title: Usefulness of Routine qSOFA Calculation at Triage to Fasten Antimicrobial Administration in Patients With Bacterial Infection in the Emergency Department: a Quasi-experimental Study

acronym: qSOFAST

summary:
The delayed administration of an adequate antimicrobial therapy is a strong predictor of impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be initiated within one hour following the recognition of sepsis or septic shock.

The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which has been recently proposed by the Third International Sepsis Consensus Definitions Task Force (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min) and altered mentation (Glasgow coma scale <15). The score ranges from 0 to 3 points. A qSOFA value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these outcomes being more common in infected patients who may be septic than in those with uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus improve the outcome of patients at risk of sepsis or septic shock.

Many patients admitted to the hospital for bacterial sepsis or septic shock are initially managed in the Emergency Department (ED). This study aims at investigating whether the routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial therapy in patients admitted to the ED with suspected or proven bacterial infection, especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3 definition).

ReferenceCitation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

name: Bloomsbury Institute of Intensive Care Medicine, University College London, London, United Kingdom

family: Singer

full_name: Mervyn Singer

given: Mervyn

name: Hofstra–Northwell School of Medicine, Feinstein Institute for Medical Research, New Hyde Park, New York

family: Deutschman

full_name: Clifford S. Deutschman

given: Clifford S.

name: Department of Critical Care and Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

family: Seymour

full_name: Christopher Warren Seymour

given: Christopher Warren

name: Department of Critical Care Medicine, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom

family: Shankar-Hari

full_name: Manu Shankar-Hari

given: Manu

name: Department of Critical Care Medicine, University of Versailles, France

name: Center for Sepsis Control and Care, University Hospital, Jena, Germany

family: Bauer

full_name: Michael Bauer

given: Michael

name: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, and Austin Hospital, Melbourne, Victoria, Australia

family: Bellomo

full_name: Rinaldo Bellomo

given: Rinaldo

name: Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University, Nashville, Tennessee

family: Bernard

full_name: Gordon R. Bernard

given: Gordon R.

name: Réanimation Médicale-Hôpital Cochin, Descartes University, Cochin Institute, Paris, France

family: Chiche

full_name: Jean-Daniel Chiche

given: Jean-Daniel

name: Critical Care Center, Emory University School of Medicine, Atlanta, Georgia

family: Coopersmith

full_name: Craig M. Coopersmith

given: Craig M.

name: Washington University School of Medicine, St Louis, Missouri

family: Hotchkiss

full_name: Richard S. Hotchkiss

given: Richard S.

name: Infectious Disease Section, Division of Pulmonary and Critical Care Medicine, Brown University School of Medicine, Providence, Rhode Island

family: Levy

full_name: Mitchell M. Levy

given: Mitchell M.

name: Department of Surgery, University of Toronto, Toronto, Ontario, Canada

family: Marshall

full_name: John C. Marshall

given: John C.

name: Emory University School of Medicine and Grady Memorial Hospital, Atlanta, Georgia

family: Martin

full_name: Greg S. Martin

given: Greg S.

family: Opal

full_name: Steven M. Opal

given: Steven M.

name: Trauma, Emergency & Critical Care Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada16Interdepartmental Division of Critical Care, University of Toronto

family: Rubenfeld

full_name: Gordon D. Rubenfeld

given: Gordon D.

name: Department of Infectious Diseases, Academisch Medisch Centrum, Amsterdam, the Netherlands

family: van der Poll

full_name: Tom van der Poll

given: Tom

name: Department of Intensive Care, Erasme University Hospital, Brussels, Belgium

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

name: Department of Critical Care Medicine, University of Pittsburgh and UPMC Health System, Pittsburgh, Pennsylvania20Associate Editor, JAMA

family: Angus

full_name: Derek C. Angus

given: Derek C.

journal_name: JAMA

oa_colors: green hybrid

evidence: open (via free pdf)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

ReferenceCitation: Petit J, Passerieux J, Maître O, Guérin C, Rozelle C, Cordeau O, Cassonnet A, Malet A, Boulain T, Barbier F; qSOFAST study group. Impact of a qSOFA-based triage procedure on antibiotic timing in ED patients with sepsis: A prospective interventional study. Am J Emerg Med. 2020 Mar;38(3):477-484. doi: 10.1016/j.ajem.2019.05.022. Epub 2019 May 10.

journal_name: The American Journal of Emergency Medicine


title: Molecular Profile of the Evolution of Inclusion Body Myositis

acronym: IBM-RNAseq

summary: This study aims at assessing the gene expression in the muscles of patients suffering from sporadic Inclusion Body Myositis (sIBM) at various stages of the disease, by comparison with muscles of control subject. The investigators use the RNA-seq technique to analyze the gene expression levels and potential alternate transcripts, including long non-coding RNAs (lncRNAs), in muscle tissue samples. The gene expression profiles will point to the genes of interest that can then become the object of future studies, in which epigenetic changes of these genes will be explored further. The value of those possible biomarkers will be assessed. The investigators will also evaluate the correlation between the gene expression profile, the degree of functional impairment, the histological picture and the presence or absence of autoantibodies.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital Pasteur 2 - Service Système Nerveux Périphérique, Muscle et SLA

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: 2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction

summary:
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .

TEE is performed for each patient of cardiac surgery during the operation time .

This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier

location_facility: Hôpital Arnaud de Villeneuve réanimation

intervention_type: Procedure

status_simplified: Completed


summary: Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.

lead_sponsor: University Hospital, Brest


title: Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain

acronym: USE-SSPC

summary: Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.

ReferenceType: derived

ReferenceCitation: Amson H, Lasselin P, Naegels B, Pardey Bracho GF, Aubrun F, Dziadzko M. Usability evaluation of sufentanil sublingual tablet analgesia in patients following Enhanced Recovery After Surgery. J Comp Eff Res. 2021 Jun;10(9):743-750. doi: 10.2217/cer-2020-0239. Epub 2021 Apr 21.

name: Département d'Anesthésie-Réanimation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Université Claude Bernard, Lyon, France

family: Amson

full_name: Harry Amson

given: Harry

sequence: first

family: Lasselin

full_name: Philippe Lasselin

given: Philippe

sequence: additional

name: Département d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard, France

family: Naegels

full_name: Bertille Naegels

given: Bertille

name: Département d'Anesthésie-Réanimation, Hôpital Pierre Wertheimer, Hospices Civils de Lyon, Université Claude Bernard, France

family: Bracho

full_name: Gilda Pardey Bracho

given: Gilda Pardey

name: U1290 RESHAPE, Université Claude Bernard Lyon 1, INSERM, Lyon, France

family: Aubrun

full_name: Frédéric Aubrun

given: Frédéric

family: Dziadzko

full_name: Mikhail Dziadzko

given: Mikhail

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Comparative Effectiveness Research

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation

intervention_type: Device


title: A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a

acronym: ANRS EP63

summary: To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.

time_perspective: Other

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient on Geriatrics Department.

acronym: OPTAH

summary: The main object is to identify and understand why some hospitalized aged patients oppose himself to treatment or diagnosis procedure. This mixed study will used a census in a geriatrics department and a qualitative research.

ReferenceCitation: Tannou T, Trimaille H, Mathieu-Nicot F, Koeberle S, Aubry R, Godard-Marceau A. Investigation of opposition to diagnostic or therapeutic procedures in older people hospitalized in acute geriatric services: the OPTAH pilot study protocol. Pilot Feasibility Stud. 2020 Dec 14;6(1):194. doi: 10.1186/s40814-020-00742-7.

family: Tannou

full_name: Thomas Tannou

given: Thomas

family: Trimaille

full_name: Hélène Trimaille

given: Hélène

family: Mathieu-Nicot

full_name: Florence Mathieu-Nicot

given: Florence

family: Koeberle

full_name: Séverine Koeberle

given: Séverine

family: Aubry

full_name: Régis Aubry

given: Régis

family: Godard-Marceau

full_name: Aurélie Godard-Marceau

given: Aurélie

currency_apc_doaj: GBP

journal_name: Pilot and Feasibility Studies

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Association Between Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease Investigated by Liver Biopsy

acronym: NASHSAS

summary:
Obstructive sleep apnea (OSA) and nonalcoholic fatty liver disease (NAFLD) are frequently encountered in patients with metabolic syndrome (MS). Several data suggest that OSA per se could be a risk factor of liver injury. Most previous studies evaluating the association between OSA severity and the severity of NAFLD used indirect markers of NAFLD including liver imaging or liver injury blood markers or have been performed in morbidly obese patients undergoing intraoperative needle liver biopsy during bariatric surgery.

The current study propose to investigate with a full night polysomnography consecutive patients undergoing percutaneous liver biopsy for suspected NAFLD.

primary_purpose: Screening

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test


title: Prevalence, Management and Follow-up of Patients With Addiction to Opioid Analgesics

summary:
The demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem There is no support for repositories to date in the context of addiction analgesics grade 2.

Risk factors of misuse as well as diagnostic tools were identified.

time_perspective: Retrospective

ipd_sharing_description: NC


acronym: SCLERODERMIE

summary:
Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity. Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators knowledge, no study yet has examined the clinical features of itch neither had used a specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in those patients.

In this descriptive study, patients followed for SSc in the departments of dermatology, rheumatology, internal medicine and pulmonology at the University Hospital of Brest were included. Participants received a questionnaire including questions about the clinical features of pruritus and 2 scores (5-D itch scale, ItchyQol).


title: Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization

acronym: SOAP

summary:
Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine.

For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.

Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.

Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.

No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.

This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.

status: Recruiting

design_allocation: Randomized

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol. 2006 Jan;175(1):217-20; discussion 220-1.

ReferenceCitation: Rosen R, Altwein J, Boyle P, Kirby RS, Lukacs B, Meuleman E, O'Leary MP, Puppo P, Robertson C, Giuliano F. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003 Dec;44(6):637-49.

ReferenceCitation: Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.

family: Thomas

full_name: James A. Thomas

given: James A.

family: Tubaro

full_name: Andrea Tubaro

given: Andrea

family: Barber

full_name: Neil Barber

given: Neil

family: d’Ancona

full_name: Frank d’Ancona

given: Frank

family: Muir

full_name: Gordon Muir

given: Gordon

family: Witzsch

full_name: Ulrich Witzsch

given: Ulrich

family: Grimm

full_name: Marc-Oliver Grimm

given: Marc-Oliver

family: Benejam

full_name: Joan Benejam

given: Joan

family: Stolzenburg

full_name: Jens-Uwe Stolzenburg

given: Jens-Uwe

family: Riddick

full_name: Antony Riddick

given: Antony

family: Pahernik

full_name: Sascha Pahernik

given: Sascha

family: Roelink

full_name: Herman Roelink

given: Herman

family: Ameye

full_name: Filip Ameye

given: Filip

family: Saussine

full_name: Christian Saussine

given: Christian

family: Bruyère

full_name: Franck Bruyère

given: Franck

family: Loidl

full_name: Wolfgang Loidl

given: Wolfgang

family: Larner

full_name: Tim Larner

given: Tim

family: Gogoi

full_name: Nirjan-Kumar Gogoi

given: Nirjan-Kumar

family: Hindley

full_name: Richard Hindley

given: Richard

family: Muschter

full_name: Rolf Muschter

given: Rolf

family: Thorpe

full_name: Andrew Thorpe

given: Andrew

family: Shrotri

full_name: Nitin Shrotri

given: Nitin

family: Graham

ReferenceCitation: Misraï V, Rouprêt M, Guillotreau J, Bordier B, Bruyère F. [Greenlight(®) photoselective vaporisation for benign prostatic hyperplasia: a systematic review]. Prog Urol. 2013 Feb;23(2):77-87. doi: 10.1016/j.purol.2012.10.013. Epub 2012 Nov 26. Review. French.

ReferenceCitation: Peyronnet B, Cornu JN, Rouprêt M, Bruyere F, Misrai V. Trends in the Use of the GreenLight Laser in the Surgical Management of Benign Prostatic Obstruction in France Over the Past 10 Years. Eur Urol. 2015 Jun;67(6):1193-1195. doi: 10.1016/j.eururo.2015.01.003. Epub 2015 Jan 17.

ReferenceCitation: Ruszat R, Wyler S, Forster T, Reich O, Stief CG, Gasser TC, Sulser T, Bachmann A. Safety and effectiveness of photoselective vaporization of the prostate (PVP) in patients on ongoing oral anticoagulation. Eur Urol. 2007 Apr;51(4):1031-8; discussion 1038-41. Epub 2006 Aug 18.

ReferenceCitation: Reich O, Bachmann A, Siebels M, Hofstetter A, Stief CG, Sulser T. High power (80 W) potassium-titanyl-phosphate laser vaporization of the prostate in 66 high risk patients. J Urol. 2005 Jan;173(1):158-60.

ReferenceCitation: Charbonneau H, Pathak A, Albenque JP, Misrai V. Greenlight™ photovaporization of the prostate in patients under rivaroxaban: Lesson learned after the first cases. Prog Urol. 2016 Apr;26(5):273-5. doi: 10.1016/j.purol.2016.02.002. Epub 2016 Mar 9.

ReferenceCitation: Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.

ReferenceCitation: Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19. Review.

ReferenceCitation: Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000 Jun;163(6):1730-3.

ReferenceCitation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

ReferenceCitation: Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.

title: 180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study

ReferenceCitation: Peyronnet B, Pradere B, Brichart N, Bodin T, Bertrand P; Members of French Group of GreenLight Users, Bruyère F. Complications associated with photoselective vaporization of the prostate: categorization by a panel of GreenLight users according to Clavien score and report of a single-center experience. Urology. 2014 Sep;84(3):657-64. doi: 10.1016/j.urology.2014.05.028.

ReferenceCitation: Charbonneau H, Pasquié M, Peyronnet B, Descazeaud A, Barry-Delongchamps N, Della Negra E, Mathieu R, Karsenty G, Long JA, Ballereau C, Azzouzi AR, Pradère B, Bruyère F, Fournier G, Lebdai S, Calves J, Corbel L, Vincendeau S, Fiard G, Thuillier C, Descotes JL, Colin P, Culty T, Hesbois A, Fuzier V, Savy N, Pathak A, Albaladejo P, Samama CM, Guerrero F, Misraï V. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial. Trials. 2018 Dec 27;19(1):705. doi: 10.1186/s13063-018-3066-9.


title: Role of Innate Lymphoid Cells in the Immunosuppression of Septic Shock

acronym: CriSIs

summary:
Less than ten years after their intial description, the comprehension of Innate Lymphoid Cells (ILCs) biology is rapidly improving. They can be classified into four subgroups (ILCs 1, 2, 3 and NK cells) on the basis of their cytokine production and transcription factor expression.

They seem to be players in infectious diseases in animals but their role in human anti-bacterial defense remains unknown.

In this prospective work, the investigators will compare ILCs phenotyping in ICU patients managed for a septic shock, comparing them to ICU patients without any infectious disease on their inclusion. The investigators will also make a large immune mapping in all patients, to place ILCs in the global immune depressed state observed in septic patients.

ReferenceCitation: Carvelli J, Piperoglou C, Bourenne J, Farnarier C, Banzet N, Demerlé C, Gainnier M, Vély F. Imbalance of Circulating Innate Lymphoid Cell Subpopulations in Patients With Septic Shock. Front Immunol. 2019 Sep 20;10:2179. doi: 10.3389/fimmu.2019.02179. eCollection 2019.

family: Carvelli

full_name: Julien Carvelli

given: Julien

family: Piperoglou

full_name: Christelle Piperoglou

given: Christelle

family: Bourenne

full_name: Jeremy Bourenne

given: Jeremy

family: Farnarier

full_name: Catherine Farnarier

given: Catherine

family: Banzet

full_name: Nathalie Banzet

given: Nathalie

family: Demerlé

full_name: Clemence Demerlé

given: Clemence

family: Gainnier

full_name: Marc Gainnier

given: Marc

family: Vély

full_name: Frédéric Vély

given: Frédéric

currency_apc_doaj: USD

journal_name: Frontiers in Immunology

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repositories:
HAL
PubMed Central

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

intervention_type: Behavioral


type: Other Identifier

title: Paracetamol Metabolism Research in Postoperative Hepatic Surgery

acronym: PARAFOI

summary:
The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable.

Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Lille


title: Etude de Cohorte Des Patients Suivis en Allergologie au CHU de Grenoble : hypersensibilité Allergique et hypersensibilité Non Allergique

acronym: BdDAllergo

summary:
The creation of a database containing the medical data of patients followed in allergology at the University Hospital of Grenoble will permit to study allergic versus non-allergic hypersensitivity drug reaction as well as the risk of cross-reactions between medicinal drugs belonging to the same pharmacological class.

The main objectives of the study are to estimate and to compare the proportion of allergic hypersensitivity drug reaction and the proportion of non allergic hypersensitivity drug reaction, and to characterize these two types of hypersensitivity drug reaction on clinical, biological and chronological aspects.

In a second time, ancillary study will be conducted in order to :

identify drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction
investigate the risk of cross-reactions between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction.

status: Terminated

ReferenceType: result

ReferenceCitation: Cousin F, Catelain A, Philips K, Favier B, Queuille E, Nicolas JF. [Immediate hypersensitivity is rarely implicated in drug induced urticaria]. Ann Dermatol Venereol. 2003 Mar;130(3):321-4. French.

ReferenceCitation: Ponvert C, Scheinmann P. [Allergic and pseudo-allergic reactions to betalactam antibiotics]. Arch Pediatr. 2003 Jul;10(7):658-65. Review. French.

ReferenceCitation: Nosbaum A, Pralong P, Rozieres A, Dargaud Y, Nicolas JF, Bérard F. [Delayed-type hypersensitivity to heparin: diagnosis and therapeutic management]. Ann Dermatol Venereol. 2012 May;139(5):363-8. doi: 10.1016/j.annder.2012.01.017. Epub 2012 Mar 9. Review. French.

family: Nosbaum

full_name: A. Nosbaum

given: A.

family: Pralong

full_name: P. Pralong

given: P.

family: Rozieres

full_name: A. Rozieres

family: Dargaud

full_name: Y. Dargaud

given: Y.

family: Nicolas

full_name: J.-F. Nicolas

family: Bérard

full_name: F. Bérard

given: F.

journal_name: Annales de Dermatologie et de Vénéréologie

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Hypersensibilité retardée aux héparines : diagnostic et prise en charge thérapeutique

lead_sponsor: University Hospital, Grenoble


title: Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment

acronym: MCoto

summary: The aim of this study is to compare the value of multifrequency tympanometry between patients with surgical indication of treatment for a Chiari type I malformation and healthy volunteers.

lead_sponsor: University Hospital, Bordeaux


title: Physiopathology of Lower Cortical Activation in COPD Patients: Contribution of Cortical Neuromodulation

summary: Patients with COPD have lower cortical activation and higher cortical inhibitory levels. The purpose of this study is to test the reversibility the lower cortical activation by counterbalancing the increased cortical inhibitory levels with neuro-modulation.

lead_sponsor: 5 Santé

lead_sponsor_type: industriel


title: Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases

acronym: GHTT

summary: Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment is indicated when there are signs of spinal cord injury. To date, several surgical techniques have been described in the treatment of this condition on small patient series. The main objective is to evaluate the long-term results of a series of 53 patients treated with a minimally invasive endoscopic procedure. The secondary objective is to explain our pre-operative planning and the technical details of our procedure. METHOD: Retrospective monocentric study on a cohort of patients treated in our department. The following medical data from our database are analyzed: Morbidity of operative gesture (duration of procedure, bleeding, postoperative complications), clinical results at the last follow-up visit (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability to walk, wish to carry out the same intervention again if necessary). On the radiological level, we evaluated the quality of the resection (total, subtotal, incomplete and impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are collected and analyzed anonymously. Expected Results: We believe we can demonstrate that thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation responsible for spinal cord compression. This with a low morbidity given the minimally invasive nature of the approach.

lead_sponsor: Hopital Foch


title: Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study

acronym: EXTUB ECLS

summary: There are no clear recommendations concerning the management of patients on ECLS (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so as to avoid accidents, notably decannulation. Moreover, there are few publications on the subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support) is a recent practice. Nonetheless, it is becoming more and more frequent in the cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits of this practice by comparing 2 populations: those with extubation while on ECLS (Extra-Corporeal Life Support) and those without.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)

acronym: DD

summary:
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.

In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool.

Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures.

We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.


title: Study of Natural Killer Immunity During Infections With CMV or AdV After Allogeneic Hematopoietic Stem Cells

acronym: Allo-NK-CMV

summary: NK cells are lymphocytes who play a role in the control of viral infections , tumor and fœtal tolerance. They belong to innate immune cells but they have a link with adaptative immunity. Indeed, after some viral infections such as CMV, Chikungunya, B hepatitis etc, a subset of NKG2C+ NK cells expands and can transfer, in murine models, a " memory " that can better control CMV infections. CMV reactivation is a major cause of morbidity and mortality after allogeneic hematopoietic ste cell transplantation in humans. The aim of this prospective study is to evaluate the role of NK cells, in particular NKG2C+ NK cells in the control of CMV but also Adenovirus after allo HSCT. Peripheral NK cells from 30 and 10 patients who reactivated respectively CMV and AdV are prospectively studied (extensive phenotyping and functional studies before and after administration of anti viral drugs) and compared with 30 allotransplanted patients who didn't reactivate CMV in a pair analysis, and 30 healthy donors serologically + for CMV.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: EudraCT Number

title: Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients

acronym: ONCOVIRAC

summary:
Glioblastoma is the most common and the most aggressive primary brain cancer in adults. Indeed, despite very intensive treatments (i.e. maximal safe surgery, radiotherapy and several lines of cytotoxic chemotherapies), inducing significant adverse events, the prognosis of glioblastoma patients remains dismal with a median overall survival of ~15 months. Therefore, more efficient and less toxic therapies are urgently needed to improve survival and quality of life of glioblastoma patients.

The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models of glioblastoma in vitro (i.e. cell line) and in vivo (i.e. xenografts in Swiss/Nude mice). Comprehensive toxicology studies of TG6002/Flucytosine have been completed in rabbits and monkeys supporting safety investigations of TG6002/Flucytosine in human patients.

Taken these data all together, TG6002/Flucytosine appears as a very promising therapeutic strategy in glioblastoma patients that merits consideration for early phase clinical trial.

primary_purpose: Treatment

intervention_type: Drug


title: TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma - A Phase Ib Clinical Study

acronym: TICIMEL

summary: This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.

status: Active, not recruiting

ReferenceCitation: Montfort A, Filleron T, Virazels M, Dufau C, Milhès J, Pagès C, Olivier P, Ayyoub M, Mounier M, Lusque A, Brayer S, Delord JP, Andrieu-Abadie N, Levade T, Colacios C, Ségui B, Meyer N. Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial. Clin Cancer Res. 2021 Feb 15;27(4):1037-1047. doi: 10.1158/1078-0432.CCR-20-3449. Epub 2020 Dec 3.

family: Montfort

full_name: Anne Montfort

given: Anne

family: Filleron

full_name: Thomas Filleron

given: Thomas

family: Virazels

full_name: Mathieu Virazels

given: Mathieu

family: Dufau

full_name: Carine Dufau

given: Carine

family: Milhès

full_name: Jean Milhès

given: Jean

family: Pagès

full_name: Cécile Pagès

given: Cécile

family: Olivier

full_name: Pascale Olivier

given: Pascale

family: Ayyoub

full_name: Maha Ayyoub

given: Maha

family: Mounier

full_name: Muriel Mounier

given: Muriel

family: Lusque

full_name: Amélie Lusque

given: Amélie

family: Brayer

full_name: Stéphanie Brayer

given: Stéphanie

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Andrieu-Abadie

full_name: Nathalie Andrieu-Abadie

family: Levade

full_name: Thierry Levade

given: Thierry

family: Colacios

full_name: Céline Colacios

given: Céline

family: Ségui

full_name: Bruno Ségui

given: Bruno

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Institut Claudius Regaud

intervention_type: Combination Product

status_simplified: Ongoing


title: Phenotypic and Functional Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis, a Pilot Study.

acronym: CATERLIS

summary:
In rheumatoid arthritis (RA) the clinical response to anti-TNFα is related to an increase in the number or in the function of Treg lymphocytes in the peripheral blood of patients. This observation suggests the central role of Tregs in homeostasis of the immune response during RA.

In the literature the Tregs frequency and phenotype in the peripheral blood are well documented, however the analyses done on the Tregs in inflamed environment are still fragmentary or disparate.

In this project Tregs phenotype as well as expression of several transcripts will be analysed in order to better characterize the Treg cell subsets within the synovial fluid. Moreover, the local inflammatory cytokines (TNF, IL-6 and IL-1) may affect both the phenotype and the suppressive function of these Tregs and a comparison between peripheral and tissue Tregs will allow us to better understand the cause of functional loss.

Outcomes:

Primary outcome: Identification and characterization of the Tregs subpopulation present in the synovial fluid for RA patients suffering an episode of acute arthritis.

Secondary outcomes: compare the phenotypic and expression profile of the Tregs present in the synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from an episode of acute arthritis.


title: MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin

acronym: MISOBOLD

summary: This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.

status: Withdrawn


title: Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early

acronym: PRECOCE TC

summary:
Observational retrospective study that included all patients meeting the inclusion criteria from 1st January 2014 to 31st December 2015.

The objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the Department in whom the sedation was not continued.


title: Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy

acronym: VPCA

summary:
As principal objective, the study aims to:

Describe the spectrum and evaluate the frequency of angiodysplasia of the nevrax;
Establish the physiopathological basis of Fowler's syndrome;
Identify FLVCR2 partners and the signaling pathways involved;
Test new candidate genes: GPR124 and possible partners of FLVCR2.

As second objective, the study aims to:

perform phenotype / genotype correlation if necessary;
and propose a prenatal diagnosis in families with identified mutations.

ReferenceCitation: Thomas S, Encha-Razavi F, Devisme L, Etchevers H, Bessieres-Grattagliano B, Goudefroye G, Elkhartoufi N, Pateau E, Ichkou A, Bonnière M, Marcorelle P, Parent P, Manouvrier S, Holder M, Laquerrière A, Loeuillet L, Roume J, Martinovic J, Mougou-Zerelli S, Gonzales M, Meyer V, Wessner M, Feysot CB, Nitschke P, Leticee N, Munnich A, Lyonnet S, Wookey P, Gyapay G, Foliguet B, Vekemans M, Attié-Bitach T. High-throughput sequencing of a 4.1 Mb linkage interval reveals FLVCR2 deletions and mutations in lethal cerebral vasculopathy. Hum Mutat. 2010 Oct;31(10):1134-41. doi: 10.1002/humu.21329.

family: Thomas

full_name: Sophie Thomas

given: Sophie

family: Encha-Razavi

full_name: Ferechté Encha-Razavi

given: Ferechté

family: Devisme

full_name: Louise Devisme

given: Louise

family: Etchevers

full_name: Heather Etchevers

given: Heather

family: Bessieres-Grattagliano

full_name: Bettina Bessieres-Grattagliano

given: Bettina

family: Goudefroye

full_name: Géraldine Goudefroye

given: Géraldine

family: Elkhartoufi

full_name: Nadia Elkhartoufi

given: Nadia

family: Pateau

full_name: Emilie Pateau

given: Emilie

family: Ichkou

full_name: Amale Ichkou

given: Amale

family: Bonnière

full_name: Maryse Bonnière

given: Maryse

family: Marcorelle

full_name: Pascale Marcorelle

family: Parent

full_name: Philippe Parent

given: Philippe

family: Manouvrier

full_name: Sylvie Manouvrier

given: Sylvie

family: Holder

full_name: Muriel Holder

family: Laquerrière

full_name: Annie Laquerrière

given: Annie

family: Loeuillet

full_name: Laurence Loeuillet

given: Laurence

family: Roume

full_name: Joelle Roume

given: Joelle

family: Martinovic

full_name: Jelena Martinovic

given: Jelena

family: Mougou-Zerelli

full_name: Soumaya Mougou-Zerelli

given: Soumaya

family: Gonzales

full_name: Marie Gonzales

given: Marie

full_name: Vincent Meyer

given: Vincent

family: Wessner

full_name: Marc Wessner

given: Marc

family: Feysot

full_name: Christine Bole Feysot

given: Christine Bole

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

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


title: Work Productivity in Hyperventilation Syndrome

acronym: WHY

summary: Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome


title: Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer

acronym: QUALIPRO

summary: This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.

primary_purpose: Health Services Research

lead_sponsor: Centre Oscar Lambret


title: Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂

summary: the investigators will include 120 patients with a diagnosis of septic shock in accordance with the definition given by the 2001 expert consensus. Two groups of patients are likely to participate in this study: Patient hospitalized in intensive care for a septic shock = Primary patient + patient who develops, the waning of his hospitalization in intensive care for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by transpulmonary thermodilution allow a patient's close monitoring during the initial phase supported. The clinical and biological data, demographic and the severity scores are collected for each patient during the first three days of stay. To predict the unfavorable evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2) is performed. the investigators analyzed mortality at day 28 in patients with increased P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted according to good clinical practice. An information will be distributed to patients.

primary_purpose: Prevention

location_facility: Assisitance Publique Hopitaux de Marseille


title: Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study

acronym: FLEGME

summary: Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma cells through a metabolic abnormality and thus helps in defining tumoral edges through a modified microscope. A multicentric, randomized study comparing 5ala guided surgery with conventional procedures showed that this technique doubles the rate of complete removal on post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free survival. More recently, fluorescein appeared as an interesting alternative fluorophore for glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its use remains scarcely studied and its clinical benefit unsure. In that context, the investigators propose a randomized trial comparing conventional " white light " surgery with fluorescein-guided resection of glioblastomas, in order to assess the relevance of this technique in glioblastomas removal.

lead_sponsor: Rennes University Hospital


title: Itch and Pain Characteristics in Skin Carcinomas

acronym: PRURITCC

summary: The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.


title: Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH

acronym: AMETHYST

summary:
Hysterectomy is one of the most performed surgery in women. Public authorities wish that one-day surgery become a majority and hysterectomy could be part of it in the future. The aim of this study is to determine the feasibility of ambulatory hysterectomy.

Patients and methods: Investigators will realize an observational descriptive survey based on questionnaires in two surgical gynecology units. Women under 70 years old, who undergo hysterectomy will be included.

lead_sponsor: University Hospital, Caen


title: Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis

acronym: HYPNOCYST

summary:
Half of the women present an episode of cystitis once in their lives. A recurrence occurs in about 20% to 30% of the patients, and half of these patients will make more than 4 episodes per year, defining recurrent cystitis (CR).

Complications such as pyelonephritis are rare (less than 0.5% of patients in the absence of underlying complication), however, CRs are responsible for a significant impact on women but also on society. Pain is at the forefront, but also the fear of not managing pollakiuria, with its social exclusion. The impact on sexuality is major. The medical circuit imposed on the patients is long and arduous. The clinical assessment sometimes reveals favorable factors, variable in pre- or post-menopause, but in the majority of cases, no explanatory cause can resolve the problem and some authors suggest resignation as a classic reaction to this problem. The only study on psychological disorders associated with recurrent cystitis suggests patients who are much more anxious than the average of female.

Hypnotherapy is an old technique, used for care in Western societies for at least two hundred years. By the word, the practitioner induces in the patient a particular state of consciousness characterized by an indifference on the outside and a hyper suggestibility. This "hypnotic" state of consciousness can be used to amplify the patient's internal resources to fight against anxiety and pain, and to eliminate symptoms.

The physiological mechanisms at work in hypnosis are the subject of recent studies becoming more and more precise. The results of these studies made it possible to objectify changes in cerebral functioning related to hypnotic trance.

A report by Inserm of 2015 confirms the effectiveness of this practice in hypnosedation, hypnoanalgesia and hypnotherapy, particularly in irritable bowel syndrome, although the methodology to be used in its evaluation is difficult and subjective. The principal investigator hypothesizes that the symptoms presented in recurrent cystitis (pain, anxiety) can be improved by hypnotherapy, and that thus the prognosis of this pathology can be totally modified.

In the absence of any study published in the literature, the investigator propose an intervention pilot study with minimal risks and constraints monocentric prospective non-randomized prospectively in 15 patients.

The main objective of this project is to demonstrate that hypnotherapy improves the psycho-emotional parameters of patients suffering from recurrent cystitis after 3 hypnosis sessions combined with home exercises performed by the patient. The evaluation will be carried out during the last session of hypnosis.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery: Prognostic Value of Pulmonary Extravascular Water Revealed by Pulmonary Ultrasound.

acronym: ODR

summary:
Today there are few studies in the literature involving patients in an ICU following major visceral surgery. There are thus few results about the prognostic value of pulmonary extravascular water in this population of patients, but also the prognostic value of pulmonary extravascular water measured at the bedside using pulmonary ultrasound.

In addition, pulmonary ultrasound will be combined with echocardiography to measure left ventricular function (LVEF) and to study the profile of the mitral valve to assess filling pressure in patients with immediate post-operative ventilation. This will make it possible to distinguish between increases in pulmonary extravascular water associated with high filling pressure and increased pulmonary water associated with low filling pressure: characteristic of lesional oedema.

The aim of this study is to determine the prognostic value of extravascular pulmonary water (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.


title: Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery

acronym: DHA

summary: Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.


title: Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)

acronym: MyB

summary:
This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training.

Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.

30 patients will be randomly assigned to groups A and B according to a ratio 2:1.

Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.

Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).

Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.

Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.

It also uses actigraphy measures to evaluate sleep quality.

lead_sponsor: Hospices Civils de Lyon


title: Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance

acronym: PRECOG

summary: The aim of the PRECOG study is to determine in a prospective interventional randomized study whether the implementation of a predictive test based on the sFLT-1/PlGF ratio improves perinatal care and reduces costs, in patients with suspected preeclampsia before 35 weeks of gestation.

ReferenceCitation: Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63.

ReferenceCitation: Sibiude J, Guibourdenche J, Dionne MD, Le Ray C, Anselem O, Serreau R, Goffinet F, Tsatsaris V. Placental growth factor for the prediction of adverse outcomes in patients with suspected preeclampsia or intrauterine growth restriction. PLoS One. 2012;7(11):e50208. doi: 10.1371/journal.pone.0050208. Epub 2012 Nov 28.

ReferenceCitation: Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennström M, Olovsson M, Brennecke SP, Stepan H, Allegranza D, Dilba P, Schoedl M, Hund M, Verlohren S. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

intervention_type: Biological


title: A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients

summary: The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).

ReferenceCitation: Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25.

family: Breyton

full_name: Anne-Esther Breyton

given: Anne-Esther

family: Goux

full_name: Aurélie Goux

given: Aurélie

family: Lambert-Porcheron

full_name: Stéphanie Lambert-Porcheron

given: Stéphanie

family: Meynier

full_name: Alexandra Meynier

given: Alexandra

family: Sothier

full_name: Monique Sothier

given: Monique

family: VanDenBerghe

full_name: Laurie VanDenBerghe

given: Laurie

family: Brack

full_name: Olivier Brack

given: Olivier

family: Disse

full_name: Emmanuel Disse

given: Emmanuel

family: Laville

full_name: Martine Laville

given: Martine

family: Vinoy

full_name: Sophie Vinoy

given: Sophie

family: Nazare

full_name: Julie-Anne Nazare

given: Julie-Anne

journal_name: Nutrition, Metabolism and Cardiovascular Diseases

lead_sponsor: Mondelēz International, Inc.

location_facility: Centre de Recherche en Nutrition Humaine Rhone-Alpe


title: Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer

acronym: PITCA

summary:
This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer.

This protocol will be based on:

A coordinated ambulatory follow-up performed by a dedicated nurse
An electronic follow-up tool used in pre- and post-surgery

Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.


title: Effects at 12 Weeks of Transcranial Direct Current Stimulation on the Cognitions of People Presenting Early Alzheimer's Disease (tDCS-AD)

acronym: tDCS-AD

summary:
TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which remains of the field of research.

Its use remains very experimental, and concerns the exploration of cognitions, in healthy and diseased subjects. There are not many studies on the elderly subject with Alzheimer's disease, nor do they document the medium- and long-term effect (more than one month), nor the effect on geriatric parameters such as Fragility indices and the risk of falls, especially at home. These characteristics are decisive because they define the level of autonomy.

The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS active) versus placebo (2-week tDCS group) for a three-month period.

lead_sponsor: Benjamin CALVET


title: Fatigue After Stroke

acronym: Fatigue AVC

summary:
Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.

The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.


title: Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients

acronym: SPAD-IRM

summary: The main objective of this study is to show MRI functional and structural differences between depressed elderly patients with a history of attempted suicide compared to depressed elderly patients with no history of attempted suicide and to elderly subjects with no personal history of depression or attempted suicide (healthy controls).

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI

acronym: SILENZ

summary: The purpose of this study is to accurately map calcaneal fibrocartilage using TE = 0 ms imaging, and then apply measurements of our control population to SpA patients with peripheral enthesis study using the calcaneal tendon as a clinical model


title: Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study

acronym: ORACLE

summary: Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.

primary_purpose: Supportive Care

ReferenceCitation: Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120.

ReferenceCitation: Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. Epub 2003 Mar 20.

ReferenceCitation: Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.

ReferenceCitation: Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22.

ReferenceCitation: Behrmann M, Lieberthal T. Category-specific treatment of a lexical-semantic deficit: a single case study of global aphasia. Br J Disord Commun. 1989 Dec;24(3):281-99.

ReferenceCitation: Crosson B. An intention manipulation to change lateralization of word production in nonfluent aphasia: current status. Semin Speech Lang. 2008 Aug;29(3):188-200; quiz C-4. doi: 10.1055/s-0028-1082883.

ReferenceCitation: Jones EV. Building the foundations for sentence production in a non-fluent aphasic. Br J Disord Commun. 1986 Apr;21(1):63-82.

lead_sponsor: University Hospital, Toulouse


title: Identification of the Molecular and/or Pathophysiological Bases of Developmental Diseases

acronym: DISCOVERY

summary: Developmental diseases include more than 3000 diseases and can associate organ malformation, dysmorphism, development disorders and/or intellectual deficiency. Even though the considerable effort in the search for genes in the last 20 years has led to the identification of thousands of genes associated with Mendelian diseases, half of the individuals with severe development anomalies remain without a genetic diagnosis. It is important to pursue the ambition to contribute to the goal fixed by Europe, namely the identification of the large majority of genes responsible for rare diseases with development anomalies, and to be able to provide genetic counselling to patients and their families. In the past, scientific research to discover genes required a large number of families and individuals and was slow and expensive to carry out. Today, this approach has been facilitated by next generation sequencing.

intervention_type: Genetic


title: Interest of tDCS in Help for Supporting Alcohol Abstinence

acronym: ITAMAA

summary: The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of abstinence at 3 months.

lead_sponsor: Centre Hospitalier Henri Laborit


title: Incidence of pNeumonia and Related ConseqUences in Nursing Home

acronym: INCUR

summary: In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. In fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. Unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the French EHPAD are extremely scare. To adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. This first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the EHPAD setting.


title: Sensori-motor and Perceptual Functions of the Posterior Parietal Cortex (PPC) in Patients With Optic Ataxia (AO) and Healthy Subjects.

acronym: PPCfonctions

summary:
To produce hand's movement directed towards a target, the investigator must combine several sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.

The aim of the study is to understand the different functions of the PPC and especially how the processes of spatial coding of the sensory information influences perception and motor planning.

In this study, the investigator want to explore the sensory motor and the perceptual performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral tests.

location_facility: U1028 INSERM - CNRS UMR 5292 Equipe ImpAct


title: Contextual Associations During Episodic Recall of Everyday or Virtual Reality

acronym: BREAL

summary:
The project is dedicated to development of new paradigms to investigate memory and attention in the rich and realistic environments. The investigator will use modern interactive digital technologies for encoding complex episodes either using mobile phone technology in everyday life or using a virtual reality life-like simulation.

He aims to characterize the role of the medial temporal lobe and prefrontal cortex during recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy participants. The secondary aim is assess how the allocation of attention during memory encoding contribute to mechanisms of the subsequent recall. He will achieve this by monitoring gaze direction during encoding and by analyzing the retrieval data as a function of the elements that participants attended / fixated during encoding.

The protocol will involve, first, behavioral testing of memory performance with encoding in the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI will be used to measure brain activity during retrieval.


title: Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine to Improve Balance in Elderly Patients

acronym: SATRACE

summary:
In more than 90% of cases, victims of fall are elderly people over 65. Nearly the third of those people fall at least 1 time by year. The incidence substantially increases for people over 80 and women are at higher risk than men.

The value of balance rehabilitation no longer needs to be demonstrated in Gerontology. Nevertheless, a more specific therapy based on the aged-related cervical problems seems to be essential. Indeed, those problems are numerous (arthrosis-like pains, joint stiffness, muscular contractures…) and often lessen vestibular and/or proprioceptive afferents. The cervical spine is a link between different systems which regulate balance, as the visual, vestibular and cervical systems (muscular, articular afferents…), and this role is key to balance control. Indeed, the cervical spine owns an exceptional function thanks to Ruffinian corpuscles, muscle and neurotendinal spindles.

Many studies point up the importance of the relation between balance, cervical spine and vestibular system, and others between tissue changes and postural adaptations in elderly people. Nevertheless, the take into consideration of all these data and their impacts in rehabilitation has not been reported yet.

This brings us to question the added-value of a cervical mobility management in balance rehabilitation in Gerontology.


title: Impact of Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex on Emotional Processing in Healthy Subjects.

acronym: EmoStimH

summary:
The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation.

Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses .

Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment, often used in major depression.

Various studies have shown that it is possible to modulate emotional processing in healthy subjects, however the impact of this modulation on attentional resources and physiological responses has not been studied. Also, the mechanisms of action of the tDCS on emotional processing are still unclear.

It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better understand the network and mechanisms at stake in the processes.

Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses.

lead_sponsor: Hôpital le Vinatier


title: Evaluation of the Visuo-attention Field of Symbols Versus Objects Visual Search in Dyslexic Subjects. DyslexiaSPOTLIGHT

summary:
dyslexia is often considered like a phonological deficit but some researches show that a visual attention (V-A) deficit can occur in dyslexia. The investigator want to show that some dyslexics have a reduced V-A field in visual search when the investigator use separable feature (letter-like).

If the investigator demonstrate that, he will show that V-A deficit can be transpose to an ability acquired before reading, the visual search. Therefore, the V-A deficit can't be a consequence of reading problem but a cause of it for some dyslexics.

The investigator could imagine an earlier diagnosis for children at risk to develop dyslexia and make reeducation more specific for the deficit observed.


title: Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)

acronym: tDCS-TOC

summary: The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.


type: Registry Identifier

title: A Pilot Study of the Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers

acronym: NEUROTAP

summary:
A majority of people undergoing rehabilitation following a stroke have a deficit of the dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance with the recommendations of learned societies is not sufficient to compensate for this deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its action on muscle, joint, circulatory and pain functions.

The use of taping would increase the duration of stimulation of the muscles of the dorsiflexors of the foot which would facilitate the motor recovery.

Data from the literature do not support the conclusion that taping is effective, but no studies evaluating the efficacy of this technique in the foot-lift deficiency of the hemiplegic patient have been found.

The investigators hypothesize that the use of taping in conjunction with common rehabilitation for hemiplegic patients following a stroke improves the stimulation of the muscles of the dorsiflexors of the foot with a positive impact on the walking.


title: Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of First Rank Symptoms on Schizophrenia: Controlled, Randomised, Double Blind Trial

acronym: Schirang

summary:
First rank symptoms are core symptoms of schizophrenia. the investigators want to offer an integrative approach to better understanding of the mechanisms involved in the first rank symptoms and therefore, in schizophrenia, as well as the neuronal modulation mechanisms obtained by rTMS. It will be to pass a functional magnetic resonance imaging (fMRI) at rest for healthy volunteers, and for patients before and after rTMS modulation, to view brain structures activated in the resting state network, and in order to study

the difference of the resting-state network between healthy volunteers and people with schizophrenia,
if the response to rTMS boost can be predicted by resting-state network of patients before treatment and
if rTMS changes activations in the brain of patients. This will ultimately provide rTMS as a treatment of first rank symptoms.


title: Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

acronym: MATPF

summary:
The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.

This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .

lead_sponsor: University Hospital, Tours

location_facility: Service de chirurgie maxillo-faciale, CHRU de TOURS


title: Social Cognition Training and Cognitive Remediation : a New Tool for 22q11.2 Deletion Syndrome

acronym: RCKID

summary:
Social cognition refers to mental operations that enable people to perceive, interpret constantly changing social informations. These processes allow people to rapidly, effortlessly and flexibly perceive and interpret rapidly-changing social information, and respond appropriately to social stimuli. Besides, this ability gives meaning to the actions of others. Impairments in this field may largely underlie social dysfunctions and reduce adaptive skills. Moreover, social cognitive disabilities contribute more or less directly to behavioral disturbances and psychiatric symptoms The "RC KID" program involves a variety of exercises in a paper and/or pencil or a computerized format or role playing and a strategy coaching approach. "RC KID" targets the emotion recognition and social interaction.

A little cartoon character (a pirate), is supposed to be very friendly and kind toward children. The pirate will accompany them throughout the program for an effective and positive reinforcement. The main goal of "RC KID" is to adjust to children's difficulties in daily life.

Moreover, since the cognitive remediation benefit is complex to apply in daily life, the program is based on a metacognitive strategy.

After a complete neuropsychological assessment and a psychoeducational session (with the child and the parents), 16 1-h-sessions of cognitive remediation with the therapist are proposed. Each session is composed of three parts: (1) computerized tasks focusing on specific emotion recognition components (20 min). RC KID is composed of 2 modules : Emotion recognition and social interaction. These tasks contain photo or video. (2) pen and paper or role playing tasks focusing on the same processes (20 min) (3) a proposal of a home-based task (during 20 min). Weekly, home tasks are proposed to the child and analyzed with the parents and the therapist. Indeed, home exercises are useful to promote the transfer of strategies to daily life and their subsequent automation. The heterogeneity of cognitive deficits in 22q11.2 deletion necessitates an individualized cognitive remediation therapy. In this regard, "RC KID" seems to be a promising tool.


title: Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology

summary:
The classic physiopathology of cardiogenic shock is explained by a systolic ventricular failure, responsible for a decrease in cardiac output associated with high systemic vascular resistances (SVR). This theory is currently challenged in light of the data collected in the SHOCK study, which assessed outcome of early revascularization versus initial medical stabilization, in cardiogenic shock following myocardial infarction.13 A sub-study highlighted depressed SVR in the population with ischemic cardiogenic shock, related to a systemic inflammatory response syndrome.14 Furthermore, mean FEVG was 30% in the SHOCK trial,13 with a similar distribution with post myocardial infarction heart failure patients without signs of shock.15-19 Thus, alteration of myocardial contractility can be only moderate in cardiogenic shock and isn't the only cause responsible for the hemodynamic instability.20 Recent studies suggest the important roles of the peripheral vascular system and neurohormonal system in the genesis and prolongation of cardiogenic shock.12 Vasodilation caused by nitrous oxide synthase activation27 explains the absence of compensating vasoconstriction observed during the SHOCK trial13, and leads to decreased systemic and coronary perfusion, thus increasing myocardial ischemia and initial ventricular dysfunction. 28,29 Cotter et al. conducted an interesting study of hemodynamic evaluation of various cardiac conditions where they observed a significant variability in the peripheral vascular status, with systemic vascular resistances collapsed in certain patients (similar to those observed in septic shock) and rather close to normal or very high resistances in other patients.21 However these data were obtained from a selected group of patients without differentiating the etiology of cardiogenic shock. Finally, the majority of available studies were limited to cardiogenic shock whose etiology was myocardial infarction.

Therapeutic management of cardiogenic shock is based in first intention on an inotropic support by Dobutamine.11,23 However, better outcomes on contractility and microcirculatory state have been observed with the use of a vasopressor support by Norepinephrine, suggesting the importance of SVR decreasing in genesis of cardiogenic shock.14,24 Recent reviews showed very few data on inotropic treatment and association with vasopressor support,22 hence the low level of recommendations in current guidelines.11,23

So far it is crucial to accurately characterize hemodynamic status and in particular the systemic vascular resistance for patients with cardiogenic shock. Important variabilities in hemodynamic profiles observed in Cooter's trial could explain the difficulty in defining an optimal therapeutic strategy.

the investigators hypothesize that the hemodynamic profile, particularly SVR, of patients with cardiogenic shock is different depending on their etiology. Ischemic cardiogenic shock should be characterized by lower SVR, in relation to a major role of systemic inflammatory response syndrome. On the contrary, non-ischemic cardiogenic shock could be associated with normal or elevated SVR, and thus could explain the variability in distribution of SVR.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisatnce Publique Hopitaux de Marseille


title: Identifying New Genetic Causes to the Disorders of Growth, Puberty and Sex Development

acronym: FORDEV

summary: Disorders of growth, puberty and sex development can have genetic causes. The exome analysis could detect new mutations responsible for these disorders and the frequency of these mutations in these disorders, their association with other malformations.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A de Rothschild


title: Perception of the Risk Associated With the Use of Cosmetics Products During Pregnancy - a Qualitative Study

acronym: PERICOS

summary:
The use of cosmetics is an important source of exposure to many chemicals including endocrine disruptors. Recently, national and international scientific recommendations have been issued to limit exposure to chemicals during pregnancy. However, the perception and the use of cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant women.

Understanding the risk perception, the knowledge, attitudes and expectations of women about the use of cosmetics during pregnancy will help to set up effective strategies to improve prevention of chemical exposure.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 0p-1-2

acronym: INFINITx-BOS

summary:
Lung transplantation (TxP) is now a validated treatment of end-stage pulmonary diseases, but long-term graft and patient survival are still hampered by the development of chronic allograft dysfunction (CLAD) affecting > 50% of patients.

The investigators propose to conduct a phase III clinical randomized trial that will assess the efficacy of Nintedanib to hamper the lung decline in LTx recipients with BOS. This is the first trial testing this molecule in lung Tx recipients. If case of demonstrated effectiveness of Nintedanib, the benefit for lung transplant patients carrying a BO is high in terms of stabilization of lung function and enhancement of survival.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Comparative Study of Captive Great Ape and Human Intestinal Microbiomes

acronym: SHAPES-CAP

summary: The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal microbiome shared by human beings and captive great apes living in proximity and in direct, daily contact. The investigators will determine the phylogenetic diversity of enterotypes (bacterial and viral) shared between human beings and great apes and will link these results with participant-observations of caretakers' activities (and contacts) with these great apes.

lead_sponsor: Institut Pasteur


title: Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit

acronym: PREDICT

summary:
The study aims to develop and validate a prediction score of chronic renal disease occurrence within 3 years after ICU discharge in patients who suffered an acute kidney failure during ICU stay and recovered normal renal function at 90 days following their discharge.

The primary study outcome is the incidence of chronic renal disease within the first 3 years after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

ReferenceCitation: Geri G, Stengel B, Jacquelinet C, Aegerter P, Massy ZA, Vieillard-Baron A; PREDICT investigators. Prediction of chronic kidney disease after acute kidney injury in ICU patients: study protocol for the PREDICT multicenter prospective observational study. Ann Intensive Care. 2018 Jul 6;8(1):77. doi: 10.1186/s13613-018-0421-7.

family: Geri

full_name: Guillaume Geri

given: Guillaume

family: Stengel

full_name: Bénédicte Stengel

given: Bénédicte

family: Jacquelinet

full_name: Christian Jacquelinet

given: Christian

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

family: Massy

full_name: Ziad A. Massy

given: Ziad A.

family: Vieillard-Baron

full_name: Antoine Vieillard-Baron

given: Antoine

family: Legriel

full_name: Stéphane Legriel

given: Stéphane

family: Laurent

full_name: Virginie Laurent

given: Virginie

family: Teboul

full_name: Jean-Louis Teboul

given: Jean-Louis

family: Tarazona

full_name: Anatole Virginie Tarazona

given: Anatole Virginie

family: Mekontso-Dessap

full_name: Armand Mekontso-Dessap

given: Armand

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Diehl

full_name: Jean-Luc Diehl

given: Jean-Luc

family: Pirracchio

full_name: Romain Pirracchio

given: Romain

family: Bigé

full_name: Naike Bigé

given: Naike

family: Dupuis

full_name: Claire Dupuis

given: Claire

family: Gaudry

full_name: Stéphane Gaudry

family: Maizel

full_name: Julien Maizel

given: Julien

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Zafrani

full_name: Lara Zafrani

given: Lara

family: Mégarbane

full_name: Bruno Mégarbane

given: Bruno

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Durbach

full_name: Antoine Durbach

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

repository_institution: California Digital Library - eScholarship

location_facility: Intensive care unit, Ambroise Pare Hospital


title: Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)

acronym: MORPHEIT

summary:
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation


title: Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients

acronym: HOT

summary:
Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of many disorders.

Recent recommendations published by the French National Health Authority ("Haute Autorité de Santé", HAS) call for the involvement of all health professionals in helping patients to stop smoking and hospitalized patients are identified as a specific target. In addition, the meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco cessation) were those that include all patients, starting during the hospitalization with a specific follow-up of at least one month, and with the addition of nicotine replacement therapy. This combination increased the odds of successful tobacco cessation by 54%.

The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on tobacco smoking consumption in a population of hospitalized patients.


title: Prospective Study of Quality of Life After Laparoscopic Removal of Essure®

acronym: ABLIMCO

summary: A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon


title: Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study

acronym: ELSE

summary: This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.

lead_sponsor: University Hospital, Angers


title: Efficacy of In-bag Morcellation

acronym: FIBROSAC

summary:
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.

The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant


title: Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).

acronym: ISYVACC

summary: Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This syndrome is characterized by persistent low blood pressure despite an optimization of preload and inotropism.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study

acronym: RISCAS

summary: Metals and oxydes are found in welding fumes and are thought to participate in increasing cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this occupational exposure on cardiovascular system in a highly exposed population, ship repairing welders and to compare this population to paired controls.

lead_sponsor: University Hospital, Brest


title: Diagnostic Performance of MRI as an Alternative to CT Following a Non-diagnostic Ultrasonography in Young Women With Acute/Subacute Abdominal Pain : a Prospective Multicenter Study

acronym: IRMADA

summary:
Objective :

To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography.

lead_sponsor: University Hospital, Montpellier


title: Exploratory Study of the Impact of a Preoperative Formal Hypnosis Session on Perioperative Anxiety Among Female Patients Hospitalised for Hysterectomy Due to Pelvic Gynecological Cancer

acronym: HYPPOGYN

summary: The research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population

lead_sponsor: University Hospital, Bordeaux


title: Community Acquired Sepsis Cohort

acronym: CASC

summary: The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.

lead_sponsor: Rennes University Hospital


title: Relevance of Peripheral Cells in the Pathophysiology of Chronic Myelomonocytic Leukemia (CMML)

summary:
Chronic Myelomonocytic Leukemia (CMML) is the most frequent of myelodysplastic/myeloproliferative syndromes, as defined by the WHO classification of myeloid malignancies. The median age at diagnosis is around 70 years with a strong male predominance. CMML is a clonal disease of the bone marrow hematopoietic stem cell mainly characterized by persistent monocytosis (>1x109/L) and the presence of immature dysplastic granulocytes in the peripheral blood of CMML patients. Allogeneic stem cell transplantation (ASCT) remains the only curative option in CMML. However, CMML patients are rarely eligible for this kind of therapy, mainly due to their advanced age. The gold standard treatment of CMML thus remains hydroxyurea, which is usually initiated when the disease becomes proliferative, and demethylating agents, which could be efficient in the most aggressive forms of CMML. Nevertheless, the pathogenesis of CMML remains poorly understood and new therapies are urgently needed for patients in treatment failure.

In recent years, a large numbers of gene mutations have been discovered in CMML, none of which are specific of this entity, as they can be encountered with different frequencies in other myeloid neoplasms. These mutated genes encode signaling molecules (NRAS, KRAS, CBL, JAK2, FLT3 and several members of the Notch pathway), epigenetic regulators (TET2, ASXL1, EZH2, IDH1, IDH2,.) and splicing factors (SF3B1, SRSF2, ZRSF2). Mutations in the transcription regulators RUNX1, NPM1 and TP53 have also been reported in CMML. However, the role of these mutations in leukemogenesis is still unclear. CMML is also characterized by defects in monocyte to macrophage differentiation. These defects in monocyte differentiation can be attributed to the presence of immature dysplastic granulocytes that secrete high levels of alpha-defensins HNP1-3 that antagonize the purinergic receptor P2RY6 in CMML patients. These CD14-/CD15+/CD24+ immature granulocytes that belong to the same clone than the leukemic monocytes seem to have immunosuppressive properties ressembling those of the myeloid-derived suppressor cells (MDCS) described in solid tumours. Whether these immature granulocytes contribute to autoimmune manifestations or immunoescape and progression of CMML is a conendrum and remains to be determined.

In this context, the proposed project aims at identifying news insights into the pathophysiology of CMML through a better definition of the phenotype and function of monocytes and immature granulocytes that characterize this pathology.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Personalisation of Exercise by Muscle Modulation, Step 1: Construction and Validation of an Algorithm for Personalisation for Pedalling Exercises

acronym: EXOMODE

summary: The aim of the EXO-MODE project is to develop an innovative algorithm for the personalisation of Concentric and / or Eccentric training programmes adapted to the individual to improve the efficiency and tolerance. This algorithm will make it possible to personalise trainings programmes according to the different profiles of subjects, determined on the basis of their personal characteristics (age, sex, comorbidities), their exercise capacity and muscle performance, their level of motivation and their perception of the workload, and of the principal objective of the training programme. The final goal is to develop a tool to allow elderly populations to exercise more easily and more effectively.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia

summary: Beside these well-known symptoms (positive symptoms (such as delirium and delusions), negative symptoms (such as affective flattening and impoverishment of speech), disorganized behavior, patients with schizophrenia show different kinds of cognitive alterations and motor abnormalities. In schizophrenia, postural impairment could increase the attentional cost of daily motor tasks, leading to a lack of attentional resources, essential to achieve complex cognitive tasks. The intrication of cognitive and postural processings (both impaired in schizophrenia) can be explored by using of a dual-task paradigm.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft

summary:
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.

The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.

lead_sponsor: University Hospital, Lille

location_facility: Diseases of Blood Service HURIEZ hospital CHRU de LILLE