title: Evolution of Maxillofacial Trauma Activity During COVID-19 Containment Measures: a French Multicentric Comparative Observational Study

acronym: Traumax

summary:
The COVID-19 global pandemic has led to a major professional and social national reorganization: professional because it involves a redeployment of medical staff and material resources, and social because it imposes prolonged containment measures on an entire population.

The maxillofacial trauma activity is mainly linked to sports or leisure accidents, fights and road accidents.

It seems to appear since the beginning of containment measures a significant drop in maxillofacial trauma activity at the national level, which, if it is demonstrated in a significant way in several French hospital centers, would allow to redeploy the material and human resources related to this activity on sectors in tension due to the pandemic.


type: Other Identifier

title: Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy

acronym: KYSINDO

summary: To evaluate the feasibility of using Indocyanine Green in the laparoscopic surgical treatment of benign organic ovarian cysts (dermoid, serous, mucinous and endometriotic) in patients with a short-term desire for pregnancy. The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. To do so, the fluorescence scores (indocyanine green staining) need to be compared to the ovarian reserve of the patient, previously verified intraoperatively and postoperatively at M6 and M12, these scores being determined according to the vascularization visualized in laparoscopy and established both by a double visual notation (Likert scale) and by a computer software (METAMORPH) objective notation. This procedure would, in patients with fertility disorders or wishing for pregnancy in the short run, reassure them about their reproductive potential immediately after the intervention. In the event of poor staining, if correlated by a decrease in ovarian reserve, the concerned patients could be referred to a MPA treatment facility much earlier in the postoperative period or, if no desire for immediate pregnancy, towards fertility preservation methods.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns

acronym: COVIPREG

summary:
A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission.

Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures.

Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth.

It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.

status: Active, not recruiting

design_allocation: Non-Randomized

primary_purpose: Screening

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological


title: Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis

acronym: UVE-FAS

summary: The study aims at defining the role of soluble CD95 Ligand in the physiopathology of the non-infectious uveitis. Soluble CD95 Ligand might have a prognostic interest as well as potential for the discovery of new therapeutic strategies

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

intervention_type: Other


title: Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients

summary:
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.

The objectives of this study are :

To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.
To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.
To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

status_simplified: Completed


title: Relationship Between the ANI Score During Standardized Painful Stimulation and the Nociceptive Response to Laryngoscopy Intubation

summary:
The objective : to investigate a correlation between ANI following a standardized nociceptive stimulus and hemodynamic or somatic reactions during orotracheal intubation.

Piloted study. ANI and hemodynamic and somatic parameters response associated tetanus stimulation followed by orotracheal intubation were collected.

ReferenceType: derived

ReferenceCitation: Jozefowicz E, Sabourdin N, Fontaine V, Lambelin V, Lejeune V, Menu H, Bourai M, Tavernier B. Prediction of reactivity during tracheal intubation by pre-laryngoscopy tetanus-induced ANI variation. J Clin Monit Comput. 2021 Jan 2. doi: 10.1007/s10877-020-00624-6. [Epub ahead of print]

family: Jozefowicz

full_name: Elsa Jozefowicz

given: Elsa

sequence: first

family: Sabourdin

full_name: Nada Sabourdin

given: Nada

sequence: additional

family: Fontaine

full_name: Vincent Fontaine

given: Vincent

family: Lambelin

full_name: Veronique Lambelin

given: Veronique

family: Lejeune

full_name: Vincent Lejeune

family: Menu

full_name: Herve Menu

given: Herve

family: Bourai

full_name: Mohamed Bourai

given: Mohamed

family: Tavernier

full_name: Benoit Tavernier

given: Benoit

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Monitoring and Computing

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Evaluation of the Management of Dental Emergencies During COVID 19 Crisis

acronym: URGDENTCOVID

summary:
"For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.

So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.

This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE). An additional study (URGDENT-NW) aiming at completing this study by focusing on patients consulting the emergency room at night and during the weekend is also in progress.

The COVID19 Crisis changed the organization and the venue of patients at the emergency dental service.

Therefore this project, based on the same protocol as URGENT and URGDENT-WE, aims at evaluating the Odontology Emergency Reception Service (SAUO) during the COVID 19 epidemy. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room ."

location_facility: Service d'odontologie, Hôpital Pitié-Salpêtrière


title: Evolution of the Quality of Life During a Twin Pregnancy

acronym: QUALIGEM

summary:
Quality of life has recently appeared as a component of health. Pregnancy has an impact on the quality of life of the parturient, whether through physical or psychological changes.

It is common to think that quality of life is altered in the context of a twin pregnancy, but this has never been scientifically demonstrated.

The hypothesis is to observe a decrease in the quality of life of pregnant women with twins at the end of pregnancy, in particular in case of a pregnancy-related pathology.


title: Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery / RECHMPL20_0210

summary:
Adults who undergo cataract surgery will be questioned after surgery about the eventual pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: type of anesthesia, duration of surgery, machines used, unexpected events, particularities noticed by the surgeon, etc.

There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Comparison of the Proportion of Covid19 Seroconversion of Caregivers Working or Not in the COVID Sector

acronym: CoSigS

summary:
According to recent publications, the percentage of caregivers infected with COVID 19 is evaluated between 10 and 30% . This great variability is due, on the one hand to the intensity of the influx of covid plus patients and, on the other hand, to the disparity in the preparation of caregivers in the face of this emergency. Indeed, we can understand that the strict application of hygiene rules can be faulted in the face of the volume of patients, the lack of protective equipment and the lack of specific training for caregivers in this area. As a result, within healthcare teams, there are many questions that generate anxiety: will I be able to provide care properly while protecting myself from the risk of contamination? This anxiety is also present and sometimes manifests itself aggressively in the entourage or in the vicinity of caregivers, due to lack of scientific data adapted to the local ecology of the crisis.

Thus, the aim of this study is to show that the risk for caregivers of being contaminated by COVID in an area dedicated to COVID positive patients is no higher than being a caregiver in a non-COVID area that he either in the adult or pediatric sector.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Limoges


title: Psychological Impact of Quarantine in Chronic Pain Patient During COVID-19 Outbreak

acronym: DolPsyCOVID

summary: In the context of quarantine with COVID-19, we will study the experience and psychological impact of pain in adult patients living with chronic pain. We will evaluate the link between the question of physical and psychological confinement in the experience of pain in this particular situation

time_perspective: Cross-Sectional


title: Evaluation of the Management of Dental Emergencies During Night and Week-ends

acronym: URGDENT-NW

summary:
For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.

So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.

This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE).

Attendance at night and during WE is important because it is sociologically and medically different from that of day and week. It is therefore important to complete this study by focusing on patients consulting the emergency room at night and during the weekend.

This work therefore responds to a request from the Odontology Emergency Reception Service (SAUO) of the Pitié-Salpêtrière Hospital Group. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room .


title: Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome

acronym: TIPEX-VOLTEX

summary: Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Casserly B, McCool FD, Saunders J, Selvakumar N, Levy MM. End-Expiratory Volume and Oxygenation: Targeting PEEP in ARDS Patients. Lung. 2016 Feb;194(1):35-41. doi: 10.1007/s00408-015-9823-6. Epub 2015 Dec 8.

ReferenceCitation: Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801.

ReferenceCitation: Olegård C, Söndergaard S, Houltz E, Lundin S, Stenqvist O. Estimation of functional residual capacity at the bedside using standard monitoring equipment: a modified nitrogen washout/washin technique requiring a small change of the inspired oxygen fraction. Anesth Analg. 2005 Jul;101(1):206-12, table of contents.

ReferenceCitation: Sahetya SK, Goligher EC, Brower RG. Fifty Years of Research in ARDS. Setting Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1429-1438. doi: 10.1164/rccm.201610-2035CI. Review. Erratum in: Am J Respir Crit Care Med. 2018 Mar 1;197(5):684-685.

ReferenceCitation: Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.

lead_sponsor: Centre Hospitalier Intercommunal Aix-Pertuis

intervention_type: Procedure


title: Outcomes of naïve Patients Operated on for an Urological Cancer or Emergency During Periods of Social COVID-19 Containment: is it Reasonable to Limit Access to Surgical Care for All?

summary:
The French healthcare system has been strongly mobilized since the start of the Covid-19 epidemic to take care of patients with Covid-19. This should not overlook the fact that some treatments, surgeries and examinations of non-Covid-19 patients must imperatively be maintained according to the assessment of their risk-benefit balance. In context, it appears that this is not always the case. In addition to the necessary social containment measures, there are general limitations on patient access to the operating theater, neglecting the individual interest of naive non-Covid-19 patients. Certain studies which report a higher and earlier risk of death of undetected and ultimately operated Covid-19 patients has reinforced, as a precaution, the massive deprogramming of naive patients and the restrictive access of surgical care for all. We believe that this could lead to a risk of delayed treatments and renunciation of care for naive patients who should not be considered at risk a priori in the event of surgery. The individual clinical and local health context should be first considered for appropriate surgical decision-making.

As such, the French Department of Health and Human Services (DGS) has given general guidelines regarding the maintenance of follow-up and care for non-Covid-19 patients in this context of containment and major mobilization of health care professionals to care for people with COVID. Surgeries which could not be postponed because of the patient's status or if their postponement exposed to a significant risk of loss of chance, if needed in the light of the recommendations issued by learned societies, were concerned. In this sense, the investigator have selected the naive Covid-19 patients from Nice Hospital who should benefit from elective or urgent urological surgeries, taking into account their individual risk and the territorial epidemic rate. Their rate of ICU stays following their surgery has been analysed and their surgical follow-up outcomes during the epidemic period evaluated, according to the anti-Covid-19 measures established in Nice Hospital by comparing them to an earlier period without Covid-19.

time_perspective: Retrospective

ipd_sharing_description: no data sharing plan has been established

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke

acronym: DETERMINE

summary: DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel


title: Does Preprocedural Ultrasound Exam of Lumbar Spine Increase the First-pass Success Rate of Epidural Space Identification Among Obese Parturients: A Randomized Controlled Open Trial

summary: Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French.

family: Balki

full_name: Mrinalini Balki

given: Mrinalini

journal_name: Canadian Journal of Anesthesia/Journal canadien d'anesthésie

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher_dissemination: Springer

publisher_group: Springer

title: Locating the epidural space in obstetric patients—ultrasound a useful tool: Continuing Professional Development

lead_sponsor: University Hospital, Caen


ReferenceCitation: Louis ML, Dumonceau RG, Jouve E, Cohen M, Djouri R, Richardet N, Jourdan E, Giraudo L, Dumoulin C, Grimaud F, George FD, Veran J, Sabatier F, Magalon J. Intra-Articular Injection of Autologous Microfat and Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Comparative Study. Arthroscopy. 2021 Oct;37(10):3125-3137.e3. doi: 10.1016/j.arthro.2021.03.074. Epub 2021 Apr 20.

family: Louis

full_name: Marie Laure Louis

given: Marie Laure

family: Dumonceau

full_name: Robinson Gravier Dumonceau

given: Robinson Gravier

family: Jouve

full_name: Elisabeth Jouve

given: Elisabeth

family: Cohen

full_name: Michel Cohen

given: Michel

family: Djouri

full_name: Rym Djouri

given: Rym

family: Richardet

full_name: Nathalie Richardet

given: Nathalie

family: Jourdan

full_name: Emmanuelle Jourdan

given: Emmanuelle

family: Giraudo

full_name: Laurent Giraudo

given: Laurent

family: Dumoulin

full_name: Chloe Dumoulin

given: Chloe

family: Grimaud

full_name: Fanny Grimaud

given: Fanny

family: George

full_name: Francoise Dignat George

given: Francoise Dignat

family: Veran

full_name: Julie Veran

given: Julie

family: Sabatier

full_name: Florence Sabatier

given: Florence

family: Magalon

full_name: Jérémy Magalon

given: Jérémy

journal_name: Arthroscopy: The Journal of Arthroscopic & Related Surgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Intra-articular Injection of Autologous Microfat and Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Comparative Study

intervention_type: Drug

ipd_sharing_description: Publication

lead_sponsor: Clinique Juge

acronym: MICROPREP

type: EudraCT Number

source: euctr

title: Intra Articular Injection of Autologous Microfat and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: a Pilot Study

summary: The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.


title: Immunological Profiling of Patients With COVID-19 in Respiratory Distress

summary: The study investigators hypothesize that the pneumonia arising in patients with COVID-19 is largely of immunopathological origin. The investigators will therefore seek to define the immune activation phenotype of patients in respiratory distress and to see if this immune signature is predictive of mortality. Finally, the investigators will look for overproduced inflammatory mediators to identify potential therapeutic targets.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak

acronym: OsPsyCOVID

summary: In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.


title: Evaluation of Knowledge About Contraception and Pregnancy Planning Among Type 1 and Type 2 Diabetes Women

acronym: DMPKA

summary:
Diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as preeclampsia, congenital malformations and macrosomia.

Preconception care is all methods to assess the best prognostic for a diabetic pregnancy. Among these methods, contraception is very important to plan the pregnancy on a chosen moment.

The content of the preconception care is well established. However, information of diabetic women concerning contraception and giabetic pregnancy has been little studied.

lead_sponsor: CHU de Reims


title: Evaluation of Respiratory Mechanics and Lung Recruitment in Patients With SARS-CoV-2 Associated Acute Respiratory Distress Syndrome

summary: The aim of this observationnal study is to describe respiratory mechanics and lung recruitement in patients with SARS-CoV-2 Associated Acute Respiratory Distress Syndrome who underwent invasive ventilation on endotracheal tube, admitted to the medical ICU of Angers university hospital . Statics measurements of respiratory system compliance were performed at 2 differents levels of PEEP (15 cmH2O and 5 cmH2O). The recruited volume is computed as the difference between the volume expired from PEEP 15 to 5 cmH2O and the volume predicted by compliance at PEEP 5 cmH2O . The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 was used to define highly recruiter patients.

lead_sponsor: University Hospital, Angers


title: Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study

acronym: TAVIWOP

summary: The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.


title: Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy

acronym: SEA ELASTO 1

summary: The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology that allowed an in vivo assessment of viscoelastic properties of tissues such as muscles. The main endpoint of this study is to assess the intra-observer and the inter-observer reproducibility of a the external anal sphincter assessment using shear wave elastography in term pregnant women.

primary_purpose: Prevention

lead_sponsor: Poitiers University Hospital


title: Promote Personalized Medicine Based on Diagnostic Genomic Tools in Order to Innovate in the Early Detection of Child Deafness in the SUDOE Space (European International Project)

acronym: GHELP

summary: To assess the diagnostic value of NGS screnning in prelingually deafned children using a new designed chip, and to evaluate its interest in a the neonatal screening program for ddetecting congenitally deafned children.

lead_sponsor: Clinica Universidad de Navarra, Universidad de Navarra


title: Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections

acronym: PK-plèvre

summary:
The incidence of pleural infection is increasing worldwide since the last two decades. Antibiotics are one of the cornerstones of the treatment of this disease and must be associated to a correct evacuation of the pleural effusion.

Data concerning the pleural diffusion of antibiotics currently used in community acquired pleural infection are scarce. The main objective of this study is to evaluate the pleural pharmacokinetic of amoxicillin and clavulanic acid in patients with a complicated pleural infection (patients who need a chest tube insertion).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

acronym: PRODEX

summary:
The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations.

Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics.

The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

status: Withdrawn

status_simplified: Unknown


title: Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

acronym: MAB IN SITRO

summary: Multicentric interventional prospective study with collection of biological samples as part of a routine care research

primary_purpose: Basic Science

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period

acronym: Resi-CoV

summary: The outbreak linked to SARS-CoV-2 infection was declared a Public Health Emergency of International Concern on 30 January 2020. In all of the emergency Departments, a major reorganization was necessary, notably with the creation of a specific channel for COVID-19 suspect patients. Thus, all caregivers involved must adapt day by day to new places of exercise, new protocols,...The major influx of patients, the precautions to be taken, the specifics of the pathology and its management have profoundly changed daily practice. This exogenous hospital tension impacts all caregivers and more particularly their resilience capacities. Resilience is defined as an ability to recover from or adjust easily to misfortune or change. The Resi-CoV study aims to assess the level of resilience of caregivers of different specialties and trades in the context of covid-19.


title: ASSESSMENT OF COMPLEXITY AND TECHNICAL DIFFICULTIES IN LIVER TRANSPLANTATION: INTERNATIONAL SURVEY OF EXPERTS

summary: The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification.

status: Enrolling by invitation

ReferenceCitation: Lee MK 4th, Gao F, Strasberg SM. Perceived complexity of various liver resections: results of a survey of experts with development of a complexity score and classification. J Am Coll Surg. 2015 Jan;220(1):64-9. doi: 10.1016/j.jamcollsurg.2014.09.017. Epub 2014 Oct 15.

ReferenceCitation: Lee MK 4th, Gao F, Strasberg SM. Completion of a Liver Surgery Complexity Score and Classification Based on an International Survey of Experts. J Am Coll Surg. 2016 Aug;223(2):332-42. doi: 10.1016/j.jamcollsurg.2016.03.039. Epub 2016 Apr 9.

ReferenceCitation: Manceau G, Benoist S, Panis Y, Rault A, Mathonnet M, Goere D, Tuech JJ, Collet D, Penna C, Karoui M. Elective surgery for tumours of the splenic flexure: a French inter-group (AFC, SFCD, FRENCH, GRECCAR) survey. Tech Coloproctol. 2020 Feb;24(2):191-198. doi: 10.1007/s10151-019-02143-2. Epub 2020 Jan 14.

ReferenceCitation: Reames BN, Blair AB, Krell RW, Groot VP, Gemenetzis G, Padussis JC, Thayer SP, Falconi M, Wolfgang CL, Weiss MJ, Are C, He J. Management of Locally Advanced Pancreatic Cancer: Results of an International Survey of Current Practice. Ann Surg. 2021 Jun 1;273(6):1173-1181. doi: 10.1097/SLA.0000000000003568.

lead_sponsor: Pitié-Salpêtrière Hospital


title: Dexamethasone Combined With Hydroxychloroquine Compared to Hydroxychloroquine Alone for Treatment of Severe Acute Respiratory Distress Syndrome Induced by Coronavirus Disease 19 (COVID-19): a Multicentre, Randomised Controlled Trial

acronym: DHYSCO

summary: Single blind randomized clinical trial designed to evaluate the efficacy of the combination of hydroxychloroquine and dexamethasone as treatment for severe Acute Respiratory Distress Syndrome (ARDS) related to coronavirus disease 19 (COVID-19). We hypothesize that dexamethasone (20 mg for 5 days followed by 10 mg for 5 days) combined with 600 mg per day dose of hydroxychloroquine for 10 days will reduce the 28-day mortality compared to hydroxychloroquine alone in patients with severe ARDS related COVID-19.

status: Terminated

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

lead_sponsor: Centre Chirurgical Marie Lannelongue

location_facility: Reanimation adulte. Hopital Marie Lannelongue


title: Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19

acronym: PHYSIO-COVID

summary:
In the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to COVID-19. From these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. It therefore seems essential to rigorously study these modifications, as they have been studied in the past for ARDS.

The aim of this non-interventional study is to describe precisely the respiratory and hemodynamic changes induced by COVID-19 in mechanically ventilated patients

.

lead_sponsor: University Hospital, Lille


title: cArdiac Non Invasive MApping in resynchronizaTION Registry

acronym: ANIMATION

summary: Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.

lead_sponsor: University Hospital, Tours


title: Retrospective Longitudinal Follow-up in Patients With Diffuse Low-grade Glioma With Multimodal MRI Assessment

acronym: SPECIFY

summary: Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment

lead_sponsor: University Hospital, Montpellier


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: CORIPLASM

title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - CORIMUNO-CORIPLASM : EFFICACY OF CONVALESCENT PLASMA TO TREAT SARS-COV2 INFECTED PATIENTS

summary:
The coronavirus disease 2019 (COVID-19) viral pneumonia is now a worldwide pandemic caused by the Severe acute respiratory virus coronavirus 2 (SARS-CoV-2). The number of cases, and associated mortality has increased dramatically since the first cases in Wuhan, China in December 2019 . To date, no specific treatment has been proven to be effective for COVID-19. Treatment is currently mainly supportive, with in particular mechanical ventilation for the critically ill patients (6.1% in a series of 1099 cases in China). Novel therapeutic approaches are in acute need. In this context, the therapeutic potential associated with convalescent plasma needs to be explored.

The objective of COVIPLASM trial (a nested trial in the CORIMUNO-19 COHORT) is to study the efficacy of convalescent plasma to treat SARS-COV2 infected patients.


title: Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia

acronym: COVIDOC

summary: Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.


title: Observational Study of the Value of Using Continuous Positive Airway Pressure (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.

acronym: APNOSIS-BIS

summary: The presence of an obstructive sleep apnea-hypopnea syndrome (OSAHS) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe OSAHS, while life expectancy, when the SAHOS is treated by continuous positive airway pressure (CPAP) is close to that of the general population. It also represents a factor of excess mortality, little known and poorly explored, in relation to morbidity and mortality occurring during the perioperative period accompanying any general anesthesia.


title: MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

acronym: ELASTUS

summary: Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU

lead_sponsor: University Hospital, Bordeaux


acronym: COVIDICUS

title: Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 pneumonia_COVIDICUS

summary:
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.

Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival.

The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.


title: Assessment of Skin Manifestations Occuring During Covid-19 Infection With a Special Focus on Chilbains

acronym: ChilblainCOVID

summary: Some patients infected by covid-19 develop skin manifestations. These manifestations are still not well known and there pathophysiology remain unclear. Among them, acral manifestation resembling to chilblains appears frequent and quite specific. The aim of this project is to better characterize the cutaneous manifestations occurring during Covid-19 infection with a special focus on chilblains. These acral manifestation could be due to a direct viral effect, but also to microthrombosis or vascularitis. Understanding the pathomechanisms involved could provide interesting clue for understanding not only the skin manifestations but also some of the other systemic symptoms associated to covid-19 infection. This study plan to characterize these acral manifestations by analyzing the clinical and dermoscopic patterns and to correlate them with the non-invasive vascular explorations but also immune and coagulopathy explorations that are done in the CHU of Nice in covid-19 patients.

ReferenceCitation: Hubiche T, Cardot-Leccia N, Le Duff F, Seitz-Polski B, Giordana P, Chiaverini C, Giordanengo V, Gonfrier G, Raimondi V, Bausset O, Adjtoutah Z, Garnier M, Burel-Vandenbos F, Dadone-Montaudié B, Fassbender V, Palladini A, Courjon J, Mondain V, Contenti J, Dellamonica J, Leftheriotis G, Passeron T. Clinical, Laboratory, and Interferon-Alpha Response Characteristics of Patients With Chilblain-like Lesions During the COVID-19 Pandemic. JAMA Dermatol. 2021 Feb 1;157(2):202-206. doi: 10.1001/jamadermatol.2020.4324.

name: Department of Dermatology, Université Côte d’Azur, CHU Nice, Nice, France

family: Hubiche

full_name: Thomas Hubiche

given: Thomas

name: Department of Pathology, Université Côte d’Azur, CHU Nice, Nice, France

family: Cardot-Leccia

full_name: Nathalie Cardot-Leccia

family: Le Duff

full_name: Florence Le Duff

name: Department of Immunology, Université Côte d’Azur, UPR 01, UR2CA, CHU Nice, Nice, France

family: Seitz-Polski

full_name: Barbara Seitz-Polski

given: Barbara

name: Department of Vascular Medicine, Université Côte d’Azur, CHU Nice, Nice, France

family: Giordana

full_name: Pascal Giordana

given: Pascal

family: Chiaverini

full_name: Christine Chiaverini

given: Christine

name: Department of Virology, Université Côte d’Azur, CHU Nice, Nice, France

name: Université Côte d’Azur, INSERM, U1065, C3M, Nice, France

family: Giordanengo

full_name: Valérie Giordanengo

given: Valérie

family: Gonfrier

full_name: Géraldine Gonfrier

given: Géraldine

name: Cerballiance Côte d’Azur, Cagnes-sur-Mer, France

family: Raimondi

full_name: Vincent Raimondi

given: Vincent

family: Bausset

full_name: Olivier Bausset

given: Olivier

family: Adjtoutah

full_name: Zoubir Adjtoutah

given: Zoubir

family: Garnier

full_name: Margaux Garnier

given: Margaux

family: Burel-Vandenbos

full_name: Fanny Burel-Vandenbos

name: Laboratory of Solid Tumors Genetics, Université Côte d’Azur, CHU Nice, Nice, France

name: Institute for Research on Cancer and Aging of Nice (IRCAN), Université Côte d’Azur, CNRS UMR 7284/INSERM U1081, Nice, France

family: Dadone-Montaudié

full_name: Bérengère Dadone-Montaudié

given: Bérengère

family: Fassbender

full_name: Véréna Fassbender

given: Véréna

family: Palladini

full_name: Aurélia Palladini

given: Aurélia

name: Department of Infectiology, Université Côte d’Azur, CHU Nice, Nice, France

family: Courjon

full_name: Johan Courjon

given: Johan

family: Mondain

full_name: Véronique Mondain

given: Véronique

name: Emergency Department, Université Côte d’Azur, CHU Nice, Nice, France

family: Contenti

full_name: Julie Contenti

name: Medical Intensive Care Unit, Université Côte d’Azur, UPR 01, UR2CA, CHU Nice, Nice, France

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Leftheriotis

full_name: Georges Leftheriotis

given: Georges

family: Passeron

full_name: Thierry Passeron

given: Thierry

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Validation of a Connected Patch, an Alternative to Conventional Monitoring

acronym: Patch

summary: The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

ReferenceCitation: Le Guen M, Squara P, Ma S, Adjavon S, Trillat B, Merzoug M, Aegerter P, Fischler M. Patch validation: an observational study protocol for the evaluation of a multisignal wearable sensor in patients during anaesthesia and in the postanaesthesia care unit. BMJ Open. 2020 Sep 25;10(9):e040453. doi: 10.1136/bmjopen-2020-040453.

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

family: Squara

full_name: Pierre Squara

given: Pierre

family: Ma

full_name: Sabrina Ma

given: Sabrina

family: Adjavon

full_name: Shérifa Adjavon

given: Shérifa

family: Trillat

full_name: Bernard Trillat

given: Bernard

family: Merzoug

full_name: Messaouda Merzoug

given: Messaouda

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

family: Fischler

full_name: Marc Fischler

given: Marc

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing_description: Data will be available in the Dryad repository

lead_sponsor: CMC Ambroise Paré


title: Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.

summary:
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.

The objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session.

For a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients.

The benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization).

The objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau


title: National Survey of Symptoms of People Aged 70 and Overs Diagnosed With COVID-19

summary: Cross-sectional study based on a French national survey aimed to described and identify the most frequent symptoms of COVID-19 older patients.

ReferenceCitation: Annweiler C, Sacco G, Salles N, Aquino JP, Gautier J, Berrut G, Guérin O, Gavazzi G. National French Survey of Coronavirus Disease (COVID-19) Symptoms in People Aged 70 and Over. Clin Infect Dis. 2021 Feb 1;72(3):490-494. doi: 10.1093/cid/ciaa792.

apc_source: openAPC

name: Department of Geriatric Medicine and Memory Clinic, Research Center on Autonomy and Longevity, University Hospital, Angers, France

name: UPRES EA 4638, Université d’Angers, Angers, France

name: Robarts Research Institute, Department of Medical Biophysics, Schulich School of Medicine and Dentistry, the University of Western Ontario, London, Ontario, Canada

family: Annweiler

full_name: Cédric Annweiler

given: Cédric

family: Sacco

full_name: Guillaume Sacco

given: Guillaume

name: Department of Clinical Gerontology, University Hospital, Bordeaux, France

family: Salles

full_name: Nathalie Salles

given: Nathalie

name: Délégation générale de la Société Française de Gériatrie et Gérontologie (SFGG), Paris, France

family: Aquino

full_name: Jean-Pierre Aquino

given: Jean-Pierre

family: Gautier

full_name: Jennifer Gautier

given: Jennifer

name: Pôle hospitalo-universitaire de gérontologie clinique, CHU de Nantes, France

family: Berrut

full_name: Gilles Berrut

given: Gilles

name: Université Côte d’Azur, Centre Hospitalier Universitaire de Nice, Service de Médecine Gériatrique et Thérapeutique, Nice, France

name: Université Côte d’Azur, CNRS UMR 7284/INSERM U108, Institute for Research on Cancer and Aging Nice (IRCAN), Faculté de médecine, Nice, France

family: Guérin

full_name: Olivier Guérin

given: Olivier

name: Service Gériatrie Clinique, Centre Hospitalo-Universitaire Grenoble-Alpes, Saint-Martin-d’Hères, France

family: Gavazzi

full_name: Gaetan Gavazzi

given: Gaetan

journal_name: Clinical Infectious Diseases

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


title: Prediction of Abatacept Discontinuation Using Test Reflecting Immunological Remission in Rheumatoid Arthritis

acronym: PADIRRA

summary: The objective of this study is to identify a panel of immunological molecular and cellular biomarkers able to predict the success of major dose-reduction or discontinuation of abatacept in rheumatoid arthritis patients

lead_sponsor: University Hospital, Rouen


title: Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment - EPILOGUE

acronym: EPILOGUE

summary:
The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction.

The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users


title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial

acronym: CORIMUNO-NIVO

summary:
It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.

This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit.

The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments.

A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.

Patients will be randomly allocated 1:1 to either nivolumab or SoC.


title: Role of the Environment and Endocrine Disruptors in Child Cryptorchidism

acronym: CRYPTENV

summary: Cryptorchidism is the most frequent congenital defect of the male newborn. It requires surgery in childhood, increases the risk of fertility disorders and cancer. As a major public health objective, it's the subject of numerous recommendations. Its frequency is increasing in some countries faster than a single genetic cause could not explain it. It may occurs in a geographic cluster. The cause of cryptorchidism involves genetic, hormonal and environmental factors. Animal studies suggest that endocrine disruptors interfere with fetal testicular migration. The aim of the study is to find out if some environmental exposition may be associated with cryptorchidism.


title: Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic

acronym: BIOCOVU

summary:
There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting.

In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources.

This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.


title: Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures With Handheld Dynamometer, in Patients With COPD

acronym: FORMES

summary:
According to the recommendations of French and international learned societies, respiratory rehabilitation is part of the care of patients with Chronic Obstructive Pulmonary Disease (COPD). Indeed, scientific work carried out for more than 10 years on the respiratory rehabilitation of patients suffering from COPD shows that respiratory rehabilitation allows a reduction of the handicap caused by the disease and an improvement in the quality of life of the patients.

A respiratory rehabilitation program (PRR) includes: individual exercise re-training, therapeutic education, respiratory physiotherapy, help with smoking cessation and nutritional and psychosocial care. Exercise retraining includes training the muscles of the lower limbs in endurance and strength combined with training the muscles of the upper limbs. Strengthening the upper limbs helps reduce dyspnea in patients with COPD. In order to determine a precise muscle building protocol, it is necessary to assess at the start of the program the maximum voluntary strength (FMV) of the different muscle groups of the upper limbs. Measuring FMV quantifies a possible frequent strength deficit in patients with COPD and the effects of the strengthening program. Currently, tests to assess FMV using isokinetic dynamometers are used as a benchmark. However, this material is little used in current practice. Portable dynamometers are used to perform simple tests and to obtain muscle strength measurements. However, the reliability of the maximum voluntary force measurements of the different muscle groups of the upper limb has not been evaluated. Studies seem necessary to determine the reproducibility of the measurement in intra and inter-examiner (Schrama 2014) and to assess its sensitivity to change during a respiratory rehabilitation program. The objectives of this study are to study the reproducibility, validity and sensitivity to change of the measurement of FMV using a portable dynamometer.

ReferenceCitation: Awatani T, Morikita I, Shinohara J, Mori S, Nariai M, Tatsumi Y, Nagata A, Koshiba H. Intra- and inter-rater reliability of isometric shoulder extensor and internal rotator strength measurements performed using a hand-held dynamometer. J Phys Ther Sci. 2016 Nov;28(11):3054-3059. Epub 2016 Nov 29.

ReferenceCitation: Nyberg A, Saey D, Maltais F. Why and How Limb Muscle Mass and Function Should Be Measured in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2015 Sep;12(9):1269-77. doi: 10.1513/AnnalsATS.201505-278PS. Review.

ipd_sharing_description: All collected data that underlie results in publication

lead_sponsor: University Hospital, Brest


title: Evaluation of Transperineal Ultrasound Technic for Diagnostic Shorted Cervical Length for Pregnant Women (2nd and 3rd Trimester) Compared to Endovaginal Technic (Gold Standard)

acronym: ECHO

summary: Endovaginal ultrasound is currently the gold standard to diagnose a shorted cervical length and, by extension, assess the risk of preterm labor. The major inconvenient is that this is an invasive method of diagnosis that tends to be poorly accepted by some patients. This study aims to evaluate the accuracy of a noninvasive transperineal ultrasound cervical measurement in comparison to the endovaginal technic in 2nd and 3nd trimester pregnant women where a cervical ultrasound is indicated.


title: CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection, Nested In The CORIMUNO-19

acronym: CORIMUNO-ANA

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

ReferenceCitation: CORIMUNO-19 Collaborative group. Effect of anakinra versus usual care in adults in hospital with COVID-19 and mild-to-moderate pneumonia (CORIMUNO-ANA-1): a randomised controlled trial. Lancet Respir Med. 2021 Mar;9(3):295-304. doi: 10.1016/S2213-2600(20)30556-7. Epub 2021 Jan 22.

family: Tharaux

full_name: Pierre-Louis Tharaux

given: Pierre-Louis

family: Pialoux

full_name: Gilles Pialoux

family: Pavot

full_name: Arthur Pavot

given: Arthur

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Hermine

full_name: Olivier Hermine

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

family: Porcher

full_name: Raphael Porcher

given: Raphael

family: Ravaud

full_name: Philippe Ravaud

family: Bureau

full_name: Serge Bureau

given: Serge

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Tibi

full_name: Annick Tibi

given: Annick

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

family: Emmerich

full_name: Joseph Emmerich

given: Joseph

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Guidet

full_name: Bertrand Guidet

given: Bertrand

family: Humbert

full_name: Marc Humbert

family: Lacombe

full_name: Karine Lacombe

given: Karine

family: Mahevas

full_name: Matthieu Mahevas

family: Pene

full_name: Frédéric Pene

given: Frédéric

family: Pourchet-Martinez

full_name: Valérie Pourchet-Martinez

given: Valérie

family: Schlemmer

full_name: Frédéric Schlemmer

family: Yazdanpanah

full_name: Yazdan Yazdanpanah

given: Yazdan

location_facility: Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris


title: Evaluation of Ethical Implication of a Training Model Necessary to Gain Access to a Surgical Innovation Device.

summary:
The surgical device used to perform PIPAC procedure is commercialized by a single manufacturer under a monopoly regimen, and a formal training (economically supported by the manufacturer) is mandatory for surgeons who want to buy the device.Relations with the company and solutions to extend training require specific analysis from an ethical point of view.
Based on the growing number of published papers from a growing number of international centers, the controlled training model is not limiting, and it is a successful model of development of this breakthrough innovation.
But with the major involvement of the industry and the control of training, the different levels of interest could induce ethical questions.

ReferenceCitation: Martellotto S, Maillot C, Villeneuve L, Eveno C, Sgarbura O, Pocard M. Restricted access to innovative surgical technique related to a specific training, is it ethical? Example of the PIPAC procedure. A systematic review and an experts survey. Int J Surg. 2020 Nov;83:235-245. doi: 10.1016/j.ijsu.2020.07.004. Epub 2020 Jul 29.

family: Martellotto

full_name: S. Martellotto

given: S.

family: Maillot

full_name: C. Maillot

given: C.

family: Villeneuve

full_name: L. Villeneuve

given: L.

family: Eveno

full_name: C. Eveno

family: Sgarbura

full_name: O. Sgarbura

given: O.

family: Pocard

full_name: M. Pocard

given: M.

journal_name: International Journal of Surgery

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

lead_sponsor: Centre de l'arthrose, Paris


title: COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients

acronym: ONCOVID

summary:
To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A).

To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).


title: Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

acronym: COVID-SER

summary: Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

ReferenceCitation: Trouillet-Assant S, Albert Vega C, Bal A, Nazare JA, Fascia P, Paul A, Massardier-Pilonchery A, D Aubarede C, Guibert N, Pitiot V, Lahousse M, Boibieux A, Makhloufi D, Simon C, Rabilloud M, Trabaud MA, Gueyffier F, Fassier JB; COVID-SER study group. Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study. BMJ Open. 2020 Nov 24;10(11):e041268. doi: 10.1136/bmjopen-2020-041268.

family: Trouillet-Assant

full_name: Sophie Trouillet-Assant

given: Sophie

family: Albert Vega

full_name: Chloe Albert Vega

given: Chloe

family: Bal

full_name: Antonin Bal

given: Antonin

family: Nazare

full_name: Julie Anne Nazare

given: Julie Anne

family: Fascia

full_name: Pascal Fascia

given: Pascal

family: Paul

full_name: Adèle Paul

given: Adèle

family: Massardier-Pilonchery

full_name: Amélie Massardier-Pilonchery

given: Amélie

family: d Aubarede

full_name: Constance d Aubarede

given: Constance

family: Guibert

full_name: Nicolas Guibert

given: Nicolas

family: Pitiot

full_name: Virginie Pitiot

given: Virginie

family: Lahousse

full_name: Matthieu Lahousse

given: Matthieu

family: Boibieux

full_name: André Boibieux

given: André

family: Makhloufi

full_name: Djamila Makhloufi

given: Djamila

family: Simon

full_name: Chantal Simon

given: Chantal

family: Rabilloud

full_name: Muriel Rabilloud

family: Trabaud

full_name: Mary Anne Trabaud

given: Mary Anne

family: Gueyffier

full_name: François Gueyffier

given: François

family: Fassier

full_name: Jean-Baptiste Fassier

given: Jean-Baptiste

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

repository_normalized: HAL

location_facility: Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet


title: Cohort Study of Patients With Primary Hepatocellular Carcinoma or Cholangiocarcinoma

acronym: CHC/CC

summary: The main objective is to describe the evolution of patients treated for a primary malignant hepatobiliary tumor (hepatocellular carcinoma or cholangiocarcinoma) over the long course.

location_facility: Serviec hépatologie-Hôpital Saint Antoine


title: Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage

acronym: ACTIPARK

summary:
Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset.

Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors.

The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.


title: Prospective Epidemiological Study Evaluating the Prevalence of Upper Limb Venous Thrombosis in a Population of Patients Hospitalized in a University Hospital

acronym: Epi-TVMS

summary:
Venous thrombosis of the upper limb is one of the manifestations of venous thromboembolic disease.

The epidemiology and management of upper limb venous thrombosis is much less well documented than that of lower limb venous thrombosis.

The investigators wished to provide epidemiological data concerning upper limb venous thrombosis in the hospital setting.

The researchers would like to know the prevalence of this pathology among patients hospitalized in a university hospital center. In order to obtain this prevalence, the investigators wish to carry out a monocentric cross-sectional descriptive study.

lead_sponsor: Nantes University Hospital


title: Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening. Comparison to Virological Testing and Multiparametric Gold Standard

summary:
All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health.

To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID.

CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary.

Ct Scan performance will be recorded and analyzed.

lead_sponsor: Poitiers University Hospital


title: Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in First-line Treatment for Patients With Metastatic Lung Adenocarcinoma: A Randomized Phase III Study

acronym: CRYOMUNE

summary:
This study aims to compare the one-year survival benefit of the association of cryoablation-pembrolizumab-pemetrexed-carboplatin versus pembrolizumab-pemetrexed-carboplatin in metastatic lung adenocarcinoma patients.

This is a multicenter, prospective, open-labeled, 2-arm comparative randomized (1:1) phase III trial.

Patients will be randomized with a 1:1 ratio into:

Arm A (experimental arm): cryoablation of one visceral lesion or bone metastasis excluding liver and sclerotic bone metastases combined with pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization.
Arm B (standard arm): pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization.

Pembrolizumab and pemetrexed-carboplatin will be prescribed and administered at the dose recommended by market authorization.

Cryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab. No treatment switching permitted.

lead_sponsor: Institut Bergonié


title: Diffusion Imaging in Acute Auto-immune Encephalitis : a Cohort of 80 Patients

summary:
The aim of this non randomised retrospective study is to investigate the imaging (MRI) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences.

Indeed, few series describe the MRI aspect of auto-immune at their beginning. Recognize early MRI abnormalities seen in auto-immune encephalitis could help reduce the time to positive diagnosis and improve the therapeutic management.

lead_sponsor: Hospices Civils de Lyon


title: Study of 12 Cases of Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis and Review of the Literature

acronym: NMDARE-HSE

summary:
Herpes Simplex Virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. Despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate.

One of the contributing factors of bad prognosis is the development of encephalitis mediated by autoantibodies, most often directed against NMDA receptors, in the weeks following viral encephalitis.

The description of this pathology is recent, the pathophysiology of this process remains poorly understood, and the management of these patients is not yet codified.


title: Impact of the Profession on Parenthood

acronym: MEDparenting

summary:
Professional constraints can have major causes on personal and couple life. In particular, some professions with major professional constraints that can be particularly impacted, such as doctors and healthcare workers.

The main objective was to demonstrate the impact of work on the desire and the fact to have children

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effect of Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardial Ischemia and Needing Coronarography : a Monocentric, Prospective, Randomized and Open-label Phase II Trial

acronym: MICROPROTECT

summary: Proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibodies (anti-PCSK9) significantly reduce the serum LDL-C level, leading to a regression of the coronary epicardial plaque demonstrated by intracoronary ultrasonography (IVUS), as well as cardiovascular events (CV) in patients with atherosclerotic CV disease treated with statin. The impact of PCSK9 inhibition on coronary microcirculation has never been assessed. However, microvascular coronary dysfunction (CMVD) is a powerful prognostic marker, irrespective of conventional CV risk factors, but also of the severity of the epicardial coronary involvement detected during coronary angiography. The investigators hypothesized that anti-PCSK9 would decrease CMVD, measured by the microcirculatory resistance index (MRI) during coronary angioplasty (Percutaneous coronary intervention, PCI) in patients with myocardial ischemia proved in myocardial scintigraphy.

ReferenceCitation: Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23.

ReferenceCitation: Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

ReferenceCitation: Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.

ReferenceCitation: Clarkson P, Celermajer DS, Powe AJ, Donald AE, Henry RM, Deanfield JE. Endothelium-dependent dilatation is impaired in young healthy subjects with a family history of premature coronary disease. Circulation. 1997 Nov 18;96(10):3378-83.

ReferenceCitation: Suwaidi JA, Hamasaki S, Higano ST, Nishimura RA, Holmes DR Jr, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation. 2000 Mar 7;101(9):948-54.

ReferenceCitation: Schächinger V, Britten MB, Zeiher AM. Prognostic impact of coronary vasodilator dysfunction on adverse long-term outcome of coronary heart disease. Circulation. 2000 Apr 25;101(16):1899-906.

ReferenceCitation: Halcox JP, Schenke WH, Zalos G, Mincemoyer R, Prasad A, Waclawiw MA, Nour KR, Quyyumi AA. Prognostic value of coronary vascular endothelial dysfunction. Circulation. 2002 Aug 6;106(6):653-8.

ReferenceCitation: Bugiardini R, Manfrini O, Pizzi C, Fontana F, Morgagni G. Endothelial function predicts future development of coronary artery disease: a study of women with chest pain and normal coronary angiograms. Circulation. 2004 Jun 1;109(21):2518-23. Epub 2004 May 10.

ReferenceCitation: Taqueti VR, Hachamovitch R, Murthy VL, Naya M, Foster CR, Hainer J, Dorbala S, Blankstein R, Di Carli MF. Global coronary flow reserve is associated with adverse cardiovascular events independently of luminal angiographic severity and modifies the effect of early revascularization. Circulation. 2015 Jan 6;131(1):19-27. doi: 10.1161/CIRCULATIONAHA.114.011939. Epub 2014 Nov 16.

ReferenceCitation: Fujii K, Kawasaki D, Oka K, Akahori H, Iwasaku T, Fukunaga M, Eguchi A, Sawada H, Masutani M, Lee-Kawabata M, Tsujino T, Ohyanagi M, Masuyama T. The impact of pravastatin pre-treatment on periprocedural microcirculatory damage in patients undergoing percutaneous coronary intervention. JACC Cardiovasc Interv. 2011 May;4(5):513-20. doi: 10.1016/j.jcin.2011.02.005.

ReferenceCitation: Seidah NG, Awan Z, Chrétien M, Mbikay M. PCSK9: a key modulator of cardiovascular health. Circ Res. 2014 Mar 14;114(6):1022-36. doi: 10.1161/CIRCRESAHA.114.301621. Review.

ReferenceCitation: Ding Z, Liu S, Wang X, Deng X, Fan Y, Sun C, Wang Y, Mehta JL. Hemodynamic shear stress via ROS modulates PCSK9 expression in human vascular endothelial and smooth muscle cells and along the mouse aorta. Antioxid Redox Signal. 2015 Mar 20;22(9):760-71. doi: 10.1089/ars.2014.6054. Epub 2015 Jan 8.

ReferenceCitation: Ferri N, Tibolla G, Pirillo A, Cipollone F, Mezzetti A, Pacia S, Corsini A, Catapano AL. Proprotein convertase subtilisin kexin type 9 (PCSK9) secreted by cultured smooth muscle cells reduces macrophages LDLR levels. Atherosclerosis. 2012 Feb;220(2):381-6. doi: 10.1016/j.atherosclerosis.2011.11.026. Epub 2011 Nov 25.

ReferenceCitation: Karagiannis AD, Liu M, Toth PP, Zhao S, Agrawal DK, Libby P, Chatzizisis YS. Pleiotropic Anti-atherosclerotic Effects of PCSK9 InhibitorsFrom Molecular Biology to Clinical Translation. Curr Atheroscler Rep. 2018 Mar 10;20(4):20. doi: 10.1007/s11883-018-0718-x. Review.

ReferenceCitation: Rochefort P, Chabaud S, Pierga JY, Tredan O, Brain E, Bidard FC, Schiffler C, Polena H, Khalil-Mgharbel A, Vilgrain I, Bachelot T. Soluble VE-cadherin in metastatic breast cancer: an independent prognostic factor for both progression-free survival and overall survival. Br J Cancer. 2017 Jan;116(3):356-361. doi: 10.1038/bjc.2016.427. Epub 2017 Jan 5.

ReferenceCitation: Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Ž, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WMM, Vlachopoulos C, Wood DA, Zamorano JL, Cooney MT; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058. doi: 10.1093/eurheartj/ehw272. Epub 2016 Aug 27.

ReferenceCitation: Ricchiuti V, Shear WS, Henry TD, Paulsen PR, Miller EA, Apple FS. Monitoring plasma cardiac troponin I for the detection of myocardial injury after percutaneous transluminal coronary angioplasty. Clin Chim Acta. 2000 Dec;302(1-2):161-70.

ReferenceCitation: Landmesser U, Chapman MJ, Stock JK, Amarenco P, Belch JJF, Borén J, Farnier M, Ference BA, Gielen S, Graham I, Grobbee DE, Hovingh GK, Lüscher TF, Piepoli MF, Ray KK, Stroes ES, Wiklund O, Windecker S, Zamorano JL, Pinto F, Tokgözoglu L, Bax JJ, Catapano AL. 2017 Update of ESC/EAS Task Force on practical clinical guidance for proprotein convertase subtilisin/kexin type 9 inhibition in patients with atherosclerotic cardiovascular disease or in familial hypercholesterolaemia. Eur Heart J. 2018 Apr 7;39(14):1131-1143. doi: 10.1093/eurheartj/ehx549.

ReferenceCitation: Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. Erratum in: Eur Heart J. 2019 Oct 1;40(37):3096.

ReferenceCitation: Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. Epub 2003 Jun 23. Erratum in: Circulation. 2003 Dec 23;108(25):3165.

ReferenceCitation: Yong AS, Layland J, Fearon WF, Ho M, Shah MG, Daniels D, Whitbourn R, Macisaac A, Kritharides L, Wilson A, Ng MK. Calculation of the index of microcirculatory resistance without coronary wedge pressure measurement in the presence of epicardial stenosis. JACC Cardiovasc Interv. 2013 Jan;6(1):53-8. doi: 10.1016/j.jcin.2012.08.019.

ReferenceCitation: Ng MK, Yong AS, Ho M, Shah MG, Chawantanpipat C, O'Connell R, Keech A, Kritharides L, Fearon WF. The index of microcirculatory resistance predicts myocardial infarction related to percutaneous coronary intervention. Circ Cardiovasc Interv. 2012 Aug 1;5(4):515-22. doi: 10.1161/CIRCINTERVENTIONS.112.969048. Epub 2012 Aug 8.

lead_sponsor: University Hospital, Grenoble


title: Dynamic Evaluation of COVID-19 Diagnostic Tests

summary:
Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated.

We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.

lead_sponsor: Tourcoing Hospital


title: Hemodynamic Characteristics of Patients With SARS-CoV-2: PiCCOVID Study

acronym: PiCCOVID

summary: The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been declared a public health emergency of international concern. Hospitalized COVID-19-positive patients requiring ICU care is increasing along with the course of epidemic. A large number of these patients developed acute respiratory distress syndrome (ARDS) according to current data. However, the related hemodynamic characteristic has so far been rarely described.

ReferenceCitation: Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.

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

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

family: Wang

full_name: Dawei Wang

given: Dawei

family: Hu

full_name: Bo Hu

given: Bo

full_name: Chang Hu

given: Chang

family: Zhu

full_name: Fangfang Zhu

given: Fangfang

family: Liu

full_name: Xing Liu

given: Xing

family: Zhang

full_name: Jing Zhang

given: Jing

full_name: Binbin Wang

given: Binbin

family: Xiang

full_name: Hui Xiang

given: Hui

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

family: Cheng

full_name: Zhenshun Cheng

given: Zhenshun

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

family: Xiong

full_name: Yong Xiong

given: Yong

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

family: Zhao

full_name: Yan Zhao

given: Yan

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

family: Li

full_name: Yirong Li

given: Yirong

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

full_name: Xinghuan Wang

given: Xinghuan

family: Peng

full_name: Zhiyong Peng

given: Zhiyong

journal_name: JAMA

oa_colors: green other

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

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

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

family: Zhou

full_name: Fei Zhou

given: Fei

family: Yu

full_name: Ting Yu

given: Ting

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

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

ReferenceCitation: Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19. Review.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. Erratum in: Intensive Care Med. 2020 Apr 6;:.

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

name: Chinese Center for Disease Control and Prevention, Beijing, China

ReferenceCitation: Schuster DP. The search for "objective" criteria of ARDS. Intensive Care Med. 2007 Mar;33(3):400-2. Epub 2007 Jan 13.

ReferenceCitation: Jozwiak M, Silva S, Persichini R, Anguel N, Osman D, Richard C, Teboul JL, Monnet X. Extravascular lung water is an independent prognostic factor in patients with acute respiratory distress syndrome. Crit Care Med. 2013 Feb;41(2):472-80. doi: 10.1097/CCM.0b013e31826ab377.

ReferenceCitation: Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5. Review.

ReferenceCitation: Shi R, Lai C, Teboul JL, Dres M, Moretto F, De Vita N, Pham T, Bonny V, Mayaux J, Vaschetto R, Beurton A, Monnet X. COVID-19 ARDS is characterized by higher extravascular lung water than non-COVID-19 ARDS: the PiCCOVID study. Crit Care. 2021 Jun 1;25(1):186. doi: 10.1186/s13054-021-03594-6.

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

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


title: Elderly Patients With Renal Insufficiency: Reasons for Using the Geriatrician, Modalities and Results of the Geriatric Evaluation, Becoming at One Year

acronym: NephroG

summary:
The incidence and prevalence of kidney failure increases with age. Elderly people with chronic kidney disease may have factors of fragility (loss of independence, comorbidities, geriatric syndromes) that can complicate the choice and implementation of the nephrological therapeutic project. Joint and early assessment of these patients by a nephrologist and a geriatrician could help to optimize the definition of care objectives and patient pathway.

There is little data on how nephrologists and geriatricians cooperate and on the description of frailties in elderly patients with renal impairment.

In this context, the objective of this study is to describe in a French university hospital the reasons for the use of geriatricians by nephrologists, the modalities of geriatric evaluation and the socio-demographic and medical characteristics (including geriatric syndromes) of very elderly patients with renal insufficiency, and then to become so at one year.

Year of implementation of this research: 2019 based on data from 2017 and 2019. Approximate number of people likely to be included in the research: 100 patients

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2

acronym: EasyCoV

summary:
Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.

Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.

We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Two Procedures of Incubator's Decontamination in a NICU

acronym: DECONTA

summary:
Nosocomial infections are responsible for morbidity and mortality in hospitalized neonates. The environment of the neonates and especially the incubators can constitute the reservoir of pathogenic bacteria. That is why decontamination of incubators is a major step in the fight against nosocomial infections in NICUs.

The hypothesize is that the usual procedure of decontamination, based on antiseptic molecules, is not sufficient to eradicate all pathogenic bacteria from the incubators.

In this study the investigator's aim to assess the efficacy of the usual procedure of decontamination and to compare it with another procedure based on steam pulverization. Another objective will be to explore a possible contamination of the hands of the healthcare workers, that can be involved in the cycle of transmission of bacteria to neonates. Finally, clinical data about the neonates housed in the incubator will be retrieved from clinical reports, to identify the occurrence of sepsis and if so, to compare the bacteria involved in the sepsis and the bacteria present in the incubator.


title: Impact of Previous Treatment With Angiotensin II Receptor Blockers in Patients With SARS-Cov2 Infection Admitted to the Intensive Care Unit on Survival and Severity of the Disease (COVID-ARA2)

summary:
The actual pandemic infection related to SARS-CoV2 results in viral pneumonitis (COVID-19), that may, in the more severe cases, lead the patients to the intensive care unit (ICU). The more frequent presentation is acute respiratory distress syndrome (ARDS).

To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor.

ACE2 belong to the renin-angiotensin-aldosteron system (SRAA), and ACE2 levels are directly modified when SRAA inhibitors are administred to patients, and ACE2 level increases particularely with Angiotensin II Receptor blockers (ARA2) use.

The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU).

COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.

lead_sponsor: University Hospital, Angers


title: Observational Tomodensitometric Study of the Anatomical Landmarks Depth Required to Perform Femoral Nerve Block or PENG Block. The Tomo-PENG Study.

acronym: Tomo-PENG

summary:
This study evaluates the depth of anatomical landmarks required in regional anaesthesia to perform either Femoral Nerve Block or PENG Block.

Measures will be performed on abdominal and pelvic computed tomography as part of daily routine patient care.

ipd_sharing_description: In accordance with future institutional decisions

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Renin Angiotensin System - CoronaVirus

acronym: SRA-COV

summary:
The aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%.

We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later).

This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE


title: Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department

acronym: VECUCHIR

summary: Surgery is the first-line treatment of localized skin cancers. Knowledge on the patient's psychological experience is limited. Therefore, the psychological impact on patients before, during and after surgery can be underestimated. Moreover, the diagnosis of cancer disturbs the patient's entire life and the onset of anxiety disorders is frequent following this announcement.

ReferenceCitation: Carr EC, Nicky Thomas V, Wilson-Barnet J. Patient experiences of anxiety, depression and acute pain after surgery: a longitudinal perspective. Int J Nurs Stud. 2005 Jul;42(5):521-30. Epub 2004 Nov 25.

ReferenceCitation: Matthias AT, Samarasekera DN. Preoperative anxiety in surgical patients - experience of a single unit. Acta Anaesthesiol Taiwan. 2012 Mar;50(1):3-6. doi: 10.1016/j.aat.2012.02.004. Epub 2012 Mar 30.

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lead_sponsor: University Hospital, Bordeaux


title: Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients: a Randomized Controlled Trial

acronym: DELIRLESS

summary:
Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs.

Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation.

Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU.

The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD.

The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau).

This is a prospective, national multicentric (21 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms:

Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.

Control group: placebo of this drug with the same schedule, during the same period of time.

The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau).

lead_sponsor: Assistance Publique - Hôpitaux de Paris