title: Validity of Ultrasound in Women Having Pelvic Floor Muscle Training

acronym: ERP

summary: The objective is to validate the use of ultrasound measurements (urethral mobility, movement of the ano-rectal angle, elastography measurements) in women with urinary incontiennce before and after pelvic floor muscle training (PFMT) : inter and intra-observer reproducibility; correlation with clinical examination (modified Oxford scale); sensitivity to change before/after pelvic floor muscle training

ReferenceCitation: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78.

ReferenceCitation: Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. Review.

ReferenceCitation: DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3.

ReferenceCitation: Petros PE, Ulmsten UI. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl. 1993;153:1-93. Review.

ReferenceCitation: Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, Denys P, Dompeyre P, Faltin D, Fatton B, Haab F, Hermieux JF, Kerdraon J, Mares P, Mellier G, Michel-Laaengh N, Nadeau C, Robain G, de Tayrac R, Jacquetin B; French College of Gynaecologists and Obstetricians. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):14-9. doi: 10.1016/j.ejogrb.2010.02.041. Epub 2010 Mar 16. Review.

ReferenceCitation: Hermieu JF, Denys P, Fritel X. [Critical review of guidelines for female urinary incontinence diagnosis and treatment]. Prog Urol. 2012 Oct;22(11):636-43. doi: 10.1016/j.purol.2012.08.004. Epub 2012 Sep 10. Review. French.

ReferenceCitation: Messelink B, Benson T, Berghmans B, Bø K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, á Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80.

ReferenceCitation: Deffieux X, Billecocq S, Demoulin G, Rivain AL, Trichot C, Thubert T. [Pelvic floor rehabilitation for female urinary incontinence: mechanisms of action]. Prog Urol. 2013 Jun;23(8):491-501. doi: 10.1016/j.purol.2013.04.002. Epub 2013 May 2. Review. French.

ReferenceCitation: Miller JM, Sampselle C, Ashton-Miller J, Hong GR, DeLancey JO. Clarification and confirmation of the Knack maneuver: the effect of volitional pelvic floor muscle contraction to preempt expected stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):773-82. doi: 10.1007/s00192-007-0525-3.

ReferenceCitation: Hung HC, Hsiao SM, Chih SY, Lin HH, Tsauo JY. Effect of pelvic-floor muscle strengthening on bladder neck mobility: a clinical trial. Phys Ther. 2011 Jul;91(7):1030-8. doi: 10.2522/ptj.20100186. Epub 2011 May 12.

ReferenceCitation: Schaer GN, Perucchini D, Munz E, Peschers U, Koechli OR, Delancey JO. Sonographic evaluation of the bladder neck in continent and stress-incontinent women. Obstet Gynecol. 1999 Mar;93(3):412-6.

ReferenceCitation: Balmforth JR, Mantle J, Bidmead J, Cardozo L. A prospective observational trial of pelvic floor muscle training for female stress urinary incontinence. BJU Int. 2006 Oct;98(4):811-7.

ReferenceCitation: Tosun OC, Solmaz U, Ekin A, Tosun G, Gezer C, Ergenoglu AM, Yeniel AO, Mat E, Malkoc M, Askar N. Assessment of the effect of pelvic floor exercises on pelvic floor muscle strength using ultrasonography in patients with urinary incontinence: a prospective randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(2):360-5. doi: 10.1589/jpts.28.360. Epub 2016 Feb 29.

ReferenceCitation: Volløyhaug I, Mørkved S, Salvesen Ø, Salvesen KÅ. Assessment of pelvic floor muscle contraction with palpation, perineometry and transperineal ultrasound: a cross-sectional study. Ultrasound Obstet Gynecol. 2016 Jun;47(6):768-73. doi: 10.1002/uog.15731. Epub 2016 May 2.

ReferenceCitation: Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects. Ultrasound Obstet Gynecol. 2004 Jan;23(1):80-92. Review.

ReferenceCitation: Bergman A, McKenzie CJ, Richmond J, Ballard CA, Platt LD. Transrectal ultrasound versus cystography in the evaluation of anatomical stress urinary incontinence. Br J Urol. 1988 Sep;62(3):228-34.

ReferenceCitation: Johnson JD, Lamensdorf H, Hollander IN, Thurman AE. Use of transvaginal endosonography in the evaluation of women with stress urinary incontinence. J Urol. 1992 Feb;147(2):421-5.

ReferenceCitation: Wise BG, Burton G, Cutner A, Cardozo LD. Effect of vaginal ultrasound probe on lower urinary tract function. Br J Urol. 1992 Jul;70(1):12-6.

ReferenceCitation: Alper T, Cetinkaya M, Okutgen S, Kökçü A, Malatyalioğlu E. Evaluation of urethrovesical angle by ultrasound in women with and without urinary stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(5):308-11.

ReferenceCitation: Koelbl H, Bernaschek G. A new method for sonographic urethrocystography and simultaneous pressure-flow measurements. Obstet Gynecol. 1989 Sep;74(3 Pt 1):417-22.

ReferenceCitation: Thompson JA, O'Sullivan PB, Briffa K, Neumann P, Court S. Assessment of pelvic floor movement using transabdominal and transperineal ultrasound. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jul-Aug;16(4):285-92. Epub 2005 Mar 22.

ReferenceCitation: Dietz HP, Clarke B, Herbison P. Bladder neck mobility and urethral closure pressure as predictors of genuine stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(5):289-93.

ReferenceCitation: Dietz HP, Clarke B. The influence of posture on perineal ultrasound imaging parameters. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(2):104-6.

ReferenceCitation: Yang SH, Huang WC, Yang SY, Yang E, Yang JM. Validation of new ultrasound parameters for quantifying pelvic floor muscle contraction. Ultrasound Obstet Gynecol. 2009 Apr;33(4):465-71. doi: 10.1002/uog.6338.

ReferenceCitation: Ferraioli G, Tinelli C, Zicchetti M, Above E, Poma G, Di Gregorio M, Filice C. Reproducibility of real-time shear wave elastography in the evaluation of liver elasticity. Eur J Radiol. 2012 Nov;81(11):3102-6. doi: 10.1016/j.ejrad.2012.05.030. Epub 2012 Jun 27.

ReferenceCitation: Berg WA, Cosgrove DO, Doré CJ, Schäfer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.

ReferenceCitation: Cosgrove DO, Berg WA, Doré CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.

ReferenceCitation: Aljuraifani R, Stafford RE, Hug F, Hodges PW. Female striated urogenital sphincter contraction measured by shear wave elastography during pelvic floor muscle activation: Proof of concept and validation. Neurourol Urodyn. 2018 Jan;37(1):206-212. doi: 10.1002/nau.23275. Epub 2017 Apr 13.

ReferenceCitation: Stafford RE, Aljuraifani R, Hug F, Hodges PW. Application of shear-wave elastography to estimate the stiffness of the male striated urethral sphincter during voluntary contractions. BJU Int. 2017 Apr;119(4):619-625. doi: 10.1111/bju.13688. Epub 2016 Nov 11.

ReferenceCitation: Kreutzkamp JM, Schäfer SD, Amler S, Strube F, Kiesel L, Schmitz R. Strain Elastography as a New Method for Assessing Pelvic Floor Biomechanics. Ultrasound Med Biol. 2017 Apr;43(4):868-872. doi: 10.1016/j.ultrasmedbio.2016.12.004. Epub 2017 Jan 17.

ReferenceCitation: Pizzoferrato AC, Fauconnier A, Bader G. [Value of ultrasonographic measurement of bladder neck mobility in the management of female stress urinary incontinence]. Gynecol Obstet Fertil. 2011 Jan;39(1):42-8. doi: 10.1016/j.gyobfe.2010.09.019. Epub 2010 Dec 24. Review. French.

ReferenceCitation: Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.

ReferenceCitation: Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30.

ReferenceCitation: Amarenco G, Arnould B, Carita P, Haab F, Labat JJ, Richard F. European psychometric validation of the CONTILIFE: a Quality of Life questionnaire for urinary incontinence. Eur Urol. 2003 Apr;43(4):391-404.

lead_sponsor: University Hospital, Caen


type: Other Identifier

title: Cross-sectional Survey on Patients With Urinary Tract Infections in Puy-de-Dôme : Epidemiology of Recurrent Urinary Tract Infections and Risk Factors

summary: Urinary tract infections (UTI) are an important part of infectious diseases. For some patients, those infections are recurrent and have many consequences such as altered quality of life, recurrent symptoms, antibiotics overuse… The primary purpose of this study is to estimate the proportion of patients in Puy-de-Dôme with recurrent urinary tract infections among patients with at least one UTI during 2019. The secondary purposes are : characteristics of patients with recurrent UTI, by sex ; determine predictive factors of recurrent UTI, by sex ; describe bacterial ecology of recurrent UTI and the proportion of multi-resistant bacteria.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation

acronym: ATECMO

summary: Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

intervention_type: Biological


title: Feasibility of a One-day-and-a-half Multidisciplinary Education and Exercise Therapy Program for Patients With Low Back Pain: a 3-month Retrospective Open Pilot Study

acronym: LC-ONE

summary: The purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.

ReferenceType: result

ReferenceCitation: Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.

ReferenceCitation: Adnan R, Van Oosterwijck J, Cagnie B, Dhondt E, Schouppe S, Van Akeleyen J, Logghe T, Danneels L. Determining Predictive Outcome Factors for a Multimodal Treatment Program in Low Back Pain Patients: A Retrospective Cohort Study. J Manipulative Physiol Ther. 2017 Nov - Dec;40(9):659-667. doi: 10.1016/j.jmpt.2017.09.001.

ReferenceCitation: Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008 Nov-Dec;8(6):948-58. Epub 2007 Nov 19. Review.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Behavioral


title: Clinical Characterisation Protocol for COVID-19 in People Living With HIV

acronym: COVIDHIV

summary:
There is very little data so far to determine whether people living with HIV (PLWHIV) are at greater risk of COVID-19 acquisition or severe disease. HIV infection is associated with deficiencies in both humoral and cell-mediated immunity that could potentially alter the course and severity of common infections. The investigators will study the correlation between clinical and immunovirological data. The singularity of this work is to have an in-depth immunovirological approach linked to the clinical characteristics in COVID-19 HIV co-infected patients. COVIDHIV is the only study to date to offer this combined approach in PLWHIV.

This protocol is a historical and prospective cohort study of PLWHIV presenting COVID-19 The primary objectives are to describe the course of COVID-19 disease in patients infected with HIV

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Other

enrollment_type: Anticipated

ipd_sharing: No

location_facility: Department of Internal Medicine and Clinical Immunology of Professor Cécile Goujard

status_simplified: Unknown


title: A Mobile App for the Self Quantification of Sleep and Behaviors : a Pilot Study With Teenagers and Young Adults

acronym: ASC-Val

summary: The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

intervention_type: Device


title: Shoulder Muscle Imbalance as a Risk for Shoulder Injury in Elite Adolescent Badminton Players : a Prospective Pilot Study

acronym: BADIRMS

summary:
Background: To assess the impact of pre-season clinical measures and rotator muscles strength on the risk of significant shoulder injury (SSI) in elite adolescent badminton players Design: Prospective cohort study Participants: Nine elite adolescents badminton players were included and followed from September 2018 to May 2019.

Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder strength testing. Isokinetic internal and external rotator shoulder muscles strength was tested at 60, 120 and 240°/s. Conventional and functional (eccentric-to-concentric) ratios (FR) were calculated. SSI collection was performed by an experienced sport physician.


title: Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection - MARNEVO-Covid

acronym: MARNEVO-Covid

summary: Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier de PAU


type: Registry Identifier

title: Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST

acronym: ORALQUEST

summary:
Feeding and eating disorders are frequent in children of the general population. They are much more frequent in children with congenital chronic diseases. The analysis of feeding and eating disorders in children is difficult since their causes are complex and multiple. In addition to the clinical examination and the instrumental investigation, a parental questionnaire is very useful in assessing these disorders. The questionnaire (testing the right period of age, evaluating the 4 aspects involved in the disorders, translated in French) does not exist. Consequently, the Necker team of the reference center, has built a hetero-questionnaire named ORALQUEST, which analyses 4 dimensions of the feeding and eating disorders of young children from 9 months to 6 years: behaviour, oral motor skills, sensory sensitivity and familial environment.

The objective of the study is to test the metrological qualities of Oralquest in children with congenital chronic diseases including feeding and eating disorders.

The questionnaire will be proposed to 7 cohorts of children who are followed in Necker for :

oesophageal atresia,
cardiac malformations,
Pierre Robin sequence,
cleft lip and palate,
autism spectrum disorders,
ex-prematurity < 32 AG,
chromosomal anomalies, and proposed to children consulting in the expert center for phobic and selective eating behaviour.

The analysis of the metrological qualities of the questionnaire include several calculation and specialized methods: inter-rate concordance; test-retest; intrinsic validity, concurrent validity, sensitivity/specificity.

status: Recruiting

location_facility: Department of Pediatry, Necker-Enfants Malades Hospital

intervention_type: Other

status_simplified: Ongoing


title: Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic by Creation and Analysis of a Biological and Tissue Collection of Pregnancy Outcomes

acronym: COroFet

summary: A new coronavirus (COVID-19) highlighted at the end of 2019 in China is spreading across all continents. Most often at the origin of a mild infectious syndrome, associating benign symptoms (such as fever, cough, and headache) to different degrees, COVID-19 can cause serious pulmonary pathologies and sometimes death. Data on the consequences during pregnancy are limited. The first Chinese data published seem to show that the symptoms in pregnant women are the same as those of the general population. There are no cases of intrauterine maternal-fetal transmission, but cases of newborns infected early suggest that there could be vertical intrauterine, perpartum or neonatal transmission. Prematurity and cases of respiratory distress in newborns of infected mothers have been described. Subsequently, an in-depth analysis of cases in pregnant women and pregnancy issues are necessary in order to improve knowledge on the subject.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: University Hospital, Toulouse

intervention_type: Diagnostic Test


title: "Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"

summary: Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. I The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

lead_sponsor: Nantes University Hospital


title: ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients

acronym: ScleroBiotique

summary: Today, the study of gut microbiota has taken a prominent place in several fields of medical research. Numerous experimental data in humans and animals suggest that an imbalance in the composition of the microbiota could contribute to the pathophysiology of systemic autoimmune diseases such as Systemic Sclerosis (SCS). A future exploration of the microbiota, a source of diagnostic and/or prognostic biomarkers, may be very useful for tomorrow's medicine by proposing therapeutic interventions based on the correction of possible imbalances in the intestinal flora. Studies of the human gut microbiota in patients with ScS are limited to low-impact investigations, due to the lack of data on the clinical and biological characterization of the patients studied, and to the absence of longitudinal studies in the same patient. For this reason, we are interested in exploring the intestinal microbiota of ScS patients in a comprehensive and longitudinal way.

ipd_sharing: Undecided

lead_sponsor: Hôpital Européen Marseille


title: Impact de la Restriction du Champ Visuel Sur l'Exploration Visuelle

acronym: REVE

summary:
To communicate with the observer and guide his gaze on the canvas, painters have developed different stylistic processes that artists, in the manner of scientists, have acquired on the functioning of human visual perception. This direct communication between the artist and the observer is strongly impacted for people with visual impairments.

In order to improve the accessibility and autonomy of visually impaired people in museums and to allow each observer to feel the visual and emotional experience closest to the original work of the artist, it is essential to identify the modifications. perceptive generated by the constriction of vision

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


title: Association of Gut Microbiota Diversity With Extended-spectrum Beta-lactamase Producing Enterobacteriales Fecal Carriage and Subsequent Infection in Intensive Care Unit: Microbe Study

acronym: Microbe

summary: Antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing Enterobacteriales (ESBL-E) are a leading cause because of their wide dissemination. Gut microbiota seems to be correlated with multi-drug resistant organism carriage. This study thus aims to analyse the correlation between gut microbiota, ESBL-E fecal carriage and subsequent infection.

lead_sponsor: University of Bordeaux

location_facility: Medical intensive care unit, Pelelgrin hospital


title: Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2

acronym: MICROVID

summary: Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.

lead_sponsor: University Hospital, Lille


title: Impact of SARS-CoV-2 Infection on the Incidence of Ventilator-acquired Infections

acronym: COVAPID

summary: Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.

ReferenceType: derived

ReferenceCitation: Rouzé A, Lemaitre E, Martin-Loeches I, Povoa P, Diaz E, Nyga R, Torres A, Metzelard M, Du Cheyron D, Lambiotte F, Tamion F, Labruyere M, Boulle Geronimi C, Luyt CE, Nyunga M, Pouly O, Thille AW, Megarbane B, Saade A, Magira E, Llitjos JF, Ioannidou I, Pierre A, Reignier J, Garot D, Kreitmann L, Baudel JL, Voiriot G, Plantefeve G, Morawiec E, Asfar P, Boyer A, Mekontso-Dessap A, Makris D, Vinsonneau C, Floch PE, Marois C, Ceccato A, Artigas A, Gaudet A, Nora D, Cornu M, Duhamel A, Labreuche J, Nseir S; coVAPid study group. Invasive pulmonary aspergillosis among intubated patients with SARS-CoV-2 or influenza pneumonia: a European multicenter comparative cohort study. Crit Care. 2022 Jan 4;26(1):11. doi: 10.1186/s13054-021-03874-1.

ReferenceCitation: Rouzé A, Martin-Loeches I, Povoa P, Metzelard M, Du Cheyron D, Lambiotte F, Tamion F, Labruyere M, Boulle Geronimi C, Nieszkowska A, Nyunga M, Pouly O, Thille AW, Megarbane B, Saade A, Diaz E, Magira E, Llitjos JF, Cilloniz C, Ioannidou I, Pierre A, Reignier J, Garot D, Kreitmann L, Baudel JL, Fartoukh M, Plantefeve G, Beurton A, Asfar P, Boyer A, Mekontso-Dessap A, Makris D, Vinsonneau C, Floch PE, Weiss N, Ceccato A, Artigas A, Bouchereau M, Duhamel A, Labreuche J, Nseir S; coVAPid Study Group. Early Bacterial Identification among Intubated Patients with COVID-19 or Influenza Pneumonia: A European Multicenter Comparative Clinical Trial. Am J Respir Crit Care Med. 2021 Sep 1;204(5):546-556. doi: 10.1164/rccm.202101-0030OC.

ReferenceCitation: Nseir S, Martin-Loeches I, Povoa P, Metzelard M, Du Cheyron D, Lambiotte F, Tamion F, Labruyere M, Makris D, Boulle Geronimi C, Pinetonde Chambrun M, Nyunga M, Pouly O, Mégarbane B, Saade A, Gomà G, Magira E, Llitjos JF, Torres A, Ioannidou I, Pierre A, Coelho L, Reignier J, Garot D, Kreitmann L, Baudel JL, Voiriot G, Contou D, Beurton A, Asfar P, Boyer A, Thille AW, Mekontso-Dessap A, Tsolaki V, Vinsonneau C, Floch PE, Le Guennec L, Ceccato A, Artigas A, Bouchereau M, Labreuche J, Duhamel A, Rouzé A; coVAPid study group. Relationship between ventilator-associated pneumonia and mortality in COVID-19 patients: a planned ancillary analysis of the coVAPid cohort. Crit Care. 2021 May 25;25(1):177. doi: 10.1186/s13054-021-03588-4. Erratum in: Crit Care. 2021 Aug 9;25(1):284.


title: Assessment of Thrombus Stiffness Using Ultrasound Elastography in Venous Thrombo-embolism.

acronym: TEVTE

summary:
Venous Thrombo-Embolic Disease (VTED) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. It represents the third cause of death after cardio-vascular disease and cancer, and encompass superficial, muscular and Deep Venous Thrombosis (DVT), and Pulmonary Embolisms (PE), which can be isolated or associated.

Ultrasound is today the most frequently used exam to diagnose DVT. However, it's unable to provide information on thrombus age or cause.

Elastography is an imaging technic which aims to analyse elastic properties of a tissue, by applying a mechanical impulse on it, and could be an interesting tool in thrombus exploration, and provide additional information.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Imaging Cardiac Phenotype of SARS-Cov-2 (Covid19) Infected Patients

acronym: COCARDE

summary: The effects of severe acute respiratory syndrome SARS-Cov-2 (Covid-19) on the myocardium and their role in the clinical course of infected patients are still unknown. Epidemiological studies report biological myocardial involvement in 10 to 25% of cases. The objective of this study is to cardiac phenotype using comprehensive cardiac imaging tools of patients infected with Covid 19 in order to explore the functional impact of the infection on the myocardium.

ReferenceCitation: Lairez O, Blanchard V, Balardy L, Vardon-Bounes F, Cazalbou S, Ruiz S, Collot S, Houard V, Rolland Y, Conil JM, Minville V. COCARDE Study-Cardiac Imaging Phenotype in Patients With COVID-19: Protocol for a Prospective Observational Study. JMIR Res Protoc. 2022 Jan 6;11(1):e24931. doi: 10.2196/24931.


title: Influence of Fatigue on the Walking Pattern in Cerebral Palsy Patients.

summary:
To date, studies do not study the influence of external disturbing factors on the market.

The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.

The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).

This study will use the GRAIL combining an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment projected on a 180 ° screen

status: Withdrawn

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

intervention_type: Procedure

lead_sponsor_type: industriel


title: Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis

acronym: OPTMETACER

summary:
Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion.

second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol


type: EudraCT Number

title: Relieving Dyspnea With Low Dose of Morphine in Patients Admitted to the Intensive Care Unit for an Acute Respiratory Failure: a Double-blind Randomized Controlled Pilot Study

acronym: OPIDYS

summary:
This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many similarities, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other populations. However, to date, data regarding the impact of morphine on dyspnea in intensive care unit patients admitted for acute respiratory failure are scarce. There may be a reluctance of physicians to prescribe opioids that is not scientifically justified.

The study will focus on patient reported outcome (PRO) criteria. The ultimate goal of this pilot study is to design the protocol of a future pragmatic trial.

primary_purpose: Treatment

ReferenceCitation: Demoule A, Deleris R, Bureau C, Lebbah S, Decavèle M, Dres M, Similowski T, Dechartres A. Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study. Trials. 2022 Sep 30;23(1):828. doi: 10.1186/s13063-022-06754-3.

ipd_sharing_description:
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

intervention_type: Drug


title: Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension

summary: To evaluate the efficacy of a 4-week fludrocortisone (FLU) treatment on systolic blood pressure depression after 5 minutes of active orthostatism in patients with neurogenic orthostatic hypotension (HON) symptomatic, despite treatment with non-drug measures with or without midodrine.

lead_sponsor: H.A.C. PHARMA


title: Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain

acronym: FRELOMB

summary:
Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Chronic low back pain is one of the most frequent reasons for consulting a physician, and one of the most common sources of disability, particularly as a result of socio-professional withdrawl. It is a major consumer of health resources (diagnostic investigations, multiple treatments) and involves heavy expenses for the investigator's health insurance system. In view of this major public health issue, in November 2017, the Health Insurance and several specialized health organizations launched a "general public" campaign to raise awareness of low back pain. This campaign, entitled "Back pain? The right treatment is movement" was designed to encourage appropriate physical activity in patients with low back pain.

Among the available therapies, multimodal programs are recommended as a first line treatment. In order to incorporate physical activity into patients' daily lives, these rehabilitation programs are based on a comprehensive multidisciplinary approach (therapeutic education, muscle strengthening, reconditioning, ergonomics, psychological, social, professional and nutritional management and cardiovascular risk factors). Although such programmes have already shown short term effectiveness, few data are available on their continued effectiveness in the medium term (1 year). This project aims to identify good and bad responders to a multimodal program in the medium term, based on common clinical parameters (Quebec City questionnaire score and spontaneous walking speed), and to identify the mechanisms underlying this response.

In addition, in clinical practice, heterogeneity in maintaining the effectiveness of the program is observed but little documented. The limited data available show a heterogeneity of these programs and one of the objectives of this project will be to identify the existing barriers and levers available to improve this situation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


acronym: AIRVM-COVID

title: Efficacy of Intravenous Almitrine in Reducing the Need for Mechanical Ventilation in Patients With Hypoxemic Acute Respiratory Failure Due to Covid-19-related Pneumonia: a Randomized Controlled Double-blind Study From the Skip-icu Consortium

source: euctr

ReferenceCitation: Kalfon P, Payen JF, Rousseau A, Chousterman B, Cachanado M, Tibi A, Audibert J, Depret F, Constantin JM, Weiss E, Remerand F, Freund Y, Simon T, Riou B. Effect of intravenous almitrine on intubation or mortality in patients with COVID-19 acute hypoxemic respiratory failure: A multicentre, randomised, double-blind, placebo-controlled trial. EClinicalMedicine. 2022 Oct;52:101663. doi: 10.1016/j.eclinm.2022.101663. Epub 2022 Sep 21.

ipd_sharing_description: Yes, upon request, after approval by the primary investigator and clinical research platform of East Paris. For the purpose of IPD meta-analysis, or secondary analysis. Unidentifying data will be shared.

summary:
The COVID-19 outbreak is associated with a surge in ICU bed requirement and substantial mortality (estimated between 0.5% and 1%). Admission in the intensive care unit (ICU) and need for mechanical ventilation is reportedly associated with an estimated hospital mortality of more than 30%. Furthermore, the surge in ICU bed requirement is a worldwide-shared issue, leading to sub-optimal ICU management.

In acute respiratory failure due to COVID-19-related pneumonia, vasoplegia with vascular enlargement inside the lung lesions and dilation of small vessels seen on chest CT scan largely account for severe hypoxemia whose physiological response is hyperventilation leading to hypocapnia. Almitrine, initially described to reduce intrapulmonary shunt by enhancement of hypoxic pulmonary vasoconstriction in combination with inhaled nitric oxide (iNO), redistributes pulmonary blood flow from shunt areas to lung units with normal ventilation/perfusion (VA/Q) ratio. Low dose of intravenous almitrine (2 µg.kg-1.min-1) alone also improves oxygenation (without combination with iNO) by selective pulmonary vasoconstriction of precapillary pulmonary arteries perfusing lung areas exposed to a hypoxic challenge with a slight increase in mean arterial pulmonary. Therefore, our hypothesis is that 5 days of low dose of almitrine therapy may improve the ventilation-perfusion (VA/Q) ratio at a relatively early stage of this specific lung disease and limit respiratory worsening and subsequent need for mechanical ventilation.


title: Accelerated Nursing Branch for the Diagnosis and Treatment of Ankle and Foot Injuries in Emergency Department: Preliminary Pilot Study

acronym: ATENA

summary:
The ankle and/or foot injuries incidence is high. Lateral ankle sprains are most common diagnosis, while fractures represent less than 15% of final diagnosis. Ankle and/or foot injuries are associated with significant morbidity in terms of pain and chronic instability. The societal cost of these injuries is significant mainly related to hospital care and sick-leave. In summary ankle and/or foot injuries are very frequent reason for emergency admission.

The study hypothesis is that an accelerated nursing care system for traumatized ankle and/or foot patients is feasible and allows patients to be cared for in accordance to current medical recommendations. Such a branch should be followed by a return to work and sports within a time frame consistent with the literature. The duration of patient management in emergency department should be short, less than that observed in a historical cohort. Finally patient satisfaction should be high. In the medium term, the implementation of an accelerated nursing branch for the diagnosis and treatment of ankle and/or foot injuries should contribute to effective care and reduction of over activity in emergency departments.

ipd_sharing_description:
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.

In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.

lead_sponsor: University Hospital, Grenoble


title: Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study

acronym: DECATEC

summary: Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. This study was designed to evaluate effects of the additional of GnRH agonist (single or 2 doses) to the routine oestrogens and progestins use as support before Frozen Embryon Transfer as compared to oestrogens and progestins only.

lead_sponsor: Hopital Foch


title: Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis An Observational Prospective Study

acronym: LIPS

summary:
When there is infection in the intra-abdominal area, bacteria secrete toxins that are absorbed by the peritoneum. These toxins then bind to lipoproteins (which carry cholesterol in the blood) and are eliminated by the liver. Phospholipid transfer protein (PLTP) is a protein that facilitates the binding of bacterial toxins to lipoproteins and thus their elimination.

The objective of this study is to study the relationship between PLTP and the elimination of bacterial toxins in humans. A better understanding of the elimination of these toxins will lead to a better understanding of the disease. The ultimate objective is to improve the management of intra-abdominal infections.


title: Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse: Cases of Synthetic Antimalarial Drugs and Anti-hypertensive Drugs

acronym: TRAPSAH

summary:
The COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold.

Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome [ARDS] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19.

Treatments currently being investigated include:

Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS;
Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists.

We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease.

Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are

Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors).
Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities.

This in order to:

To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD.
To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


title: Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma

acronym: PSYCHO-CBC

summary: The aim of this study was to identify psycho-social factors associated with diagnostic delay in advanced basal cell carcinomas. Thus, the objective is to develop recommendations to better identify CBCa populations at risk, improve earlier their diagnosis and thus their care with an adequate and targeted information.

ReferenceCitation: Garrouteigt C, Broc G, Legrand A, Quintard B, Beylot-Barry M. Facilitators of and obstacles to consultation in patients with advanced basal cell carcinoma: a French pilot study. Arch Dermatol Res. 2021 Dec;313(10):829-835. doi: 10.1007/s00403-020-02175-x. Epub 2021 Jan 12.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Dermatologie - Hôpital Saint André


title: Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life

summary:
Conserving surgery followed by adjuvant radiotherapy is currently the therapeutic standard for patient with Breast Cancer. Symptoms are common among patients receiving this treatment. Ten percent of them will develop severe and chronic radio-induced toxicities, such as breast radio-induced-fibrosis impairing their quality of life (QoL). Yet, paying attention to symptom improves the empowerment and psychological adjustment to the disease. Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control, and to enhance patient-clinician communication patient satisfaction, as well as well-being.Benefits of systems to elicit e-PRO improve reliable measure of health-related quality of life (QoL) remains discussed.

To date, there are few specific treatments for these severe radio-induced fibrosis except the antifibrotic combinaison Pentoxifylline/Vitamin E with inconsistent result.

Since 2000, we and others have developed a mechanistic approach modulating the severity of RIF by targeting the Rho/ROCK/CTGF pathway, especially by inhibiting Rho activation by pravastatin. Our preclinical data, then followed by the Phase II PRAVACUR-01 trial, concluded that the use of pravastatin has an anti-fibrotic action on different experimental models and reduces the severity of the grade of fibrosis in 50% of patients.

Patients can now benefit from this new anti-fibrotic agent.

Taken as a whole, these data encourage combining both drug (pravastatin) and non-pharmacological intervention , in particular e-PRO, in the RIF management.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: A Phase II Randomized Trial, Non Comparative, Evaluating Chemotherapy Associated Cisplatin, 5-fluorouracil and Docetaxel at Adapted Doses in Patients With Locally Advanced Squamous Cell Carcinoma

acronym: TPFmORL

summary:
The objective of this study is to evaluate the efficacity of the combination of cisplatin-5-FU and docetaxel in adapted doses in term of response to treatment without toxicity

.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou


title: Observational Retrospective Study Evaluating Efficacy and Safety of Ialuset Cream or Gauzepad in Second Degree Burns Use for Children

summary:
Observational retrospective monocentric study occured in the univeristy hospital center of Bensançon the department of pediatric surgery.

Data of patients treated in the hospital between January 2016 and January 2019 have been collected.

lead_sponsor: Laboratoires Genévrier


title: Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus : to a Form of Lichen Planus-like Lupus Erythematosus ?

summary: Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) and subacute cutaneous lupus erythematosus (SCLE) is a rare phenomenon seldom reported in literature. The investigators hypothesize that clinic-immunologic assessment and detailed investigation of cutaneous biopsy specimen of PPK and erythema of patients suffering from SLE and SCLE could lead to determine more precisely nosological settings of this injury. Report the different therapeutics with efficacy assessment could be helpful to highlight useful treatment for these patients.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Sensitivity of the Search for a Heterophory-Vertical-Labile (HV-Labile) for Ambulatory Screening for Specific Learning Disabilities (SLD) or Developmental Coordination Disorder (DCD).

acronym: TDys

summary: To evaluate, in primary care, the sensitivity of Heterophory-Vertical-Labile (HV-Labile) in ambulatory screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). in children aged 8 to 12 years.

primary_purpose: Screening

ReferenceCitation: Quercia P, Quercia M, Feiss LJ, Allaert F. The distinctive vertical heterophoria of dyslexics. Clin Ophthalmol. 2015 Sep 25;9:1785-97. doi: 10.2147/OPTH.S88497. eCollection 2015.

ipd_sharing_description: IPD will not be shared with other researchers.

lead_sponsor: CNGE IRMG Association


title: Evaluation of a COVID-19 Screening Strategy Combining Chest Low Dose CT and RT-PCR Test for Patients Admitted for Surgical or Interventional Procedures During the COVID 19 Outbreak

acronym: COVID-Scan

summary:
This research aims to improve the screening for COVID-19 upon admission to the Montpellier University Hospital for an act under general anesthesia or at high risk of transmission of the virus. Indeed, routine nasal swabs present many false negatives (60 to 70%) and many patients with the coronavirus have little or no symptoms. Performing a chest CT scan can reveal early signs very suggestive of viral pneumoniae due to the new coronavirus without additional risk compared to a simple chest X-ray (no injection of contrast medium, low exposure).

The objective is to assess the sensitivity of the diagnosis of COVID-19 by carrying out a nasopharyngeal RT-PCR and a low dose thoracic scanography at the hospital admission of patients scheduled to a procedure under general anesthesia or at risk of aerosolization (surgery, endoscopy, procedures involving risk of interventional radiology) in order to limit the risks of transmission to healthcare professionals or other patients and to rationalize the use of protective equipment.

This is an observational research without modification of care in the setting of COVID-19 pandemia. All clinical and biological data will be issued from routine care and medical charts. Routine use of CT scan and nasal swabs is an institutional approved strategy. Serologic tests will be performed as soon as available from serum collection collected after routine blood analysis. All data will be anonymously recorded after information and non-opposition of the patient.


title: Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions

summary:
The evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. The Polylactic Interference Screws are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the PIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

Objective IKDC score (clinical evaluation) Subjective IKDS score (functional evaluation) Safety (report of any adverse event) Follow-up of the patient's recovery

lead_sponsor: Biomatlante


title: Cohort Study Evaluating the Epidemiological Characteristics of Coronavirus Infection (SARS-CoV-2) in Patients With MS or NMO

acronym: COVISEP

summary: The purpose of this study is to collect French medical data for patients with Multiple Sclerosis (MS) or NeuroMyelitis Optica (NMO) spectrum disorder who are diagnosed or strongly suspected of being infected with Covid19. The objective of this study is to provide scientific information regarding the possible risk factors in these patients, as a large part of them receive immunomodulatory or immunosuppressive treatments. The main objective of this study is thus to determine the epidemiological (eg, age, form of disease, disability) and pharmacological (related to immunomodulatory or immunosuppressive treatments) factors favoring the occurrence of a severe form of Covid-19 in MS and NMO patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Efficacy of Transcranial Direct Current Stimulation (tDCS) in Patients Suffering From Pathological Use of Internet Gaming : Randomized, Controlled, Double-blind, Monocentric Pilot Study

acronym: StimNET

summary:
The Internet has grown considerably in the last twenty years, and as a result, cases of excessive iinterney use have emerged. These cases, which have clinical similarities with substance addiction, involve the various activities related to the Internet (online gambling, discussion forums, online networking, e-mail, pornography, shopping, etc.). However, to date, only the pathological use of Internet gaming (PUIG) is referenced in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, section III).

In PUIG, an individual loses control when gambling online. He/she typically spends 8 to 10 hours on this activity, sometimes without eating or sleeping. Usual obligations, such as school or work, or family obligations are neglected. PUIG can cause great psychological and social suffering. Neurological complications (epilepsy) and deaths (cardiac arrest) related to PUIG have also been reported. These situations are all the more dramatic because they often affect adolescents and young adults. In Asia, PUIG has become a public health problem. To date, no treatment has been validated for this disorder.

Non-invasive brain stimulation (NIBS) techniques can modulate neural activity in the dorsolateral prefrontal cortex (DLPFC). This modulation makes it possible to reduce addictive behaviours through different mechanisms (reduction of craving, impulsivity, and decision-making disorders). These techniques could be effective for PUIG.


title: CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II

acronym: CIRCULATE

summary: The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.

location_facility: Fédération Francophone de Cancérologie Digestive


title: Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns

acronym: COVIPREG

summary:
A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission.

Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures.

Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth.

It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.


title: Treatment and Long-term Outcomes of Pediatric Patient With Penetrating Crohn's Disease: the Multicenter Cross-sectional Study

acronym: Pediatric B3

summary:
The incidence of Crohn's disease (CD) increased the last few years, especially in children, with 20% percent of CD patients diagnosed during childhood. The CD is a chronic disease without curative treatment, medical or surgical, and evolution is longer in children, avoid iterative digestive resections and their consequences in these patients is a major issue.

The beginning of the disease at pediatric age is considered to be a poor prognostic factor and is considered to be more aggressive than that of adults: more extensive, more active and requiring more immunosuppressive treatments, with a more frequent dependence on corticosteroids and a shorter delay between the beginning of symptoms and the first surgery. After 5 years of evolution, 13 to 50% of patients with early pediatric MC have undergone intestinal resection.

The Paris' classification defined 3 phenotypes or behaviors in pediatric Crohn's disease. Penetrating phenotype (B3) is a heterogeneous group defined by the presence of intra-abdominal perforation, fistulas or abscesses. The B3 phenotype is a risk factor for pejorative evolution in CD with a risk increased of surgical resection.

In the pediatric population, the natural history of patients with penetrating CD is unknown. Most studies focus on CD beginning at pediatric age but with penetrating complications occurring in adulthood or pediatric penetrating CD but with relatively short follow-up. The risk of recurrence of the penetrating disease after a first complication in childhood is unknown, the factors influencing this risk also. And, there is no consensus either concerning optimal B3 management in children, and the practices are variable from specialist to specialist.

After describing the pediatric population with penetrating CD, the aim of this study was to know the incidence of bowel resection for B3 episode. The secondary aims were to describe the immediate management and long-term evolution of these patients and to identify risk factors for adverse evolution.

time_perspective: Cross-Sectional


title: Pronostic Value of Diaphragmatic Excursion Measurement in Patients With Acute Respiratory Failure in the ED.

acronym: PREDIRE

summary:
Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die.

Measurement of diaphragmatic motion (excursion) at ultrasonography is a noninvasive measure, allowing to assess diaphragm dysfunction. It could be useful in predicting poor prognosis in ED patients with respiratory failure .

In this study the investigators will compare the prognostic value of diaphragmatic excursion measurement at ultrasonography to that of the National Early Warning Score (NEWS) 2 in patients presenting with acute respiratory failure in the ED

The Investigators made the hypothesis that measurement of diaphragmatic excursion in ED patients with acute respiratory failure could be of value in predicting the need for ventilatory support or mortality within 28 days from ED admission


title: Relationship Between the ANI Score During Standardized Painful Stimulation and the Nociceptive Response to Laryngoscopy Intubation

summary:
The objective : to investigate a correlation between ANI following a standardized nociceptive stimulus and hemodynamic or somatic reactions during orotracheal intubation.

Piloted study. ANI and hemodynamic and somatic parameters response associated tetanus stimulation followed by orotracheal intubation were collected.

ReferenceCitation: Jozefowicz E, Sabourdin N, Fontaine V, Lambelin V, Lejeune V, Menu H, Bourai M, Tavernier B. Prediction of reactivity during tracheal intubation by pre-laryngoscopy tetanus-induced ANI variation. J Clin Monit Comput. 2022 Feb;36(1):93-101. doi: 10.1007/s10877-020-00624-6. Epub 2021 Jan 2.


title: Evaluation of the Management of Dental Emergencies During COVID 19 Crisis

acronym: URGDENTCOVID

summary:
"For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.

So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.

This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE). An additional study (URGDENT-NW) aiming at completing this study by focusing on patients consulting the emergency room at night and during the weekend is also in progress.

The COVID19 Crisis changed the organization and the venue of patients at the emergency dental service.

Therefore this project, based on the same protocol as URGENT and URGDENT-WE, aims at evaluating the Odontology Emergency Reception Service (SAUO) during the COVID 19 epidemy. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room ."

location_facility: Service d'odontologie, Hôpital Pitié-Salpêtrière


title: A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome

summary: The purpose of this pilot study is to evaluate the effects of Atomoxetine, a selective noradrenaline reuptake inhibitor, on impulsivity in patients with Tourette's syndrome.

ReferenceType: background

ReferenceCitation: Ansquer S, Belin-Rauscent A, Dugast E, Duran T, Benatru I, Mar AC, Houeto JL, Belin D. Atomoxetine decreases vulnerability to develop compulsivity in high impulsive rats. Biol Psychiatry. 2014 May 15;75(10):825-32. doi: 10.1016/j.biopsych.2013.09.031. Epub 2013 Oct 11.

ReferenceCitation: Chamberlain SR, Del Campo N, Dowson J, Müller U, Clark L, Robbins TW, Sahakian BJ. Atomoxetine improved response inhibition in adults with attention deficit/hyperactivity disorder. Biol Psychiatry. 2007 Nov 1;62(9):977-84. Epub 2007 Jul 17.

ReferenceCitation: Kehagia AA, Housden CR, Regenthal R, Barker RA, Müller U, Rowe J, Sahakian BJ, Robbins TW. Targeting impulsivity in Parkinson's disease using atomoxetine. Brain. 2014 Jul;137(Pt 7):1986-97. doi: 10.1093/brain/awu117. Epub 2014 Jun 3.

ReferenceCitation: Allen AJ, Kurlan RM, Gilbert DL, Coffey BJ, Linder SL, Lewis DW, Winner PK, Dunn DW, Dure LS, Sallee FR, Milton DR, Mintz MI, Ricardi RK, Erenberg G, Layton LL, Feldman PD, Kelsey DK, Spencer TJ. Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders. Neurology. 2005 Dec 27;65(12):1941-9.

lead_sponsor: Poitiers University Hospital


title: Evolution of the Quality of Life During a Twin Pregnancy

acronym: QUALIGEM

summary:
Quality of life has recently appeared as a component of health. Pregnancy has an impact on the quality of life of the parturient, whether through physical or psychological changes.

It is common to think that quality of life is altered in the context of a twin pregnancy, but this has never been scientifically demonstrated.

The hypothesis is to observe a decrease in the quality of life of pregnant women with twins at the end of pregnancy, in particular in case of a pregnancy-related pathology.

lead_sponsor: Hospices Civils de Lyon


title: Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery / RECHMPL20_0210

summary:
Adults who undergo cataract surgery will be questioned after surgery about the eventual pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: type of anesthesia, duration of surgery, machines used, unexpected events, particularities noticed by the surgeon, etc.

There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.


title: Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. A Qualitative Cross-sectional Study of Professionals, Patients, Parents of Sick Children, and Expert Patients, in the Context of Triple Negative or Luminal B Breast Cancer, Metastatic Uveal Melanoma and Pediatric Cancers.

summary: Resistance to treatment is one of the major themes in cancer research. Despite this, the definition and clinical implications of resistance to treatment remain under-explored, and patient-physician communication in this context still constitutes a challenge. When resistance to cancer treatments occurs, physicians not only have to explain to the patient the phenomenon of resistance, often based on complex results (biological results, genomic tests, imaging, etc.), but also need to offer alternative therapies, whilst fostering shared medical decision-making. These different tasks are particularly challenging for clinicians, especially since there are large individual differences at patient level. Indeed, each patient has his or her own unique information needs, capacity for understanding, and level of desire to participate in treatment decisions.

ReferenceCitation: Brédart A, Rault A, Terrasson J, Seigneur E, De Koning L, Hess E, Savignoni A, Cottu P, Pierga JY, Piperno-Neumann S, Rodrigues M, Bouleuc C, Dolbeault S. Helping Patients Communicate With Oncologists When Cancer Treatment Resistance Occurs to Develop, Test, and Implement a Patient Communication Aid: Sequential Collaborative Mixed Methods Study. JMIR Res Protoc. 2022 Jan 12;11(1):e26414. doi: 10.2196/26414.

lead_sponsor: Institut Curie


title: Usability of a Serious Game to Rehabilitate Gaze Stability in Children With Vestibular Deficit: "Kids Gaze Rehabilitation"

acronym: KG-REHAB

summary: Since the early 2000s, vestibular rehabilitation has been proposed as a therapeutic tool to improve the balancing function and the various motor skills in children, in particular in children with hearing loss suffering from concomitant vestibular deficit. It has been demonstrated in adults with vestibular deficit that the fact of adding to the classic exercises on the control of balance per se and habituation, specific exercises of adaptation and substitution of the vestibulo-ocular reflex brought therapeutic benefit. These exercises, which are started in the presence of the physiotherapist and then continued by the patient himself at his home, aim to improve the stabilization of the gaze during head movements. In pediatrics, however, performing them is more difficult than conventional exercises, since their immediate interest is not well understood by the child, who may be reluctant to perform them. The present project aims to enrich the therapeutic offer by a pediatric rehabilitation method of eye stabilization sufficiently playful to win adherence to treatment, including in the absence of the physiotherapist when the child is at home.


title: Skin Decolonization of Children Hospitalized in Intensive Care Unit by Daily Toilet : Mild Soap Versus Chlorhexidine Gluconate 2% Pad

acronym: DCpedrea

summary: The purpose of this study is to evaluate the efficacy and duration of the skin decolonization brought by a daily wash using Chlorhexidine Gluconate 2% pad compared to a standard wash with mild soap in children hospitalized in intensive care unit.


title: Evaluation of the Management of Dental Emergencies During Night and Week-ends

acronym: URGDENT-NW

summary:
For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.

So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.

This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE).

Attendance at night and during WE is important because it is sociologically and medically different from that of day and week. It is therefore important to complete this study by focusing on patients consulting the emergency room at night and during the weekend.

This work therefore responds to a request from the Odontology Emergency Reception Service (SAUO) of the Pitié-Salpêtrière Hospital Group. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room .


title: Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire

acronym: QEV-FR

summary: There is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.


title: Study of Maternal Pharmacokinetic and Placental Transfer of Levetiracetam

acronym: EPICEINTE

summary:
Hypotheses: The treatment of epilepsy during pregnancy is difficult because of the risk of anti-epileptic drugs on the one hand and the risk of destabilization of epilepsy in the mother on the other hand. There is limited data on the pharmacokinetics (concentration study) and pharmacodynamics (efficacy and toxicity effects study) of levetiracetam in pregnant women. The few studies focus on few women and show very strong interindividual variability and a tendency to decrease total concentrations.

Main objective: To develop a population pharmacokinetic model of levetiracetam during pregnancy. After the study, this model could be used to propose dose adjustments to maintain stable concentrations in pregnant women throughout pregnancy.

Secondary objectives:

Describe placental transfer during childbirth and during a medical termination of pregnancy
Link the concentration and its variation in the individual to the effects of treatment

ReferenceCitation: Pennell PB. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology. 2003 Sep 1;61(6 Suppl 2):S35-42. Review.

ReferenceCitation: Tomson T, Palm R, Källén K, Ben-Menachem E, Söderfeldt B, Danielsson B, Johansson R, Luef G, Ohman I. Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation. Epilepsia. 2007 Jun;48(6):1111-6. Epub 2007 Mar 22.

ReferenceCitation: Westin AA, Reimers A, Helde G, Nakken KO, Brodtkorb E. Serum concentration/dose ratio of levetiracetam before, during and after pregnancy. Seizure. 2008 Mar;17(2):192-8. doi: 10.1016/j.seizure.2007.11.027. Epub 2008 Jan 3.


title: Outcomes of naïve Patients Operated on for an Urological Cancer or Emergency During Periods of Social COVID-19 Containment: is it Reasonable to Limit Access to Surgical Care for All?

summary:
The French healthcare system has been strongly mobilized since the start of the Covid-19 epidemic to take care of patients with Covid-19. This should not overlook the fact that some treatments, surgeries and examinations of non-Covid-19 patients must imperatively be maintained according to the assessment of their risk-benefit balance. In context, it appears that this is not always the case. In addition to the necessary social containment measures, there are general limitations on patient access to the operating theater, neglecting the individual interest of naive non-Covid-19 patients. Certain studies which report a higher and earlier risk of death of undetected and ultimately operated Covid-19 patients has reinforced, as a precaution, the massive deprogramming of naive patients and the restrictive access of surgical care for all. We believe that this could lead to a risk of delayed treatments and renunciation of care for naive patients who should not be considered at risk a priori in the event of surgery. The individual clinical and local health context should be first considered for appropriate surgical decision-making.

As such, the French Department of Health and Human Services (DGS) has given general guidelines regarding the maintenance of follow-up and care for non-Covid-19 patients in this context of containment and major mobilization of health care professionals to care for people with COVID. Surgeries which could not be postponed because of the patient's status or if their postponement exposed to a significant risk of loss of chance, if needed in the light of the recommendations issued by learned societies, were concerned. In this sense, the investigator have selected the naive Covid-19 patients from Nice Hospital who should benefit from elective or urgent urological surgeries, taking into account their individual risk and the territorial epidemic rate. Their rate of ICU stays following their surgery has been analysed and their surgical follow-up outcomes during the epidemic period evaluated, according to the anti-Covid-19 measures established in Nice Hospital by comparing them to an earlier period without Covid-19.

ipd_sharing_description: no data sharing plan has been established

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of the Impact of Using LabPad® Point-of-care to Measure International Normalized Ratio (INR) at Home on the Patient's Follow up on VKA

acronym: INRADOM

summary: This study evaluates the impact of using LabPad® point-of-care to measure International Normalized Ratio (INR) at home on the patient's follow up on vitamine K antagonist (VKA) treatment during 6 months.

lead_sponsor: Medicalps


acronym: MICROPREP

title: Intra Articular Injection of Autologous Microfat and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: a Pilot Study

lead_sponsor: Clinique Juge

ReferenceCitation: Louis ML, Dumonceau RG, Jouve E, Cohen M, Djouri R, Richardet N, Jourdan E, Giraudo L, Dumoulin C, Grimaud F, George FD, Veran J, Sabatier F, Magalon J. Intra-Articular Injection of Autologous Microfat and Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Comparative Study. Arthroscopy. 2021 Oct;37(10):3125-3137.e3. doi: 10.1016/j.arthro.2021.03.074. Epub 2021 Apr 20.

ipd_sharing_description: Publication

summary: The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.


title: Immunological Profiling of Patients With COVID-19 in Respiratory Distress

summary: The study investigators hypothesize that the pneumonia arising in patients with COVID-19 is largely of immunopathological origin. The investigators will therefore seek to define the immune activation phenotype of patients in respiratory distress and to see if this immune signature is predictive of mortality. Finally, the investigators will look for overproduced inflammatory mediators to identify potential therapeutic targets.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak

acronym: OsPsyCOVID

summary: In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.

lead_sponsor: University Hospital, Lille


title: Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field - Artefact

acronym: Artefact

summary: Investigator team hypothesize that artifacts generated by the presence of an acoustic implant subjected to the magnetic field of the MRI are variable depending on the type of sequence and can be reduced by structural modifications of the implant and by variations in its appearance positioning with respect to the magnetic field MRI.

primary_purpose: Basic Science

lead_sponsor: Ramsay Générale de Santé


title: Evaluation of Respiratory Mechanics and Lung Recruitment in Patients With SARS-CoV-2 Associated Acute Respiratory Distress Syndrome

summary: The aim of this observationnal study is to describe respiratory mechanics and lung recruitement in patients with SARS-CoV-2 Associated Acute Respiratory Distress Syndrome who underwent invasive ventilation on endotracheal tube, admitted to the medical ICU of Angers university hospital . Statics measurements of respiratory system compliance were performed at 2 differents levels of PEEP (15 cmH2O and 5 cmH2O). The recruited volume is computed as the difference between the volume expired from PEEP 15 to 5 cmH2O and the volume predicted by compliance at PEEP 5 cmH2O . The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 was used to define highly recruiter patients.

lead_sponsor: University Hospital, Angers


title: Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

acronym: HYPERPIC

summary: Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy

acronym: SEA ELASTO 1

summary: The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology that allowed an in vivo assessment of viscoelastic properties of tissues such as muscles. The main endpoint of this study is to assess the intra-observer and the inter-observer reproducibility of a the external anal sphincter assessment using shear wave elastography in term pregnant women.

primary_purpose: Prevention


title: Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

acronym: EndoRevI

summary:
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis.

In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease.

The objective of this retrospective study is to evaluate the life-threatening, limb salvage and associated prognostic factors in patients with Peripheral Arterial Occlusive Disease supported by endovascular revascularization in the vascular medicine department of the GHPSJ.

ReferenceCitation: Yannoutsos A, Lin F, Billuart O, Gaisset R, Sacco E, Beaussier H, Buronfosse A, Mourad JJ, Emmerich J, Lazareth I, Priollet P. Predictive value of admission blood pressure for 3-month mortality in patients undergoing revascularization for critical limb ischemia. J Hypertens. 2020 Dec;38(12):2409-2415. doi: 10.1097/HJH.0000000000002556.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

acronym: PRODEX

summary:
The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations.

Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics.

The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

lead_sponsor: University Hospital, Limoges


title: Body Composition Monitor to Quantify Fluid Overload Related to Vascular Leak in Septic Shock Patients

acronym: FOTOShock

summary:
Fluid management in septic shock patients remain a great challenge. Insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies.

Several invasive and non invasive strategies have been developed during the past years to monitor the hemodynamic state of septic shock patients, but no method has been validated to objectively quantify fluid overload in septic shock patients.

The Body Composition Monitor (BCM) allow for measurement of total body water (TBW), extracellular water (ECW) and intracellular water (ICW) volumes using bioimpedancemetry. The BCW is daily used in patients who undergo renal dialysis to assess the effectiveness of fluid removal. The BCM has never been validated in septic shock patients.

The aim of the study is to investigate the accuracy of the BCM to measure the variation of the TBW during a fluid challenge of 500 ml of saline during the early phase of septic shock.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period

acronym: Resi-CoV

summary: The outbreak linked to SARS-CoV-2 infection was declared a Public Health Emergency of International Concern on 30 January 2020. In all of the emergency Departments, a major reorganization was necessary, notably with the creation of a specific channel for COVID-19 suspect patients. Thus, all caregivers involved must adapt day by day to new places of exercise, new protocols,...The major influx of patients, the precautions to be taken, the specifics of the pathology and its management have profoundly changed daily practice. This exogenous hospital tension impacts all caregivers and more particularly their resilience capacities. Resilience is defined as an ability to recover from or adjust easily to misfortune or change. The Resi-CoV study aims to assess the level of resilience of caregivers of different specialties and trades in the context of covid-19.


title: MEningioma Detection Using Non Contrast MRI TecHniquEs

acronym: MENTHE

summary:
Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for 35% of central nervous system tumors, and its incidence is estimated at 3% in large autopsy series.

The current gold standard for screening and monitoring cerebral meningiomas is MRI with injection of gadoline-contrast product. However, the use of some of these products is problematic, due to gadolinium deposits observed in patients who have had several injections during their lifetime, especially in patients followed for multiple sclerosis.

Recently, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued recommendations concerning the screening of meningiomas in patients at risk, particularly in people treated with cyproterone acetate. It is a synthetic progestogen steroid with anti-androgenic properties. It is used to treat hyperandrogenic syndromes in women or in the palliative treatment of prostate cancer in men. Its long-term use seems to be associated with a significant over-risk of developing meningiomas, brain tumours affecting meninges. This increased risk is multiplied by 7 in women exposed to high doses of cyproterone acetate, and by 20 over a cumulative dose of 60 grams, or about 5 years of treatment at 50 mg/day or 10 years at 25 mg/day. The ANSM recommends that a cerebral MRI be performed at the beginning of treatment for all patients, as well as a control MRI renewed at 5 years and then every 2 years if the MRI at 5 years is normal. These recommendations will lead to a large number of MRIs involving an injection of contrast agent in this population, with potential immediate or delayed serious adverse effects.

New techniques, such as Arterial Spin Labelling (ASL), or black blood sequences optimized for contrast detection, have been developed. These could detect meningeal anomalies and more particularly meningiomas without contrast injection, or with a significantly lower dose of contrast agent.

These techniques have not been specifically studied for screening or monitoring meningeal lesions, but it seems relevant and important to be able to validate protocols that reduce gadolinium doses given the high number of screening and follow-up MRIs in the general population.

Patients presenting for brain MRI for meningioma screening or follow-up will have the usual MRI sequences for their management, and the FABIR sequences without injection, added for research. These new sequences will add approximately 8 minutes of additional examination time.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Dexamethasone Combined With Hydroxychloroquine Compared to Hydroxychloroquine Alone for Treatment of Severe Acute Respiratory Distress Syndrome Induced by Coronavirus Disease 19 (COVID-19): a Multicentre, Randomised Controlled Trial

acronym: DHYSCO

summary: Single blind randomized clinical trial designed to evaluate the efficacy of the combination of hydroxychloroquine and dexamethasone as treatment for severe Acute Respiratory Distress Syndrome (ARDS) related to coronavirus disease 19 (COVID-19). We hypothesize that dexamethasone (20 mg for 5 days followed by 10 mg for 5 days) combined with 600 mg per day dose of hydroxychloroquine for 10 days will reduce the 28-day mortality compared to hydroxychloroquine alone in patients with severe ARDS related COVID-19.

ipd_sharing_description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

lead_sponsor: Centre Chirurgical Marie Lannelongue

location_facility: Reanimation adulte. Hopital Marie Lannelongue


title: Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19

acronym: PHYSIO-COVID

summary:
In the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to COVID-19. From these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. It therefore seems essential to rigorously study these modifications, as they have been studied in the past for ARDS.

The aim of this non-interventional study is to describe precisely the respiratory and hemodynamic changes induced by COVID-19 in mechanically ventilated patients

.


title: Essure Permanent Birth Control, Effectiveness and Safety: A French Survey

acronym: prevessure

summary:
Since 2002, in CHU Amiens, Essure implants started to be used for women in need of voluntary sterilization in accordance with French national recommendations. Recently patient committees emerged to alert health agency and governments about various symptoms possibly link to the Essure implants. New studies have been launched in order to determinate if Essure implants were involved with the symptoms described. According to the scientific literature no solid link between Essure and the symptomatology was highlighted. French National College of Gynecologists and Obstetricians send a letter of information for patient and gynecologists. French National agency of medicament suspended Essure authorization in august 2017 for 3 months. Bayer industry decided to withdraw from the market the Essure implants in autumn 2017. Currently Essure procedures have been stopped to be used in CHU Amiens since august 2017. But, in CHU Amiens, health institutions still have to manage patients with Essure implants and potential adverse effects.

The purpose of this study is to determine if the patients treated between 2002 and 2017 with Essure implant present complications, had a proper follow up after the Essure implantation, and that the Essure implantation respected the medical guidelines in order to offer the best medical care with these new informations.

Medical data from patients who received Essure procedure will be collected with medical file and a survey about adverse effects will be submitted to patients by phone if they agree to take part of the study after loyal information.


title: Validity, Reliability and Feasibility of an Automated Photographic Measurement/Assessment of Food Intake in the Hospitalized Elderly

acronym: PAMPILLE

summary:
Malnutrition affects 50% to 70% of hospitalized elderly people, and is all the more worrying in the elderly because of its clinical impact. A measurement of food consumption is essential to recognize needs, monitor the nutritional status of the elderly in hospital and implement specific therapeutic action such as supplements or an increase in energy-protein to combat malnutrition or the risk of malnourishment. Unfortunately, this measure is rarely done effectively in practice, keeping the patient in nutritional deficit, contributing to a risk of increased morbidity and mortality.

Although weighing food intake is the reference method, it is a routine burden for healthcare teams. To overcome these constraints in hospital environments, intake is estimated by food readings over three consecutive days using a semi-quantitative method. It should be noted that this method remains complex, imprecise and reserved only for the most malnourished patients. In recent years, the development of photographic methods has become an interesting alternative to the measurement by weight. Based on photographs taken before and after the meal in order to deduce what is actually ingested, these methods obtain results comparable to the weighing method, though there is still a number of limitations (need for human intervention, constraint to have standardized menus in weight and lack of nutritional management adapted to patients). To overcome these limitations, an automated photographic method based on modern techniques for automatic processing of 2D and 3D images coupled with techniques derived from artificial intelligence has recently been developed in the investigator's unit, but has not yet been validated.

The originality and innovation of this project lies in the automated analysis of the photos taken and the conversion into percentage of remaining food thanks to the design of algorithms for image preprocessing and neural classification by a 2D and 3D software (patent pending).

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis

acronym: COARDIG

summary: The late-stage forms of degenerative osteoarthritis (OA) are very debilitating and less affordable to therapy. The main objective is to identify early onset symptoms of hand OA patients through imaging techniques (such as ultrasound and MRI). Our primary endpoint is to specify patients with high risk of radiological profression (X-ray).

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Rheumatology, CHU Montpellier


title: Factors Influencing Risk of Progression of Chronic Kidney Disease in Patients With Severe Renal Failure

acronym: FAIR-PROGRESS

summary: The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort.


title: Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist

acronym: EchoCirrho

summary: The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status.


title: Platino-resistance in Ovarian Cancer

acronym: PlatinOv

summary:
Prospective, monocentric study aiming to identify factors involved in platinum based-chemotherapy resistance in patients with epithelial ovarian cancer (all stages).

Patients will receive treatment (platinum based-chemotherapy) according to the standard practices.

A prospective database and an associated biological collection will be performed during 5 years:

For each patient: clinical, biological, epidemiological and therapeutic treatment data will be collected during the standard therapeutic care.
Biological samples (blood samples, tumor biopsy specimens and ascites samples) will be collected for all patients. These samples will be collected at the same time as those taken in standard practice (no additional biopsy will be performed for the study).

Study participation of each patient will be 5 years.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: A Dose Block-randomized, Double Blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Dosing of HL217 Eye Drop in Healthy Male Subjects

summary:
The study is a single center, double-blind, randomized, parallel group, multiple ascending dose study in 16 healthy male volunteers. Subjects will receive multiple eye drop doses during 14 days of the treatment (HL217 or placebo according to the randomization). There will be 2 cohorts of 8 subjects (6 HL217 vs 2 placebo) receiving the following doses:

Cohort 1 : two drops of 3 mg/mL of the treatment in one eye twice a day (low dose),
Cohort 2 : two drops of 3 mg/mL of the treatment in one eye 4 times a day (high dose).

lead_sponsor: Hanlim Pharm. Co., Ltd.


title: NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial

acronym: NEUROTHERM

summary:
The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo.

The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.


title: Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients

acronym: VIRARE

summary: Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects.