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

location_facility: GH La Rochelle Ré Aunis-Service de Dermatologie

location_facility: University Hospital of Tours, Service de Dermatologie

location_facility: Centre Eugène Marquis -Service d'Oncologie médicale

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

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

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


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.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Versailles Hospital

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

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


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.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Limoges

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

status_simplified: Unknown


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.

study_start_date_type: Actual

lead_sponsor: Institut de Cancérologie de Lorraine

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

intervention_type: Radiation

lead_sponsor_type: industriel


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.

status: Recruiting

design_allocation: Randomized

lead_sponsor: University Hospital, Montpellier

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

intervention_type: Other

status_simplified: Ongoing


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.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: University Hospital, Brest

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

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.

ReferenceType: derived

ReferenceCitation: Kroemer M, Turco C, Spehner L, Viot J, Idirène I, Bouard A, Renaude E, Deschamps M, Godet Y, Adotévi 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). pii: e001478. doi: 10.1136/jitc-2020-001478.

family: Kroemer

full_name: Marie Kroemer

given: Marie

sequence: first

family: Turco

full_name: Celia Turco

given: Celia

sequence: additional

family: Spehner

full_name: Laurie Spehner

given: Laurie

family: Viot

full_name: Julien Viot

given: Julien

family: Idirène

full_name: Idir Idirène

given: Idir

family: Bouard

full_name: Adeline Bouard

given: Adeline

family: Renaude

full_name: Elodie Renaude

given: Elodie

family: Deschamps

full_name: Marina Deschamps

given: Marina

family: Godet

full_name: Yann Godet

given: Yann

family: Adotévi

full_name: Olivier Adotévi

given: Olivier

family: Limat

full_name: Samuel Limat

given: Samuel

family: Heyd

full_name: Bruno Heyd

given: Bruno

family: Jary

full_name: Marine Jary

given: Marine

family: Loyon

full_name: Romain Loyon

given: Romain

family: Borg

full_name: Christophe Borg

given: Christophe

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal for ImmunoTherapy of Cancer

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)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Régional Universitaire de Besançon


location_country: Italy France

acronym: AMYDARA

location_facility: Amyloidosis Research and Treatment Center

source: euctr

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

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


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.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Héquet 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:
Institut Curie - René Huguenin Hospital
René Dubos Hospital
Poissy Interegional Hospital Center
Institut Curie
Bichat Beaujon University Hospital
André Mignot Hospital - Versailles
Louis Mourier Hospital
Victor Dupouy Hospital
Antoine Béclère Hospital


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.

family: Saulnier

full_name: Pierre Jean Saulnier

given: Pierre Jean

family: Briet

full_name: Claire Briet

given: Claire

family: Gand

full_name: Elise Gand

given: Elise

family: Chaillous

full_name: Lucy Chaillous

given: Lucy

family: Dubois

full_name: Severine Dubois

given: Severine

family: Bonnet

full_name: Fabrice Bonnet

given: Fabrice

family: Leguerrier

full_name: Anne Marie Leguerrier

given: Anne Marie

family: Fradet

full_name: Gérard Fradet

given: Gérard

family: Delcourt Crespin

full_name: Ingrid Delcourt Crespin

given: Ingrid

family: Kerlan

full_name: Veronique Kerlan

given: Veronique

family: Gouet

full_name: Didier Gouet

given: Didier

family: Perlemoine

full_name: Caroline Perlemoine

given: Caroline

family: Ducluzeau

full_name: Pierre Henri Ducluzeau

given: Pierre Henri

family: Pichelin

full_name: Matthieu Pichelin

given: Matthieu

family: Wargny

full_name: Matthieu Wargny

family: Gonder-Frederick

full_name: Linda Gonder-Frederick

given: Linda

family: Ragot

full_name: Stephanie Ragot

given: Stephanie

family: Hadjadj

full_name: Samy Hadjadj

given: Samy

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

journal_name: Journal of Diabetes and its Complications

oa_colors: green other

evidence: open (author manuscript)

version: acceptedVersion

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

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

repository_normalized: HAL

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


type: EudraCT Number

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.

ReferenceType: background

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ReferenceCitation: Lépine JP, Gasquet I, Kovess V, Arbabzadeh-Bouchez S, Nègre-Pagès L, Nachbaur G, Gaudin AF. [Prevalence and comorbidity of psychiatric disorders in the French general population]. Encephale. 2005 Mar-Apr;31(2):182-94. 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. 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.

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.

ReferenceCitation: Goldberg RJ, Mor V. A survey of psychotropic use in terminal cancer patients. Psychosomatics. 1985 Sep;26(9):745-8, 751.

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.

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.

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.

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.

ReferenceCitation: Newport DJ, Nemeroff CB. Assessment and treatment of depression in the cancer patient. J Psychosom Res. 1998 Sep;45(3):215-37. Review.

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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.

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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.

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.

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.

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. 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.

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. Review.

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. Review.

ReferenceCitation: Ujeyl M, Müller-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. Review. German.

ReferenceCitation: Willner P, Scheel-Krüger 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. Review.

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.

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. Review.

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.

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. Review.

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.

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.

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.

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, Haanpää 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. Review.

ipd_sharing: Undecided

ipd_sharing_description: Undecided yet

lead_sponsor: University Hospital, Lille

location_facility: Groupt Hopitaux Instit Catho de Lille - Lomme


lead_sponsor: Boehringer Ingelheim

location_country: Italy France Spain

acronym: LUX-Bladder 1

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.

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).


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.

primary_purpose: Supportive Care

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

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

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

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

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

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

lead_sponsor: Association Francaise pour la Recherche Thermale

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

intervention_type: Behavioral


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: CH Intercommunal de Villeneuve-Saint-Georges

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

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


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

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

intervention_type: Device


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: Nestlé

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

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

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

location_facility: Assistance Publique-Hôpitaux de Marseille, Hôpital NORD

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


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

status: Terminated

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


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-Fènoël 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-naïve subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Lawal

full_name: Adebayo Lawal

given: Adebayo

family: Pulido

full_name: Federico Pulido

given: Federico

family: Soto-Malave

full_name: Ruth Soto-Malave

given: Ruth

family: Gathe

full_name: Joseph Gathe

given: Joseph

family: Tian

full_name: Min Tian

given: Min

family: Fredrick

full_name: Linda M. Fredrick

given: Linda M.

family: Podsadecki

full_name: Thomas J. Podsadecki

given: Thomas J.

family: Nilius

full_name: Angela M. Nilius

given: Angela M.

journal_name: HIV Clinical Trials

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Examination of Noninferiority, Safety, and Tolerability of Lopinavir/ritonavir and Raltegravir Compared with Lopinavir/ritonavir and Tenofovir/ Emtricitabine in Antiretroviral-Naïve Subjects: The PROGRESS Study, 48-Week Results

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, Martínez-Rebollar M, González-Cordon A, Lonca M, Mallolas J, Blanco JL, Gatell JM, Martínez 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.

family: Katlama

full_name: Christine Katlama

given: Christine

family: Valantin

full_name: Marc A Valantin

given: Marc A

family: Algarte-Genin

full_name: Michele Algarte-Genin

given: Michele

family: Duvivier

full_name: Claudine Duvivier

given: Claudine

family: Lambert-Niclot

full_name: Sidonie Lambert-Niclot

given: Sidonie

family: Girard

full_name: Pierre M Girard

given: Pierre M

family: Molina

full_name: Jean M Molina

given: Jean M

family: Hoen

full_name: Bruno Hoen

given: Bruno

family: Pakianather

full_name: Sophie Pakianather

given: Sophie

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Arribas JR, Horban A, Gerstoft J, Fätkenheuer 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. Review. Erratum in: Drugs. 2015 Apr;75(5):561.

ReferenceCitation: Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Sève A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fènoël 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.

name: Pôle de Biopathologies, Centre Hospitalier Régional d’Orléans

name: Centre national de la recherche scientifique

name: Institut national de la santé et de la recherche médicale U1016, Institut Cochin

name: Laboratoire de Microbiologie clinique, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris France

title: 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

ReferenceCitation: Hocqueloux L, Raffi F, Prazuck T, Bernard L, Sunder S, Esnault JL, Rey D, Le Moal G, Roncato-Saberan M, André M, Billaud E, Valéry A, Avettand-Fènoël 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.

name: Service des Maladies Infectieuses et Tropicales, CHR d’Orléans–La Source, Tours

name: Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Tours

name: Service des Maladies Infectieuses, CHU Bretonneau, Tours

name: Service des Maladies Infectieuses et Tropicales, CHG de Niort

name: Service des Maladies Infectieuses, CHD de Vendée, La Roche-sur-Yon

name: Le Trait d’Union, Hôpitaux Universitaires de Strasbourg

name: Service des Maladies Infectieuses, CHU La Milétrie, Poitiers

name: Service des Maladies Infectieuses, Groupe Hospitalier de La Rochelle–Ré–Aunis, Nancy

name: Service des Maladies Infectieuses, CHRU-Brabois, Nancy

name: Département d’Informatique Médicale, CHR d’Orléans–La Source, France

name: Laboratoire de Microbiologie clinique, CHU Necker and Université Paris Descartes, Sorbonne Paris Cité

name: Unité de Biostatistique et de Recherche Clinique, CHU de Caen; EA2656 Groupe de Recherche sur l’Adaptation Microbienne (GRAM 2.0), Université Caen Normandie, Caen, France

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


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

acronym: EXDRE

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

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

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

name: Laboratoire Interuniversitaire de Biologie de la Motricité Université de Lyon, Université Jean Monnet  Saint‐Etienne France

family: Merlet

full_name: Angèle N. Merlet

given: Angèle N.

name: Unité de Myologie, Service de Physiologie Clinique et de l'Exercice Hôpital Universitaire de Saint‐Etienne  Saint‐Etienne France

family: Féasson

full_name: Léonard Féasson

given: Léonard

name: Service de Médecine Interne Hôpital Henri‐Mondor (AP‐HP), Université Paris‐Est Créteil (UPEC)  Créteil France

name: Service de Santé Publique Hôpital Henri‐Mondor (AP‐HP), Université Paris‐Est Créteil  Créteil France

family: Bartolucci

full_name: Pablo Bartolucci

given: Pablo

name: Laboratoire Interuniversitaire de Biologie de la Motricité Université Savoie Mont Blanc  Chambéry France

family: Hourdé

full_name: Christophe Hourdé

given: Christophe

name: Institute of Neuroscience Université Catholique de Louvain  Louvain‐la‐Neuve Belgium

family: Schwalm

full_name: Céline Schwalm

given: Céline

name: Service de Réhabilitation Cardiaque Hôpital Henri‐Mondor (Assistance Publique–Hôpitaux de Paris [APHP])  Créteil France

family: Gellen

full_name: Barnabas Gellen

given: Barnabas

family: Galactéros

full_name: Frédéric Galactéros

given: Frédéric

family: Deldicque

full_name: Louise Deldicque

given: Louise

family: Francaux

full_name: Marc Francaux

given: Marc

family: Messonnier

full_name: Laurent A. Messonnier

given: Laurent A.

journal_name: American Journal of Hematology

oa_host_type: publisher

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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

name: Laboratoire Interuniversitaire de Biologie de la Motricité, Université de Lyon, Université Jean Monnet, Saint-Etienne, France;

name: Laboratoire Interuniversitaire de Biologie de la Motricité, Université Savoie Mont Blanc, Chambéry, France;

name: Institut National de la Recherche Agronomique, Unité de Nutrition Humaine, Saint Genès Champanelle, France;

family: Coudy-Gandilhon

full_name: Cécile Coudy-Gandilhon

given: Cécile

family: Béchet

full_name: Daniel Béchet

given: Daniel

name: Service de Réhabilitation Cardiaque, Hôpital Henri-Mondor (Assistance Publique–Hôpitaux de Paris [APHP]), Créteil, France;

family: Rupp

full_name: Thomas Rupp

given: Thomas

name: Service de Médecine Interne, Hôpital Henri-Mondor (AP-HP), Université Paris-Est Créteil (UPEC), Créteil, France;

name: Service de Santé Publique, Hôpital Henri-Mondor (AP-HP), UPEC, Créteil, France; and

name: Unité de Myologie, Service de Physiologie Clinique et de l’Exercice, Hôpital Universitaire de Saint-Etienne, Saint-Etienne, France

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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


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


title: Phase III Randomized Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma : Standard 3D Conformational Radiotherapy Versus Intensity-modulated Radiotherapy With Simultaneous-integrated Boost Guided by Magnetic Resonance Spectroscopic Imaging

acronym: SPECTRO GLIO

summary:
This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up.

Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or surgical specimen) and who meet all eligibility criteria will be randomized in one chemoradiotherapy arm :

Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide
Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring will be regular and standardized. The main objective of this study is to improve overall survival of patients treated in experimental group (with simultaneous integrated boost).

ReferenceCitation: Laprie A, Ken S, Filleron T, Lubrano V, Vieillevigne L, Tensaouti F, Catalaa I, Boetto S, Khalifa J, Attal J, Peyraga G, Gomez-Roca C, Uro-Coste E, Noel G, Truc G, Sunyach MP, Magné N, Charissoux M, Supiot S, Bernier V, Mounier M, Poublanc M, Fabre A, Delord JP, Cohen-Jonathan Moyal E. Dose-painting multicenter phase III trial in newly diagnosed glioblastoma: the SPECTRO-GLIO trial comparing arm A standard radiochemotherapy to arm B radiochemotherapy with simultaneous integrated boost guided by MR spectroscopic imaging. BMC Cancer. 2019 Feb 21;19(1):167. doi: 10.1186/s12885-019-5317-x.

family: Laprie

full_name: Anne Laprie

given: Anne

family: Ken

full_name: Soléakhéna Ken

given: Soléakhéna

family: Filleron

full_name: Thomas Filleron

family: Lubrano

full_name: Vincent Lubrano

given: Vincent

family: Vieillevigne

full_name: Laure Vieillevigne

given: Laure

family: Tensaouti

full_name: Fatima Tensaouti

given: Fatima

family: Catalaa

full_name: Isabelle Catalaa

given: Isabelle

family: Boetto

full_name: Sergio Boetto

given: Sergio

family: Khalifa

full_name: Jonathan Khalifa

given: Jonathan

family: Attal

full_name: Justine Attal

given: Justine

family: Peyraga

full_name: Guillaume Peyraga

given: Guillaume

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Uro-Coste

full_name: Emmanuelle Uro-Coste

given: Emmanuelle

family: Noel

full_name: Georges Noel

given: Georges

family: Truc

full_name: Gilles Truc

family: Sunyach

full_name: Marie-Pierre Sunyach

given: Marie-Pierre

family: Magné

full_name: Nicolas Magné

given: Nicolas

family: Charissoux

full_name: Marie Charissoux

given: Marie

family: Supiot

full_name: Stéphane Supiot

given: Stéphane

family: Bernier

full_name: Valérie Bernier

given: Valérie

family: Mounier

full_name: Muriel Mounier

given: Muriel

family: Poublanc

full_name: Muriel Poublanc

family: Fabre

full_name: Amandine Fabre

given: Amandine

ReferenceCitation: Ken S, Deviers A, Filleron T, Catalaa I, Lotterie JA, Khalifa J, Lubrano V, Berry I, Péran P, Celsis P, Moyal EC, Laprie A. Voxel-based evidence of perfusion normalization in glioblastoma patients included in a phase I-II trial of radiotherapy/tipifarnib combination. J Neurooncol. 2015 Sep;124(3):465-73. doi: 10.1007/s11060-015-1860-8. Epub 2015 Jul 19.

title: Voxel-based evidence of perfusion normalization in glioblastoma patients included in a phase I–II trial of radiotherapy/tipifarnib combination

location_facility: Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer)

location_facility: Institut de Cancerologie Lucien Neuwirth


title: Evaluation of 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas

summary: The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

location_facility:
Maison de Haut Lévêque CHU
Hôpital Beaujon APHP
Hospices Civils de Lyon
Hôpital St-Antoine
Hôpital de Hautepierre
Hôpital C Huriez
CHU Hôpital Pontchaillou
Institut Paoli Calmettes
CHU Rangueil
CHU Nord
CHU


title: A Multidisciplinary Program for Preventing Falls "Identify, Prevent and Get up": Impact on Falls in Elderly Inpatients

acronym: IPR

summary: Falls among elderly inpatients are common, multifactorial and associated with a significant increase of complications and morbidity. According to a recent Cochrane review, the effectiveness of fall prevention program has been assessed in community-dwelling and in long stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study aims to measure the impact of a multidisciplinary prevention program on falls in elderly inpatients.

primary_purpose: Prevention

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Service de Médecine gériatrique, Centre Hospitalier Lyon-Sud

location_facility: Centre Hospitalier d'Annecy - Pôle de Gériatrie - Centre Hospitalier d'Annecy

location_facility: Hospices Civils de Lyon - Hôpital Frédérique Dugoujon

location_facility: Hospices Civils de Lyon - Hôpital Pierre Garraud

location_facility: Hospices Civils de Lyon - Service de Médecine gériatrique, Hôpital Edouard Herriot

location_facility: Hospices Civils de Lyon - Service de Gériatrie - Hôpital des Charpennes

location_facility: Centre Hospitalier Gériatrique du Mont d'Or

location_facility: Centre Hospitalier de Bourg en Bresse - Pôle filière gériatrique, Centre Hospitalier de Bourg en Bresse

location_facility: Hospices Civils de Lyon - Hôpital Antoine Charial

location_facility: Centre Hospitalier Lucien Hussel - Pôle gérontologie

location_facility: Centre Hospitalier d'Ardèche Méridionale - Service de Gériatrie, Centre Hospitalier d'Ardèche Méridionale


title: An Open Label, Non-randomized, First-in-human, Multi-centre Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Locally Administered DT01 in Combination With Radiotherapy and Concomitant Dose of Chloroquine in Patients With Local Metastatic Melanoma With Relapsed Cutaneous/Subcutaneous Tumors Including Melanoma-in-transit

acronym: DRIIM

summary:
Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation.

DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design.

The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment.

lead_sponsor: DNA Therapeutics

location_facility: Groupe Hospitalier Cochin - Hôtel Dieu-Broca


title: Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial

summary:
Aim : Effect of external biliary duct stent after hepatectomy on the occurence of postoperative biliary fistula.

Methods : French prospective multicenter randomized trial. Population study: Adult patients who underwent hepatectomy (> 2 segments) on non-cirrhotic liver.

Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a external biliary duct stent. With this hypothesis, the number of patients required to be equal to 152 per group for a total of 304 patients.

Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma, biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat biliary fistula, during of hospital stay and biliary fistula.

Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total duration of the study is 3 years and 3 months.

ReferenceType: result

ReferenceCitation: Maulat C, Regimbeau JM, Buc E, Boleslawski E, Belghiti J, Hardwigsen J, Vibert E, Delpero JR, Tournay E, Arnaud C, Suc B, Pessaux P, Muscari F. Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial. Br J Surg. 2020 Jun;107(7):824-831. doi: 10.1002/bjs.11405. Epub 2020 Jan 9.

name: Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France

family: Maulat

full_name: C Maulat

given: C

name: Department of Digestive Surgery, Amiens University Hospital, Amiens, France

name: Simplifications des Soins Patients Chirurgicaux Complexes (SSPC), Unit of Clinical Research, University of Picardie Jules Verne, Amiens, France

family: Regimbeau

full_name: J-M Regimbeau

given: J-M

name: Department of Digestive Surgery and Liver Transplantation, Hôtel Dieu, Clermont-Ferrand University Hospital, Clermont-Ferrand, France

family: Buc

full_name: E Buc

given: E

name: Department of Digestive Surgery and Liver Transplantation, Claude Huriez Hospital, Lille, France

family: Boleslawski

full_name: E Boleslawski

name: Department of Digestive Surgery and Liver Transplantation, Beaujon Hospital, Clichy, France

family: Belghiti

full_name: J Belghiti

given: J

name: Department of Digestive Surgery, La Conception University Hospital, Marseille, France

family: Hardwigsen

full_name: J Hardwigsen

name: Department of Digestive Surgery and Liver Transplantation, Centre Hépato-Biliaire, Paul Brousse Hospital, Villejuif, France

family: Vibert

full_name: E Vibert

name: Department of Digestive Surgery, Paoli Calmettes Institute, Marseille, France

family: Delpero

full_name: J-R Delpero

given: J-R

name: Department of Epidemiology and Clinical Research, Toulouse University Hospital, Toulouse, France

family: Tournay

full_name: E Tournay

family: Arnaud

full_name: C Arnaud

family: Suc

full_name: B Suc

given: B

name: Department of Digestive Surgery, Strasbourg University Hospital, IRCAD, Strasbourg, France

family: Pessaux

full_name: P Pessaux

given: P

family: Muscari

full_name: F Muscari

given: F

journal_name: British Journal of Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital Saint Antoine
Toulouse Purpan
Hôpital St Eloi
Hôpital beaujon
Hôpital Claude Huriez
hôpital Haute Pierre
Hôpital Paul Brousse
Hotel Dieu
Institut Paoli Calmettes
CHU la conception
CHU

intervention_type: Procedure


title: A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease

acronym: TAILORIX

summary: To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.

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

ReferenceCitation: Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85.

ReferenceCitation: Lémann M, Mary JY, Duclos B, Veyrac M, Dupas JL, Delchier JC, Laharie D, Moreau J, Cadiot G, Picon L, Bourreille A, Sobahni I, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial. Gastroenterology. 2006 Apr;130(4):1054-61.

ReferenceCitation: D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkühn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.

ReferenceCitation: Baert F, Moortgat L, Van Assche G, Caenepeel P, Vergauwe P, De Vos M, Stokkers P, Hommes D, Rutgeerts P, Vermeire S, D'Haens G; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn's disease. Gastroenterology. 2010 Feb;138(2):463-8; quiz e10-1. doi: 10.1053/j.gastro.2009.09.056. Epub 2009 Oct 8.

ReferenceCitation: Louis E, Vernier-Massouille G, Grimaud JC, et al. Infliximab discontinuation in Crohn's disease patients in stable remission on combined therapy with immunosuppressors: a prospective ongoing cohort study. Gastroenterology 2009, 136:A-146

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

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

family: Colombel

full_name: Jean Frédéric Colombel

given: Jean Frédéric

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Mantzaris

full_name: Gerassimos J. Mantzaris

given: Gerassimos J.

family: Kornbluth

full_name: Asher Kornbluth

given: Asher

family: Rachmilewitz

full_name: Daniel Rachmilewitz

given: Daniel

family: Lichtiger

full_name: Simon Lichtiger

given: Simon

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Diamond

full_name: Robert H. Diamond

given: Robert H.

family: Broussard

full_name: Delma L. Broussard

given: Delma L.

family: Tang

full_name: Kezhen L. Tang

given: Kezhen L.

family: van der Woude

full_name: C. Janneke van der Woude

given: C. Janneke

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease

ReferenceCitation: Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. Epub 2006 Aug 22.

ReferenceCitation: Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010 Jan;59(1):49-54. doi: 10.1136/gut.2009.183095.

ReferenceCitation: Van Moerkercke W, Ackaert C, Compernolle G, Jürgens M, Cleynen I, Van Assche G, Rutgeerts P, Gils A, Vermeire S. High infliximab trough levels are associated with mucosal healing in Crohn's disease. Gastroenterology 2010; 138 (Supp 1), S-60.

ReferenceCitation: Louis E, Collard A, Oger AF, Degroote E, Aboul Nasr El Yafi FA, Belaiche J. Behaviour of Crohn's disease according to the Vienna classification: changing pattern over the course of the disease. Gut. 2001 Dec;49(6):777-82.

ReferenceCitation: Vermeire S, van Assche G, Rutgeerts P. Review article: Altering the natural history of Crohn's disease--evidence for and against current therapies. Aliment Pharmacol Ther. 2007 Jan 1;25(1):3-12. Review.

ReferenceCitation: Schnitzler F, Fidder H, Ferrante M, Noman M, Arijs I, Van Assche G, Hoffman I, Van Steen K, Vermeire S, Rutgeerts P. Mucosal healing predicts long-term outcome of maintenance therapy with infliximab in Crohn's disease. Inflamm Bowel Dis. 2009 Sep;15(9):1295-301. doi: 10.1002/ibd.20927.

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

ReferenceCitation: Frøslie KF, Jahnsen J, Moum BA, Vatn MH; IBSEN Group. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology. 2007 Aug;133(2):412-22. Epub 2007 Jun 2.

ReferenceCitation: Rimola J, Rodriguez S, García-Bosch O, Ordás I, Ayala E, Aceituno M, Pellisé M, Ayuso C, Ricart E, Donoso L, Panés J. Magnetic resonance for assessment of disease activity and severity in ileocolonic Crohn's disease. Gut. 2009 Aug;58(8):1113-20. doi: 10.1136/gut.2008.167957. Epub 2009 Jan 9.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
CHU Bordeaux - Pessac
Chu Rennes
CHRU Lille
Chu Nancy
Hopital Saint Louis
Chu Reims
Chu Tours
Chu Amiens
Hopital Beaujon
CHU NICE
Chu Toulouse
Chu Clermont-Ferrand


title: Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study

acronym: EDUPSO

summary: The primary objective of this research protocol is to assess the effect of a structured therapeutic education program on the quality of life of patients with moderate to severe psoriasis

ReferenceCitation: Viguier M, Livideanu C, Beylot-Barry M, Richard MA, Paul C, Bachelez H, Aubin F; Groupe de Recherche sur le Psoriasis. Observational case series on a group of psoriasis patients who failed to respond to any TNF blockers. J Dermatolog Treat. 2014 Feb;25(1):75-7. doi: 10.3109/09546634.2013.806766. Epub 2013 Jun 20.

location_facility:
Archet Hospital
Saint Joseph Hospital
Unversity Hospital
Timone Hospital
University Hospital
Saint-Louis Hospital
Edouard Herriot
Haut Leveque Hospital


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

acronym: KETIS

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

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

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_normalized: University of Melbourne - Minerva Access

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

license: cc-by

license_normalized: cc-by

repository_institution: University of Nottingham - Repository@Nottingham

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

repository_institution: University of Bristol - Bristol Research

location_facility: CHRU de Tours - Clinique Psychiatrique Universitaire

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied


title: Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial

acronym: SHS-Pemphigus

summary: The bullous pemphigoid treatment is based on corticosteroids continued for several years. Pemphigus causes some patients a psychological impact and sometimes major vulnerability that can occur not only at diagnosis but also at later stages of disease progression. Our hypothesis is that these episodes of vulnerability may be under four kinds of factors that may be connected to the plurality of the history of these patients, and the resources they can mobilize throughout this experience, generating inequality in management and "work" around the disease.

lead_sponsor: University Hospital, Rouen

location_facility: Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix

location_facility: CHU de Clermont-Ferrand Hôpital d'Estaing


title: Lower Limb Ischaemic Per-conditioning in Acute Cerebral Infarction (<H6): Multicenter Randomized Study With Stratification on IV Thrombolysis and PROBE Design (Prospective Randomized Open Trial With Blinded End-Point)

acronym: RESCUE-BRAIN

summary:
Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first cause of acquired disability, and the 2nd cause of dementia and death. The only approved treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is mainly correlated to the final infarct size. The objective of neuroprotective treatments is to reduce the final size of the cerebral infarction.

The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral ischemia by reducing the final size of cerebral infarction animal models. The per-CID corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized control trial involving 250 patients within 6 first hours of myocardial infarction and candidate for primary angioplasty.

ReferenceCitation: Pico F, Lapergue B, Ferrigno M, Rosso C, Meseguer E, Chadenat ML, Bourdain F, Obadia M, Hirel C, Duong DL, Deltour S, Aegerter P, Labreuche J, Cattenoy A, Smadja D, Hosseini H, Guillon B, Wolff V, Samson Y, Cordonnier C, Amarenco P. Effect of In-Hospital Remote Ischemic Perconditioning on Brain Infarction Growth and Clinical Outcomes in Patients With Acute Ischemic Stroke: The RESCUE BRAIN Randomized Clinical Trial. JAMA Neurol. 2020 Jun 1;77(6):725-734. doi: 10.1001/jamaneurol.2020.0326.

name: Department of Neurology and Stroke Center, Versailles Mignot Hospital, Versailles, France

name: University of Versailles Saint-Quentin-en-Yvelines and Paris-Saclay University, Saint-Aubin, France

name: Laboratoire de Recherche Vasculaire Translationnelle, Inserm U1148, Paris, France

family: Pico

full_name: Fernando Pico

given: Fernando

name: Neurology and Stroke Center, Hôpital Foch, Suresnes, France

family: Lapergue

full_name: Bertrand Lapergue

given: Bertrand

name: Department of Degenerative and Vascular Cognitive Disorders, Inserm U1171, Université de Lille, Lille, France

name: Department of Neurology, Centre Hospitalier Universitaire de Lille, Lille, France

family: Ferrigno

full_name: Marc Ferrigno

given: Marc

name: Assistance Publique-Hopitaux de Paris, Service des Urgences Cerebro-Vasculaires, Hôpital Pitié-Salpêtrière, Paris, France

name: Centre National de la Recherche Scientifique, Inserm U1127, Unite Mixte de Recherche 7225, Institut du Cerveau et de la Moelle Epiniere, Sorbonne Universite, Paris, France

family: Rosso

full_name: Charlotte Rosso

given: Charlotte

name: Assistance Publique-Hôpitaux de Paris, Department of Neurology and Stroke Center, Bichat University Hospital, Universite Paris Diderot, Sorbonne Cite, Paris, France

family: Meseguer

full_name: Elena Meseguer

given: Elena

family: Chadenat

full_name: Marie-Laure Chadenat

given: Marie-Laure

family: Bourdain

full_name: Frederic Bourdain

given: Frederic

name: Neurology and Stroke Center, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France

family: Obadia

full_name: Michael Obadia

given: Michael

family: Hirel

full_name: Catherine Hirel

given: Catherine

family: Duong

full_name: Duc Long Duong

given: Duc Long

family: Deltour

full_name: Sandrine Deltour

given: Sandrine

name: Assistance Publique-Hôpitaux de Paris, Vieillissement et Maladies Chroniques, IndianaSERM, Unité Mixte de Recherche 1168, Universite de Versailles Saint-Quentin-en-Yvelines, Versailles, France

name: Department of Biostatistics, Université de Lille, Lille, France

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

name: Unité de Recherche EA 2694–Sante Publique: Epidemiologie et Qualite des Soins, Centre Hospitalier Universitaire de Lille, Lille, France

family: Labreuche

full_name: Julien Labreuche

given: Julien

name: Délégation à la Recherche Clinique, Versailles Mignot Hospital, Versailles, France

family: Cattenoy

full_name: Amina Cattenoy

given: Amina

name: Stroke Unit, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

family: Smadja

full_name: Didier Smadja

given: Didier

name: Assistance Publique-Hopitaux de Paris, Stroke Center, Henri Mondor Hospital, Université Paris-Est Créteil, Creteil, France

family: Hosseini

full_name: Hassan Hosseini

given: Hassan

name: Department of Neurology, University Hospital of Nantes, Nantes, France

family: Guillon

full_name: Benoit Guillon

given: Benoit

name: Stroke Unit, Strasbourg University Hospital, Strasbourg, France

family: Wolff

full_name: Valérie Wolff

given: Valérie

family: Samson

full_name: Yves Samson

given: Yves

family: Cordonnier

full_name: Charlotte Cordonnier

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

journal_name: JAMA Neurology

ReferenceCitation: Pico F, Rosso C, Meseguer E, Chadenat ML, Cattenoy A, Aegerter P, Deltour S, Yeung J, Hosseini H, Lambert Y, Smadja D, Samson Y, Amarenco P. A multicenter, randomized trial on neuroprotection with remote ischemic per-conditioning during acute ischemic stroke: the REmote iSchemic Conditioning in acUtE BRAin INfarction study protocol. Int J Stroke. 2016 Oct;11(8):938-943. doi: 10.1177/1747493016660098. Epub 2016 Jul 19.

name: Neurology Department and Stroke Centre, Centre Hospitalier de Versailles, Le Chesnay, France

name: Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France

name: INSERM LVTS (Laboratory for Vascular Translational Science)-1148, Paris, France

name: AP-HP, Urgences Cerebro-Vasculaires, Pitié-Salpêtrière Hospital, Paris, France

name: UPMC, Univ Paris 06, Centre de Recherche de l’Institut du Cerveau et de la Moëlle épinière, Paris, France

name: Department of Neurology and Stroke Centre, AP-HP Bichat University Hospital, Paris-Diderot University and Medical School, Paris, France

name: Versailles Délégation à la Recherche Clinique (DRCI), Mignot Hospital, Le Chesnay, France

name: Department Santé Publique et Unité de Recherche Clinique, AP-HP, Hôpital A Paré, Boulogne, France

name: Stroke Center Mondor Hospital and School of Medicine, Créteil, France

name: SAMU 78, Centre Hospitalier de Versailles, Le Chesnay, France

name: Stroke Center Sud Francilien Hospital, Evry, France


title: A Phase III b, Multicenter Study of the Efficacy and Safety of Aflibercept Switch in Patients With Exudative AMD With Detachment of the Retinal Pigment Epithelium and Previously Treated With Ranibizumab Intravitreal Injection. (ARI2)

summary:
The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis.

The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.

ReferenceCitation: Mouallem-Beziere A, Blanco-Garavito R, Richard F, Miere A, Jung C, Rozet JM, Souied EH. GENETICS OF LARGE PIGMENT EPITHELIAL DETACHMENTS IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Apr;40(4):663-671. doi: 10.1097/IAE.0000000000002454.

family: Mouallem-Beziere

full_name: Alexandra Mouallem-Beziere

given: Alexandra

family: Blanco-Garavito

full_name: Rocio Blanco-Garavito

given: Rocio

family: Richard

full_name: Florence Richard

given: Florence

family: Miere

full_name: Alexandra Miere

family: Jung

full_name: Camille Jung

given: Camille

family: Rozet

full_name: Jean-Michel Rozet

given: Jean-Michel

family: Souied

full_name: Eric H. Souied

given: Eric H.

journal_name: Retina

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre d'explorations ophtalmologiques de l'odéon

location_facility: Centre Hospitalier Intercommunal de Créteil


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

acronym: FC-Rev

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

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

family: Roger

full_name: Claire Roger

given: Claire

family: Zieleskiewicz

full_name: Laurent Zieleskiewicz

given: Laurent

family: Demattei

full_name: Christophe Demattei

given: Christophe

family: Lakhal

full_name: Karim Lakhal

given: Karim

family: Piton

full_name: Gael Piton

given: Gael

family: Louart

full_name: Benjamin Louart

given: Benjamin

family: Constantin

full_name: Jean-Michel Constantin

family: Chabanne

full_name: Russell Chabanne

given: Russell

family: Faure

full_name: Jean-Sébastien Faure

given: Jean-Sébastien

family: Mahjoub

full_name: Yazine Mahjoub

given: Yazine

family: Desmeulles

full_name: Isabelle Desmeulles

given: Isabelle

family: Quintard

full_name: Hervé Quintard

given: Hervé

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Muller

full_name: Laurent Muller

currency_apc_doaj: GBP

journal_name: Critical Care

repository_institution: PubMed Central - Europe PMC

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

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

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

location_facility: CHU de Nantes - Hôpital Guillaume et René Laennec


lead_sponsor: InnaVirVax

location_country: Germany France Spain

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

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

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


title: Prognostic Interest of Leucocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry During the Acute Phase of Sepsis

summary: Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if they are considered separately. The extensive experimental data which have been published contrast with the hematological data collected by the physician at patient's bedside especially regarding neutrophils and platelets levels. When there is no obvious clinical sign, a biological tool reflecting the patient's immune status could be useful to understand the physiopathology of Sepsis and to predict the progression of the disease in the patient. On the long-term it could also help to define management strategies.

ReferenceCitation: Daix T, Guerin E, Tavernier E, Mercier E, Gissot V, Hérault O, Mira JP, Dumas F, Chapuis N, Guitton C, Béné MC, Quenot JP, Tissier C, Guy J, Piton G, Roggy A, Muller G, Legac É, de Prost N, Khellaf M, Wagner-Ballon O, Coudroy R, Dindinaud E, Uhel F, Roussel M, Lafon T, Jeannet R, Vargas F, Fleureau C, Roux M, Allou K, Vignon P, Feuillard J, François B; Septiflux Trial Group. Multicentric Standardized Flow Cytometry Routine Assessment of Patients With Sepsis to Predict Clinical Worsening. Chest. 2018 Sep;154(3):617-627. doi: 10.1016/j.chest.2018.03.058. Epub 2018 Apr 26.

family: Daix

full_name: Thomas Daix

given: Thomas

family: Guerin

full_name: Estelle Guerin

given: Estelle

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Gissot

full_name: Valérie Gissot

given: Valérie

family: Hérault

full_name: Olivier Hérault

given: Olivier

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Dumas

full_name: Florence Dumas

family: Chapuis

full_name: Nicolas Chapuis

given: Nicolas

family: Guitton

full_name: Christophe Guitton

family: Béné

full_name: Marie C. Béné

given: Marie C.

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Tissier

full_name: Cindy Tissier

given: Cindy

family: Guy

full_name: Julien Guy

given: Julien

full_name: Gaël Piton

given: Gaël

family: Roggy

full_name: Anne Roggy

given: Anne

full_name: Grégoire Muller

given: Grégoire

family: Legac

full_name: Éric Legac

given: Éric

family: de Prost

full_name: Nicolas de Prost

family: Khellaf

full_name: Mehdi Khellaf

given: Mehdi

family: Wagner-Ballon

full_name: Orianne Wagner-Ballon

given: Orianne

family: Coudroy

full_name: Rémi Coudroy

given: Rémi

family: Dindinaud

full_name: Elodie Dindinaud

given: Elodie

family: Uhel

full_name: Fabrice Uhel

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

location_facility: CHU Dijon - Service Réanimation Médicale

location_facility: CHU Limoges - Service de réanimation polyvalente

location_facility: CHU Orléans - Service de Réanimation Médicale

location_facility: CHU Bordeaux - Service Réanimation Médicale


title: Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)

acronym: ASAP

summary: The primary objective of the study is to compare the brain amyloid load in fully, partially and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using PET with [F18]AV45.

lead_sponsor: University Hospital, Tours

location_facility: University Hospital of Toulouse - Purpan

location_facility: University Hospital of Besançon- Jean Minjoz