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

acronym: CRYPTENV

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

sponsor_collaborators:
University Hospital, Montpellier
University Hospital, Bordeaux


type: Other Identifier

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

acronym: BIOCOVU

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

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

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

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Lille

lead_sponsor_type: academique

status_simplified: Unknown


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

acronym: FORMES

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

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

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Supportive Care

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Awatani T, Morikita I, Shinohara J, Mori S, Nariai M, Tatsumi Y, Nagata A, Koshiba H. Intra- and inter-rater reliability of isometric shoulder extensor and internal rotator strength measurements performed using a hand-held dynamometer. J Phys Ther Sci. 2016 Nov;28(11):3054-3059. doi: 10.1589/jpts.28.3054. Epub 2016 Nov 29.

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

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in publication

lead_sponsor: University Hospital, Brest

intervention_type: Other

status_simplified: Completed


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

acronym: ECHO

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

design_allocation: Randomized

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens


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

acronym: CORIMUNO-ANA

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

primary_purpose: Treatment

ReferenceType: derived

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

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris

intervention_type: Drug


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

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

time_perspective: Cross-Sectional

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

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

version: acceptedVersion

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

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre de l'arthrose, Paris

lead_sponsor_type: industriel


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

acronym: ONCOVID

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

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

design_allocation: Non-Randomized

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


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

acronym: COVID-SER

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

status: Recruiting

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

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: Hospices Civils de Lyon

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

intervention_type: Diagnostic Test

status_simplified: Ongoing


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

acronym: CHC/CC

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

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Serviec hépatologie-Hôpital Saint Antoine


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

acronym: ACTIF-PARK

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

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

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

primary_purpose: Other


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

acronym: Epi-TVMS

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

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

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

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

lead_sponsor: Nantes University Hospital


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

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

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

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

Ct Scan performance will be recorded and analyzed.

time_perspective: Retrospective

lead_sponsor: Poitiers University Hospital


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

acronym: CRYOMUNE

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

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

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

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

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

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

lead_sponsor: Institut Bergonié

intervention_type: Device

appel_a_projets: PHRCK

region: Nouvelle-Aquitaine

nom_etablissement: INSTITUT BERGONIE

type_etablissement: CLCC

acronyme: CRYOMUNE

titre: CRYOMUNE-Cryoablation en association (ou non) avec pembrolizumab et pemetrexed-carboplatine en première ligne de traitement chez des patients atteints d'un adénocarcinome bronchique métastatique : étude randomisée de phase III

discipline_principale: cancer

nom_porteur: PALUSSIERE

prenom_porteur: Jean


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

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

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


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

acronym: NMDARE-HSE

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

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

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


title: Impact of the Profession on Parenthood

acronym: MEDparenting

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

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

lead_sponsor: University Hospital, Clermont-Ferrand


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

acronym: MICROPROTECT

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

ReferenceCitation: Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.

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

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

ReferenceCitation: Clarkson P, Celermajer DS, Powe AJ, Donald AE, Henry RM, Deanfield JE. Endothelium-dependent dilatation is impaired in young healthy subjects with a family history of premature coronary disease. Circulation. 1997 Nov 18;96(10):3378-83. doi: 10.1161/01.cir.96.10.3378.

ReferenceCitation: Suwaidi JA, Hamasaki S, Higano ST, Nishimura RA, Holmes DR Jr, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation. 2000 Mar 7;101(9):948-54. doi: 10.1161/01.cir.101.9.948.

ReferenceCitation: Schachinger V, Britten MB, Zeiher AM. Prognostic impact of coronary vasodilator dysfunction on adverse long-term outcome of coronary heart disease. Circulation. 2000 Apr 25;101(16):1899-906. doi: 10.1161/01.cir.101.16.1899.

ReferenceCitation: Halcox JP, Schenke WH, Zalos G, Mincemoyer R, Prasad A, Waclawiw MA, Nour KR, Quyyumi AA. Prognostic value of coronary vascular endothelial dysfunction. Circulation. 2002 Aug 6;106(6):653-8. doi: 10.1161/01.cir.0000025404.78001.d8.

ReferenceCitation: Bugiardini R, Manfrini O, Pizzi C, Fontana F, Morgagni G. Endothelial function predicts future development of coronary artery disease: a study of women with chest pain and normal coronary angiograms. Circulation. 2004 Jun 1;109(21):2518-23. doi: 10.1161/01.CIR.0000128208.22378.E3. Epub 2004 May 10.

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

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

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

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

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

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

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

ReferenceCitation: Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WMM, Vlachopoulos C, Wood DA, Zamorano JL, Cooney MT; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058. doi: 10.1093/eurheartj/ehw272. Epub 2016 Aug 27. No abstract available.

ReferenceCitation: Ricchiuti V, Shear WS, Henry TD, Paulsen PR, Miller EA, Apple FS. Monitoring plasma cardiac troponin I for the detection of myocardial injury after percutaneous transluminal coronary angioplasty. Clin Chim Acta. 2000 Dec;302(1-2):161-70. doi: 10.1016/s0009-8981(00)00365-x.

ReferenceCitation: Landmesser U, Chapman MJ, Stock JK, Amarenco P, Belch JJF, Boren J, Farnier M, Ference BA, Gielen S, Graham I, Grobbee DE, Hovingh GK, Luscher TF, Piepoli MF, Ray KK, Stroes ES, Wiklund O, Windecker S, Zamorano JL, Pinto F, Tokgozoglu L, Bax JJ, Catapano AL. 2017 Update of ESC/EAS Task Force on practical clinical guidance for proprotein convertase subtilisin/kexin type 9 inhibition in patients with atherosclerotic cardiovascular disease or in familial hypercholesterolaemia. Eur Heart J. 2018 Apr 7;39(14):1131-1143. doi: 10.1093/eurheartj/ehx549. No abstract available.

ReferenceCitation: Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.

ReferenceCitation: Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23. Erratum In: Circulation. 2003 Dec 23;108(25):3165.

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

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

lead_sponsor: University Hospital, Grenoble


title: Dynamic Evaluation of COVID-19 Diagnostic Tests

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

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

lead_sponsor: Tourcoing Hospital


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

acronym: PiCCOVID

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

ReferenceCitation: Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. Erratum In: Nature. 2020 Dec;588(7836):E6.

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

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

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

license: unspecified-oa

license_normalized: unspecified-oa

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

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

ReferenceCitation: Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available. Erratum In: Intensive Care Med. 2020 Apr 6;:

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

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Schuster DP. The search for "objective" criteria of ARDS. Intensive Care Med. 2007 Mar;33(3):400-2. doi: 10.1007/s00134-006-0499-5. Epub 2007 Jan 13. No abstract available.

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

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

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes


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

acronym: NephroG

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

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

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

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

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


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

acronym: EasyCoV

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

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

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

lead_sponsor: University Hospital, Montpellier

collaborators: CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier


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

acronym: DECONTA

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

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

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

intervention_type: Biological


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

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

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

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

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

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

lead_sponsor: University Hospital, Angers


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

acronym: Tomo-PENG

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

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

ipd_sharing_description: In accordance with future institutional decisions

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Renin Angiotensin System - CoronaVirus

acronym: SRA-COV

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

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

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE


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

acronym: VECUCHIR

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

ReferenceCitation: Carr EC, Nicky Thomas V, Wilson-Barnet J. Patient experiences of anxiety, depression and acute pain after surgery: a longitudinal perspective. Int J Nurs Stud. 2005 Jul;42(5):521-30. doi: 10.1016/j.ijnurstu.2004.09.014. Epub 2004 Nov 25.

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

ReferenceCitation: Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.

ReferenceCitation: Reddi D, Curran N. Chronic pain after surgery: pathophysiology, risk factors and prevention. Postgrad Med J. 2014 Apr;90(1062):222-7; quiz 226. doi: 10.1136/postgradmedj-2013-132215. Epub 2014 Feb 26.

ReferenceCitation: Kain ZN, Sevarino FB, Rinder C, Pincus S, Alexander GM, Ivy M, Heninger G. Preoperative anxiolysis and postoperative recovery in women undergoing abdominal hysterectomy. Anesthesiology. 2001 Mar;94(3):415-22. doi: 10.1097/00000542-200103000-00009.

ReferenceCitation: Gaudry E, Vagg P, Spielberger CD. Validation of the State-Trait Distinction in Anxiety Research. Multivariate Behav Res. 1975 Jul 1;10(3):331-41. doi: 10.1207/s15327906mbr1003_6.

ReferenceCitation: Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.

ReferenceCitation: Lee EH, Klassen AF, Cano SJ, Nehal KS, Pusic AL. FACE-Q Skin Cancer Module for measuring patient-reported outcomes following facial skin cancer surgery. Br J Dermatol. 2018 Jul;179(1):88-94. doi: 10.1111/bjd.16671. Epub 2018 May 23.

ReferenceCitation: Lee EH, Klassen AF, Nehal KS, Cano SJ, Waters J, Pusic AL. A systematic review of patient-reported outcome instruments of nonmelanoma skin cancer in the dermatologic population. J Am Acad Dermatol. 2013 Aug;69(2):e59-67. doi: 10.1016/j.jaad.2012.09.017. Epub 2012 Oct 24.

ReferenceCitation: Chernyshov PV, Lallas A, Tomas-Aragones L, Arenbergerova M, Samimi M, Manolache L, Svensson A, Marron SE, Sampogna F, Spillekom-vanKoulil S, Bewley A, Forsea AM, Jemec GB, Szepietowski JC, Augustin M, Finlay AY. Quality of life measurement in skin cancer patients: literature review and position paper of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient Oriented Outcomes, Melanoma and Non-Melanoma Skin Cancer. J Eur Acad Dermatol Venereol. 2019 May;33(5):816-827. doi: 10.1111/jdv.15487. Epub 2019 Apr 8.

ReferenceCitation: Rhee JS, Matthews BA, Neuburg M, Smith TL, Burzynski M, Nattinger AB. Skin cancer and quality of life: assessment with the Dermatology Life Quality Index. Dermatol Surg. 2004 Apr;30(4 Pt 1):525-9. doi: 10.1111/j.1524-4725.2004.30169.x.

ReferenceCitation: van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.

lead_sponsor: University Hospital, Bordeaux


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

acronym: DELIRLESS

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

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

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

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

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

This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms:

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

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

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

primary_purpose: Prevention

ReferenceCitation: Sigaut S, Couffignal C, Esposito-Farese M, Degos V, Molliex S, Boddaert J, Raynaud-Simon A, Durand-Zaleski I, Marcault E, Jacota M, Dahmani S, Paugam-Burtz C, Weiss E. Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Dec 24;11(12):e053908. doi: 10.1136/bmjopen-2021-053908.

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

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: DELIRLESS

titre: Prévention du délirium post-opératoire par la mélatonine après chirurgie pour fracture du membre inférieur chez les patients âgés : un essai contrôlé randomisé

discipline_principale: anesthesiology / resuscitation

nom_porteur: PAUGAM-BURTZ

prenom_porteur: Catherine


title: Characterization of the Postural Habits of Wheelchair Users in an Ecological Situation and Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor Integrating an Artificial Intelligence Algorithm

acronym: Es-Alert

summary:
Spinal cord injuries and people with Duchenne Muscular Dystrophy or Infant Spinal Muscular Atrophy (ISA) are prone to pain and pressure sores associated with prolonged sitting. For this reason, it is recommended that people with spinal cord injuries release pressure every 15 to 30 minutes and motorized wheelchair users use the electric positioning functions at least 1 minute every hour.

The aim is to prevent and/or reduce pain and pressure sores. These devices could help to observe daily the variability of users' pressure maps, their impact on occupational performance, the link with pain and redness and could propose customized adjustments.

ReferenceType: result

ReferenceCitation: Drummond D, Breed AL, Narechania R. Relationship of spine deformity and pelvic obliquity on sitting pressure distributions and decubitus ulceration. J Pediatr Orthop. 1985 Jul-Aug;5(4):396-402. doi: 10.1097/01241398-198507000-00002.

ReferenceCitation: Gawlitta D, Li W, Oomens CW, Baaijens FP, Bader DL, Bouten CV. The relative contributions of compression and hypoxia to development of muscle tissue damage: an in vitro study. Ann Biomed Eng. 2007 Feb;35(2):273-84. doi: 10.1007/s10439-006-9222-5. Epub 2006 Nov 29.

ReferenceCitation: Sprigle S, Maurer C, Holowka M. Development of valid and reliable measures of postural stability. J Spinal Cord Med. 2007;30(1):40-9. doi: 10.1080/10790268.2007.11753913.


title: Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies From B Lymphocytes of Patients Who Have Been Followed for Infection or Colonization With Pseudomonas Aeruginosa: a Prospective Monocentric Trial

acronym: ABAC-IBS

summary:
Pseudomonas aeruginosa is a pathogenic bacteria for human, especially in hospital settings. It can sometimes be multi-resistant to many or even to all antibiotics usually used for its treatment.

The aim of the study is to isolate and produce therapeutic antibodies against the bacteria Pseudomonas aeruginosa in order to provide an alternative treatment to antibiotics in case of infection with an antibiotic-resistant strain of Pseudomonas aeruginosa.

ReferenceCitation: DiGiandomenico A, Sellman BR. Antibacterial monoclonal antibodies: the next generation? Curr Opin Microbiol. 2015 Oct;27:78-85. doi: 10.1016/j.mib.2015.07.014. Epub 2015 Aug 25.

ReferenceCitation: Czaplewski L, Bax R, Clokie M, Dawson M, Fairhead H, Fischetti VA, Foster S, Gilmore BF, Hancock RE, Harper D, Henderson IR, Hilpert K, Jones BV, Kadioglu A, Knowles D, Olafsdottir S, Payne D, Projan S, Shaunak S, Silverman J, Thomas CM, Trust TJ, Warn P, Rex JH. Alternatives to antibiotics-a pipeline portfolio review. Lancet Infect Dis. 2016 Feb;16(2):239-51. doi: 10.1016/S1473-3099(15)00466-1. Epub 2016 Jan 13.

ReferenceCitation: Rappuoli R, Bottomley MJ, D'Oro U, Finco O, De Gregorio E. Reverse vaccinology 2.0: Human immunology instructs vaccine antigen design. J Exp Med. 2016 Apr 4;213(4):469-81. doi: 10.1084/jem.20151960. Epub 2016 Mar 28.

ReferenceCitation: Walker LM, Huber M, Doores KJ, Falkowska E, Pejchal R, Julien JP, Wang SK, Ramos A, Chan-Hui PY, Moyle M, Mitcham JL, Hammond PW, Olsen OA, Phung P, Fling S, Wong CH, Phogat S, Wrin T, Simek MD; Protocol G Principal Investigators; Koff WC, Wilson IA, Burton DR, Poignard P. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature. 2011 Sep 22;477(7365):466-70. doi: 10.1038/nature10373.

ReferenceCitation: Holzlohner P, Hanack K. Generation of Murine Monoclonal Antibodies by Hybridoma Technology. J Vis Exp. 2017 Jan 2;(119):54832. doi: 10.3791/54832.


title: 1- Year Follow-up After TAVR Performed Without Systematic Intensive Care Unit Admission

acronym: TAVICU

summary:
Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those > 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown.

Objective:

The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI.

Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those > 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown.

Objective:

The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI.

ipd_sharing_description: NC


title: Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +

acronym: eChoVid

summary:
The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients [1-2]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose [2-5].

The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1.

The secondary objectives are:

Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations.
Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator.
Evaluate in suspected or COVID-19 patients, the risk of clinical worsening based on pulmonary ultrasound abnormalities during follow-up of hospitalized patients.
Evaluate the ultrasound evolution profiles of pulmonary lesions in patients whose clinical evolution is favorable.
Evaluate the incidence of thromboembolic events in patients who worsen secondarily.

ReferenceCitation: The recommendations of the French Radiology Society in the context of COVID-19 [Internet]. [cited 2020 Apr 1]. Available from: http://www.thema-radiologie.fr/actualites/2618/les-recommandations-de-la-societe-francaise-de-radiologie-dans-un-contexte-de-covid-19.html

ReferenceCitation: WHO | Disease Commodity Packages [Internet]. [cited 2020 Apr 1]. Available from: https://www.who.int/emergencies/what-we-do/prevention-readiness/disease-commodity-packages/en/

ReferenceCitation: Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.

ReferenceCitation: Poggiali E, Dacrema A, Bastoni D, Tinelli V, Demichele E, Mateo Ramos P, Marciano T, Silva M, Vercelli A, Magnacavallo A. Can Lung US Help Critical Care Clinicians in the Early Diagnosis of Novel Coronavirus (COVID-19) Pneumonia? Radiology. 2020 Jun;295(3):E6. doi: 10.1148/radiol.2020200847. Epub 2020 Mar 13. No abstract available.

ReferenceCitation: Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.


acronym: MultiCov

intervention_type: Procedure

summary:
The novel coronavirus SARS-CoV-2 (COVID-19) is an emerging respiratory virus that causes pneumonia. WHO data reported admission to the intensive care unit (ICU) for 6% of patients, with a mortality rate reaching 45%. To date, apart from therapeutic trials, ICU management is symptomatic, based on organ failure support therapies. In the initial phase, the therapeutic management also includes empiric antimicrobial therapy (90% of patients, in accordance with LRTI guidelines (ATS 2019) and SRLF Guidelines (2020). One challenge for the ICU physicians is the timing for discontinuation of antimicrobial treatment, especially in case of shock or ARDS, considering that a substantial proportion of COVID-19 pneumonia patients may have pulmonary bacterial coinfection/superinfection. In order to avoid unnecessary prolonged antimicrobial therapy, and subsequent selective pressure, two tests could be combined in a personalized antibiotic strategy:

Procalcitonin (PCT): PCT is a useful tool to guide antibiotics discontinuation in community-acquired pneumonia) and viral pneumonia (PMID24612487).
Respiratory multiplex PCR FA-PPP (Biomérieux®): panel has been enlarged, including 8 viruses and 18 bacteria (quantitative analysis). The turnaround time is short. Sensitivity is high (99%, PMID32179139). It may contribute, in combination with conventional tests, to accelerate and improve the microbiological diagnosis during severe COVID-19 pneumonia.

The hypothesize of the study is that the combination of the mPCR FA-PPP and PCT could be used to reduce antibiotics exposure in patients with severe confirmed COVID-19 pneumonia, with a higher clinical efficacy and safety as compared with a conventional strategy.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
BioMérieux

location_facility: Intensive care department-Hospital Tenon

title: Use of a Respiratory Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Patients With Severe Confirmed COVID-19 Pneumonia : a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial

type: EudraCT Number

source: euctr


title: Biomarkers Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events

acronym: JOBSTRESS

summary:
Emergency medicine is a unique specialty focusing on a breadth of acute care, on demand . Shift work is also a fundamental component of emergency medicine, and is associated with chronic stress, including stress at work. Consequently, stress may lead to symptoms of mental exhaustion, physical fatigue, detachment from work, and feelings of diminished competence . Emergency physicians (EPs) are exposed to a complex interplay between stress (life-and-death emergencies - a defining characteristic of their job), sleep deprivation, and fatigue due to repeated changes in, and duration of shifts. Work-related exhaustion can lead to various physical and psychological symptoms, and also may be associated with delayed decision-making . The combined effects of stress and fatigue can impact on job performance, often resulting in otherwise preventable medical errors. Moreover, prolonged stress may expose EPs to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease. All these contribute to the premature departure of EPs to other specialties. Furthermore, low HRV has been associated with stress, burnout, and is linked with an increased risk of cardiovascular diseases.

This project proposes to evaluate if life-and-death emergencies or specific situations will induce abrupt changes in HRV among emergency physicians. Moreover, we would like to compare reactions between being an actor (EPs) and being a spectator and assess the role of expertise and habituation to stressful emergency situations.

primary_purpose: Screening

intervention_type: Behavioral


title: Deployment o the Multidisciplinary Prospective Cohort Imminent

acronym: IMMINeNT

summary:
Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions.

Beyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as "targeted therapies". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment.

These similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.

lead_sponsor: University Hospital, Lille

collaborators: FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs

collaborators: Fond de dotation de la Société Française de Dermatologie (SFD)


title: Telephony Or Videophony for Isolated elDerly in Maine-Et-Loire 49 During COVID-19

summary:
The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for these fragile populations. The only source of residual social ties during a period of confinement remains dematerialised communication via the various existing communication channels (in particular telephone calls or video telephony).

As soon as the COVID-19 crisis began and the first visiting restrictions were imposed on patients in the geriatric department of the Angers Univesity Hospital and the Retirement Home / long-term care unit, acute care geriatric unit of Angers offered patients and residents the opportunity to organize communication with their relatives via videophone calls. Initial feedback from the field shows us that, contrary to our intuition, patients and residents are not necessarily asking for communication to the outside world and, when they are, the preferred channel is not necessarily video telephony but often a simple phone call with relatives. Even though the vast majority of projects aimed at setting up communication aids for the elderly now rely on videophonic support, these initial observations in everyday care situations raise questions about the directions taken in this area. Also, the investigators ask themselves the following question: in the absence of a physical meeting, what is the preferred means of communication for elderly people in isolation in hospital or in Retirement Home? This study will make it possible to propose the most appropriate solutions for breaking isolation for the hospitalized or institutionalized geriatric population in order to limit as much as possible the increase in social isolation imposed by restrictions on movement during epidemics.

ReferenceCitation: Sacco G, Lleonart S, Simon R, Noublanche F, Annweiler C; TOVID Study Group. Communication Technology Preferences of Hospitalized and Institutionalized Frail Older Adults During COVID-19 Confinement: Cross-Sectional Survey Study. JMIR Mhealth Uhealth. 2020 Sep 18;8(9):e21845. doi: 10.2196/21845.

version: submittedVersion

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

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

publisher_dissemination: JMIR Publications


title: Percutaneous Radiofrequency Ablation of Parietal Endometriosis : a Pilot Study (PRFA)

acronym: PRFA

summary:
Parietal endometriosis is the implantation of endometrial tissue in abdominal structures more superficial than the peritoneum. It is a rare form of the disease (incidence estimated between 0.04 and 12% among women operated on for endometriosis depending on the series) but is classically resistant to medical treatment and can be disabling. Surgical resection is currently the reference treatment in the event of failure of hormonal treatment, despite the sometimes significant skin scars and the risk of parietal fragility that may require a cure of venting by parietal prosthesis. The recurrence rate after surgical resection is 4.3%. The use of radiofrequency for therapeutic purposes is nowadays described in multiple applications such as cardiac arrhythmia, neurological and spinal disorders, as well as for the treatment of liver, kidney, prostate, breast, lung or skin cancers. Its use has already been reported in the field of benign gynecology with, in particular, demonstrated efficacy in the treatment of uterine fibroids by laparoscopic, trans-vaginal or percutaneous means. There are also large published series on radiofrequency for the treatment of adenomyosis, by the transvaginal and laparoscopic route.

In the context of parietal endometriosis, this would be a minimally invasive, percutaneous treatment. Ultrasound guidance allowing good targeting of the lesions and the procedure would most often be carried out on an outpatient basis and under local anaesthesia. And in case of failure or partial effectiveness, the reference treatment would remain accessible for these patients.

There is only one published case of the use of radiofrequency in parietal endometriosis (case reports). Despite results that seem encouraging in terms of a rapid and prolonged therapeutic effect on symptoms, no further cases or series have been published since.

Our study aims to investigate the feasibility of percutaneous radiofrequency treatment for parietal endometriosis, with the secondary objective of evaluating the safety, efficacy and risk factors for failure of the technique.

10 patients will be treated. For follow-up all patients will have an ultrasound and MRI before treatment, then an ultrasound at 1 month, 3 months and 6 months post-treatment and a second MRI at 6 months post-treatment. The investigators will also evaluate pain and quality of life with specific questionnaires at each visit.

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: Role of the Protozoa Cryptosporidium in the Development of Colorectal Cancer in Humans

acronym: Crypto-K

summary: It has been reported that Cryptosporidium parvum, a species of a protozoan frequently isolated from humans and animals, is able to induce digestive adenocarcinoma in a rodent model. Consistently, some epidemiological studies have reported an association with cryptosporidiosis in patients with colorectal adenocarcinoma. However, the correlation between cryptosporidiosis and human digestive cancer remains unclear at this time, and it is not known whether this intracellular parasite, considered an opportunistic agent, is able to induce gastrointestinal malignancies in humans. In order to add new arguments for a probable association between cryptosporidiosis and digestive human cancer, the main aim of this study is to determine prevalence and to identify species of Cryptosporidium among a French digestive cancer population.

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
Institut Pasteur de Lille

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: Normal Ventilatory and Perfusion Pulmonary Function in TEMP: Generation of 3D Statistical Maps From Normal Examinations

summary:
Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity.

In that context, it would be of interest to build statistical maps from registrered normal studies and propose a new methodology for normal SPECT delineation

lead_sponsor: University Hospital, Brest

location_facility: Médecine nucléaire - Hôpital Morvan (CHRU de Brest)


acronym: DIVE

summary:
Prospective monocentric randomized controlled open-label proof-of-concept study in cross-over of two 1-month periods and a long-term follow-up period not to exceed September 30, 2023, with 2 groups: Intracerebroventricular A-dopamine versus optimized oral medical treatment in parkinsonian patients at the stage of severe motor complications (fluctuations and dyskinesias) related to oral L-dopa.

In this study it will be expected to: 1) a higher benefit on motor symptoms 2) without tachyphylaxis, 3) a good ergonomic of the intra-abdominal pump refilled with A-dopamine every two weeks as compared with the numerous daily L-dopa doses and 4) a good safety profile of this classical neurosurgical procedure.

sponsor_collaborators:
University Hospital, Lille
InBrain Pharma

title: A New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine (Dopamine Stored in Anaerobia) for Severe Motor Fluctuations in Parkinson's Disease?


title: Biological Samples Collection From Patients and Caregivers Treated at Bordeaux University Hospital for Asymptomatic and Symptomatic Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Infection (COVID-19).

summary:
The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization.

In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline.

The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: A Feasibility Study to Assess Connected Bikes as a Means of Adapted Physical Activity in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Allografts

acronym: EVAADE

summary:
To date, allogeneic haematopoietic stem cell transplantation (aHSCT) is the only curative treatment for many paediatric and young adult haematological pathologies (acute leukaemia, myelodysplastic syndromes, haemoglobinopathies, bone marrow aplasia, severe combined immunodeficiency). Despite the major therapeutic progress made over the last 50 years, particularly in terms of supportive care, post-transplant morbidity and mortality remains high. Infectious complications, whose incidence varies between 30 and 60%, are the first cause of mortality in the immediate post-transplant period.

In order to protect the patient from the occurrence of severe infectious episodes, aHSCTmust be performed in a highly protected environment (positive pressure chambers).

This has implications for the experience and impact of hospitalization on the patient and family. This is particularly true in paediatrics, whether in children, adolescents or young adults, where it is not only the patient's quality of life that is at stake, but also their emotional and psychomotor development. In these patients, prolonged hospitalization (at least 6 weeks) in a sterile room will be responsible for physical deconditioning accompanied by a decrease in muscle mass, itself concomitant with undernutrition, and an increase in sedentary lifestyle. This prolonged hospitalisation in a sterile room, associated with myeloablative treatments, is therefore the cause of social isolation of patients, but it is also often synonymous with physical inactivity leading to a rapid decrease in physical condition, quality of life and an increase in fatigue.

Today, the benefits of physical activity (PA) during and after cancer treatment have been widely demonstrated.

The objective is to evaluate the feasibility of an adapted physical activity program during the isolation phase for achieving aHSCT in children, adolescents and young adults. This is a prospective, interventional, monocentric cohort study conducted at the Institute of Paediatric Haematology and Oncology in Lyon. The intervention will take place during the isolation phase and consists of an adapted physical activity (APA) program defined at inclusion, integrating supervised sessions with an APA teacher, as well as autonomous sessions. The program is individualized according to age, aerobic capacity, and PA preferences. Sessions are also tailored to the biological, psychological, and social parameters of patients.

The total duration of the intervention is 3 months. To date, no PA studies have been performed in patients under 21 years of age requiring aGCSH during the sterile isolation phase. EVAADE will therefore be the first study in this population to offer an innovative procedure with a connected device.

status: Withdrawn

lead_sponsor: Centre Leon Berard

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique


acronym: INHASCO

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma.

The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only.

Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

status: Terminated

title: Protective Role of Inhaled Steroids for Covid-19 Infection


title: Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease

acronym: PIONEER

summary:
Chronic Kidney Disease (CKD) induces many metabolic troubles especially for the advanced CKD (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (GFR). Among them, muscle wasting is common and multifactorial, partially explained by an imbalance between protein catabolism and synthesis. Muscular strength is also affected beyond the reduction of the lean body mass, resulting in profound fatigue.

The present study seeks to quantify the prevalence of low muscular strength production (dynapenia) in a cohort of elderly patients with advanced CKD, through a maximal voluntary contraction (MVC) handgrip test compared to control data available in the literature, matched in term of age and sex. It also aims to investigate the link between the reported fatigue (subjective) and the evolution of the MVC, called critical force (fcrit) during a fatiguing task (objective fatigability).

ReferenceCitation: Chatrenet A, Beaune B, Fois A, Pouliquen C, Audebrand JM, Torreggiani M, Paris D, Durand S, Piccoli GB. PhysIOpathology of NEuromuscular function rElated to fatigue in chronic Renal disease in the elderly (PIONEER): study protocol. BMC Nephrol. 2020 Jul 25;21(1):305. doi: 10.1186/s12882-020-01976-6.

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories:
HAL
PubMed Central
iris.unito.it

repositories_concat: HAL;PubMed Central;iris.unito.it

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Hospitalier le Mans

sponsor_collaborators:
Centre Hospitalier le Mans
Le Mans Universite


title: ACE Inhibitors or ARBs Discontinuation for Clinical Outcome Risk Reduction in Patients Hospitalized for the Endemic Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection: the Randomized ACORES-2 Study

summary:
Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19.

Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death.

Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19.

It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitié-Salpêtrière

location_facility: Cardiologie, Groupe Hospitalier Pitié-Salpêtrière


title: Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand

acronym: HYMN

summary:
Ultrasound-guided infiltration is a common procedure and is known to be locally painful. This care-induced pain leads to strong apprehension in patients who need to benefit from this procedure.

The practice of hypnosis to improve the patient's comfort during a treatment has appeared progressively in hospital departments.

Among the various existing conversational hypnosis techniques, there is the "magic glove" technique. This is the technique that will be used in this study.

The investigators wish to evaluate the interest of hypnosis on the pain felt by the patient when performing an echo-guided infiltration of the hand, one of the most painful extremities during infiltrations.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Evaluation of the Blood-brain Barrier Disruption During Chronic Kidney Disease by 99mTc-DTPA Cerebral Scintigraphy (BREIN)

acronym: BREIN

summary:
Patients with Chronic Kidney Disease (CKD) have impaired psycho-cognitive functions in parallel with deteriorating kidney function. The pathophysiology of cognitive impairment in CKD is poorly understood and there is currently no therapy to limit cognitive decline. As kidney function deteriorates, uremic toxins accumulate in the patient's body. Their cerebral toxicity, whether direct or indirect through cerebral endothelial dysfunction, is a hypothesis that may explain the cognitive abnormalities, as well as the increased severity of strokes in patients with CKD. Among uremic toxins, indoxyl sulfate (IS) is an indolic toxin that is poorly purified by dialysis and whose high levels have already been shown to be associated with an increased cardiovascular risk in patients with CKD. Our hypothesis is that the psycho-cognitive disorders observed in patients with CKD are linked to cerebral endothelial dysfunction associated with high levels of IS.

In two models of CKD in rats, found impaired cognitive performance and increased blood-brain barrier (BBB) permeability, as assessed by brain scintigraphy with 99mTc-DTPA, compared to healthy control rats. Impaired cognitive performance was correlated with BBB permeability and circulating IS levels. Rats receiving an IS-enriched diet had higher BBB permeability and more impaired cognitive performance than MRC rats without an IS-enriched diet, suggesting a central role of IS.

The 99mTc-DTPA brain scintigraphy has already been used in clinical research to assess the BBB disruption after stroke, outside the context of CKD, and the tracer is available in human nuclear medicine.

Our hypothesis is that patients with CKD would have increased permeability of the BBB compared to healthy age- and sex-matched controls, and that this permeability would correlate with circulating levels of IS as in our preclinical animal models.

The main objective of this project is to evaluate the permeability of the BBB by brain scintigraphy with 99mTc-DTPA in patients with end-stage CKD and compare it to healthy age- and sex-matched controls.

A 18-month inclusion period will allow us to recruit 15 patients with end-stage CKD and 15 healthy volunteers matched in age and gender, as an important number of patients with end-stage CKD are followed in our department. If we confirm the results obtained in animal models, we will be able to propose the analysis of BBB disruption in isotope imaging as a criterion for evaluating therapeutic approaches modulating the toxicity of indolic uremic toxins in order to limit cognitive decline.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille

intervention_type: Radiation


title: Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

acronym: SPEQUA

summary:
This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection.

Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints, earl/temporal bone, colorectal carcinosis.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon


title: Surgery in Context of Terrorist Attack : Report of the 121st Annual Congress of French Association of Surgery

summary: The aim of the study is to assess the surgical knowledge of French Surgeons in cas of Terrorist Attack.

ipd_sharing_description: No sharing plan

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes

acronym: MAGE

summary: Alzheimer disease is the most common neurodegenerative brain disease that causes cognitive impairment in the elderly but also behavioral and psychological symptoms. Among these symptoms, agitation is one of the most dangerous because it put the patient and their caregivers in danger. Sleep disorders can be the cause of many psychiatric symptoms leading directly or indirectly to agitation. Music therapy is the non-drug therapy which has been shown to be the most effective in managing agitation and sleep disorders. With the MAGE protocol, the investigators propose to take care of behavioral disorders in severe Alzheimer patients living in nursing home through sequences of music therapy (stimulation, relaxation) automatically initiated by an actigraph that will detect sleep disorders. These subjects will be exposed for 2 weeks over a month. Behavioral and sleep disorders will be evaluated objectively by actigraphy but also by standardized scales, as the others neuropsychiatric symptoms found classically in this disease. Thanks to this project, the investigators hope to improve the quality of life of these patients by preventing them from putting themselves in danger, by reducing their neuropsychiatric symptoms and their use of medication, which has often deleterious side effect and also by reducing the workload of caregivers.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Cutaneous Adverse Effects Occurring in Children Under Biological Therapy Given for Chronic Inflammatory Diseases

acronym: MDEBMIC

summary: Biological treatments (BT) are commonly prescribed to treat chronic inflammatory diseases in children. Paradoxical reactions during treatment with a biological agent can be defined as the appearance or exacerbation of a pathological condition that usually responds to this class of drug while treating a patient for another condition. Limited data are available in children treated by BT on cutaneous paradoxical reactions, or any other cutaneous adverse events occurring during treatment. On the contrary, dermatologists tend to see and manage increasing numbers of cutaneous adverse events, including paradoxical reactions. The aim of this project is to describe the incidence of cutaneous adverse events, including cutaneous paradoxical reactions, occurring in the pediatric population, during a treatment by BT given for a chronic inflammatory disease.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study

acronym: PREDICT

summary:
Coronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death.

Currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR.

It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors.

It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.


title: ACTI-PACT : Programme d'ACcompagnement à l'acTIvité Physique Chez la Personne Âgée de 75 Ans et Plus, hospitalisée en CourT séjour gériatrique

acronym: ACTI-PACT

summary:
The main objective is to assess the effect, compared to usual care, of a nursing accompaniment or nursing assistant intervention in the physical activity of patients hospitalized in the geriatric stay, on the daily number of steps.

The secondary objectives consist in evaluating the effect, compared to usual care, of a nursing or nursing assistant's intervention in physical activity of elderly patients hospitalized on a short geriatric stay in terms of:

The change of the daily physical exertion in metabolic equivalent
The change of the daily number of steps
The change of care course
The change of in falls occurrence
The change of autonomy patient
The change of travels habits

appel_a_projets: PHRIP

region: Pays de la Loire

nom_etablissement: CHR ANGERS

type_etablissement: CH

acronyme: ACTI-PACT

titre: Programme d'ACcompagnement à l'acTIvité physique chez la Personne Âgée de 75 ans et plus, hospitalisée en CourT séjour gériatrique

discipline_principale: médecine physique et réadaptation

nom_porteur: Noublanche

prenom_porteur: Frédéric


title: An Open-Label Phase 1 Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects

summary: The study is a monocentric, open label, phase 1 study to evaluate the pharmacokinetics, and in particular the dose proportionality of setanaxib and its metabolites after a single oral dose (400 mg, 800 mg, 1200 mg, and 1600 mg) (Part 1) and after multiple oral doses (Part 2).

ReferenceCitation: Gage MC, Thippeswamy T. Inhibitors of Src Family Kinases, Inducible Nitric Oxide Synthase, and NADPH Oxidase as Potential CNS Drug Targets for Neurological Diseases. CNS Drugs. 2021 Jan;35(1):1-20. doi: 10.1007/s40263-020-00787-5. Epub 2021 Jan 30.

lead_sponsor: Calliditas Therapeutics AB


title: Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal Pituitary Surgery

acronym: Copeptin-surg

summary:
Endoscopic trans-sphenoidal pituitary endoscopic surgery is one of the main axes of management of tumours of the sellar region.

Central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery, with a prevalence of up to 30% of cases. It is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin (AVP) by the posterior pituitary (Melmed et al, 2017).

In the absence of specific treatment, diabetes insipidus can lead to severe ionic and osmotic disorders, mainly acute dehydration with the risk of severe consequences particularly neurological.

Monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period.

To date, diabetes insipidus is initially suspected before the appearance of major polyuria. Several biological assays (urinary density, natraemia, urinary osmolarity and plasma) can help to confirm the diagnosis, but the sensitivity and specificity of these biomarkers remains quite low for this indication.

The determination of MVA is difficult because this hormone is unstable ex vivo. To date, its use in current practice remains complicated.

MVA and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions.

Copeptin has a relatively short in vivo half-life of about 25 minutes, as does MVA, but is more stable in vitro when blood has been drawn.

Its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest.

lead_sponsor: CHU de Reims


title: Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients

acronym: Stomie 3D

summary:
The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients. To reduce the negative impact of the stoma, patients are seen in preoperative consultation by the stoma nurses. This consultation allows to show the patients the appearance of a stoma (through a photograph), the equipment used and how it works.

In 2016, McKenna et al. showed the interest of marking (with felt pen) the ostomy site on the abdomen in preoperative. In this study, patients with preoperative marking had a higher post-operative quality of life score than patients without marking (p=0.03).

Quality of life was assessed using the STOMA-QOL score. This quality of life score is specific for ostomy patients. It assesses 4 dimensions: sleep, intimate relationships, relationships with family and close friends, relationships with people other than family and close friends. This questionnaire includes 20 questions and has been validated in 5 languages including French.

The aim of this pilot study is to evaluate the post-operative quality of life of ostomy patients who have benefited from a preoperative therapeutic education session with the placement of the 3D printed ostomy button versus felt-tip marking, during the 15 days prior to the operation.


title: Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO and the French Pharmacovigilance Databases (MyeloRIB)

summary:
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (MDS) and/or acute myeloid leukaemia (AML). Today, data about MDS/AML are scarce.

The objective was to investigate reports of MDS/AML adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib and veliparib using the World Health Organization (WHO) and the French pharmacovigilance databases.

ReferenceCitation: Morice PM, Leary A, Dolladille C, Chretien B, Poulain L, Gonzalez-Martin A, Moore K, O'Reilly EM, Ray-Coquard I, Alexandre J. Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: a safety meta-analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database. Lancet Haematol. 2021 Feb;8(2):e122-e134. doi: 10.1016/S2352-3026(20)30360-4. Epub 2020 Dec 18. Erratum In: Lancet Haematol. 2021 Feb;8(2):e105.

lead_sponsor: University Hospital, Caen


title: Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects

acronym: EyeProxy

summary: The goal of this study is the multimodal exploration via eyetracking, MRI and EEG data of ocular movements and the corresponding brain activation during ecologic visual stimulation in the healthy population.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Grenoble Institut des Neurosciences
GIPSA-LAB


title: Study of Thrombotic Complications After Abdominal Aortic Aneurysm Surgery With or Without Infection: AAA-IT

acronym: AAA-IT

summary: The aim of our study is to evaluate the incidence of post-operative thrombotic complications after abdominal aortic aneurysm surgery in the context of atherosclerosis or infectious aneurysm and its links with preoperative inflammation and hemostasis.


title: Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy

acronym: BBASL

summary: The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.


title: Evaluation of the Diagnostic Value of a Biomarker of Non-surgical Knee Osteoarthritis: Subchondral Bone Perfusion (GENU-PERF)

acronym: GENU-PERF

summary:
Osteoarthritis is a very common pathology, especially in an aging population, and a source of disability. Based on standard radiography, the diagnosis is performed late based on the loss of the cartilage thickness. In this context, prosthetic replacement of the joint is a frequent outcome. New diagnostic biomarkers and herapeutic targets are therefore logically research priorities identified by the European League Against Rheumatisms, osteoarthritis ad hoc committee. The inflammation related to the development of this pathology is mainly studied at the cellular level and essentially in animals. Since inflammatory and vascular phenomena are closely intertwined, medical imaging of the subchondral bone vascularization appears interesting.

The dynamic contrast-enhanced T1 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) technique allows the identification of changes in the osteoarthritic subchondral bone vascularization. In osteoarthritic animals, these changes could be identified before the cartilaginous lesions became visible, and could be correlated with the severity of osteoarthritis.

This study would be the first to correlate subchondral bone perfusion measurements (performed with the DCE sequence) of early cartilaginous lesions of the knee, identified by non-invasive MRI (T2 mapping) in humans. This examination will be performed on a 3 Tesla MRI.

If a correlation is demonstrated in the early stages of osteoarthritis in both humans and animals, then infusion of subchondral bone could become a biomarker of osteoarthritis, and serve as a follow-up evaluation of future treatments.

ReferenceCitation: Conaghan PG, Kloppenburg M, Schett G, Bijlsma JW; EULAR osteoarthritis ad hoc committee. Osteoarthritis research priorities: a report from a EULAR ad hoc expert committee. Ann Rheum Dis. 2014 Aug;73(8):1442-5. doi: 10.1136/annrheumdis-2013-204660. Epub 2014 Mar 13.


title: Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain

acronym: NOTRANDO

summary:
The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice (NOTES). It avoids incisions and therefore scarring, and could reduce post-operative pain. It is now developing in the field of transvaginal gynecology (vNOTES).

This study is the first prospective randomized study comparing the vNOTES technique to laparoscopy with postoperative pain assessment for performing a salpingectomy. The hypothesis is that the use of vNOTES transvaginal endoscopic surgery would reduce the post-operative pain of patients compared to laparoscopy in the context of a salpingectomy.