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.

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type: Other Identifier

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.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Raskovalova T, Scheffen L, Jacob MC, Chevalier S, Tondeur S, Bulabois B, Meunier M, Szymanski G, Lefebvre C, Planta C, Dumestre-Perard C, Gonnet N, Garban F, Merle R, Park S, Labarère J. Flow cytometry lyophilised-reagent tube for quantifying peripheral blood neutrophil myeloperoxidase expression in myelodysplastic syndromes (MPO-MDS-Develop): protocol for a diagnostic accuracy study. BMJ Open. 2022 Oct 7;12(10):e065850. doi: 10.1136/bmjopen-2022-065850.

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.

lead_sponsor: University Hospital, Grenoble

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


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).

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


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.

time_perspective: Prospective

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

status: Unknown status

enrollment_type: Anticipated

intervention_type: Biological

status_simplified: Unknown


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

study_type: Interventional

primary_purpose: Other

lead_sponsor: Versailles Hospital

intervention_type: Diagnostic Test


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.

status: Recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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.

ReferenceType: background

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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: Functional Benefits of Multisite Surgery for the Upper Limb of Children With Cerebral Palsy

summary: The aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with Cerebral Palsy on unilateral functional capacities and bimanual performance. The investigators also assessed the attainment of individualized goals and tracked any potential factors that may have an impact on final results.

ipd_sharing: No

lead_sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

location_facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

lead_sponsor_type: industriel


title: Assessment of Air Contamination Risk by Sars-Cov2 During Visceral Surgery in COVID19 Patients: Pilot Study.

acronym: COELIOCOVID

summary: Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract. Protection of health care workers during surgery has been increased and some guidelines advocate for abandoning laparoscopy in COVID19 patients for fear of contamination, evenghtough this does not benefit the patient. However, Sars-Cov2 contamination risk during visceral surgery remains unknown. Inadequate protection is unnecessary costful and can be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travel through droplet and air during visceral surgery. 2) Laparoscopy, because of the pneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrant more droplet contamination, which would justified increased protection.

primary_purpose: Prevention

lead_sponsor: University Hospital, Lille


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.


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).

design_allocation: Randomized

primary_purpose: Treatment

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

intervention_type: Drug


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.


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

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Procedure


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.

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.

lead_sponsor: GCS IHFB Cognacq-Jay

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


type: EudraCT Number

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.

status: Withdrawn

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.

study_start_date_type: Anticipated

lead_sponsor: ResMed

intervention_type: Device


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.

time_perspective: Other

lead_sponsor: Centre Hospitalier Arras


title: Estimation of the Incidence of Colonization of Peripheral Venous Catheters After Skin Disinfection With 0.5% Sodium Hypochlorite, Preceded or Not by an Application of 70% Ethanol: Pilot, Monocentric, Randomized, Open-label Study

acronym: DACLEAN

summary:
The peripheral venous catheter is the most commonly used medical device in the hospital setting. Infectious complications are infrequent, bacterial or fungal, and local or systemic (catheter-related bacteremia). The latter prolong the length of hospitalization and increase the cost of care and mortality. For peripheral venous catheters, the risk of catheter-related bacteremia is lower (0.2-0.7 episodes per 1000 catheter days) than for other intravascular devices. However, the much higher number of peripheral venous catheters used explains a total number of infections close to that of other catheters. Colonization is usually the preliminary step to catheter infection. It is far more common than infection. Skin disinfection prior to catheter insertion is therefore essential to prevent this complication.

Currently, Chlorhexidine or Povidone Iodine in alcoholic solution is recommended before insertion of a peripheral venous catheter. Although rare, allergies may contraindicate these antiseptics. The widespread use of antiseptics in recent years for hand disinfection, mouthwashes or body baths could increase the risk of the development of strains that have become less sensitive, or even resistant, to currently available antiseptics. Allergies and reduced sensitivity require the search for alternatives to currently available solutions. Sodium hypochlorite is used to disinfect mucous membranes or healthy skin before an invasive procedure in children under 30 months of age. Very few studies have evaluated its efficacy in adults for this same indication, despite the fact that it was the first antiseptic used to prevent infections.

The aim of this study is to estimate the colonization rate of peripheral venous catheters after skin disinfection with 0.5% sodium hypochlorite (Dakin®) alone or preceded by an application of 70% ethanol.

lead_sponsor: Poitiers University Hospital


title: Effect of a Dietary Supplement Based on Magnesium, Vitamins, Rhodiola and L-theanine (Stress Resist®), on Stress in Stressed Subjects: Randomized Study Versus Placebo.

acronym: MAGRITTE

summary: The aim is to study the effect of a dietary supplement on stress and pain through questionnaires and follow-up of physiological parameters, and functional Magnetic Resonance Imaging (fMRI) in stressed healthy subjects versus stressed healthy subjects without treatment.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Dietary Supplement


title: A Prospective Study Evaluating the Effectiveness of Juvederm Volift With Lidocaine for Treatment of the Aging Hands

summary: This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: Allergan


title: Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic ; International Cohort Study

summary:
This study will describe the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will focus on hemodynamic failure and organ dysfunction after surgery.

Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

This investigator-led, non-commercial, non-interventional does not collect any patient identifiable information.

lead_sponsor: Nantes University Hospital


title: OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

acronym: OCTAVO

summary:
Studies suggest an association between retinal abnormalities and NCD (Neuro Cognitive Disorders) whether they are linked to proven or prodromal Alzheimer's disease (aMCI : amnestic mild cognitive impairment), or to other neurodegenerative diseases such as frontotemporal dementia or Lewy body diseases.

These retinal anomalies objectified by OCT-A (Optical coherence tomography angiography) and adaptive optics (AO) appear different depending on the pathologies and could therefore serve as markers in vivo of the pathophysiological processes underlying NCD.

No study to date has studied the retina and its vessels in NCD using adaptive optics. In this pilot study, we are proposing a combination of two new ophthalmological imaging techniques (OCT-A and AO), which allow rapid in vivo analysis in a completely non-invasive way of the morphology of small vessels as well as architecture of the retina to better specify the retinal anomalies associated with NCD. We will compare the parameters in OCT-A and AO between patients with NCD and controls without NCD (with memory complaint or without) and will seek to determine if there are different profiles according to the causes of NCD.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Maneuver for Evaluating the Potential Recruitability of the Pulmonary Parenchyme in Patients With ARDS

acronym: MERP

summary: This study will try to define the threshold of the recruitable volume (Vrec), obtained by a derecruitment maneuver, that permit to identify patients responder or not to alveolar recruitment maneuvers.

ReferenceCitation: Chen L, Brochard L. Lung volume assessment in acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Jun;21(3):259-64. doi: 10.1097/MCC.0000000000000193. Review.

ReferenceCitation: Hess DR. Recruitment Maneuvers and PEEP Titration. Respir Care. 2015 Nov;60(11):1688-704. doi: 10.4187/respcare.04409. Review.

ReferenceCitation: Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators, Cavalcanti AB, Suzumura ÉA, Laranjeira LN, Paisani DM, Damiani LP, Guimarães HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascón GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.

ReferenceCitation: Chen L, Chen GQ, Shore K, Shklar O, Martins C, Devenyi B, Lindsay P, McPhail H, Lanys A, Soliman I, Tuma M, Kim M, Porretta K, Greco P, Every H, Hayes C, Baker A, Friedrich JO, Brochard L. Implementing a bedside assessment of respiratory mechanics in patients with acute respiratory distress syndrome. Crit Care. 2017 Apr 4;21(1):84. doi: 10.1186/s13054-017-1671-8.

ReferenceCitation: Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.

lead_sponsor: University Hospital, Caen

location_facility: Centre Hospitalier Universitaire - CHU Caen


title: Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic

acronym: SOCOVID

summary:
Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. On the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation.

COVID-19 itself, has several components:

An apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular
A secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. A secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases.
A thromboembolic action


title: Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID

summary:
Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses.

Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies.

If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination.

The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.


title: Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients

acronym: Gluco-TIPS

summary: Decompensated cirrhosis is associated with sarcopenia. TIPS is an efficient treatment of portal hypertension. Based on our retrospective data, TIPS induces in 30% of cirrhotic patients metabolic disorders associated with diabetes or pre-diabetes. The main objective is to measure the cumulative incidence of diabetes and pre-diabetes 6 months after TIPS insertion.

lead_sponsor: University Hospital, Toulouse


title: Measurement of Airway Opening Pressure (AOP) in Patients With Acute Respiratory Distress Syndrom With Pressure Volume Curve on the Ventilator and With Electrical Impedance Tomography (EIT) Derived Method in Comparison of the Curves in Patients With or Without Covid 19 Pneumoniae.

acronym: POVA-TIE

summary:
Mechanical ventilation in ARDS requires protective ventilation and PEEP. Airway closer has to be overcome to reduce lung heterogeneity, AOP is measured globally with a ventilator PV curve without PEEP. EIT derived PV curve is another method that could determine heterogeneity of AOP between both lung.

This study aims to determine whether AOP measured with EIT derived PV curve is similar to AOP on the ventilator PV curve and see if AOP is different between lungs.

If airway closer is higher on one lung, global AOP on the ventilator PV curve probably estimates the other lung.

lead_sponsor: University Hospital, Bordeaux

location_facility: HOPITAL HAUT-LEVEQUE - Service Réanimation thoracique


title: Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR

acronym: SALICOV

summary:
Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.

Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique

summary:
The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20).

The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma.

Translated with www.DeepL.com/Translator (free version)

lead_sponsor: Versailles Hospital


title: Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study

summary: Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.

ReferenceCitation: Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, García-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.

ReferenceCitation: Roca O, Messika J, Caralt B, García-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.

lead_sponsor: Hôpital Louis Mourier

location_facility: Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris


title: Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19

acronym: DOCOV

summary:
The management of patients with SARS-CoV2 in respiratory distress can expose to corneal or retinal lesions induced by the stay in intensive care.

Examination by ophthalmologists would make it possible to detect the most of the ophthalmologic problems known in intensive care and to provide an early, preventive or curative therapeutic response when possible, in order to avoid irreversible visual loss.

The object of the research is to assess the presence and the importance of surface ophthalmologic lesions, the presence and the importance of retinal or optic nerve lesions, in order to improve the monitoring and primary prevention of this population


title: Identification of Predictive Immune Biomarkers Based on the Understanding of COVID-19 Pathogenesis to Influence Therapeutic Management

acronym: COVIDBioToul

summary: The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. The project aim is to create a prospective cohort of biological samples collected from well characterized COVID-19 patients. This project aims first to identify based on these samples an early immune signature predictive of clinical worsening of COVID-19 patients in order to improve their management, and secondarily to better understand pathophysiological mechanisms underlying the different phases of the disease in order to identify innovative therapeutic targets and vaccine perspectives.

primary_purpose: Basic Science

ReferenceCitation: Dimeglio C, Herin F, Da-Silva I, Gernigon C, Porcheron M, Chapuy-Regaud S, Izopet J. Decreased Efficiency of Neutralizing Antibodies from Previously Infected or Vaccinated Individuals against the B.1.617.2 (Delta) SARS-CoV-2 Variant. Microbiol Spectr. 2022 Aug 31;10(4):e0270621. doi: 10.1128/spectrum.02706-21. Epub 2022 Jul 5.

ReferenceCitation: Dimeglio C, Herin F, Da-Silva I, Jougla I, Pradere C, Porcheron M, Martin-Blondel G, Chapuy-Regaud S, Izopet J. Heterologous ChAdOx1-S/BNT162b2 Vaccination: Neutralizing Antibody Response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2022 Apr 9;74(7):1315-1316. doi: 10.1093/cid/ciab705.

ReferenceCitation: Kreutmair S, Unger S, Núñez NG, Ingelfinger F, Alberti C, De Feo D, Krishnarajah S, Kauffmann M, Friebel E, Babaei S, Gaborit B, Lutz M, Jurado NP, Malek NP, Goepel S, Rosenberger P, Häberle HA, Ayoub I, Al-Hajj S, Nilsson J, Claassen M, Liblau R, Martin-Blondel G, Bitzer M, Roquilly A, Becher B. Distinct immunological signatures discriminate severe COVID-19 from non-SARS-CoV-2-driven critical pneumonia. Immunity. 2021 Jul 13;54(7):1578-1593.e5. doi: 10.1016/j.immuni.2021.05.002. Epub 2021 May 9. Erratum in: Immunity. 2022 Feb 8;55(2):366-375.


title: Randomized Controlled Trial Comparing the Effect of a Parent-guided Speech and Language Therapy Program During the Summer Holidays With an Adapted Holiday Book on the Reading Level of Children With Visual-attentional Dyslexia

acronym: REEDVAC

summary:
"After summer break, the reading performance of dyslexic children declines more than those of non-dyslexic children. Indeed, during the summer, dyslexic children are less inclined to read and their consultations with speech therapist are usually suspended.

Intensive speech therapy programs proved to be efficient during the summer, to maintain reading level of dyslexic children. However these programs are expensive and not easy to generalise. Some other studies tested reading therapy programs applied by parents at home. It proved to be effective and feasible.

Thus, the hypothesis of the present study is: a parent-administered reading therapy program during the summer break could stabilise the reading performance of dyslexic children after the summer. On the contrary the investigators assume the control group reading performance would decrease."

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Registry Identifier

title: Feasibility, Safety and Medico-economic Study of Magnetic-end Double-J Ureteral Stent Use in Children

acronym: EFUJA

summary:
Double-J ureteral stent (DJUS) is one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.

Classically, DJUS are introduced and removed in the operation room, under general anesthesia, using a cystoscope.

The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop.

To remove the magnetic stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip is inserted into the urethra in the outpatient clinic.

The purpose of this study is to demonstrate the feasibility and safety of magnetic-end Double-J ureteral stent use in children and to perform a medico-economic study.


title: Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients: Role of Androgens

summary: Asthma is more common in females than in males but the difference has not been explained yet. Group 2 innate lymphoid cells (ILC2) have recently emerged as critical players in the initiation of allergic responses but their implications in the difference between males and females in terms of asthma prevalence has not been fully studied. The aim of this project is to compare the proportion of ILC2 in blood between males and females with asthma.


title: Digestive Events in Duchenne Muscular Dystrophy Patients

acronym: DIGD

summary: Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients

ipd_sharing_description: All clinician and biologist involved in the follow-up of these patients

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population

acronym: NIPESTIM

summary: NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.

ReferenceCitation: Lebrun S, Boccara J, Cailliau E, Herbet M, Tavernier B, Constant I, Sabourdin N. Quantitative assessment of a pediatric nociception monitor in children under sevoflurane anesthesia. Reg Anesth Pain Med. 2022 Jun 2. pii: rapm-2022-103547. doi: 10.1136/rapm-2022-103547. [Epub ahead of print]

lead_sponsor: University Hospital, Lille


title: Projet GonioSEF: Etude de faisabilité d'un Dispositif d'amélioration du défaut de Report d'Appui Pendant la Marche en Phase Portante Chez Des Sujets présentant Une Atteinte du système Nerveux Central

acronym: GONIOSEF

summary: The main hypothesis of the present study is that a safer knee joint is likely to encourage post stroke patients at an early stage to rely on their hemiparetic leg and transfer their weight onto it while walking. The main purpose of the present work is to assess the feasibility of FES-induced muscular control of the hemiplegic knee joint in order to improve stance phase support symmetry recovery in individuals with post stroke hemiplegia. Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb based on the real-time estimation of the knee angle and support phase.

lead_sponsor: Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie

location_facility: Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie


title: COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.

acronym: COVID-OLD

summary: This study propose to describe risk factors for acute and long term mortality of COVID 19 in patients up to 70 years old.

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

ReferenceCitation: Gavazzi G, Krause KH. Ageing and infection. Lancet Infect Dis. 2002 Nov;2(11):659-66. Review.

ReferenceCitation: High KP, Bradley S, Loeb M, Palmer R, Quagliarello V, Yoshikawa T. A new paradigm for clinical investigation of infectious syndromes in older adults: assessment of functional status as a risk factor and outcome measure. Clin Infect Dis. 2005 Jan 1;40(1):114-22. Epub 2004 Dec 6.

ReferenceCitation: Seynaeve D, Augusseau-Rivière B, Couturier P, Morel-Baccard C, Landelle C, Bosson JL, Gavazzi G, Mallaret MR. Outbreak of Human Metapneumovirus in a Nursing Home: A Clinical Perspective. J Am Med Dir Assoc. 2020 Jan;21(1):104-109.e1. doi: 10.1016/j.jamda.2019.03.015. Epub 2019 May 14.

ReferenceCitation: Caupenne A, Ingrand P, Ingrand I, Forestier E, Roubaud-Baudron C, Gavazzi G, Paccalin M. Acute Clostridioides difficile Infection in Hospitalized Persons Aged 75 and Older: 30-Day Prognosis and Risk Factors for Mortality. J Am Med Dir Assoc. 2020 Jan;21(1):110-114. doi: 10.1016/j.jamda.2019.07.002. Epub 2019 Sep 17.

ReferenceCitation: Gavazzi G, Paccalin M, de Wazieres B, Roubaud-Baudron C, Fraisse T, Bernard L, Legout L, Aquino JP, Guerin O, Forestier E, Burden of influenza in older patients over the 2016-2017 winter season in France. XXIXth ECCMID Amsterdam. (Nethderland) 2019

lead_sponsor: University Hospital, Grenoble


title: Transpulmonary Driving Pressure in ARDS COVID19 Patients / TRANSPULMONARY-COVID19

acronym: TRANSPULMONARY

summary: A majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed an acute respiratory distress syndrome (ARDS) according to BERLIN criteria. Gattinoni et al. recently described that the ARDS related to SARS-CoV-2 was not a "Typical" ARDS. Patients affected by this infection present indeed a major hypoxemia, which was surprisingly associated in early phase with a high compliance of respiratory system, more than 50 ml/cm H2O in most cases. The cornerstone of current treatment in case of ARDS is the use of "lung protective" ventilation, including limited tidal volumes (VT), low end-inspiratory plateau pressures while maintaining sufficiently-high positive end-expiratory pressures (PEEP). However, high levels of PEEP in patients may have detrimental effects on hemodynamic status and fluid retention, particularly when the respiratory system compliance is normal. High PEEP may also lead to overdistension and an increase of alveolar dead space. The airway pressures commonly monitored does not reliably reflect the impact of pressures on the lung parenchyma. Elastance of chest wall may indeed largely influence values of airways pressions. In contrast, transpulmonary pressure obtained using esophageal pressure (Pes) directly reflect lung overdistension risk and lung properties. In order to better understand this new kind of ARDS characterized by modest recruitable profile and to better personalize mechanical ventilation setting and therapy it is obvious to precise transpulmonary pressure.

lead_sponsor: University Hospital, Montpellier


title: Prevalence of Periodontal Diseases in Inflammatory Bowel Diseases : a Pilot-study

acronym: MICIMaP

summary: Periodontal diseases are highly prevalent inflammatory diseases. It is now well known that they are correlated with numerous systemic diseases as : diabetes, chronic obstructive pulmonary disease, metabolic syndrome or rheumatoid arthritis. Recently, periodontal diseases have been correlated with inflammatory bowel diseases (IBD). IBD include two types, Crohn's disease and Ulcerative Colitis. It could be a significant risk factor for the pathogenesis of periodontal disease. These diseases present common features : a high prevalence worldwide, multifactorial pathogenies with common mechanisms. To date, no study has linked activity of IBD and periodontal diseases. The authors hypotheses that the prevalence of periodontal diseases could be increased in patient presenting an active IBD

lead_sponsor: CHU de Reims


title: RRisk Factors Worsening COVID19 (Coronavirus Infectious Disease 2019) for Outpatient With Home Monitoring (COVID-A-DOMEVA Study)

acronym: COVIDADOMEVA

summary:
The main objective of the COVIDADOMEVA study is to identify the risk factors aggravating the COVID-19 (risk or protective factors), in out-patients suspected of being infected with precocious home monitoring.

The primary event defining the aggravation will be then: hospitalization (medicine, resuscitation) or death.

The studied potential risk factors will be mainly:

Socio-demographic: age, sex, place of residence or income
Comorbidities
Clinical signs: asthenia, dyspnea (kinetics)…
Drugs other than those related to the infection

For this research project, this study needs to use the patient's data of the COVIDADOM cohort (patients suspected of being infected with SARS-CoV-2 with home monitoring) and will collect some supplementary data (clinical and biological). All these data will be integrated and analyzed in the PREDIMED clinical data lake platform (The implementation of PREDIMED has been approved by the French authority in terms of GDPR, CNIL, on October 10, 2019).

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ReferenceCitation: Fang L, Karakiulakis G, Roth M. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? Lancet Respir Med. 2020 Apr;8(4):e21. doi: 10.1016/S2213-2600(20)30116-8. Epub 2020 Mar 11. Erratum in: Lancet Respir Med. 2020 Jun;8(6):e54.

ReferenceCitation: OMS. Soins à domicile pour les patients COVID-19 qui présentent des symptômes bénins, et prise en charge de leurs contacts. Lignes directrices provisoires, 17 mars 2020 (5pages). WHO reference number : WHO/2019-nCoV/IPC/HomeCare/2020.3

ReferenceCitation: Jordan RE, Adab P, Cheng KK. Covid-19: risk factors for severe disease and death. BMJ. 2020 Mar 26;368:m1198. doi: 10.1136/bmj.m1198.


title: Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS

acronym: TECH-ICOPA

summary:
"Brain-computer interfaces (BCIs) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. BCIs represent a very active and promising field of research among devices for people with severe motor disabilities. As the currently available systems correspond to research prototypes, they are not adapted to daily live situations. On the other hand, some systems have recently been commercialized, principally for video games but they are not satisfactory for use as a substitute technology in disability.

A BCI's prototype for alternative communication using a virtual keyboard, the P300 Speller, has been developed by the National Institute for Research in Digital Science and Technology (Athena team - Nice University). This prototype includes an EEG-cap with gel based active electrodes. A recent study conducted on 20 patients with ALS (University Hospital, Nice) demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility. To achieve a system that can be used in daily live in severely disabled patients, technical developments are necessary.

The investigators have conceptualized and developed an ergonomic, comfortable, headset, including dry electrodes to allow a prolonged use of the system.

The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved. This study is a monocentric usability study conducted on ALS people.

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children

acronym: CALIN

summary:
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.

Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.

Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.

intervention_type: Behavioral


title: Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19

acronym: CovRep

summary:
The specificity of the adaptive immune response (AIR), and its balance between effector T cells (Teffs) and regulatory T cells (Tregs), is most likely a major determinant of the outcome of a Covid-19 infection.

We aim to analyze (i) the cellular components and (ii) the specificity of the AIR to COVID-19 in 60 patients with moderate and severe form of the disease. This should have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.


title: Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by (SARS-CoV-2): Predictive Interest in Short-term Evolution

acronym: VOC-COVID

summary: The study of volatile organic compounds (VOCs) detected in exhaled air is an innovative research area for respiratory diseases. This analysis can be done by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOCs without identifying them. The VOCs in exhaled air in patients hospitalized for COVID-19 infection are analysed in this study, using electronic noses.

lead_sponsor: Hopital Foch


title: Comparison of 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents

summary:
Attention Deficit Disorder with or without Hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic.

The investigator will performed a controlled and randomized research to compare the effects of two neurofeedback protocols on the repercussions of Attention Deficit AD / Hyperactivity Disorder (HD) symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux pédiatriques de Nice CHU Lenval


title: Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area

acronym: HACSA

summary:
While international guidelines have indicated that use of a routine invasive strategy was favored for high-risk patients with NSTE-ACS and for all STE- ACS, the lower risk patients successfully reperfused and carrefully selected may perhaps not benefit of this systematic strategy. Evaluation of complications occurring in a contemporary population of ACS may help to evaluate the need of ICU strategy. Coupled with favorable outcomes in many patients, these data may be an opportunity for testing of strategies to refine triage to less costly hospital care units. The investigators thus want to compare, through an observational and prospective study, the event rate of two groups of patients with ACS admitted to ICU . Patients are classified as "high risk" and "low risk" according to specific medical criteria validated in the literature. The study will include all consecutive patients admitted for NSTACS and STACS admitted to the intensive care department of the Montpellier university hospital with the diagnosis of ACS confirmed by coronary angiography.

Our primary goal is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, painful recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason.

Our hypothesis is that low-risk patients will have very few events and no fatal events and that they could not require intensive care unit admission .


title: Assessment of Orality Disorders in Children With Food Allergies

acronym: ALLERGORAL

summary:
Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.

The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Angers


title: Impact of a Strategy Combining Morphine Savings and a Loco-regional Anesthesia Technique on the Quality of Post-operative Rehabilitation of Cesareans Performed Under Peri-spinal Anesthesia

acronym: REHACESAR

summary:
The aim of REHACESAR is to study the impact of an association of a low dose of neuraxial morphine and a locoregional anesthesia (TAP block or catheter for continuous wound infiltration) on quality of recovery after cesarean delivery under regional anesthesia.

To assess the quality of recovery, women complete the self-questionnaire Quality Of Recovery (QOR)15 on D-1 (the day before cesarean, if elective), D+1, +2 and +3 after surgery.

The QOR-15 is a 15 items questionnaire which provides a valid and efficient evaluation of the postoperative quality of recovery.

REHACESAR is a prospective observational study. It takes place in the maternity of the CHR Metz-Thionville hospital.

status: Terminated

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis Context.

acronym: ROSA

summary: The recent studies suggest that secretions from medullary adipocytes are involved in the mechanisms of bone loss in osteoporosis (OP) through their actions on neighbouring osteoforming cells, the osteoblasts. The objective of the research is the development of new cellular models representing the aging skeleton to confirm this hypothesis. To this end, osteoblasts will be isolated from human bone fragments coming from femoral heads discarded during total hip replacement surgery. The osteoblastic response to secreted factors released from medullary adipocytes of commercial origin will be analysed using conditioned media incubations. This phenotypic response will be quantified for each subject through the analysis of gene expression levels. Inter-subject phenotype variations will be related to bone density and microarchitecture data obtained by X-ray microtomography. This will assess the existence of a correlation between the osteoblast response to adipocyte secretions and the degree of osteoporosis of the subject from whom the cells are derived.


title: Evaluation of the Improvement of Pigmented Skin Lesions in Patients With Mastocytosis After Performing 2 Sessions of Pigment Laser : Pilot Study Conducted at a Reference Centre Mastocytoses (LaserMasto)

acronym: LaserMasto

summary:
Cutaneous mastocytosis can be isolated or associated with systemic involvement. Urticaria pigmentosa affects around 80 to 85% of adult patients with cutaneous mastocytosis. It is also frequently present in patients with mastocytosis associated with systemic involvement (80% of patients in our experience).

This skin damage is one of the causes of deterioration in quality of life in patients with mastocytosis, through the loss of self-esteem, due to the appearance of lesions. However there are not treatment for urticaria pigmentosa.

Skin involvement in mastocytosis is linked to the accumulation of abnormal mast cells in the dermis. However, the mast cells are not pigmented and the brown-brown color characteristic of Urticaria pigmentosa is explained by melanin pigmentation of the epidermal basal layer.

lead_sponsor: University Hospital, Toulouse

location_facility: Larrey Hospital - Toulouse University Hospital


title: Developement and Evaluation of Serological Assays for COVID-19

acronym: SEROCOV

summary: The primary objective of the study aims to evaluate serological assays of virus Covid-19.

location_facility: Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP


title: Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

summary:
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components.

Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis.

Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19.

Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.


title: Computerized Facial Recognition for Automated Diagnosis of the Facio-Scapulo-Humeral Muscular Dystrophy (FSMHD): Pilot Study

summary:
The clinical diagnosis of Facio-Scapulo-Humeral Muscular Dystrophy (FSHMD) requires the movement of patients to a medical centre and a lengthy examination involving medical personnel, and may be underestimated in the most moderate cases. Thus, it requires costly and burdensome logistics both for patients living in remote areas and having to undertake long and expensive travel, and for clinical staff. This is an obstacle to large-scale diagnosis. The investigators plan to alleviate these limitations through the use of digital facial analysis technology that would enable large-scale diagnosis of patients through telemedicine.

Motivated by the reasons described above and by preliminary results, the goal of this project is to develop methods to automatically detect and monitor the progression of this disease using computer vision algorithms. In order to do this, the investigators will first build up a bank of images and videos of patients with moderate to severe FSHMD, patients with other muscular dystrophies causing facial muscle asymmetry, as well as control subjects without facial involvement. Each of these subjects will be characterized clinically and genetically.

The investigators will then develop computer tools using video and audio sensors capable of detecting facial muscle damage in patients with FSHMD and differentiating them from control subjects on the one hand and patients with other muscular dystrophies on the other hand. The investigators wish to use the most recent advances in terms of "deep-learning" and improve their architecture in order to achieve our objectives.

In addition to this holistic approach, the investigators will study facial recognition approaches capable of accurately identifying different facial areas on images, as well as the relevance of different statistical properties of facial dynamics (duration and intensity). These algorithms will also be useful for monitoring the evolution of facial damage in order to develop a specific measurement tool that could be used in patient follow-up and in clinical trials on early stages of the disease.


title: Assessment of Extra Vascular Lung Water and Pulmonary Permeability by Transpulmonary Thermodilution in Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

acronym: PiCCOVID

summary:
Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury with alteration of biomechanics (lower respiratory system compliance) mostly associated with increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI) accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS patients, as suggested by expert's recommendations, using a transpulmonary thermodilution (TPTD) technique.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for the definition of ARDS. However, many of these patients have a particular form of ARDS with severe hypoxemia often associated with near normal respiratory system compliance. This combination is almost never seen in severe ARDS. Thus other mechanisms (including probably vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2.

EVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The aim of this study is to evaluate these two parameters in order to best characterize and understand the mechanisms related to SARS-CoV-2.

Based on observation of several cases in intensive care units (ICU), the investigators hypothesize that there are following different SARS-CoV-2 patterns:

Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI.
Low compliance due to increased edema, high lung recruitability, high EVLW and high PVPI.


title: Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia

summary:
Studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, SARS-CoV and Middle East respiratory syndrome coronavirus, MERS-CoV) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions.

Patients with SARS-CoV pneumonia had fibrotic pulmonary sequelae at 45 days (lower DLCO in 27.3% of cases and radiological lesions in 21.5% of cases). In the MERS-CoV pneumonia study, patients had radiological sequelae in 33% of cases and the 12-month evaluation showed persistence of radiological abnormalities in 23.7% of the cases despite an improvement in respiratory function.

Clinical presentation and therapeutic management of severe SARS-CoV-2 infection are in part similar to those induced by SARS-CoV and MERS-CoV. Long-term respiratory complications are therefore expected.

ReferenceCitation: Perotin JM, Gierski F, Bolko L, Dury S, Barrière S, Launois C, Dewolf M, Chouabe S, Bongrain E, Picard D, Tran E, N'Guyen Y, Mourvillier B, Servettaz A, Rapin A, Marcus C, Lebargy F, Kaladjian A, Salmon JH, Deslee G. Cluster analysis unveils a severe persistent respiratory impairment phenotype 3-months after severe COVID-19. Respir Res. 2022 Aug 2;23(1):199. doi: 10.1186/s12931-022-02111-9.