title: Practice in Clinical and Molecular Thoracic European Pathology Laboratories During the COVID-19 Pandemic.

summary: The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when handling human samples, remains poorly understood, as well as the impact of the COVID-19 pandemic in routine clinical and molecular pathology practice, and for personal working in pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis of thoracic diseases.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Correlation of VEGF-A and Fluid Balance in Septic Shock

acronym: VEGFluid

summary:
VEGF is a key molecule in the control of vascular permeability via interactions with the VEGF-receptor on the endothelial cell. Several authors reported plasma VEGF levels are elevated in sepsis shock and associated with increased mortality (1,2).

In septic shock, the main elements of treatment are intravenous fluids, appropriate antibiotics and vasopressors. Some authors observed positive fluid balance is associated with increased mortality rates in patients (3,4).

To the best of our knowledge, no studies have shown a correlation between VEGF levels and the fluid balance. The aim of our study was to determine the role of VEGF in capillary leakage and the positive fluid balance in septic shock.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: University Hospital, Rouen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Use of Lung Ultrasound for COVID-19 Patient's Initial Triage Assessment and Early Monitoring: a Pilot Study

acronym: QUICK

summary: The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

status_simplified: Completed


title: Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages

acronym: MacFibOsis

summary: Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from patients with a history of asbestosis or silica exposure and comparison of these capacities with those of MDM from healthy donors.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Rennes University Hospital

intervention_type: Biological


title: Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study

acronym: EFABE

summary: : Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Drug


title: Using the SpiderMass(TM) for in Vivo and Real Time Mass Spectrometry Analysis of Subject's Epidermis Suffering From Chronic Inflammatory Dermatosis Compared to Control Groups

summary:
The physiological states of the skin are characterized by a certain homeostasis linked to the balance of the metabolic pathways. When these pathways are deregulated, the proteic, lipidic and metabolic is affected. It is thus possible to follow a change in the state of the skin by looking at change in the associated molecular profile.

The PRISM laboratory (INSERM U1192) in Lille has developed an innovative system laser called SpiderMass composed of 4 parts:

A laser used for the micro-sampling of material in vivo,
A transport transfer line of the ablated particles,
A mass spectrometer that analyzes them in real time and generates the molecular profiles of the epidermis,
A data analysis procedure.

The SpiderMass(TM) is of great interest for the study of the skin because it allows non-invasive vivo characterization, and therefore without biopsy or sample preparation. In addition, it will complement techniques already used in the research center such as FTIR spectroscopy. Indeed, in acne studies the FTIR allows to obtain only the Fatty Acid Triglycerid ratio while the SpiderMass permits to detail these lipid classes by each observed molecule on the surface of the skin and follow their evolution.

primary_purpose: Basic Science

lead_sponsor: Pierre Fabre Dermo Cosmetique

lead_sponsor_type: industriel


title: Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.

summary:
Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor.

Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS.

However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers.

There are other positioning techniques such as the "upright" position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS.

However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details.

Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table.

The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.

ReferenceType: background

ReferenceCitation: Umbrello M, Formenti P, Bolgiaghi L, Chiumello D. Current Concepts of ARDS: A Narrative Review. Int J Mol Sci. 2016 Dec 29;18(1). pii: E64. doi: 10.3390/ijms18010064. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans

intervention_type: Procedure


title: Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia

acronym: ALADIN

summary:
Background. Cancer is the leading cause of death by disease in children. Most pediatric tumors differ from adult tumors in terms of biological and clinical characteristics. In children, the part of genetic determinism could be higher since the role of environmental factors may be less pronounced than in adults and that a young age at onset is a main feature of genetic cancer predisposition. Recent studies suggested that a number of genetic predisposition remains to be characterized.

Methods. Trio-Based whole exome sequencing of germline DNA from patients (children and adults diagnosed with cancers between 0 and 17 years) and parents will be performed prospectively in a multicentric study including 40 unselected cases of malignant tumor. Participating hospitals will include the CHU of Montpellier, the CHU de Nice and the AP-HP. Tumor analysis will include whole exome analysis and transcriptome for the identification of therapeutic target and contribute to confirm potential link between constitutive mutations and tumor phenotype (such as loss of expression, loss of heterozygosity).

Perspectives. This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier

intervention_type: Genetic


title: Evaluation of the Effect of Music on Young Practitioner's Stress During Endodontic Treatment

acronym: MUSIQUENDO

summary:
According to several studies, patients consider endodontic treatment as one of the most stress-inducing dental procedures. Two studies demonstrated that music enables the patient to be less stressed during RCT.

RCTs are also stressful for the practitioner, and particularly for students who start their dental practice. Endodontic and prosthetic cares are considered the most demanding by students. RCT requires high degree of precision in gestures and patience because those technical acts are, in part, blindly realised and can be long. In a preliminary study, it was found that the most stress-inducing steps for the students during endodontic treatment are root-canal preparation and filling.

The beneficial side of listening to music on the patient's stress during RCT has been proved; but to our knowledge, no study assessed the effect of listening to music on the stress of the practitioner and more particularly of the young practitioner, during endodontic treatment, and in particular during root canal preparation. This is the main aim of this study.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest


title: Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study

acronym: PARI

summary: Many ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.

ReferenceType: derived

ReferenceCitation: Cohen R, Béchet S, Gelbert N, Frandji B, Vie Le Sage F, Thiebault G, Kochert F, Cahn-Sellem F, Werner A, Ouldali N, Levy C. New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era. Pediatr Infect Dis J. 2021 Jul 1;40(7):674-680. doi: 10.1097/INF.0000000000003116.

family: Cohen

full_name: Robert Cohen

given: Robert

sequence: first

family: Béchet

full_name: Stéphane Béchet

given: Stéphane

sequence: additional

family: Gelbert

full_name: Nathalie Gelbert

given: Nathalie

family: Frandji

full_name: Bruno Frandji

given: Bruno

family: Vie Le Sage

full_name: François Vie Le Sage

given: François

family: Thiebault

full_name: Georges Thiebault

given: Georges

family: Kochert

full_name: Fabienne Kochert

given: Fabienne

family: Cahn-Sellem

full_name: Fabienne Cahn-Sellem

family: Werner

full_name: Andreas Werner

given: Andreas

family: Ouldali

full_name: Naim Ouldali

given: Naim

family: Levy

full_name: Corinne Levy

given: Corinne

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Pediatric Infectious Disease Journal

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


intervention_type: Diagnostic Test

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: POLYbio

type: EudraCT Number

source: euctr

title: Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug

summary: The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)>3.2. The second one is RA in clinical remission defined by a DAS28<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.


title: Thyroid Biological Toxicity and Tumor Response in Patients Treated With NIVOLUMAB 2nd Line in Non-small Cell Bronchopulmonary Cancer

acronym: THYRONIVO

summary: This is an observational, retrospective and monocentric study, conducted at the university Hospital of Brest The primary objective is to assess the association between the occurrence of thyroid dysfunction in patients treated with Nivolumab® for a non-small cell lung cancer and prognosis and therapeutic response The second objective is to assess prognosis and therapeutic response according to severity and subtype of thyroid dysfunction

time_perspective: Retrospective

ipd_sharing_description: All collected data that underlie results in a publication


title: Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus

summary:
An inflammatory state of the nasal cells (very close to keratinocytes) could favour the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.

Staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that colonizes approximately 2 billion people worldwide Staphylococcus aureus is also a leading cause of community and healthcare-associated infection. Staphylococcus aureus has demonstrated its ability to invade many non-professional phagocytic cell lines such as keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. During pro-inflammatory stimulation, internalization of Staphylococcus aureus into keratinocytes is mainly mediated by ICAM-1. These results suggest that, in humans, an inflammatory state of the nasal cells (very close to keratinocytes) could promote the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.

primary_purpose: Diagnostic


title: Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery

acronym: MACS

summary:
to analyze the feasibility for patients with early luminal breast cancer to be compliant with a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before breast cancer surgery.

It's a Pilot study, monocentric, randomized

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.

family: Kushi

full_name: Lawrence H. Kushi

given: Lawrence H.

family: Doyle

full_name: Colleen Doyle

given: Colleen

family: McCullough

full_name: Marji McCullough

given: Marji

family: Rock

full_name: Cheryl L. Rock

given: Cheryl L.

family: Demark-Wahnefried

full_name: Wendy Demark-Wahnefried

given: Wendy

family: Bandera

full_name: Elisa V. Bandera

given: Elisa V.

family: Gapstur

full_name: Susan Gapstur

given: Susan

family: Patel

full_name: Alpa V. Patel

given: Alpa V.

family: Andrews

full_name: Kimberly Andrews

given: Kimberly

family: Gansler

full_name: Ted Gansler

given: Ted

name: The American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee

journal_name: CA: A Cancer Journal for Clinicians

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: American Cancer Society guidelines on nutrition and physical activity for cancer prevention

ReferenceCitation: Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26. Review. Erratum in: CA Cancer J Clin. 2013 May;63(3):215.

family: Meyerhardt

full_name: Jeffrey Meyerhardt

given: Jeffrey

family: Courneya

full_name: Kerry S. Courneya

given: Kerry S.

family: Schwartz

full_name: Anna L. Schwartz

given: Anna L.

family: Hamilton

full_name: Kathryn K. Hamilton

given: Kathryn K.

family: Grant

full_name: Barbara Grant

given: Barbara

ReferenceCitation: Cairns RA, Mak TW. Fire and water: Tumor cell adaptation to metabolic conditions. Exp Cell Res. 2017 Jul 15;356(2):204-208. doi: 10.1016/j.yexcr.2017.04.029. Epub 2017 Apr 27. Review.

ReferenceCitation: Vander Heiden MG, DeBerardinis RJ. Understanding the Intersections between Metabolism and Cancer Biology. Cell. 2017 Feb 9;168(4):657-669. doi: 10.1016/j.cell.2016.12.039. Review.

repository_institution: Massachusetts Institute of Technology - DSpace@MIT

ReferenceCitation: Chen Y, Ling L, Su G, Han M, Fan X, Xun P, Xu G. Effect of Intermittent versus Chronic Calorie Restriction on Tumor Incidence: A Systematic Review and Meta-Analysis of Animal Studies. Sci Rep. 2016 Sep 22;6:33739. doi: 10.1038/srep33739.

ReferenceCitation: Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020. Review.

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

repository_institution: University College London - UCL Discovery

title: Promoting Health and Longevity through Diet: From Model Organisms to Humans

ReferenceCitation: Lv M, Zhu X, Wang H, Wang F, Guan W. Roles of caloric restriction, ketogenic diet and intermittent fasting during initiation, progression and metastasis of cancer in animal models: a systematic review and meta-analysis. PLoS One. 2014 Dec 11;9(12):e115147. doi: 10.1371/journal.pone.0115147. eCollection 2014.

title: Roles of Caloric Restriction, Ketogenic Diet and Intermittent Fasting during Initiation, Progression and Metastasis of Cancer in Animal Models: A Systematic Review and Meta-Analysis

ReferenceCitation: O'Flanagan CH, Smith LA, McDonell SB, Hursting SD. When less may be more: calorie restriction and response to cancer therapy. BMC Med. 2017 May 24;15(1):106. doi: 10.1186/s12916-017-0873-x. Review.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Weber DD, Aminzadeh-Gohari S, Tulipan J, Catalano L, Feichtinger RG, Kofler B. Ketogenic diet in the treatment of cancer - Where do we stand? Mol Metab. 2020 Mar;33:102-121. doi: 10.1016/j.molmet.2019.06.026. Epub 2019 Jul 27. Review.

title: Ketogenic diet in the treatment of cancer – Where do we stand?

ReferenceCitation: A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial

summary: This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.

lead_sponsor: Centre d'Expertise sur l'Altitude EXALT

location_facility: Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley


title: Multicenter RCT Comparing Two Brushes of Different Diameters for Biliary Stenosis: RX Cytology Brush, BOSTON vs. Infinity® Brush, US Endoscopy. BIB Study (BIliary Brushing)

acronym: BIB

summary: The aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years

lead_sponsor: Société Française d'Endoscopie Digestive

intervention_type: Device


title: Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration

summary:
Methodology:

The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations

lead_sponsor: Orphelia Pharma


title: A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction

acronym: EndoPTS

summary: The project will highlight the potential benefit of endovascular therapy on post thrombotic syndrome reduction after proximal iliac DVT. There is actually not real standard of care for the treatment of this pathology. A clear evidence of efficacy of endovascular therapy will be of great benefit for both the patients and the healthcare system, and will provide new data for further international guidelines

lead_sponsor: University Hospital, Grenoble

location_facility: Grenoble-Alps University Hospital (CHUGA)


title: Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.

acronym: MONA

summary:
Background :

Diabetes is correlated to an increase in patient morbidity and mortality. The pathophysiology of diabetes is still poorly understood. Significant variations in blood sugar have been shown over time in patients with cystic fibrosis with or without diabetes. No study has evaluated the association between the nutritional profile and the glucose tolerance in adult with cystic fibrosis, by integrating data on energy consumption (detailed nutritional profile) and energy expenditure (rest energy expenditure, body composition, and physical activity).

Given the epidemiological changes in cystic fibrosis correlated to the increased prevalence of diabetes and the clinical impact of nutritional status, the association between these factors remains to be studied.

Objectives of the study :

- Main objective :

To describe adult patients with cystic fibrosis in terms of :

Nutritional profile
Food behaviour
Physical activity
Rest energy expenditure
Body composition - Secondary objectives : To research the association between the nutritional profile and the glucose tolerance.

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de médecine interne - CRCM Lyon Adultes, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon


title: Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS (Acute Respiratory Distress Syndrome) on SARS-CoV2 Viral Pneumonia Requiring Mechanical Ventilation

acronym: CognitiVID

summary:
The new coronavirus pandemic responsible for the severe acute respiratory syndrome SARS-CoV2 requires, in its severe forms, the use of invasive ventilation in intensive care.

The first patients seen in intensive care presented with neurological symptoms and usually not seen in non-viral ARDS or due to other viral causes. These were mainly restless awakenings, attempts at self-extubation and confusional syndromes. Although the data in the literature do not seem to reveal the presence of SARS-CoV2 in the CSF of these patients, certain elements seem to show parenchymal brain damage with the description of hypometabolism of the frontal regions. In addition, most of these patients present a memory complaint after going into intensive care (personal data not published).

We do not know to date what is the cognitive and psychic profile of these patients, nor what will be their future evolution. Some patients may require specific neuro-cognitive rehabilitation.

The aim of this study is to assess the cognitive profile of patients infected with COVID-19 who have used invasive ventilation in the intensive care unit of Paris Saint-Joseph hospital since April 2020, in order to be able to compare them between them and follow their evolution in the medium term. This work could make it possible to describe the specific cognitive impairment of SARS-CoV2, by trying to evade other causes of cognitive disorders in patients hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic disorders, etc.).

The main objective is to follow the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with the use of ventilatory resuscitation.

ReferenceCitation: Alkeridy WA, Almaghlouth I, Alrashed R, Alayed K, Binkhamis K, Alsharidi A, Liu-Ambrose T. A Unique Presentation of Delirium in a Patient with Otherwise Asymptomatic COVID-19. J Am Geriatr Soc. 2020 Jul;68(7):1382-1384. doi: 10.1111/jgs.16536. Epub 2020 May 16.

name: Department of MedicineKing Saud University Riyadh Saudi Arabia

name: Geriatric Division, Department of MedicineUniversity of British Columbia Vancouver Canada

family: Alkeridy

full_name: Walid A. Alkeridy

given: Walid A.

name: College of Medicine Research CenterKing Saud University Riyadh Saudi Arabia

family: Almaghlouth

full_name: Ibrahim Almaghlouth

given: Ibrahim

family: Alrashed

full_name: Rashed Alrashed

given: Rashed

family: Alayed

full_name: Khalid Alayed

given: Khalid

name: Department of Pathology, College of MedicineKing Saud University Riyadh Saudi Arabia

family: Binkhamis

full_name: Khalifa Binkhamis

given: Khalifa

family: Alsharidi

full_name: Aynaa Alsharidi

given: Aynaa

name: Department of Physical Therapy, Aging, Mobility, and Cognitive Neuroscience Laboratory, Faculty of MedicineUniversity of British Columbia Vancouver Canada

name: Center for Hip Health and Mobility, Vancouver Coastal Health Research InstituteUniversity of British Columbia Vancouver Canada

family: Liu‐Ambrose

full_name: Teresa Liu‐Ambrose

given: Teresa

journal_name: Journal of the American Geriatrics Society

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

title: A Unique Presentation of Delirium in a Patient with Otherwise Asymptomatic COVID ‐19

ReferenceCitation: Helms J, Kremer S, Merdji H, Clere-Jehl R, Schenck M, Kummerlen C, Collange O, Boulay C, Fafi-Kremer S, Ohana M, Anheim M, Meziani F. Neurologic Features in Severe SARS-CoV-2 Infection. N Engl J Med. 2020 Jun 4;382(23):2268-2270. doi: 10.1056/NEJMc2008597. Epub 2020 Apr 15.

name: Strasbourg University Hospital, Strasbourg, France

family: Helms

full_name: Julie Helms

given: Julie

family: Kremer

full_name: Stéphane Kremer

given: Stéphane

family: Merdji

full_name: Hamid Merdji

given: Hamid

family: Clere-Jehl

full_name: Raphaël Clere-Jehl

given: Raphaël

family: Schenck

full_name: Malika Schenck

given: Malika

family: Kummerlen

full_name: Christine Kummerlen

given: Christine

family: Collange

full_name: Olivier Collange

given: Olivier

family: Boulay

full_name: Clotilde Boulay

given: Clotilde

family: Fafi-Kremer

full_name: Samira Fafi-Kremer

given: Samira

family: Ohana

name: University of Strasbourg, Strasbourg, France

ReferenceCitation: Bouattour N, Farhat N, Hadjkacem H, Hdiji O, Sakka S, Dammak M, Mhiri C. [Five-word test calibration in a Tunisian population of healthy subjects]. Pan Afr Med J. 2019 Sep 30;34:58. doi: 10.11604/pamj.2019.34.58.14472. eCollection 2019. French.

title: Étalonnage du test des cinq mots dans une population tunisienne de sujets sains

ReferenceCitation: Maillet D, Matharan F, Le Clésiau H, Bailon O, Pérès K, Amieva H, Belin C. TNI-93: A New Memory Test for Dementia Detection in Illiterate and Low-Educated Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):896-903. doi: 10.1093/arclin/acw065.


title: Study Through Imaging of Mediastinal and Abdominopelvic Secondary Lymphoid Organs (Lymph Nodes) in Patients With Severe Combined Immunodeficiencies (SCID) Who Have Recieved Bone Narrow Allograft

acronym: LymphImaging

summary:
To investigate the presence of seconday of lymphoid organs in patients who underwent allogenic hematopoietic stem cell transplantation 15 to 45 years ago.

The goal aims to assess the development of seconday lymphoid organs given the fact that the absence of myeloablation these patients present a split chimerism between T lymphocytes and the other leucocytes. Thus, they may not be able to generate seconday lymphoid organs. Practically, whole body MRI is being used to visualise and quantify both mediastinal and intraabdominal lymph nodes. Delta will be compared with those obtained in healthy age-matched individuals. It is scheduled to include 15 patients and 15 controls.

ReferenceCitation: Berteloot L, Molina TJ, Bruneau J, Picard C, Barlogis V, Secq V, Abdo C, Boddaert N, Griscelli C, Neven B, Fischer A. Alternative pathways for the development of lymphoid structures in humans. Proc Natl Acad Sci U S A. 2021 Jul 20;118(29). pii: e2108082118. doi: 10.1073/pnas.2108082118.

family: Berteloot

full_name: Laureline Berteloot

given: Laureline

family: Molina

full_name: Thierry Jo Molina

given: Thierry Jo

family: Bruneau

full_name: Julie Bruneau

family: Picard

full_name: Capucine Picard

given: Capucine

family: Barlogis

full_name: Vincent Barlogis

given: Vincent

family: Secq

full_name: Véronique Secq

given: Véronique

family: Abdo

full_name: Chrystelle Abdo

given: Chrystelle

family: Boddaert

full_name: Nathalie Boddaert

given: Nathalie

family: Griscelli

full_name: Claude Griscelli

given: Claude

family: Neven

full_name: Bénédicte Neven

given: Bénédicte

family: Fischer

full_name: Alain Fischer

given: Alain

bso_classification: Biology (fond.)

journal_name: Proceedings of the National Academy of Sciences

lead_sponsor: Association Pour l'Aide a la Recherche en Immunologie Pediatrique


title: Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM

acronym: RIPHIGEO

summary: Cerebral palsy is the most frequent motor deficiency in children. Among other, it can leads to spastic diplegia or hemiplegia. Walking abilities is an important skill to the families' point of view in term of independence in curent life. Improving the walking parameters has been the main objective in several studies of rehabilitation. The G-EO system is a last generation robot assisting gait training that can adjust cadence, walk lengh, ankle and hip angles and other walking parameters to movement captation. Its superiority in terms of walking abilities has been demonstrated in adults with stroke sequelae. Only one study was realized in pediatric patients with spastic diplegia with promising results. The investigators hypothesize that intensive robot-assited gait training using the G-EO system in hemiplegic children can improve their walking abilities.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Retrospective Study Assessing the Concordance of the IHC4 Score Performed in Local Pathology Laboratory or in a Central Laboratory to a Molecular Gold Standard Test Endopredict in Breast Cancer Infiltrating ER+ HER2-

acronym: GEFPICS IHC4

summary: Retrospective observational, multicentric study assessing the immunohistochemistry (IHC) based test IHC4 score in infiltrating early breast cancer: comparison of the score performed in local laboratory vs in a central laboratory and concordance with a molecular gold standard classifier (EndoPredict).

status: Active, not recruiting

lead_sponsor: UNICANCER


title: Interest of a Period of Fasting Before Extubation in Resuscitation Patients: a Prospective Observational Study

acronym: NUTRIGUS

summary:
Orotracheal extubation in resuscitation is a situation in which there is an elevated risk of inhalation. In resuscitation, enteral nutrition that is administered in a continuous flow is likely to accumulate in the stomach. Gastric motility in resuscitation patients may be impaired for many reasons:

Iatrogenic: Catecholamines, sedatives and opioids slow down the digestive system and decrease the tone of the lower esophageal sphincter
Shock, polytrauma, sepsis, pain or discomfort, or mechanical ventilation again create an alteration in gastric emptying.

Enteral nutrition is commonly discontinued to manage extubation, but it is not systematic. Discontinuation leads to a decrease in caloric intake.

Gastric ultrasound is a minimally invasive, reliable and promising means of monitoring that allows the stomach to be visualized directly. Studies on healthy subjects and in anaesthesia have made it possible to validate ultrasound in the context of the study of gastric content using both quantitative (including measurement of the antral area) and qualitative criteria. Measurement of the antral area was also studied in resuscitation. Antral area and gastric volume are closely related, with a correlation coefficient ranging from 0.6 to 0.91.

Identifying patients at risk of inhalation by ultrasound could allow individualized enteral nutrition management prior to extubation in the resuscitation unit, and thus optimize nutritional management.

The objective of the study is to identify factors associated with greated antral area in patients hospitalized in the intensive care unit. The hypothesis is that continued enteral nutrition before extubation is associated with increased gastric volume as measured by ultrasound.

ReferenceCitation: Nguyen M, Drihem A, Berthoud V, Dransart-Raye O, Bartamian L, Gounot I, Guinot PG, Bouhemad B. Fasting does not guarantee empty stomach in the intensive care unit: A prospective ultrasonographic evaluation (The NUTRIGUS study). Anaesth Crit Care Pain Med. 2021 Nov 4;40(6):100975. doi: 10.1016/j.accpm.2021.100975. [Epub ahead of print]

family: Nguyen

full_name: Maxime Nguyen

given: Maxime

family: Drihem

full_name: Anne Drihem

given: Anne

family: Berthoud

full_name: Viven Berthoud

given: Viven

family: Dransart-Raye

full_name: Ophélie Dransart-Raye

given: Ophélie

family: Bartamian

full_name: Loic Bartamian

given: Loic

family: Gounot

full_name: Isabelle Gounot

given: Isabelle

family: Guinot

full_name: Pierre-Grégoire Guinot

given: Pierre-Grégoire

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

journal_name: Anaesthesia Critical Care & Pain Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique

acronym: NEEDLE-VISIO

summary: Real-time ultrasound guidance for central venous catheter catheterism is recommended in order to reduce complication, in particular for internal jugular site1. Nevertheless, the usefulness of ultrasound guidance for subclavian approach remains controversial, in particular because needle visualisation is more complex as compared to jugular site2,3. New magnetic devices (Needle-pilotTM device, Samsung Healthcare) could theoretically allow a better needle visualisation and a better success rate. The investigators hypothesize that such device could improve the feasibility of subclavian catheterism. As this device has not been evaluated in patients, the investigators decided to perform a simulation study on a human torso mannequin. This methodology has been already used by Vogel et al in 20154. The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilot™ device.

ReferenceCitation: Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1:CD011447. doi: 10.1002/14651858.CD011447. Review.

ReferenceCitation: Jiang L, Zhang M, Ma Y. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis: Several Facts Need To Be Noticed. Crit Care Med. 2015 Oct;43(10):e474-5. doi: 10.1097/CCM.0000000000001071.

ReferenceCitation: Vogel JA, Haukoos JS, Erickson CL, Liao MM, Theoret J, Sanz GE, Kendall J. Is long-axis view superior to short-axis view in ultrasound-guided central venous catheterization? Crit Care Med. 2015 Apr;43(4):832-9. doi: 10.1097/CCM.0000000000000823.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes, Hôpital Universitaire Carémeau


title: Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer

acronym: IPSYLON

summary: The cancer diagnostic announcement and cancer care are both physical and psychological highlights. The main objective is to analyze significant psychological difficulties in children aged 6 to 16 treated for cancer.

status: Terminated

lead_sponsor: Centre Leon Berard

status_simplified: Unknown


title: Prospective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic Sclerosis

acronym: SCLERAMAC

summary: To define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse cutaneous or interstitial lung damage of systemic sclerosis.

ReferenceCitation: van Gelder T, Le Meur Y, Shaw LM, Oellerich M, DeNofrio D, Holt C, Holt DW, Kaplan B, Kuypers D, Meiser B, Toenshoff B, Mamelok RD. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit. 2006 Apr;28(2):145-54. Review.

ReferenceCitation: Zahr N, Arnaud L, Marquet P, Haroche J, Costedoat-Chalumeau N, Hulot JS, Funck-Brentano C, Piette JC, Amoura Z. Mycophenolic acid area under the curve correlates with disease activity in lupus patients treated with mycophenolate mofetil. Arthritis Rheum. 2010 Jul;62(7):2047-54. doi: 10.1002/art.27495.

ReferenceCitation: Chaigne B, Gatault P, Darrouzain F, Barbet C, Degenne D, François M, Szymanski P, Rabot N, Golea G, Diot E, Maillot F, Lebranchu Y, Nivet H, Paintaud G, Halimi JM, Guillevin L, Büchler M. Mycophenolate mofetil in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis: a prospective pharmacokinetics and clinical study. Clin Exp Immunol. 2014 May;176(2):172-9. doi: 10.1111/cei.12246.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission

acronym: Nutriker

summary:
Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.

This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.

lead_sponsor: Rennes University Hospital


title: Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD

acronym: iPACT

summary: Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. PACT is the therapy with the highest evidences when Parents delivered the intervention themselves.

ReferenceCitation: Jurek L, Occelli P, Denis A, Amestoy A, Maffre T, Dauchez T, Oreve MJ, Baghdadli A, Schroder C, Jay A, Zelmar A, Revah-Levy A, Gallifet N, Aldred C, Garg S, Green J, Touzet S, Geoffray MM; IFPAD study group. Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol. BMJ Open. 2021 Apr 7;11(4):e044669. doi: 10.1136/bmjopen-2020-044669.

family: Jurek

full_name: Lucie Jurek

given: Lucie

family: Occelli

full_name: Pauline Occelli

given: Pauline

family: Denis

full_name: Angelique Denis

given: Angelique

family: Amestoy

full_name: Anouck Amestoy

given: Anouck

family: Maffre

full_name: Thierry Maffre

given: Thierry

family: Dauchez

full_name: Tom Dauchez

given: Tom

family: Oreve

full_name: Marie-Joelle Oreve

given: Marie-Joelle

family: Baghdadli

full_name: Amaria Baghdadli

given: Amaria

family: Schroder

full_name: Carmen Schroder

given: Carmen

family: Jay

full_name: Agathe Jay

given: Agathe

family: Zelmar

full_name: Amélie Zelmar

given: Amélie

family: Revah-Levy

full_name: Anne Revah-Levy

family: Gallifet

full_name: Natacha Gallifet

given: Natacha

family: aldred

full_name: Catherine aldred

given: Catherine

family: Garg

full_name: Shruti Garg

given: Shruti

family: Green

full_name: Jonathan Green

given: Jonathan

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

family: Geoffray

full_name: Marie-Maude Geoffray

given: Marie-Maude

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ


title: Observational Study of the Pharmacological Reversal of the Residual Neuromuscular Blockade in Bariatric Surgery

acronym: NEOCURE

summary:
Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage.

According to the French guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. In morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. To calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight.

Due to this practice variability, It may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.

lead_sponsor: Poitiers University Hospital


title: Cognitive Functions in Adults With Sickle Cell Disease and Cognitive Complaints: Neuropsychological Assessment and Links to Demographic, Clinical, Biological, Neuroradiological Outcomes and Validation of a Cognitive Assessment Tool.

acronym: Drépa-COG

summary:
Sickle cell disease (SCD) is an inherited blood disorder. Symptoms include acute and chronic complications. Due to progress in SCD care, patients with SCD are living longer than before and we focus more attention in chronic complications.

Children with SCD experience worse cognitive functions than healthy children, and fewer is known about cognitive functions in adults. Studies suggest lower cognitive performance in SCD, mostly in executive functions and processing speed, but the biological and anatomical substrates of cognitive decline are not yet well established in SCD. Often times, cognitive impairments and cerebral disorders are not diagnosed and treated in adults with SCD.

The main objective of this study is to propose a deep neuropsychological assessment in adults with SCD and cognitive complaints and to highlight links between cognitive functions and clinical, biological and neuroradiological markers. The hypothesis of this study is that cognitive functions are associated with severity of the SCD, with bood abnormalities, with MRI markers and Transcranial Doppler (TCD) markers of cerebrovascular disease. The secondary objective of this study is to validate a brief cognitive assessment tool (BEARNI tool) in adults with SCD.

This study is an observational cross-sectional study that will enroll adults with SCD and cognitive complaint.

intervention_type: Behavioral


title: Virtual Reality for Preoperative Anxiety in Interventional Cardiology

acronym: No PANIC

summary: Improving the management of perioperative anxiety is important. Anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. These findings are also true in interventional cardiology. That is why, for several months, the Grenoble University hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). Following a survey of the patients of Grenoble university hospital, a gray area persists in their care. The room where the patient attends his examination. The investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.


title: Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors

acronym: RASTAF

summary:
Hepatic metastases are common in solid cancers (up to 30% of patients with colorectal cancer and up to 50% of patients during their follow-up). The incidence of primary liver cancer increases due to the increase in chronic liver diseases induced by excessive alcohol consumption, hepatitis B and C viruses, and excess fat in the liver. Surgical excision of these liver lesions is the reference treatment but it cannot always be realised.

Stereotactic radiotherapy is a recent technique proposed to hepatic metastases treatment from solid cancers and primary hepatic lesions (HCC or cholangiocarcinomas); it is possible to deliver high doses of radiation in the most conformational way possible in order to limit the irradiation of the non-tumor liver. The results of this stereotactic radiotherapy are currently very good with control rates of 75 to 80% at 1 and 2 years with acceptable rates of severe toxicities of 10%. However, the fear of hepatic, digestive (colon, esophagus, stomach) or even cardiac toxicities limits its using to the majority of patients because coupled with a conventional scanner it do not allow direct visualization of the lesion.

Due to its non-irradiating nature, MRI guided stereotactic radiotherapy can generate continuous imaging, during the irradiation session, offering " in live " a visualization of the tumor target and organs at risk of proximity. In increasing the precision and safety in the delivery of irradiation, it allows to hope for several areas for improvement of treatment:

reduced uncertainty margins
an increase in the dose delivered
the accessibility of tumor lesions near sensitive organs (esophagus, stomach, heart chambers, intestines, duodenum, right kidney).

More, this accelerator allows a re-optimization of the initial dosimetric plan to the anatomical changes of the day to allow an MRI guided adaptive radiotherapy.

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Radiation


title: Electrocardiogram in General Practice : the EGG Study

acronym: EGG

summary:
Existing resources to assist interpretation of ElectroCardioGram (ECG) in general practice provide specialized and comprehensive reading based on pathologies and ElectroCardioGram (ECG) signs rather than ElectroCardioGram (ECG) indications.

Describing practices in general medicine could help prioritize the relevance of clinical and ECG signs for the general practitioner, enabling to adjust the reading given the context.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Episodic Specificity Induction: Research of Its Explanatory Mechanisms and Application to Normal and Pathological Ageing.

acronym: INSPE

summary: Episodic Specificity Induction (ESI) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. But it remains to be determined 1) whether the mechanisms targeted by the ESI affect memory or executive functioning and 2) whether amnestic type (aMCI) or dysexecutive type (dMCI) mild cognitive impairment patients would benefit differently from this training, which has never been tested. By comparing the effect of the ESI on these patients, this would open up new perspectives for their symptomatic care.

location_facility: Centre Mémoire Ressources Recherche de Lyon, Institut du Vieillissement, Hôpital des Charpennes


title: Metacognition Assessment in Patient With Multiple Sclerosis

acronym: METACOGSEP

summary: This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.

ReferenceCitation: Calabrese P. Neuropsychology of multiple sclerosis--an overview. J Neurol. 2006 Feb;253 Suppl 1:I10-5. Review.

ReferenceCitation: Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X. Review.

ReferenceCitation: Beatty WW, Monson N. Metamemory in multiple sclerosis. J Clin Exp Neuropsychol. 1991 Mar;13(2):309-27.


title: Multimarker Approach for Acute Dyspnea in Elderly Patients Admitted in the Emergency Department

acronym: READ-MA

summary:
Elderly people constitute the largest proportion of emergency department (ED) patients, representing 12% of all ED admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for ED admission, and patients suffering from cardiovascular disease are those whose ED visit lasts longest.

The diagnostic approach in the ED in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.

Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides alone suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.

Some authors have studied other biomarkers showing their performance in the diagnosis of ALSHF. These are biomarkers involved in remodeling and myocardial fibrosis (ST2, Galectin-3) or involved in myocardial injury (High-sensitivity Troponin-I).

Therefore, a combined "multimarker" approach could improve the diagnostic performance of ALSHF.

READ (NCT02531542) is a diagnostic study including patients over the age of 75 admitted to acute dyspnea in the ED, to demonstrate the superiority of an ultrasound protocol (the READ protocol) on NT-proBNP in the ALSHF diagnosis.

The hypothesis is that the diagnostic accuracy of a multimarker diagnostic approach, namely the READ-MA method, combining NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3 would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to the ED.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Evaluation of an Immersive Audiovisual Distraction Device Impact on Peroperative Opioid Consumption. A Prospective Randomized Controlled Study

acronym: AmbuCineView

summary:
This study evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption for outpatient procedures with Remifentanil added to local anesthesia.

Half of patients will receive an audiovisual distraction device while the other half not.

ReferenceCitation: Marsdin E, Noble JG, Reynard JM, Turney BW. Audiovisual distraction reduces pain perception during shockwave lithotripsy. J Endourol. 2012 May;26(5):531-4. doi: 10.1089/end.2011.0430. Epub 2012 Feb 8.

ReferenceCitation: Lee DW, Chan AC, Wong SK, Fung TM, Li AC, Chan SK, Mui LM, Ng EK, Chung SC. Can visual distraction decrease the dose of patient-controlled sedation required during colonoscopy? A prospective randomized controlled trial. Endoscopy. 2004 Mar;36(3):197-201.

ReferenceCitation: Eccleston C, Crombez G. Pain demands attention: a cognitive-affective model of the interruptive function of pain. Psychol Bull. 1999 May;125(3):356-66. Review.

ReferenceCitation: Boselli E. Interest of Analgesia/Nociception Index (ANI) for monitoring the relative parasympathetic tone in anesthetized and awake patients. Douleurs (Paris) (2018)

ReferenceCitation: Boselli et al. Analgesia monitoring using Analgesia/Nociception Index: Results of clinical studies in awake and anesthetized patients. Le Praticien en anesthésie réanimation. 2015;19:78-86

ReferenceCitation: Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971.

ReferenceCitation: Papaioannou V, Chouvarda I, Gaertner E, Benyamina M, Ferry A, Maurel V, Soussi S, Blet A, Chaouat M, Plaud B, Mebazaa A, Legrand M; PRONOBURN Group. Heart rate variability and cardiac baroreflex inhibition-derived index predicts pain perception in burn patients. Burns. 2016 Nov;42(7):1445-1454. doi: 10.1016/j.burns.2016.04.017. Epub 2016 May 8.

ReferenceCitation: Issa R, Julien M, Décary E, Verdonck O, Fortier LP, Drolet P, Richebé P. Evaluation of the analgesia nociception index (ANI) in healthy awake volunteers. Can J Anaesth. 2017 Aug;64(8):828-835. doi: 10.1007/s12630-017-0887-z. Epub 2017 Apr 21.

ReferenceCitation: Boselli E, Musellec H, Martin L, Bernard F, Fusco N, Guillou N, Hugot P, Paqueron X, Yven T, Virot C. Effects of hypnosis on the relative parasympathetic tone assessed by ANI (Analgesia/Nociception Index) in healthy volunteers: a prospective observational study. J Clin Monit Comput. 2018 Jun;32(3):487-492. doi: 10.1007/s10877-017-0056-5. Epub 2017 Aug 20.

ReferenceCitation: Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloë PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.

ReferenceCitation: Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137. Review.

ReferenceCitation: Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914. Review.

ReferenceCitation: Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.

ReferenceCitation: Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.

ReferenceCitation: Abend R, Dan O, Maoz K, Raz S, Bar-Haim Y. Reliability, validity and sensitivity of a computerized visual analog scale measuring state anxiety. J Behav Ther Exp Psychiatry. 2014 Dec;45(4):447-53. doi: 10.1016/j.jbtep.2014.06.004. Epub 2014 Jun 18.

ReferenceCitation: Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41.

ReferenceCitation: Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12.

ReferenceCitation: Wismeijer AA, Vingerhoets AJ. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268-78. Review.

lead_sponsor: University Hospital, Caen


title: Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.

acronym: ESPACE

summary: The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling

acronym: CoviDiagMS

summary:
Since March 2020, SARS-CoV2 virus (nCoV19; COVID-19) is considered pandemic. Its high rate of spread and infection in the human population and the lack of effective and validated treatment have led the authorities of several countries to confine their populations to slow the spread of COVID-19. As part of the management of this health crisis, the screening of individuals is essential in order to isolate "infected cases". These screening tests are currently performed on nasopharyngeal swabs using RT-PCR for the detection of viral RNA. Although sensitive and specific, these tests remain relatively long (2-5 hours), expensive and the strong international demand for nucleic extraction kits and enzymes are factors limiting the implementation of widespread screening (problem of supply of swabs, molecular biology consumables).

In order to prevent the risks of a shortage of screening means, we propose to develop an innovative alternative strategy, PCR-free, based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status (oral pathologies) based on the analysis of their saliva, but also as a tool for the identification of respiratory viruses from cell culture supernatants. In addition, we have expertise and skills in the field of MALDI-TOF MS profiling and have implemented new strategies to improve the quality of profiles and their analysis, particularly in the context of entomological and vector identification projects. Finally, recent Chinese studies have reported that COVID-19 was detectable in saliva by RT-PCR.

The main objective of this study is to develop a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Laveran


title: Results of FilmArray® Gastro-intestinal Panel (GI Panel) and Serum Procalcitonin (PCT) in Acute Colitis and Infectious Diarrhea in the Emergency Department.

acronym: PRODIARRAY

summary:
Acute diarrhea and acute colitis of infectious origin are common reasons for consultation at the emergency department. The current etiological diagnostic approach is limited to the determination of markers of inflammation, such as CRP and blood leukocytes, which lack specificity and sensitivity for bacterial infection. The stool culture can detect bacterial pathogens in the stool with a result at least 48 hours later and a positivity rate <50%.

This study will describe the procalcitonin (PCT) concentrations (a biomarker of bacterial infection) in this population to evaluate its usefulness depending on the viral or bacterial etiology identified by stool multiplex gastro-intestinal PCR panel (GI panel) and stool culture.

The investigators hypothesize that PCT levels will be higher if the GI panel or the stool culture identifies a bacteria or a parasite, as it is the case in respiratory tract infections. If there is a detection of a virus by the GI panel or both the stool culture and the GI panel are negative, the investigators expect that PCT values will be lower or negative.

the investigators will include the patients admitted to the ED with a suspicion of infectious diarrhea or acute colitis in order to have a large representative panel of infectious diarrhea etiologies.

Only the patients having a blood sample prescribed as the routine care will be included. The blood sample is useful for dosing CRP and whole blood cell count (WBC), which are part of current biologic analyses performed in this context. After getting the patient's consent, the investigator will add the PCT dosage in blood sampling and will ask the patient to provide a stool sample, in order to have a stool culture and to perform an extended investigation for the pathogens through multiplex PCR technology (Filmarray ®GI panel).

The physician will be asked if all these results (the ones ordered currently together with the dosage of PCT and the GI panel) will change his/her decision to start an antibiotic.

Patients will receive a phone call at day 15 after their initial admission in the emergency department and will be asked if he/she has consulted a new physician or if a new treatment by antibiotics was started.

Data collection procedures: Data from the medical file will be collected by the investigators and the emergency department clinical research assistant. All the data will be pseudonymized. The collection will be done at the day of admission in the emergency department and after the phone interview at Day15.


title: Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols

acronym: SOUMO

summary:
Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.

The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.

lead_sponsor: Hôpital le Vinatier


title: Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.

acronym: RECHOBIOL

summary: Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period <48 hours in case of pPROM.


title: Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home

acronym: Frailcoach

summary:
Since the last few decades, developed societies have been evolving towards a global aging of their populations. This evolution has been accompanied by the problematic of the dependence of aging populations. Dependence is today a challenge posed to social, healthcare or medico-social organizations.

Many studies have shown the positive effect of changes in health (physical activity, nutrition, socialization) on functional abilities of aged subjects. Intervention at subject's home is an easy and inexpensive way to delay the onset of dependence in the elderly population. Health coaching is defined as "a regular series of phone calls between the patient and the health care professional to support and encourage the patient and promote healthy behaviors such as treatment control, healthy eating and physical activity ".

lead_sponsor: CHU de Reims


title: Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers

acronym: ProVegOmics

summary:
The dietary shift from animal to plant protein sources is one of the key aspects of the nutritional transition towards more sustainable food system and diets. However the metabolic implication of this shift in protein sources are still poorly understood.

This project aims to characterize and understand the metabolic orientations specifically induced by animal and vegetable dietary proteins, in order to better analyze the metabolic reorientations that would result from the expected increase in the share of plant proteins in different dietary contexts, especially those of the Western type, often associated with the development of metabolic deregulations (obesity and cardiometabolic risk).


title: Evaluation of Staple Watson Wrist Arthrodesis

acronym: ESWWA

summary:
When the wrist is damaged, for traumatic or degenerative reasons, the cartilage is worn out and the bones rub together: this is osteoarthritis. In order to stop this pain, it may be necessary to block these bones from each other, sacrificing mobility to achieve indolence.

Multiple techniques are described according to the type of osteoarthritis and for each type of osteoarthritis itself, but the principle remains the same. The methods currently commonly proposed are the staple and the screwed plate.

The aim of the study is to evaluate the surgical practice of the Orthopaedics and Traumatology department of the University Hospital of Rennes, and its long-term results, as this type of surgery is intended to be definitive.


title: Feasibility Study of an Adapted and Supported Water Polo Program to Reduce Fatigue Related to Cancer and Improve Psychological and Social Recovery in Patients With Breast Cancer Remission

acronym: AQUA-POLO

summary: The main objective of the study is to assess the feasibility of a coached physical activity program in the form of an accompanied and adapted water polo program by evaluating the interest aroused in patients for this proposal. treatments (number of participants and sessions performed).

lead_sponsor: Institut Paoli-Calmettes


title: Multimodal Analysis of Ocular Surface for Screening Dry Eye Disease

acronym: MAOS-S

summary: Two methods allow to evaluate tear breakup time (BUT): without prior dye instillation (No Dye BreakUp Time NDBUT) or after fluorescein instilation (FBUT). The interconnections between those two values are unknown

location_facility: Opthtalmology Departement, Bicêtre Hospital


title: CAncer, NUtrition and Taste - Validation of the CANUT-QVA Questionnaire on Eating Habits in Cancer Patients

acronym: CANUT-QVA

summary:
Cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, Ear Nose and Throat (ENT), bronchial tubes). This undernutrition leads to major weight loss and cachexia, and may represent the first sign of a call for a diagnosis of cancer. Cancer-related undernutrition is multi-factorial origins and has multiple consequences.

Chemotherapy treatments can induce various adverse effects in patients, including sensory disturbances at the beginning of treatment in addition to disturbances that may already be present before any treatment. The alteration of taste and odour, observed in 86% of patients, can induce a change in food preferences, promote the development of aversions, and therefore, lead to a significant reduction in the pleasure of eating. Loss of appetite, decreased food intake and the development of aversions to certain foods are situations experienced by a large proportion of patients treated with chemotherapy.

The assessment of taste disorders in patients treated with chemotherapy is established through the use of questionnaires, interviews and taste tests.

Changes in the perception and identification of salty, sweet, bitter and sour flavours are common in patients treated with chemotherapy.

As regards food products, patients report developing olfactory hypersensitivity mainly for food of animal origin, in particular for odours of fish, frying, cheese and eggs.

The CANUT project aims to study the effect of pathology and chemotherapy on gustatory and olfactory mechanisms, and in particular on interindividual differences in the perception and appreciation of food.

In order to monitor the evolution of patients' eating habits over time, the diet-related quality of life questionnaire (CANUT-QVA) was constructed from items selected from the Well-being related to Food questionnaire (WELLBFQ) after eliminating questions that were too general or expressed in terms of importance to use perception-related responses as a priority.

After this part, an evaluation of the 9 dimensions of the CANUT-QVA questionnaire will be performed.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud, Service pneumologie


title: Computer-assisted Fetal Monitoring - Cardiology

acronym: SURFAO-CARDIO

summary:
In the context of fetal heart monitoring (prenatal and during childbirth), the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from non-invasive sensors on the maternal abdomen, a fetal electrocardiogram (ECGf) of great quality allowing a clinical diagnosis (follow-up of the FHR (Fetal Heart Rate)) and extraction of ECG waveforms).

The approach proposes a technological breakthrough shared by a consortium of researchers and clinicians. The originality is driven by innovative methodological choices: the use of a multimodal system (ECG coupling with PCG (phonocardiography)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need to support the monitoring process, and by setting up a multimodal database.

The objective is to feed a database that will be used in the future to develop ECGf extraction methods.

ReferenceCitation: Noorzadeh S, Rivet B, Gumery PY. An application of Gaussian processes on ocular artifact removal from EEG. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:554-7. doi: 10.1109/EMBC.2015.7318422.

family: Noorzadeh

full_name: Saman Noorzadeh

given: Saman

family: Rivet

full_name: Bertrand Rivet

given: Bertrand

family: Gumery

full_name: Pierre-Yves Gumery

given: Pierre-Yves

genre: proceedings

genre_raw: proceedings-article

journal_name: 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC)

oa_host_type: repository

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

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

publisher: IEEE

publisher_dissemination: IEEE

publisher_group: IEEE

publisher_normalized: IEEE

ReferenceCitation: Noorzadeh S, Niknazar M, Rivet B, Fontecave-Jallon J, Gumery PY, Jutten C. Modeling quasi-periodic signals by a non-parametric model: application on fetal ECG extraction. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1889-92. doi: 10.1109/EMBC.2014.6943979.

family: Niknazar

full_name: Mohammad Niknazar

given: Mohammad

family: Fontecave-Jallon

full_name: Julie Fontecave-Jallon

given: Julie

family: Jutten

full_name: Christian Jutten

given: Christian

journal_name: 2014 36th Annual International Conference of the IEEE Engineering in Medicine and Biology Society

title: Modeling quasi-periodic signals by a non-parametric model: Application on fetal ECG extraction

lead_sponsor: University Hospital, Grenoble


title: PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

acronym: MacroSAS

summary:
Obstructive sleep apnea (OSA) syndrome is associated with increased vascular dysfunction and atherosclerosis. Especially, it has been shown that OSA associated intermittent hypoxia represents a pro inflammatory stimulus resulting in macrophage polarization.

Protein tyrosine phosphatase 1B (PTP1B) is a negative regulator of insulin signaling pathways involved in atherosclerosis. It has been shown that myeloid PTP1B deficiency protects against atherosclerosis.

As hypoxia has also been shown to increase PTP1B expression and activity, this study will evaluate the myeloid PTP1B expression and activity in patients with OSA as compared to controls and will investigate myeloid PTP1B involvement in the vascular pro inflammatory precess described in OSA.

lead_sponsor: University Hospital, Angers


title: Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa

acronym: BodyBabe

summary:
The BodyBabe studies aims to evaluate the perceptions that young mothers with anorexia nervosa (active or in remission) have of their own body and of the body of their child. The evaluations are carried out with self-assessment questionnaires and silhouette scales at three time points: D0 (during the stay at the maternity hospital), D15 (15 days after delivery) and M9 (9 months after delivery).

The output expected from this study is to validate a questionnaire to help healthcare providers to adapt their care of women with anorexia nervosa during the pregnancy and the post-partum period.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Fixation of the Orogastric Tube: Which Method for the Newborn ?

acronym: BABAFIX

summary:
It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.

To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.

Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.

The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes: a Randomized Controlled Trial vs Usual Care

acronym: CLOSEAP+

summary:
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated T2D patients.

A wide acceptance of the AP usage in T2D care will strongly depend on the identification of subpopulations and care settings where the AP could significantly improve the risk- and cost-benefit balances of T2D management as compared to established practice.

The aim of this interventional study, therefore, is to investigate whether a therapeutic solution combining an automated insulin delivery AP system with a tailored HHP service can improve blood glucose control, reduce the rate of acute metabolic complications (hypoglycaemia and hyperglycaemia), improve both the patients quality of life and experience, and reduce the healthcare related costs in patients with uncontrolled Type 2 Diabetes needing home nursing care for their daily insulin treatment versus usual care.

lead_sponsor: Air Liquide Santé International


title: Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins

summary:
The incidence of twin pregnancies has increased and currently accounts for 1.8% of all deliveries. 47.5% of twins are born prematurely (vs. 6% for singletons) of which 9.9% before 32SA. Caesarean section rates are also higher than for singletons (53.7% vs 19.2%) and 31.8% of caesarean sections are performed before delivery.

The optimal mode of delivery for preterm twins remains controversial. The latest recommendations for clinical practice emphasize that it is not appropriate to recommend one mode of delivery rather than another in the case of twin pregnancies at any term.

In view of all these elements, we wished to carry out a retrospective study at the Montpellier University Hospital in order to compare the neonatal outcome of preterms twins according to their mode of delivery : planned vaginal delivery versus planned cesarean delivery.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: T Cell/B Cell Collaboration in Multiple Sclerosis: Exploring an Intimate Relationship

acronym: MUST-BE

summary: This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level.

time_perspective: Other

lead_sponsor: Rennes University Hospital


title: Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)

acronym: CHIC

summary: Cardiac surgery needs the use of cardiopulmonary bypass. During this time, it is necessary to prevent thrombosis with high level of heparin and to control the good efficiency with a point of care test. Investigators want to test if two different devices, Hemochron and Istat, are giving similar results.

location_facility: Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL


title: Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification

acronym: DEFI

summary: The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.

lead_sponsor: YSLab


title: E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study

acronym: EPOPEE

summary:
This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .

45 patients will be included.

Patients will be followed during 6 months.

primary_purpose: Health Services Research

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: T-piece Versus Pressure-support for the Spontaneous Breathing Trial Before Extubation in Patients at High-risk of Reintubation: a Multicenter Randomized Controlled Trial

acronym: TiP-Ex

summary:
The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.

To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.

Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.

ReferenceCitation: Thille AW, Coudroy R, Gacouin A, Ehrmann S, Contou D, Dangers L, Romen A, Guitton C, Lacave G, Quenot JP, Lacombe B, Pradel G, Terzi N, Prat G, Labro G, Reignier J, Beduneau G, Dellamonica J, Nay MA, Rouze A, Delbove A, Sedillot N, Mira JP, Bourenne J, Lautrette A, Argaud L, Levrat Q, Devaquet J, Vivier E, Azais MA, Leroy C, Dres M, Robert R, Ragot S, Frat JP; REVA research network. T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX). BMJ Open. 2020 Nov 24;10(11):e042619. doi: 10.1136/bmjopen-2020-042619.

family: Thille

full_name: Arnaud W Thille

given: Arnaud W

family: Coudroy

full_name: Rémi Coudroy

given: Rémi

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Contou

full_name: Damien Contou

given: Damien

family: Dangers

full_name: Laurence Dangers

given: Laurence

family: Romen

full_name: Antoine Romen

given: Antoine

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Lacave

full_name: Guillaume Lacave

given: Guillaume

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Lacombe

full_name: Béatrice Lacombe

given: Béatrice

family: Pradel

full_name: Gael Pradel

given: Gael

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

family: Prat

full_name: Gwenael Prat

given: Gwenael

family: Labro

full_name: Guylaine Labro

given: Guylaine

family: Reignier

full_name: Jean Reignier

given: Jean

family: Beduneau

full_name: Gaetan Beduneau

given: Gaetan

family: Dellamonica

full_name: Jean Dellamonica

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Rouze

full_name: Anahita Rouze

given: Anahita

family: Delbove

full_name: Agathe Delbove

family: Sedillot

full_name: Nicholas Sedillot

given: Nicholas

family: Mira

full_name: Jean-Paul Mira

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

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

ipd_sharing_description: Data will be made available after reasonable request and it has been discussed among the steering committee


title: Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age.

acronym: TDR-Arthrite

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

summary:
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm".

The aims of this study are:

To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU
To identify specific risk factors for AKI
To explore pathophysiologic mechanism of AKI during COVID-19 infection

location_facility: Intensive care units attached to the Hospices Civils de Lyon (HCL)


title: Bringing Semi-quantitative PET-TDM FDG Data and Texture Analysis to Clinical, Histological and Immuno-histochemical Characteristics of Primary Mammary Tumors Triple Negatives

acronym: FICTION

summary:
"Triple Negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the HER-2 gene. This type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. Accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. Such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging.

The investigator's goal is to characterize by innovative methods (anatomo-pathological in particular Of Immunohistochemistry, and morpho-functional imaging (TEP-TDM FDG) semi-quantitative and texture) in a population of Triple Negative Breast Cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.

lead_sponsor: Institut Cancerologie de l'Ouest


title: The Use of Neuromuscular Blockade Monitor as a Strategy for Neuromuscular Blockade Agents Saving in ICU COVID-19 Patients

acronym: TOF-COVID

summary:
This is a retrospective case-controlled study of the effect of the use of a neuromuscular blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.

The use of NMB agents during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of NMB agents. Large amount of such patient admitted in a short time has led to a shortage of NMB agents, particularly cisatracurium.

The use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists.

The aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.

location_facility: Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon


title: Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives

acronym: DIABPCO

summary: The aim of this study is to evaluate if the participation of COPD patients to a workshop on advance directives increases the number of patients who write them.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire


title: Development of a Monocentric and Prospective Clinical and Biological Database in Sarcoma

acronym: BCBSarcome

summary: A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Sarcoma

ReferenceCitation: Ducimetière F, Lurkin A, Ranchère-Vince D, Decouvelaere AV, Péoc'h M, Istier L, Chalabreysse P, Muller C, Alberti L, Bringuier PP, Scoazec JY, Schott AM, Bergeron C, Cellier D, Blay JY, Ray-Coquard I. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PLoS One. 2011;6(8):e20294. doi: 10.1371/journal.pone.0020294. Epub 2011 Aug 3.

family: Ducimetière

full_name: Françoise Ducimetière

given: Françoise

family: Lurkin

full_name: Antoine Lurkin

family: Ranchère-Vince

full_name: Dominique Ranchère-Vince

given: Dominique

family: Decouvelaere

full_name: Anne-Valérie Decouvelaere

given: Anne-Valérie

family: Péoc'h

full_name: Michel Péoc'h

given: Michel

family: Istier

full_name: Luc Istier

given: Luc

family: Chalabreysse

full_name: Philippe Chalabreysse

given: Philippe

family: Muller

full_name: Christine Muller

given: Christine

family: Alberti

full_name: Laurent Alberti

given: Laurent

family: Bringuier

full_name: Pierre-Paul Bringuier

given: Pierre-Paul

family: Scoazec

full_name: Jean-Yves Scoazec

given: Jean-Yves

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

family: Bergeron

full_name: Christophe Bergeron

family: Cellier

full_name: Dominic Cellier

given: Dominic

family: Blay

full_name: Jean-Yves Blay

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

currency_apc_doaj: USD

journal_name: PLoS ONE

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

title: Incidence of Sarcoma Histotypes and Molecular Subtypes in a Prospective Epidemiological Study with Central Pathology Review and Molecular Testing

ReferenceCitation: Mastrangelo G, Coindre JM, Ducimetière F, Dei Tos AP, Fadda E, Blay JY, Buja A, Fedeli U, Cegolon L, Frasson A, Ranchère-Vince D, Montesco C, Ray-Coquard I, Rossi CR. Incidence of soft tissue sarcoma and beyond: a population-based prospective study in 3 European regions. Cancer. 2012 Nov 1;118(21):5339-48. doi: 10.1002/cncr.27555. Epub 2012 Apr 19.

ReferenceCitation: Crago AM, Singer S. Clinical and molecular approaches to well differentiated and dedifferentiated liposarcoma. Curr Opin Oncol. 2011 Jul;23(4):373-8. doi: 10.1097/CCO.0b013e32834796e6. Review.

ReferenceCitation: Lokka S, Scheel AH, Dango S, Schmitz K, Hesterberg R, Rüschoff J, Schildhaus HU. Challenging dedifferentiated liposarcoma identified by MDM2-amplification, a report of two cases. BMC Clin Pathol. 2014 Jul 28;14:36. doi: 10.1186/1472-6890-14-36. eCollection 2014.

ReferenceCitation: Marine JC, Lozano G. Mdm2-mediated ubiquitylation: p53 and beyond. Cell Death Differ. 2010 Jan;17(1):93-102. doi: 10.1038/cdd.2009.68. Review.

ReferenceCitation: Ray-Coquard I, Blay JY, Italiano A, Le Cesne A, Penel N, Zhi J, Heil F, Rueger R, Graves B, Ding M, Geho D, Middleton SA, Vassilev LT, Nichols GL, Bui BN. Effect of the MDM2 antagonist RG7112 on the P53 pathway in patients with MDM2-amplified, well-differentiated or dedifferentiated liposarcoma: an exploratory proof-of-mechanism study. Lancet Oncol. 2012 Nov;13(11):1133-40. doi: 10.1016/S1470-2045(12)70474-6. Epub 2012 Oct 17.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study Involving Gastroenterologists From Trainees to Experts

summary: Endoscopic characterization of colorectal lesions has become essential to predict histology and choose the best therapeutic strategy. We have created the CONECCT classification grouping all the endoscopic criteria already published in a single table. To validate this classification, we carried out this comparative study evaluating the endoscopic characterization performance of all recognized classifications and CONECCT in terms of inter-observer agreement and histological prediction.

lead_sponsor: Hôpital Edouard Herriot


title: Therapeutic Optimization in Patients in Acute Geriatric Care at University Hospital of Montpellier: Follow-up One Month After Discharge From Hospital

summary:
This study involves patients who will be discharged from Montpellier University Hospital (acute geriatric care unit) between January and March 2020.

The primary objective is to assess the number of difference(s) in patient's medicines between the discharge from hospital (acute geriatric care unit) and one month after this discharge.

The secondary objectives are:

to assess the number of changes of medicines between the patient's admission and discharge from hospital (acute geriatric care unit);
to evaluate the number of inappropriate medicines in patient's treatment at hospital admission (in acute geriatric care unit) and one month after the discharge from hospital;
to evaluate the number of failures found in the transmission of information between the hospital and the general practitioner/pharmacy one month after the patient's discharge from hospital (acute geriatric care unit).


title: Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial

acronym: FAAC

summary:
Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone.

Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias.

Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study.

The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.

lead_sponsor: University Hospital, Caen


title: Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients - MApping Gait and Balance Issues With Current Shaping

acronym: MAGIC

summary: Deep brain stimulation of the NST is effective for cardinal motor signs in patients with idiopathic Parkinson's disease (IPD), its effects on gait disturbances, especially freezing of gait-FOG, and falls are variable from one patient to another, in part depending on the location of the NST-stimulating contact. The ability to change the shape of the current field, and thus the volume of activated tissue, with a directional stimulation electrode is a new treatment option for NSC SCP patients with Parkinson's disease. In this pilot research program, the main objective is to determine the impact of directional DBS on gait and balance issues for PD patients implanted in the STN, using previously described anatomical and functional data for gait disturbances to guide directional programming. Ten patients with Patients with severe form of Parkinson's disease eligible to deep brain stimulation of the subthalamic nucleus, will be included in two French sites.

lead_sponsor: University Hospital, Rouen


title: Ability of Changes in Analgesia Nociception Index to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room. REVANI Trial

acronym: REVANI

summary: Volume expansion is the cornerstone of perioperative hemodynamic optimization. The main objective of volume expansion is to increase and maximize stroke volume. Hemodynamic changes have an impact on the autonomic nervous system. The analysis of heart rate variability allows an exploration of the autonomic nervous system and could therefore provide information on the effect of volume expansion. The Analgesia Nociception Index (ANI) is an analgesia monitor based on the concept of heart rate variability. By deviating from its original use, the investigators wish to evaluate the ability of ANI to identify a response to volume expansion.

lead_sponsor: University Hospital, Bordeaux


title: Interest Assessment of the Blue Protocol in Improving Diagnosis of Dyspneic Patients in Pre- and Intra-hospital Emergency Medicine

acronym: Blue P

summary:
Acute dyspnea is a common disease in emergency medicine. Mortality remains high is estimated at 15%. One third of initial diagnoses before paraclinical examination are estimated to be inaccurate. Lung ultrasound is a quick and immediate examination. Also, it is provided and performed at the bedside. The " Blue protocol " was designed by Daniel A. Lichtenstein as a diagnostic aid in dyspneic patients. It allows to obtain a diagnostic in more than 90% of acute dyspnea. However there is no validation in emergency medicine.

The main purpose is to evaluate the interest of the " Blue protocol "in the management and orientation of the dyspneic patient

lead_sponsor: Centre Hospitalier Universitaire, Amiens