an undetectable plasma viral load (pVL) (<50 cp/ml). On the other hand it is well established that aging increases comorbidities among PLHIV and the burden of co-medications.[2] This also has the consequence of frequent drug-drug interactions. In this context it is important to decrease pills burden, side-effects and drug-drug interactions, while maintaining undetectability.

Currently, there is a strong interest for medical research to validate lightened regimens (i.e. bithérapies [3-7] and monothérapies [8,9], particularly in a maintenance strategy, with the primary objective of reducing burden of pills and side effects. Several monotherapy trials using a boosted protease inhibitor (PI/r) showed high level of viral suppression, even if this proportion was not always non-inferior to maintaining a triple therapy. [8,9] Fortunately, when virological failure occurred under monotherapy virologic suppression was easily restored by the addition of two NRTI. Patients who are most likely to maintain viral suppression under a reduced scheme are those that have a high nadir (> 100 CD4 / mm3), no previous AIDS event and a sustained virologic suppression (>12 months).

Monotherapy is the option that best reduces the burden of pills and the risk of side effects or drug-drug interactions. It must be considered using very powerful molecule that harbor a strong binding to its ligand in order to minimize the risk of selecting resistant mutants in the case of virologic failure. To be as simple as possible in its use, it must be a single agent administered as a single dose once a day and not boosted if possible. The molecule must have very good tolerance. Finally, to be effective in viral sanctuaries this molecule should have a good (or sufficient) diffusion to ensure effective Cmin on wild viral strains. Dolutegravir meets all these exigences.[10] In addition, our team recently presented results of a pilot study showing that the switch of a successful combined antiretroviral regimen to dolutegravir monotherapy maintained undetectable viral load (<20 cp/ml) after a median of 7 months (range 6.5-10 months).

ReferenceCitation: May MT, Gompels M, Delpech V, Porter K, Orkin C, Kegg S, Hay P, Johnson M, Palfreeman A, Gilson R, Chadwick D, Martin F, Hill T, Walsh J, Post F, Fisher M, Ainsworth J, Jose S, Leen C, Nelson M, Anderson J, Sabin C; UK Collaborative HIV Cohort (UK CHIC) Study. Impact on life expectancy of HIV-1 positive individuals of CD4+ cell count and viral load response to antiretroviral therapy. AIDS. 2014 May 15;28(8):1193-202. doi: 10.1097/QAD.0000000000000243.

ReferenceCitation: Nachega JB, Parienti JJ, Uthman OA, Gross R, Dowdy DW, Sax PE, Gallant JE, Mugavero MJ, Mills EJ, Giordano TP. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials. Clin Infect Dis. 2014 May;58(9):1297-307. doi: 10.1093/cid/ciu046. Epub 2014 Jan 22.

ReferenceCitation: Cahn P, Andrade-Villanueva J, Arribas JR, Gatell JM, Lama JR, Norton M, Patterson P, Sierra Madero J, Sued O, Figueroa MI, Rolon MJ; GARDEL Study Group. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014 Jul;14(7):572-80. doi: 10.1016/S1473-3099(14)70736-4. Epub 2014 Apr 27.

ReferenceCitation: Prazuck T, Zucman D, Avettand-Fenoel V, Ducasse E, Bornarel D, Mille C, Rouzioux C, Hocqueloux L. Long-term HIV-1 virologic control in patients on a dual NRTI regimen. HIV Clin Trials. 2013 May-Jun;14(3):120-6. doi: 10.1310/hct1403-120.

ReferenceCitation: Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.

ReferenceCitation: Calin R, Paris L, Simon A, Peytavin G, Wirden M, Schneider L, Valantin MA, Tubiana R, Agher R, Katlama C. Dual raltegravir/etravirine combination in virologically suppressed HIV-1-infected patients on antiretroviral therapy. Antivir Ther. 2012;17(8):1601-4. doi: 10.3851/IMP2344. Epub 2012 Sep 3.

ReferenceCitation: Monteiro P, Perez I, Laguno M, Martinez-Rebollar M, Gonzalez-Cordon A, Lonca M, Mallolas J, Blanco JL, Gatell JM, Martinez E. Dual therapy with etravirine plus raltegravir for virologically suppressed HIV-infected patients: a pilot study. J Antimicrob Chemother. 2014 Mar;69(3):742-8. doi: 10.1093/jac/dkt406. Epub 2013 Oct 14.

ReferenceCitation: Katlama C, Valantin MA, Algarte-Genin M, Duvivier C, Lambert-Niclot S, Girard PM, Molina JM, Hoen B, Pakianather S, Peytavin G, Marcelin AG, Flandre P. Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS. 2010 Sep 24;24(15):2365-74. doi: 10.1097/QAD.0b013e32833dec20.

ReferenceCitation: Arribas JR, Horban A, Gerstoft J, Fatkenheuer G, Nelson M, Clumeck N, Pulido F, Hill A, van Delft Y, Stark T, Moecklinghoff C. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS. 2010 Jan 16;24(2):223-30. doi: 10.1097/QAD.0b013e3283348944.

ReferenceCitation: Greig SL, Deeks ED. Abacavir/dolutegravir/lamivudine single-tablet regimen: a review of its use in HIV-1 infection. Drugs. 2015 Apr;75(5):503-14. doi: 10.1007/s40265-015-0361-6. Erratum In: Drugs. 2015 Apr;75(5):561.

ReferenceCitation: Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Seve A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fenoel V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.

publisher_dissemination: Oxford University Press

ReferenceCitation: Hocqueloux L, Raffi F, Prazuck T, Bernard L, Sunder S, Esnault JL, Rey D, Le Moal G, Roncato-Saberan M, Andre M, Billaud E, Valery A, Avettand-Fenoel V, Parienti JJ, Allavena C; MONCAY study group. Dolutegravir Monotherapy Versus Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial. Clin Infect Dis. 2019 Oct 15;69(9):1498-1505. doi: 10.1093/cid/ciy1132.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHD de VENDEE
CHU de STRASBOURG
CHR d'ORLEANS
CH de NIORT
CHU de NANCY
CH de LA ROCHELLE
CHRU de NANTES
CHRU de POITIERS
CHRU de TOURS


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

acronym: EXDRE

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

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

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

oa_host_type: publisher

evidence: open (via free article)

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

publisher_dissemination: American Society of Hematology

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Centre de Référence des Syndromes Drépanocytaires Majeurs

collaborators: Laboratoire de Physiologie de l'Exercice

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


title: A Phase 1b Open-Label, Dose Escalation Study of PRTX-100 in Adult Patients With Persistent/Chronic Immune Thrombocytopenia

summary: Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may lead to improved platelet levels where these are decreased due to immunological pathologies and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The primary objective of the study is to assess the efficacy of PRTX-100 in terms of platelet response in patients with chronic/persistent ITP.

lead_sponsor: Protalex, Inc.

location_country:
United Kingdom
France

location_facility:
Guy's and St. Thomas Hospital
CH Lyon Sud
Derriford Hospital
Mondor Hospital
UCLH
Côte de Nacre Hospital
CHU
Hammersmith Hospital
Royal London Hospital
University Hospital Southampton
CH La Timone
Canceropole
Haut-Levêque Hospital
St. Georges' Hospital
Claude Huriez Hospital
University Hospital