title: Comparative Evaluation of the Evolution of Emerging Biological Markers (sST2, Copeptin, Chromogranin, NGAL, suPAR and Cystatin) in Patients Hospitalized for Acute Heart Failure (AHF) Depending on Their Management: Conventional or Therapeutic Adjustment According to Daily Ultrasound. Ancillary Study to the JECICA Study (AOI GCS MERRI 2015).

summary: This is a bi-centric, prospective randomized study to evaluate the contribution of rapid echocardioscopy at the patient's bedside to improving the prognosis of patients hospitalized for acute heart failure. The following markers will be evaluated: sST2, Copeptin, chromogranin, NGAL, suPAR and cystatin.

ReferenceCitation: Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. doi: 10.1016/j.amjcard.2007.01.037. Epub 2007 Apr 18.

ReferenceCitation: Capomolla S, Ceresa M, Pinna G, Maestri R, La Rovere MT, Febo O, Rossi A, Paganini V, Caporotondi A, Guazzotti G, Gnemmi M, Mortara A, Cobelli F. Echo-Doppler and clinical evaluations to define hemodynamic profile in patients with chronic heart failure: accuracy and influence on therapeutic management. Eur J Heart Fail. 2005 Jun;7(4):624-30. doi: 10.1016/j.ejheart.2004.07.013.

ReferenceCitation: Chakko S, Woska D, Martinez H, de Marchena E, Futterman L, Kessler KM, Myerberg RJ. Clinical, radiographic, and hemodynamic correlations in chronic congestive heart failure: conflicting results may lead to inappropriate care. Am J Med. 1991 Mar;90(3):353-9. doi: 10.1016/0002-9343(91)80016-f.

ReferenceCitation: Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.

ReferenceCitation: Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

ReferenceCitation: Goonewardena SN, Spencer KT. Handcarried echocardiography to assess hemodynamics in acute decompensated heart failure. Curr Heart Fail Rep. 2010 Dec;7(4):219-27. doi: 10.1007/s11897-010-0030-8.

ReferenceCitation: Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.

ReferenceCitation: Huet F, Nicoleau J, Dupuy AM, Curinier C, Breuker C, Castet-Nicolas A, Lotierzo M, Kalmanovich E, Zerkowski L, Akodad M, Adda J, Agullo A, Leclercq F, Pasquie JL, Battistella P, Roubille C, Fesler P, Mercier G, Bourel G, Cristol JP, Roubille F. STADE-HF (sST2 As a help for management of HF): a pilot study. ESC Heart Fail. 2020 Apr;7(2):774-778. doi: 10.1002/ehf2.12663. Epub 2020 Mar 13.

ReferenceCitation: Lei J, Dhamoon AS, Wang J, Iannuzzi M, Liu K. Walking the tightrope: Using quantitative Doppler echocardiography to optimize ventricular filling pressures in patients hospitalized for acute heart failure. Eur Heart J Acute Cardiovasc Care. 2016 Apr;5(2):130-40. doi: 10.1177/2048872615573517. Epub 2015 Feb 18.

ReferenceCitation: Lotierzo M, Dupuy AM, Kalmanovich E, Roubille F, Cristol JP. sST2 as a value-added biomarker in heart failure. Clin Chim Acta. 2020 Feb;501:120-130. doi: 10.1016/j.cca.2019.10.029. Epub 2019 Oct 31.

ReferenceCitation: McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology; Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. No abstract available. Erratum In: Eur J Heart Fail. 2013 Mar;15(3):361-2.

ReferenceCitation: Metra M, Cotter G, Gheorghiade M, Dei Cas L, Voors AA. The role of the kidney in heart failure. Eur Heart J. 2012 Sep;33(17):2135-42. doi: 10.1093/eurheartj/ehs205. Epub 2012 Aug 10.

ReferenceCitation: Nguyen VT, Ho JE, Ho CY, Givertz MM, Stevenson LW. Handheld echocardiography offers rapid assessment of clinical volume status. Am Heart J. 2008 Sep;156(3):537-42. doi: 10.1016/j.ahj.2008.04.015. Epub 2008 Jun 17.

ReferenceCitation: Ovbiagele B, Goldstein LB, Higashida RT, Howard VJ, Johnston SC, Khavjou OA, Lackland DT, Lichtman JH, Mohl S, Sacco RL, Saver JL, Trogdon JG; American Heart Association Advocacy Coordinating Committee and Stroke Council. Forecasting the future of stroke in the United States: a policy statement from the American Heart Association and American Stroke Association. Stroke. 2013 Aug;44(8):2361-75. doi: 10.1161/STR.0b013e31829734f2. Epub 2013 May 22. Erratum In: Stroke. 2015 Jul;46(7):e179.

ReferenceCitation: Parrinello G, Torres D, Paterna S, Di Pasquale P, Mezzero M, Licata G. The challenge of the volume status assessment in heart failure. Am Heart J. 2009 Apr;157(4):e19-20; author reply e21. doi: 10.1016/j.ahj.2008.12.001. Epub 2009 Jan 31. No abstract available.

ReferenceCitation: Remes J, Miettinen H, Reunanen A, Pyorala K. Validity of clinical diagnosis of heart failure in primary health care. Eur Heart J. 1991 Mar;12(3):315-21. doi: 10.1093/oxfordjournals.eurheartj.a059896.

ReferenceCitation: Ricci JE, Kalmanovich E, Robert C, Chevallier T, Aguilhon S, Solecki K, Akodad M, Cornillet L, Soullier C, Cayla G, Lattuca B, Roubille F. Management of acute heart failure: Contribution of daily bedside echocardiographic assessment on therapy adjustment with impact measure on the 30-day readmission rate (JECICA). Contemp Clin Trials Commun. 2018 Aug 9;12:103-108. doi: 10.1016/j.conctc.2018.07.006. eCollection 2018 Dec.

ReferenceCitation: Ronco C, Cicoira M, McCullough PA. Cardiorenal syndrome type 1: pathophysiological crosstalk leading to combined heart and kidney dysfunction in the setting of acutely decompensated heart failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. doi: 10.1016/j.jacc.2012.01.077. Epub 2012 Jul 25.

ReferenceCitation: Ross JS, Chen J, Lin Z, Bueno H, Curtis JP, Keenan PS, Normand SL, Schreiner G, Spertus JA, Vidan MT, Wang Y, Wang Y, Krumholz HM. Recent national trends in readmission rates after heart failure hospitalization. Circ Heart Fail. 2010 Jan;3(1):97-103. doi: 10.1161/CIRCHEARTFAILURE.109.885210. Epub 2009 Nov 10.

ReferenceCitation: Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.

ReferenceCitation: Tuppin P, Cuerq A, de Peretti C, Fagot-Campagna A, Danchin N, Juilliere Y, Alla F, Allemand H, Bauters C, Drici MD, Hagege A, Jondeau G, Jourdain P, Leizorovicz A, Paccaud F. Two-year outcome of patients after a first hospitalization for heart failure: A national observational study. Arch Cardiovasc Dis. 2014 Mar;107(3):158-68. doi: 10.1016/j.acvd.2014.01.012. Epub 2014 Mar 21.

ReferenceCitation: Vitarelli A, Gheorghiade M. Transthoracic and transesophageal echocardiography in the hemodynamic assessment of patients with congestive heart failure. Am J Cardiol. 2000 Aug 17;86(4A):36G-40G. doi: 10.1016/s0002-9149(00)00990-5.

ReferenceCitation: Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Montpellier University Hospital, Arnaud de Villeneuve


study_start_date_type: Actual

acronym: LESS

intervention_type: Drug

lead_sponsor: UNICANCER

summary:
Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women. Adjuvant endocrine therapy (ET) is associated with substantial side effects and long-term decreased quality of life.

Moreover, while it has been shown that ET provides a real benefit in reducing the relapse rate over time, the deterioration in quality of life may also have a negative effect on patient adherence to treatment. It is therefore important to offer treatment to women with low-risk cancer less intensive treatment strategies. If recent trials tested longer durations as compared to 5 years for high-risk cancers, older trials have tested shorter durations. The 5-year duration appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among high-risk patients. However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients.

sponsor_collaborators: UNICANCER Agendia

location_facility: Centre Hospitalier Universitaire de Limoges

status: Recruiting

title: Single-arm Study to De-escalate Adjuvant Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk of Metastasis

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

study_completion_date_type: Anticipated

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA

acronym: CBRA

summary: This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Hopital Nord Franche-Comte

location_facility: ICANS (Institut de Cancérologie de Strasbourg)

intervention_type: Device

lead_sponsor_type: academique


title: Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room

acronym: BOREV

summary:
Virtual Reality (VR) is an interactive and immersive technology that allows you to evolve in a three-dimensional environment created by computer. It appeals to the senses of people by reproducing universes close to reality or imaginary. This process is currently the subject of numerous studies in the field of health because it is a non-invasive tool, a non-pharmacological alternative for the management of pain, anxiety and patient satisfaction.

People with cancer can have a complex care pathway with psychological, anxiety-provoking and potentially painful repercussions. It is for these reasons that offering VR in the operating room for certain procedures under local anesthesia would improve the experience and comfort of care.

BOREV study will assess the interest of VR on pain for procedures under local anesthesia in the operating room in the context of cancer care. The software used, called HypnoVR©, is a medical device, developed specifically for the management of anxiety and pain through hypnosis, sophrology and relaxation techniques.

The main objective of this study is to compare the maximum pain felt with and without RV for different oncological surgical procedures performed under local anesthesia including anesthetic procedures and surgical procedures. The secondary objectives that will support this research are: the evaluation of the level of anxiety, the link with the pain component via the Analgesia Nociception Index (ANI), as well as the satisfaction of the patient and the operator.

According to the results obtained, the VR device could lead to a change in practice in the management of patients and thus be offered on a larger scale within the framework of the management of pain and anxiety

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Institut Cancerologie de l'Ouest


title: Real-world Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Lurbinectedin as Part of the French Early Access Program (ATU).

acronym: LURBICLIN

summary: LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate effectiveness and safety of lurbinectedin in real-world conditions.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27. Erratum In: Lancet Oncol. 2020 Dec;21(12):e553.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

collaborators:
Groupe Français de Pneumo-Cancérologie
PharmaMar

location_facility:
Villefranche-Sur-Saône - CH
Institut Curie

status_simplified: Completed


title: Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes

acronym: HCL-VHP

summary:
While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes.

The investigators conduct a retrospective, observational, and single-center study to evaluate the acceptability, safety, and efficacy of a CLID system in patients living with T1D (≥2 years) with a HbA1c>11% in the past 12 months and a mean HbA1c >10% over the past three years. Efficacy was assessed using continuous glucose monitoring parameters.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Sud Francilien

location_facility:
Penfornis
Centre Hospitalier Sud Francilien

intervention_type: Other


title: Development of a Personalised Therapeutic Approach for Cancer Patients With Resting Hypermetabolism

summary:
Half of all cancer patients show an increase in resting energy expenditure. The causes of hypermetabolism have only recently been investigated in cancerology. One established cause is inflammation, but other causes have yet to be identified.

The interest in hypermetabolism is due to the fact that it appears early, before the onset of clinical deterioration (weight loss, sarcopenia, altered performance status) and that it correlates with patient morbidity and mortality. Like the other parameters that make up cachexia, it is both a predictor of toxicity and reduced efficacy of anti-tumour treatments and a prognostic factor, regardless of the tumour.

A therapeutic goal is to correct hypermetabolism for two reasons:

avoid progression to clinical cachexia, which is an independent cause of morbidity and mortality
increase the efficacy of anti-PD1/PDL1 immunotherapies. This new class of therapy has revolutionised the therapeutic management of many cancers but is less effective in cases of inflammation and/or altered performance status and/or hypermetabolism.

Investigator hypothesises that it is possible to develop a patient-specific treatment to correct hypermetabolism, depending on the predominant clinical or biological cause.

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier le Mans

location_facility:
Hôpital COCHIN
Centre Hospitalier Du Mans


title: Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.

summary: The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

lead_sponsor: Polyclinique Bordeaux Nord Aquitaine

sponsor_collaborators:
Polyclinique Bordeaux Nord Aquitaine
SI-BONE, Inc.

location_facility:
Hôpitaux Universitaires de Marseille
Polyclinique Bordeaux Nord Aquitaine


title: Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN Pilot)

summary:
The study aims to evaluate the impact of promoting advice on the latest evidence-based diet and lifestyle recommendations for cancer prevention at colorectal cancer (CRC) screening among individuals who may be at higher risk for developing CRC. The overall aim of this LIFE-SCREEN pilot study is to test the trial methods and procedures to be used in the LIFE-SCREEN cluster randomized RCT, in order to discover obstacles and problems prior to the main RCT so that corrective actions can be taken to improve the research process.

The patients (n=40) will be recruited at the Centre Léon Bérard and at the Hôpital Edouard Herriot at the time of CRC screening.

After inclusion, the intervention material (documents explaining the strategies to achieve and maintain recommended behaviours as part of a healthier lifestyle) may be given to the patient during the pre-colonoscopy consultation and/or at the post-colonoscopy visit. Weight, height and blood pressure will be measured during the pre-colonoscopy consultation. Patients will be invited to complete a baseline questionnaire to collect information on their lifestyle, state of health and socio-demographic status. Approximately four to six weeks after, patients will also be asked to complete an evaluation questionnaire asking for their opinion on this material and the procedures. Focus groups with available and willing participants and hospital staff will be organized at the end of the pilot phase recruitment, to gather additional information on the intervention procedures. In addition, all hospital staff will be asked to complete an assessment questionnaire.

Biological samples will then also be collected to test the objective baseline measure of nutritional changes used in the RCT. In order to assess the feasibility and the acceptability of urine, faecal and blood sample collection in this population, the first ten participants recruited (n=10) will be given the option to refuse one or more of the biological sample collections (phase I). Participants will also be asked to complete a questionnaire to provide information on their opinion and willingness to donate biological samples. This assessment questionnaire will allow us to refine the strategies for the other 30 participants (phase II). In this phase II, biological samples will be compulsory (phase IIa) or optional (phase IIb) for all 30 participants.

primary_purpose: Prevention

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
Hôpital Edouard Herriot (HCL)


title: Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units

acronym: PREMALIM

summary:
Hypothesis : Bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump.
Main criteria : Comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.

primary_purpose: Other

lead_sponsor: University Hospital, Limoges

location_facility:
Centre Hospitalier Henri Duffaut
Limoges university hospital

intervention_type: Procedure


title: SOMESThesia in Patients With Head and Neck Cancer: Variability and Influence on the ALIMentation Experience

acronym: SOMEST'ALIM

summary:
Cancer patients are at high risk for undernutrition. A study with head and neck cancer patients showed that 50% suffered from undernutrition (Prevost et al., 2014). Sensory alterations may also involve sensory changes from the physiological structures of the mouth or neural pathways and hedonic changes, i.e., although food may taste the same as usual, that taste is no longer judged as pleasant. These changes lead to an aversion to food and a decrease in the pleasure of eating (Bernhardson et al., 2009).

Despite the large number of published studies on taste and smell alterations in diverse cancer populations, few have examined other dimensions of oral sensory alterations. Studies focusing on somesthesia have mostly been conducted in the area of oral physiology or stomatology in relation to oral pain and rehabilitation (Howes, Wongsriruksa, Laughlin, Witchel, & Miodownik, 2014).

Regarding food perception, somesthesia provides information about both texture, temperature, and trigeminal sensations. These sensations are detected by mechanical, thermal, nociceptive receptors present throughout the oral epithelium (Simons & Carstens, 2008). In addition to taste and smell, food perception is influenced by oral somatosensation and studies have demonstrated an interrelated relationship between these oral sensations (Spence, Piqueras-Fiszman 2016). Therefore, ther might have a correlation between oral somatosensation and food preferences, subsequently influencing eating behavior and food consumption. A standard method, using a so-called Von Frey Hair monofilament, to assess tactile sensation was developed by Etter et al. (Etter, N. M et al.,. J. Vis. Exp. 2020) but has so far been only minimally used in Ear, Nose and Throat (ENT) cancer (Bearelly, Wang, & Cheung, 2017; Bodin, Jäghagen, & Isberg, 2004; Elfring, Boliek, Seikaly, Harris, & Rieger, 2012).

The aim of the study is to determine the variability and role of somatosensory perception (texture, pungency transmitted through the trigeminal system, and temperature) on food preferences in cancer patients compared to healthy volunteers.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Oncologie médicale, Hôpital de la Croix-Rousse

location_facility: Centre de recherche de l'Institut Paul Bocuse


title: Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification

acronym: PREDICS

summary:
This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery.

Patients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. The rest of their management will be in line with standard practice.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHR Metz-Thionville/Hopital Mercy
CHR Metz-Thionville_Hopital Bel Air


type: Other Identifier

title: Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)

acronym: VESICOM

summary: The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hospices Civils de Lyon
CHU de Saint-Etienne


title: Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study

acronym: MAKI

summary: The purpose of this study is to assess the impact of Acute Kidney Injury (AKI) characteristics on long-term renal prognosis in Intensive Care Unit (ICU) patients.

ReferenceCitation: Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.

ReferenceCitation: Lewington AJ, Cerda J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013 Sep;84(3):457-67. doi: 10.1038/ki.2013.153. Epub 2013 May 1.

ReferenceCitation: Chawla LS, Bellomo R, Bihorac A, Goldstein SL, Siew ED, Bagshaw SM, Bittleman D, Cruz D, Endre Z, Fitzgerald RL, Forni L, Kane-Gill SL, Hoste E, Koyner J, Liu KD, Macedo E, Mehta R, Murray P, Nadim M, Ostermann M, Palevsky PM, Pannu N, Rosner M, Wald R, Zarbock A, Ronco C, Kellum JA; Acute Disease Quality Initiative Workgroup 16.. Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol. 2017 Apr;13(4):241-257. doi: 10.1038/nrneph.2017.2. Epub 2017 Feb 27.

ReferenceCitation: Truche AS, Ragey SP, Souweine B, Bailly S, Zafrani L, Bouadma L, Clec'h C, Garrouste-Orgeas M, Lacave G, Schwebel C, Guebre-Egziabher F, Adrie C, Dumenil AS, Zaoui P, Argaud L, Jamali S, Goldran Toledano D, Marcotte G, Timsit JF, Darmon M. ICU survival and need of renal replacement therapy with respect to AKI duration in critically ill patients. Ann Intensive Care. 2018 Dec 17;8(1):127. doi: 10.1186/s13613-018-0467-6.

ReferenceCitation: Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

ReferenceCitation: Perinel S, Vincent F, Lautrette A, Dellamonica J, Mariat C, Zeni F, Cohen Y, Tardy B, Souweine B, Darmon M. Transient and Persistent Acute Kidney Injury and the Risk of Hospital Mortality in Critically Ill Patients: Results of a Multicenter Cohort Study. Crit Care Med. 2015 Aug;43(8):e269-75. doi: 10.1097/CCM.0000000000001077.

ReferenceCitation: Coelho S, Fonseca JN, Gameiro J, Jorge S, Velosa J, Lopes JA. Transient and persistent acute kidney injury in acute liver failure. J Nephrol. 2019 Apr;32(2):289-296. doi: 10.1007/s40620-018-00568-w. Epub 2018 Dec 19.

ReferenceCitation: Kim CS, Bae EH, Ma SK, Kweon SS, Kim SW. Impact of Transient and Persistent Acute Kidney Injury on Chronic Kidney Disease Progression and Mortality after Gastric Surgery for Gastric Cancer. PLoS One. 2016 Dec 9;11(12):e0168119. doi: 10.1371/journal.pone.0168119. eCollection 2016.

ReferenceCitation: Bhatraju PK, Mukherjee P, Robinson-Cohen C, O'Keefe GE, Frank AJ, Christie JD, Meyer NJ, Liu KD, Matthay MA, Calfee CS, Christiani DC, Himmelfarb J, Wurfel MM. Acute kidney injury subphenotypes based on creatinine trajectory identifies patients at increased risk of death. Crit Care. 2016 Nov 17;20(1):372. doi: 10.1186/s13054-016-1546-4.

ReferenceCitation: Horne KL, Packington R, Monaghan J, Reilly T, McIntyre CW, Selby NM. The effects of acute kidney injury on long-term renal function and proteinuria in a general hospitalised population. Nephron Clin Pract. 2014;128(1-2):192-200. doi: 10.1159/000368243. Epub 2014 Nov 28.

ReferenceCitation: Horne KL, Packington R, Monaghan J, Reilly T, Selby NM. Three-year outcomes after acute kidney injury: results of a prospective parallel group cohort study. BMJ Open. 2017 Mar 29;7(3):e015316. doi: 10.1136/bmjopen-2016-015316.

ReferenceCitation: Forni LG, Darmon M, Ostermann M, Oudemans-van Straaten HM, Pettila V, Prowle JR, Schetz M, Joannidis M. Renal recovery after acute kidney injury. Intensive Care Med. 2017 Jun;43(6):855-866. doi: 10.1007/s00134-017-4809-x. Epub 2017 May 2.

ReferenceCitation: Heung M, Steffick DE, Zivin K, Gillespie BW, Banerjee T, Hsu CY, Powe NR, Pavkov ME, Williams DE, Saran R, Shahinian VB; Centers for Disease Control and Prevention CKD Surveillance Team. Acute Kidney Injury Recovery Pattern and Subsequent Risk of CKD: An Analysis of Veterans Health Administration Data. Am J Kidney Dis. 2016 May;67(5):742-52. doi: 10.1053/j.ajkd.2015.10.019. Epub 2015 Dec 12.

ReferenceCitation: See EJ, Toussaint ND, Bailey M, Johnson DW, Polkinghorne KR, Robbins R, Bellomo R. Risk factors for major adverse kidney events in the first year after acute kidney injury. Clin Kidney J. 2019 Dec 20;14(2):556-563. doi: 10.1093/ckj/sfz169. eCollection 2021 Feb.

ReferenceCitation: Bucaloiu ID, Kirchner HL, Norfolk ER, Hartle JE 2nd, Perkins RM. Increased risk of death and de novo chronic kidney disease following reversible acute kidney injury. Kidney Int. 2012 Mar;81(5):477-85. doi: 10.1038/ki.2011.405. Epub 2011 Dec 7.

ReferenceCitation: Uchino S, Bellomo R, Bagshaw SM, Goldsmith D. Transient azotaemia is associated with a high risk of death in hospitalized patients. Nephrol Dial Transplant. 2010 Jun;25(6):1833-9. doi: 10.1093/ndt/gfp624. Epub 2010 Jan 6.

ReferenceCitation: Pannu N, James M, Hemmelgarn B, Klarenbach S; Alberta Kidney Disease Network. Association between AKI, recovery of renal function, and long-term outcomes after hospital discharge. Clin J Am Soc Nephrol. 2013 Feb;8(2):194-202. doi: 10.2215/CJN.06480612. Epub 2012 Nov 2.

ReferenceCitation: Sood MM, Shafer LA, Ho J, Reslerova M, Martinka G, Keenan S, Dial S, Wood G, Rigatto C, Kumar A; Cooperative Antimicrobial Therapy in Septic Shock (CATSS) Database Research Group. Early reversible acute kidney injury is associated with improved survival in septic shock. J Crit Care. 2014 Oct;29(5):711-7. doi: 10.1016/j.jcrc.2014.04.003. Epub 2014 Apr 18.

ReferenceCitation: Uhel F, Peters-Sengers H, Falahi F, Scicluna BP, van Vught LA, Bonten MJ, Cremer OL, Schultz MJ, van der Poll T; MARS consortium. Mortality and host response aberrations associated with transient and persistent acute kidney injury in critically ill patients with sepsis: a prospective cohort study. Intensive Care Med. 2020 Aug;46(8):1576-1589. doi: 10.1007/s00134-020-06119-x. Epub 2020 Jun 8.

ReferenceCitation: Schiffl H, Lang SM, Fischer R. Long-term outcomes of survivors of ICU acute kidney injury requiring renal replacement therapy: a 10-year prospective cohort study. Clin Kidney J. 2012 Aug;5(4):297-302. doi: 10.1093/ckj/sfs070.

ReferenceCitation: Goldstein SL, Chawla L, Ronco C, Kellum JA. Renal recovery. Crit Care. 2014 Jan 6;18(1):301. doi: 10.1186/cc13180.

ReferenceCitation: Chew STH, Hwang NC. Acute Kidney Injury After Cardiac Surgery: A Narrative Review of the Literature. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1122-1138. doi: 10.1053/j.jvca.2018.08.003. Epub 2018 Aug 7.

ReferenceCitation: Kellum JA. Persistent Acute Kidney Injury. Crit Care Med. 2015 Aug;43(8):1785-6. doi: 10.1097/CCM.0000000000001102. No abstract available.

ReferenceCitation: Pickering JW, Frampton CM, Endre ZH. Evaluation of trial outcomes in acute kidney injury by creatinine modeling. Clin J Am Soc Nephrol. 2009 Nov;4(11):1705-15. doi: 10.2215/CJN.00820209. Epub 2009 Sep 3.

ReferenceCitation: Pickering JW, Endre ZH. Baseline creatinine: where to from here? Nephrol Dial Transplant. 2011 Jun;26(6):2056; author reply 2056-7. doi: 10.1093/ndt/gfr099. Epub 2011 Mar 18. No abstract available.

ReferenceCitation: Zavada J, Hoste E, Cartin-Ceba R, Calzavacca P, Gajic O, Clermont G, Bellomo R, Kellum JA; AKI6 investigators. A comparison of three methods to estimate baseline creatinine for RIFLE classification. Nephrol Dial Transplant. 2010 Dec;25(12):3911-8. doi: 10.1093/ndt/gfp766. Epub 2010 Jan 25.

ReferenceCitation: De Rosa S, Samoni S, Ronco C. Creatinine-based definitions: from baseline creatinine to serum creatinine adjustment in intensive care. Crit Care. 2016 Mar 15;20:69. doi: 10.1186/s13054-016-1218-4.

ReferenceCitation: Ichai C, Vinsonneau C, Souweine B, Armando F, Canet E, Clec'h C, Constantin JM, Darmon M, Duranteau J, Gaillot T, Garnier A, Jacob L, Joannes-Boyau O, Juillard L, Journois D, Lautrette A, Muller L, Legrand M, Lerolle N, Rimmele T, Rondeau E, Tamion F, Walrave Y, Velly L; Societe francaise d'anesthesie et de reanimation (Sfar); Societe de reanimation de langue francaise (SRLF); Groupe francophone de reanimation et urgences pediatriques (GFRUP); Societe francaise de nephrologie (SFN). Acute kidney injury in the perioperative period and in intensive care units (excluding renal replacement therapies). Ann Intensive Care. 2016 Dec;6(1):48. doi: 10.1186/s13613-016-0145-5. Epub 2016 May 27.

ReferenceCitation: Bhatraju PK, Zelnick LR, Chinchilli VM, Moledina DG, Coca SG, Parikh CR, Garg AX, Hsu CY, Go AS, Liu KD, Ikizler TA, Siew ED, Kaufman JS, Kimmel PL, Himmelfarb J, Wurfel MM. Association Between Early Recovery of Kidney Function After Acute Kidney Injury and Long-term Clinical Outcomes. JAMA Netw Open. 2020 Apr 1;3(4):e202682. doi: 10.1001/jamanetworkopen.2020.2682.

ReferenceCitation: Jones J, Holmen J, De Graauw J, Jovanovich A, Thornton S, Chonchol M. Association of complete recovery from acute kidney injury with incident CKD stage 3 and all-cause mortality. Am J Kidney Dis. 2012 Sep;60(3):402-8. doi: 10.1053/j.ajkd.2012.03.014. Epub 2012 Apr 27.

ReferenceCitation: Ye N, Xu Y, Bellomo R, Gallagher M, Wang AY. Effect of nephrology follow-up on long-term outcomes in patients with acute kidney injury: A systematic review and meta-analysis. Nephrology (Carlton). 2020 Aug;25(8):607-615. doi: 10.1111/nep.13698. Epub 2020 Feb 18.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Centre Jean-Perrin
CHU clermont-ferrand

intervention_type: Biological


title: Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI

acronym: TREAT

summary:
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).

Once a diagnosis has been made and the decision to treat these patients has been taken, the procedure (AVR or TAVI) must be performed rapidly given the poor prognosis of the disease without treatment. Studies have shown that on the waiting list, the probability of death and hospitalisation for heart failure increases with time. This delay could also reduce the effectiveness of TAVI, thus affecting the performance of the healthcare system.

In this study, an intervention combining an e-health component (tool intended for patients, families and health professionals in contact with patients), and an organisational component (for TAVI implanting centres) has been designed. The aim of this study is to evaluate the effectiveness of this intervention.

lead_sponsor: University Hospital, Rouen

location_facility:
Brest University Hospital
CHU de Rouen


title: Study of the Postural Reactions of Balance Compared Between Real Environment and Virtual Environment With Avatar and Reinforced Visual Signal.

summary: The scientific literature shows that there is a degradation of balance in virtual reality. This trial investigates the introduction of a full-body avatar and/or enhanced visual cues on the reduction of the degradation.

lead_sponsor: Pôle Saint Hélier

sponsor_collaborators:
Pôle Saint Hélier
Hopital La Musse

location_facility:
Pôle Saint Hélier
Hôpital la Musse


title: Nociception Level Index (NoL) Variation After Standardized Stimulation Under General Anesthesia in Children

acronym: STIMNOL

summary: The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Lille

location_facility:
Hopital Roger Salengro, CHU Lille
Hu Est Parisien Site Trousseau Aphp

status_simplified: Unknown


title: Kinetics of C-Reactive Protein During the Overall Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty

acronym: CRP KIN

summary: The primary objective of the study focuses on the kinetics of plasma CRP measured during the overall management (before the angioplasty procedure until the discharge of hospitalization) of patients with ST+ ACS requiring emergency transluminal angioplasty.

ReferenceCitation: Milwidsky A, Ziv-Baran T, Letourneau-Shesaf S, Keren G, Taieb P, Berliner S, Shacham Y. CRP velocity and short-term mortality in ST segment elevation myocardial infarction. Biomarkers. 2017 May-Jun;22(3-4):383-386. doi: 10.1080/1354750X.2017.1279218. Epub 2017 Jan 25.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Cardiology department, Ambroise Paré hospital, APHP

location_facility: Intensive care unit, Ambroise Paré hospital, APHP


title: Effect of Lumbar Surgery on Complexity During a Walking Task in the Chronic Low Back Pain Patient

acronym: LOBAFRACS

summary:
Lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. There are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients.

The impact of lumbar surgery on complexity in this painful context has never been studied. Theoretically, the restriction of mobility imposed by lumbar surgery should limit the subject's adaptive capacities (of one or more lumbar segments) and thus reduce complexity. Nevertheless, improvement in pain intensity levels could allow the patient to find better motor adaptation capacities, necessary for a positive evolution in the long-term.

The aim of this study was to investigate the evolution of gait complexity in chronic low back pain patients pre- and post-surgery. If surgery improves the adaptability of walking through an antalgic benefit exceeding the induced stiffness, the complexity of walking should be superior after surgery.

This is a proof-of-concept study in which the study investigators hypothesize that measuring complexity by fractal analysis during a walking task will show the increase in gait complexity induced by lumbar surgery at 3 and 6 months after surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nîmes
Polyclinique Grand Sud


title: Prevalence of Endolymphatic Hydrops in Patients With a History of Congenital Cytomegalovirus Infection With Symptomatic Cochleo-vestibular Involvement

acronym: HYDROPS-CMV

summary: The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital Fondation Adolphe de Rothschild
Hôpital Robert Debre


title: Effect of an Electronic Alert Management System Using Caregivers' Observations and Machine Learning Algorithm to Reduce the Use of Emergency Department Visits and Unplanned Hospitalizations Among Older People

summary:
Development, validation and impact of an alert management system using social workers' observations and machine learning algorithms to predict 7-to-14-day alerts for the risk of Emergency Department (ED) Visit and unplanned hospitalization.

Multi-center trial implementation of electronic Home Care Aides-reported outcomes measure system among patients, frail adults >= 65 years living at home and receiving assistance from home care aides (HCA).

status: Active, not recruiting

ReferenceCitation: Clerencia-Sierra M, Calderon-Larranaga A, Martinez-Velilla N, Vergara-Mitxeltorena I, Aldaz-Herce P, Poblador-Plou B, Machon-Sobrado M, Egues-Olazabal N, Abellan-van Kan G, Prados-Torres A. Multimorbidity Patterns in Hospitalized Older Patients: Associations among Chronic Diseases and Geriatric Syndromes. PLoS One. 2015 Jul 24;10(7):e0132909. doi: 10.1371/journal.pone.0132909. eCollection 2015.

ReferenceCitation: Kahn JH, Magauran BG Jr, Olshaker JS, Shankar KN. Current Trends in Geriatric Emergency Medicine. Emerg Med Clin North Am. 2016 Aug;34(3):435-52. doi: 10.1016/j.emc.2016.04.014.

ReferenceCitation: Gasperini B, Cherubini A, Pierri F, Barbadoro P, Fedecostante M, Prospero E. Potentially preventable visits to the emergency department in older adults: Results from a national survey in Italy. PLoS One. 2017 Dec 21;12(12):e0189925. doi: 10.1371/journal.pone.0189925. eCollection 2017.

ReferenceCitation: McCusker J, Verdon J. Do geriatric interventions reduce emergency department visits? A systematic review. J Gerontol A Biol Sci Med Sci. 2006 Jan;61(1):53-62. doi: 10.1093/gerona/61.1.53.

ReferenceCitation: Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.

ReferenceCitation: Chen CC, Wang C, Huang GH. Functional trajectory 6 months posthospitalization: a cohort study of older hospitalized patients in Taiwan. Nurs Res. 2008 Mar-Apr;57(2):93-100. doi: 10.1097/01.NNR.0000313485.18670.e2.

ReferenceCitation: Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.

ReferenceCitation: Camargo CA Jr, Tsai CL, Sullivan AF, Cleary PD, Gordon JA, Guadagnoli E, Kaushal R, Magid DJ, Rao SR, Blumenthal D. Safety climate and medical errors in 62 US emergency departments. Ann Emerg Med. 2012 Nov;60(5):555-563.e20. doi: 10.1016/j.annemergmed.2012.02.018.

ReferenceCitation: Crane SJ, Tung EE, Hanson GJ, Cha S, Chaudhry R, Takahashi PY. Use of an electronic administrative database to identify older community dwelling adults at high-risk for hospitalization or emergency department visits: the elders risk assessment index. BMC Health Serv Res. 2010 Dec 13;10:338. doi: 10.1186/1472-6963-10-338.

ReferenceCitation: Hu Z, Jin B, Shin AY, Zhu C, Zhao Y, Hao S, Zheng L, Fu C, Wen Q, Ji J, Li Z, Wang Y, Zheng X, Dai D, Culver DS, Alfreds ST, Rogow T, Stearns F, Sylvester KG, Widen E, Ling XB. Real-time web-based assessment of total population risk of future emergency department utilization: statewide prospective active case finding study. Interact J Med Res. 2015 Jan 13;4(1):e2. doi: 10.2196/ijmr.4022.

ReferenceCitation: Takahashi PY, Heien HC, Sangaralingham LR, Shah ND, Naessens JM. Enhanced risk prediction model for emergency department use and hospitalizations in patients in a primary care medical home. Am J Manag Care. 2016 Jul;22(7):475-83.

ReferenceCitation: Denis F, Krakowski I. How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? J Med Internet Res. 2021 Sep 9;23(9):e30549. doi: 10.2196/30549.

ReferenceCitation: Bouazza YB, Chiairi I, El Kharbouchi O, De Backer L, Vanhoutte G, Janssens A, Van Meerbeeck JP. Patient-reported outcome measures (PROMs) in the management of lung cancer: A systematic review. Lung Cancer. 2017 Nov;113:140-151. doi: 10.1016/j.lungcan.2017.09.011. Epub 2017 Sep 23.

ReferenceCitation: Schick-Makaroff K, Karimi-Dehkordi M, Cuthbertson L, Dixon D, Cohen SR, Hilliard N, Sawatzky R. Using Patient- and Family-Reported Outcome and Experience Measures Across Transitions of Care for Frail Older Adults Living at Home: A Meta-Narrative Synthesis. Gerontologist. 2021 Apr 3;61(3):e23-e38. doi: 10.1093/geront/gnz162.

ReferenceCitation: Veyron JH, Friocourt P, Jeanjean O, Luquel L, Bonifas N, Denis F, Belmin J. Home care aides' observations and machine learning algorithms for the prediction of visits to emergency departments by older community-dwelling individuals receiving home care assistance: A proof of concept study. PLoS One. 2019 Aug 13;14(8):e0220002. doi: 10.1371/journal.pone.0220002. eCollection 2019.

ReferenceCitation: Huntley AL, Chalder M, Shaw ARG, Hollingworth W, Metcalfe C, Benger JR, Purdy S. A systematic review to identify and assess the effectiveness of alternatives for people over the age of 65 who are at risk of potentially avoidable hospital admission. BMJ Open. 2017 Aug 1;7(7):e016236. doi: 10.1136/bmjopen-2017-016236.

ReferenceCitation: Seibert K, Domhoff D, Bruch D, Schulte-Althoff M, Furstenau D, Biessmann F, Wolf-Ostermann K. Application Scenarios for Artificial Intelligence in Nursing Care: Rapid Review. J Med Internet Res. 2021 Nov 29;23(11):e26522. doi: 10.2196/26522.

ReferenceCitation: Gray JT, Walker A. Avoiding admissions from the ambulance service: a review of elderly patients with falls and patients with breathing difficulties seen by emergency care practitioners in South Yorkshire. Emerg Med J. 2008 Mar;25(3):168-71. doi: 10.1136/emj.2007.050732.

ReferenceCitation: Mason S, O'Keeffe C, Knowles E, Bradburn M, Campbell M, Coleman P, Stride C, O'Hara R, Rick J, Patterson M. A pragmatic quasi-experimental multi-site community intervention trial evaluating the impact of Emergency Care Practitioners in different UK health settings on patient pathways (NEECaP Trial). Emerg Med J. 2012 Jan;29(1):47-53. doi: 10.1136/emj.2010.103572.

ReferenceCitation: Mason S, Knowles E, Colwell B, Dixon S, Wardrope J, Gorringe R, Snooks H, Perrin J, Nicholl J. Effectiveness of paramedic practitioners in attending 999 calls from elderly people in the community: cluster randomised controlled trial. BMJ. 2007 Nov 3;335(7626):919. doi: 10.1136/bmj.39343.649097.55. Epub 2007 Oct 4.

ReferenceCitation: Soril LJ, Leggett LE, Lorenzetti DL, Noseworthy TW, Clement FM. Reducing frequent visits to the emergency department: a systematic review of interventions. PLoS One. 2015 Apr 13;10(4):e0123660. doi: 10.1371/journal.pone.0123660. eCollection 2015.

ReferenceCitation: Belmin J, Auffray JC, Berbezier C, Boirin P, Mercier S, de Reviers B, Golmard JL. Level of dependency: a simple marker associated with mortality during the 2003 heatwave among French dependent elderly people living in the community or in institutions. Age Ageing. 2007 May;36(3):298-303. doi: 10.1093/ageing/afm026. Epub 2007 Mar 24.

ReferenceCitation: O'Connell S, Palmer R, Withers K, Saha N, Puntoni S, Carolan-Rees G; PROMs, PREMs and Effectiveness Programme. Requirements for the collection of electronic PROMS either "in clinic" or "at home" as part of the PROMs, PREMs and Effectiveness Programme (PPEP) in Wales: a feasibility study using a generic PROM tool. Pilot Feasibility Stud. 2018 Jul 4;4:90. doi: 10.1186/s40814-018-0282-8. eCollection 2018.

ReferenceCitation: Duncanson E, Bennett PN, Viecelli A, Dansie K, Handke W, Tong A, Palmer S, Jesudason S, McDonald SP, Morton RL; Symptom monitoring WIth Feedback Trial (SWIFT) Investigators. Feasibility and acceptability of e-PROMs data capture and feedback among patients receiving haemodialysis in the Symptom monitoring WIth Feedback Trial (SWIFT) pilot: protocol for a qualitative study in Australia. BMJ Open. 2020 Nov 6;10(11):e039014. doi: 10.1136/bmjopen-2020-039014.

ReferenceCitation: Anderson KO, Palos GR, Mendoza TR, Cleeland CS, Liao KP, Fisch MJ, Garcia-Gonzalez A, Rieber AG, Nazario LA, Valero V, Hahn KM, Person CL, Payne R. Automated pain intervention for underserved minority women with breast cancer. Cancer. 2015 Jun 1;121(11):1882-90. doi: 10.1002/cncr.29204. Epub 2015 Feb 24.

ReferenceCitation: Adam R, Burton CD, Bond CM, de Bruin M, Murchie P. Can patient-reported measurements of pain be used to improve cancer pain management? A systematic review and meta-analysis. BMJ Support Palliat Care. 2017 Dec;7(4):0. doi: 10.1136/bmjspcare-2016-001137. Epub 2016 Nov 22.

ReferenceCitation: Mooney KH, Beck SL, Friedman RH, Farzanfar R, Wong B. Automated monitoring of symptoms during ambulatory chemotherapy and oncology providers' use of the information: a randomized controlled clinical trial. Support Care Cancer. 2014 Sep;22(9):2343-50. doi: 10.1007/s00520-014-2216-1. Epub 2014 Apr 1.

ReferenceCitation: Vasey B, Ursprung S, Beddoe B, Taylor EH, Marlow N, Bilbro N, Watkinson P, McCulloch P. Association of Clinician Diagnostic Performance With Machine Learning-Based Decision Support Systems: A Systematic Review. JAMA Netw Open. 2021 Mar 1;4(3):e211276. doi: 10.1001/jamanetworkopen.2021.1276.

ReferenceCitation: Adler-Milstein J, Chen JH, Dhaliwal G. Next-Generation Artificial Intelligence for Diagnosis: From Predicting Diagnostic Labels to "Wayfinding". JAMA. 2021 Dec 28;326(24):2467-2468. doi: 10.1001/jama.2021.22396. No abstract available.

ReferenceCitation: Barrachina-Fernandez M, Maitin AM, Sanchez-Avila C, Romero JP. Wearable Technology to Detect Motor Fluctuations in Parkinson's Disease Patients: Current State and Challenges. Sensors (Basel). 2021 Jun 18;21(12):4188. doi: 10.3390/s21124188.

ReferenceCitation: Khalil H, Bell B, Chambers H, Sheikh A, Avery AJ. Professional, structural and organisational interventions in primary care for reducing medication errors. Cochrane Database Syst Rev. 2017 Oct 4;10(10):CD003942. doi: 10.1002/14651858.CD003942.pub3.

ReferenceCitation: Beaudouin, Valérie and Bloch, Isabelle and Bounie, David and Bounie, David and Clémençon, Stéphan and d'Alché-Buc, Florence and Eagan, James and Maxwell, Winston and Mozharovskyi, Pavlo and Parekh, Jayneel, Flexible and Context-Specific AI Explainability: A Multidisciplinary Approach (March 23, 2020). Available at SSRN: https://ssrn.com/abstract=3559477 or http://dx.doi.org/10.2139/ssrn.3559477

ReferenceType: derived

ReferenceCitation: Belmin J, Villani P, Gay M, Fabries S, Havreng-Thery C, Malvoisin S, Denis F, Veyron JH. Real-world Implementation of an eHealth System Based on Artificial Intelligence Designed to Predict and Reduce Emergency Department Visits by Older Adults: Pragmatic Trial. J Med Internet Res. 2022 Sep 8;24(9):e40387. doi: 10.2196/40387.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: JMIR Publications

ipd_sharing_description: anonymized Statistical data will be available

lead_sponsor: Presage

collaborators: Assistance Publique Hopitaux De Marseille


title: Investigation of the Persistence of SARS-CoV-2 in the Olfactory Mucosa of Patients With Prolonged Symptoms of COVID-19 With Neurocognitive Complaints: a Prospective Cross-sectional Multicenter Case / Control Study (NEUROCOVID)

acronym: NEUROCOVID

summary: NEUROCOVID is a prospective multicenter study comparing the proportion of patients with SARS-CoV-2 viral RNA at the level of the olfactory clefts in a group of cases compared to a group of controls as well as the correlations between the virological and cellular abnormalities observed in the olfactory mucosa and the severity of the clinical neurological profile

collaborators:
Hotel Dieu Hospital
Institut Pasteur
Hôpital Lariboisière Fernand Widal

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital Lariboisière-Fernand-Widal
Hôpital Fondation A. de Rothschild


title: Prevalence of High Plasmatic 3-O-Methyldopa Level in a Specific Population of Patients With a Symptomatology Compatible With AADC Deficiency (Aromatic L-Amino Acid Decarboxylase)

acronym: DOPADEF

summary:
O-MethyDopa (3-OMD) is a metabolite of the Dopaminergic pathway that accumulates in case of a default in the neurotransmitter biosynthesis due to a key enzyme deficiency: Aromatic L-Amino Acid Decarboxylase (AADC) deficiency. 3-OMD is a validated biomarker specific for this AADC enzyme defect.

The purpose of this study is to assess the prevalence of the elevation of 3-OMD in a predominantly pediatric targeted population with symptoms compatible with AADC deficiency; that will allow us to specify the indications for this screening test according to the clinical symptoms of the patients with the aim, ultimately, of optimizing the diagnosis of AADC deficiency.

lead_sponsor: University Hospital, Montpellier

location_facility:
Chu de Toulouse
Angers University Hospital

intervention_type: Diagnostic Test


title: Study of the Immunomodulation of the Immune Response in Hidradenitis Suppurativa and in Vitro and ex Vivo Evaluation of a New Therapeutic Strategy (IMOHS)

acronym: IMOHS

summary:
Hidradenitis suppurativa (HS), also known as Verneuil's disease, is a chronic inflammatory dermatosis of the hair follicule located mainly in the skin folds (axillae, inguinal, submammary, etc.).

Currently, treatments are mainly limited to the use of broad-spectrum antibiotics in order to control outbreaks of hidradenitis suppurativa. Surgical treatment is the only curative treatment, but requires disfiguring removals with major scarring consequences.

Pathophysiologically, HS appears to be a primary abnormality of the pilosebaceous-apocrine unit, causing follicular occlusion, followed by the development of perifollicular cysts with commensal bacterial overgrowth, and finally rupture into the dermis causing an exaggerated inflammatory response. At present, few studies have examined the role of the regulatory immune system and its involvement in this disease.

We are also interested in analyzing the impact of new therapeutic strategies on hidradenitis suppurativa, and more particularly the impact of photodynamic therapy (PDT) which is a technique that has been used for a long time in dermatology, notably for the treatment of precancerous and cancerous lesions.

This technique has shown interesting results on inflammatory dermatoses such as acne.

This research consists in studying the immunomodulation of the immune response in HS and in evaluating a new therapeutic strategy based on PDT alone or in combination with antimicrobial peptides (PAMs).

status: Not yet recruiting

lead_sponsor: Lille Catholic University

location_facility: Hôpital Saint Philibert - Service de Chirurgie Viscérale

location_facility: Hôpital Saint Vincent-de-Paul, Service de Dermatologie-Vénéréologie


type: Registry Identifier

title: Phase II Study Evaluating the Safety and Efficacy of NerVFIX Treatment for Trauma or Accidental Nerve Section of the Wrist

summary: The purpose of this open, multicenter trial is to assess the impact of a nerve regeneration conduit made of allogeneic artery or vein from umbilical cord lining on the regeneration of wrist nerve.

lead_sponsor: TBF Genie Tissulaire

location_facility: Institut Chirurgical de la Main et du Membre Supérieur


title: Nephroblastoma With Vena Cava Thrombosis : Multicenter Study Over 20 Years - Analysis of Key Elements of Surgical Management

acronym: VIN

summary:
Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.

The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.

location_facility:
Hôpital Necker-Enfants Malades
Hôpital Kremlin Bicêtre


title: Evaluation of Anti-C1s, Anti-HMGB1 and Anti-C1q Autoantibodies in the Pathogenesis for Patients With Systemic Lupus Erythematosus (SLE)

summary:
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage.

Dysfunction of proteins initially known to initiate the classical pathway for complement activation (C1q and C1s), and their functional interference with the multifunctional protein HMGB1 (High-Mobility Group Box 1), appears to be associated with SLE. On the other hand, C1s, HMGB1 and C1q can be targeted by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies from lupus patients, whose functional impact remains to be explored, in particular for non-canonical functions, independent of the complement activation cascade.

Studies are needed to investigate the pathogenic role of these autoantibodies in SLE, including possible interference with the inactivation of HMGB1.

This project plans to investigate the role of anti-C1s, anti-HMGB1 and anti-C1q autoantibodies in the pathogenesis of Systemic Lupus Erythematosus. This pilot study will be performed for 30 patients with active SLE on serum, realized for routine patient care. The investigators will identify the molecular targets recognized by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies purified from the SLE patients' serum. The investigators will also explore the functional role of these purified autoantibodies.

ReferenceCitation: Dunkelberger JR, Song WC. Complement and its role in innate and adaptive immune responses. Cell Res. 2010 Jan;20(1):34-50. doi: 10.1038/cr.2009.139. Epub 2009 Dec 15.

ReferenceCitation: Macedo AC, Isaac L. Systemic Lupus Erythematosus and Deficiencies of Early Components of the Complement Classical Pathway. Front Immunol. 2016 Feb 24;7:55. doi: 10.3389/fimmu.2016.00055. eCollection 2016.

ReferenceCitation: Schaper F, Westra J, Bijl M. Recent developments in the role of high-mobility group box 1 in systemic lupus erythematosus. Mol Med. 2014 Mar 13;20(1):72-9. doi: 10.2119/molmed.2014.00019.

ReferenceCitation: Yeo JG, Leong J, Arkachaisri T, Cai Y, Teo BH, Tan JH, Das L, Lu J. Proteolytic inactivation of nuclear alarmin high-mobility group box 1 by complement protease C1s during apoptosis. Cell Death Discov. 2016 Sep 12;2:16069. doi: 10.1038/cddiscovery.2016.69. eCollection 2016.

ReferenceCitation: He S, Lin YL. In vitro stimulation of C1s proteolytic activities by C1s-presenting autoantibodies from patients with systemic lupus erythematosus. J Immunol. 1998 May 1;160(9):4641-7.

ReferenceCitation: Moroni G, Quaglini S, Radice A, Trezzi B, Raffiotta F, Messa P, Sinico RA. The value of a panel of autoantibodies for predicting the activity of lupus nephritis at time of renal biopsy. J Immunol Res. 2015;2015:106904. doi: 10.1155/2015/106904. Epub 2015 Feb 26.

ReferenceCitation: Lintner KE, Wu YL, Yang Y, Spencer CH, Hauptmann G, Hebert LA, Atkinson JP, Yu CY. Early Components of the Complement Classical Activation Pathway in Human Systemic Autoimmune Diseases. Front Immunol. 2016 Feb 15;7:36. doi: 10.3389/fimmu.2016.00036. eCollection 2016.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University Hospital, Marseille

location_facility:
CHU Grenoble Alpes
AP-HM_Hôpital de la Conception


title: Computational Medical Imaging (Radiomics) and Prediction of Diffusion/FLAIR Mismatch in Stroke Patients

acronym: RADIOMIXSTROKE

summary:
Stroke is a public health issue and a priority for our institution. MRI plays an essential role in the management of stroke. In this context, the contribution of MRI is diagnostic, etiological and prognostic.

Among the MRI parameters evaluated in the acute phase of the stroke, the evaluation of the mismatch between the DIFFUSION and FLAIR sequences is crucial as it will directly contribute to the therapeutic decision. A FLAIR-diffusion mismatch, i.e., a lesion with a diffusion but not a FLAIR hypersignal, identifies patients whose time of onset of symptoms is probably less than 4.5 hours. It is therefore understandable that the main arterial recanalization techniques performed in the acute phase are primarily reserved for patients with a positive mismatch.

In current practice, mismatch assessment is performed subjectively, by visually comparing the two sequences, which is known to be the cause of a lack of reproducibility and diagnostic performance.

Computational medical imaging techniques ("radiomics") have recently gained momentum and offer the prospect of automated and therefore more reproducible analysis of medical imaging data. In stroke patients, radiomics extracted from FLAIR imaging could thus contribute to describe the "diffusion flair" mismatch in a continuous and objective way.

For the time being, data analysis cannot be performed in real time due to technical constraints. If it is proven that radiomics can reliably analyze the mismatch on the FLAIR sequence alone, the next step will be to make the analysis feasible in clinical routine (i.e. in a time frame adapted to the therapeutic management).

ReferenceCitation: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repositories_concat: CiteSeerX

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Thomalla G, Cheng B, Ebinger M, Hao Q, Tourdias T, Wu O, Kim JS, Breuer L, Singer OC, Warach S, Christensen S, Treszl A, Forkert ND, Galinovic I, Rosenkranz M, Engelhorn T, Kohrmann M, Endres M, Kang DW, Dousset V, Sorensen AG, Liebeskind DS, Fiebach JB, Fiehler J, Gerloff C; STIR and VISTA Imaging Investigators. DWI-FLAIR mismatch for the identification of patients with acute ischaemic stroke within 4.5 h of symptom onset (PRE-FLAIR): a multicentre observational study. Lancet Neurol. 2011 Nov;10(11):978-86. doi: 10.1016/S1474-4422(11)70192-2. Epub 2011 Oct 4.

ReferenceCitation: Qiu W, Kuang H, Nair J, Assis Z, Najm M, McDougall C, McDougall B, Chung K, Wilson AT, Goyal M, Hill MD, Demchuk AM, Menon BK. Radiomics-Based Intracranial Thrombus Features on CT and CTA Predict Recanalization with Intravenous Alteplase in Patients with Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2019 Jan;40(1):39-44. doi: 10.3174/ajnr.A5918. Epub 2018 Dec 20.

ReferenceCitation: Chen Q, Xia T, Zhang M, Xia N, Liu J, Yang Y. Radiomics in Stroke Neuroimaging: Techniques, Applications, and Challenges. Aging Dis. 2021 Feb 1;12(1):143-154. doi: 10.14336/AD.2020.0421. eCollection 2021 Feb.

ReferenceCitation: Tang TY, Jiao Y, Cui Y, Zhao DL, Zhang Y, Wang Z, Meng XP, Yin XD, Yang YJ, Teng GJ, Ju SH. Penumbra-based radiomics signature as prognostic biomarkers for thrombolysis of acute ischemic stroke patients: a multicenter cohort study. J Neurol. 2020 May;267(5):1454-1463. doi: 10.1007/s00415-020-09713-7. Epub 2020 Feb 1.

ReferenceCitation: Feng R, Badgeley M, Mocco J, Oermann EK. Deep learning guided stroke management: a review of clinical applications. J Neurointerv Surg. 2018 Apr;10(4):358-362. doi: 10.1136/neurintsurg-2017-013355. Epub 2017 Sep 27.

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
CHRU Lille
Groupe Hospitalier Paris Saint-Joseph


title: Screening for Familial Hypercholesterolemia in Children Using the Blotter Method, or Dried Blood Spot

acronym: CHOLESPOT

summary:
Purpose:

Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia.

Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture.

The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement

Hypothesis

to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia
to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia

location_facility: Hospices Civils de Lyon, Dept of Endocrinology

location_facility: Hospices Civils de Lyon, Service d'Hépatologie et de Gastro-Entérologie et Nutrition Pédiatrique


title: Effect of Carrot Seed and Rose Hip Extracts on Weight Management in Subjects With Overweight or Moderate Obesity. A Controlled, Randomized and Double-blind Study.

acronym: PHYTOENIX

summary: The aim of this study is to assess the effect of a food supplement containing extracts of carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity.

lead_sponsor: Institut Pasteur de Lille

location_facility: Institute of Cardiometabolism And Nutrition

intervention_type: Dietary Supplement


title: Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women

acronym: PsyCOVIDUMGEN

summary:
In December 2019, infection with a novel coronavirus SARS-CoV-2 emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it carries, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, in the perinatal period, the fear of childbirth also includes a more or less important part of anxiety-producing uncertainty. This addition of stress factors is likely to increase the prevalence of perinatal anxiety disorders, particularly psychotraumatic experiences of childbirth and peri-traumatic dissociative states. Health and social measures, such as confinement, restriction of access of accompanying persons to maternity services, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a mother-infant separation, are also likely to have psychopathological consequences.

Studies specifically concerning the psychological effects of the COVID-19 pandemic context have been published. Among them, the French COVIPREV study, carried out in the general population during the first and second week of the containment period (beginning mid-March 2020), reported a prevalence of anxiety of 26.7% and 21.5% respectively. These prevalences are significantly higher than the usual prevalence estimated at 13.5% in the same population. Many international studies show an increase in the prevalence of postnatal depression in the current pandemic context. In the population of pregnant women, an Italian study on the psychological impact of the COVID-19 pandemic in 100 women in pregnancy, with no psychiatric history, in Naples during the second half of March 2020, found a positive score on the Impact of Event Scale-Revised (IES-R) for more than half of the women and a positive anxiety score on the State-Trait Anxiety Inventory (STAI-S) for 68% of the women The same observation was made in Quebec where two cohorts of pregnant women (between 4 and 41 weeks of amenorrhea) subjected to self-questionnaires evaluating different dimensions of their mental health, a first one recruited before the pandemic phase of 496 women and a second one of 1258 women recruited online between April 2 and 13, 2020, have been analyzed. Women in the second cohort had significantly higher levels of depressive and anxiety symptoms, more dissociative symptoms and post-traumatic stress symptoms. In China, a multicenter study in 25 hospitals in 10 provinces across the country that included 4124 women in the third trimester of pregnancy from January 1 to February 9, 2020, when the epidemic was publicly announced on January 20, 2020, again reported increased levels of anxiety and depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) in pregnant women after the announcement compared to before. Finally, similar results are reported by Turkish researchers showing again a high prevalence of depressive symptoms during pregnancy (35.4%) during the COVID-19 pandemic. In the perinatal context, it has been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression.

In the context of the COVID-19 pandemic, three maternity units of the PREMA University Hospital Federation (FHU PREMA), the Paris Saint-Joseph Hospital Group (GhPSJ), the Louis Mourier Hospital (APHP) and the Port-Royal Maternity Unit (APHP), in partnership with the Boulevard Brune Psychopathology Center (CPBB) and the Psychiatry Department of the Louis Mourier Hospital (APHP), have set up, as of June 2020 a care protocol consisting of a screening offered systematically to women in postpartum at D1 of their delivery, intended to identify those presenting anxiety and depressive perinatal symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Thus, the PsyCOVIDUM project to estimate the prevalence of depressive symptoms in the immediate postpartum period just after delivery at different times during the pandemic episode was initiated in the three FHU PREMA maternity hospitals.

This study aims at the constitution of a DNA and serum biobank in voluntary women presenting or not a depression with an antenatal onset identified at the maternity hospital. This collection would eventually allow the evaluation of the role of inflammatory and genetic biological factors in the occurrence of antenatal onset depression on an independent cohort.

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.

publisher_dissemination: American Medical Association

ReferenceCitation: Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Kayem G, Lecarpentier E, Deruelle P, Bretelle F, Azria E, Blanc J, Bohec C, Bornes M, Ceccaldi PF, Chalet Y, Chauleur C, Cordier AG, Desbriere R, Doret M, Dreyfus M, Driessen M, Fermaut M, Gallot D, Garabedian C, Huissoud C, Luton D, Morel O, Perrotin F, Picone O, Rozenberg P, Sentilhes L, Sroussi J, Vayssiere C, Verspyck E, Vivanti AJ, Winer N, Alessandrini V, Schmitz T. A snapshot of the Covid-19 pandemic among pregnant women in France. J Gynecol Obstet Hum Reprod. 2020 Sep;49(7):101826. doi: 10.1016/j.jogoh.2020.101826. Epub 2020 Jun 4.

ReferenceCitation: Rasmussen SA, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and Pregnancy: Responding to a Rapidly Evolving Situation. Obstet Gynecol. 2020 May;135(5):999-1002. doi: 10.1097/AOG.0000000000003873.

ReferenceCitation: Walker KF, O'Donoghue K, Grace N, Dorling J, Comeau JL, Li W, Thornton JG. Maternal transmission of SARS-COV-2 to the neonate, and possible routes for such transmission: a systematic review and critical analysis. BJOG. 2020 Oct;127(11):1324-1336. doi: 10.1111/1471-0528.16362. Epub 2020 Jul 22.

ReferenceCitation: Shigemura J, Ursano RJ, Morganstein JC, Kurosawa M, Benedek DM. Public responses to the novel 2019 coronavirus (2019-nCoV) in Japan: Mental health consequences and target populations. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-282. doi: 10.1111/pcn.12988. Epub 2020 Feb 23. No abstract available.

ReferenceCitation: Achtyes E, Keaton SA, Smart L, Burmeister AR, Heilman PL, Krzyzanowski S, Nagalla M, Guillemin GJ, Escobar Galvis ML, Lim CK, Muzik M, Postolache TT, Leach R, Brundin L. Inflammation and kynurenine pathway dysregulation in post-partum women with severe and suicidal depression. Brain Behav Immun. 2020 Jan;83:239-247. doi: 10.1016/j.bbi.2019.10.017. Epub 2019 Nov 5.

location_facility:
Groupe Hospitalier Paris Saint-Joseph
Maternité Louis Mourier


title: Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial

summary:
This study is a multicentric randomised (2 groups, ratio 1:1) Post Market Clinical Follow-up trial. 38 subjects (teeth) requiring a simple tooth extraction or multiple tooth extraction on the same quadrant and taking curative or preventive antithrombotic treatment will be included (19 in each group).

The aim of the study is to assess the efficacy of ETIK COLLAGENE (Topical hemostatic collagen-product) on the hemostasis (time to stop bleeding) after tooth extraction.

The hemostasis is measured by assessing the presence of bleeding within the first 8 minutes post-extraction.

Group 1: intra-alveolar placement of ETIK COLLAGENE immediately after tooth extraction.

Group 2: the alveolus is left empty after tooth extraction (the use of ETIK COLLAGENE is delayed 8 minutes after tooth extraction, before suture).

Subjects will be followed-up to 7 days.

lead_sponsor: ACTEON Group

sponsor_collaborators:
ACTEON Group
Slb Pharma

location_facility:
Faculté d'odontologie du CHU Nantes
CSD Rennes


title: Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)

acronym: SEVIRE

summary:
Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with "noisy" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.

Thus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.

The investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.

lead_sponsor: University Hospital, Tours

location_facility: Le Centre universitaire de pédopsychiatrie

location_facility: Pedopsychiatry, University Hospital, Tours

intervention_type: Behavioral

appel_a_projets: PHRIP

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: SEVIRE

titre: Utilisation de la réalité virtuelle immersive pour entrainer les capacités de traitement multisensoriel des enfants de 8 à 16 ans avec un Trouble du Spectre de l'Autisme : Etude pilote randomisée

discipline_principale: psychiatrie / addictologie

nom_porteur: Claire

prenom_porteur: Remi


title: Influence of Podal Sensory Information on Static and Locomotion, Using Foam and Orthopaedic Insoles

summary: Sensory foot integration is evaluated by foam under feet both in research and clinical contexts. However, there is no norm defined regarding foam characteristics and this evaluation is mostly performed using a static task. Our goal is to better understand the impact of the modification of plantar information by foam both during static task and locomotion task. The purpose is to standardize evaluation methods and define reference values for a better follow-up and diagnosis of patients.

lead_sponsor: University of Rennes 2

location_facility:
IFPEK Rennes
M2S laboratory


title: Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries

acronym: BEBEDOL

summary: Understanding babies' signals is essential to meet their needs. Recent works suggest that crying provides useful information, not only allowing parents to recognize their baby among others (static information), but also to distinguish between mild discomfort and pain cries (dynamic information). The perception of this information by adults involves a "parental" brain network including brain areas involved in empathy, attention, emotional regulation, motor as well as regions of the limbic system or associated with the reward network.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
HCL
Chu Saint-Etienne


title: Optimization of a Tool for Predicting Postoperative Clinical Evolution After Lumbar Surgery Multicenter Longitudinal Prospective Study on a National Cohort Clinical Evolution After Lumbar Surgery

acronym: DeepSurgery

summary: The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green (success) orange (treatment failure ), red patient (complication) in order to optimize his medical care up to 6 months.

ReferenceType: result

ReferenceCitation: Andre A, Peyrou B, Carpentier A, Vignaux JJ. Feasibility and Assessment of a Machine Learning-Based Predictive Model of Outcome After Lumbar Decompression Surgery. Global Spine J. 2022 Jun;12(5):894-908. doi: 10.1177/2192568220969373. Epub 2020 Nov 19.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: SAGE Publications

lead_sponsor: Cortexx Medical Intelligence

sponsor_collaborators:
Cortexx Medical Intelligence
Ramsay Générale de Santé
Elsan
Malakoff-Humanis

location_facility:
Polyclinique Jean Villar
Clinique Geoffroy Saint-Hilaire


title: Interest of EMDR (Eye Movement Desensitization and Reprocessing) Psychotherapy in the Management of Schizophrenic Disorders

acronym: EMDRpsychose

summary: The purpose of this study is to determine the interest of the use of EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the management of psychotic disorders, in particular schizophrenic disorders.

status: Terminated

lead_sponsor: Hôpital NOVO

location_facility: Departement of Psychiatry -Hospital Paul Guiraud

location_facility: Departement of Psychiatry - Hospital René Dubos


title: Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Randomized, Double-blind, Placebo-controlled Trial.

acronym: OROSOL

summary:
Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants.

It is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa; An ulcer appears which will increase in size due to subsequent bacterial, fungal and / or viral growth, while the leakage of toxins through damaged capillaries causes irritation and a burning sensation. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing.

Depending on the severity of the ulceration, infection and feeding possibilities, mucositis is scored between grade 0 (absent) and grade 4 (maximum) (according to the WHO (World Health Organization) classification or the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), the latter degree most often requiring a modification of the anticancer treatment which may have an impact on the prognosis of the disease.

Although, theoretically, mucositis is easy to treat because it only requires simple cleaning of the ulcers and stimulation of the growth of the underlying healthy cells to make up for the loss of substance, there are currently only limited symptomatic treatments available.

ReferenceCitation: Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.

ReferenceCitation: Velez I, Tamara LA, Mintz S. Management of oral mucositis induced by chemotherapy and radiotherapy: an update. Quintessence Int. 2004 Feb;35(2):129-36.

ReferenceCitation: Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Centre Jean-Perrin
CHU clermont-ferrand


title: Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.

summary:
Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).

A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo/Centre Jean Bernard


title: Real World Effectiveness of Capmatinib in Patients With Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)

acronym: CapmATU

summary: CapmATU study will evaluate time to treatment failure, progression-free survival, overall survival, best response and safety in patients with advanced MET-dysregulated non-small cell lung cancer who received capmatinib as part of an expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique


title: Study of the Ecological and Evolutionary Dynamics of Escherichia Coli in the Digestive Commensal Flora

acronym: EVE

summary:
Escherichia coli (E. coli) poses a major public health problem. E. coli is not only a commensal of the digestive tract but also a major opportunistic pathogen, first cause of urinary tract infections, first cause of bacteremia. However, little is known about the dynamics of intestinal colonization of the human host. Understanding the dynamics of colonization is crucial because selection for the major traits of E. coli is antibiotic resistance and virulence (the propensity to cause infection) works in commensalism, in the gut, not in infections. This study will make possible for the first time to study the colonization dynamics of E. coli in a large healthy host population.

The main objective is to quantify the succession (gain, loss or replacement) of E. coli strains in the gut microbiota in healthy volunteers and how it depends on the properties of the host and the bacteria. This study will thus provide a better understanding of the E. Coli's epidemiological dynamics and the development of certain traits such as antibiotic resistance.

To reach this goal, the study will take place in two successive phases :

A first pilot phase will first be conducted with 50 healthy volunteers. During this pilot phase, a stool sample will be taken. The strains isolated during this pilot phase will be sequenced, making possible to characterize the strains present and the strains' possible changes between two stool samples. Succession rates will be estimated. The optimal sampling rate that maximizes accuracy in estimating succession rates will be identified and retained for the second phase.

A second phase, a prospective cohort study will also be conducted in 200 healthy volunteers.

During this second phase, healthy volunteers who participated in the first phase will be able to continue their participation and new volunteers will be selected. The healthy volunteers included in the prospective cohort study will be followed up with visits and stool samples which will be defined according to the results of the pilot phase.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Bichat Hospital, Clinical Investigation Center


title: Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

acronym: EGHYA

summary: The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.

time_perspective: Other

collaborators: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility:
APHM
Hopital Sainte Musse


title: Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents - Blood Collection From Patients With Thyroid Disorders

acronym: IFCC-TSH

summary:
Given the prevalence and gravity of thyroid disorders, timely diagnosis, initiation, and monitoring of therapy are important to restrict the impact of the disease on public health. Measurement of serum thyroid stimulating hormone (TSH) concentrations is an indispensable tool to confirm the disease and clinical management.

Reference intervals (RI) reported along with the laboratory data are an integral part of the interpretation process. Since many laboratory measurements are not yet comparable, RIs are typically established for each assay and are considered assay-specific. In this context, physicians who request test results from different laboratories are faced with challenges owing to different RIs. Assay-specific RIs are also problematic for patients who are seen by different doctors/different countries and more generally, assay-specific measurement results limit the development of modern public health standards.

Paramount to the goal of using common RIs is the establishment of metrological traceability of in vitro diagnostic (IVD) medical devices-also called standardization. As the International Federation of Clinical Chemistry (IFCC) Committee for Standardization of Thyroid Function Tests (C-STFT) members, the investigators decided to focus efforts on immunoassays for TSH in partnership with the IVD industry.

Although a reference measurement procedure existed for free thyroxine, the investigators considered this option for TSH unlikely and developed a pragmatic approach to harmonization rather than standardization.

Harmonization is important in order to guarantee comparability of results obtained in different laboratories. The harmonization process is conducted by assigning target values to a large set of samples, based on the results obtained by as many IVD-manufacturers as possible (ref 2). Important here is the fact that these samples must cover the full measuring range of a TSH assay, and so it is necessary to include samples from people with thyroid disease.

The primary objective of the study is the constitution of blood samples collection from patients with thyroid disorders in order to harmonize several commercially available immunoassays used for the determination of thyroid hormone concentrations in the blood.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service D'endocrinologie - Hôpital Louis Pradel - Hospices Civils de Lyon

location_facility: Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon


title: An Experimental Medicine, Low Grade Interventional, Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Advanced Solid Tumours

acronym: IMMUNOPBMC

summary: The aim of the study is to gain knowledge concerning expression of immune markers on immune cell subpopulation of PBMCs from subjects without cancer diagnosis and cancer patients. Few studies have addressed the question of the difference of peripheric immune cells between these two populations without a specific focus on an immune cell population or an indication, and with a multiparametic approach. The present study will combine phenotypic (using cell population markers and immune checkpoints) and functional analyses toallow to better interpret non-clinical results obtained with either subjects without cancer or cancer patient material and provide rationale to use material from subjects without cancer diagnosis for functional tests. It would also argument a go to healthy volunteer's clinical trials for assessing peripheral pharmacodynamic (PD), receptor occupancy (RO) and safety (Cytokine release syndrome, CRS), in the context of early drug development in immuno-oncology. Finally, generated data will be used to feed quantitative system pharmacology (QSP) models to increase their robustness and better predict drug pharmacology in humans.

lead_sponsor: Centre Georges Francois Leclerc

collaborators: Institut de Recherches Internationales Servier

location_facility:
CIC du CHU
Centre Georges Francois Leclerc


title: Pilot Study Evaluating the Feasibility and the Preliminary Effects of a Cognitive Remediation Method by Rhythmic, Vocal and Embodied Musical Learning for Stabilized Schizophrenic Patients.

acronym: ARCoS

summary:
ARCoS is a pilot study evaluating the feasibility and preliminary effects of a method of cognitive remediation by a Rhythmic, Vocal and Embodied Musical Learning for a population of stabilized schizophrenic patients. 20 stabilized schizophrenics patients will participate in the study for 9 months, i) 6 months of Musical learning (24 sessions over the 6 months) ; ii) and 3 months of follow-up post cognitive remediation. Assessments of attention deficits, inhibitory abilities, negative symptoms and anxiety, will carried out at baseline (V1, M0), third month (M3), sixth month (M6) after the start of the intervention and third months after the end of the intervention (M9).

The primary endpoint will be the proportion of patients who have attended at least 80% of the musical training sessions over the 6 months (participation in at least 19/24 sessions).

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse
CH Marchant


title: Prospective, Open Label, Post Marketing Study of the Safety and Effectiveness of HArmonyCa Injectable Gel for Mid-face Soft Tissue Augmentation

acronym: HArmonyCa EUMD

summary: Prospective, open label, post marketing study of the safety and effectiveness of HArmonyCa injectable gel for mid-face soft tissue augmentation

ipd_sharing: Yes

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

lead_sponsor: Allergan

location_facility: Eurofins Dermscan Pharmascan /ID# 240921


title: Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

acronym: DALICATH

summary:
The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit).

As the secondary objectives, the study aims to evaluate according to treatment group:

Cure rate at DAY 14 and DAY 90 (EOS);
Mortality rate within 90 days of follow-up;
Time to negativation of blood cultures;
Patient's quality of life;
Hospitalization length of stay;
Cost-utility analyses;
Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

collaborators: Centre National de Référence des staphylocoques

location_facility: Infectious Diseases Department, CH PERIGUEUX

location_facility: Infectious Diseases Department, Raymond-Poincaré Hospital - APHP