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.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


type: Other Identifier

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.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Pierre Fabre Dermo Cosmetique

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


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.

status: Recruiting

design_allocation: Randomized

primary_purpose: Other

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):64. doi: 10.3390/ijms18010064.

lead_sponsor: Centre Hospitalier Régional d'Orléans

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


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

sponsor_collaborators:
University Hospital, Montpellier
Soroptimist association of Monaco

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.

study_type: Observational

time_perspective: Prospective

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, Bechet 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.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: Undecided

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne

collaborators: AFPA (Association Française de Pédiatrie Ambulatoire)


acronym: POLYbio

intervention_type: Diagnostic Test

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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: 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

primary_purpose: Treatment

type: EudraCT Number

source: euctr

ipd_sharing: No


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

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing_description: All collected data that underlie results in a publication

status_simplified: Completed


title: Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors

acronym: PSOAS

summary:
Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.

The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.

lead_sponsor: University Hospital, Lille

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation


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

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


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.

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. Erratum In: CA Cancer J Clin. 2013 May;63(3):215.

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.

publisher_dissemination: Elsevier

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.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Massachusetts Institute of Technology - DSpace@MIT

version: submittedVersion

repositories_concat: PubMed Central;dspace.mit.edu

unpaywall_oa_status: hybrid

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.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

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.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

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.

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.

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.

ReferenceCitation: A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7. No abstract available.

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


title: Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19

summary:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Even if in the vast majority of viral infection results in a mild illness, it can also progress to a severe form with sometimes fatal consequences.

Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been widely described since the start of the pandemic. This manifests itself at the biological level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers, sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).

At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic management targeting these cytokines are currently underway in COVID-19.

Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ and IL-6 seem to be key mediators of hyperinflammation.

Plasma ferritin is a biological marker of inflammation, long known, associated with various infectious, hematological and immunological conditions. An increase in ferritin levels has in particular been associated with an unfavorable development in certain infections such as influenza and certain authors have moreover shown an association between plasma ferritin and the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool for SAM, and could make it possible to differentiate the latter from severe sepsis in intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or CRS.

The plasma dosage of ferritin, associated with that of its glycosylated fraction, could therefore be a diagnostic (difference between SAM and severe sepsis in intensive care), prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected with SARS-CoV-2.

The objective of this study is to retrospectively assess the prognostic value of ferritin and glycosylated ferritin in SARS-CoV-2 infection in hospitalized.

lead_sponsor: Hospices Civils de Lyon


title: Effect of Milk Consumption, Containing A2 β-caseins Only, on Digestive Comfort. A Randomized and Double-blind Study

summary:
Lactose, naturally present in milk, can cause digestive discomfort. Delactosed milk is currently the only one alternative to cow's milk for intolerant people. As some of them do not digest milk, it was completely remove from their diet. However, are they really intolerant to lactose or intolerant to milk (or to another of its compounds)? Do β-caseins play a role in this intolerance? β-caseins are proteins naturally present in milk. Two types of β-caseins were identified: A1 and A2. These types differ according to the genetic profile of the cow and depend on the breed. The rare clinical studies interested in this topic suggest that:

consumption of milk A1 versus consumption of milk A2 can lead to: softer stools, delayed transit, as well as pro-inflammatory effects in some individuals,
consumption of A2 milk significantly reduces gastrointestinal symptoms and improves digestive comfort in lactose intolerant people.

Thus, it would be interesting to be able to assess the effect of a consumption of A2A2 milk type compared to A1A2 milk type, both on the parameters of digestive comfort and on inflammatory parameters.

lead_sponsor: Institut Pasteur de Lille


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

intervention_type: Drug


title: Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

acronym: SOHO

summary: First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

ReferenceCitation: Frat JP, Quenot JP, Badie J, Coudroy R, Guitton C, Ehrmann S, Gacouin A, Merdji H, Auchabie J, Daubin C, Dureau AF, Thibault L, Sedillot N, Rigaud JP, Demoule A, Fatah A, Terzi N, Simonin M, Danjou W, Carteaux G, Guesdon C, Pradel G, Besse MC, Reignier J, Beloncle F, La Combe B, Prat G, Nay MA, de Keizer J, Ragot S, Thille AW; SOHO-COVID Study Group and the REVA Network. Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1212-1222. doi: 10.1001/jama.2022.15613.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

lead_sponsor: Poitiers University Hospital

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

type_etablissement: CHUR

acronyme: SOHO-study

titre: Impact sur la mortalité d'une stratégie comprenant l'oxygénothérapie standard versus l'oxygénothérapie à haut débit nasal dans l'insuffisance respiratoire aiguë hypoxémique : essai prospectif, randomisé, contrôlé.

discipline_principale: anesthésiologie / réanimation

nom_porteur: FRAT

prenom_porteur: Jean-Pierre


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.

time_perspective: Cross-Sectional

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.

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. No abstract available.

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.

ReferenceCitation: Maillet D, Matharan F, Le Clesiau H, Bailon O, Peres 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.

ReferenceCitation: Vialatte de Pemille C, Ray A, Michel A, Stefano F, Yim T, Bruel C, Zuber M. Prevalence and prospective evaluation of cognitive dysfunctions after SARS due to SARS-CoV-2 virus. The COgnitiVID study. Rev Neurol (Paris). 2022 Oct;178(8):802-807. doi: 10.1016/j.neurol.2022.03.014. Epub 2022 May 13.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019

summary: The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.

ipd_sharing_description: NC


title: Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.

acronym: cardiac shock

summary: Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the difficulty of establishing a strict and consensual definition, it is accepted that the CC clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at least 30 minutes or need for vasopressor support) associated with signs of visceral hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This definition of the European Society of Cardiology (ESC) masks however the great variability of hemodynamic tables grouped under the term of CC and severity levels, also variable.However, it was suggested that the etiology of CC influenced both its hemodynamic profile and therefore its therapeutic management but also its prognosis in the medium and long term.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)

acronym: RVDD

summary:
Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated.

Emphysema by increasing intrathoracic pressure appears to affect cardiac function.

Interestingly, previous studies have shown a link between the telediastolic volume of the right ventricle (measured by RMI) and the intensity of emphysema.

Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.

To verify this hypothesis the investigators will perform KT loop procedures in order to acquire intracardiac pressure/volume curves before and after lung volume reduction.

The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac contractility and loading conditions.


title: Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner

acronym: REPERADO

summary: This research aims to create a tool for detection of mental health disorders in adolescents with chronic pain. The first part is testing a screening questionnaire and comparing in with existing questionnaires. The second part involves two focus group with the adolescents aimed at recording their perception of the questionnaire.

study_start_date_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre de la douleur et de la migraine-Hôpital Trousseau

intervention_type: Behavioral


title: Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

acronym: COVID-TEST

summary: This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

lead_sponsor: CMC Ambroise Paré


title: Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)

acronym: ERESI

summary:
Many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage.

In multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a breakdown of the blood-brain barrier. During inflammation, activated microglia may contain high levels of iron, characterizing its activated state.

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild


title: Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients

acronym: GONEARS

summary:
The origin of knee osteoarthritis is multifactorial but the disease is strongly related to age. The pain and functional disability are the main reasons for consultation. Non-pharmaceutical treatment is always indicated.

The rehabilitation will reduce the pain, maintain or partially recover the amplitude of the movements as well as fight against vicious analgesic attitudes and strengthen the muscles to stabilize the joints. A program of self-rehabilitation exercises performed at home may be prescribed to people with knee osteoarthritis. It must include exercises adapted to the patient's functional abilities and painful level and requires education to improve the patient's motivation to practice a regular exercise program. However, adherence to such exercises is low, and until 2016 there was no objective way to find out the reasons for patients' lack of adherence to self-workout programs. The EARS ("Exercise Adherence Rating Scale" or Adhesion to Physical Exercise Programs) is validated in 2016 and reliable to evaluate the physical activity of patients with low back pain.

As far as we know, this questionnaire is the only one validated in the international literature, a validation for French patients is currently underway. We believe this tool can be used for patients with knee osteoarthritis after minor changes.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome : a Randomized Controlled Trial

acronym: STL-DR-PREV

summary: The purpose of this study is to determine whether a scleral buckling surgical procedure performed on fellow eyes of patients with genetically confirmed Stickler syndrome can prevent the occurrence retinal detachment and/or severe vision loss of the study eye.

status: Not yet recruiting

ReferenceCitation: Monin C, Van Effenterre G, Andre-Sereys P, Haut J. [Prevention of retinal detachment in Wagner-Stickler disease. Comparative study of different methods. Apropos of 22 cases]. J Fr Ophtalmol. 1994;17(3):167-74. French.

ReferenceCitation: Abeysiri P, Bunce C, da Cruz L. Outcomes of surgery for retinal detachment in patients with Stickler syndrome: a comparison of two sequential 20-year cohorts. Graefes Arch Clin Exp Ophthalmol. 2007 Nov;245(11):1633-8. doi: 10.1007/s00417-007-0609-2. Epub 2007 Jun 20.

ReferenceCitation: Carroll C, Papaioannou D, Rees A, Kaltenthaler E. The clinical effectiveness and safety of prophylactic retinal interventions to reduce the risk of retinal detachment and subsequent vision loss in adults and children with Stickler syndrome: a systematic review. Health Technol Assess. 2011 Apr;15(16):iii-xiv, 1-62. doi: 10.3310/hta15160.

ReferenceCitation: Ang A, Poulson AV, Goodburn SF, Richards AJ, Scott JD, Snead MP. Retinal detachment and prophylaxis in type 1 Stickler syndrome. Ophthalmology. 2008 Jan;115(1):164-8. doi: 10.1016/j.ophtha.2007.03.059. Epub 2007 Aug 2.

ReferenceCitation: Fincham GS, Pasea L, Carroll C, McNinch AM, Poulson AV, Richards AJ, Scott JD, Snead MP. Prevention of retinal detachment in Stickler syndrome: the Cambridge prophylactic cryotherapy protocol. Ophthalmology. 2014 Aug;121(8):1588-97. doi: 10.1016/j.ophtha.2014.02.022. Epub 2014 May 1.

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: STL DR PREV

titre: Essai randomisé comparant l'efficacité du cerclage chirurgical dans la prévention du décollement de rétine dans le Syndrome de Stickler génétiquement confirmé

discipline_principale: ophtalmologie

nom_porteur: BREZIN

prenom_porteur: Antoine


title: Assessment of Language Disorders in Multiple Sclerosis Patients

acronym: LANSEP

summary:
Multiple sclerosis (MS) is an autoimmune disease of the central nervous systems that results in focal inflammatory lesions and then diffuse and degenerative inflammatory phenomena. It is considered to be the leading cause of non-traumatic disability in young adults.

Cognitive impairment is a common and disabling part of MS. Studies carried out in the years 1990-2000 estimated their frequency to be between 40 and 60% of MS patients: they reflect the natural history of the disease. Effective treatments for the inflammatory component of the disease that are now available may have led to a reduction in their frequency.

Cognitive disorders were identified at an early stage of the disease and affect certain areas preferentially:

The most common achievement is the reduction in the speed of information processing. It is present from the early stage of the disease. Progressive deterioration over time is observed, which is a prognostic factor for long-term cognitive decline.

Long-term memory was impaired in 40-65% of patients in historical cohorts. More specifically, encoding and retrieval were affected, with storage and consolidation being preserved.

The attainment of executive functions is also common.
Phonemic and semantic fluency are also disturbed in MS patients. Among cognitive impairments, language impairment has been little studied in MS: in 2016 only 22 controlled studies were identified. The assessments carried out were most often partial, making it impossible to define the characteristics or to conclude that specific linguistic impairments are independent of other cognitive impairments. Finally, recent studies suggest that the frequency of language impairment in MS may be underestimated.

Therefore, it seems important to assess the prevalence of language disorders in a large cohort of patients with RRMS or MS, and to characterize these disorders by identifying the linguistic processes involved and the brain substrates involved. This will make it possible to envisage the implementation of more systematic screening for language disorders in MS and to improve patient management, in particular by developing targeted rehabilitation protocols.

collaborators:
Groupe Hospitalier Pitie-Salpetriere
Saint Antoine University Hospital

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


title: Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy

summary: Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Semen analyses were normal according to the World Health Organization criteria. Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed for spontaneous fertility or ART to conceive. The investigators would like to see how many surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy rate. The investigators would like to assess how many diagnosis was done after surgery and how many pregnancy were obtained. The investigators search other prognostic factors than age or parity.


title: Development and Validation of an Automated Three-dimensional Cephalometry Method

summary: This study is aimed to develop and assess the validity of an algorithm for automated three-dimensional cephalometry.

collaborators: Laboratoire de Biomécanique Georges Charpak

location_facility: Service de Chirurgie Maxillo-Faciale, Service de Chirurgie Maxillo-Faciale


title: Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns

acronym: Coropreg

summary: The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
INSERM, Epopé team


title: Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma

acronym: PRESATHMA

summary:
Severe asthma is a condition characterized by a lower sensitivity to high doses of inhaled corticosteroids combined with a second controller, most often a long-acting bronchodilator. It concerns approximately 5% of asthmatics. Treatment failure and co-morbidities induced by systemic corticosteroid therapy can cause debilitating dyspnea, limited physical activity, and impaired quality of life. Severe asthma could therefore be associated with major presenteeism, defined as the presence of an employee at work despite his health issues and which implies a limitation of the employee's productive capacity. Uncontrolled asthma and co-morbidities of asthma have been shown to be associated with a decrease in work productivity that includes absenteeism and presenteeism. Although there is little data, a recent study found a decline in work productivity in severe asthma. Various factors associated with presenteeism could be involved, such as asthma control, frequency and severity of exacerbations, comorbidities, or treatments.

Biotherapies targeting the signaling pathways involved in airway inflammation improve asthma control, decrease the frequency of asthma exacerbations which are major determinants of quality of life, improve lung function, and allow oral steroid sparing. Biotherapies could therefore be associated with a decrease in presenteeism.

The objective of the study is to describe the evolution of presenteeism at work, evaluated by the WPAI: Asthma, after 6 months of treatment by biotherapy and to identify factors associated with this evolution


title: Systemic Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome : a Case Control Study

acronym: DESS

summary: Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a syndrome described at the end of the 20th century. Generally, it has a benign course. It is revealed by acute headaches, in different circumstances such as sexual activity, physical exertion or emotional disturbances. But, in few cases, it might be complicated by seizure, stroke and subarachnoid haemorrhage. The diagnosis is confirmed on radiological examination, which shows diffuse cerebral vasoconstriction of brain vessel. It calls reversible because at three month, vasoconstriction disappears. Most cases occur during post partum or after serotoninergic/adrenergic drug use. The pathophysiology is unknown but a transient disturbance in the control of cerebrovascular tone by sympathic hyperactivity and/or endothelial dysfunction are suspected. The assessment of endothelial dysfunction in brain is possible with transcranial doppler. Chen et al. showed an impairment of vasodilatation post apnea induced called BHI on RCVS subjects compared with healthy control. BHI is a reflect of endothelial function in brain. Currently, investigators do not know if endothelial dysfunction occurred only in brain or if it may occur in systemic vessel. Some case reports talk about systemic complication such as kidney infarct or hepatic arterial vasospasm so a systemic vascular dysfunction may be suspected. In this study, researchers will study systemic endothelial function by measure of the pulse wave velocity during RCVS and after its recovering at 3 months, and compare it at healthy controls.

lead_sponsor: Nantes University Hospital


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(1):CD011447. doi: 10.1002/14651858.CD011447.

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. No abstract available.

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

intervention_type: Device


title: Abdominal Massage to Prevent Postoperative Ileus as Part of an Enhanced Recovery Program After Colorectal Surgery

acronym: MATRAC

summary:
Post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of nausea and vomiting. It occurs in about 15-20% of colorectal surgeries. Some preventive measures have been included in the Enhanced Recovery After Surgery Program such as early mobilisation and enteral feeding or minimal invasive approach.

Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported.

Various studies have evaluated the value of physiotherapy and massage for resumption of normal bowel function. A study from Rouen University Hospital demonstrated that a mechanical stress to the cuteaneous tissue by LPG Cellu M50® machine would reduce pain and lower the time to first flatus. Similar results were obtained after Cardiac surgery. In a preclinical study on operated rats, abdominal massage also improved normal bowel function recovery.

Physiotherapist plays a key role in RAC. Their action on respiratory function (movement of diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a reduction of time of hospitalization. Even though the results on time to first flatus and anxiety seem interesting, Deep abdominal massage has never been evaluated.

ReferenceCitation: Le Blanc-Louvry I, Costaglioli B, Boulon C, Leroi AM, Ducrotte P. Does mechanical massage of the abdominal wall after colectomy reduce postoperative pain and shorten the duration of ileus? Results of a randomized study. J Gastrointest Surg. 2002 Jan-Feb;6(1):43-9. doi: 10.1016/s1091-255x(01)00009-9.

ReferenceCitation: Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.

ReferenceCitation: Dreyer NE, Cutshall SM, Huebner M, Foss DM, Lovely JK, Bauer BA, Cima RR. Effect of massage therapy on pain, anxiety, relaxation, and tension after colorectal surgery: A randomized study. Complement Ther Clin Pract. 2015 Aug;21(3):154-9. doi: 10.1016/j.ctcp.2015.06.004. Epub 2015 Jun 12.

ReferenceCitation: Chapelle SL, Bove GM. Visceral massage reduces postoperative ileus in a rat model. J Bodyw Mov Ther. 2013 Jan;17(1):83-8. doi: 10.1016/j.jbmt.2012.05.004. Epub 2012 Aug 12.

ReferenceCitation: Navalgund A, Axelrod S, Axelrod L, Singhal S, Tran K, Legha P, Triadafilopoulos G. Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J Gastrointest Surg. 2019 May;23(5):982-989. doi: 10.1007/s11605-018-4030-4. Epub 2018 Nov 2.

lead_sponsor: University Hospital, Grenoble


title: Management of Infant Digestive Disorders and Quality of Life

summary: The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.

lead_sponsor: Société des Produits Nestlé (SPN)

sponsor_collaborators:
Société des Produits Nestlé (SPN)
Keyrus Biopharma


title: Feasibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA

acronym: REMARK

summary:
Use HeprAN ™ membrane (coated with heparin) should be allow the success of dialysis sessions, with adequate dialysis parameters, in patients treated by long-term anticoagulation with VKA, without addition of heparin perdialytic.

Less use of heparin (UFH or LMWH) during hemodialysis session should be allow a decrease of bleedings (moderate or major) and blood transfusions for hemodialysed patients with HeprAN ™ membrane and treated by long-term anticoagulation with VKA

lead_sponsor: CHU de Reims


title: Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity

acronym: IMISS

summary: Gougerot-Sjögren syndrome or Sjögren syndrome is a chronic autoimmune disease belonging to connectivitis, the classic triad of symptoms being the association of a sicca syndrome (generally predominant in the mouth and / or ocular, but also present at the cutaneous, vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. The study investigators hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby promoting microbial translocation, would have immunomodulatory effects that could be correlated to changes in the activity of Gougerot-Sjögren disease.


title: AiCR : Artificial Intelligence in Cardiac aRrest Application of an Algorithm in the Prognosis of Recovered Cardiorespiratory Arrests

acronym: AiCR

summary:
The overall incidence of cardiorespiratory arrest in Europe is estimated at 350,000 to 700,000 cases per year. Survival rate is estimated at 10.7% for all rhythm disorders combined.

Several examples of AI application in the medical field exist. Ting et al have developed a computer tool capable of diagnosing the presence of diabetic retinopathy with excellent power. In resuscitation, Celi et al proposed a tool capable of predicting the need for crystalloid vascular filling during a systemic inflammatory state. In Nature in 2018, Komorowski demonstrated the efficacy of AI in the hemodynamic management of sepsis. In a study of the renal response to fluid challenge, Zhang et al. demonstrate the effectiveness of the learning machine.

Objectives: Determination of an algorithm capable of predicting the mortality of patients admitted to intensive care units (ICU) for ACR from hospitalization reports (CRH). Also use of the algorithm to predict the risk of recurrence of the arrest, the duration of mechanical ventilation, the appearance of sepsis, the development of organ failure, prediction of the CPC (Cerebral Performance Category), time to obtain catecholamine withdrawal, the appearance of acute renal failure with or without the need for extra-renal purification (EER) and duration under EER, the average length of stay.

This project is part of a larger, nationwide project with greater power, and includes all the data generated during hospitalization in intensive care.

Method: an estimated total number of patients included in this study to be between 300 and 500. The population will come from the intensive care units of Nice, Antibes, Cannes, Grasse.

Inclusion will be retrospective, on CRH, CR of CT imaging (cerebral and thoraco-abdomino-pelvic), MRI, EEG, and daily follow-up words, from 2014 to the end of 2020.

After anonymisation, application of semantisation using natural language processing (NLP) methods. The data to be extracted are entered in a document written by intensive care physicians. These data will then be stored in a database. In order to meet the main objective, we will develop a computer algorithm capable of predicting mortality in the study population. This algorithm, based on a large database, can be designed using machine learning or even deep learning techniques depending on the amount of data to be processed.

lead_sponsor: Centre Hospitalier Universitaire de Nice

collaborators: Institut National de Recherche en Informatique et en Automatique


title: Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)

acronym: SCVPC

summary:
Summary:

Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in the University hospital of Brest.

The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey.

time_perspective: Other

lead_sponsor: University Hospital, Brest


title: Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal

acronym: EVOL

summary:
Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most frequent consequences is the replacement of nasogastric tube because of the vomiting. Vomiting is due to the distension of the stomach and information on the evolution of gastric filling after surgery could help to better understand the physiopathology of POI. It could also give indication to help the physician in the management of POI.

The ultrasonography has been shown to be a reliable technic to assess the gastric emptying.

To date, there is no indication in the literature about the evolution of the gastric filling after colorectal surgery while these information could help to identify patients at risk for POI and to predict the need for POI replacement.

lead_sponsor: University Hospital, Angers


title: Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.

summary: From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).

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


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.

sponsor_collaborators: 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: Description of neurolOgical Involvement Observed During SARS COV2 Infection

acronym: NeuroSARS

summary: Description of the neurological impairment: clinico-radiological and electrophysilogical correlations

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Detection of SARS-CoV-2 in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)

acronym: COVISPERM

summary: The objective of this study is to look for the presence of SARS-CoV-2 in the semen of patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.


title: Observatory of Nasopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis and in Healthy Child - Ancillary Study for Detection of E Coli ESBL Carriers

summary: This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.

ReferenceCitation: Ouldali N, Cohen R, Levy C, Gelbert-Baudino N, Seror E, Corrard F, Vie Le Sage F, Michot AS, Romain O, Bechet S, Bonacorsi S, Angoulvant F, Varon E. Pneumococcal susceptibility to antibiotics in carriage: a 17 year time series analysis of the adaptive evolution of non-vaccine emerging serotypes to a new selective pressure environment. J Antimicrob Chemother. 2019 Oct 1;74(10):3077-3086. doi: 10.1093/jac/dkz281.

publisher_dissemination: Oxford University Press

ReferenceCitation: Rybak A, Levy C, Bonacorsi S, Bechet S, Vie le Sage F, Elbez A, Varon E, Cohen R. Antibiotic Resistance of Potential Otopathogens Isolated From Nasopharyngeal Flora of Children With Acute Otitis Media Before, During and After Pneumococcal Conjugate Vaccines Implementation. Pediatr Infect Dis J. 2018 Mar;37(3):e72-e78. doi: 10.1097/INF.0000000000001862.

ReferenceCitation: Birgy A, Bidet P, Levy C, Sobral E, Cohen R, Bonacorsi S. CTX-M-27-Producing Escherichia coli of Sequence Type 131 and Clade C1-M27, France. Emerg Infect Dis. 2017 May;23(5):885. doi: 10.3201/eid2305.161865. No abstract available.

oa_colors: green diamond

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Centers for Disease Control

ReferenceCitation: Cohen R, Varon E, Doit C, Schlemmer C, Romain O, Thollot F, Bechet S, Bonacorsi S, Levy C. A 13-year survey of pneumococcal nasopharyngeal carriage in children with acute otitis media following PCV7 and PCV13 implementation. Vaccine. 2015 Sep 22;33(39):5118-26. doi: 10.1016/j.vaccine.2015.08.010. Epub 2015 Aug 11.

ReferenceCitation: Cohen R, Levy C, Bonnet E, Thollot F, Boucherat M, Fritzell B, Derkx V, Bingen E, Varon E. Risk factors for serotype 19A carriage after introduction of 7-valent pneumococcal vaccination. BMC Infect Dis. 2011 Apr 18;11:95. doi: 10.1186/1471-2334-11-95.

ReferenceCitation: Cohen R, Bingen E, Levy C, Thollot F, Boucherat M, Derkx V, Varon E. Nasopharyngeal flora in children with acute otitis media before and after implementation of 7 valent pneumococcal conjugate vaccine in France. BMC Infect Dis. 2012 Mar 7;12:52. doi: 10.1186/1471-2334-12-52.

ReferenceCitation: Levy C, Vie le Sage F, Varon E, Chalumeau M, Grimprel E, Cohen R. Pediatric Ambulatory and Hospital Networks for Surveillance and Clinical Epidemiology of Community-Acquired Infections. J Pediatr. 2018 Mar;194:269-270.e2. doi: 10.1016/j.jpeds.2017.11.050. Epub 2018 Feb 22. No abstract available.

ReferenceCitation: Vermee Q, Cohen R, Hays C, Varon E, Bonacorsi S, Bechet S, Thollot F, Corrard F, Poyart C, Levy C, Raymond J. Biofilm production by Haemophilus influenzae and Streptococcus pneumoniae isolated from the nasopharynx of children with acute otitis media. BMC Infect Dis. 2019 Jan 11;19(1):44. doi: 10.1186/s12879-018-3657-9.

ReferenceCitation: Birgy A, Madhi F, Jung C, Levy C, Cointe A, Bidet P, Hobson CA, Bechet S, Sobral E, Vuthien H, Ferroni A, Aberrane S, Cuzon G, Beraud L, Gajdos V, Launay E, Pinquier D, Haas H, Desmarest M, Dommergues MA, Cohen R, Bonacorsi S; Group of the National Observatory of Urinary tract Infection due to ESBL-producing Enterobacteriaceae in children. Diversity and trends in population structure of ESBL-producing Enterobacteriaceae in febrile urinary tract infections in children in France from 2014 to 2017. J Antimicrob Chemother. 2020 Jan 1;75(1):96-105. doi: 10.1093/jac/dkz423.

ReferenceCitation: Mizrahi A, Cohen R, Varon E, Bonacorsi S, Bechet S, Poyart C, Levy C, Raymond J. Non typable-Haemophilus influenzae biofilm formation and acute otitis media. BMC Infect Dis. 2014 Jul 19;14:400. doi: 10.1186/1471-2334-14-400.

ReferenceCitation: Birgy A, Levy C, Bidet P, Thollot F, Derkx V, Bechet S, Mariani-Kurkdjian P, Cohen R, Bonacorsi S. ESBL-producing Escherichia coli ST131 versus non-ST131: evolution and risk factors of carriage among French children in the community between 2010 and 2015. J Antimicrob Chemother. 2016 Oct;71(10):2949-56. doi: 10.1093/jac/dkw219. Epub 2016 Jun 20.

ReferenceCitation: Hau I, Levy C, Caeymaex L, Cohen R. Impact of pneumococcal conjugate vaccines on microbial epidemiology and clinical outcomes of acute otitis media. Paediatr Drugs. 2014 Feb;16(1):1-12. doi: 10.1007/s40272-013-0044-2.

ReferenceCitation: Birgy A, Cohen R, Levy C, Bidet P, Courroux C, Benani M, Thollot F, Bingen E. Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae in French children. BMC Infect Dis. 2012 Nov 21;12:315. doi: 10.1186/1471-2334-12-315.

ReferenceCitation: Caeymaex L, Varon E, Levy C, Bechet S, Derkx V, Desvignes V, Doit C, Cohen R. Characteristics and outcomes of acute otitis media in children carrying streptococcus pneumoniae or haemophilus influenzae in their nasopharynx as a single otopathogen after introduction of the heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 May;33(5):533-6. doi: 10.1097/INF.0000000000000213.

ReferenceCitation: Cohen R, Levy C, Bingen E, Koskas M, Nave I, Varon E. Impact of 13-valent pneumococcal conjugate vaccine on pneumococcal nasopharyngeal carriage in children with acute otitis media. Pediatr Infect Dis J. 2012 Mar;31(3):297-301. doi: 10.1097/INF.0b013e318247ef84.

ReferenceCitation: Cohen R, Levy C, Bingen E, Bechet S, Derkx V, Werner A, Koskas M, Varon E. [Nasopharyngeal carriage of children 6 to 60 months during the implementation of the 13-valent pneumococcal conjugate vaccine]. Arch Pediatr. 2012 Oct;19(10):1132-9. doi: 10.1016/j.arcped.2012.07.013. Epub 2012 Aug 24. French.

ReferenceCitation: Cohen R, Levy C, Thollot F, de La Rocque F, Koskas M, Bonnet E, Fritzell B, Varon E. Pneumococcal conjugate vaccine does not influence Staphylococcus aureus carriage in young children with acute otitis media. Clin Infect Dis. 2007 Dec 15;45(12):1583-7. doi: 10.1086/523734. Erratum In: Clin Infect Dis. 2008 Feb 1;46(3):489.

ReferenceCitation: Cohen R, Levy C, de La Rocque F, Gelbert N, Wollner A, Fritzell B, Bonnet E, Tetelboum R, Varon E. Impact of pneumococcal conjugate vaccine and of reduction of antibiotic use on nasopharyngeal carriage of nonsusceptible pneumococci in children with acute otitis media. Pediatr Infect Dis J. 2006 Nov;25(11):1001-7. doi: 10.1097/01.inf.0000243163.85163.a8.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


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


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

lead_sponsor: Hospices Civils de Lyon

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


title: Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey

summary:
With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID).

Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: "COPID19".

COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password.

Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.

lead_sponsor: Imagine Institute


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: Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS

acronym: EXODYS

summary: Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients without endothelial dysfunction.


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: Hôpital NOVO

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: Ducimetiere F, Lurkin A, Ranchere-Vince D, Decouvelaere AV, Peoc'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.

ReferenceCitation: Mastrangelo G, Coindre JM, Ducimetiere F, Dei Tos AP, Fadda E, Blay JY, Buja A, Fedeli U, Cegolon L, Frasson A, Ranchere-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.

ReferenceCitation: Lokka S, Scheel AH, Dango S, Schmitz K, Hesterberg R, Ruschoff 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.

evidence: open (via page says license)

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

publisher_dissemination: Springer

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.

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: The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family

summary: Given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. Thanks to families and relatives data, it will allow to improve the analyses carried out by the "Societal Cancer Observatory" in 2016.

lead_sponsor: Poitiers University Hospital


title: Evaluation of Tidal Volume Challenge to Detect Preload-responsiveness in Patients With Acute Respiratory Distress Syndrome (ARDS) During Prone Position

acronym: PR-ARDS-PP

summary: Evaluation of preload responsiveness in ARDS patients during prone position is difficult and only one study showed Trendelenburg manoeuvre can be used in this group of patients. This study aims to investigate whether end-expiratory occlusion test, tidal volume challenge (using the changes in PPV) can be used to evaluate preload responsiveness in patients with ARDS ventilated with a low tidal volume and who underwent a PP session.

ReferenceCitation: Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. doi: 10.1056/NEJM200005043421806. No abstract available.

ReferenceCitation: Vieillard-Baron A, Matthay M, Teboul JL, Bein T, Schultz M, Magder S, Marini JJ. Experts' opinion on management of hemodynamics in ARDS patients: focus on the effects of mechanical ventilation. Intensive Care Med. 2016 May;42(5):739-749. doi: 10.1007/s00134-016-4326-3. Epub 2016 Apr 1.

ReferenceCitation: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

ReferenceCitation: Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

oa_host_type: publisher

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Jozwiak M, Monnet X, Teboul JL. Optimizing the circulation in the prone patient. Curr Opin Crit Care. 2016 Jun;22(3):239-45. doi: 10.1097/MCC.0000000000000308.

ReferenceCitation: Jozwiak M, Teboul JL, Anguel N, Persichini R, Silva S, Chemla D, Richard C, Monnet X. Beneficial hemodynamic effects of prone positioning in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1428-33. doi: 10.1164/rccm.201303-0593OC.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Guerin C, Beuret P, Constantin JM, Bellani G, Garcia-Olivares P, Roca O, Meertens JH, Maia PA, Becher T, Peterson J, Larsson A, Gurjar M, Hajjej Z, Kovari F, Assiri AH, Mainas E, Hasan MS, Morocho-Tutillo DR, Baboi L, Chretien JM, Francois G, Ayzac L, Chen L, Brochard L, Mercat A; investigators of the APRONET Study Group, the REVA Network, the Reseau recherche de la Societe Francaise d'Anesthesie-Reanimation (SFAR-recherche) and the ESICM Trials Group. A prospective international observational prevalence study on prone positioning of ARDS patients: the APRONET (ARDS Prone Position Network) study. Intensive Care Med. 2018 Jan;44(1):22-37. doi: 10.1007/s00134-017-4996-5. Epub 2017 Dec 7.

ReferenceCitation: Wheeler AP, Bernard GR. Acute lung injury and the acute respiratory distress syndrome: a clinical review. Lancet. 2007 May 5;369(9572):1553-1564. doi: 10.1016/S0140-6736(07)60604-7.

ReferenceCitation: Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0.

ReferenceCitation: Roch A, Guervilly C, Papazian L. Fluid management in acute lung injury and ards. Ann Intensive Care. 2011 May 30;1(1):16. doi: 10.1186/2110-5820-1-16.

ReferenceCitation: Teboul JL, Monnet X, Chemla D, Michard F. Arterial Pulse Pressure Variation with Mechanical Ventilation. Am J Respir Crit Care Med. 2019 Jan 1;199(1):22-31. doi: 10.1164/rccm.201801-0088CI.

ReferenceCitation: Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guerin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0.

ReferenceCitation: Sibbald WJ, Paterson NA, Holliday RL, Baskerville J. The Trendelenburg position: hemodynamic effects in hypotensive and normotensive patients. Crit Care Med. 1979 May;7(5):218-24.

ReferenceCitation: Geerts BF, van den Bergh L, Stijnen T, Aarts LP, Jansen JR. Comprehensive review: is it better to use the Trendelenburg position or passive leg raising for the initial treatment of hypovolemia? J Clin Anesth. 2012 Dec;24(8):668-74. doi: 10.1016/j.jclinane.2012.06.003.

ReferenceCitation: Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

ReferenceCitation: Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.

ReferenceCitation: Shi R, Ayed S, Moretto F, Azzolina D, De Vita N, Gavelli F, Carelli S, Pavot A, Lai C, Monnet X, Teboul JL. Tidal volume challenge to predict preload responsiveness in patients with acute respiratory distress syndrome under prone position. Crit Care. 2022 Jul 18;26(1):219. doi: 10.1186/s13054-022-04087-w.

lead_sponsor: Bicetre Hospital


title: Language and Brain Rhythms

acronym: LaBRhythms

summary:
For humans and other animals, predicting the timing of sensory events is essential for their daily behavior. Importantly, natural sensory stimulation (such as movements, music, or speech) can present temporal regularities allowing for temporal prediction of incoming sensory information. For instance, individuals can easily predict in time the next step of a walker, or the next beat of a song based on the rhythm. The phenomenon of temporal prediction has for now only been investigated experimentally in deterministic scenarios, i.e. when the duration between two sensory events is fixed, or when stimuli present a regular beat. The objective of this project is to understand how we process more natural, hence more complex forms of temporal regularities, and how individuals make inferences on the timing of sensory events based on past temporal statistics of sensory information. This is particularly important for speech processing, considering that speech is an acoustic signal that is known to possess some form of temporal regularity, and yet is not purely rhythmic nor does have a deterministic temporal structure. Temporal regularities are specific to each spoken language, and both native and non-native language listeners are known to use temporal acoustic cues during speech listening. This affects speech comprehension and has a strong impact during language learning. Hence, understanding the processing of temporal regularities in speech can help improve language abilities in first and second language learners.

The project is composed of four experiments. The first behavioral experiment will investigate how auditory perception is affected by the temporal statistics of past sensory information using artificial stimuli. The second axis will investigate the neural mechanisms underlying auditory timing processing with electroencephalography (EEG). The last Magnetoencephalography (MEG, experiment 3) and EG (rxperiement 4) experiment will test the role of temporal statistics in an ecological setting, namely speech listening. The project will thus provide strong theoretical advances as it will give new insights on brain mechanisms for the processing of complex temporal information in audition and speech, and their role in language comprehension. It will also provide methodological advances. Specifically, the project will contribute to the development and validation of cutting-edge methods in MEG. Namely, it will aim at creating new tools to investigate the neural correlates of auditory and speech processing with an unprecedented temporal and spatial resolution.

location_facility: Centre de Recherche en Neuroscience de Lyon


title: Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Secondary Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.

acronym: RMR

summary: Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

lead_sponsor: Institut Paoli-Calmettes


title: Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA

summary:
The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have shed new light on the classification of endometrial carcinomas.

After carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with POLE mutations, the "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group, and the "high number of copies" group).

This histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date.

The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.

ipd_sharing_description:
Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time.

If we failed to obtain results we perhaps send plasma in other laboratory


title: Pain Monitoring After Breast Biopsy: Benefit of E-health

acronym: BIO-PSY

summary:
Each year, approximately 1500 breast biopsies (1000 microbiopsies and 500 macrobiopsies) are performed in the radiologic department of the Montpellier Cancer Institute (ICM). This exam, which is relatively easy for the radiologist, can however lead to major anxiety for patients. Indeed, previous studies show that about 50% of women undergoing a breast biopsy have significant anxiety affects.

Anxiety associated with the risks of biopsy, potential breast cancer diagnosis and/or lack of routine sedation procedures increase patient concerns. Distress prior to biopsy is associated with greater pain and discomfort during the procedure. The psychological distress that persists after the biopsy is related to a worse psychological management of side effects of the biopsy breast (e.g., sensitivity, skin irritation).

Limiting apprehension, worry and anxiety induced by the uncertainty linked to the biopsy results and the biopsy-related pain should be an integral part of the medical care through the patient follow-up during, after and until the diagnosis is announced. In light of these challenges, new alternative methods are emerging to enhance patient knowledge, develop procedural skills, improve confidence and mitigate procedural anxiety. However, to our knowledge, few methods have been developed during this period of 'waiting-time'. Currently, only care instructions and a consultation to announce the results (about 10 days after the procedure) are proposed to patients at the end of biopsy. Patients are also encouraged to call if they suspect complications such as infection or bleeding.

In this context, the investigators propose to integrate a pain management after biopsy via e-health system through the patient's medical care. Radiologist/patient communication could have an impact on patients' anxiety and health-related issues, given the challenging nature of discussions around need for breast biopsy and potential implications of the results. Indeed, paying attention and focusing on symptoms as patients experience them improves their empowerment and their adjustment to the disease.

Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control and to enhance patient-clinician communication patient satisfaction, as well as well-being. In addition, it is known that improved communication between patients and medical staff to less anxiety after a biopsy and that anxiety is related to pain.

Taken as a whole, these elements encourage the integration of e-health and e-PRO for the management of pain and anxiety in patients undergoing a biopsy. The benefits of e-PRO are still being discussed in terms of quality of life (Qol) and psychological distress. The investigator propose to integrate two types of e-health intervention: 1/e-PRO collected by connected objects (smartphone or tablet) as they were used in previous studies, and 2/ e-PRO collected by a phone consultation, which values human communication between the medical staff and the patient.

In case of significant pain, the collection of e-PRO by any of these e-health interventions will generate an alert and a reactive and responsive care.

In fine, the purpose of this research is to improve the medical organization and care of post-biopsy patients by proposing an innovative connected patient technology, regardless of their remoteness from the hospital.

Social inequalities will be reduced by lending a tablet to patients who do not have such a device with a 4G key.

status: Active, not recruiting

ReferenceCitation: Pineault P. Breast Cancer Screening: Women's Experiences of Waiting for Further Testing. Oncol Nurs Forum. 2007 Jul;34(4):847-53. doi: 10.1188/07.ONF.847-853.

ReferenceCitation: Lampic C, Thurfjell E, Bergh J, Sjoden PO. Short- and long-term anxiety and depression in women recalled after breast cancer screening. Eur J Cancer. 2001 Mar;37(4):463-9. doi: 10.1016/s0959-8049(00)00426-3.

ReferenceCitation: Iwamitsu Y, Shimoda K, Abe H, Tani T, Okawa M, Buck R. Anxiety, emotional suppression, and psychological distress before and after breast cancer diagnosis. Psychosomatics. 2005 Jan-Feb;46(1):19-24. doi: 10.1176/appi.psy.46.1.19.

ReferenceCitation: Grimm LJ, Shelby RA, Knippa EE, Langman EL, Miller LS, Whiteside BE, Soo MSC. Patient Perceptions of Breast Cancer Risk in Imaging-Detected Low-Risk Scenarios and Thresholds for Desired Intervention: A Multi-Institution Survey. J Am Coll Radiol. 2018 Jun;15(6):911-919. doi: 10.1016/j.jacr.2018.02.010. Epub 2018 Mar 30.

ReferenceCitation: Dorfman CS, Lamb E, Van Denburg A, Wren AA, Soo MS, Faircloth K, Gandhi V, Shelby RA. The relationship between holding back from communicating about breast concerns and anxiety in the year following breast biopsy. J Psychosoc Oncol. 2018 Mar-Apr;36(2):222-237. doi: 10.1080/07347332.2017.1395939. Epub 2018 Jan 11.

ReferenceCitation: Andrykowski MA, Carpenter JS, Studts JL, Cordova MJ, Cunningham LL, Beacham A, Sloan D, Kenady D, McGrath P. Psychological impact of benign breast biopsy: a longitudinal, comparative study. Health Psychol. 2002 Sep;21(5):485-94.

ReferenceCitation: Mema E, Cho E, Ryu YK, Jadeja P, Wynn R, Taback B, Ha R. In the Setting of Negative Mammogram, Is Additional Breast Ultrasound Necessary for Evaluation of Breast Pain? Curr Probl Diagn Radiol. 2019 Mar-Apr;48(2):117-120. doi: 10.1067/j.cpradiol.2017.12.007. Epub 2018 Jan 9.

ReferenceCitation: Roark AA, Ebuoma LO, Ortiz-Perez T, Sepulveda KA, Severs FJ, Wang T, Benveniste AP, Sedgwick EL. Impact of Simulation-Based Training on Radiology Trainee Education in Ultrasound-Guided Breast Biopsies. J Am Coll Radiol. 2018 Oct;15(10):1458-1463. doi: 10.1016/j.jacr.2017.09.016. Epub 2017 Dec 6.

ReferenceCitation: Denis F, Lethrosne C, Pourel N, Molinier O, Pointreau Y, Domont J, Bourgeois H, Senellart H, Tremolieres P, Lizee T, Bennouna J, Urban T, El Khouri C, Charron A, Septans AL, Balavoine M, Landry S, Solal-Celigny P, Letellier C. Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx029. Erratum In: J Natl Cancer Inst. 2018 Apr 1;110(4):436.

ReferenceCitation: Basch E, Artz D, Dulko D, Scher K, Sabbatini P, Hensley M, Mitra N, Speakman J, McCabe M, Schrag D. Patient online self-reporting of toxicity symptoms during chemotherapy. J Clin Oncol. 2005 May 20;23(15):3552-61. doi: 10.1200/JCO.2005.04.275.

ReferenceCitation: Berry DL, Blumenstein BA, Halpenny B, Wolpin S, Fann JR, Austin-Seymour M, Bush N, Karras BT, Lober WB, McCorkle R. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011 Mar 10;29(8):1029-35. doi: 10.1200/JCO.2010.30.3909. Epub 2011 Jan 31.

ReferenceCitation: Chen J, Ou L, Hollis SJ. A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Serv Res. 2013 Jun 11;13:211. doi: 10.1186/1472-6963-13-211.

ReferenceCitation: Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027. Erratum In: JAMA. 2003 Feb 26;289(8):987.

ReferenceCitation: Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S, MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501. doi: 10.1200/JCO.2013.53.5948. Epub 2014 Apr 7.

ReferenceCitation: Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4.

ReferenceCitation: Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24. doi: 10.1200/JCO.2004.06.078.

ReferenceCitation: Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689.

ReferenceCitation: Santana MJ, Feeny D, Johnson JA, McAlister FA, Kim D, Weinkauf J, Lien DC. Assessing the use of health-related quality of life measures in the routine clinical care of lung-transplant patients. Qual Life Res. 2010 Apr;19(3):371-9. doi: 10.1007/s11136-010-9599-3. Epub 2010 Feb 10.

ReferenceCitation: Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21.

ReferenceCitation: Atkinson TM, Ryan SJ, Bennett AV, Stover AM, Saracino RM, Rogak LJ, Jewell ST, Matsoukas K, Li Y, Basch E. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 2016 Jun 3.

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