title: Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia

acronym: RIMACI

summary:
The chronic coronary artery disease could be detected by a drop in the expression of A2A receptors to adenosine, while high values of the KD / EC50 ratio are a sign of coronary ischemia. Knowing the number of A2A receptors in circulating lymphocytes could allow detection of coronary artery disease and evaluating the functionality of A2A receptors in circulating lymphocytes could allow quantification of myocardial ischemia.

Thus, a simple and unique blood sample would quickly detect patients with life-threatening coronary ischemia. This would avoid prolonged hospitalizations and costly non-invasive tests (stress echocardiography, myocardial scintigraphy) in patients without coronary artery disease.

location_facility: Assistance Publique Hopitaux de Marseille


type: Other Identifier

title: GENetic Fronto Temporal Dementia Initiative in Lille

acronym: GENFI-LILLE

summary: GENFI Lille is a French cohort that belongs to the international initiative GENFI2, a five year longitudinal biomarker cohort study of genetic FTD and its associated disorders (including MND/ALS) investigating members of families with a known mutation in GRN or MAPT or an expansion in C9orf72 (including those affected with the disorder as well as at-risk members of families).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_facility: Hôpital Roger Salengro, CHRU de Lille - CMRR

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy

summary: This is a transversal monocentric study comparing two groups of women (group 1, patient group : patients who have been treated for a breast cancer with taxane-based chemotherapy ; group 2, control group : healthy volunteers). The aim of this study is to evaluate if a difference exists regarding the maximal isometric muscle strength between group 1 and 2.

status: Completed

study_completion_date_type: Actual

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: Institut de cancérologie Strasbourg Europe

location_facility: Institut de Cancerologie Strasbourg Europe

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Impact of Adipose Tissue in COVID-19 : From Pathophysiology to Therapeutic Perspectives

acronym: COVIFAT

summary: Overweight or obese patients are particularly exposed to severe forms of COVID-19. Few data suggest that adipose tissue infected with SARS-CoV-2 could be involved in the onset of the cytokine storm seen in severe forms of COVID-19. The aim of this study is to determine the pathogenesis of SARS-CoV-2-infection of adipose tissue. In particular the investigators will study how this virus enters the adipocyte and how it modulates metabolism and inflammation in the adipose tissue. From these data, the investigators hope to determine at the adipose tissue level, original therapeutic targets to modulate the effects of SARS-CoV-2 at the systemic level.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Registry Identifier

title: Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases

acronym: Co-VIS

summary: The primary objective of the study is to compare the effectiveness of the use of a transparent covering visor with that of the face mask, with or without the use of video sequences, for speech therapy rehabilitation of oral-linguo-facial praxies in the context of the COVID 19 epidemic.

location_facility: Unité de Soins de Rééducation Post Réanimation, Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP


title: Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old

summary: The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome

lead_sponsor: Hôpital le Vinatier

intervention_type: Behavioral


title: Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients

summary:
This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of :

one group of patients receiving anthracyclines and taxanes
a second group of patients receiving anthracyclines, taxanes and trastuzumab.


title: Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice

acronym: AUTICOPP

summary: The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Hilton CL, Harper JD, Kueker RH, Lang AR, Abbacchi AM, Todorov A, LaVesser PD. Sensory responsiveness as a predictor of social severity in children with high functioning autism spectrum disorders. J Autism Dev Disord. 2010 Aug;40(8):937-45. doi: 10.1007/s10803-010-0944-8.

family: Hilton

full_name: Claudia L. Hilton

given: Claudia L.

sequence: first

family: Harper

full_name: Jacquelyn D. Harper

given: Jacquelyn D.

sequence: additional

family: Kueker

full_name: Rachel Holmes Kueker

given: Rachel Holmes

family: Lang

full_name: Andrea Runzi Lang

given: Andrea Runzi

family: Abbacchi

full_name: Anna M. Abbacchi

given: Anna M.

family: Todorov

full_name: Alexandre Todorov

given: Alexandre

family: LaVesser

full_name: Patricia D. LaVesser

given: Patricia D.

bso_classification: Social sciences

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Autism and Developmental Disorders

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Sensory Responsiveness as a Predictor of Social Severity in Children with High Functioning Autism Spectrum Disorders

ReferenceCitation: Hirvikoski T, Mittendorfer-Rutz E, Boman M, Larsson H, Lichtenstein P, Bölte S. Premature mortality in autism spectrum disorder. Br J Psychiatry. 2016 Mar;208(3):232-8. doi: 10.1192/bjp.bp.114.160192. Epub 2015 Nov 5.

family: Hirvikoski

full_name: Tatja Hirvikoski

given: Tatja

family: Mittendorfer-Rutz

full_name: Ellenor Mittendorfer-Rutz

given: Ellenor

family: Boman

full_name: Marcus Boman

given: Marcus

family: Larsson

full_name: Henrik Larsson

given: Henrik

family: Lichtenstein

full_name: Paul Lichtenstein

given: Paul

family: Bölte

full_name: Sven Bölte

given: Sven

bso_classification: Medical research

journal_name: British Journal of Psychiatry

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Royal College of Psychiatrists

publisher_dissemination: Royal College of Psychiatrists

publisher_group: Royal College of Psychiatrists

publisher_normalized: Royal College of Psychiatrists

ReferenceCitation: Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26.

ReferenceCitation: Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71.

ReferenceCitation: Dubois A, Rattaz C, Pry R, Baghdadli A. [Autism and pain - a literature review]. Pain Res Manag. 2010 Jul-Aug;15(4):245-53. Review. French.

ReferenceCitation: Allely CS. Pain sensitivity and observer perception of pain in individuals with autistic spectrum disorder. ScientificWorldJournal. 2013 Jun 13;2013:916178. doi: 10.1155/2013/916178. Print 2013. Review.

name: Institute of Health and Wellbeing, University of Glasgow, RHSC Yorkhill, Glasgow G3 8SJ, UK

family: Allely

full_name: C. S. Allely

given: C. S.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: The Scientific World Journal

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: University of Salford - University of Salford Institutional Repository

title: Pain Sensitivity and Observer Perception of Pain in Individuals with Autistic Spectrum Disorder

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Prevalence of Laryngeal Disorders After Childhood Cardiac Surgery and Evaluation of Their Long-term Recovery

acronym: RECUP-TML

summary: Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon


title: Cure COVID: A Prospective, Controlled, Randomized Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection

summary: This is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of GNS561 in patients with COVID-19.

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: Genoscience Pharma

intervention_type: Drug


title: Clinical Database and Biobank of Patients With Inflammatory Myopathies: the MASC Project (Myositis, DNA, Serum, Cells) (MASC)

acronym: MASC

summary: Myositis are rare diseases for which the development of a cohort associated with a bank of biological samples (biobank) will allow for the conduct of researches to better delineate the underlying pathophysiology and find cures. This prospective cohort of patients with myositis will allow for identification of factors favouring the occurrence of myositis, whether they are constitutional (genetic) or acquired (environmental or drug). Different subgroups of myositis used for prognostication will be identified based on clinico-demographical variables, the nature of the organs involved beyond peripheral muscles (cardiac, diaphragm) and biomarkers abnormalities.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Internal Medicine and clinical immunology


title: Cardiac Output Measurement in Critically Ill Patient in Sinus Rhythm: a Comparison Between Transpulmonary Thermodilution and Transthoracic Echocardiography

acronym: TPTD-TTE-SR

summary: Cardiac output monitoring is a key component for the diagnosis and management of critically ill patients. The two less invasive methods commonly used in intensive care are transthoracic echocardiography and transpulmonary thermodilution. The objective of this study is to compare accuracy and trending ability of CO measurement by TPTD and TTE in critically ill patients with sinus rhythm.

lead_sponsor: University Hospital, Toulouse


title: Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis

acronym: RACAMYL

summary:
Cardiac amyloidosis is a restrictive cardiomyopathy with a potentially severe prognosis that can be life-threatening. It is linked in the vast majority of cases to a light chain deposition of immunoglobulin or transthyretin. Although myocardial involvement is predominant, other locations are possible: the atrioventricular conduction system, coronary arteries and valve leaflets. In systematic histological analyzes, deposits of amyloidosis infiltrating the aortic valve have been reported with a frequency of up to 74% for degenerative RA. The nature of these deposits has never been established because the immunostaining carried out all remained negative, probably due to decalcification prior to cutting. Currently, these deposits are considered to be local degenerative phenomena without clinical repercussions. However, the use of bone scintigraphy has shown a high prevalence, between 14 and 16%, of ATTR cardiac amyloidosis in patients with severe RA. The diagnosis of ATTR amyloidosis has been proven histologically in a few patients. Sequencing of the TTR gene has shown that they are mainly wild forms. In fact, the prevalence of transthyretin mutations in our local cohort is 20%.

The objective of this study is to determine by proteomic analysis based on mass spectrometry, the prevalence of ATTR aortic valve amyloidosis in patients undergoing surgical valve replacement for degenerative aortic stenosis.

primary_purpose: Prevention


title: Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection

acronym: COVID-CMR

summary: The aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Biological


title: Study of INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit (INFLA-SEPSIS)

acronym: INFLA-SEPSIS

summary: septic shock is the first cause of mortality in intensive care unit. Innate immunity is the body's first line of defense against pathogens


title: Feasibility Study of Smoking Cessation for the Staff of a Hospital Center Through a Treatment Proposal Combining Nicotine Substitutes, Psychological Support, Nutritional Assistance and Hypnosis.

summary: The recorded prevalence of daily smoking among health professionals (doctors, nurses, midwives, etc.), regardless of their mode of practice (salaried or self-employed, etc.) varies between 14 and 23%. In health care institutions, according to the studies, the prevalence of daily smoking among staff, caregivers and non-caregivers ranges from 17% to 27%. These professionals who continue to smoke, although they are particularly well informed about the risks they run, probably constitute a group with specific withdrawal difficulties. Beyond the impact on their own health, the smoking status of caregivers could also have an impact on the management of tobacco patients. There are very few studies of the impact of interventions on the smoking status of caregivers in health care facilities. The combination of several intervention modalities can facilitate the participation of target professionals and generate efficiency synergies.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: The Association Between Central Serous Chorioretinopathy and the Obstructive Sleep Apnea

acronym: CRSA

summary: This goal of this study is to know the association between the central serous chorioretinopathy and the obstructive sleep apnea. Many studies have been done in order to assess the association between the central serous chorioretinopathy and obstructive sleep apnea and the results are always controverses actually.

time_perspective: Retrospective

lead_sponsor: Poitiers University Hospital


title: Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study

acronym: ProneSpontCov

summary: Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Höpitaux de Marseille


title: Clinical Evaluation of a Multipurpose CZT Camera in Gated Tomographic Radionuclide Angiography: a Head to Head Comparison With a Cardiac Dedicated CZT Device

acronym: STARGAC

summary:
Tomographic radionuclide angiography (or blood pool) is a reproducible method to evaluate left ventricular ejection fraction that is needed during oncological treatments or to evaluate cardiopathies.

Cardiac-dedicated CZT systems allowed dose or time reduction. Multipurpose CZT cameras have not yet been evaluated in this indication. Moreover, the impact of attenuation correction is not known.

ReferenceType: background

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

ReferenceCitation: Carver JR, Shapiro CL, Ng A, Jacobs L, Schwartz C, Virgo KS, Hagerty KL, Somerfield MR, Vaughn DJ; ASCO Cancer Survivorship Expert Panel. American Society of Clinical Oncology clinical evidence review on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects. J Clin Oncol. 2007 Sep 1;25(25):3991-4008. Epub 2007 Jun 18. Review.

ReferenceCitation: Curigliano G, Cardinale D, Suter T, Plataniotis G, de Azambuja E, Sandri MT, Criscitiello C, Goldhirsch A, Cipolla C, Roila F; ESMO Guidelines Working Group. Cardiovascular toxicity induced by chemotherapy, targeted agents and radiotherapy: ESMO Clinical Practice Guidelines. Ann Oncol. 2012 Oct;23 Suppl 7:vii155-66.

ReferenceCitation: Garcia EV, Faber TL, Esteves FP. Cardiac dedicated ultrafast SPECT cameras: new designs and clinical implications. J Nucl Med. 2011 Feb;52(2):210-7. doi: 10.2967/jnumed.110.081323. Epub 2011 Jan 13. Review.

ReferenceCitation: Garcia EV. Are SPECT measurements of myocardial blood flow and flow reserve ready for clinical use? Eur J Nucl Med Mol Imaging. 2014 Dec;41(12):2291-3. doi: 10.1007/s00259-014-2924-2.

ReferenceCitation: Slomka PJ, Berman DS, Germano G. New cardiac cameras: single-photon emission CT and PET. Semin Nucl Med. 2014 Jul;44(4):232-51. doi: 10.1053/j.semnuclmed.2014.04.003. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.

acronym: PICOFLAP

summary: A fibula free flap can be used for the reconstruction of a mandible or a maxillar when the lack of bonne exceeds 3cm. This flap is made of the fibula bone, some muscle around, the fibular vascular pedicle and a skin paddle to reconstruct the gum. Once this flap has been taken and transposed on the face, the leg is closed with a split thickness skin graft to replace the skin paddle. But the healing on this site is often a problem: this is partly due to the high rate of early graft's loss due to local devascularization (3 to 55% of loss). The skin grafting is generally improved by the application of a dressing sewn and left in place during 5 to 7 days postoperative (standard method). This study will evaluate the efficiency of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites, compared to the standard method. A prospective randomized evaluation will be done, comparing the PICO® to a conventional dressing. The main aim of the study is the evaluation of the impact of this portative system on the healing of the skin grafted donor site, in terms of rate of skin take, time of healing, complications and medical costs. The patients will be seen preoperatively to decide on their inclusion in the protocol. They will be reviewed at day 10 to evaluate the engraftment and possible local complications on the donor site. They will then be reviewed at day 20 and day 30 and until complete healing. The follow up will be of 12 months maximum. A medical cost evaluation will be done comparing the costs generated by the care on the donor site in the 2 groups.

lead_sponsor: University Hospital, Montpellier

intervention_type: Device


title: Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site

acronym: RESPECT

summary: This is a non randomized, monocentric, descriptive, transversal and prospective study. The purpose of this study is to assess the compliance with patient expressed choice regarding subsequent care and death -if occured- site (at hospital or at home) after hospitalisation for terminally ill patients with an onco-hematologic solid tumor in palliative care and to identify reasons for potential non-compliance.


type: Other Grant/Funding Number

title: Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development in the Human Fallopian Tube: TUBPOP.

acronym: TUBPOP

summary: In order to evaluate if gametes and preimplantation embryos are in vivo exposed to environmental chemicals, the detection of 6 molecules representative of 3 persistent organic pollutants families will be performed in the mucosa of fallopian tubes obtained after bilateral salpingectomy performed for sterilization purpose in 20 women and compared with concentrations in adipose tissue. This feasibility study is a preliminary step before larger clinical surveys and in vitro studies.

ReferenceCitation: Rappaport SM. Genetic Factors Are Not the Major Causes of Chronic Diseases. PLoS One. 2016 Apr 22;11(4):e0154387. doi: 10.1371/journal.pone.0154387. eCollection 2016.

ReferenceCitation: Lee DH, Jacobs DR Jr, Porta M. Hypothesis: a unifying mechanism for nutrition and chemicals as lifelong modulators of DNA hypomethylation. Environ Health Perspect. 2009 Dec;117(12):1799-802. doi: 10.1289/ehp.0900741. Epub 2009 Jul 8.

ReferenceCitation: Dereumeaux C, Saoudi A, Pecheux M, Berat B, de Crouy-Chanel P, Zaros C, Brunel S, Delamaire C, le Tertre A, Lefranc A, Vandentorren S, Guldner L. Biomarkers of exposure to environmental contaminants in French pregnant women from the Elfe cohort in 2011. Environ Int. 2016 Dec;97:56-67. doi: 10.1016/j.envint.2016.10.013. Epub 2016 Oct 24.

ReferenceCitation: Lee WC, Fisher M, Davis K, Arbuckle TE, Sinha SK. Identification of chemical mixtures to which Canadian pregnant women are exposed: The MIREC Study. Environ Int. 2017 Feb;99:321-330. doi: 10.1016/j.envint.2016.12.015. Epub 2016 Dec 29.

ReferenceCitation: Watkins AJ, Fleming TP. Blastocyst environment and its influence on offspring cardiovascular health: the heart of the matter. J Anat. 2009 Jul;215(1):52-9. doi: 10.1111/j.1469-7580.2008.01033.x. Epub 2009 Feb 9. Review.


title: Rate of Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele at 10 Years and Over After Rectopexy Intervention.

acronym: PEXITY

summary:
Prolapse of the rectum is a pathology that preferentially affects older women with a significant impact on quality of life. A very large number of therapeutic approaches can be proposed (functional treatment, surgical techniques by perineal approach and surgical techniques by anterior approach).

D'Hoore and Pennix described Ventral Rectopexy with prosthetic reinforcement which is accepted as a standard of treatment in much of Europe for externalized prolapse but remains maligned in much of the world. Due to the relatively recent appearance of this technique and the great variability in the management methods, the long-term results of Ventral Rectopexy have been little studied.

This surgical technique is the preferred approach offered at CHU Grenoble Alpes. Pr Faucheron have internationally recognized experience in surgical grip with a very high patient volume in recent years.

ReferenceCitation: D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5.

ReferenceCitation: Faucheron JL, Voirin D, Riboud R, Waroquet PA, Noel J. Laparoscopic anterior rectopexy to the promontory for full-thickness rectal prolapse in 175 consecutive patients: short- and long-term follow-up. Dis Colon Rectum. 2012 Jun;55(6):660-5. doi: 10.1097/DCR.0b013e318251612e.

ReferenceCitation: Faucheron JL, Trilling B, Girard E, Sage PY, Barbois S, Reche F. Anterior rectopexy for full-thickness rectal prolapse: Technical and functional results. World J Gastroenterol. 2015 Apr 28;21(16):5049-55. doi: 10.3748/wjg.v21.i16.5049. Review.

ReferenceCitation: Trilling B, Sage PY, Reche F, Barbois S, Waroquet PA, Faucheron JL. Early experience with ambulatory robotic ventral rectopexy. J Visc Surg. 2018 Feb;155(1):5-9. doi: 10.1016/j.jviscsurg.2017.05.005. Epub 2018 Feb 1.

lead_sponsor: University Hospital, Grenoble


title: Measuring the Impact of Low Radiotherapy Doses on Bone Marrow

acronym: MIFADORESOL

summary: Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the bone marrow is high. There is a lack of prospective studies and comparative trials to customize the constraints according to the presence or absence of chemotherapy and correlated to the patient's bone marrow potential. This monocentric and prospective study conducted by Strasbourg Europe Cancerology Institute aims to evaluate hematological toxicity (anemia, thrombocytopenia, leukopenia) in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, or cervix cancer. One hundred patients will be included in the study, including patients treated with exclusive radiotherapy, radiochemotherapy, or radiohormonal therapy. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy. Secondary endpoints are the evaluation of viral, bacterial and fungal infections during and for three months following radiotherapy, as well as the evaluation of the impact of radiation-induced hematological toxicity on the administration of chemotherapy for the concerned patients. The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study.


title: Postoperative Score Predictive of the Prognosis of Acetabular Fractures

summary: Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the postoperative reduction. This score is based on the quality of postoperative reduction assessed on pelvic radios. In addition, the thresholds for poor / good results were determined empirically.

ReferenceCitation: Matta JM, Mehne DK, Roffi R. Fractures of the acetabulum. Early results of a prospective study. Clin Orthop Relat Res. 1986 Apr;(205):241-50.

ReferenceCitation: Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.

ReferenceCitation: Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.

family: Verbeek

full_name: Diederik O. Verbeek

given: Diederik O.

family: van der List

full_name: Jelle P. van der List

given: Jelle P.

family: Villa

full_name: Jordan C. Villa

given: Jordan C.

family: Wellman

full_name: David S. Wellman

given: David S.

family: Helfet

full_name: David L. Helfet

given: David L.

journal_name: Journal of Bone and Joint Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Jouffroy P, Sebaaly A, Aubert T, Riouallon G. Improved acetabular fracture diagnosis after training in a CT-based method. Orthop Traumatol Surg Res. 2017 May;103(3):325-329. doi: 10.1016/j.otsr.2016.10.020. Epub 2016 Dec 23.

family: Jouffroy

full_name: P. Jouffroy

given: P.

family: Sebaaly

full_name: A. Sebaaly

given: A.

family: Aubert

full_name: T. Aubert

given: T.

family: Riouallon

full_name: G. Riouallon

given: G.

journal_name: Orthopaedics & Traumatology: Surgery & Research

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Verbeek DO, van der List JP, Moloney GB, Wellman DS, Helfet DL. Assessing Postoperative Reduction After Acetabular Fracture Surgery: A Standardized Digital Computed Tomography-Based Method. J Orthop Trauma. 2018 Jul;32(7):e284-e288. doi: 10.1097/BOT.0000000000001161.

family: Moloney

full_name: Gele B. Moloney

given: Gele B.

journal_name: Journal of Orthopaedic Trauma

title: Assessing Postoperative Reduction After Acetabular Fracture Surgery: A Standardized Digital Computed Tomography–Based Method

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Post-operative Hernias After Radical Cystectomy : Incidence and Risks Factors

summary: Post-operative hernias after cystectomy are frequent (our review of the literature with meta-analysis found an incidence of evisceration at 5%, median eventrations at 8% and peristomal hernias at 14%). These represent a non-negligible and partially morbidity. avoidable, subject to proper assessment of personal and surgical risk factors

status: Active, not recruiting

ipd_sharing_description: NC

intervention_type: Procedure


title: Monocentric Prospective Randomized Controlled Study Comparing the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique (N-Sleeve) in Morbidly Obese Patients

acronym: NSLEEVE

summary: The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique


title: Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections

acronym: CRISBO

summary:
Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI.

The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.


title: Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) in the Critically Ill Patient: Pharmacokinetic Study. (CHLORO-VID)

acronym: CHLORO-VID

summary: This study is a prospective, observational, open, monocentric multisite, pharmacokinetic study of hydroxychloroquine in critically ill patients. The aim of this study is to assess the pharmacokinetic behavior of hydroxychloroquine in COVID-19 critically ill patients treated with crushed hydroxychloroquine tablets (administered enterally using a nasogastric tube).

status: Suspended

status_simplified: Unknown


title: Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

acronym: SASTHMA

summary: There is an increase in the prevalence of obstructive apnea-hypopnea syndrome (OSA) in children for which the pathophysiological explanation is unknown. The main objective is to compare pharyngeal collapsibility in asthmatic children with SHS score > 2.75 or ≤ 2.75 (OSA prediction score validated in French). Secondary objectives: Compare pharyngeal size, tracheal size, loop gain and its components (controller, plant), lung volumes and expired and nasal NO in asthmatic children with SHS score > 2.75 or ≤ 2.75. The bias due to the possible existence of an alveolar hyperventilation syndrome associated with asthma will be taken into account.


title: An Open-label, Non-Comparative Study to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of Mexiletine in Adolescents and Children With Myotonic Disorders

summary: This is an open-label, multi-centre, single arm, interventional study to describe the steady-state PK, safety, and efficacy of mexiletine in paediatric patients (6 to <18 years of age) with myotonic disorders.

lead_sponsor: Lupin Ltd.


title: Molecular Analysis of the Surnantant of Echoguidated Bronchoscopic Cytopunctions in Lung Cancer

acronym: CELTICS

summary: The wide uptake of "liquid biopsy" diagnostics in the care of advanced cancer patients highlights the desire for improved access to tumor allowing accurate tumor genotyping (1). Genotyping of plasma cfDNA is now routine for detection of EGFR driver mutations at diagnosis of NSCLC, or for detection of the EGFR T790M mutation after TKI resistance, and is an emerging approach for the detection of other drivers (HER2 or BRAF mutations, ALK or ROS1 fusions…) (2) or the estimation of tumor mutation burden (TMB) (3). However, the most sensitive plasma genotyping platforms still have a sensitivity of only 70%-80%, such that a negative result requires tissue biopsy confirmation.


title: Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma: a Multicenter Retrospective Study With Review of the Literature

acronym: PROSTEO

summary: Sacrococcygeal teratoma (SCT) is the most common fetal and neonatal tumor. However, predicting factors of evolution, sequelae and relapse are still unreliable because of small-cohort studies. This study aims at identifying prenatal and postnatal prognostic factors of evolution of SCT during pregnancy, of postnatal relapse, and of medium and long-term sequelae (urinary, digestive, esthetic, psychologic) in order to improve parental counseling when the diagnosis of SCT is made during pregnancy.


title: Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift in Patients Who Can't Use CPAP or MAD

acronym: AP-FLUID

summary:
Obstructive sleep apnea (OSA) is characterized by complete or partial upper-airway collapse during sleep associated with sleepiness. OSA causes severe impairments in quality of life (sleepiness, tiredness, concentration difficulties). Moreover, OSA has adverse consequences on the cardiovascular system by causing intermittent hypoxia, increased sympathetic nervous system activation and vascular endothelial dysfunction.

Continuous Positive Airway Pressure (CPAP) and mandibular advanced devices (MAD) remain the two first-line therapies for OSA. However, not all patients are eligible for these treatments or are not able to follow for a lifelong therapy and therefore do not use it consistently.

A recent meta-analysis has confirmed that regular physical activity reduces OSA by approximately 28% (Mendelson et al. 2018). However, an important inter-individual variability exists and no study to date has identified characteristics of patients who respond to these interventions.

The aim of this Prospective study, single-site, non-randomized 4-week trial is to evaluate the impact of a 4-week physical activity intervention on the apnea-hypopnea index (AHI) in OSA patients based on their baseline fluid shift level.

Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.


title: Immediate Suture or Directed Wound Healing? Comparative Study of Their Respective Values Following a Punch Skin Biopsy (CICAT)

acronym: CICAT

summary: The skin punch-biopsies are frequently used technical acts in the current medical practice. However, while these skills are actually easy to perform, the subsequent healing procedure remains still poorly harmonized. Indeed, it usually depends on the physicians personal experiences and some preconceived considerations without any reliable scientific background. This study aims to explore the performances of a directed wound healing behaviour in comparison with the suture.

lead_sponsor: Centre Hospitalier le Mans


title: Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain

acronym: TICKLE

summary: Also known as a "moving itch", knismesis is a mildly annoying sensation caused by a light movement on the skin, such as from a crawling insect. Its underlying mechanism rely on spatial summation, i.e. amplification of the signal due to summation of stimulated fields, like it is for dynamic allodynia in neuropathic pain. This physiological study aims at determining the physical factors of the cutaneous stimulation inducing knismesis as well as the effect of confounding factors. The main area of exploration will be the back, because of its size and the possibility to blind the participant. The information collected, along with animal data in surrogate models, would help to better understand neuropathic pain in the future.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Comparison of Woven EndoBridge Device Sizing With Conventional Measurements and Virtual Simulation Using the Sim&Size Software: A Multi-Center Experience

acronym: VS-WEB

summary: Selection of the appropriate size of the device is mandatory during aneurysm treatment with a WEB. The Investigators aimed to investigate if virtual simulation with Sim&Size software may have an impact on technical, angiographic, and clinical outcomes after WEB treatment. Data from two large-volume centers were collected and compared (January 2017-January 2020). Virtual simulation was systematically adopted in one center, while conventional sizing was used in the other one. Outcomes were the duration of intervention, the radiation dose (mGy), the number of corrective interventions for inappropriate WEB size, the number of WEBs not deployed, angiographic occlusion, and complications. Univariate and multivariate linear models were adopted.

ReferenceType: derived

ReferenceCitation: Cagnazzo F, Marnat G, Ferreira I, Daube P, Derraz I, Dargazanli C, Lefevre PH, Gascou G, Riquelme C, Morganti R, Berge J, Gariel F, Barreau X, Costalat V. Comparison of Woven EndoBridge device sizing with conventional measurements and virtual simulation using the Sim&Size software: a multicenter experience. J Neurointerv Surg. 2021 Oct;13(10):924-929. doi: 10.1136/neurintsurg-2020-017060. Epub 2020 Dec 23.

family: Cagnazzo

full_name: Federico Cagnazzo

given: Federico

family: Marnat

full_name: Gaultier Marnat

given: Gaultier

family: Ferreira

full_name: Ivan Ferreira

given: Ivan

family: Daube

full_name: Pierre Daube

given: Pierre

family: Derraz

full_name: Imad Derraz

given: Imad

family: Dargazanli

full_name: Cyril Dargazanli

given: Cyril

family: Lefevre

full_name: Pierre-Henri Lefevre

given: Pierre-Henri

family: Gascou

full_name: Gregory Gascou

given: Gregory

family: Riquelme

full_name: Carlos Riquelme

given: Carlos

family: Morganti

full_name: Riccardo Morganti

given: Riccardo

family: Berge

full_name: Jérôme Berge

given: Jérôme

family: Gariel

full_name: Florent Gariel

given: Florent

family: Barreau

full_name: Xavier Barreau

given: Xavier

family: Costalat

full_name: Vincent Costalat

given: Vincent

journal_name: Journal of NeuroInterventional Surgery

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: Prospective Comparative Study of the SoCoLoc vs ISAR Scales for the Identification of Complex Elderly Patients in the Emergency Department of the Annecy Genevois Hospital.

acronym: SOCOLOC

summary:
With the help of medical progress, life expectancy has increased in our country, resulting in an increase in the number of elderly people and especially so-called complex patients. These complex elderly patients present with a combination of poly pathology, locomotor disorders and loss of autonomy, which leads to increased risks of hospitalization, re-hospitalization or difficulty in remaining at home. These risks could be reduced by early adapted care specific to this type of patient. To do this, it is necessary to identify these complex elderly patients as early as possible in their care pathway.

Screening complex elderly patients in the emergency department would require trained and educated staff, or the use of a simple, rapid and reliable diagnostic scale. The purpose of this study is to compare two scales for the screening of complex elderly patients, whose use is adapted to the Hospital Emergency Department environment.

This study assess the diagnostic performance of the ISAR and SoCoLoc scales for complex elderly patients.

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Influence of the COVId-19 Pandemic on STRESS and Eating Habits

acronym: COVISTRESSNutr

summary: The Coronavirus has caused containment of more than a third of the world's population. Containment can drastically change lifestyle habits, including eating habits such as the number of meals, meal times or their composition. However, there is currently no data on the influence of confinement on eating habits.


title: Bimodal and Coaxial High Resolution Ophtalmic Imaging

acronym: AOSLO-OCT

summary:
The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques.

The use of an adaptive optics system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many retinal microstructures: photoreceptors, vessels, bundles of nerve fibers.

Recently, the development of the coupling of the two main imaging techniques, the Adaptive Optics Ophthalmoscope with Optical Coherence Tomography, enables unparalleled three-dimensional in vivo cell-scale imaging, while remaining comfortable for the patients.

The purpose of this project is to evaluate the performance of this system for imaging micrometric retinal structures.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Impact of Arterial Cannulation Site on Vasopressor Requirement During Cardiac Surgery: a Monocentric Prospective Cohort Study

acronym: ATRAP-GCS

summary: Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.

lead_sponsor: Hospices Civils de Lyon


title: Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy

acronym: RELATE

summary: This observational study as an objective of characterizing the population of patients treated within the neurovascular unit of the Pierre Wertheimer hospital (Hospices Civils de Lyon) in order to determine their phenotype (age, sex, risk factors, etc.) and its evolution over time. It also aims to assess the management of ischemic stroke (IS) in the neurovascular unit of Pierre Wertheimer Hospital. We will assess in particular the pre-hospital and hospital care times, the type of medical care (thrombolysis and / or thrombectomy) as well as the efficiency of this care (effective recanalization, outcome of patient, etc.).


title: Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers

acronym: COVISTRESSWork

summary: Coronavirus has caused containment of more than half of the world's population and a major and rapid reorganization of clinical and support services. The spread of coronavirus (COVID-19) has posed significant challenges for occupational health services. However, there is currently no data on the influence of this epidemic on the practice and feelings of dental surgeons and associates


title: Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)

acronym: RE-CoV-ERY

summary:
For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS.

The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).


title: Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome

acronym: QUAVIMAX

summary: The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?

acronym: ACTI-MPJ-BM

summary:
Periodic Limb Movements during Sleep (PLMs) are episodes of repetitive, stereotypical, hallux or foot movements. They could induce sleep disturbance, fatigue, daytime sleepiness and impaired quality of life but also increased cardiovascular risk by rising heart rate and blood pressure at night. Gold standard for PLMs diagnosis is based on electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG).

PLMs prevalence is higher in patients with spinal cord injury (SCI) possibly due to a loss of encephalic inhibition on a spinal motion generator. In these patients, PLMs can also be wrongly considered as spasms sometimes leading to the unjustified implantation of an intrathecal Lioresal pump.

In the general population, drug treatments for PLMs, particularly dopamine agonists, limit the impact of these abnormal movements on sleep fragmentation, daytime alertness and quality of life. Underdiagnosed PLMs in SCI patients can lead to exacerbate cognitive, mood and painful disorders due to the close interaction between sleep disorders and neurocognitive, psychological and painful manifestations.

PLMs appropriate diagnosis appeared mandatory in those patients but accessibility and delayed availability remain challenging. In addition, sleep laboratories are often unable to accommodate with SCI patients.

In this context, actigraphy, an easy-to-use, cheaper and easily renewable diagnostic tool would be interesting. In the general population, sensitivity to diagnose PLMs was between 0.79 and 1 and specificity between 0.6 and 0.83. Due to lower limbs impairment, increased specificity is expected SCI patients (decrease voluntary activity).

The new generation of actigraph (MotionWatchR) could have better characteristics thanks to the development of a specific software which integrate both lower limbs in the same analysis.

As primary objective, this prospective monocentric study aims to evaluate the performances of lower limbs actigraphy for PLMs diagnosis versus gold standard.

ReferenceCitation: Siddiqui F, Strus J, Ming X, Lee IA, Chokroverty S, Walters AS. Rise of blood pressure with periodic limb movements in sleep and wakefulness. Clin Neurophysiol. 2007 Sep;118(9):1923-30. Epub 2007 Jun 27.

ReferenceCitation: Proserpio P, Lanza A, Sambusida K, Fratticci L, Frigerio P, Sommariva M, Stagni EG, Redaelli T, De Carli F, Nobili L. Sleep apnea and periodic leg movements in the first year after spinal cord injury. Sleep Med. 2015 Jan;16(1):59-66. doi: 10.1016/j.sleep.2014.07.019. Epub 2014 Oct 7.

ReferenceCitation: Foschi M, Rizzo G, Liguori R, Avoni P, Mancinelli L, Lugaresi A, Ferini-Strambi L. Sleep-related disorders and their relationship with MRI findings in multiple sclerosis. Sleep Med. 2019 Apr;56:90-97. doi: 10.1016/j.sleep.2019.01.010. Epub 2019 Jan 21. Review.

ReferenceCitation: Telles SC, Alves RS, Chadi G. Spinal cord injury as a trigger to develop periodic leg movements during sleep: an evolutionary perspective. Arq Neuropsiquiatr. 2012 Nov;70(11):880-4. Review.

ReferenceCitation: Levy J, Hartley S, Mauruc-Soubirac E, Leotard A, Lofaso F, Quera-Salva MA, Bensmail D. Spasticity or periodic limb movements? Eur J Phys Rehabil Med. 2018 Oct;54(5):698-704. doi: 10.23736/S1973-9087.17.04886-9. Epub 2017 Dec 4.

ReferenceCitation: Allen R. Dopamine and iron in the pathophysiology of restless legs syndrome (RLS). Sleep Med. 2004 Jul;5(4):385-91. Review.

ReferenceCitation: Guilleminault C, Flagg W. Effect of baclofen on sleep-related periodic leg movements. Ann Neurol. 1984 Mar;15(3):234-9.

ReferenceCitation: Plante DT. Leg actigraphy to quantify periodic limb movements of sleep: a systematic review and meta-analysis. Sleep Med Rev. 2014 Oct;18(5):425-34. doi: 10.1016/j.smrv.2014.02.004. Epub 2014 Feb 17. Review.

ReferenceCitation: Kobayashi M, Namba K, Ito E, Nishida S, Nakamura M, Ueki Y, Furudate N, Kagimura T, Usui A, Inoue Y. The validity of the PAM-RL device for evaluating periodic limb movements in sleep and an investigation on night-to-night variability of periodic limb movements during sleep in patients with restless legs syndrome or periodic limb movement disorder using this system. Sleep Med. 2014 Jan;15(1):138-43. doi: 10.1016/j.sleep.2013.08.790. Epub 2013 Oct 31.

ReferenceCitation: Ferri R, Fulda S, Manconi M, Högl B, Ehrmann L, Ferini-Strambi L, Zucconi M. Night-to-night variability of periodic leg movements during sleep in restless legs syndrome and periodic limb movement disorder: comparison between the periodicity index and the PLMS index. Sleep Med. 2013 Mar;14(3):293-6. doi: 10.1016/j.sleep.2012.08.014. Epub 2012 Oct 12.

location_facility: Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP


title: Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?

acronym: BIOHACK

summary: Novel concepts in quantum biology of rotator cuff repair9-11 and author's novel findings on biomodulation12 inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. In this proof-of-concept trial, 146 patients will be randomized 1:1 to either a 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol or a control group immobilized in a standard abduction sling for 6 weeks. Healing will be evaluated using the Sugaya classification on MRI at 1 year post-operatively.

lead_sponsor: Clinique Générale dAnnecy


title: Impact of the COVID-19 Epidemic on the Hospital Journey of Patients With Cancer of the Digestive System: Description of Typical Pathways and Simulation Model

acronym: KOVID

summary:
The hospital care of patients with cancerous pathology is part of a multidisciplinary care path that includes many stages. The treatment conditions in this course vary depending on the reasons that led to suspect the existence of a cancerous pathology: accidental discovery, screening, warning signs (sometimes expressed in an acute form) or referral for treatment in charge after the diagnosis has already been made. As soon as the patient presents to the hospital, various expertises are mobilized to establish the diagnosis, carry out the extension assessment and assess the comorbidities and conditions that may have an impact on the choice of treatments. During this initial evaluation, each file is evaluated in a Multidisciplinary Consultation Meeting to define the optimal therapeutic strategy which will often include several stages involving surgery, radiotherapy, medical oncology (chemotherapy, immunotherapy, targeted therapy, etc. hormone therapy), interventional radiology, and / or supportive oncological care (nutrition, pain treatment, correction of metabolic abnormalities, palliative care, etc.). This treatment path is considered to be very complex and the fluidity of its organization determines the processing times.

The management of patients in a cancer department may vary depending on the organization specific to each hospital. The health crisis induced by the COVID-19 epidemic, associated with the containment measures put in place from March 19 to May 11, 2020, have limited the use of patients in hospitals, even for emergency activities. It has also led to a reorganization of scheduled activities within establishments, with a concentration of resources around unscheduled care, in particular COVID patients. In many establishments, the other activities were, for many, deprogrammed with postponed appointments. The impact of this epidemic on the hospital journey of patients with cancerous pathology is the subject of questions at the national level. The delays in diagnosis and treatment induced have possibly had an impact on the quality of the care and on the delays with, as a corollary, a possible loss of opportunity for the patient.

ReferenceCitation: Belle A, Barret M, Bernardini D, Tarrerias AL, Bories E, Costil V, Denis B, Gincul R, Karsenti D, Koch S, Laquiere A, Lecomte T, Quentin V, Rahmi G, Robaszkiewicz M, Vaillant E, Vanbiervliet G, Vienne A, Dumeiran F, Gronier O, Chaussade S; French Society of Digestive Endoscopy (Société Française d'Endoscopie Digestive). Impact of the COVID-19 pandemic on gastrointestinal endoscopy activity in France. Endoscopy. 2020 Dec;52(12):1111-1115. doi: 10.1055/a-1201-9618. Epub 2020 Jun 17.

name: Gastroenterology and Digestive Oncology, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France

family: Belle

full_name: Arthur Belle

given: Arthur

family: Barret

full_name: Maximilien Barret

given: Maximilien

name: Gastroenterology Department, La Casamance Private Hospital, Aubagne, France

family: Bernardini

full_name: David Bernardini

given: David

name: Gastroenterology Department, Hôpital Foch, Suresnes, Île-de-France, France

family: Tarrerias

full_name: Anne-Laure Tarrerias

given: Anne-Laure

name: Gastroenterology Department, Hôpital Privé de Provence, Aix En Provence, France

family: Bories

full_name: Erwan Bories

given: Erwan

name: Gastroenterology Department, Pôle Santé des 4 Temps, Puteaux, France

family: Costil

full_name: Vianna Costil

given: Vianna

name: Médecine A, Hôpital Pasteur, Colmar, France

family: Denis

full_name: Bernard Denis

given: Bernard

name: Service de Gastroentérologie, Hôpital Edouard Herriot, Lyon, France

family: Gincul

full_name: Rodica Gincul

given: Rodica

name: Digestive Endoscopy Unit, Clinique de Paris-Bercy, Charenton-le-Pont, France

family: Karsenti

full_name: David Karsenti

name: Gastroenterology Department, CHU Besançon, Besançon, France

family: Koch

full_name: Stephane Koch

given: Stephane

name: Gastroenterology Department, Hôpital St Joseph, Marseille, France

family: Laquiere

full_name: Arthur Laquiere

name: Department of Hepatogastroenterology and Digestive Oncology, Trousseau University Hospital, Tours, France

family: Lecomte

full_name: Thierry Lecomte

given: Thierry

name: Digestive Endoscopy Unit, Hôpital St Brieuc, St Brieuc, France

family: Quentin

full_name: Vincent Quentin

name: Gastroenterology and Digestive Endoscopy, Georges Pompidou European Hospital, Paris, France

family: Rahmi

full_name: Gabriel Rahmi

given: Gabriel

name: Department of Gastrointestinal Endoscopy, CHRU de Brest, Brest, France

family: Robaszkiewicz

full_name: Michel Robaszkiewicz

given: Michel

name: Department of Gastroenterology, Centre médical du Nord, Lille, France

family: Vaillant

full_name: Eric Vaillant

given: Eric

name: Digestive Endoscopy, Hôpital de L'Archet 2, Nice, France

family: Vanbiervliet

full_name: Geoffroy Vanbiervliet

given: Geoffroy

name: Department of Gastroenterology, Hôpital privé d'Anthony, Anthony, France

family: Vienne

full_name: Ariane Vienne

given: Ariane

name: Gastroenterology Department, Société française d'endoscopie digestive, Limoges, France

family: Dumeiran

full_name: Franck Dumeiran

given: Franck

name: Department of Gastroenterology and Hepatology, Clinique Sainte Barbe, Strasbourg, France

family: Gronier

full_name: Olivier Gronier

given: Olivier

family: Chaussade

full_name: Stanislas Chaussade

given: Stanislas

name: for the French Society of Digestive Endoscopy (Société Française d’Endoscopie Digestive)

journal_name: Endoscopy

oa_colors: green other

ReferenceCitation: Søreide K, Hallet J, Matthews JB, Schnitzbauer AA, Line PD, Lai PBS, Otero J, Callegaro D, Warner SG, Baxter NN, Teh CSC, Ng-Kamstra J, Meara JG, Hagander L, Lorenzon L. Immediate and long-term impact of the COVID-19 pandemic on delivery of surgical services. Br J Surg. 2020 Sep;107(10):1250-1261. doi: 10.1002/bjs.11670. Epub 2020 Apr 30. Review.

name: Department of Gastrointestinal Surgery, Stavanger University Hospital, Stavanger, Norway

name: Department of Clinical Medicine, University of Bergen, Bergen, Norway

name: Department of Surgery, Sunnybrook and University of Toronto, Toronto, Ontario, Canada

name: Department of Surgery, University of Chicago, Chicago, Illinois, USA

name: Department for General, Visceral and Transplant Surgery, Frankfurt University Hospital, Goethe University, Frankfurt/Main, Germany

name: Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway

name: Institute of Clinical Medicine, University of Oslo, Oslo, Norway

name: Department of Surgery, Chinese University of Hong Kong, Hong Kong, China

name: Department of Surgery, Hospital Clinico San Carlos, Madrid, Spain

name: Department of Surgery, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori, Milan, Spain

name: City of Hope Comprehensive Cancer Center, Duarte, California, USA

name: Melbourne School of Public Health, University of Melbourne, Melbourne, Victoria, Australia

name: Institute of Surgery, St Luke's Medical Centre, Metro Manila, Philippines

name: Department of Surgery, Makati Medical Centre, Makati, Philippines

name: Department of General Surgery, National Kidney and Transplant Institute, Quezon City, Philippines

name: Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada

name: Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA

name: Department of Plastic and Oral Surgery, Boston Children's Hospital, Boston, Massachusetts, USA

name: Lund University WHO Collaborating Centre for Surgery and Public Health, Paediatric Surgery, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden

name: General Surgery Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Catholic University, Rome, Italy

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Grosclaude P, Azria D, Guimbaud R, Thibault S, Daubisse-Marliac L, Cartron G, Renaudie MJ, Dalbies PA, Delord JP, Bauvin E. [COVID-19 impact on the cancer care structuration: Example of the multidisciplinary team meeting dedicated to oncology in Occitanie]. Bull Cancer. 2020 Jul - Aug;107(7-8):730-737. doi: 10.1016/j.bulcan.2020.05.001. Epub 2020 May 18. French.

title: Impact du SARS-CoV2 sur la structuration de la prise en charge du cancer : exemple de la tenue des RCP de cancérologie en Occitanie

ReferenceCitation: Sud A, Jones ME, Broggio J, Loveday C, Torr B, Garrett A, Nicol DL, Jhanji S, Boyce SA, Gronthoud F, Ward P, Handy JM, Yousaf N, Larkin J, Suh YE, Scott S, Pharoah PDP, Swanton C, Abbosh C, Williams M, Lyratzopoulos G, Houlston R, Turnbull C. Collateral damage: the impact on outcomes from cancer surgery of the COVID-19 pandemic. Ann Oncol. 2020 Aug;31(8):1065-1074. doi: 10.1016/j.annonc.2020.05.009. Epub 2020 May 19.

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Gelman A, Rubin DB. Markov chain Monte Carlo methods in biostatistics. Stat Methods Med Res. 1996 Dec;5(4):339-55.


title: HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment

acronym: HLA-G-COVID

summary: The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.

lead_sponsor: Hopital Foch


title: Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging

acronym: NEW MEG

summary: Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.


title: Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia

acronym: DENWOLUTION

summary:
Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, especially in tropical and sub-tropical countries. A promising strategy aimed at blocking the circulation of arboviruses is to release Aedes aegypti mosquitoes carrying the endosymbiotic bacterium Wolbachia. In 2019, the Wolbachia strategy was implemented in Nouméa as part of the World Mosquito Program. This intervention will modify the epidemiological profile of arboviruses in New Caledonia.

Epidemiological surveillance of arboviruses requires molecular characterization of the virus contained in the serum obtained from the blood collected from patients. This molecular characterization by RNA isolation techniques, RT-qPCR monitoring and sequencing allows the construction of phylogenetic trees.

In the context of the implementation of the World Mosquito Program in Nouméa, the investigators plan to follow the molecular evolution of arboviruses, over the period preceding the releases of mosquitoes carrying Wolbachia (from 1995 to 2019) then over a period of 5 years. following the releases.

At the same time, the virus can be isolated by cell culture techniques and in vitro infections, allowing its study in vitro in cells or in vivo in mosquitoes. This study allows us to measure the impact of the Wolbachia strategy on the evolution of the virus's ability to replicate in cells in the presence of Wolbachia and to be transmitted by the mosquito.

ReferenceCitation: Inizan C, Minier M, Prot M, O'Connor O, Forfait C, Laumond S, Marois I, Biron A, Gourinat AC, Goujart MA, Descloux E, Sakuntabhai A, Tarantola A, Simon-Lorière E, Dupont-Rouzeyrol M. Viral evolution sustains a dengue outbreak of enhanced severity. Emerg Microbes Infect. 2021 Dec;10(1):536-544. doi: 10.1080/22221751.2021.1899057.

name: URE Dengue and Arboviruses, Institut Pasteur in New Caledonia, Institut Pasteur International Network, Nouméa, New Caledonia

family: Inizan

full_name: Catherine Inizan

given: Catherine

family: Minier

full_name: Marine Minier

given: Marine

name: Evolutionary genomics of RNA viruses, Institut Pasteur, Paris, France

family: Prot

full_name: Matthieu Prot

given: Matthieu

family: O’Connor

full_name: Olivia O’Connor

given: Olivia

name: Health Authorities (DASS), Nouméa, New Caledonia

family: Forfait

full_name: Carole Forfait

given: Carole

family: Laumond

full_name: Sylvie Laumond

given: Sylvie

name: Internal medicine and infectious diseases department, Territorial Hospital Center (CHT), Dumbéa, New Caledonia

family: Marois

full_name: Ingrid Marois

given: Ingrid

name: Microbiology laboratory, Territorial Hospital Center (CHT), Dumbéa, New Caledonia

family: Biron

full_name: Antoine Biron

given: Antoine

family: Gourinat

full_name: Ann-Claire Gourinat

given: Ann-Claire

family: Goujart

full_name: Marie-Amélie Goujart

given: Marie-Amélie

family: Descloux

full_name: Elodie Descloux

given: Elodie

name: Functional genetics of infectious diseases Unit, Institut Pasteur, Paris, France

name: CNRS UMR2000: Génomique évolutive, modélisation et santé (GEMS), Paris, France

family: Sakuntabhai

full_name: Anavaj Sakuntabhai

given: Anavaj

name: URE Epidemiology, Institut Pasteur in New Caledonia, Institut Pasteur International Network, Nouméa, New Caledonia

family: Tarantola

full_name: Arnaud Tarantola

given: Arnaud

family: Simon-Lorière

full_name: Etienne Simon-Lorière

given: Etienne

family: Dupont-Rouzeyrol

full_name: Myrielle Dupont-Rouzeyrol

given: Myrielle

currency_apc_doaj: GBP

journal_name: Emerging Microbes & Infections

license: cc-by

license_normalized: cc-by

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

host_type: repository

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Informa UK Limited

publisher_dissemination: Informa


title: Immunological Mechanisms of Rejection in Uterine Transplantation

acronym: MARNI

summary: The objective of this study is to understand the mechanisms of rejection in uterine transplantation and to search for non-invasive markers of rejection. The biological samples necessary for our research have been or will be collected during procedures (biopsies, smears, vaginal swab, blood tests) carried out as part of the scheduled follow-up of patients. These will be samples whose collection is minimally or not invasive


title: DWI Cerebellar Infarct Volume as Predictor of Outcomes After Endovascular Treatment of Acute Basilar Artery Occlusion

acronym: CIV-ABAO

summary: Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. Our aim was to analyze if pre-EVT diffusion-weighted images cerebellar infarct volume (CIV) was a predictor of 90-day outcomes.


title: Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in Patients Referred to the Emergency Reception Service for Suspected COVID-19 Infection: Diagnostic Value and for Rapid Screening

acronym: VOC-COVID-Diag

summary:
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).

Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.


title: Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial

acronym: APP-LIL

summary:
Introduction: Surgery performed under low insufflation pressure combined with micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the average length of stay.

This technique, currently underdeveloped has never been evaluated in the literature for appendectomy.

Main objective of the study: to obtain a reduction in postoperative pain when using the low-impact laparoscopy technique for appendectomies.

Secondary objectives: to study the feasibility of LIL in appendectomies, to obtain a reduction in the average length of stay, a reduction in the consumption of analgesics, a reduction in costs, and a more rapid resumption of activities.

Material and methods :

This is a prospective, single-center, double-blind study. The inclusion criterion is the presence of acute uncomplicated appendicitis. The number of subjects to be included in each group is evaluated at 25. The subjects are divided into two groups preoperatively:

Conventional group: insufflation pressure at 12mmHg and conventional instrumentation
LIL group: insufflation pressure at 7mmHg and micro-laparoscopy instrumentation.

Identical dressings are put in place at the end of the procedure in order to hide from the patient the protocol in which he was included.

Pain assessment is recorded daily during the first postoperative week. The consumption of analgesics is also recorded. Then on the 7th day, 15th day and 30th postoperative day. During hospitalization, readings are taken by the nurse. At home, the data is entered by the patient via the Link4Life smartphone application.

Conclusion: LIL applied to appendectomy has never been evaluated in the literature. It would allow a reduction in postoperative pain, the average length of stay for patients as well as improved rehabilitation.


title: Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution

acronym: ESSAIMS

summary: The objective is to compare the care including the solution of ambient sensory biofeedback "Inner Garden", compared to the care without this solution, on the regulation of behavioral disorders during a crisis requiring to take the child out of group care. The nursing support with the "Inner Garden" tool in three care units will be compared with the practice in six other units not equipped with this tool.

ReferenceCitation: Domon-Archambault V, Terradas MM, Drieu D, De Fleurian A, Achim J, Poulain S, Jerrar-Oulidi J. Mentalization-Based Training Program for Child Care Workers in Residential Settings. J Child Adolesc Trauma. 2019 Jun 21;13(2):239-248. doi: 10.1007/s40653-019-00269-x. eCollection 2020 Jun.

ReferenceCitation: Niquille M, Gremion C, Welker S, Damsa C. [Agitation in prehospital setting: view of emergency physicians]. Rev Med Suisse. 2007 Aug 15;3(121):1839-46. Review. French.

ReferenceCitation: Tereno S, Soares I, Martins C, Celani M, Sampaio D. Attachment styles, memories of parental rearing and therapeutic bond: a study with eating disordered patients, their parents and therapists. Eur Eat Disord Rev. 2008 Jan;16(1):49-58.

ReferenceCitation: Lewis GF, Hourani L, Tueller S, Kizakevich P, Bryant S, Weimer B, Strange L. Relaxation training assisted by heart rate variability biofeedback: Implication for a military predeployment stress inoculation protocol. Psychophysiology. 2015 Sep;52(9):1167-74. doi: 10.1111/psyp.12455. Epub 2015 Jun 11.

ReferenceCitation: Zeman J, Shipman K, Suveg C. Anger and sadness regulation: predictions to internalizing and externalizing symptoms in children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):393-8.

ReferenceCitation: Chicchi Giglioli IA, Pallavicini F, Pedroli E, Serino S, Riva G. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders. Comput Math Methods Med. 2015;2015:862942. doi: 10.1155/2015/862942. Epub 2015 Aug 3. Review.

ReferenceCitation: Baus O, Bouchard S. Moving from virtual reality exposure-based therapy to augmented reality exposure-based therapy: a review. Front Hum Neurosci. 2014 Mar 4;8:112. doi: 10.3389/fnhum.2014.00112. eCollection 2014. Review.

ReferenceCitation: Gold G, Fazio L, Stolz JH, Herrman FR, Gattelet P, Zekry D. [Assessment of behavior in non-psychiatric settings: use of a simple and reliable method]. Rev Med Suisse. 2012 Nov 7;8(361):2119-21. French.

ReferenceCitation: Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46.

ipd_sharing: Yes

ipd_sharing_description:
Data will be made available with publication. Keyword are Child Behavior, Psychomotor Agitation, Psychiatric Nursing, Child Day Care Center, Tool Use Behavior, Emotional Regulation.

The available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication.

Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication.

International standard unit will be used.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Comparative Randomized Study of Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery

acronym: VIDAMO

summary:
For a long time, the fear of the dental surgeon has been the main reason why a percentage of the population avoids regular consultation.

There are many techniques to manage anxiety (tell-show-do, positive reinforcement, live modeling, etc). Now, virtual reality offers this possibility as a non-drug alternative technique.

Few studies have assessed the value of virtual reality in peroperative during an oral surgery procedure.

It is interesting to compare the immediate post-operative anxiety level between groups using virtual reality headset (RV) versus standard protocol (hydroxyzine + music with headphones : SMP)

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation

acronym: ImmunEO

summary: The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.


title: Assessment of Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Patients With Multiple Myeloma

summary: Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. The main objective is to assess the correlation between vertebral bone marrow fat fraction and bone fragility represented by a severity score of vertebral fractures. The secondary objective is to assess the correlation with clinical and biological prognostic factors and scores..

time_perspective: Other

location_facility: AP-HP, Lariboisière Hospital, Osteo-Articular, Visceral and Vascular Imaging department


title: Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population

summary: The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.


title: Evolution of the Proteinuria / Creatininuria Ratio in the First Month of Life in the Preterm Infant

acronym: PROTI-PREMA

summary:
From the first days of life, the newborn presents a "physiological" proteinuria explained by the coexistence of a glomerular and tubular immaturity, all the more marked as the gestational age (GA) is weak. In the child term, proteinuria decreases the first month and its persistence is the marker of kidney damage. The persistence of proteinuria in preterm infants is also considered a marker of renal impairment; however, neither the "physiological" values nor the pattern of urinary excretion of proteins in the first month of life are known.

The proteinuria / creatininuria ratio is a validated indicator of proteinuria, as it is correlated with 24-hour urine proteinuria.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study

summary:
Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases.

Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.

lead_sponsor: Hospital Nord

location_facility: Departement anesthesie reanimation hopital nord


title: Evaluation of the Efficacy, Safety and Tolerability of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19). A Randomised, Open-label, Proof of Concept, Phase 2 Study

acronym: CYCLOVID

summary:
COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first designated as 2019-nCoV).

The disease manifestations of COVID-19 can range from mild, self-resolving respiratory disease to severe pneumonia, ARDS, multiorgan failure, and ultimately death. In early reports, the mortality rate among patients admitted to hospital and with confirmed SARS-CoV-2 infection was reported to be between 4 and 15%. Although the disease can afflict all age groups, elderly patients and patients with underlying comorbidities such as high body mass index, hypertension, diabetes, cardiovascular disease, or cerebrovascular disease are at risk of developing severe disease and dying.

There are currently no etiologic treatments for COVID-19, and efforts are underway to identify therapeutics that could be effective in controlling this disease.

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


type: EudraCT Number

title: Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients

acronym: NICOVID

summary:
The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. To current knowledge, there is no treatment yet that that can prevent infection from SARS-COV-2 virus, nor the disease progression to a severe form.

Daily active smokers are rare among outpatients or hospitalized COVID-19 patients.

Several arguments suggest that nicotine could be responsible for this protective effect thank to the nicotinic acetylcholine receptor (nAChR).

Based on epidemiological data and experimental data from scientific literature, we hypothesize that nicotine could inhibit the penetration and spread of the virus and improve the management of COVID19 , particularly in hospitalized patients to prevent adverse outcomes (death, transfer to intensive care unit, care limitation, mechanical ventilation an high flow oxygen).


title: Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale

acronym: PSYCHOSTIM

summary: Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)

ReferenceCitation: Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommée E, Pelissier P, Fraix V, Thobois S, Moro E, Martinez-Martin P. The Neuropsychiatric Fluctuations Scale for Parkinson's Disease: A Pilot Study. Mov Disord Clin Pract. 2018 Mar 23;5(3):265-272. doi: 10.1002/mdc3.12607. eCollection 2018 May-Jun.

name: Movement Disorders Unit, Department of Psychiatry Neurology and Neurological Rehabilitation; CHU Grenoble; Grenoble France

name: Grenoble Institut des Neurosciences; Grenoble Alpes University; France

family: Schmitt

full_name: Emmanuelle Schmitt

given: Emmanuelle

name: Department of Clinical Neuroscience, Hôpitaux Universitaires de Genève; University of Geneva; Switzerland

family: Krack

full_name: Paul Krack

given: Paul

family: Castrioto

full_name: Anna Castrioto

given: Anna

name: Hospices Civils de Lyon, Hôpital Neurologique; Neurologie C; Lyon France

name: Faculté de Médecine et de Maïeutique Lyon Sud Charles Mérieux, Université de Lyon 1; Université de Lyon; Lyon France

name: CNRS, UMR 5229; Centre de Neurosciences Cognitives; Bron France

family: Klinger

full_name: Helene Klinger

given: Helene

family: Bichon

full_name: Amelie Bichon

given: Amelie

family: Lhommée

full_name: Eugénie Lhommée

given: Eugénie

family: Pelissier

full_name: Pierre Pelissier

given: Pierre

family: Fraix

full_name: Valerie Fraix

given: Valerie

family: Thobois

full_name: Stephane Thobois

given: Stephane

family: Moro

full_name: Elena Moro

given: Elena

name: National Center of Epidemiology; Carlos III Institute of Health; Madrid Spain

name: CIBERNED; Carlos III Institute of Health; Madrid Spain

family: Martinez-Martin

full_name: Pablo Martinez-Martin

given: Pablo

journal_name: Movement Disorders Clinical Practice

oa_colors: green hybrid

evidence: open (via free article)

repository_institution: PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Abbes M, Lhommée E, Thobois S, Klinger H, Schmitt E, Bichon A, Castrioto A, Xie J, Fraix V, Kistner A, Pélissier P, Seigneuret É, Chabardès S, Mertens P, Broussolle E, Moro E, Krack P. Subthalamic stimulation and neuropsychiatric symptoms in Parkinson's disease: results from a long-term follow-up cohort study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):836-843. doi: 10.1136/jnnp-2017-316373. Epub 2018 Feb 7.

family: Abbes

full_name: Marie Abbes

given: Marie

full_name: Stéphane Thobois

given: Stéphane

full_name: Hélène Klinger

given: Hélène

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

title: Subthalamic stimulation and neuropsychiatric symptoms in Parkinson’s disease: results from a long-term follow-up cohort study

ReferenceCitation: Hogg E, Wertheimer J, Graner S, Tagliati M. Deep Brain Stimulation and Nonmotor Symptoms. Int Rev Neurobiol. 2017;134:1045-1089. doi: 10.1016/bs.irn.2017.05.022. Epub 2017 Jul 3. Review.

journal_name: Nonmotor Parkinson’s: The Hidden Face - Management and the Hidden Face of Related Disorders

ReferenceCitation: Kurtis MM, Rajah T, Delgado LF, Dafsari HS. The effect of deep brain stimulation on the non-motor symptoms of Parkinson's disease: a critical review of the current evidence. NPJ Parkinsons Dis. 2017 Jan 12;3:16024. doi: 10.1038/npjparkd.2016.24. eCollection 2017. Review.

title: The effect of deep brain stimulation on the non-motor symptoms of Parkinson’s disease: a critical review of the current evidence

ReferenceCitation: Azulay JP, Witjas T, Eusebio A. Effect of subthalamic deep brain stimulation on non-motor fluctuations in Parkinson's disease. J Neural Transm (Vienna). 2013 Apr;120(4):655-7. doi: 10.1007/s00702-012-0958-9. Epub 2012 Dec 23. Review.

title: Effect of subthalamic deep brain stimulation on non-motor fluctuations in Parkinson’s disease


title: Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder

acronym: GIETSA

summary: The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored

primary_purpose: Supportive Care

ReferenceCitation: 1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.

ReferenceCitation: 2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.

ReferenceCitation: Rusconi-Serpa S, Sancho Rossignol A, McDonough SC. Video feedback in parent-infant treatments. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):735-51. doi: 10.1016/j.chc.2009.02.009. Review.


title: PRONing to Facilitate Weaning From ECMO in Patients With Refractory Acute Respiratory Distress Syndrome

acronym: PRONECMO

summary:
ECMO has emerged as a promising intervention that may provide more efficacious supportive care to patients with refractory severe acute respiratory distress syndrome (ARDS). The largest randomized trial of ECMO for severe forms of ARDS was recently published and demonstrated no significant benefit from early initiation of ECMO with respect to 60-day mortality, when compared with a strategy of conventional mechanical ventilation (MV) (ref EOLIA). However, a rescue ECMO option was used by 28% of the controls, which is likely to have diluted the potential positive effect of ECMO. One may argue that a less restrictive primary endpoint, such as death or rescue ECMO, would have yielded positive findings.

Meanwhile, improvements in technology have made ECMO safer and easier to use, allowing for the potential of more widespread application in patients with ARDS. VV-ECMO can be used as a life-saving rescue therapy in patients with ARDS when MV cannot maintain adequate oxygenation or CO2 elimination. Alternatively, VV-ECMO may be used in patients who remain hypoxemic during MV (i.e., PaO2/FiO2<80 mmHg) despite optimization of MV (including the application of high levels of positive end-expiratory pressure (PEEP), neuromuscular blockers, and prone positioning) and allow "lung rest" by lowering airway pressures and tidal volume to ameliorate ventilator-induced lung injury (VILI).

Prone positioning (PP) has been used for more than 30 years in patients with acute hypoxemic respiratory failure and in particular with ARDS. Initially, PP in ARDS patients was proposed as an efficient mean to improve oxygenation, sometimes dramatically, in a large number of patients. In addition, it is now clear, and data are still accumulating, that PP is also able to prevent VILI which is as important as maintaining safe gas exchange in mechanical ventilation. Therefore, PP is a strategy that covers the two major goals of ventilator support in ARDS patients, maintaining safe oxygenation and preventing VILI and reducing mortality at the end. This latter objective makes sense on ECMO as one of the main objective of this device is to markedly reduce VILI by resting the lung.

Considering that PP is a valuable and safe therapy to reduce VILI, its combination with ECMO could enhance VILI prevention. In recent preliminary studies, it was reported that the combination of VV-ECMO and PP was associated with a dramatic improvement in oxygenation, in pulmonary and thoracic compliance and in chest X-ray findings. It may thus facilitate the weaning of ECMO and can be performed without compromising the safety of the patients. Lung recruitment and improvement in ventilation/perfusion mismatch on prone position may both contribute to improve oxygenation. PP may therefore be efficient to hasten the weaning of VV-ECMO when atelectasis and ventilation/perfusion mismatch occur under ultra-protective ventilation even in patients in whom pre-ECMO PP failed. In addition, it could also enhance ventilator induced lung injury prevention on ECMO.


title: Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure.

summary:
Preserving pulpal vitality is a major challenge when excavating deep caries lesions without severe symptomatology. Pulpal exposure alters success of the treatment (dropping from 93% for indirect pulp treatment with selective excavation to 11% for direct pulpotomy) and thus prognosis of dental organ and cost-effectiveness of the treatment. The preoperative x-ray is a complementary examination which allows to estimate the depth of the carious lesion. In clinical practice, it is currently difficult to accurately measure this depth on preoperative radiographs. This lack of precision leads to a decrease in the effective capacity of the operator to predict the risk of pulpal exposure. Their interpretation is considered imprecise and is not used as a diagnostic element.

The aim of this study was to determine if the use of pre-operative retroalveolar radiographs can help to predict pulpal exposure risk.

ReferenceCitation: Gasqui MA, Pérard M, Decup F, Monsarrat P, Turpin YL, Villat C, Gueyffier F, Maucort-Boulch D, Roche L, Grosgogeat B. Place of a new radiological index in predicting pulp exposure before intervention for deep carious lesions. Oral Radiol. 2021 May 5. doi: 10.1007/s11282-021-00530-w. [Epub ahead of print]

family: Gasqui

full_name: Marie-Agnès Gasqui

given: Marie-Agnès

family: Pérard

full_name: Matthieu Pérard

given: Matthieu

family: Decup

full_name: Franck Decup

given: Franck

family: Monsarrat

full_name: Paul Monsarrat

family: Turpin

full_name: Yann-Loïg Turpin

given: Yann-Loïg

family: Villat

full_name: Cyril Villat

given: Cyril

family: Gueyffier

full_name: François Gueyffier

given: François

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Roche

full_name: Laurent Roche

given: Laurent

family: Grosgogeat

full_name: Brigitte Grosgogeat

given: Brigitte

journal_name: Oral Radiology

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

location_facility: Professeur des Universités- Praticien Hospitalier

intervention_type: Radiation


title: Working Memory Training With Attention Process Training (APT-II) in Older Adults With Mild Cognitive Impairment : Impacts on Cognition and Ecological Activities

acronym: APT-II

summary: Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia but do not meet the criteria for dementia. Cognitive rehabilitation makes it possible to compensate, at least in part, for cognitive deficits with the ultimate goal of reducing their impact in everyday life. The objective of the research is to evaluate the short- and long-term effectiveness and generalization of an attention and working memory training program (APT-II) on cognition and ecological activities in MCI patients with a randomized controlled trial. Thirty MCI patients will be randomly assigned between a "cognitive training with APT-II" condition and a control (routine care) condition. The intervention will consist of an 8-week individual cognitive training program (2 sessions/week), training different attentional components and working memory. This has the advantage of insisting on the transfer of the acquired knowledge in sessions to daily activities. To evaluate the effectiveness of the treatment, cognitive and functional follow-up measures (including a virtual reality task) are administered at several time intervals. This project should contribute to better management of cognitive disorders by offering a new standardized rehabilitation tool in French to clinical practice.

ReferenceCitation: Baddeley A, Logie R, Bressi S, Della Sala S, Spinnler H. Dementia and working memory. Q J Exp Psychol A. 1986 Nov;38(4):603-18.

ReferenceCitation: Barker-Collo SL, Feigin VL, Lawes CM, Parag V, Senior H, Rodgers A. Reducing attention deficits after stroke using attention process training: a randomized controlled trial. Stroke. 2009 Oct;40(10):3293-8. doi: 10.1161/STROKEAHA.109.558239. Epub 2009 Jul 23.

ReferenceCitation: Belleville S, Boller B. Comprendre le stade compensatoire de la maladie d'Alzheimer et agir pour promouvoir la cognition et la plasticité cérébrale. Can J Exp Psychol. 2016 Dec;70(4):288-294.

ReferenceCitation: Blanchet S, McCormick L, Belleville S, Gély-Nargeot MC, Joanette Y. [Mild cognitive impairments in the elderly: a critical review]. Rev Neurol (Paris). 2002 Jan;158(1):29-39. Review. French.

ReferenceCitation: Kim H, Chey J, Lee S. Effects of multicomponent training of cognitive control on cognitive function and brain activation in older adults. Neurosci Res. 2017 Nov;124:8-15. doi: 10.1016/j.neures.2017.05.004. Epub 2017 Jun 1.

ReferenceCitation: Palmese CA, Raskin SA. The rehabilitation of attention in individuals with mild traumatic brain injury, using the APT-II programme. Brain Inj. 2000 Jun;14(6):535-48.

ReferenceCitation: Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. Erratum in: Arch Neurol 1999 Jun;56(6):760.

ReferenceCitation: Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Author response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Aug 21;91(8):373-374. doi: 10.1212/WNL.0000000000006042.

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lead_sponsor: University of Paris 5 - Rene Descartes


title: Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue: Proof of Concept Against PET-CT in Patients Affected by Pheochomocytoma and/or Paraganglioma

acronym: MICROBAT

summary: Patients affected by pheochromocytoma (PHEO) have brown-adipose tissue (BAT) hyperactivation. They perform, in routine settings, a FDG PET-CT scan. The high metabolic activity of BAT and its ability to consume both glucose and fatty acid suggest that it may have potential as a therapeutic target in the treatment of obesity. However, alternative non-invasive techniques to PET-CT BAT detection still need more validation. Accordingly, our aim will be to measure the temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test in PHEO patients.

lead_sponsor: University of Avignon