title: Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital

summary: Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.

ipd_sharing_description: All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.

lead_sponsor: Centre Hospitalier La Chartreuse

location_facility: Cardiovascular and thoracic surgery Unit - Dijon University Hopital


title: Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia

acronym: ANOSIRM

summary: To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.

study_start_date_type: Actual

status: Withdrawn

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Study of Retinal Vascular Parameters in Patients With Wilson's Disease

acronym: WILLY

summary:
The rare disease reference center " Wilson disease and other rare copper-related diseases" of the Rothschild Foundation follows a large number of patients with Wilson's with varying degrees of impairment and located at different times of their care.

Many people with Wilson's disease have a characteristic greenish-brown ring, known as Kayser-Fleischer, appearing at the periphery of the cornea due to a deposit of copper at the Descemet membrane. As a general rule, if the patient is compliant with his treatment, the ring usually disappears within a few years, although it may persist in some patients. However, apart from the stage of diagnosis, and the evolution of the ring, ophthalmological examinations are little used for the follow-up of these patients.

The objective of this study is to describe the retinal parameters, in particular vascular with two new retinal imaging technologies (OCT-A :Optical Coherence Tomography-Angiography , Adaptive optics) in patients with Wilson's disease and to correlate them with the parameters of the usual follow-up of these patients (hepatic assessment, exchangeable plasma copper, neurological scores, compliance, etc.).

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study

acronym: COVIDHomeless

summary:
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.

The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).

Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Biological


title: Insuffisance Cardiaque Sous Carfilzomib: étude Prospective

acronym: ICARE

summary: Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.

ipd_sharing: Undecided

lead_sponsor: European Georges Pompidou Hospital

location_facility: Assistance Publique Hôpitaux de Paris - Centre Université de Paris


title: Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib

acronym: FABRIC

summary: Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.


title: Cardio-Oncologie: étude Pilote évaluant la faisabilité, Utilité Concrète, Interdisciplinaire d'Une Unité Spécialisée

acronym: CONFUCIUS

summary:
Cardio-oncology is an emerging field. Most of the data available have been issued from either retrospective analysis, industry data or pharmacovigilance data. These data sources include a number of bias.

CONFUCIUS is a single tertiary centre prospective registry including all patients who have been referred for cardio-oncology assessemnt.

The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations (e.g., type of cancer) and/or drugs.


title: Impact of the Rheumatoid Factor on Serological Testing Performance for Covid-19 in Rheumatoid Arthritis Patients

acronym: COVID-SERA

summary: Due to the Covid-19 worldwide outbreak, fragile patients with immune diseases, notably rheumatoid arthritis (RA), have to be even more specifically and carefully followed-up. However, it has been shown that false postive serological results often occured while detecting antibodies directed against SARS-CoV-2 in patients with positive rheumatodoid factor (RF). The investigators propose here to investigated this issue. Therefore, the investigators will test three different immunoassays on this specific population. The investigators aim to establish these assays specificity and the levels of RF for which there is a risk of anti-SARS-CoV-2 false positivity and thus ensure a better follow-up of RA patients. The RF isotype will be analysed to determine whether there is a correlation and the impact of the presence of anti-CCP (citrullinated cyclic antipeptide antibodies) will be studied and assessed.

status: Completed

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Evaluation of a Data Transmission Solution for Connected Nutrition Pump for Patients Treated by Home Parenteral Nutrition (HPN). Proof of Concept, Prospective, Monocentric, Non-randomized, and Open-label Study.

acronym: SERENE-eNUTRI

summary:
Patients requiring long-term home parenteral nutrition (HPN) suffer from chronic intestinal insufficiency. The causes of this syndrome can be either anatomical (extensive resection of the small bowel) or functional (occlusion, pseudo-occlusion, malabsorption). Consequences mean that patients are unable to cover their oral energy and / or hydroelectrolytic needs.

As a result, these patients survive only through a nutritional support by the venous route (parenteral nutrition). However, this lifesaving therapy requires complex technological nutritional support issues at home, which will influence the personal life of the patients.

At home, HPN therapy is performed by nutrition pumps providing a constant flow and able to detect anomalies.

In this context, the development of connected systems that allow informations transmission could help patient's caregiving by the different persons involved in his follow-up (prescribing physicians, home support nurses, patients and relatives, manufacturers).

The main objective of this study is to evaluate the performance of an end-to-end data transmission chain which integrates a nutrition pump connected to a medical IoT module (developped by Maatel) able to send information to an applicative layer (software interface PatHView2, developped by Orange Labs) via different transmission modes : LoRaWAN (Long Range Wide-area network), BLE (Bluetooth Low Energy), GSM LTE-M (Global System for Mobile Communications, Long Term Evolution - Machine Type Communication).

primary_purpose: Device Feasibility

ReferenceType: background

ReferenceCitation: Pironi L, Miglioli M, Ruggeri E, Longo N, Suriani U, Maselli S, Gnudi S, Barbara L. Home parenteral nutrition for the management of chronic intestinal failure: a 34 patient-year experience. Ital J Gastroenterol. 1993 Oct;25(8):411-8.

ReferenceCitation: Detsky AS, McLaughlin JR, Abrams HB, L'Abbe KA, Whitwell J, Bombardier C, Jeejeebhoy KN. Quality of life of patients on long-term total parenteral nutrition at home. J Gen Intern Med. 1986 Jan-Feb;1(1):26-33.

lead_sponsor: University Hospital, Grenoble

intervention_type: Device


title: Social Cognition in Patients With Amyotrophic Lateral Sclerosis

acronym: COSISLA

summary:
Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood.

In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Angers


title: Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer

summary:
Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%.

Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2, SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer patients is suggested in several Chinese series. Cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.

lead_sponsor: CHU de Reims


title: Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)

acronym: COVADO

summary: The lockdown of the French population is a health measure put in place in response to the pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from Monday 16 March to Monday 11 May 2020. The national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. These decisions have led to an unprecedented state of stress for the entire French population, the consequences of which are unknown in the short, medium or long term. The objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients

acronym: CONFI-LOMB

summary:
The current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates health concerns, but is also accompanied by many other psychological, social, economic, professional, etc. consequences as well as numerous changes in behavior and lifestyles, notably due to confinement.

While the prevention of chronic low back pain and its management are primarily based on the practice of regular physical and sports activity, other psychological factors (stress, anxiety, depression), socioeconomic (low level of education, resources), professionals (physical workload, job dissatisfaction), etc. also have a major role in the onset and the persitence of low back pain.

Thus, it is to be supposed that the current context, and more particularly the confinement to which the population has been constrained for almost 2 months, have and will have notable consequences on the evolution of lumbar symptoms in chronic low back pain patients. However, the entanglement of different factors related to containment will potentially have different consequences depending on the individual. It therefore seems difficult to predict how the lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease in regular physical activity and the increase in anxiety in this context of insecurity could lead to an increase in pain, it could just as well consider that the decrease in stress work, strenuous physical work or travel time from work to home can, on the contrary, have a favorable effect.

The objective of this study is to assess the confinement effect on low back pain intensity in chronic low back pain patients.

This is an observational, descriptive, transversal and pluricentric study conducted by a single questionnaire.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Cross-Sectional


title: Human Endogenous Retroviruses in Acute Myeloid Leukemia: Expression and Immune Impact

acronym: ERVAL

summary:
Allogeneic hematopoietic stem cell transplantation (HSCT) is the only curative therapy for numerous malignant hematologic diseases. Despite recent advances in the field, relapse rates are still high and the first cause of death. The identification of new relevant therapeutic targets is therefore urgently needed.

Human endogenous retroviruses (HERVs) are accounting for 8% of the human genome. While silenced at the steady state (mainly by methylation mechanisms), HERVs reactivations have been described in different conditions such as auto-immune diseases or cancer, leading to an innate and adaptive immune response. Several questions are raised in the field of hematology where few data are available, and the exact role of HERVs in these diseases is still to define.

Our team is currently working on the role of HERVs in different types of cancer. We developed a bioinformatics approach to identify overexpressed HERVs from RNAseq data. We also developed in vitro assays to assess the immunogenicity of different peptides from HERVs open reading frames and showed that several epitopes shared among different HERVs can induce a specific CD8+ T cell response. More recently, we have analyzed 151 acute myeloid leukemia (AML) RNAseq data from TCGA and identified multiple overexpressed HERVs in this disease. Immunogenicity test are currently ongoing with patient's blood at diagnosis.

The main objective of this part of our project is to analyze the establishment of a HERVs-specific CD8+ T cell response participating in graft-versus-leukemia effect after HSCT for AML patients. Secondary objectives are to analyze relations between this response and different clinical factors such as the onset of GVHD or relapse.

Peripheral blood mononuclear cells (PBMCs) from AML patients will be extracted and frozen at different time point: diagnosis, complete remission (pre-HSCT) and after HSCT (M3, M6 and M12). This prospective protocol is currently ongoing at the Centre Hospitalier Lyon Sud, with around 30 samples already available.

After having selected relevant HERVs, specific dextramers identified by DNA barcode will be synthesized. These dextramers allowing the identification of specific T cell responses directed against up to 1000 epitopes, we will be able to screen specific T cells directed against HERVs overexpressed in AML for most common HLA. Dextramer staining will be performed on PBMCs after thawing. Positive cells will be sorted by flow cytometry and DNA will be expanded by PCR before performing sequencing, allowing the identification of specific sequences by its unique DNA barcode.

The analyze of HERVs-specific CD8+ T cell responses after HSCT will allow us to better define HERVs role in the onset of graft-versus-leukemia effect. A specific T cell response without GvHD will define the relevance of such peptides as tumor specific antigens.

lead_sponsor: Hospices Civils de Lyon


title: Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes

summary:
About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown.

This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.

ReferenceType: derived

ReferenceCitation: Cagnazzo F, Piotin M, Escalard S, Maier B, Ribo M, Requena M, Pop R, Hasiu A, Gasparotti R, Mardighian D, Piano M, Cervo A, Eker OF, Durous V, Sourour NA, Elhorany M, Zini A, Simonetti L, Marcheselli S, Paolo NN, Houdart E, Guédon A, Ligot N, Mine B, Consoli A, Lapergue B, Cordona Portela P, Urra X, Rodriguez A, Bolognini F, Lebedinsky PA, Pasco-Papon A, Godard S, Marnat G, Sibon I, Limbucci N, Nencini P, Nappini S, Saia V, Caldiera V, Romano D, Frauenfelder G, Gallesio I, Gola G, Menozzi R, Genovese A, Terrana A, Giorgianni A, Cappellari M, Augelli R, Invernizzi P, Pavia M, Lafe E, Cavallini A, Giossi A, Besana M, Valvassori L, Macera A, Castellan L, Salsano G, Di Caterino F, Biondi A, Arquizan C, Lebreuche J, Galvano G, Cannella A, Cosottini M, Lazzarotti G, Guizzardi G, Stecco A, Tassi R, Bracco S, Bianchini E, Micieli C, Pascarella R, Napoli M, Causin F, Desal H, Cotton F, Costalat V; ET-COVID-19 Study Group*. European Multicenter Study of ET-COVID-19. Stroke. 2021 Jan;52(1):31-39. doi: 10.1161/STROKEAHA.120.031514. Epub 2020 Nov 23.

name: Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France (F. Cagnazzo, V. Costalat).

family: Cagnazzo

full_name: Federico Cagnazzo

given: Federico

sequence: first

name: Interventional Neuroradiology Department, Rothschild Foundation Hospital, Paris, France (M. Piotin, S.E., B. Maier).

family: Piotin

full_name: Michel Piotin

given: Michel

sequence: additional

family: Escalard

full_name: Simon Escalard

given: Simon

family: Maier

full_name: Benjamin Maier

given: Benjamin

name: Stroke Unit, Neurology, Hospital Vall d’Hebron, Barcelona, Catalonia, Spain (M. Ribo, M. Requena).

family: Ribo

full_name: Marc Ribo

given: Marc

family: Requena

full_name: Manuel Requena

given: Manuel

name: Department of Interventional Neuroradiology, Strasbourg University Hospitals (R.P., A.H.).

family: Pop

full_name: Raoul Pop

given: Raoul

family: Hasiu

full_name: Anca Hasiu

given: Anca

name: Neuroradiology and Stroke Units, Spedali Civili, Brescia, Italy (R.G., D.M.).

family: Gasparotti

full_name: Roberto Gasparotti

given: Roberto

family: Mardighian

full_name: Dikran Mardighian

given: Dikran

name: Department of Neuroradiology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy (M. Piano, A. Cervo).

family: Piano

full_name: Mariangela Piano

given: Mariangela

family: Cervo

full_name: Amedeo Cervo

given: Amedeo

name: Department of Diagnostic and Interventional Neuroradiology, Hospices Civils, Lyon, France (O.F.E., V.D., F. Cotton).

family: Eker

full_name: Omer Faruk Eker

given: Omer Faruk

family: Durous

full_name: Vincent Durous

given: Vincent

name: Department of Neuroradiology, Pitié Salpêtrière Hospital, Paris, France (N.-A.S., M.E.).

family: Sourour

full_name: Nader-Antoine Sourour

given: Nader-Antoine

family: Elhorany

full_name: Mahmoud Elhorany

given: Mahmoud

name: Department of Neurology and Stroke Center (A.Z.), IRCCS Istituto di Scienze Neurologiche di Bologna, Maggiore Hospital, Bologna, Italy.

family: Zini

full_name: Andrea Zini

given: Andrea

name: Neuroradiology Unit (L.S.), IRCCS Istituto di Scienze Neurologiche di Bologna, Maggiore Hospital, Bologna, Italy.

family: Simonetti

full_name: Luigi Simonetti

given: Luigi

name: Neurologia d’Urgenza e Stroke Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy (S.M., N.N.P.).

family: Marcheselli

full_name: Simona Marcheselli

given: Simona

family: Paolo

full_name: Nuzzi Nunzio Paolo

given: Nuzzi Nunzio

name: Department of Neurology, Hôpital Lariboisière, University of Paris, France (E.H., A. Guédon).

family: Houdart

full_name: Emmanuel Houdart

given: Emmanuel

family: Guédon

full_name: Alexis Guédon

given: Alexis

name: Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium (N. Ligot, B. Mine).

family: Ligot

full_name: Noémie Ligot

given: Noémie

family: Mine

name: Department of Diagnostic and Therapeutic Neuroradiology, Hôpital Foch Suresnes FR, University of Versailles Saint Quentin-en-Yvelines, France (A. Consoli, B.L.).

name: Stroke Unit, Hospital Universitario de Bellvitge, Barcelona, Spain (P.C.P.).

name: Comprehensive Stroke Unit, Hospital Clínic de Barcelona, Catalonia, Spain (X.U., A.R.).

name: Interventional Neuroradiology Department, CHRU Colmar, France (F.B., P.A.L.).

name: Department of Radiology, University Hospital of Angers, France (A.P.-P.).

name: Department of Neurology, Angers University Hospital, France (S.G.).

name: Interventional Neuroradiology Department, CHRU Bordeaux, France (G.M.).

name: Stroke Unit, Department of Neurology, Bordeaux University, CHRU Bordeaux; France (I.S.).

name: Department of Interventional Neuroradiology, University of Florence, Italy (N. Limbucci, S.N.).

name: Stroke Unit, Ospedale Careggi-University Hospital, Firenze, Italy (P.N.).

name: Neurology and Stroke Unit, Santa Corona Hospital, Pietra Ligure (V.S., V. Caldiera).

name: Department of Neuroradiology, “San Giovanni di Dio e Ruggi d’Aragona” Hospital, Salerno, Italy (D.R., G.F.).

name: Department of Radiology, Azienda ospedaliera “SS Antonio e Biagio e C. Arrigo”, Alessandria, Italy (I.G., G. Gola).

name: Headache Centre, Department of Medicine and Surgery, Parma, Italy (R.M., A. Genovese).

name: Department of Neuroradiology, ASST Sette Laghi, University of Insubria, Varese, Italy (A.T., A. Giorgianni).

name: Stroke Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy (M.C., R.A.).

name: Neuroradiology and Neurology Units, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy (P.I., M. Pavia).

name: Radiology, Diagnostic and Interventional Neuroradiology Unit, Policlinico IRCCS San Matteo, Pavia, Italy (E.L.).

name: Cerebrovascular Department, IRCCS Mondino Foundation, Pavia, Italy (A. Cavallini).

name: SC Neurologia, Dipartimento Interaziendale Neuroscienze, Cremona, Italy (A. Giossi, M.B.).

name: Department of Neuroradiology, ASST Monza, Italy (L.V., A.M.).

name: RCCS Ospedale Policlinico San Martino, Genova, Italia (L.C., G.S.).

name: Department of Neuroradiology and Endovascular Therapy, Besancon, France (F.D.C., A.B.).

name: Department of Neurology, Hôpital Gui de Chauliac, Montpellier, France (C.A.).

name: Department of Biostatistics, University of Lille, CHU Lille, EA 2694-Santé Publique: Épidémiologie et Qualité des Soins, France (J.L.).

name: ARNAS Garibaldi, Catania, Italy (G. Galvano, A. Cannella).

name: Neuroradiology Unit, Ospedale Cisanello, Pisa, Italy (M.C., G.L.).

name: A.O.U. Maggiore della Carita, Novara, Italy (G. Guizzardi, A.S.).

name: Interventional Neuroradiology and Stroke Units, Ospedale S. Maria delle Scotte-University Hospital, Siena, Italy (R.T., S.B.).

name: Neuroradiology Unit, ASST West Milan, Legnano Hospital (E.B., C.M.).

name: Neuroradiology Unit, IRCCS Santa Maria Nuova, Hospital Reggio Emilia (R.P. M.N.).

name: Interventional Neuroradiology Unit and Stroke Unit, Padova, Italy (F. Causin).

name: Service de Neuroradiologie Diagnostique et Interventionnelle du CHU de Nantes, France (H.D.).

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Exploring Brain Damages After COVID-19 Infection

acronym: BRAINCOV

summary: Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux


title: CACOLAC : Randomized Trial of Citrulline Administration in the Hospital Patient in Intensive Care for COVID-19 Acute Respiratory Distress Syndrome

acronym: CACOLAC

summary:
Respiratory involvement of SARS-CoV2 leads to acute respiratory distress syndrome (ARDS) and significant immunosuppression (lymphopenia) exposing patients to long ventilation duration and late mortality linked to the acquisition of nosocomial infections.

Lymphopenia characteristic of severe forms of ARDS secondary to SARS-CoV2 infection may be linked to expansion of MDSCs and arginine depletion of lymphocytes.

Severe forms of COVID-19 pneumonitis are marked by persistent ARDS with acquisition of nosocomial infections as well as by prolonged lymphocytic dysfunction associated with the emergence of MDSC.

It has been found in intensive care patients hypoargininaemia, associated with the persistence of organ dysfunction (evaluated by the SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, the enteral administration of ARG was not deleterious and increased the synthesis of ornithine, suggesting a preferential use of ARG by the arginase route, without significant increase in argininaemia nor effect on immune functions. L-citrulline (CIT), an endogenous precursor of ARG, is an interesting alternative to increase the availability of ARG. Recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis, corrects hypoargininemia, with convincing data on immunological parameters such as lymphopenia, which is associated with mortality, organ dysfunction and the occurrence of nosocomial infections. The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function. The hypothesis is therefore that CIT supplementation is more effective than the administration of ARG to correct hypoargininaemia, decrease lymphocyte dysfunction, correct immunosuppression and organ dysfunction in septic patients admitted to intensive care.

The main objective is to show that, in patients hospitalized in intensive care for ARDS secondary to COVID-19 pneumonia, the group of patients receiving L-citrulline for 7 days, compared to the group receiving placebo, has a score of organ failure decreased on D7 (evaluated by the SOFA score) or by the last known SOFA score if the patient has died or been resuscitated.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Rennes University Hospital


type: EudraCT Number

title: Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

acronym: HORNbILL

summary: The study aims at assessing the efficacy and the safety of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency.

ReferenceCitation: Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum in: Intensive Care Med. 2018 Feb 23;:.

ReferenceCitation: Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, François B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohé J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

name: From Service de Médecine Intensive et Réanimation, Hôpital Raymond Poincaré, Garches (D.A., V.M.), Laboratory of Infection and Inflammation Unité 1173, University of Versailles Saint-Quentin-en-Yvelines, INSERM, Montigny-le-Bretonneux (D.A.), Service de Pharmacologie Clinique–Centre d’Investigation Clinique (CIC) INSERM 1414, Centre Hospitalier Universitaire (CHU) de Rennes–Université de Rennes 1, Hôpital Pontchaillou, Rennes (A.R., E.B.), Service de Réanimation Médicale (C.B.-B.) and Service...

family: Annane

full_name: Djillali Annane

given: Djillali

family: Renault

full_name: Alain Renault

given: Alain

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Siami

full_name: Shidasp Siami

given: Shidasp

family: Cariou

full_name: Alain Cariou

family: Forceville

full_name: Xavier Forceville

given: Xavier

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Martin

full_name: Claude Martin

given: Claude

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Misset

full_name: Benoît Misset

given: Benoît

family: Ali Benali

full_name: Mohamed Ali Benali

given: Mohamed

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Chimot

full_name: Loïc Chimot

given: Loïc

family: Charpentier

full_name: Claire Charpentier

given: Claire

family: François

full_name: Bruno François

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Petitpas

full_name: Franck Petitpas

given: Franck

family: Constantin

location_facility: General Intensive care Unit, Raymond Poincaré Hospital, APHP


intervention_type: Drug

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: LOVIT ARDS

location_facility: Department Intensive Care Unit, Hospital Raymond Poincaré - APHP

type: Registry Identifier

source: euctr

title: A Multicentre Concealed-Allocation Parallel-Group Blinded Randomized Controlled Trial to Ascertain the Effect of High-Dose Intravenous Vitamin C Compared to Placebo on Mortality or Persistent Organ Dysfunction at 28 Days in Septic Intensive Care Unit Patients

summary:
The primary objective of the study aims to compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 28 days on intensive care unit (ICU) patients.

As secondary objectives, the study aims:

To compare the effect of high-dose intravenous vitamin C vs. placebo on:

6-month mortality;
6-month HRQoL;
organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU);
global tissue dysoxia (at baseline);
oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU, and if still intubated);
occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria20;

acute hemolysis as defined by:

clinician judgment of hemolysis, as recorded in the chart, or

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.

Severe hemolysis:

- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells;

hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8 mmol/L.
To assess baseline vitamin C levels in study participants (before the first dose of investigational product).


title: "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19

acronym: GERONIMO 19

summary:
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older.

In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity.

Apart from an increase in oxygen therapy, no specific treatment is currently proposed.

The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution.

Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients.

This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.

lead_sponsor: Versailles Hospital


title: Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy

acronym: TRANSCOVID

summary: The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Diagnostic Test


title: Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.

acronym: COVID-PSL

summary:
COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world.

If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date).

However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms.

Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc.

Given the novelty of this infection, several questions remain:

What are all the symptoms that can be contracted by a COVID-19 patient?
Are there clinical forms not described?
What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis?
What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments

acronym: DERMACLIC

summary: The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, lung, digestive system or ENT (Ear, nose and throat).

primary_purpose: Supportive Care

lead_sponsor: Institut Curie


title: Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis

acronym: CannabisRIC

summary:
Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis.

The aim of this study is to assess the percentage of patients who use cannabis to better relieve their pain or anxiety in chronic inflammatory rheumatism.

time_perspective: Other

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)

acronym: IMITO

summary:
Current methods to assess superficial size and area of pressure ulcers are either time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or necessitating to touch the patient's skin (using commun rulers).

A free smartphone application (for IOS or Android) has recently been developed to measures skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A photograph is taken with the smartphone, the limits of the lesion is then drawn with the health carers' finger on the phone's screen. The application computes the length, width and surface of the ulcer.

This technique has not yet been validated, although it has been used to measure various types of skin lesions.

The objective of this study is to validate this measurement technique on a sample of pressure ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by comparison to the currently most frequently used techniques (Transparency Tracings and ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.

imitoMeasure is a new smartphone application to measure wounds size. The present study assesses validity of the measure against common measures (ruler-based and transparency tracings), and the inter- and intra-rater reliability.

ReferenceCitation: Do Khac A, Jourdan C, Fazilleau S, Palayer C, Laffont I, Dupeyron A, Verdun S, Gelis A. mHealth App for Pressure Ulcer Wound Assessment in Patients With Spinal Cord Injury: Clinical Validation Study. JMIR Mhealth Uhealth. 2021 Feb 23;9(2):e26443. doi: 10.2196/26443.

family: DO KHAC

full_name: Ariane DO KHAC

given: Ariane

family: JOURDAN

full_name: Claire JOURDAN

family: FAZILLEAU

full_name: Sylvain FAZILLEAU

given: Sylvain

family: PALAYER

full_name: Claire PALAYER

family: LAFFONT

full_name: Isabelle LAFFONT

given: Isabelle

family: DUPEYRON

full_name: Arnaud DUPEYRON

given: Arnaud

family: VERDUN

full_name: Stephane VERDUN

given: Stephane

family: GELIS

full_name: Anthony GELIS

given: Anthony

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JMIR mHealth and uHealth

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

title: Clinical validation of a mHealth App for wound assessment: correlation and reliability study (Preprint)


title: Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020

summary:
Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG proposes to conduct a new epidemiological study on primary PLC in order to evaluate and analyze the changes that have occurred over the last decade.

Primary endpoint:

Estimate 1-year- and 5-year-mortality rates in patients with PLC.

Secondary endpoints:

Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020
Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies
Estimate prognostic factors
Compare patient and tumor characteristics to those observed for KBP-2010-CPHG and KBP-2000-CPHG studies
Compare observed survival rates to those reported for KBP-2000-CPHG and KBP-2010-CPHG studies

location_facility: Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)


title: Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit

acronym: CO-Qo-ICU

summary:
Pneumonia caused by infection at SARS-CoV2 may be complicated by an acute respiratory detress syndrome need to take care in intensive care unit and can lead to mechanical ventilation. COVID-19 is a pandemic disease and lot of patients will survive of severe pneumoniae at SARS-CoV2 treat in ICU. At this time, there is no data about functional prognosis at long term.

This aim of this study is to evaluate the recovery of quality of life, respiratory function, neuromuscular function at long term and incidence of post-traumatic stress disorder. Patients will follow during 1year after out of ICU with 3 consultations at 3month, 6month and 12month. At each consultation patients will be evaluated about respiratory function, effort tolerance via 6minutes walking test, psychologic function with IES-R and HAD score and quality of life with SF36.

The hypothesis is that patients who survived of ARDS post infection at SARS-CoV2 have persistent functional limitation and alteration of quality of life one year after being discharged from the ICU.

ipd_sharing_description: No Data sharing plan has been established

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder

acronym: COVID-TRAUMA

summary:
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence.

It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later.

Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.

lead_sponsor: Institut Paoli-Calmettes


title: Ex Vivo Study of Drugs Transfer Across the Placenta

acronym: DRUGS-PTP

summary: Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.

ReferenceCitation: Schneider H, Panigel M, Dancis J. Transfer across the perfused human placenta of antipyrine, sodium and leucine. Am J Obstet Gynecol. 1972 Nov 15;114(6):822-8.

ReferenceCitation: Hutson JR, Garcia-Bournissen F, Davis A, Koren G. The human placental perfusion model: a systematic review and development of a model to predict in vivo transfer of therapeutic drugs. Clin Pharmacol Ther. 2011 Jul;90(1):67-76. doi: 10.1038/clpt.2011.66. Epub 2011 May 11. Review. Erratum in: Clin Pharmacol Ther. 2011 Sep;90(3):479.


title: Feasibility Study of the ETOILE Program, a Therapeutic Education Program in Pediatric Hematology About Acute Lymphoblastic Leukemia and Allogenic Hematopoietic Steam Cells Transplantation, for Patient and Caregivers

acronym: ETOILE

summary: Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed.


title: Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

acronym: HYPNOICU

summary: Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.


title: Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients

acronym: NEPHRACTIVE

summary:
Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.

Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.

Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.

Nevertheless, there are no data on the medico-economic impact of such a program.

Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.

The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.

lead_sponsor: Clinique Néphrologique Saint-Exupéry

location_facility: Clinique Néphrologique Saint Saint-Exupéry


title: End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room: Prospective Randomized Clinical Trial Comparing Two Occlusion Tests (EXPIRE)

acronym: EXPIRE

summary: The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.


title: Sleep Apnea Syndrome and Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) After a First Stroke

acronym: ASCENT

summary:
This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset.

The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, and non-fatal acute coronary disease.

1620 patients, in the acute phase of a first stroke, TIA or recurrent TIA will be included in the cohort.

Clinical, neuroimaging, sensorimotor, cognitive and biological parameters will be collected at inclusion. Three months after stroke or TIA onset, polysomnography will be performed for SDB diagnosis. Patients will be considered as having SDB for an Apnea-Hypopnea Index (AHI) > 15 events/hour, or to the control group otherwise. The same clinical, imaging, cognitive and biological assessments than during the first visit will be performed; incident (new) cardiovascular events will be collected. Three months later, and at 1, 2, 3, 4 and 5 years after SDB diagnosis, the same clinical, cognitive, sensorimotor, and sleep-related evaluations will be performed. In addition to the aforementioned parameters, incident cardiovascular outcomes will be collected, at the same time points. The primary study outcome will be retrieved one year after stroke onset.

ReferenceCitation: GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

ReferenceCitation: Javaheri S, Barbe F, Campos-Rodriguez F, Dempsey JA, Khayat R, Javaheri S, Malhotra A, Martinez-Garcia MA, Mehra R, Pack AI, Polotsky VY, Redline S, Somers VK. Sleep Apnea: Types, Mechanisms, and Clinical Cardiovascular Consequences. J Am Coll Cardiol. 2017 Feb 21;69(7):841-858. doi: 10.1016/j.jacc.2016.11.069. Review.

ReferenceCitation: Hermann DM, Bassetti CL. Role of sleep-disordered breathing and sleep-wake disturbances for stroke and stroke recovery. Neurology. 2016 Sep 27;87(13):1407-16. doi: 10.1212/WNL.0000000000003037. Epub 2016 Aug 3. Review.

ReferenceCitation: Seiler A, Camilo M, Korostovtseva L, Haynes AG, Brill AK, Horvath T, Egger M, Bassetti CL. Prevalence of sleep-disordered breathing after stroke and TIA: A meta-analysis. Neurology. 2019 Feb 12;92(7):e648-e654. doi: 10.1212/WNL.0000000000006904. Epub 2019 Jan 11.

ReferenceCitation: Lisabeth LD, Sánchez BN, Lim D, Chervin RD, Case E, Morgenstern LB, Tower S, Brown DL. Sleep-disordered breathing and poststroke outcomes. Ann Neurol. 2019 Aug;86(2):241-250. doi: 10.1002/ana.25515. Epub 2019 Jun 19.

ReferenceCitation: Brill AK, Horvath T, Seiler A, Camilo M, Haynes AG, Ott SR, Egger M, Bassetti CL. CPAP as treatment of sleep apnea after stroke: A meta-analysis of randomized trials. Neurology. 2018 Apr 3;90(14):e1222-e1230. doi: 10.1212/WNL.0000000000005262. Epub 2018 Mar 9.

ReferenceCitation: Amarenco P, Lavallée PC, Labreuche J, Albers GW, Bornstein NM, Canhão P, Caplan LR, Donnan GA, Ferro JM, Hennerici MG, Molina C, Rothwell PM, Sissani L, Školoudík D, Steg PG, Touboul PJ, Uchiyama S, Vicaut É, Wong LK; TIAregistry.org Investigators. One-Year Risk of Stroke after Transient Ischemic Attack or Minor Stroke. N Engl J Med. 2016 Apr 21;374(16):1533-42. doi: 10.1056/NEJMoa1412981.

ReferenceCitation: Amarenco P, Lavallée PC, Monteiro Tavares L, Labreuche J, Albers GW, Abboud H, Anticoli S, Audebert H, Bornstein NM, Caplan LR, Correia M, Donnan GA, Ferro JM, Gongora-Rivera F, Heide W, Hennerici MG, Kelly PJ, Král M, Lin HF, Molina C, Park JM, Purroy F, Rothwell PM, Segura T, Školoudík D, Steg PG, Touboul PJ, Uchiyama S, Vicaut É, Wang Y, Wong LKS; TIAregistry.org Investigators. Five-Year Risk of Stroke after TIA or Minor Ischemic Stroke. N Engl J Med. 2018 Jun 7;378(23):2182-2190. doi: 10.1056/NEJMoa1802712. Epub 2018 May 16.

ReferenceCitation: Wardlaw JM, Brazzelli M, Chappell FM, Miranda H, Shuler K, Sandercock PA, Dennis MS. ABCD2 score and secondary stroke prevention: meta-analysis and effect per 1,000 patients triaged. Neurology. 2015 Jul 28;85(4):373-80. doi: 10.1212/WNL.0000000000001780. Epub 2015 Jul 1. Review.

ReferenceCitation: Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. Review.

ReferenceCitation: Wahlund LO, Barkhof F, Fazekas F, Bronge L, Augustin M, Sjögren M, Wallin A, Ader H, Leys D, Pantoni L, Pasquier F, Erkinjuntti T, Scheltens P; European Task Force on Age-Related White Matter Changes. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke. 2001 Jun;32(6):1318-22.

ReferenceCitation: Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

ReferenceCitation: Cramer SC, Wolf SL, Adams HP Jr, Chen D, Dromerick AW, Dunning K, Ellerbe C, Grande A, Janis S, Lansberg MG, Lazar RM, Palesch YY, Richards L, Roth E, Savitz SI, Wechsler LR, Wintermark M, Broderick JP. Stroke Recovery and Rehabilitation Research: Issues, Opportunities, and the National Institutes of Health StrokeNet. Stroke. 2017 Mar;48(3):813-819. doi: 10.1161/STROKEAHA.116.015501. Epub 2017 Feb 7.

ReferenceCitation: Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1. Erratum in: Stroke. 2015 Feb;46(2):e54.

ReferenceCitation: Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. Review.

ReferenceCitation: Lévy P, Kohler M, McNicholas WT, Barbé F, McEvoy RD, Somers VK, Lavie L, Pépin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. Review.

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Kohler

full_name: Malcolm Kohler

given: Malcolm

family: McNicholas

full_name: Walter T. McNicholas

given: Walter T.

family: Barbé

full_name: Ferran Barbé

given: Ferran

family: McEvoy

full_name: R. Doug McEvoy

given: R. Doug

family: Somers

full_name: Virend K. Somers

given: Virend K.

family: Lavie

full_name: Lena Lavie

given: Lena

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

journal_name: Nature Reviews Disease Primers

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Obstructive sleep apnoea syndrome

ReferenceCitation: Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.

ReferenceCitation: Lévy P, Tamisier R, Minville C, Launois S, Pépin JL. Sleep apnoea syndrome in 2011: current concepts and future directions. Eur Respir Rev. 2011 Sep 1;20(121):134-46. doi: 10.1183/09059180.00003111. Review.

ReferenceCitation: McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

ReferenceCitation: Alexiev F, Brill AK, Ott SR, Duss S, Schmidt M, Bassetti CL. Sleep-disordered breathing and stroke: chicken or egg? J Thorac Dis. 2018 Dec;10(Suppl 34):S4244-S4252. doi: 10.21037/jtd.2018.12.66. Review.

ReferenceCitation: Loke YK, Brown JW, Kwok CS, Niruban A, Myint PK. Association of obstructive sleep apnea with risk of serious cardiovascular events: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):720-8. Epub 2012 Jul 24. Review.

ReferenceCitation: Duss SB, Brill AK, Bargiotas P, Facchin L, Alexiev F, Manconi M, Bassetti CL. Sleep-Wake Disorders in Stroke-Increased Stroke Risk and Deteriorated Recovery? An Evaluation on the Necessity for Prevention and Treatment. Curr Neurol Neurosci Rep. 2018 Sep 7;18(10):72. doi: 10.1007/s11910-018-0879-6. Review.

ReferenceCitation: Bassetti CL, Milanova M, Gugger M. Sleep-disordered breathing and acute ischemic stroke: diagnosis, risk factors, treatment, evolution, and long-term clinical outcome. Stroke. 2006 Apr;37(4):967-72. Epub 2006 Mar 16.

ReferenceCitation: Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41.

ReferenceCitation: Sahlin C, Sandberg O, Gustafson Y, Bucht G, Carlberg B, Stenlund H, Franklin KA. Obstructive sleep apnea is a risk factor for death in patients with stroke: a 10-year follow-up. Arch Intern Med. 2008 Feb 11;168(3):297-301. doi: 10.1001/archinternmed.2007.70.

ReferenceCitation: Aaronson JA, van Bennekom CA, Hofman WF, van Bezeij T, van den Aardweg JG, Groet E, Kylstra WA, Schmand BA. The effect of obstructive sleep apnea and treatment with continuous positive airway pressure on stroke rehabilitation: rationale, design and methods of the TOROS study. BMC Neurol. 2014 Feb 25;14:36. doi: 10.1186/1471-2377-14-36.

ReferenceCitation: Kaneko Y, Hajek VE, Zivanovic V, Raboud J, Bradley TD. Relationship of sleep apnea to functional capacity and length of hospitalization following stroke. Sleep. 2003 May 1;26(3):293-7.

ReferenceCitation: Duss SB, Seiler A, Schmidt MH, Pace M, Adamantidis A, Müri RM, Bassetti CL. The role of sleep in recovery following ischemic stroke: A review of human and animal data. Neurobiol Sleep Circadian Rhythms. 2016 Nov 29;2:94-105. doi: 10.1016/j.nbscr.2016.11.003. eCollection 2017 Jan. Review.

ReferenceCitation: Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. Epub 2003 Jul 10.

ReferenceCitation: Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6.

ReferenceCitation: Kendzerska T, Wilton K, Bahar R, Ryan CM. Short- and long-term continuous positive airway pressure usage in the post-stroke population with obstructive sleep apnea. Sleep Breath. 2019 Dec;23(4):1233-1244. doi: 10.1007/s11325-019-01811-9. Epub 2019 Feb 28.

ReferenceCitation: Tsivgoulis G, Alexandrov AV, Katsanos AH, Barlinn K, Mikulik R, Lambadiari V, Bonakis A, Alexandrov AW. Noninvasive Ventilatory Correction in Patients With Acute Ischemic Stroke: A Systematic Review and Meta-Analysis. Stroke. 2017 Aug;48(8):2285-2288. doi: 10.1161/STROKEAHA.117.017661. Epub 2017 Jun 8. Review.

ReferenceCitation: Parra O, Sánchez-Armengol Á, Capote F, Bonnin M, Arboix A, Campos-Rodríguez F, Pérez-Ronchel J, Durán-Cantolla J, Martínez-Null C, de la Peña M, Jiménez MC, Masa F, Casadon I, Alonso ML, Macarrón JL. Efficacy of continuous positive airway pressure treatment on 5-year survival in patients with ischaemic stroke and obstructive sleep apnea: a randomized controlled trial. J Sleep Res. 2015 Feb;24(1):47-53. doi: 10.1111/jsr.12181. Epub 2014 Jul 21. Erratum in: J Sleep Res. 2015 Aug;24(4):474.

ReferenceCitation: Martínez-García MA, Campos-Rodríguez F, Soler-Cataluña JJ, Catalán-Serra P, Román-Sánchez P, Montserrat JM. Increased incidence of nonfatal cardiovascular events in stroke patients with sleep apnoea: effect of CPAP treatment. Eur Respir J. 2012 Apr;39(4):906-12. doi: 10.1183/09031936.00011311. Epub 2011 Sep 29.

ReferenceCitation: Barbé F, Durán-Cantolla J, Sánchez-de-la-Torre M, Martínez-Alonso M, Carmona C, Barceló A, Chiner E, Masa JF, Gonzalez M, Marín JM, Garcia-Rio F, Diaz de Atauri J, Terán J, Mayos M, de la Peña M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366.

family: Durán-Cantolla

full_name: Joaquín Durán-Cantolla

given: Joaquín

family: Sánchez-de-la-Torre

full_name: Manuel Sánchez-de-la-Torre

given: Manuel

family: Martínez-Alonso

full_name: Montserrat Martínez-Alonso

given: Montserrat

full_name: for the Spanish Sleep and Breathing Network

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

title: Effect of Continuous Positive Airway Pressure on the Incidence of Hypertension and Cardiovascular Events in Nonsleepy Patients With Obstructive Sleep Apnea

ReferenceCitation: Kim Y, Koo YS, Lee HY, Lee SY. Can Continuous Positive Airway Pressure Reduce the Risk of Stroke in Obstructive Sleep Apnea Patients? A Systematic Review and Meta-Analysis. PLoS One. 2016 Jan 5;11(1):e0146317. doi: 10.1371/journal.pone.0146317. eCollection 2016. Review.

ReferenceCitation: Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41.

ReferenceCitation: Amarenco P, Bogousslavsky J, Caplan LR, Donnan GA, Hennerici MG. Classification of stroke subtypes. Cerebrovasc Dis. 2009;27(5):493-501. doi: 10.1159/000210432. Epub 2009 Apr 3. Review.

ReferenceCitation: Naylor AR, Ricco JB, de Borst GJ, Debus S, de Haro J, Halliday A, Hamilton G, Kakisis J, Kakkos S, Lepidi S, Markus HS, McCabe DJ, Roy J, Sillesen H, van den Berg JC, Vermassen F, Esvs Guidelines Committee, Kolh P, Chakfe N, Hinchliffe RJ, Koncar I, Lindholt JS, Vega de Ceniga M, Verzini F, Esvs Guideline Reviewers, Archie J, Bellmunt S, Chaudhuri A, Koelemay M, Lindahl AK, Padberg F, Venermo M. Editor's Choice - Management of Atherosclerotic Carotid and Vertebral Artery Disease: 2017 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jan;55(1):3-81. doi: 10.1016/j.ejvs.2017.06.021. Epub 2017 Aug 26.

ReferenceCitation: Schulz R, Seeger W, Fegbeutel C, Hüsken H, Bödeker RH, Tillmanns H, Grebe M. Changes in extracranial arteries in obstructive sleep apnoea. Eur Respir J. 2005 Jan;25(1):69-74.

ReferenceCitation: Ehrhardt J, Schwab M, Finn S, Guenther A, Schultze T, Witte OW, Rupprecht S. Sleep apnea and asymptomatic carotid stenosis: a complex interaction. Chest. 2015 Apr;147(4):1029-1036. doi: 10.1378/chest.14-1655.

ReferenceCitation: Suzuki M, Shimamoto K, Sekiguchi H, Harada T, Satoya N, Inoue Y, Yamaguchi K, Kawana M. Arousal index as a marker of carotid artery atherosclerosis in patients with obstructive sleep apnea syndrome. Sleep Breath. 2019 Mar;23(1):87-94. doi: 10.1007/s11325-018-1664-0. Epub 2018 May 19.

ReferenceCitation: Eken SM, Jin H, Chernogubova E, Li Y, Simon N, Sun C, Korzunowicz G, Busch A, Bäcklund A, Österholm C, Razuvaev A, Renné T, Eckstein HH, Pelisek J, Eriksson P, González Díez M, Perisic Matic L, Schellinger IN, Raaz U, Leeper NJ, Hansson GK, Paulsson-Berne G, Hedin U, Maegdefessel L. MicroRNA-210 Enhances Fibrous Cap Stability in Advanced Atherosclerotic Lesions. Circ Res. 2017 Feb 17;120(4):633-644. doi: 10.1161/CIRCRESAHA.116.309318. Epub 2016 Nov 28.

ReferenceCitation: Wang LQ, Wang CL, Xu LN, Hua DF. The expression research of miR-210 in the elderly patients with COPD combined with ischemic stroke. Eur Rev Med Pharmacol Sci. 2016 Nov;20(22):4756-4760.

ReferenceCitation: Duncan PW, Lai SM, Bode RK, Perera S, DeRosa J. Stroke Impact Scale-16: A brief assessment of physical function. Neurology. 2003 Jan 28;60(2):291-6.

ReferenceCitation: Nadarajah M, Mazlan M, Abdul-Latif L, Goh HT. Test-retest reliability, internal consistency and concurrent validity of Fatigue Severity Scale in measuring post-stroke fatigue. Eur J Phys Rehabil Med. 2017 Oct;53(5):703-709. doi: 10.23736/S1973-9087.16.04388-4. Epub 2016 Oct 21.

ReferenceCitation: Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6.

ReferenceCitation: Flamand-Roze C, Falissard B, Roze E, Maintigneux L, Beziz J, Chacon A, Join-Lambert C, Adams D, Denier C. Validation of a new language screening tool for patients with acute stroke: the Language Screening Test (LAST). Stroke. 2011 May;42(5):1224-9. doi: 10.1161/STROKEAHA.110.609503. Epub 2011 Apr 12.

ReferenceCitation: Spitzer RL. More on pseudoscience in science and the case for psychiatric diagnosis. A critique of D.L. Rosenhan's "On Being Sane in Insane Places" and "The Contestual Nature of Psychiatric Diagnosis". Arch Gen Psychiatry. 1976 Apr;33(4):459-70.

ReferenceCitation: Birkbak J, Clark AJ, Rod NH. The effect of sleep disordered breathing on the outcome of stroke and transient ischemic attack: a systematic review. J Clin Sleep Med. 2014 Jan 15;10(1):103-8. doi: 10.5664/jcsm.3376. Review.


title: Development and Prospective Validation of a Standardized Flow Cytometric Assay of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes.

acronym: MPO-MDS-Develp

summary:
Myelodysplastic syndromes (MDS) comprise a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. The diagnosis of MDS relies on peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage. Cytopenia is evidenced with hemogram while dysplasia requires bone marrow aspirate, which is an invasive procedure .

Considering the low prevalence of disease among subjects referred for suspected MDS, many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms. Therefore, an objective assay based on a peripheral blood sample that accurately discriminates MDS from other cytopenia etiologies is highly desirable.

We have previously developed and refined a flow cytometric analysis protocol for quantifying neutrophil MPO expression in peripheral blood at three university-affiliated hospitals (i.e., Clermont-Ferrand, Saint-Etienne, and Grenoble) (Raskovalova et al, Hematologica 2019). We found that the robust coefficient of variation (RCV, computed as the robust standard deviation divided by the median) within an individual subject was the best parameter in discriminating patients with versus without MDS.

Although promising, flow cytometric analysis of neutrophil MPO expression in peripheral blood is technically complex, time consuming, and not standardized. Hence, its performance requires specific expertise and the results show substantial variability. A single ready-to-use tube with lyophilized antibodies would have the potential to standardize the measurement of neutrophil MPO expression in peripheral blood across laboratories, with results available within 30-60 min in routine practice.

In this study, the investigators hypothesize that a standardized and semi-automatic flow cytometric assay of neutrophil MPO expression in peripheral blood could accurately rule out MDS and obviate the need for bone marrow aspiration and biopsy, with sensitivity and negative predictive value estimates approaching 100%.

In this observational diagnostic accuracy study, burden will be null for recruited patients. No specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. A test result will have no impact on patient management. .Compliance with current guidelines disseminated by the French Haute Autorité de Santé (HAS) will be advocated for the diagnostic work-up of patients with suspected MDS. No follow-up visits are planned in this cross-sectional study.

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description: The principal investigators will respond directly to data requests by providing a de-identified data set. Individual participant data that underlie the results reported in the published articles (i.e., main text, tables, figures, and appendices) will be supplied.


title: One-year Outcome of Critically Ill Patients With Systemic Rheumatic Disease: a Multicenter Cohort Study

acronym: ProSyDICU

summary: Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. The aim of this study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a retrospective cohort study (2006 - 2016).

lead_sponsor: University Hospital, Montpellier


title: Psychological Impact of Quarantine During the COVID-19 Outbreak and Worsening of Cardiovascular Risk in the French General Population: a Prospective Cohort Study

acronym: PSYCOV-CV

summary: In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.

lead_sponsor: University Hospital, Toulouse


title: Study of INFLAmmasome NLRP3 and PLAtelets Functions During Severe COVID-19 Infection

acronym: CO-QUETTES

summary: COVID-19 pandemic is a severe viral sepsis characterized by the occurrence of Acute respiratory distress syndrome (ARDS) whose pathophysiology is little described


title: RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19

summary: the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients


title: Impact of New Genomic Tools on the Management of Patients With Multidrug-resistant Tuberculosis

acronym: GENO-MDR

summary: In the context of the emergence of cases of multidrug-resistant tuberculosis (MDR-TB) it is crucial to improve patient's management. Therefore, assessing the place of innovative strategies enabling the diagnosis of those cases (e.g. WGS and Deeplex-MycTB) in the personalized care of patients with MDR-TB and the rationalization of medical biology procedures is a major issue. This project participates to these goals since the investigators will : (i) assess the diagnostic qualities and the performance of the different innovatives strategies enabling detection of resistance to anti-tuberculosis drugs, (ii) assess the impact of these strategies in the implementation of personalized treatments for MDR-TB patients, and (iii) assess the overall costs of these strategies.


title: Maternal-Foetal Transmission of COVID-19

summary:
One case of maternal-fetal transmission of SARS Cov-2 was published (1). Ig M and Ig G were found at two hours after birth of a new born from a mother COVID-19. Another study on few newborns COVID-19 reported that the SARS-Cov-2 was not transmitted in utero but only after birth.

Although there are few data on COVID-19 during pregnancy, according to our national data collections, it appears to be responsible for miscarriages and fetal deaths. There are also intrauterine growth restrictions and an increase of the rate of cesarean sections for maternal indications. Therefore, it is essential to know if there is a maternal viremia which infects the fetus because the consequences in terms of management would be completely different.

In fact, the potential intrauterine infection will lead to antenatal monitoring of these patients with an antenatal diagnosis and may be a treatment.

Therefore, it seems essential to explore the mode of transmission to the newborn since many newborns have COVID-19 infection The investigators will propose to all pregnant women SARS- Cov-2 positive to perform PCR SARS-Cov-2 tests and /or serology's (IgM and Ig G) on the amniotic fluid, the blood cord and the placenta.

ReferenceCitation: Dong L, Tian J, He S, Zhu C, Wang J, Liu C, Yang J. Possible Vertical Transmission of SARS-CoV-2 From an Infected Mother to Her Newborn. JAMA. 2020 May 12;323(18):1846-1848. doi: 10.1001/jama.2020.4621.

ReferenceCitation: Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13.

ReferenceCitation: Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.

ReferenceCitation: Woo PC, Lau SK, Wong BH, Tsoi HW, Fung AM, Chan KH, Tam VK, Peiris JS, Yuen KY. Detection of specific antibodies to severe acute respiratory syndrome (SARS) coronavirus nucleocapsid protein for serodiagnosis of SARS coronavirus pneumonia. J Clin Microbiol. 2004 May;42(5):2306-9.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4

acronym: ORTHOPHTALMO

summary:
Visual developmental abnormalities affect 10 to 15% of the population under 6 years of age and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood has consequences on the quality of life of individuals but will also represent a cost to society due to the increased risk of visual impairment.

The screening protocol for this study recommends that a screening examination for amblyopia and amblyogenic factors be routinely performed by an orthoptist in children between 3 and 4 year old. This examination should include, as a minimum, a standardised measurement of visual acuity, a cover test and a measurement of refraction by photoscreener. In the event of a positive screening, the child must then be referred to an ophthalmologist so as to complete an ophthalmological examination.

The aim of this protocol is to propose screening tests usually performed with a high specificity, in order to avoid congestion of ophthalmological services (i.e. by avoiding excessive or unnecessary referral of children to the ophthalmologist) without losing sensitivity by combining several tests.

The orthoptists' role in this screening protocol is to facilitate an extensive screening coverage of the population in this age group, as they are more easily accessed by the patients and more equitably spread in the community than ophthalmologists.

Therefore, by initially screening and then referring less children to the ophthalmologist, the aim is to reduce waiting times in the access of ophthalmological services which could be detrimental in terms of treatment success rates for patients acutely needing care.

Based on the referral of children between 3 and 4 years of age by the orthoptist to an ophthalmologist, the analysis of the data from the standard screening protocol used in our centre will enable us to validate it scientifically. The referral thresholds can thus be secondarily adjusted for each test if the initial objectives are not achieved (specificity > 90% and sensitivity > 87%). The aim of this study is also to observe a change in the patient flow by reducing the volume of consultations with the ophthalmologist currently required based on the present referral rate. The efficiency of the screening protocol by calculating the probable economic gain linked to the modification of the screening circuit will be secondarily studying in this protocol

lead_sponsor: Clinique Rive Gauche


title: Couple and Spouse Caregiver in Huntington's Disease

acronym: COCOON

summary: The objectives are to better document the psychosocial status and needs of caregiver of HD patients and understand the dyad functioning, facing the disease at various stages.

lead_sponsor: University Hospital, Lille


title: Identification of New Diagnostic Protein Markers for Colorectal Cancer in Circulating Tumor Exosomes

summary:
The search for biochemical markers in patient's blood for non-invasive colorectal cancer diagnostic has not yielded satisfactory results to date. The search for blood in the stool by enzymatic techniques has certainly allowed the diminution of colorectal cancer mortality but its low sensitivity is still a disadvantage. The new immunological tests for search blood test in the stool are more sensitive and more specific but still insufficient. The originality of this project is based on the use of new technology developed in fundamental research based on the detection of circulating exosomes from tumor cells in the patient's serum. The detection of protein markers transported by tumor exosomes is original and innovative approach because it's still not considered in the literature. The use of innovative and non-invasive health technologies for the patient is an important factor in the care of patients in their health care journey. The non-invasive nature of the project could reduce the reticence of patients to participate in cancer screening.

The results expected from the study can have a direct impact on the management of patients suspected of having colon cancer and thus make it possible to optimize the earliness of their diagnosis.

lead_sponsor: CHU de Reims


title: Extension of the Analgesia of an Interscalene Block of the Brachial Plexus by Combined Injection of Dexamethasone and Dexmedetomidine, After Arthroscopic Shoulder Surgery: Randomized, Controlled, Double-blind Trial

acronym: INDEX

summary: The main objective of the study is to demonstrate the efficacy of Dexmedetomidine on the prolongation of analgesia obtained by interscalenic bloc of the brachial plexus and intravenous injection of Dexamethasone (efficacy objective).

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


title: sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?

summary: Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.

ReferenceCitation: Dupont V, Kanagaratnam L, Goury A, Poitevin G, Bard M, Julien G, Bonnivard M, Champenois V, Noel V, Mourvillier B, Nguyen P. Excess Soluble fms-like Tyrosine Kinase 1 Correlates With Endothelial Dysfunction and Organ Failure in Critically Ill Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 May 18;72(10):1834-1837. doi: 10.1093/cid/ciaa1007.

name: Medical Intensive Care Unit, University Hospital of Reims, Reims, France

name: EA-3801, SFT CAP-Santé, University of Reims Champagne Ardenne, France

family: Dupont

full_name: Vincent Dupont

given: Vincent

name: Clinical Research Unit, University Hospital of Reims, Reims, France

family: Kanagaratnam

full_name: Lukshe Kanagaratnam

given: Lukshe

family: Goury

full_name: Antoine Goury

given: Antoine

family: Poitevin

full_name: Gaël Poitevin

given: Gaël

family: Bard

full_name: Mathieu Bard

given: Mathieu

family: Julien

full_name: Gauthier Julien

given: Gauthier

family: Bonnivard

full_name: Michel Bonnivard

given: Michel

family: Champenois

full_name: Vanessa Champenois

given: Vanessa

name: Department of Internal Medicine, Clinical Immunology and Infectious Diseases, University Hospital of Reims, Reims, France

family: Noel

full_name: Violaine Noel

given: Violaine

family: Mourvillier

full_name: Bruno Mourvillier

given: Bruno

family: Nguyen

full_name: Philippe Nguyen

given: Philippe

journal_name: Clinical Infectious Diseases

oa_colors: green hybrid

evidence: open (via free article)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


title: Urinary Biomarkers (TIMP-2 and IGFBP7) for Early Diagnostic Assessment of Acute Kidney Injury in Patients With SARS-CoV-2 (COVID-19)

acronym: COVID-AKI

summary: Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.


title: Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care

summary:
It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease.

The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training.

In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient.

Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic.

In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient.

In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause.

Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality.

And a new applicability in the pulmonary recruitment by PEEP titration has been presented.

The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.

ipd_sharing_description: No data sharing plan has been established


title: Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation

acronym: RHUMACOVID

summary: The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: TWICE-IRI: Optimization of Second-line Therapy With Aflibercept, Irinotecan (Day 1 or Day 1,3), 5-Fluorouracile and Folinic Acid in Patients With Metastatic Colorectal Cancer. A Randomized Phase III Study.

acronym: TWICE-IRI

summary: Optimization of second-line therapy with aflibercept, irinotecan (day1 or day 1,3), 5fluorouracile and folinic acid in patients with metastatic colorectal cancer. A randomized Phase III study.

ReferenceCitation: Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313.

ReferenceCitation: Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. Epub 2003 Dec 2.

ReferenceCitation: Jolivet J. Role of leucovorin dosing and administration schedule. Eur J Cancer. 1995 Jul-Aug;31A(7-8):1311-5. Review.

ReferenceCitation: Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausová J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012 Oct 1;30(28):3499-506. Epub 2012 Sep 4.

ReferenceCitation: Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, André T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tzekova V, Collins S, Oliner KS, Rong A, Gansert J. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4.

ReferenceCitation: Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Van Cutsem E, Grothey A, Prausová J, Garcia-Alfonso P, Yamazaki K, Clingan PR, Lonardi S, Kim TW, Simms L, Chang SC, Nasroulah F; RAISE Study Investigators. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015 May;16(5):499-508. doi: 10.1016/S1470-2045(15)70127-0. Epub 2015 Apr 12. Erratum in: Lancet Oncol. 2015 Jun;16(6):e262.

family: Tabernero

full_name: Josep Tabernero

given: Josep

family: Yoshino

full_name: Takayuki Yoshino

given: Takayuki

family: Cohn

full_name: Allen Lee Cohn

given: Allen Lee

family: Obermannova

full_name: Radka Obermannova

given: Radka

family: Bodoky

full_name: Gyorgy Bodoky

given: Gyorgy

family: Garcia-Carbonero

full_name: Rocio Garcia-Carbonero

given: Rocio

family: Ciuleanu

full_name: Tudor-Eliade Ciuleanu

given: Tudor-Eliade

family: Portnoy

full_name: David C Portnoy

given: David C

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Grothey

full_name: Axel Grothey

given: Axel

family: Prausová

full_name: Jana Prausová

given: Jana

family: Garcia-Alfonso

full_name: Pilar Garcia-Alfonso

given: Pilar

family: Yamazaki

full_name: Kentaro Yamazaki

given: Kentaro

family: Clingan

full_name: Philip R Clingan

given: Philip R

family: Lonardi

full_name: Sara Lonardi

given: Sara

family: Kim

full_name: Tae Won Kim

given: Tae Won

family: Simms

full_name: Lorinda Simms

given: Lorinda

family: Chang

full_name: Shao-Chun Chang

given: Shao-Chun

family: Nasroulah

full_name: Federico Nasroulah

given: Federico

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Guichard S, Cussac D, Hennebelle I, Bugat R, Canal P. Sequence-dependent activity of the irinotecan-5FU combination in human colon-cancer model HT-29 in vitro and in vivo. Int J Cancer. 1997 Nov 27;73(5):729-34.

ReferenceCitation: Mullany S, Svingen PA, Kaufmann SH, Erlichman C. Effect of adding the topoisomerase I poison 7-ethyl-10-hydroxycamptothecin (SN-38) to 5-fluorouracil and folinic acid in HCT-8 cells: elevated dTTP pools and enhanced cytotoxicity. Cancer Chemother Pharmacol. 1998;42(5):391-9.

ReferenceCitation: Mans DR, Grivicich I, Peters GJ, Schwartsmann G. Sequence-dependent growth inhibition and DNA damage formation by the irinotecan-5-fluorouracil combination in human colon carcinoma cell lines. Eur J Cancer. 1999 Dec;35(13):1851-61.

ReferenceCitation: Falcone A, Di Paolo A, Masi G, Allegrini G, Danesi R, Lencioni M, Pfanner E, Comis S, Del Tacca M, Conte P. Sequence effect of irinotecan and fluorouracil treatment on pharmacokinetics and toxicity in chemotherapy-naive metastatic colorectal cancer patients. J Clin Oncol. 2001 Aug 1;19(15):3456-62.

ReferenceCitation: Mabro M, Louvet C, André T, Carola E, Gilles-Amar V, Artru P, Krulik M, de Gramont A; GERCOR. Bimonthly leucovorin, infusion 5-fluorouracil, hydroxyurea, and irinotecan (FOLFIRI-2) for pretreated metastatic colorectal cancer. Am J Clin Oncol. 2003 Jun;26(3):254-8.

ReferenceCitation: Mabro M, Artru P, André T, Flesch M, Maindrault-Goebel F, Landi B, Lledo G, Plantade A, Louvet C, de Gramont A. A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients. Br J Cancer. 2006 May 8;94(9):1287-92.

ReferenceCitation: Bidard FC, Tournigand C, André T, Mabro M, Figer A, Cervantes A, Lledo G, Bengrine-Lefevre L, Maindrault-Goebel F, Louvet C, de Gramont A. Efficacy of FOLFIRI-3 (irinotecan D1,D3 combined with LV5-FU) or other irinotecan-based regimens in oxaliplatin-pretreated metastatic colorectal cancer in the GERCOR OPTIMOX1 study. Ann Oncol. 2009 Jun;20(6):1042-7. doi: 10.1093/annonc/mdn730. Epub 2009 Jan 19.

ReferenceCitation: Chibaudel B, Maindrault-Gœbel F, Bachet JB, Louvet C, Khalil A, Dupuis O, Hammel P, Garcia ML, Bennamoun M, Brusquant D, Tournigand C, André T, Arbaud C, Larsen AK, Wang YW, Yeh CG, Bonnetain F, de Gramont A. PEPCOL: a GERCOR randomized phase II study of nanoliposomal irinotecan PEP02 (MM-398) or irinotecan with leucovorin/5-fluorouracil as second-line therapy in metastatic colorectal cancer. Cancer Med. 2016 Apr;5(4):676-83. doi: 10.1002/cam4.635. Epub 2016 Jan 24.

ReferenceCitation: Carola C, Ghiringhelli F, Kim S, André T, Barlet J, Bengrine-Lefevre L, Marijon H, Garcia-Larnicol ML, Borg C, Dainese L, Steuer N, Richa H, Benetkiewicz M, Larsen AK, de Gramont A, Chibaudel B. FOLFIRI3-aflibercept in previously treated patients with metastatic colorectal cancer. World J Clin Oncol. 2018 Sep 14;9(5):110-118. doi: 10.5306/wjco.v9.i5.110.

ReferenceCitation: Ghiringhelli F, Vincent J, Beltjens F, Bengrine L, Ladoire S. Fluorouracil, leucovorin and irinotecan associated with aflibercept can induce microscopic colitis in metastatic colorectal cancer patients. Invest New Drugs. 2015 Dec;33(6):1263-6. doi: 10.1007/s10637-015-0295-6. Epub 2015 Oct 22.

ReferenceCitation: Rubbia-Brandt L, Giostra E, Brezault C, Roth AD, Andres A, Audard V, Sartoretti P, Dousset B, Majno PE, Soubrane O, Chaussade S, Mentha G, Terris B. Importance of histological tumor response assessment in predicting the outcome in patients with colorectal liver metastases treated with neo-adjuvant chemotherapy followed by liver surgery. Ann Oncol. 2007 Feb;18(2):299-304. Epub 2006 Oct 23.

ReferenceCitation: Blazer DG 3rd, Kishi Y, Maru DM, Kopetz S, Chun YS, Overman MJ, Fogelman D, Eng C, Chang DZ, Wang H, Zorzi D, Ribero D, Ellis LM, Glover KY, Wolff RA, Curley SA, Abdalla EK, Vauthey JN. Pathologic response to preoperative chemotherapy: a new outcome end point after resection of hepatic colorectal metastases. J Clin Oncol. 2008 Nov 20;26(33):5344-51. doi: 10.1200/JCO.2008.17.5299. Epub 2008 Oct 20.

ReferenceCitation: Bonnetain F, Dahan L, Maillard E, Ychou M, Mitry E, Hammel P, Legoux JL, Rougier P, Bedenne L, Seitz JF. Time until definitive quality of life score deterioration as a means of longitudinal analysis for treatment trials in patients with metastatic pancreatic adenocarcinoma. Eur J Cancer. 2010 Oct;46(15):2753-62. doi: 10.1016/j.ejca.2010.07.023. Epub 2010 Aug 17.

location_facility: Franco-British Hospital - GCS IHFB Cognacq-Jay


title: Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies

acronym: HYACINTHE

summary: The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.

lead_sponsor: Institut de cancérologie Strasbourg Europe

location_facility: Institut de Cancérologie Strasbourg Europe


title: Relationship Between Obesity and Severe Acute Respiratory Syndrome Coronavirus-2 in Patient With SARS-CoV-2 Admitted in Intensive Care : A Multicenter Retrospective Cohort Study

summary: This study will involve collection of pseudonymized data from hospital-based data reporting at multiple international sites. Collating data from a large volume of patients with COVID-19 admitted in ICU across multiple international sites will enable investigation of whether obesity is a risk factor for complicated from of SARS-CoV-2 in adult patients and whether this association is independent of other cardiometabolic risk factors.

location_facility: Centre Hospitalier Régional & Universitaire de Lille (CHRU)


title: Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial

acronym: Humidifier

summary: To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

lead_sponsor: ResMed


title: Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context

acronym: RECOVERY

summary: Compare the resting energy expenditure of COVID-19 patients (obese or non-obese) in intensive care unit with mechanical ventilation to a control group of non-COVID-19 intensive care patients.

lead_sponsor: Centre Hospitalier Arras