title: Determination of Biomarkers for the Prediction of Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia

acronym: CortiCORONA

summary:
The primary objective of this study is to demonstrate (at the time of admission) biomarkers of interest (Human Plasma BAK125 panel + interferon panel) for dexamethasone responders versus non-responders in SARS-CoV-2 hypoxemic pneumonia.

The secondary objectives are to describe and compare between groups:

The number of days without mechanical ventilation
The need for mechanical ventilation
28-day mortality
Progression towards acute respiratory distress syndrome (ARDS)
Change in the qSOFA score
Length of hospitalization
The change in the extent of lesions on thoracic computed tomography scan between inclusion and D7 (or the day of discharge from hospital if <D7)
Change in biomarkers on D0, D2, D4, D7 (NFS, liver tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
Demonstrate other biomarkers of interest from the usual management (NFS, liver function tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
Change in biomarkers evaluated by mass spectrometry (on a blood sample) on D0 and D7 +/- 2 days
The initial viral load (within 48 hours preceding D0) and at D7 of inclusion estimated from the nasopharyngeal SARS-CoV-2 RT-PCR
Initial SARS-CoV-2 serology and on D7 from inclusion
The A38G polymorphism of the gene coding for Club Cell Secretory Protein (CCSP) for each patient
Short-term complications related to corticosteroid therapy
The quantitative and qualitative impact of corticosteroid therapy on lymphocytes from patients with COVID-19.

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

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel).

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospitals of Montpellier
Clinique du Parc


title: Predictive Score for Non-traumatic Secondary Headache After an Emergency Call

acronym: CEPHAREG

summary: The study objective was to identify predictive criteria of severe non-traumatic secondary headache among the information gathered during telephone interview conducted by the on-call regulating physician at the Centre15.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482. Review. Erratum in: Headache. 2015 Feb;55(2):356.

ReferenceCitation: Goldstein JN, Camargo CA Jr, Pelletier AJ, Edlow JA. Headache in United States emergency departments: demographics, work-up and frequency of pathological diagnoses. Cephalalgia. 2006 Jun;26(6):684-90.

ReferenceCitation: Valade D. The Emergency Headache Center at the Lariboisière Hospital: 7 years with more than 70,000 patients. Intern Emerg Med. 2008 Oct;3 Suppl 1:S3-7. doi: 10.1007/s11739-008-0191-6.

ReferenceCitation: Perry JJ, Sivilotti MLA, Sutherland J, Hohl CM, Émond M, Calder LA, Vaillancourt C, Thirganasambandamoorthy V, Lesiuk H, Wells GA, Stiell IG. Validation of the Ottawa Subarachnoid Hemorrhage Rule in patients with acute headache. CMAJ. 2017 Nov 13;189(45):E1379-E1385. doi: 10.1503/cmaj.170072. Erratum in: CMAJ. 2018 Feb 12;190(6):E173.

ReferenceCitation: Perry JJ, Stiell IG, Sivilotti ML, Bullard MJ, Hohl CM, Sutherland J, Émond M, Worster A, Lee JS, Mackey D, Pauls M, Lesiuk H, Symington C, Wells GA. Clinical decision rules to rule out subarachnoid hemorrhage for acute headache. JAMA. 2013 Sep 25;310(12):1248-55. doi: 10.1001/jama.2013.278018.

ReferenceCitation: Pari E, Rinaldi F, Gipponi S, Venturelli E, Liberini P, Rao R, Padovani A. Management of headache disorders in the Emergency Department setting. Neurol Sci. 2015 Jul;36(7):1153-60. doi: 10.1007/s10072-015-2148-7. Epub 2015 Mar 10. Erratum in: Neurol Sci. 2015 Jul;36(7):1161.

ReferenceCitation: Chey WY, Kusakcioglu O, Dinoso V, Lorber SH. Gastric secretion in patients with chronic pancreatitis and in chronic alcoholics. Arch Intern Med. 1968 Nov;122(5):399-403.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Regional Hospital center of Orleans
CHRU de Tours

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)

acronym: SAPL-LUPUS

summary: The purpose of that register is to collect medical information about patients suffering of APS with or without associated SLE.

time_perspective: Other

ReferenceType: derived

ReferenceCitation: Morel N, Bonnet C, Mehawej H, Le Guern V, Pérard L, Roumier M, Brezin A, Godeau B, Haroche J, Benhamou Y, Lambert M, Yelnik CM, Maillard N, Bodaghi B, Piette JC, Costedoat-Chalumeau N. CATASTROPHIC ANTIPHOSPHOLIPID SYNDROME AND POSTERIOR OCULAR INVOLVEMENT: Case Series of 11 Patients and Literature Review. Retina. 2021 Nov 1;41(11):2332-2341. doi: 10.1097/IAE.0000000000003185.

family: Morel

full_name: Nathalie Morel

given: Nathalie

sequence: first

family: Bonnet

full_name: Clémence Bonnet

given: Clémence

sequence: additional

family: Mehawej

full_name: Hanane Mehawej

given: Hanane

family: Le Guern

full_name: Véronique Le Guern

given: Véronique

family: Pérard

full_name: Laurent Pérard

given: Laurent

family: Roumier

full_name: Mathilde Roumier

given: Mathilde

family: Brezin

full_name: Antoine Brezin

given: Antoine

family: Godeau

full_name: Bertrand Godeau

given: Bertrand

family: Haroche

full_name: Julien Haroche

given: Julien

family: Benhamou

full_name: Ygal Benhamou

given: Ygal

family: Lambert

full_name: Marc Lambert

given: Marc

family: Yelnik

full_name: Cécile M Yelnik

given: Cécile M

family: Maillard

full_name: Nicolas Maillard

given: Nicolas

family: Bodaghi

full_name: Bahram Bodaghi

given: Bahram

family: Piette

full_name: Jean-Charles Piette

given: Jean-Charles

family: Costedoat-Chalumeau

full_name: Nathalie Costedoat-Chalumeau

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Retina

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Catastrophic antiphospholipid syndrome and posterior ocular involvement

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Claude Huriez
Hôpital Cochin


type: Registry Identifier

title: Efficacy of Therapeutic Management of Periodontitis on the Clinical Manifestations of Rheumatoid Arthritis: the Randomized, Controlled ESPERA Trial.

acronym: ESPERA

summary:
Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for example).

Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing a complex pluridisciplinary treatment approach. Recent studies have reported an increased prevalence of RA patients with periodontal disease. Others studies show that periodontal treatment induces a significant decrease of the sedimentation rate and of the DAS28. Periodontitis is suspected to be an independent, aggravating factor in patients with RA (given the definition from NIH : an aggravating factor is something that makes a condition worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is hypothesised that treating periodontitis in RA patients showing signs of periodontitis could result in improvement in RA disease activity. To date the role of periodontitis as an aggravating factor in these patients remains unclear, and only RCT designs can reasonably be used to test this causal hypothesis. There still remains some RA patients who have persistent symptoms and frequent exacerbations despite specialist care and continuous treatment, so results of treating aggravating factors are needed. As the majority of patients will benefit from a systematic evaluation and treatment of aggravating factors, the periodontal treatment strategy need to be tested.

The aim of this randomised controlled trial is to assess the effectiveness of periodontal treatment for rheumatoid arthritis patients.

To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

location_facility: Pôle Odontologie Hôpital Purpan - Pavillon Rayer

intervention_type: Procedure

status_simplified: Completed


type: EudraCT Number

title: A Dose Escalation Phase I Study With an Extension Part Evaluating the Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With a Small Molecule CSF-1R Tyrosine Kinase Inhibitor (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers

acronym: MEDIPLEX

summary: Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have limited efficacy as single agents in both of these tumor types. Recent preclinical studies point towards alternatively activated (M2-type) macrophages as possible culprits in inducing local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents. We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages, thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1 blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose escalation study in order to evaluate the safety and clinical activity of a combined treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical activity of the combination at the RP2D.

lead_sponsor: Centre Leon Berard

location_facility:
IUCT-oncopole
Centre Léon Bérard

intervention_type: Drug


title: Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study

acronym: RECONISE

summary: Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

location_facility:
CHU Toulouse
Hôpital Pellegrin

intervention_type: Radiation


title: Assessment of Netosis During COVID-19, Under Treatment With Anakinra, an Interleukin-1 Receptor Antagonist

summary:
During their activation in response to an infectious stimulus or during chronic inflammatory processes, blood and tissue neutrophils modify their functional phenotype and produce numerous toxic mediators. In particular, they rapidly release chromatin filaments covered with numerous granular and cytoplasmic components called "Neutrophil Extracellular Traps" (NETs). This phenomenon, called netosis, has been implicated in many diseases, in particular in viral infections during which this response can be useful for the anti-infectious response at the initial phase, then deleterious when it becomes toxic. for the tissue environment. This has been shown in particular during post-pneumonia acute respiratory distress syndrome.

The intensity of netosis is therefore an early factor in activating neutrophils and inflammation. Given the major biological signs of inflammation observed in patients with COVID-19 as soon as they enter the hospital [C-Reactive protein (CRP), Interleukin-6 (IL-6), D-dimers, etc.), it seems particularly interesting to better document this inflammation.

status: Active, not recruiting

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Twaddell SH, Baines KJ, Grainge C, Gibson PG. The Emerging Role of Neutrophil Extracellular Traps in Respiratory Disease. Chest. 2019 Oct;156(4):774-782. doi: 10.1016/j.chest.2019.06.012. Epub 2019 Jun 29. Review.

family: Twaddell

full_name: Scott H. Twaddell

given: Scott H.

family: Baines

full_name: Katherine J. Baines

given: Katherine J.

family: Grainge

full_name: Christopher Grainge

given: Christopher

family: Gibson

full_name: Peter G. Gibson

given: Peter G.

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Granger V, Peyneau M, Chollet-Martin S, de Chaisemartin L. Neutrophil Extracellular Traps in Autoimmunity and Allergy: Immune Complexes at Work. Front Immunol. 2019 Dec 3;10:2824. doi: 10.3389/fimmu.2019.02824. eCollection 2019. Review.

family: Granger

full_name: Vanessa Granger

given: Vanessa

family: Peyneau

full_name: Marine Peyneau

given: Marine

family: Chollet-Martin

full_name: Sylvie Chollet-Martin

given: Sylvie

family: de Chaisemartin

full_name: Luc de Chaisemartin

given: Luc

currency_apc_doaj: USD

journal_name: Frontiers in Immunology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Bendib I, de Chaisemartin L, Granger V, Schlemmer F, Maitre B, Hüe S, Surenaud M, Beldi-Ferchiou A, Carteaux G, Razazi K, Chollet-Martin S, Mekontso Dessap A, de Prost N. Neutrophil Extracellular Traps Are Elevated in Patients with Pneumonia-related Acute Respiratory Distress Syndrome. Anesthesiology. 2019 Apr;130(4):581-591. doi: 10.1097/ALN.0000000000002619.

name: From the Medical Intensive Care Unit, DHU A-TVB, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil Cedex 94010, France (I.B., G.C., K.R., A.M.D., N.d.P.); Groupe de Recherche Clinique CARMAS, Faculté de Médecine de Créteil, Université Paris Est Créteil, Créteil Cedex 94010, France (I.B., G.C., K.R., A.M.D., N.d.P.); Immunology Laboratory « Autoimmunité et Hypers

family: Bendib

full_name: Inès Bendib

given: Inès

family: Schlemmer

full_name: Frédéric Schlemmer

given: Frédéric

family: Maitre

full_name: Bernard Maitre

given: Bernard

family: Hüe

ReferenceCitation: Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.

publisher: American Society for Clinical Investigation

ReferenceCitation: Ruan Q, Yang K, Wang W, Jiang L, Song J. Correction to: Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Jun;46(6):1294-1297. doi: 10.1007/s00134-020-06028-z.

ReferenceCitation: Sarzi-Puttini P, Giorgi V, Sirotti S, Marotto D, Ardizzone S, Rizzardini G, Antinori S, Galli M. COVID-19, cytokines and immunosuppression: what can we learn from severe acute respiratory syndrome? Clin Exp Rheumatol. 2020 Mar-Apr;38(2):337-342. Epub 2020 Mar 22. Review.

ReferenceCitation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16.

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Kupferschmidt K, Cohen J. Race to find COVID-19 treatments accelerates. Science. 2020 Mar 27;367(6485):1412-1413. doi: 10.1126/science.367.6485.1412.

publisher: American Association for the Advancement of Science (AAAS)

ReferenceCitation: Mahase E. Covid-19: what treatments are being investigated? BMJ. 2020 Mar 26;368:m1252. doi: 10.1136/bmj.m1252.

ReferenceCitation: Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov. 2020 Mar;19(3):149-150. doi: 10.1038/d41573-020-00016-0.

location_facility:
CHU Bichat Claude Bernard
Groupe Hospitalier Paris Saint-Joseph


title: French National Observatory of Patients With Thymic Epithelial Tumor

acronym: RYTHMIC

summary: RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the objective of territorial coverage by regional expert centers and systematic discussion of patients management at national tumor board.

ReferenceCitation: Chalabreysse L, Thomas De Montpreville V, De Muret A, Hofman V, Lantuejoul S, Parrens M, Payan MJ, Rouquette I, Secq V, Girard N, Marx A, Besse B, Molina TJ. [Rythmic-pathology: the French national pathology network for thymic epithelial tumours]. Ann Pathol. 2014 Feb;34(1):87-91. doi: 10.1016/j.annpat.2014.01.010. Epub 2014 Feb 21. French.

ReferenceCitation: Hadoux J, Girard N, Besse B. [Thymic epithelial neoplasms: updates on diagnosis, staging, biology and management in France]. Bull Cancer. 2012 Nov;99(11):1045-55. doi: 10.1684/bdc.2012.1659. Review. French.

ReferenceCitation: Thomas de Montpréville V, Quilhot P, Chalabreysse L, De Muret A, Hofman V, Lantuéjoul S, Parrens M, Payan MJ, Rouquette I, Secq V, Girard N, Besse B, Marx A, Molina TJ. Glut-1 intensity and pattern of expression in thymic epithelial tumors are predictive of WHO subtypes. Pathol Res Pract. 2015 Dec;211(12):996-1002. doi: 10.1016/j.prp.2015.10.005. Epub 2015 Oct 19.

ReferenceCitation: Remon J, Girard N, Mazieres J, Dansin E, Pichon E, Greillier L, Dubos C, Lindsay CR, Besse B. Sunitinib in patients with advanced thymic malignancies: Cohort from the French RYTHMIC network. Lung Cancer. 2016 Jul;97:99-104. doi: 10.1016/j.lungcan.2016.04.024. Epub 2016 May 3. Erratum in: Lung Cancer. 2016 Nov;101:146.

ReferenceCitation: Merveilleux du Vignaux C, Dansin E, Mhanna L, Greillier L, Pichon E, Kerjouan M, Clément-Duchêne C, Mennecier B, Westeel V, Robert M, Quantin X, Zalcman G, Thiberville L, Lena H, Molina T, Calcagno F, Fournel P, Mazières J, Besse B, Girard N. Systemic Therapy in Advanced Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort. J Thorac Oncol. 2018 Nov;13(11):1762-1770. doi: 10.1016/j.jtho.2018.08.005. Epub 2018 Aug 21.

ReferenceCitation: Basse C, Thureau S, Bota S, Dansin E, Thomas PA, Pichon E, Lena H, Massabeau C, Clément-Duchene C, Massard G, Westeel V, Quantin X, Oulkhouir Y, Danhier S, Lerouge D, Tanguy R, Thillays F, Le Pechoux C, Dubray B, Thiberville L, Besse B, Girard N. Multidisciplinary Tumor Board Decision Making for Postoperative Radiotherapy in Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort. J Thorac Oncol. 2017 Nov;12(11):1715-1722. doi: 10.1016/j.jtho.2017.07.023. Epub 2017 Jul 31.

ReferenceCitation: Drevet G, Collaud S, Tronc F, Girard N, Maury JM. Optimal management of thymic malignancies: current perspectives. Cancer Manag Res. 2019 Jul 22;11:6803-6814. doi: 10.2147/CMAR.S171683. eCollection 2019.

ReferenceCitation: Remon J, Girard N, Mazieres J, Dansin E, Pichon E, Greillier L, Dubos C, Lindsay CR, Besse B. Erratum to "Sunitinib in patients with advanced thymic malignancies: cohort from the French RYTHMIC network" [Lung Cancer, 97 (July 2016), 99-104]. Lung Cancer. 2016 Nov;101:146. doi: 10.1016/j.lungcan.2016.09.014. Epub 2016 Oct 6.

ReferenceCitation: Rouquette I, Taranchon-Clermont E, Gilhodes J, Bluthgen MV, Perallon R, Chalabreysse L, De Muret A, Hofman V, Marx A, Parrens M, Secq V, Thomas de Montpreville V, Galateau-Salle F, Brousset P, Milia J, Girard N, Besse B, Molina TJ, Mazières J. Immune biomarkers in thymic epithelial tumors: expression patterns, prognostic value and comparison of diagnostic tests for PD-L1. Biomark Res. 2019 Dec 4;7:28. doi: 10.1186/s40364-019-0177-8. eCollection 2019.

ReferenceCitation: Girard N, Merveilleux Du Vignaux C, Molina T, Besse B, Rythmic R. [Thymic tumors]. Rev Prat. 2017 Apr;67(4):430-434. French.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Villejuif - Institut Gustave Roussy
Paris - Institut Curie

lead_sponsor_type: industriel


type: Other Identifier

title: IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

acronym: ActiMon

summary: The primary objective of this study is to search for, in vitro, elements associated with IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant and pro-inflammatory factors) and to describe their prevalence in female patients with a history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) compared to control women.

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi

intervention_type: Biological


title: Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis

acronym: EMOSOCIAL-MS

summary:
In addition to the physical, cognitive and psychological symptoms experienced by individuals with Multiple Sclerosis (MS), there is new research which indicates that some individuals with MS have a deficit in emotional processing, specifically, facial affect recognition. Emotional processing is defined as "a central aspect of social cognition". Models of social cognition indicate that emotional processing is an essential component of interpersonal relationships. The failure to accurately perceive other's emotions has been shown to lead to difficulty in social relationships, misinterpreting other's affect, and consequently, inappropriate responding.

However, even though a significant number of individuals with MS have impairments in emotional processing, we do not yet have an understanding of how these impairments affect the social functioning of individuals with MS, including the impact of these deficits on family structure. It is well-known that MS impacts one's social functioning including factors such as employment, daily living activities and interpersonal relationships. Recently a strong correlation was observed between reduced social participation in MS and quality of life. There is evidence to suggest that emotional processing deficits lie at the heart of this reduced social participation in persons with MS, leading to decreased social functioning and thus reduced quality of life. However, to date, this hypothesis has not been tested.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Bordeaux
CHU de Dijon


title: Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer

acronym: EPIDROP

summary: The use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. However, their detection and capture are still a challenge as they are very rare in the bloodstream. In this clinical trial named "EPIDROP", the investigators will use an innovative device called EPIDROP (for EPIspot in a DROP) in metastatic prostate cancer. EPIDROP is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic CTCs at the single cell level. The investigators will stain cells in the sample for EpCAM, PSMA, CD45 before to encapsulate them one by one in microdroplets and measure the PSA secretion by only the viable CTCs. This study aims to demonstrate the non-inferiority of the EPIDROP compared to the CellSearch system.

location_facility:
University Hospital Center
University Center, Hospital


title: Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?

acronym: IPOLAP

summary:
The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients.

Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis

status: Terminated

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble

location_facility: CHU de Grenoble - Unité des troubles du mouvement

location_facility: CHU de Grenoble - Médecine Physique et de Réadapatation

intervention_type: Behavioral

status_simplified: Unknown


title: Bronchial REmodeling in Severe Preschool Wheezing chIldren and Risk of Exacerbation

acronym: RESPIRE

summary: Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components that characterizes severe asthma which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. We identified using latent class analysis two classes of patients. Compared to the second class, the first class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, mucus gland mass and bronchial fibrosis. We then hypothesized that this first latent class identified children at risk of asthma exacerbations.

location_facility:
CHU de Bordeaux
CHU de Toulouse


title: Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial

summary:
Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.

Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de nice - Anesthésie Réanimation
Institut Arnaut Tzanck


title: Medico-economic Evaluation of Therapeutic Adaptation Guided by the Soluble Suppression of Tumorigenicity 2 (sST-2) Biomarker in the Management of Patients With Acute Heart Failure

acronym: ICAME

summary: Management of patients with heart Failure remains a major health concern because of the high rate of rehospitalization, mortality and induced-cost. Biomarkers could help to guide the management of patients with heart failure (HF). Soluble suppression of tumorigenicity 2 (sST2) appears as a promising biomarker. As a working hypothesis, we postulate that sST2 values monitoring could be an helpful guide for medical management in an attempt to reduce hospital readmission.

primary_purpose: Other

ipd_sharing: Yes

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

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission National Informatic Liberty).

location_facility:
Arnaud de Villeneuve Hospital
Lapeyronie Hospital


acronym: RECAP 2

summary:
The main objective is to identify obstacles and elements facilitating the implementation of a tracking device Broncho Pulmonary Cancer during the course of care.

The secondary objective is to assess patient knowledge and information received on their previous occupational exposure during their professional activity.

This is a prospective multicenter study of qualitative methodology through in-depth interviews conducted with patients treated at ICLN and CHU Saint-Etienne

status: Unknown status

lead_sponsor: Institut de Cancérologie de la Loire

location_facility:
CHU Saint-Etienne
ICLN


title: Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST

acronym: REAVIST

summary:
Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.

Observational, prospective, randomized, open-label, monocentric study.

primary_purpose: Supportive Care

lead_sponsor: Rennes University Hospital


title: Quantitative Analysis of Myocardial Uptake of 99mTclabeled Bone Radiopharmaceuticals Using New Whole-body CZT-based SPECT-CT Cameras, at Baseline and During Medical Treatment With Tafamidis in Patients With Cardiac Transthyretin Amyloidosis

acronym: REMOD-TTR

summary:
Introduction: Transthyretin cardiac amyloidosis (ATTR) is an important cause of heart failure. Cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is used as a noninvasive diagnostic criterion in patients without detectable monoclonal protein. The visual assessment remains the main noninvasive criterion for the diagnosis. Medical therapy using tafamidis meglumine that binds to transthyretin and prevents amyloidogenesis, recently demonstrated a reduction in all-cause mortality and cardiovascular-related hospitalizations. As a consequence, there is a need for quantitative approaches that would be useful for diagnosis and prognosis assessment but also for the evaluation of patient therapeutic response.

Materials and methods: The investigators aim to include 35 patients with a suspected diagnosis of cardiac ATTR amyloidosis in whom a cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is planned as part of routine noninvasive diagnosis work-up. Using a test-retest approach, the aim is to compare a quantitative method vs. conventional semi-quantitative approaches for the assessment of cardiac uptake of bone radiopharmaceuticals using new 3D CZT-based SPECT-CT cameras in patients with suspected cardiac ATTR amyloidosis. The investigators estimated that 20 patients will have a diagnosis of cardiac ATTR amyloidosis. In the latter patients, the aim is to evaluate the impact of 6-month therapy using tafamidis on quantitative and semi-quantitative assessment of cardiac uptake of bone radiopharmaceuticals Perspectives: This new non invasive imaging techniques for the quantitative assessment of the amyloid burden in patients with cardiac ATTR amyloidosis may help identify the responders and the patients who should benefit from dose intensification.

lead_sponsor: University Hospital, Caen

location_facility:
CHU de Caen
Clinique du Bois

intervention_type: Diagnostic Test


title: Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin in Metastatic Colorectal Cancer Carcinoma An Open-label Phase II

summary: The investigators propose a phase II clinical trial with the objective to investigate the potential clinical interest to associate regorafenib with a metronomic chemotherapy combining capecitabine, cyclophosphamide and low-dose aspirin, for the treatment of patients with metastatic colorectal cancer. The main objective of the study will be to achieve 15% of objective response rate in patients treated with multimodal metronomic chemotherapy and regorafenib.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Hôpital Nord Franche-Comté
CHU de Besançon


title: Brainstem Dysfunction in Ventilated and Deeply Sedated COVID-19 Critically Ill Patients: a Prospective Observational Study

acronym: BRAINSTEM-COV

summary: The purpose of this study is to determine the prevalence of brainstem dysfunction in critically ill ventilated and deeply sedated patients hospitalized in the Intensive Care Unit (ICU) for a SARS-CoV-s2 infection.

ReferenceCitation: Rohaut B, Porcher R, Hissem T, Heming N, Chillet P, Djedaini K, Moneger G, Kandelman S, Allary J, Cariou A, Sonneville R, Polito A, Antona M, Azabou E, Annane D, Siami S, Chrétien F, Mantz J, Sharshar T; Groupe d'Exploration Neurologique en Réanimation (GENER). Brainstem response patterns in deeply-sedated critically-ill patients predict 28-day mortality. PLoS One. 2017 Apr 25;12(4):e0176012. doi: 10.1371/journal.pone.0176012. eCollection 2017.

location_facility:
Hôpital Cochin
HEGP


title: Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C/D Ratio

acronym: TIPS

summary:
This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation.

A differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between "high rate metabolism" (defined as a concentration/dose ratio, C/D ratio, lower than 1.04 µg/l/mg) and other patients.

The primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either < or >= 1.04 µg/l/mg, in order to detect differences in tacrolimus metabolization between these groups.

ReferenceCitation: Jouve T, Fonrose X, Noble J, Janbon B, Fiard G, Malvezzi P, Stanke-Labesque F, Rostaing L. The TOMATO Study (Tacrolimus Metabolization in Kidney Transplantation): Impact of the Concentration-Dose Ratio on Death-censored Graft Survival. Transplantation. 2020 Jun;104(6):1263-1271. doi: 10.1097/TP.0000000000002920.

ReferenceCitation: Jouve T, Noble J, Rostaing L, Malvezzi P. An update on the safety of tacrolimus in kidney transplant recipients, with a focus on tacrolimus minimization. Expert Opin Drug Saf. 2019 Apr;18(4):285-294. doi: 10.1080/14740338.2019.1599858. Epub 2019 Apr 1. Review.

ReferenceCitation: Thölking G, Fortmann C, Koch R, Gerth HU, Pabst D, Pavenstädt H, Kabar I, Hüsing A, Wolters H, Reuter S, Suwelack B. The tacrolimus metabolism rate influences renal function after kidney transplantation. PLoS One. 2014 Oct 23;9(10):e111128. doi: 10.1371/journal.pone.0111128. eCollection 2014.

ReferenceCitation: Egeland EJ, Robertsen I, Hermann M, Midtvedt K, Størset E, Gustavsen MT, Reisæter AV, Klaasen R, Bergan S, Holdaas H, Hartmann A, Åsberg A. High Tacrolimus Clearance Is a Risk Factor for Acute Rejection in the Early Phase After Renal Transplantation. Transplantation. 2017 Aug;101(8):e273-e279. doi: 10.1097/TP.0000000000001796.

ipd_sharing: Undecided

location_facility:
Grenoble University Hospital
Saint Etienne University Hospital


title: Physical Activity in Dialysis: Clinical and Biological Impact

summary:
Physical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases.

The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. This can lead to serious adverse events during the lifetime of these patients, such as arteriopathy which can result in amputation, deterioration of general condition, loss of independence and depression of wasting away.

Despite the need to promote physical activity in this population of hemodialysis patients with CRF, little is known about the effects of a supervised physical activity conducted in these patients.

With this study, the investigators propose to assess the effects of a physical activity program on several parameters, in hemodialysis subjects.

ReferenceCitation: Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.

ReferenceCitation: Vina J, Sanchis-Gomar F, Martinez-Bello V, Gomez-Cabrera MC. Exercise acts as a drug; the pharmacological benefits of exercise. Br J Pharmacol. 2012 Sep;167(1):1-12. doi: 10.1111/j.1476-5381.2012.01970.x. Review.

ReferenceCitation: Sietsema KE, Amato A, Adler SG, Brass EP. Exercise capacity as a predictor of survival among ambulatory patients with end-stage renal disease. Kidney Int. 2004 Feb;65(2):719-24.

ReferenceCitation: Kopple JD, Kim JC, Shapiro BB, Zhang M, Li Y, Porszasz J, Bross R, Feroze U, Upreti R, Kalantar-Zadeh K. Factors affecting daily physical activity and physical performance in maintenance dialysis patients. J Ren Nutr. 2015 Mar;25(2):217-22. doi: 10.1053/j.jrn.2014.10.017. Review.

ReferenceCitation: Panaye M, Kolko-Labadens A, Lasseur C, Paillasseur JL, Guillodo MP, Levannier M, Teta D, Fouque D. Phenotypes influencing low physical activity in maintenance dialysis. J Ren Nutr. 2015 Jan;25(1):31-9. doi: 10.1053/j.jrn.2014.07.010. Epub 2014 Oct 8.

ReferenceCitation: Matsuzawa R, Roshanravan B, Shimoda T, Mamorita N, Yoneki K, Harada M, Watanabe T, Yoshida A, Takeuchi Y, Matsunaga A. Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. J Ren Nutr. 2018 Jan;28(1):45-53. doi: 10.1053/j.jrn.2017.07.004. Epub 2017 Sep 8.

ReferenceCitation: Matsuzawa R, Matsunaga A, Wang G, Kutsuna T, Ishii A, Abe Y, Takagi Y, Yoshida A, Takahira N. Habitual physical activity measured by accelerometer and survival in maintenance hemodialysis patients. Clin J Am Soc Nephrol. 2012 Dec;7(12):2010-6. doi: 10.2215/CJN.03660412. Epub 2012 Sep 13.

ReferenceCitation: Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.

ReferenceCitation: Heiwe S, Jacobson SH. Exercise training in adults with CKD: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Sep;64(3):383-93. doi: 10.1053/j.ajkd.2014.03.020. Epub 2014 Jun 7. Review.

ReferenceCitation: Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barillà A, Battaglia Y, Rapanà RM, Zuccalà A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1. Erratum in: J Am Soc Nephrol. 2018 Jul;29(7):2028.

ReferenceCitation: Olvera-Soto MG, Valdez-Ortiz R, López Alvarenga JC, Espinosa-Cuevas Mde L. Effect of Resistance Exercises on the Indicators of Muscle Reserves and Handgrip Strength in Adult Patients on Hemodialysis. J Ren Nutr. 2016 Jan;26(1):53-60. doi: 10.1053/j.jrn.2015.06.006. Epub 2015 Aug 8.

ReferenceCitation: Isnard-Rouchon M, Coutard C. [Exercise as a protective cardiovascular and metabolic factor in end stage renal disease patients]. Nephrol Ther. 2017 Dec;13(7):544-549. doi: 10.1016/j.nephro.2017.01.027. Epub 2017 Nov 7. French.

ReferenceCitation: Lopes AA, Lantz B, Morgenstern H, Wang M, Bieber BA, Gillespie BW, Li Y, Painter P, Jacobson SH, Rayner HC, Mapes DL, Vanholder RC, Hasegawa T, Robinson BM, Pisoni RL. Associations of self-reported physical activity types and levels with quality of life, depression symptoms, and mortality in hemodialysis patients: the DOPPS. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1702-12. doi: 10.2215/CJN.12371213. Epub 2014 Oct 2.

ReferenceCitation: Matsuzawa R, Aoyama N, Yoshida A. Clinical Characteristics of Patients on Hemodialysis With Peripheral Arterial Disease. Angiology. 2015 Nov;66(10):911-7. doi: 10.1177/0003319715572678. Epub 2015 Feb 18.

ReferenceCitation: Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. Review. Erratum in: J Am Coll Cardiol. 2017 Mar 21;69(11):1520.

lead_sponsor: Elsan

location_facility:
Clinique Bouchard
Polyclinique les Fleurs


title: Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU - TORREA

acronym: ToRRéa

summary: Study objective is to assess the interest of the relational touch before an arterial puncture to reduce pain on patient in intensive care unit.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital
University Hospital TOURS


title: Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME

acronym: LACME

summary: Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Saint Etienne
Hospices civils de Lyon


title: Metabolomics and Transcriptomics Approaches to Identify Muscular Biomarkers in Amyotrophic Lateral Sclerosis

acronym: METABOMU

summary: The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to diagnosis. The second objective is to better understand the pathogenesis of this disease by the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Tours

location_facility: Service de chirurgie orthopédique et traumatologique, CHRU de TOURS


title: Comparison of Cytokines Production and Cellular Recruitment in Gingival Crevicular Fluid (GCF) and Granulation Tissue From Periodontitis, Peri-implantitis and Healthy Patients Leading to Activation of Osteoclasts and Bone Resorption

acronym: DUOROPA

summary:
Recent data found that peri-implantitis may differ from periodontitis at the histological level in terms of extent and composition of the cellular components. From human biopsies, it has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger proportion of granulocytes and macrophages in peri-implantitis lesions compared to periodontitis lesions. Following experimental peri-implantitis, it has been observed a continuing bone loss around dental implants after ligature removal; whereas, such a progression was not observed around teeth after cessation of the experimental periodontitis. The factors influencing the recruitment and the activation of osteoclasts in both diseases have not been compared yet.

Hypothesis : The more rapid and more severe alveolar bone destruction occurring in peri-implantitis compared to periodontitis is due at least in part to differences in the inflammatory process in these diseases.

Aim: to study the cytokine profile produced by gingival explants from periodontitis or peri-implantitis sites and to test the consequences on alteration of bone remodelling activity using in vitro approach.

Materials and methods The investigators will establish a collection of human gingival samples from patients undergoing surgical treatment of periodontitis or peri-implantitis. The investigators will test pro-inflammatory cytokines and chemokines release and consequences on osteoclast differentiation and activity.

lead_sponsor: University of Paris 5 - Rene Descartes

location_facility:
Hospital Charles Foix APHP
Hospital Rotschild


title: Pilot Study on the Development of Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium in the Post-stroke Early Recovery Phase Evaluated by Functional Near-infrared Spectroscopy (fNIRS)

acronym: ERASM

summary: The main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test Fugl-Meyer.

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

location_facility: CHRU de Montpellier - Hôpital Lapeyronie


title: Effectiveness of Personalized Nutrition Advice Delivered Via Dietary Consultations for Optimizing Dietary Calcium Intake in Patients With Multiple Sclerosis (MS) and Monitored as Outpatients: a Randomized, Single-blind, Bicentric Study

acronym: CalciCoach

summary:
The main objective of this study is to measure effectiveness at 6 months of personalized dietary advice versus dietary counseling via delivery of a standard advice sheet for optimizing dietary calcium intake (assessed by a food survey based on CIQUAL* data) in MS patients with ambulatory monitoring.

*CIQUAL Data: Table of nutritional food composition available on the ANSES (National Agency for Sanitary Security of Food, Environment and Labour) website, published by the Observatory of the Nutritional Quality of Foods. This table includes 1,500 sheets of 58 nutritional components. The data is integrated into the software for calculating ingesta (DATAMEAL) at the Nîmes University Hospital.

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Development of Synthetic Metabolic and Genetic Networks for the Detection of Urogenital Cancers

acronym: SynBioDiag

summary: This is a category 3 human study, prospective, comparative, in parallel groups. A comparative qualitative and quantitative analysis of several markers in 250 samples is proposed.

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospital
Clinique Beau Soleil


title: Video Self-observation as a Therapeutic Tool for Improving the Insight of Patients With Schizophrenia Disorders

acronym: VideoInsight

summary:
The deficit of awareness of pathology (or insight) is a common symptom in patients with schizophrenia and has a negative impact on the prognosis of the disease. Current treatments aren't effective enough on this symptom (Pijnenbord et al., 2013).

Previous studies have shown a positive impact of videos of patients themselves on insight but they lacked power. This technique needs more investigation. The study aims to improve the patient's awareness of pathology with a video of themselves recorded in the acute phase of their illness. Patients will watch this video after clinical stabilization. This is a randomized controlled and single blinded trial. A population of 60 patients (30 in each group) will be included. The impact on the insight, symptomatology, treatment adherence and functional remission will be evaluated.

The video of patient is useful for a personalized clinical follow-up. Its use for therapeutic purposes would be innovative and could be extended to other applications in psychiatry, especially as this tool is readily available.

location_facility:
University Hospital of Nîmes
University Hospital of Montpellier


title: Impact of COVID-19 on the Benefit of Cardiac Rehabilitation

acronym: REACARDIOCOVID

summary:
The COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity [> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease…]. This polymorphism is linked to vasculitis and the immune response.

Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities.

On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form.

Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 [1.9; 3.1], for cardiovascular pathologies of 2.93 [1.73; 4.96]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation.

Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.).

It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type.

Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement.

The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

family: Zhou

full_name: Fei Zhou

given: Fei

family: Yu

full_name: Ting Yu

given: Ting

family: Du

full_name: Ronghui Du

given: Ronghui

family: Fan

full_name: Guohui Fan

given: Guohui

family: Liu

full_name: Ying Liu

given: Ying

full_name: Zhibo Liu

given: Zhibo

family: Xiang

full_name: Jie Xiang

given: Jie

family: Wang

full_name: Yeming Wang

given: Yeming

family: Song

full_name: Bin Song

given: Bin

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Guan

full_name: Lulu Guan

given: Lulu

family: Wei

full_name: Yuan Wei

given: Yuan

family: Li

full_name: Hui Li

given: Hui

family: Wu

full_name: Xudong Wu

given: Xudong

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Tu

full_name: Shengjin Tu

given: Shengjin

family: Zhang

full_name: Yi Zhang

given: Yi

family: Chen

full_name: Hua Chen

given: Hua

family: Cao

full_name: Bin Cao

journal_name: The Lancet

oa_colors: green hybrid

evidence: open (via free pdf)

license: implied-oa

license_normalized: implied-oa

ReferenceCitation: Chen T, Wu D, Chen H, Yan W, Yang D, Chen G, Ma K, Xu D, Yu H, Wang H, Wang T, Guo W, Chen J, Ding C, Zhang X, Huang J, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ. 2020 Mar 26;368:m1091. doi: 10.1136/bmj.m1091. Erratum in: BMJ. 2020 Mar 31;368:m1295.

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

name: Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Pulmonary Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Emergency Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

title: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China

ReferenceCitation: Guan WJ, Liang WH, Zhao Y, Liang HR, Chen ZS, Li YM, Liu XQ, Chen RC, Tang CL, Wang T, Ou CQ, Li L, Chen PY, Sang L, Wang W, Li JF, Li CC, Ou LM, Cheng B, Xiong S, Ni ZY, Xiang J, Hu Y, Liu L, Shan H, Lei CL, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Cheng LL, Ye F, Li SY, Zheng JP, Zhang NF, Zhong NS, He JX; China Medical Treatment Expert Group for COVID-19. Comorbidity and its impact on 1590 patients with COVID-19 in China: a nationwide analysis. Eur Respir J. 2020 May 14;55(5). pii: 2000547. doi: 10.1183/13993003.00547-2020. Print 2020 May.

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

ReferenceCitation: Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.

name: Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China

name: Cardiovascular Research Institute, Wuhan University, Wuhan, China

name: Hubei Key Laboratory of Cardiology, Wuhan University, Wuhan, China

name: Shanghai Chest Hospital, Department of Cardiology, Shanghai Jiaotong University, Shanghai, China

name: Department of Endocrinology, Renmin Hospital of Wuhan University, Wuhan, China

name: Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, China

name: Department of Radiology, Renmin Hospital of Wuhan University, Wuhan, China

ReferenceCitation: Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21;323(15):1510.

name: National Centre for Infectious Diseases, Singapore

name: Lee Kong Chian School of Medicine, Singapore

name: Yong Loo Lin School of Medicine, Singapore

name: Saw Swee Hock School of Public Health, Singapore

name: for the Singapore 2019 Novel Coronavirus Outbreak Research Team

ReferenceCitation: Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May - Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. Review.

location_facility:
Groupe Hospitalier Paris Saint-Joseph
Hôpital Corentin Celton


title: Assessment of the Efficacy and Safety of Epidural Electrical Stimulation of the Lumbosacral Spinal Cord in the Symptomatic Treatment of Motor, Vesico-sphincter and Genito-sexual Disorders in Patients With Incomplete Spinal Cord Injuries

acronym: Parastim

summary:
Neurological disability caused by traumatic lesions of the spinal cord is a significant challenge for medicine and society. These lesions, leading to sublesional central nervous system dysfunction, include sensorimotor, vesico-sphincter and genito-sexual disorders. To date, there is no treatment that enables spinal cord function to be restored.

Preclinical studies have been able to demonstrate the recovery of locomotor activity with a combination of locomotor training, pharmacological intervention and epidural electrical stimulation of the lumbosacral spinal cord (EESS) in adult rats with spinal cord transection. An American team have recently been able to show that EESS, combined with locomotor training, caused neurological improvement in four paraplegic patients, with electromyographic muscular activation patterns similar to those observed during walking. In fact, these authors also showed an improvement, under stimulation, of the VS and GS functions, but with no detailed documentation.

Starting with a conceptual and preclinical rationale, and with proof of clinical concept demonstrated in several reported cases, we propose a clinical trial with an original cross-over design to validate the hypothesis that EESS combined with training in patients with incomplete spinal cord injuries would, with a good tolerance profile, allow motor, vesico-sphincter (VS) and genito-sexual (GS) disorders to be restored in patients with incomplete spinal cord injuries.

lead_sponsor: Hopital Foch

location_facility:
Hôpital Foch
Hôpital Raymond Poincaré

intervention_type: Device


title: Étude Prospective d'évaluation de la cinétique Sanguine de Cellules Immunitaires et de Cytokines Immunosuppressives après Exposition à un Inhibiteur Des Checkpoints de l'immunité (ICI) : étude de l'Impact de la chimiothérapie

acronym: CINECI

summary:
Non-small cell lung cancer (NSCLC) is the most common histological form, accounting for 85% of all bronchopulmonary cancers (PBC). The advent of Immunity Checkpoint Inhibitors (ICIs) targeting Programmed cell Death-1 (PD-1) is changing current treatment algorithms.

Preliminary results from work carried out in the Medical Oncology Department of the University Hospital of Tours suggest that immunotherapy targeting ICI, when administered beforehand, increases the effect of catch-up chemotherapy. In NSCLC, the progression-free survival (PFS) of 3rd line chemotherapy after anti-PD-1 immunotherapy was better than the PFS of 3rd line chemotherapy performed at the end of conventional chemotherapy. Moreover, the combination of chemotherapy and immunotherapy gives paradoxically better results than immunotherapy alone.

Immunotherapy restores the anti-tumor T immunity inhibited by the cancer cell. While the mode of action of ICIs is well known, the mechanisms of resistance to them are poorly understood. Several pathways are evoked, in particular the modulation of cellular interactions within the tumour microenvironment (TME), the molecular expression profile of cancer cells, or the immunological status of the patient.

Regulatory T lymphocytes (Treg) participate in the maintenance of immune system homeostasis by ensuring tolerance to self antigens. Within TME, Treg inhibit anti-tumor T cell activity and potentiate tumor proliferation. The latter, by specifically recognizing tumor antigens, block the activity of effector T lymphocytes directed against tumor cells. Thus, an increase in circulating Treg concentrations and in TME is a poor prognostic factor, especially in NSCLC.

Gemcitabine chemotherapy is commonly used in the management of NSCLC. Recent data show that gemcitabine decreases Treg activity and regulates levels of anti-inflammatory TME cytokines such as IL10, TGF-β and interferon-Ɣ.

The hypothesis of this study is that the decrease in Treg blood concentration by catch-up chemotherapy restores sensitivity to immunotherapy.

location_facility: Medical oncology department, University Hospital, Tours

location_facility: Pneumology department, University Hospital, Tours


title: A Randomized Double-blind Trial Evaluating the Live Birth Rate After Transfer of Embryos Cultured in Time Lapse Incubator Compared With Conventional Incubator: Embryoselect

acronym: EmbryoSelect

summary: The aim of the research is to evaluate the results of the first in vitro fertilization (IVF) attempt according to the type of embryo culture. From the fertilization to the day 2 transfer, embryos are cultured in standard incubator or in a time lapse technology (TLT). TLT offers an uninterrupted culture environment with a morphokinetic evaluation, whereas culture in standard incubator involves discontinuous morphological embryo evaluation. The principal objective is to compare the live birth rate after the fresh embryo transfer, in a cohort of women less than 39 years-old.

location_facility:
CHU Bordeaux
clinique Belharra


title: Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics

acronym: PROSPERO

summary: This French multicentre open-label randomized trial will test the hypothesis that a coordinated health circuit based on obstetric risks, backed up by an electronic patient care reporting information system will optimize the continuum of pregnancy care monitoring. The electronic patient care reporting information system will be shared between patients, private practice physicians/midwifes, hospital physicians/midwifes and supervised by a coordinating midwife.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hospices Civils de Lyon
Hôpital Femme Mère Enfant


title: Xploring Venlafaxine Pharmacokinetic Variability by a Phenotyping Approach

acronym: MARVEL

summary:
Regarding the direct costs and the social value of depression, the decision of an antidepressant treatment prescription must be optimized as much as possible. The development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence burden and costs of affective disorders.

There is hope that biomarkers will be found to guide treatment selection. It might be of decisive interest to be able to assess an individual's metabolism activity. We propose here to explore the relationship between the activity of drug-metabolizing enzymes (DME) and transporters- assessed by a phenotypic approach and the efficacy of antidepressants. We will focus on venlafaxine (V) that provides a reasonable second-step choice for patients with depression and is used extensively in psychiatric practice, and the metabolism of which involves several cytochromes (CYP) P450 enzymes and the transporter P-gp.

Thus, the primary objective of this study is to study the correlation between the concentration of V and its metabolite ODesmethylV (V+ODV) and drug metabolism variability assessed by a phenotypic approach, in patients with major depressive disorder and MADRS ≥ 20 despite 4 weeks of V at 150mg or less

ReferenceCitation: Lloret-Linares C, Daali Y, Chevret S, Nieto I, Molière F, Courtet P, Galtier F, Richieri RM, Morange S, Llorca PM, El-Hage W, Desmidt T, Haesebaert F, Vignaud P, Holtzmann J, Cracowski JL, Leboyer M, Yrondi A, Calvas F, Yon L, Le Corvoisier P, Doumy O, Heron K, Montange D, Davani S, Déglon J, Besson M, Desmeules J, Haffen E, Bellivier F. Exploring venlafaxine pharmacokinetic variability with a phenotyping approach, a multicentric french-swiss study (MARVEL study). BMC Pharmacol Toxicol. 2017 Nov 7;18(1):70. doi: 10.1186/s40360-017-0173-2.

family: Lloret-Linares

full_name: Célia Lloret-Linares

given: Célia

family: Daali

full_name: Youssef Daali

given: Youssef

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Nieto

full_name: Isabelle Nieto

given: Isabelle

family: Molière

full_name: Fanny Molière

given: Fanny

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Galtier

full_name: Florence Galtier

given: Florence

family: Richieri

full_name: Raphaëlle-Marie Richieri

given: Raphaëlle-Marie

family: Morange

full_name: Sophie Morange

given: Sophie

family: Llorca

full_name: Pierre-Michel Llorca

given: Pierre-Michel

family: El-Hage

full_name: Wissam El-Hage

given: Wissam

family: Desmidt

full_name: Thomas Desmidt

given: Thomas

family: Haesebaert

full_name: Frédéric Haesebaert

given: Frédéric

family: Vignaud

full_name: Philippe Vignaud

family: Holtzmann

full_name: Jerôme Holtzmann

given: Jerôme

family: Cracowski

full_name: Jean-Luc Cracowski

given: Jean-Luc

family: Leboyer

full_name: Marion Leboyer

given: Marion

family: Yrondi

full_name: Antoine Yrondi

given: Antoine

family: Calvas

full_name: Fabienne Calvas

given: Fabienne

family: Yon

full_name: Liova Yon

given: Liova

family: Le Corvoisier

full_name: Philippe Le Corvoisier

family: Doumy

full_name: Olivier Doumy

given: Olivier

family: Heron

full_name: Kyle Heron

given: Kyle

family: Montange

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

repository_institution: University of Geneva - Archive ouverte UNIGE

location_facility:
Fernand Widal hospital
Lariboisiere hospital


title: Apport de l'Immuno-TEP préciblée Avec l'Anticorps bispécifique Anti-ACE x Anti-HSG TF2 et le Peptide IMP-288 marqué au Gallium-68 Pour l'Imagerie Des Patients Potentiellement Candidats à Une Chirurgie d'exérèse et/ou Thermoablation Locale d'Une ou Plusieurs métastases, au Diagnostic ou Lors de la Rechute de Cancers Colo-rectaux (CCR) Exprimant l'antigène Carcino-embryonnaire (ACE): Comparaison au Bilan Conventionnel

acronym: iTEP Colon

summary: Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA.

ReferenceCitation: Touchefeu Y, Bailly C, Frampas E, Eugène T, Rousseau C, Bourgeois M, Bossard C, Faivre-Chauvet A, Rauscher A, Masson D, David A, Cerato E, Carlier T, Sharkey RM, Goldenberg DM, Barbet J, Kraeber-Bodere F, Bodet-Milin C. Promising clinical performance of pretargeted immuno-PET with anti-CEA bispecific antibody and gallium-68-labelled IMP-288 peptide for imaging colorectal cancer metastases: a pilot study. Eur J Nucl Med Mol Imaging. 2021 Mar;48(3):874-882. doi: 10.1007/s00259-020-04989-3. Epub 2020 Aug 21.

family: Touchefeu

full_name: Y. Touchefeu

given: Y.

family: Bailly

full_name: C. Bailly

given: C.

family: Frampas

full_name: E. Frampas

given: E.

family: Eugène

full_name: T. Eugène

given: T.

family: Rousseau

full_name: C. Rousseau

family: Bourgeois

full_name: M. Bourgeois

given: M.

family: Bossard

full_name: C. Bossard

family: Faivre-Chauvet

full_name: A. Faivre-Chauvet

given: A.

family: Rauscher

full_name: A. Rauscher

family: Masson

full_name: D. Masson

given: D.

family: David

full_name: A. David

family: Cerato

full_name: E. Cerato

family: Carlier

full_name: T. Carlier

family: Sharkey

full_name: R. M. Sharkey

given: R. M.

family: Goldenberg

full_name: D. M. Goldenberg

given: D. M.

family: Barbet

full_name: J. Barbet

given: J.

family: Kraeber-Bodere

full_name: F. Kraeber-Bodere

given: F.

family: Bodet-Milin

full_name: C. Bodet-Milin

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Nantes University Hospital

location_facility:
CHU
Institut de cancérologie de l'Ouest


title: Randomized and Prospective Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer

acronym: OPTICOACH

summary: Evaluate the impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study for breast cancer in professionnally active patients.

lead_sponsor: Institut Curie


title: Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation

acronym: Core AF

summary: The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for the automatic identification of atrial fibrillation (AF).

ipd_sharing_description: Individual patient data (IPD) are considered as confidential in this study. After the end the final quality control, the database will be frozen and all the IPD will be archived.

lead_sponsor: Withings

location_facility:
ICPC Turin
ICPC Floréale


title: Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?

acronym: COL-FOP

summary:
Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.

A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain.

The hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.

location_facility:
CHU
Institut Hospitalier Franco-Britannique


title: Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Clinical Trial of Two Strategies (DINO-FIRST Versus BALLON-FIRST)

acronym: BESTWAY

summary: Labour induction is an obstetrical procedure, which artificially starts the process of cervix dilation, in order to induce labour. Several methods of labour induction exist : mechanical ones (using dilatation balloons) or pharmacological ones (using prostaglandins or oxytocin). This trial aims to compare, in case of non-favourable cervix, the strategy of labour induction using the Propess® method first (Dino-first) versus the strategy beginning with the use of a dilatation balloon (Ballon-first), with respect of the usual practice and the current guidelines.

location_facility:
Montpellier University Hospital
Nimes University Hospital


title: Relationships Between Hemolysis, Erythrosis, Circulating Microparticles and Vascular Function in Patients With Hereditary Spherocytosis

acronym: VASCUSPHERO

summary:
Background : Patients with hereditary spherocytosis (HS) are characterized by increased red blood cell (RBC) fragility and a loss of RBC deformability. While the clinical variability of the disease may be heterogenous from one patient to another, some studies reported the occurrence of vascular complications, notably in patients who have been splenectomized.

Purpose : The aim of the study is to test the associations between the degree of vascular dysfunction and the extent of hemolysis, the amount of circulating microparticles, the level of erythrosis and the degree of RBC biophysical alterations.

Abstract : Recent studies reported the occurrence of vascular complications in patients with HS, notably in patients who have previously been splenectomized. However, the exact reasons of these complications are unknown and no study investigated the vascular function in HS patients.

Main objective Highlight the presence of altered vascular function in HS patients and test the relationships with the level of hemolysis and circulating microparticles.

Secondary objectives To evaluate the associations between clinical severity and 1) the level of vascular dysfunction and 2) several biomarkers (hemolysis, hematological parameters, circulating microparticles, erythrosis, RBC biophysical properties).

location_facility: Institut d'Hématologie et Oncologie PEdiatrique (iHOPe)


title: Pediatric Immune Response to Multi-Organ Dysfunction

acronym: PedIMOD

summary:
Multiple organ dysfunction (MOD) is defined by the association of at least two failures of vital organs, with various etiologies (septic shock, polytrauma, acute respiratory distress syndrome, etc.). Associated mortality remains high in children (between 20 and 50%).

In septic shock, one of the main causes of MOD, induced immunosuppression can occur, with immune alterations affecting all cells of immunity. This induced immunosuppression is associated with an additional risk of secondary acquired infections and death in adults. Among all the cells and all the markers studied, the expression of Human Leukocyte Antigen - DR isotype (HLA-DR) on the surface of the monocyte (mHLA-DR, expressed in number of sites per cell) appeared as one of the best biomarkers of this induced immunosuppression. Decreased expression of monocyte Human Leukocyte Antigen - DR isotype (mHLA-DR) in adults is linked to an increased risk of developing secondary infection and death.

These results were confirmed by team in the context of pediatric septic shock, with an attack of innate immunity in the foreground. Persistent lowering of mHLA-DR for more than 3 days after onset of shock was associated with the occurrence of secondary acquired infections: 50% of children had mHLA-DR of less than 8000 sites / cells on D3, of which 60 % developed secondary infection within 30 days. No child with mHLA-DR greater than 8000 sites / cells had secondary infection.

Such immune alterations appear to be non-specific for septic shock, as they have also been described after multiple trauma or severe respiratory infections.

The hypothesize is that multi-systemic aggression leading to multi-visceral failure syndrome could also lead to significant immunosuppression, regardless of the etiology of this MOD.

At present, the proportion of persistent immunosuppression induced by MOD, all etiologies combined, is poorly documented in pediatrics. Estimating this proportion in a large pediatric cohort, while exploring as fully as possible the associated immune alterations and acquired secondary infections, would improve the pathophysiological understanding and pediatric specificities of this phenomenon.

location_facility:
Hôpital Femme Mère Enfant
Hopital Mère Enfant


title: A National, Randomized, Open-label Study Comparing Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated With Methotrexate Administered by Auto-injector Versus Administration by Conventional Subcutaneous Injection.

acronym: Self-i

summary: The primary objective of the study is to compare, in patients treated with methotrexate injection for rheumatoid arthritis, the compliance and the health assessment questionnaire evolution for the administration by auto-injector versus administration by conventional subcutaneous injection, after 6 months of treatment.

ReferenceCitation: Saraux A, Hudry C, Zinovieva E, Herman-Demars H; Self-I Investigators group. Use of Auto-Injector for Methotrexate Subcutaneous Self-Injections: High Satisfaction Level and Good Compliance in SELF-I Study, a Randomized, Open-Label, Parallel Group Study. Rheumatol Ther. 2019 Mar;6(1):47-60. doi: 10.1007/s40744-018-0134-2. Epub 2018 Dec 13.

family: Saraux

full_name: Alain Saraux

given: Alain

family: Hudry

full_name: Christophe Hudry

given: Christophe

family: Zinovieva

full_name: Elena Zinovieva

given: Elena

family: Herman-Demars

full_name: Hélène Herman-Demars

given: Hélène

family: Aouadi

full_name: Lahouari Aouadi

given: Lahouari

family: Arif

full_name: Azzedine Arif

given: Azzedine

family: Arty-Hue

full_name: Heyliette Arty-Hue

given: Heyliette

family: Banal

full_name: Frederic Banal

given: Frederic

family: Banse

full_name: Christopher Banse

given: Christopher

family: Baron

full_name: Jean-Jacques Baron

given: Jean-Jacques

family: Basch

full_name: Andre Basch

given: Andre

family: Berton

full_name: Valerie Berton

given: Valerie

family: Bitar

full_name: Salma Bitar

given: Salma

family: Cantagrel

full_name: Alain Cantagrel

family: Cayla

full_name: Pierre Cayla

given: Pierre

family: Combe

full_name: Bernard Combe

given: Bernard

family: Cornaille-Lafage

full_name: Genevieve Cornaille-Lafage

given: Genevieve

family: Duplantier

full_name: Dominique Duplantier

given: Dominique

family: Dellaroli

full_name: Martine Elbaz Dellaroli

given: Martine Elbaz

family: Ferrazzi

full_name: Veronique Ferrazzi

given: Veronique

family: Flipo

full_name: Rene-Marc Flipo

given: Rene-Marc

family: Fulpin

full_name: Jean Fulpin

given: Jean

family: Gardiol

full_name: Jean-Claude Gardiol

given: Jean-Claude


title: Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function

acronym: Tewlip

summary:
The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term LCPN and help in electrolyte and water balance.

The objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal barrier function will be assessed through the transepidermal water loss (TEWL) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE (SO-based or FO-containing) will be compared using a randomized double blind crossover design, using patients as their own control. Each IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and red blood cell EFA profile will be determinate in order to facilitate result interpretation.

location_facility:
Hospices Civils de Lyon
Centre Hospitalier Lyon Sud


title: Identification of a Biomarker Associated With Cis-duplication of the SMN1 Gene Aiming at Improving the Genetic Counseling in Spinal Muscular Atrophy Families

acronym: BADGES

summary:
Spinal Muscular Atrophy (SMA) is a neuromuscular disorder characterized by loss of motor neurons in the anterior horn of the spinal cord and leading to muscle atrophy. SMA has an autosomal recessive inheritance and affects 1 in 6000 infants with a carrier frequency of 1 in 40. In most cases, it is caused by homozygous gene deletion or gene conversion of the SMN1 gene (0+0 genotype) on 5q11-q13. This genomic region has been duplicated and inverted during evolution. Thus the SMN1 gene has a very homologous copy, called SMN2. Genetic counseling aim at detecting carriers with only one copy of the SMN1 gene (0+1 genotype). SMA carrier testing relies on total copy number quantification of the SMN1 copies by quantitative PCR methods. Nevertheless, cis-duplication of the SMN1 gene on one allele and deletion on the second allele (2+0 genotype) can lead to a misinterpretation as molecular methods show 2 copies of the SMN1 gene and cannot detect the carrier status.

The aim of the study is the characterization of a biomarker specific of the cis-duplication of the SMN1 gene in order to allow the detection of this 2+0 genotype which constitutes a trap for genetic counseling. We will use molecular combing to identify a genomic morse code (GMC) composed of a combination of probes specific of a structural motif on the cis-duplication chromosome. The characterization of this GMC is based on the comparison of two sample groups:

The test group, with a maximum of 137 individuals carrying 3 copies of the SMN1 gene (suggesting a cis-duplication on one allele)
The control-1 group, with a maximum of 137 individuals carrying 2 copies of the SMN1 gene

A pilot study performed on 24 samples in the two groups is needed to define the exact sample number necessary for statistical analysis of the study. When the GMC will be characterized, its specificity will be evaluated by testing two sample groups:

The test group, with 37 individuals carrying 3 copies of the SMN1 gene
The control-2 group, with 37 individuals carrying 3 copies of the SMN2 gene Molecular combing needs long DNA fibers and usual methods for DNA extraction are not appropriate. This project requires new blood samples for specific DNA extraction.

If this project is successful, during a second project, this GMC will be converted into a simple and cheap PCR-based method. We will then evaluate the sensitivity of this method on our sample collection, notably on individuals with the 2+0 genotype defined by familial genotyping.

lead_sponsor: University Hospital, Rouen

location_facility:
Nantes University Hospital
Rouen University Hospital


title: Complications Risk Factors in Patients Hospitalized for COVID-19 Infection: Role of Proteins Electrophoresis

acronym: COVELEC

summary: The inflammation is central in COVID-19 infections. Our aim is to evaluate the clinical value of measuring inflammation by using serum protein electrophoresis (SPE). SPE evaluation of inflammation should be able to predict outcome, follow up evolution or treatment efficacy in patients with coronavirus infection and thus anticipate their evolution to severe viral infection and allow an optimal clinical management. SPE inflammation diagnostics will be benchmarked with other diagnostics of inflammation, currently used more routinely.

ReferenceCitation: Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.

ReferenceCitation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

name: From the NHC Key Laboratory of Biosafety, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (N.Z., W.W., J.S., X.Z., B.H., R.L., P.N., X.M., D.W., W.X., G.W., G.F.G., W.T.), and the Department of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (X.L.) — both in Beijing; Wuhan Jinyintan Hospital (D.Z.), the Division for Viral Disease Detection, Hubei Provincial Center for Disease Control and Prevention (B.Y., F.Z.), and...

family: Zhu

full_name: Na Zhu

family: Zhang

full_name: Dingyu Zhang

given: Dingyu

family: Wang

full_name: Wenling Wang

given: Wenling

family: Li

full_name: Xingwang Li

given: Xingwang

family: Yang

full_name: Bo Yang

given: Bo

family: Song

full_name: Jingdong Song

given: Jingdong

family: Zhao

full_name: Xiang Zhao

given: Xiang

family: Huang

full_name: Baoying Huang

given: Baoying

family: Shi

full_name: Weifeng Shi

given: Weifeng

family: Lu

full_name: Roujian Lu

given: Roujian

family: Niu

full_name: Peihua Niu

given: Peihua

family: Zhan

full_name: Faxian Zhan

given: Faxian

family: Ma

full_name: Xuejun Ma

given: Xuejun

full_name: Dayan Wang

given: Dayan

family: Xu

full_name: Wenbo Xu

given: Wenbo

family: Wu

full_name: Guizhen Wu

given: Guizhen

family: Gao

full_name: George F. Gao

given: George F.

family: Tan

full_name: Wenjie Tan

given: Wenjie

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

ReferenceCitation: Xu XW, Wu XX, Jiang XG, Xu KJ, Ying LJ, Ma CL, Li SB, Wang HY, Zhang S, Gao HN, Sheng JF, Cai HL, Qiu YQ, Li LJ. Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-Cov-2) outside of Wuhan, China: retrospective case series. BMJ. 2020 Feb 19;368:m606. doi: 10.1136/bmj.m606. Erratum in: BMJ. 2020 Feb 27;368:m792.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

name: From the State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (W.G., W.L., J.H., R.C., C.T., T.W., S.L., Jin-lin Wang, N.Z., J.H., W.L.), the Departments of Thoracic Oncology (W.L.), Thoracic Surgery and Oncology (J.H.), and Emergency Medicine (Z.L.), First Affiliated Hospital of Guangzhou Medical University, and Guangzhou Eighth People’s Hospital,...

name: Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Pulmonary Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

ReferenceCitation: Del Rio C, Malani PN. 2019 Novel Coronavirus-Important Information for Clinicians. JAMA. 2020 Mar 17;323(11):1039-1040. doi: 10.1001/jama.2020.1490.

ReferenceCitation: Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.

ReferenceCitation: Pei G, Zhang Z, Peng J, Liu L, Zhang C, Yu C, Ma Z, Huang Y, Liu W, Yao Y, Zeng R, Xu G. Renal Involvement and Early Prognosis in Patients with COVID-19 Pneumonia. J Am Soc Nephrol. 2020 Jun;31(6):1157-1165. doi: 10.1681/ASN.2020030276. Epub 2020 Apr 28.

ReferenceCitation: Zhang X, Cai H, Hu J, Lian J, Gu J, Zhang S, Ye C, Lu Y, Jin C, Yu G, Jia H, Zhang Y, Sheng J, Li L, Yang Y. Epidemiological, clinical characteristics of cases of SARS-CoV-2 infection with abnormal imaging findings. Int J Infect Dis. 2020 May;94:81-87. doi: 10.1016/j.ijid.2020.03.040. Epub 2020 Mar 20.

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ReferenceCitation: Sun D, Li H, Lu XX, Xiao H, Ren J, Zhang FR, Liu ZS. Clinical features of severe pediatric patients with coronavirus disease 2019 in Wuhan: a single center's observational study. World J Pediatr. 2020 Jun;16(3):251-259. doi: 10.1007/s12519-020-00354-4. Epub 2020 Mar 19.

ReferenceCitation: Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.

publisher_dissemination: American Society for Clinical Investigation

ReferenceCitation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16.

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Lee N, Chan MC, Lui GC, Li R, Wong RY, Yung IM, Cheung CS, Chan EC, Hui DS, Chan PK. High Viral Load and Respiratory Failure in Adults Hospitalized for Respiratory Syncytial Virus Infections. J Infect Dis. 2015 Oct 15;212(8):1237-40. doi: 10.1093/infdis/jiv248. Epub 2015 Apr 22.

ReferenceCitation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

ReferenceCitation: O'Connell TX, Horita TJ, Kasravi B. Understanding and interpreting serum protein electrophoresis. Am Fam Physician. 2005 Jan 1;71(1):105-12. Review.

ReferenceCitation: Szymanowicz A, Cartier B, Couaillac JP, Gibaud C, Poulin G, Rivière H, Le Carrer D; Groupe de Travail du Collège National de Biochimie des Hôpitaux. [A proposal of ready-made interpretative comments applicable to serum protein electrophoresis]. Ann Biol Clin (Paris). 2006 Jul-Aug;64(4):367-80. Review. French.

ReferenceCitation: Concato J, Peduzzi P, Holford TR, Feinstein AR. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol. 1995 Dec;48(12):1495-501.

ReferenceCitation: Peduzzi P, Concato J, Feinstein AR, Holford TR. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995 Dec;48(12):1503-10.

ReferenceCitation: Kim ES, Chin BS, Kang CK, Kim NJ, Kang YM, Choi JP, Oh DH, Kim JH, Koh B, Kim SE, Yun NR, Lee JH, Kim JY, Kim Y, Bang JH, Song KH, Kim HB, Chung KH, Oh MD; Korea National Committee for Clinical Management of COVID-19. Clinical Course and Outcomes of Patients with Severe Acute Respiratory Syndrome Coronavirus 2 Infection: a Preliminary Report of the First 28 Patients from the Korean Cohort Study on COVID-19. J Korean Med Sci. 2020 Apr 6;35(13):e142. doi: 10.3346/jkms.2020.35.e142.

ReferenceCitation: Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium, Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum in: JAMA. 2020 May 26;323(20):2098.


title: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.

acronym: PERSONA

summary: The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.

ReferenceCitation: Blanke O, Ortigue S, Landis T, Seeck M. Stimulating illusory own-body perceptions. Nature. 2002 Sep 19;419(6904):269-70.

ReferenceCitation: Blanke O. Multisensory brain mechanisms of bodily self-consciousness. Nat Rev Neurosci. 2012 Jul 18;13(8):556-71. doi: 10.1038/nrn3292. Review.

ReferenceCitation: Sierra M, Berrios GE. The Cambridge Depersonalization Scale: a new instrument for the measurement of depersonalization. Psychiatry Res. 2000 Mar 6;93(2):153-64.

ReferenceCitation: Farrer C, Frey SH, Van Horn JD, Tunik E, Turk D, Inati S, Grafton ST. The angular gyrus computes action awareness representations. Cereb Cortex. 2008 Feb;18(2):254-61. Epub 2007 May 8.

ReferenceCitation: Frith CD, Blakemore SJ, Wolpert DM. Abnormalities in the awareness and control of action. Philos Trans R Soc Lond B Biol Sci. 2000 Dec 29;355(1404):1771-88. Review.

ReferenceCitation: Mantovani A, Simeon D, Urban N, Bulow P, Allart A, Lisanby S. Temporo-parietal junction stimulation in the treatment of depersonalization disorder. Psychiatry Res. 2011 Mar 30;186(1):138-40. doi: 10.1016/j.psychres.2010.08.022. Epub 2010 Sep 15.

ReferenceCitation: Sierra M, Phillips ML, Ivin G, Krystal J, David AS. A placebo-controlled, cross-over trial of lamotrigine in depersonalization disorder. J Psychopharmacol. 2003 Mar;17(1):103-5.

ReferenceCitation: Sierra M, Baker D, Medford N, David AS. Unpacking the depersonalization syndrome: an exploratory factor analysis on the Cambridge Depersonalization Scale. Psychol Med. 2005 Oct;35(10):1523-32.

ReferenceCitation: Sierra M. Depersonalization disorder: pharmacological approaches. Expert Rev Neurother. 2008 Jan;8(1):19-26. Review.

ReferenceCitation: Sierra M, David AS. Depersonalization: a selective impairment of self-awareness. Conscious Cogn. 2011 Mar;20(1):99-108. doi: 10.1016/j.concog.2010.10.018. Epub 2010 Nov 17. Review.

ReferenceCitation: Simeon D, Guralnik O, Hazlett EA, Spiegel-Cohen J, Hollander E, Buchsbaum MS. Feeling unreal: a PET study of depersonalization disorder. Am J Psychiatry. 2000 Nov;157(11):1782-8.

ReferenceCitation: Simeon D, Kozin DS, Segal K, Lerch B, Dujour R, Giesbrecht T. De-constructing depersonalization: further evidence for symptom clusters. Psychiatry Res. 2008 Jan 15;157(1-3):303-6. Epub 2007 Oct 23.

lead_sponsor: Centre Hospitalier St Anne

location_facility:
Centre Hospitalier Sainte-Anne
Saint-Antoine Hospital


title: Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms.

acronym: DETECT

summary: Telemedicine may facilitate adequate treatment of Neuropsychiatric symptoms (NPS) by identifying underlying causes and tailoring a treatment plan (pharmacological or non-pharmacologic treatments including provision of staff education and support, training in problem solving, and targeted therapy directed at the underlying causes for specific behaviors).

ReferenceCitation: Piau A, Nourhashemi F, De Mauléon A, Tchalla A, Vautier C, Vellas B, Duboue M, Costa N, Rumeau P, Lepage B, Soto Martin M. Telemedicine for the management of neuropsychiatric symptoms in long-term care facilities: the DETECT study, methods of a cluster randomised controlled trial to assess feasibility. BMJ Open. 2018 Jun 12;8(6):e020982. doi: 10.1136/bmjopen-2017-020982.

family: Piau

full_name: Antoine Piau

given: Antoine

family: Nourhashemi

full_name: Fati Nourhashemi

given: Fati

family: De Mauléon

full_name: Adélaïde De Mauléon

given: Adélaïde

family: Tchalla

full_name: Achille Tchalla

given: Achille

family: Vautier

full_name: Claude Vautier

given: Claude

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: Duboue

full_name: Maryline Duboue

given: Maryline

family: Costa

full_name: Nadège Costa

given: Nadège

family: Rumeau

full_name: Pierre Rumeau

given: Pierre

family: Lepage

full_name: Benoit Lepage

given: Benoit

family: Soto Martin

full_name: Maria Soto Martin

given: Maria

currency_apc_doaj: GBP

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Toulouse

location_facility: UHToulouse UHLimoges