title: Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

acronym: SCLEROLF

summary:
Prospective monocentric study of patients with systemic sclerosis disease.

The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease.

The secondary outcomes are:

To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients.
To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease

ReferenceCitation: Amital H, Agmon-Levin N, Shoenfeld N, Arnson Y, Amital D, Langevitz P, Balbir Gurman A, Shoenfeld Y. Olfactory impairment in patients with the fibromyalgia syndrome and systemic sclerosis. Immunol Res. 2014 Dec;60(2-3):201-7. doi: 10.1007/s12026-014-8573-5.

ReferenceCitation: Bombini MF, Peres FA, Lapa AT, Sinicato NA, Quental BR, Pincelli ÁSM, Amaral TN, Gomes CC, Del Rio AP, Marques-Neto JF, Costallat LTL, Fernandes PT, Cendes F, Rittner L, Appenzeller S. Olfactory function in systemic lupus erythematosus and systemic sclerosis. A longitudinal study and review of the literature. Autoimmun Rev. 2018 Apr;17(4):405-412. doi: 10.1016/j.autrev.2018.02.002. Epub 2018 Feb 11. Review.


title: Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock

acronym: AMINO BESTDOSE

summary: Amikacin dose optimization is challenging in critically ill patients. The use of BestDose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/L) after administration of the second dose of amikacin, associated with improved outcome. The study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the BestDose software in the interventional group will reach the predefined PK/PD targets.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Robotic-assisted Diastasis of the Rectus Abdominis Muscles Repair: Evaluation of a Minimally Invasive Surgical Procedure

summary: The objective of the study is to evaluate the feasibility of a robot-assisted minimally invasive surgical technique for the management of diastasis of the rectus abdominis. The effectiveness of this robotic surgery will be evaluated on the intermuscular distance measurement above and under umbilicus using ultrasound or CT-scan imaging.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Mommers EHH, Ponten JEH, Al Omar AK, de Vries Reilingh TS, Bouvy ND, Nienhuijs SW. The general surgeon's perspective of rectus diastasis. A systematic review of treatment options. Surg Endosc. 2017 Dec;31(12):4934-4949. doi: 10.1007/s00464-017-5607-9. Epub 2017 Jun 8. Review.

ReferenceCitation: Sperstad JB, Tennfjord MK, Hilde G, Ellström-Engh M, Bø K. Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain. Br J Sports Med. 2016 Sep;50(17):1092-6. doi: 10.1136/bjsports-2016-096065. Epub 2016 Jun 20.

ReferenceCitation: Akram J, Matzen SH. Rectus abdominis diastasis. J Plast Surg Hand Surg. 2014 Jun;48(3):163-9. doi: 10.3109/2000656X.2013.859145. Epub 2013 Nov 21. Review.

ReferenceCitation: Orthopoulos G, Kudsi OY. Feasibility of Robotic-Assisted Transabdominal Preperitoneal Ventral Hernia Repair. J Laparoendosc Adv Surg Tech A. 2018 Apr;28(4):434-438. doi: 10.1089/lap.2017.0595. Epub 2018 Jan 2.

ReferenceCitation: Sugiyama G, Chivukula S, Chung PJ, Alfonso A. Robot-Assisted Transabdominal Preperitoneal Ventral Hernia Repair. JSLS. 2015 Oct-Dec;19(4). pii: e2015.00092. doi: 10.4293/JSLS.2015.00092.

ReferenceCitation: Nahabedian MY. Management Strategies for Diastasis Recti. Semin Plast Surg. 2018 Aug;32(3):147-154. doi: 10.1055/s-0038-1661380. Epub 2018 Jul 24. Review.

ReferenceCitation: Beer GM, Schuster A, Seifert B, Manestar M, Mihic-Probst D, Weber SA. The normal width of the linea alba in nulliparous women. Clin Anat. 2009 Sep;22(6):706-11. doi: 10.1002/ca.20836.

ReferenceCitation: Bellido Luque J, Bellido Luque A, Valdivia J, Suarez Gráu JM, Gomez Menchero J, García Moreno J, Guadalajara Jurado J. Totally endoscopic surgery on diastasis recti associated with midline hernias. The advantages of a minimally invasive approach. Prospective cohort study. Hernia. 2015 Jun;19(3):493-501. doi: 10.1007/s10029-014-1300-2. Epub 2014 Aug 21.

ReferenceCitation: Driver VR, Hanft J, Fylling CP, Beriou JM; Autologel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Manage. 2006 Jun;52(6):68-70, 72, 74 passim.

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Impact of Routine Assessment of Health-Related Quality of Life Coupled With Therapeutic Information on Compliance With Endocrine Therapy in Patients With Non-metastatic Breast Cancer

acronym: COMPLIANCE

summary: Only 59% of women with breast cancer (BC) treated with Endocrine Therapy (ET) remain compliant one year upon initial prescription, despite its proven effectiveness in reducing recurrence and improving survival. Health-related quality of life (HRQoL) in BC has been widely studied and the positive effects of its routine evaluation on the improvement of communication between patients and medical staff and survival have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Since compliance is a multidimensional phenomenon, a multifaceted intervention is necessary to improve it. Thus, the investigators hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with delivery of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

ReferenceCitation: Huiart L, Bardou VJ, Giorgi R. [The importance of adherence to oral therapies in the field of oncology: the example of breast cancer]. Bull Cancer. 2013 Oct;100(10):1007-15. doi: 10.1684/bdc.2013.1830. Review. French.

ReferenceCitation: Ayres LR, Baldoni Ade O, Borges AP, Pereira LR. Adherence and discontinuation of oral hormonal therapy in patients with hormone receptor positive breast cancer. Int J Clin Pharm. 2014 Feb;36(1):45-54. doi: 10.1007/s11096-013-9833-5. Epub 2013 Aug 11. Review.

ReferenceCitation: Hugtenburg JG, Timmers L, Elders PJ, Vervloet M, van Dijk L. Definitions, variants, and causes of nonadherence with medication: a challenge for tailored interventions. Patient Prefer Adherence. 2013 Jul 10;7:675-82. doi: 10.2147/PPA.S29549. Print 2013.

ReferenceCitation: Egede LE, Gebregziabher M, Dismuke CE, Lynch CP, Axon RN, Zhao Y, Mauldin PD. Medication nonadherence in diabetes: longitudinal effects on costs and potential cost savings from improvement. Diabetes Care. 2012 Dec;35(12):2533-9. doi: 10.2337/dc12-0572. Epub 2012 Aug 21.

ReferenceCitation: Cheung WY, Lai EC, Ruan JY, Chang JT, Setoguchi S. Comparative adherence to oral hormonal agents in older women with breast cancer. Breast Cancer Res Treat. 2015 Jul;152(2):419-27. doi: 10.1007/s10549-015-3455-7. Epub 2015 Jun 13.

ReferenceCitation: Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012 Jul;134(2):459-78. doi: 10.1007/s10549-012-2114-5. Epub 2012 Jun 12. Review.

ReferenceCitation: Weaver KE, Camacho F, Hwang W, Anderson R, Kimmick G. Adherence to adjuvant hormonal therapy and its relationship to breast cancer recurrence and survival among low-income women. Am J Clin Oncol. 2013 Apr;36(2):181-7. doi: 10.1097/COC.0b013e3182436ec1.

ReferenceCitation: Hsieh KP, Chen LC, Cheung KL, Chang CS, Yang YH. Interruption and non-adherence to long-term adjuvant hormone therapy is associated with adverse survival outcome of breast cancer women--an Asian population-based study. PLoS One. 2014 Feb 21;9(2):e87027. doi: 10.1371/journal.pone.0087027. eCollection 2014.

ReferenceCitation: Taketani K, Tokunaga E, Yamashita N, Tanaka K, Akiyoshi S, Okada S, Ando K, Kimura Y, Saeki H, Oki E, Morita M, Kusumoto T, Maehara Y. Early discontinuation of adjuvant hormone therapy is associated with a poor prognosis in Japanese breast cancer patients. Surg Today. 2014 Oct;44(10):1841-6. doi: 10.1007/s00595-013-0762-7. Epub 2013 Oct 19.

ReferenceCitation: Hadji P, Blettner M, Harbeck N, Jackisch C, Lück HJ, Windemuth-Kieselbach C, Zaun S, Kreienberg R. The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer. Ann Oncol. 2013 Jun;24(6):1505-12. doi: 10.1093/annonc/mds653. Epub 2013 Feb 1.

ReferenceCitation: Ziller V, Kyvernitakis I, Knöll D, Storch A, Hars O, Hadji P. Influence of a patient information program on adherence and persistence with an aromatase inhibitor in breast cancer treatment--the COMPAS study. BMC Cancer. 2013 Sep 4;13:407. doi: 10.1186/1471-2407-13-407.

ReferenceCitation: Markopoulos C, Neven P, Tanner M, Marty M, Kreienberg R, Atkins L, Franquet A, Gnant M, Neciosup S, Tesarova P, Barni S, Deschamp V. Does patient education work in breast cancer? Final results from the global CARIATIDE study. Future Oncol. 2015;11(2):205-17. doi: 10.2217/fon.14.179.

ReferenceCitation: Hadji P. Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. Crit Rev Oncol Hematol. 2010 Feb;73(2):156-66. doi: 10.1016/j.critrevonc.2009.02.001. Epub 2009 Mar 18. Review.

ReferenceCitation: Madan A, Borckardt JJ, Connell A, Book SB, Campbell S, Gwynette MF, Wimberly LA, Wagner M, Weinstein B, McLeod-Bryant S, Cooney H, Herbert J. Routine assessment of patient-reported outcomes in behavioral health: room for improvement. Qual Manag Health Care. 2010 Jan-Mar;19(1):70-81. doi: 10.1097/QMH.0b013e3181ccbc53.

ReferenceCitation: Epplein M, Zheng Y, Zheng W, Chen Z, Gu K, Penson D, Lu W, Shu XO. Quality of life after breast cancer diagnosis and survival. J Clin Oncol. 2011 Feb 1;29(4):406-12. doi: 10.1200/JCO.2010.30.6951. Epub 2010 Dec 20.

ReferenceCitation: Takada K, Kashiwagi S, Fukui Y, Goto W, Asano Y, Morisaki T, Takashima T, Hirakawa K, Ohira M. Prognostic value of quality-of-life scores in patients with breast cancer undergoing preoperative chemotherapy. BJS Open. 2018 Nov 26;3(1):38-47. doi: 10.1002/bjs5.50108. eCollection 2019 Feb.

ReferenceCitation: Chu WO, Dialla PO, Roignot P, Bone-Lepinoy MC, Poillot ML, Coutant C, Arveux P, Dabakuyo-Yonli TS. Determinants of quality of life among long-term breast cancer survivors. Qual Life Res. 2016 Aug;25(8):1981-90. doi: 10.1007/s11136-016-1248-z. Epub 2016 Feb 25.

ReferenceCitation: Lavdaniti M, Owens DA, Liamopoulou P, Marmara K, Zioga E, Mantzanas MS, Evangelidou E, Vlachou E. Factors Influencing Quality of Life in Breast Cancer Patients Six Months after the Completion of Chemotherapy. Diseases. 2019 Feb 24;7(1). pii: E26. doi: 10.3390/diseases7010026.

ReferenceCitation: Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24.

ReferenceCitation: Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. Erratum in: J Clin Oncol. 2016 Jun 20;34(18):2198. Erratum in: J Clin Oncol. 2019 Feb 20;37(6):528.

ReferenceCitation: Denis F, Lethrosne C, Pourel N, Molinier O, Pointreau Y, Domont J, Bourgeois H, Senellart H, Trémolières P, Lizée T, Bennouna J, Urban T, El Khouri C, Charron A, Septans AL, Balavoine M, Landry S, Solal-Céligny P, Letellier C. Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx029. Erratum in: J Natl Cancer Inst. 2018 Apr 1;110(4):436.

ReferenceCitation: Pinheiro LC, Wheeler SB, Reeder-Hayes KE, Samuel CA, Olshan AF, Reeve BB. Investigating Associations Between Health-Related Quality of Life and Endocrine Therapy Underuse in Women With Early-Stage Breast Cancer. J Oncol Pract. 2017 May;13(5):e463-e473. doi: 10.1200/JOP.2016.018630. Epub 2017 Mar 14.

ReferenceCitation: Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S, MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501. doi: 10.1200/JCO.2013.53.5948. Epub 2014 Apr 7. Review.

ReferenceCitation: Ruland CM, Andersen T, Jeneson A, Moore S, Grimsbø GH, Børøsund E, Ellison MC. Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial. Cancer Nurs. 2013 Jan-Feb;36(1):6-17. doi: 10.1097/NCC.0b013e31824d90d4.

ReferenceCitation: Eggersmann TK,Harbeck N, Schinkoethe T, Riese C. eHealth solutions for therapy management in oncology. Breast Cancer Manag. 2018; 6(3):101-106.

ReferenceCitation: Holzner B, Giesinger JM, Pinggera J, Zugal S, Schöpf F, Oberguggenberger AS, Gamper EM, Zabernigg A, Weber B, Rumpold G. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring. BMC Med Inform Decis Mak. 2012 Nov 9;12:126. doi: 10.1186/1472-6947-12-126.

ReferenceCitation: Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44.

ReferenceCitation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.

ReferenceCitation: Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition).2001.

ReferenceCitation: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74.

ReferenceCitation: Lepine JP, Godchau M, Brun P. Anxiety and depression in inpatients. Lancet. 1985 Dec 21-28;2(8469-70):1425-6.

ReferenceCitation: Costet N, Lapierre V, Benhamou E, Le Galès C. Reliability and validity of the Functional Assessment of Cancer Therapy General (FACT-G) in French cancer patients. Qual Life Res. 2005 Jun;14(5):1427-32.

ReferenceCitation: Conroy T, Mercier M, Bonneterre J, Luporsi E, Lefebvre JL, Lapeyre M, Puyraveau M, Schraub S. French version of FACT-G: validation and comparison with other cancer-specific instruments. Eur J Cancer. 2004 Oct;40(15):2243-52.

ReferenceCitation: Brédart A, Anota A, Young T, Tomaszewski KA, Arraras JI, Moura De Albuquerque Melo H, Schmidt H, Friend E, Bergenmar M, Costantini A, Vassiliou V, Hureaux J, Marchal F, Tomaszewska IM, Chie WC, Ramage J, Beaudeau A, Conroy T, Bleiker E, Kulis D, Bonnetain F, Aaronson NK; EORTC Quality of Life Group. Phase III study of the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and specific complementary outpatient module (EORTC OUT-PATSAT7). Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12786. Epub 2017 Nov 2.

ReferenceCitation: Rascle N, Bruchon-Schweitzer M, Sarason IG. Short form of Sarason's Social Support Questionnaire: French adaptation and validation. Psychol Rep. 2005 Aug;97(1):195-202.

ReferenceCitation: Bruchon-Schweitzer M. Psychologie de la santé. Modèles, concepts et méthodes. 1er éd. Paris : Dunod. 2002A.

ReferenceCitation: Velikova G, Keding A, Harley C, Cocks K, Booth L, Smith AB, Wright P, Selby PJ, Brown JM. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer. 2010 Sep;46(13):2381-8. doi: 10.1016/j.ejca.2010.04.030. Epub 2010 Jun 1.

ReferenceType: derived

ReferenceCitation: Mamguem Kamga A, Di Martino C, Anota A, Paget-Bailly S, Coutant C, Arveux P, Desmoulins I, Dabakuyo-Yonli TS. Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial. Trials. 2020 Jun 16;21(1):527. doi: 10.1186/s13063-020-04397-w.

lead_sponsor: Centre Georges Francois Leclerc

lead_sponsor_type: industriel


title: Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception: a Retrospectif Moncentric Study

acronym: EMV RPOC AVM

summary:
Background:

Hypervascularized products of conception remain a topic debated in terms of definitions (ultrasound criteria, need complement by angio MRI) and management. The different uterine vascular lesions are often confused. This is a recurrent problem and care are heterogeneous. The aim of the study is to evaluate the management of these entities in CHU of Montpellier and determine more homogeneous care. The investigators further aimed to evaluate clinical presentation, ultrasound criteria, complications and the gynaecological and obstetrical outcomes of patients •Methods: This study will be conducted in compliance of ethic comitee. The investigators will collect data from 64 individuals, aged 18 to 50, suffering from uterine vascular lesions associated or not with products of conception between 2013 and 2019. Caracterisitics of the population, ultrasound and angio MRI data will be collected. Management wll be described as expectative, surgery or embolization of uterine arteries and the success or not will be noted. The investigators will question patients on their gynaecologic and obstetrical outcomes by telephone.

•Discussion: The investigators aim to define and characterize the different lesions, establish ultrasound criteria that would guide treatments. Describe the current treatments and compare them in terms of efficiency and safety in order to establish a homogeneous treatment protocol in our center

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Feasibility and Clinical Impact Study of Non Pharmacological Interventions Targeting the Subject's Empowerment Among Slackline, Mindfulness, Adapted Physical Activity, Self-hypnosis, Qi Gong Versus Usual Care in Management of Chronic Pain

acronym: ELISAD

summary: This feasability study aims to compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong versus usual care in the management of chronic pain.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Supportive Care

ReferenceCitation: Shipton EA, Shipton EE, Shipton AJ. A Review of the Opioid Epidemic: What Do We Do About It? Pain Ther. 2018 Jun;7(1):23-36. doi: 10.1007/s40122-018-0096-7. Epub 2018 Apr 6. Review.

ReferenceCitation: Skelly AC, Chou R, Dettori JR, Turner JA, Friedly JL, Rundell SD, Fu R, Brodt ED, Wasson N, Winter C, Ferguson AJR. Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK519953/

ReferenceCitation: Devan H, Hale L, Hempel D, Saipe B, Perry MA. What Works and Does Not Work in a Self-Management Intervention for People With Chronic Pain? Qualitative Systematic Review and Meta-Synthesis. Phys Ther. 2018 May 1;98(5):381-397. doi: 10.1093/ptj/pzy029.

ReferenceCitation: Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019. Review.

ReferenceCitation: Olsen MF, Bjerre E, Hansen MD, Tendal B, Hilden J, Hróbjartsson A. Minimum clinically important differences in chronic pain vary considerably by baseline pain and methodological factors: systematic review of empirical studies. J Clin Epidemiol. 2018 Sep;101:87-106.e2. doi: 10.1016/j.jclinepi.2018.05.007. Epub 2018 May 21. Review.

lead_sponsor: University Hospital, Grenoble

status_simplified: Unknown


type: EudraCT Number

title: Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project

acronym: TOFAT

summary:
Inflammatory rheumatic diseases (IRD), such as rheumatoid arthritis, are characterized by adverse changes in body composition. Lean mass and bone mineral density are usually reduced while adiposity (total fat mass, visceral adiposity…) is increased in comparison with healthy controls. Many factors may influence the body composition of those patients such as aging, Disease Modifying Anti-Rheumatic Drugs (DMARDs), nutrition and physical activity.

However, data on body composition and adverse changes under DMARDs in patients with rheumatoid arthritis (RA) are actually scarce. This is the case with tofacitinib (targeted synthetic DMARD or tsDMARD) while preliminary data let us think that this treatment may influence body composition and bone mineral density.

This study is going to be the first to focus on changes in body composition (fat mass and lean mass), bone mineral density and bone marrow adiposity under tofacitinib.

status: Suspended

ReferenceCitation: Dodington DW, Desai HR, Woo M. JAK/STAT - Emerging Players in Metabolism. Trends Endocrinol Metab. 2018 Jan;29(1):55-65. doi: 10.1016/j.tem.2017.11.001. Epub 2017 Nov 27. Review.

ReferenceCitation: Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.

ReferenceCitation: Tatsumi Y, Nakao YM, Masuda I, Higashiyama A, Takegami M, Nishimura K, Watanabe M, Ohkubo T, Okamura T, Miyamoto Y. Risk for metabolic diseases in normal weight individuals with visceral fat accumulation: a cross-sectional study in Japan. BMJ Open. 2017 Jan 16;7(1):e013831. doi: 10.1136/bmjopen-2016-013831.

ReferenceType: result

ReferenceCitation: Book C, Karlsson MK, Akesson K, Jacobsson LT. Early rheumatoid arthritis and body composition. Rheumatology (Oxford). 2009 Sep;48(9):1128-32. doi: 10.1093/rheumatology/kep165. Epub 2009 Jul 13.

ReferenceCitation: Haugeberg G, Uhlig T, Falch JA, Halse JI, Kvien TK. Bone mineral density and frequency of osteoporosis in female patients with rheumatoid arthritis: results from 394 patients in the Oslo County Rheumatoid Arthritis register. Arthritis Rheum. 2000 Mar;43(3):522-30.

ReferenceCitation: Toussirot É, Mourot L, Dehecq B, Wendling D, Grandclément É, Dumoulin G; CBT-506. TNFα blockade for inflammatory rheumatic diseases is associated with a significant gain in android fat mass and has varying effects on adipokines: a 2-year prospective study. Eur J Nutr. 2014 Apr;53(3):951-61. doi: 10.1007/s00394-013-0599-2. Epub 2013 Oct 31.

ReferenceCitation: Marouen S, Barnetche T, Combe B, Morel J, Daïen CI. TNF inhibitors increase fat mass in inflammatory rheumatic disease: a systematic review with meta-analysis. Clin Exp Rheumatol. 2017 Mar-Apr;35(2):337-343. Epub 2016 Dec 13. Review.

ReferenceCitation: Engvall IL, Tengstrand B, Brismar K, Hafström I. Infliximab therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over 21 months. Arthritis Res Ther. 2010;12(5):R197. doi: 10.1186/ar3169. Epub 2010 Oct 21.

ReferenceCitation: Tournadre A, Pereira B, Dutheil F, Giraud C, Courteix D, Sapin V, Frayssac T, Mathieu S, Malochet-Guinamand S, Soubrier M. Changes in body composition and metabolic profile during interleukin 6 inhibition in rheumatoid arthritis. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):639-646. doi: 10.1002/jcsm.12189. Epub 2017 Mar 18.

ReferenceCitation: Letarouilly JG, Paccou J, Badr S, Chauveau C, Broux O, Clabaut A. Stimulatory Effect of Tofacitinib on Bone Marrow Adipocytes Differentiation. Front Endocrinol (Lausanne). 2022 Jul 6;13:881699. doi: 10.3389/fendo.2022.881699. eCollection 2022.

lead_sponsor: University Hospital, Lille

intervention_type: Drug


title: Middle Ear Implant: Assessment of Satisfaction in the Medium Term

acronym: IOM

summary:
Currently, the data from the literature do not evaluate the use of the middle ear implant in implanted patients in the medium term (10 years and over) but only in the short term (1-5 years).

Based on the observation of the absence of these data, we considered it necessary to evaluate in the medium term the satisfaction of the patients carrying a middle ear implant and their rate of abandonment with a horizon of 10 to 20 years of apparatus.

lead_sponsor: Hospices Civils de Lyon


type: Other Identifier

title: Tracking Information Flow in the Brain: A Unified and General Framework for Dynamic Communication in Brain Networks

acronym: BRAINDYN

summary: The brain is composed of a set of areas specialized in specific computations whose outputs need to be transferred to other specialized areas for cognition to emerge. To account for context-dependent behaviors, the information must be flexibly routed through the fixed anatomy of the brain. The aim of this project is to test a general framework for this flexible communication between brain areas based on nested oscillations. The general idea is that internally-driven slow oscillations (<20Hertz) either set-up or prevent the communication between brain areas. Stimulus-driven gamma oscillations (>30Hertz), nested in the slow oscillations, can then be directed to task-relevant areas of the network. This multimodal, multi-scale approach uses magnetoencephalography using a 3-Dimensional (3D) printed individual head-cast system and transcranial stimulation in experiments manipulating visual processing, attention and memory to test core predictions of this framework. The theoretical approach and the methodological development used in this basic science study will provide the basis for future fundamental and clinical research.

primary_purpose: Basic Science

location_facility: Centre de Recherche en Neuroscience de Lyon INSERM

intervention_type: Device


title: CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS

acronym: RE-CON

summary:
Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used.

The subjective refraction techniques of keratoconus-carrying patients have never been studied.

The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus.

The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.

primary_purpose: Treatment

ReferenceCitation: Metzger M, Navel V, Barrière JV, Kwiatkowski F, Hébraud J, Mulliez A, Béral L, Chiambaretta F, Dutheil F. Benefits of using corneal topography to choose subjective refraction technique in keratoconus (RE-CON): a prospective comparative crossover clinical study. Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):197-207. doi: 10.1007/s00417-021-05382-y. Epub 2021 Aug 20.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

acronym: TEMPET

summary:
Connected medicine "2.0" is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc.

However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization.

lead_sponsor: Centre Henri Becquerel


title: Study of the Effectiveness of a Guided Compensatory Cognitive Remediation Program for Family Caregivers in Schizophrenia: a Randomized Pilot Study

acronym: CIRCUS

summary:
Cognitive impairments are extremely common in schizophrenia and strongly predict deficit in daily functioning, the poor managing medication and multiple hospitalizations. Cognitive remediation is recognized to have an impact on cognitive impairments by engaging preserved cognitive functions or by implementing environmental supports that sustain independent living.

Pr. Velligan (University of San Antonio) developed and tested a manualized intervention, called Cognitive Adaptation Training. In this program, trained mental health specialists implement compensatory technique such as environmental supports in the individual's living environment to live more independently and achieve greater self-sufficiency.

However, implementing this program needs a lot of professionals and time to maintain CAT effects. This type of intervention is not often done in community care and explains the large number of patients who are dependent on family members for daily living activities. Training family members in this form of intervention would be an appropriate way to resolve these issues. Families expressed a real interest in these types of home-support strategies that CAT offers. Recently, Pr. Kidd and Pr. Velligan developed a CAT version for families and created a manual accessible to people without any knowledge of cognitive deficit. This manual helps families to select specific cognitive-adaptative strategies with their relative to achieve targeted goals. Thism ethod has been translated in French.

The aim of this study was to examine whether Web-based family Cognitive Adaptation Training can improve functioning, medication adherence and negative symptoms for individuals with schizophrenia and reduce burden for family members.

A total of 60 Dyads consisting of one caregiver and one supported individual with schizophrenia will be randomized to either a Web-based family Cognitive Adaptation Training or an Internet-based control condition. Primary outcome measured will be the score on the life skills profile. Secondary outcomes will include the global score of the Zarit burden Interview, PANSS negative score, and medication adherence.

This type of intervention is expected to be developed in territorial area where professionals are not trained to cognitive remediation and therefore substantially lowers the barrier to the deployment of cognitive intervention with other psychosocial interventions for individual with schizophrenia and their caregivers.

location_facility: Service Universitaire de psychiatrie adulte


title: Systematic Screening and Identification of Psychoactive Substances Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department

acronym: DRUGS

summary:
Adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. Although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. This is therefore a priority for all healthcare providers to identify early use and abuse of drugs in the youth's population.

The addictive process underlies environmental, genetic and individual causes. That is why it is somehow possible to identify individuals at risk based on some common sociological, cultural and environmental risk factors.

Due to the acute consequences of psychoactive substances abuses, Emergency Departments are main checkpoints for the screening of young drug users. Indeed, one patient out of five admitted in an Emergency Department shows a positive blood alcohol concentration regardless of the reason for their admission. This rate is twice as high as in the overall population. Hence, Emergency Departments are at the front-line for screening, caring, referral and transfer of psychoactive substances users. That is why the Emergency Department is the best place for this study.

In 2004, the special consultations of young consumers were founded in order to deal with these special cases where dependence is not yet established or installed and care has to be adapted to the age. Offering help to this age range represents a real challenge since only 20% of the teenagers come to visit this special consultations on their own initiative. The rest of teenagers are either obliged by their parents or sentenced by a court. The investigators assume that the repetition of care offered to the teenagers by repeated emergency admissions could trigger their own desire to overcome their drug use disorders and visit the Addictionology Department.


title: Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis?

acronym: CASCAD

summary:
Acute cholangitis (AC) occurs when biliary stenosis, due to various benign causes (often gallstones) or the presence of a tumour, leads to cholestasis and biliary infection. AC is a life-threatening infection if not diagnosed and treated in time, its mortality ranges from 1.4% to 5.2%. AC can be classified into different stages of severity depending on organ failure. A severity classification has been proposed by the Asian recommendations of Tokyo 2013: Grade I (Benin), Grade II (Moderate) and Grade III (Severe).

AC treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment. It is currently recommended that patients with severe CA (Grade III) have biliary drainage within 24 hours, although it has not been shown to improve their survival. The emergence of antibiotic-resistant germs, which is a public health issue, calls for reasonable and considered use of antibiotics. Reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing. 7 to 10 days of antibiotic treatment is common in the treatment of CA. A 14-day treatment is recommended in case of associated bacteremia. A recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with CA associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days. However, this study was monocentric retrospective and compared groups that were unbalanced in terms of CA severity. The optimal duration of antibiotic therapy in the treatment of CA in critically ill patients hospitalized in intensive care remains poorly known.

The main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with AC admitted in intensive care unit (ICU).

lead_sponsor: Nantes University Hospital


title: Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.

acronym: CARPAPA

summary: Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.

primary_purpose: Diagnostic

lead_sponsor: Association pour la Recherche Clinique et Immunologique

intervention_type: Diagnostic Test


title: Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families

acronym: JACintHE

summary: Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas

summary:
Background: The association of transcatheter arterial chemotherapy infusion (TAC) with percutaneous ablation (PT) has been introduced as a method to increase the ablative zone. The aim of this study was to evaluate the efficacy of PT and TAC performed in a single session for HCCs between 30 and 50 mm or oligonodular up to 30 mm.

Methods: Thirty patients with a histologically proven HCC, uninodular between 30 and 50 mm or oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination treatment ("PT+TAC group"). A "control" group consisted of 34 patients with uninodular HCC up to 30 mm without any poor prognostic criteria treated with PT alone ("PT group").

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Electric Wheelchair Driving Performance in Simulator Compared to Driving in a Real-life Situation, in a Population of Regular Drivers With Neurological Disorders

summary:
The device that is the subject of this investigation is a solution for driving simulation of an electric wheelchair. It is intended to enable patients who are likely to acquire an electric wheelchair to train in a virtual environment, favorable to the safety of training, to its repetition, and to produce more varied, rich training environments and more tailored to specific and individualized needs. These solutions will make it easier to access real-world driving for patients who are currently experiencing learning difficulties.

It is expected that this investigation demonstrates the reproducibility of driving performance in electric wheelchair driving simulator compared to the real world.

lead_sponsor: Pôle Saint Hélier


title: Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Healthy Elderly and Young Adults Volunteers

summary: In the elderly, pharmacokinetics is altered. Gastric juice pH is elevated which influences drug solubility and absorption. Drug distribution is decreased in the elderly because of decreased cardiac output, increased peripheral vascular resistance, diminished blood flow in the liver and the kidneys, reduced total amount of water in the body. Drug metabolism and biotransformation mainly take place in the liver and is often reduced. Drug elimination is altered very often because of reduced excretory (renal and hepatic) function. All these changes may lead to significant pharmacokinetic changes in geriatric population. A formal pharmacokinetic clinical study is being conducted in order to assess the need of dose adjustment in the elderly population.

lead_sponsor: Genfit


title: Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction

acronym: TESLA

summary: This study evaluates the effect of a transcutaneous electrical stimulation in critically ill patients compared to a sham electrical stimulation to decrease the incidence of diaphragm dysfunction before mechanical ventilation weaning.

primary_purpose: Prevention

lead_sponsor: Groupe Hospitalier du Havre


title: Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases

acronym: SMACS

summary:
In daily practice, several scales are used to evaluate patients with small vessel diseases of the brain (SVD). However, these scales exclude key symptoms such as apathy and mood disorders observed in SVD. Furthermore, the use of a combination of scales does not allow neither a very sensitive assessment of clinical changes, neither an overall assessment of a patient's outcome.

Moreover, there is no scale dedicated to cognitive, emotional and behavioural complaints in patients with SVD. These patients are evaluated with scales used in neurodegenerative diseases such as Alzheimer's disease and frontotemporal dementia. These are scales that have been developed in the elderly and they are not sensitive to minor complaints. It is needful to develop scales adapted to patients with SVD in order to understand the consequences of the disease symptoms on their daily life at inclusion and during follow-up.


title: AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

acronym: AngioCHIC

summary: In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Retrospective Study of Causes Associated With Small Fiber Neuropathies.

acronym: EtioNPF

summary:
Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis.

Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic.

As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population.

Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment.

The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN.

The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: A Cross-sectional Survey to Evaluate Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

summary:
The primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages provided in the material.

The secondary objective of the study is to evaluate if healthcare professionals know Dengvaxia product information, namely, age indication and contraindications.

time_perspective: Cross-Sectional

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi Pasteur, a Sanofi Company


title: Impact of the Use of "Point of Care" Ultrasound on the Length of Stay in the Emergency Department During an Episode of Renal Colic

acronym: ECHOLINE

summary:
The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. It recommends the control of pain by nonsteroidal anti-inflammatory drugs and analgesics, the implementation of an urinary test strip and the use of emergency imaging for compiled forms and patient with medical specificities.

Currently, two imaging techniques are recommended during an episode of renal colic:

Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h
The non-injected scanner for complicated forms In simple forms, the decision to perform any examination remains at the discretion of the physician but with a tendency to carry out a scanner systematically even in the absence of criteria of severity or complication.

The use of the scanner exposes the patient to large doses of radiation even if it is a low dose scanner.

In recent years, studies have been conducted to determine whether the ultrasound, particularly "point of care" ultrasound performed by an emergency physician could be an alternative in the management of renal colic. Studies show that the sensitivity and specificity of ultrasound is comparable to that of the scanner. It has been found that the performance of an ultrasound by the emergency physician allows the decrease in irradiation and also in costs. In 2014,a study published in the New England Journal of Medicine emphasized that the ultrasound performed by the emergency physician would perform just as well as that performed by the radiologist and would result in a decreased time in the emergency room.

The Korean study, published in 2016 in the Clinical and Experimental Emergency Medicine (CEEM), despite some statistical inconsistencies, shows a significant reduction in the time of care by 74 minutes. In this context, we would like to conduct a single-centre, randomised, controlled, open-label study comparing a group of patients benefiting from point of care ultrasound versus a group of patients not benefiting from it. The goal is to determine whether the early ultrasound performed by the emergency physician by detecting expansions of the pelvicalyceal cavities reduces the time spent in the emergency department.

lead_sponsor: Lille Catholic University


title: Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database

summary:
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE.

Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database

lead_sponsor: University Hospital, Caen


title: The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy

acronym: ASSIST

summary: Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Targeting Interleukin 1 Receptor Accessory Protein (IL1RAP) Expressing Acute Myeloid Leukemic (AML) Cells by Chimeric Antigen Receptor (CAR) Engineered T-cells

acronym: CAR-LAM

summary:
AML is one of the most aggressive forms of leukemia, where bone marrow transplantation remains the gold standard treatment, with its known associated toxicities and related mortality. Despite progress in the treatment of leukemic malignancies, especially the emergence of targeted- and immuno-therapies arising from biological genomic knowledge, there remains a need to provide additional strategies for refractory/relapsing (R/R) patients

Aim of this study is to collect biological samples of AML patients in order to validate our Chimeric Antigen Receptor T-cells immunotherapy approach

primary_purpose: Screening


title: Study of the Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy

acronym: BOM-ZEN

summary:
The bone marrow aspiration and biopsy (BMAB) is an essential and indispensable examination for the diagnosis and the follow-up of the hematological diseases but which remains painful and dread by the patients. Until then it was performed manually using a trocar. It is now practiced most often using a tool (like a small drill), device that pierces through the external iliac bone to extract a bone cylinder that will be analyzed

If the gesture is faster than with the manual method, it remains overall painful and the noise generated by the drill that passes through the periosteum of the iliac bone is impressive for the patient.

Prevention measures to limit pain and anxiety are put in place during the examination: local anesthesia, with or without a lidocaine patch, as well as inhalation of a mixture of nitrous oxide and oxygen (MEOPA®). These, recommended by the "Standards, Options, Recommendation" (SOR) often remain insufficient and are not devoid of undesirable effects.

Despite these precautions, several studies show that the action remains painful and anxiety-provoking.

An exploratory survey carried out in the hematology department of the François Baclesse Center in 2013 confirms these results and specifies that the pain remains present for another 30 minutes after the examination.

The investigators believe that associating a psycho-corporeal technique, as is sophrology, with the usual care, could contribute to the decrease of the threshold of pain and anxiety during the BMAB and avoid the use of a premedication.

The effectiveness of sophrology as a complementary technique in the field of pain prevention in invasive procedures is recognized by observations and clinical results. This complementary therapy, among others, has its place in the hospital.

To date, to investigator's knowledge, there is no published, randomized study evaluating the effectiveness of sophrology on pain in invasive procedures.

The investigators propose a study whose main objective is to evaluate the effectiveness of a session of sophrology on the pain felt during the realization of the BMAB, in patients with hematological malignancy. This session will be provided by a sophrologist nurse This study should include 90 patients undergoing a BMAB over a 24-month period.


title: Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma of 3 to 6 Months After the Intensive Care Unit Leaving

acronym: RESPET

summary: This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Retrospective Descriptive Study on Retroplacental Hematomas in Finistère

acronym: HEMOPLACENTA

summary: Cases with placental abruption will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018. First trimester PAPPA and bhCG levels will be recorded. PlGF levels will be measured in women with an available first trimester serum sample. Histological findings in placentas, course of pregnancies, maternal and fetal characteristics will described and compared between cases with and without placental chronic inflammation.


title: Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?

summary:
Visceral hypersensitivity is frequent in IBS population up to 60% and is correlated with severity and altered quality of life. Sleeping troubles are most frequent in IBS population. Insomnia is a frequent disorder with an important cost for healthcare. Insomnia could decrease pain threshold.

Visceral hypersensitivity was never measure in patients with insomnia. The hypothesis is IBS patients with insomnia probably have lower visceral pain threshold.

The objective is to assess pain threshold during a barostat procedure in in IBS patients with or without insomnia in comparison with healthy volunteers or patients with insomnia.

If the hypothesis are confirmed, insomnia should be look at in IBS patients and its treatments could improve visceral hypersensitivity and IBS symptoms.

status: Not yet recruiting

lead_sponsor: University Hospital, Rouen


title: Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy

acronym: AJIACT

summary: This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.


type: Registry Identifier

title: Study of Ventricular Repolarization in Patients With Premature Ovarian Insufficiency and Influence of Estrogen-progestin Replacement Therapy

acronym: QT-IOP

summary: Ventricular repolarization, measured by corrected QT interval (QTc), is influenced by sex hormones. A QTc above 460msec predisposes to the risk of "torsades-de-pointes"(TdP). The investigators have recently shown that estradiol determines an increase in QTc elongation and progesterone shortens it. In addition, high gonadotropin levels (FSH or LH) are associated with QTc prolongation. Hypergonadotropic hypogonadisms (low progesterone and high gonadotropins) are therefore hormonal situations that promote QTc prolongation. Premature ovarian insufficiency (POI) is one of them. Its management is based on the prescription of hormone replacement therapy (HRT). Epidemiological studies have shown that these patients would be at increased risk of cardiovascular mortality. Our team is interested in the effect of this pathological hormonal situation and its HRT on ventricular repolarization in order to define whether this is a population at risk for long QTc.


acronym: SPLEMENGO

intervention_type: Biological

title: Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia

source: euctr

ReferenceCitation: Borrow R. Advances with vaccination against Neisseria meningitidis. Trop Med Int Health. 2012 Dec;17(12):1478-91. doi: 10.1111/j.1365-3156.2012.03085.x. Epub 2012 Sep 4. Review.

ReferenceCitation: Frosi G, Biolchi A, Lo Sapio M, Rigat F, Gilchrist S, Lucidarme J, Findlow J, Borrow R, Pizza M, Giuliani MM, Medini D. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 2013 Oct 9;31(43):4968-74. doi: 10.1016/j.vaccine.2013.08.006. Epub 2013 Aug 14.

ReferenceCitation: Murphy E, Andrew L, Lee KL, Dilts DA, Nunez L, Fink PS, Ambrose K, Borrow R, Findlow J, Taha MK, Deghmane AE, Kriz P, Musilek M, Kalmusova J, Caugant DA, Alvestad T, Mayer LW, Sacchi CT, Wang X, Martin D, von Gottberg A, du Plessis M, Klugman KP, Anderson AS, Jansen KU, Zlotnick GW, Hoiseth SK. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009 Aug 1;200(3):379-89. doi: 10.1086/600141.

ReferenceCitation: Balmer P, Falconer M, McDonald P, Andrews N, Fuller E, Riley C, Kaczmarski E, Borrow R. Immune response to meningococcal serogroup C conjugate vaccine in asplenic individuals. Infect Immun. 2004 Jan;72(1):332-7.

ReferenceCitation: 5. Hcsp. Avis du hcsp relatif à l'utilisation du vaccin bexsero® (novartis vaccines and diagnostics). 2013. (link:http://www.hcsp.fr/explore.cgi/telecharger?nomfichier=hcspa20131025_vaccmeningocoquebbexsero®.pdf.

ReferenceCitation: McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, Pollard AJ. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014 Jul;33(7):760-6. doi: 10.1097/INF.0000000000000327.

ReferenceCitation: Wasserstrom H, Bussel J, Lim LC, Cunningham-Rundles C. Memory B cells and pneumococcal antibody after splenectomy. J Immunol. 2008 Sep 1;181(5):3684-9.

ReferenceCitation: Mori M, Morris SC, Orekhova T, Marinaro M, Giannini E, Finkelman FD. IL-4 promotes the migration of circulating B cells to the spleen and increases splenic B cell survival. J Immunol. 2000 Jun 1;164(11):5704-12.

ReferenceCitation: Sullivan JL, Ochs HD, Schiffman G, Hammerschlag MR, Miser J, Vichinsky E, Wedgwood RJ. Immune response after splenectomy. Lancet. 1978 Jan 28;1(8057):178-81.

ReferenceCitation: Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969 Jun 1;129(6):1307-26.

summary: The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.


title: A Prospective, Monocentric, Uncontrolled Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume

acronym: BeautyVolume

summary:
Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection.

In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.

Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.

lead_sponsor: Laboratoires Vivacy


title: Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis B Virus (HBV)/Hepatitis D Virus (HDV) Co-infection With Severe Fibrosis Injuries, or Moderate Fibrosis Injuries Associated With Persistent Increase of ALT

acronym: BuleDelta

summary: This is a prospective, multicentric, non comparative study, with a retrospective data collection aiming at evaluating the efficacy and safety of bulevirtide in patients with chronic HBV/HDV co-infection with severe fibrosis injuries, or moderate fibrosis injuries associated with persistent increase of ALT.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Treating Phobias Using Emotional Regulation Developed by the Tipi Association

acronym: RE

summary:
Background In emotional regulation, the patient remembers an emotional situation, focuses his attention on his physical sensations when he relives a recent emotion, and let evolve his sensations.
Method Evaluate the relevance of this method by an interventional study, in a pre-post mono group, on patients suffering from phobia.
Objective The investigators aim to validate the effectiveness of this emotional regulation method and compare its results with that of conventional methods. Sessions are individual and repeated until the disappearance of phobic fear.

The present study may contribute to propose a new possibility to treat phobias in a simple and fast way.

lead_sponsor: University Hospital, Montpellier


title: Seniors'Health Paths " PAERPA ", a Support Being Made Available to General Practionners for Assistance in the Management of Elderly Persons at Risk of Losing Their Independence. Review of the Implementation of the Arrangement on the Est-héraultais Territory.

acronym: PAERPA

summary:
•Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan " PPS". The main objective of this study was to evaluate the implementation of this device through the achievement or not of the objectives set by the PPS.

•Methods: Descriptive cohort study with retrospective inclusion and prospective follow-up from the East Herault CTA database. All patients over 60 years old living at home and having a PPS written between September 2017 and April 2018 were included. PPS monitoring for 1 year. Description of this population then analysis of PPS.

•Discussion: Our study aims to evaluate the implementation of the device to identify ways to improve the device for the management of subjects at risk of loss of autonomy.


title: Evaluation of the Establishment of a Hospital Medication Report for Pharmacists and General Practitioners

acronym: EvalMedReport

summary:
Drug Related Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing (included medication error and inappropriate prescription) to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative activity in concert with other health care professionals and offered directly to the patient for improved quality use of medicines. Pharmaceutical care identifies and resolves actual or potential DRPs.

In our clinical practice, during the patient admission in internal medicine unit, a medication reconciliation process was conducted according to a validated protocol. The first step consists of getting the Best Possible Medication History (BPMH), defined as the most comprehensive list of all medications taken by the patient. The second step consists of comparing the BPMH with admission prescription made by the physician in charge. During pharmacist interview, pharmacist discussed about medication adherence and knowledge. The third step consists of characterizing, solving and documenting DRPs.

During the patient's hospitalization, the pharmacist participates at the medication prescription revision. At the discharge of hospitalization, a pharmaceutical standardised interview is carried out during which the pharmacist explains the modifications of treatments to the patient. During this interview, the hospital pharmacist updates the latest treatment changes. For patient with more than 65 years old and long-term affection (or patient with more than 75 years old with or without long-term affection) and 5 medications, the hospital pharmacist write a medication discharge report (MDR) to patient, community pharmacist and general practitioner.

For each medication, the investigators collected its name, dosage, dosage forms and frequency of administration. For each DRP, the investigators collected the type of DRP and the drug classes (according to anatomical therapeutic chemical classification system).

For each MDR, the investigators collected number of medication, number and type of DRP including inappropriate prescription.


title: Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography: Comparison of the Injection of Contrast in the Upper and Lower Caval Territories (FOP-TP)

acronym: FOP-TP

summary: The investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of FOP found by transesophageal echocardiography in a population of patients undergoing lung transplantation.

lead_sponsor: Hopital Foch


title: Randomized Study Comparing the Low Impact Laparoscopy Concept to Conventional Laparoscopy in Terms of Ambulatory Care

acronym: RANDOLIL

summary:
Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS.

The feasibility and safety of laparoscopy is well established, particularly in the field of gynecology, but this technique often causes postoperative pain. Techniques are being developed to reduce postoperative pain in laparoscopic surgery. Low pressure insufflation (7 to 10 mmHg) compared to standard pressure insufflation (12 to 15 mmHg) significantly reduces postoperative pain. Microcoelioscopy (use of 3 mm trocars instead of 5 to 12 mm trocars in standard laparoscopy), by reducing the size of incisions, also significantly reduces postoperative pain.

The Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation and microcoelioscopy which would have the advantage of reducing postoperative pain. This technique would therefore, by reducing postoperative pain, to improve outpatient management, particularly in cases of hysterectomies for which the outpatient management rate could be increased.

The hypothesis is that using the Low Impact Laparoscopy concept would increase outpatient management rate compared to conventional laparoscopy in gynecological surgeries for hysterectomy.

The study aims to compare the Low Impact Laparoscopy concept with conventional laparoscopy in terms of ambulatory care rates in patients undergoing surgery for hysterectomy.

lead_sponsor: Hospices Civils de Lyon


title: Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease. URAM 3

summary: As part of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease appears as a second-line treatment indicated in a situation of failure after treatment with percutaneous needle aponeurotomy.The results of second-line surgery in terms of safety and efficacy have not been specifically evaluated in patients who underwent failed percutaneous needle aponeurotomy. This evaluation nevertheless appears necessary for the validation of a medical-surgical strategy during Dupuytren's disease.

lead_sponsor: Ramsay Générale de Santé


title: Keratoconus, Corneal Diseases and Transplant Registry (KCDTR)

acronym: KCDTR

summary:
The cornea is the clear layer in front of the iris and pupil. It protects the iris and lens and helps focus light on the retina. Corneal diseases are serious conditions that can cause clouding, distortion, scarring and eventually blindness. There are several types of corneal disease with keratoconus being one of the most prominent.

Keratoconus is a weakening and thinning of the central cornea. This thinking causes the cornea to develop a cone-shaped deformity leading to vison loss. Keratoconus is usually bilateral affecting people between 10 and 25.

This project aims to collect data on patient suffering with corneal diseases and the treatments they receive, including corneal transplantation, over a period of time during routine clinical practice.

A clinical registry such as this can be a very useful tool to provide a real-world view of clinical practice, patient outcomes, safety, and comparative effectiveness.

•Methods:

Data will be collected from the medical records of patients who have suffered from corneal disease and have undergone treatment in the Ophthalmology department of the CHU Montpellier.

A standardized set of data will be collected for all patients. This will include, demographic and social date such as lifestyle and occupation, current and past pathologies and treatment received. This is data that is already collected as part of routine clinical practice.

This will be an ongoing registry with the aim of collecting the maximum data possible. The more patients that are entered and the longer the follow up for each patient, the more valuable the data will become.

•Discussion:

The aim of this registry to help create a better understanding of variations in treatment and outcomes; to examine factors that influence prognosis; to describe treatment patterns, including appropriateness and effectiveness of treatment and disparities in the delivery of care; to monitor safety and harm and to measure quality of care.

In the long term the data collected in the registry may serve as a basis for the development of evidence-based clinical management guidelines to help clinicians deliver the most appropriate treatment for corneal diseases in the safest and most efficient manner.


title: Etude de la prévalence de la Douleur Chronique et de Ses Facteurs de Risque après Une Hospitalisation en réanimation Chirurgicale

acronym: DOUCREA

summary:
The objective of this observational, prospective study is to evaluate the incidence of chronic pain at 3 months after ICU discharge in patients with a prolonged ICU stay (i.e. ≥3 days).

Investigators will assess the proportion of patients with chronic pain (defined according to the Brief Pain Inventory questionnaire), by interview at 3 months after ICU discharge.

All data potentially associated with chronic pain will be collected, including the type of surgery, the acute pain (intensity and duration) during the ICU stay, the type and dose of opioids received, patients comorbidity...

Patients will be follow-up at 6 and 12 months to identify impact on quality of life.

lead_sponsor: University Hospital, Angers


title: VAlidation of an Self Administered Questionnaire in French for Assessment of Cardio Respiratory Reserve

acronym: VAQAR

summary:
The guidelines of the European Society of Cardiology (ESC) for preoperative management in non-cardiac surgery make the estimation of patients' maximum oxygen uptake (VO2peak) one of the cornerstones of preoperative evaluation.

Indeed, below a certain threshold of VO2 peak fixed in the literature at 15 milliliters/kilogram/minutes (ml/kg/min) (or 4 Metabolic Equivalent of Task - MET), the ESC recommends to carry out additional non-invasive examinations to evaluate the coronary risk of these patients.

In current practice, this evaluation is performed in anesthesia consultation by non-standard interview. The question "Can you go up a floor or climb a hill?" permits to classify patients with more or less VO2 peak than 4 MET.

However, several studies, including one published in the Lancet in 2018, show that this evaluation doesn't assess correctly the VO2peak of the patients nor predict post-operative cardiac complications.

In the same study, the evaluation of a standardized self-questionnaire, the Duke Activity Status Index (DASI), found a good correlation between the value of this pre-operative score and the 30-day mortality as well as the occurrence of infarction.

This self-questionnaire contains a dozen questions about the physical activities of daily life that patients are able or not to perform (household, various physical activity). It has also been validated in medical patients as being well correlated with the value of VO2 peak in the case of an answer by a third party (r = 0.81, p <0.001) and satisfactory in the case of a self-questionnaire (r = 0.58 , p <0.001).

This self-questionnaire exists in English but there is no validated translation in French. Given the cultural differences, it seems necessary in order to use it in a French-speaking context to go through a scientific validation stage. A validation study of DASI in Portuguese has already been published recently, serving as a methodological basis for a French translation.

The purpose of this study is to carry out a validation of a standardized self-questionnaire in French. It will be distributed to patients referred for a VO2peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon). The results of VO2peak predicted by the self-questionnaire will be compared to the VO2 peak measured during the examination.


title: NTM-net Study: Liposomal Amikacin Inhalation in M.Abscessus Patients

summary:
Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results.

The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes


title: Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans

acronym: DETTECH

summary:
NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. This hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue.

In the literature, some studies concerning the use of the NIRS method for the study of urodynamics exist. They seem to show a correlation between the data of the urodynamic assessment and the data obtained with the NIRS method. Certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase.

The aim of the study is to analyze the NIRS signal and find correlation with urodynamic data.

primary_purpose: Device Feasibility

lead_sponsor: BioSerenity


title: Study of Autophagy and the Effects of GALIG Gene Products in HIV-1 Infected Patients Who Are Under Antiretroviral Therapy Since Primary-infection, Chronic Phase, or Never Treated.

acronym: ATGALIG-HIV

summary:
Little is known about autophagy during HIV infection. Recently, two different teams reported important dysfunctions of autophagy in HIV-infected patients despite sustained suppressive antiretroviral therapy. As altered autophagy is strongly linked to cellular senescence and chronic inflammation, two hallmarks of HIV-infected patients despite long-term suppressive antiretroviral therapy, it is important to improve our knowledge in the area.

Our main objective is to determine whether all or part of mononuclear cell subpopulations (CD4+ and CD8+ T lymphocytes, and monocytes) exhibit a defect in autophagy function in a cohort of HIV-infected patients who are virologically-controlled (plasma HIV RNA <50 copies / ml) either spontaneously (i.e. HIV controllers or post-treatment controllers) or after they started antiretroviral therapy at different time points (i.e. at the acute or chronic phases), as compared with a control group (i.e. uninfected healthy blood donors).

ReferenceCitation: Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV infection as a chronic disease. Lancet. 2013 Nov 2;382(9903):1525-33. doi: 10.1016/S0140-6736(13)61809-7. Epub 2013 Oct 23. Review.

ReferenceCitation: Ipp H, Zemlin A. The paradox of the immune response in HIV infection: when inflammation becomes harmful. Clin Chim Acta. 2013 Feb 1;416:96-9. doi: 10.1016/j.cca.2012.11.025. Epub 2012 Dec 7. Review.

ReferenceCitation: Serrano A, El Haddad S, Moal F, Prazuck T, Legac E, Robin C, Brulé F, Charpentier S, Normand T, Legrand A, Hocqueloux L, Mollet L. Dysregulation of apoptosis and autophagy gene expression in peripheral blood mononuclear cells of efficiently treated HIV-infected patients. AIDS. 2018 Jul 31;32(12):1579-1587. doi: 10.1097/QAD.0000000000001851.

ReferenceCitation: Gómez-Mora E, Robert-Hebmann V, García E, Massanella M, Clotet B, Cabrera C, Blanco J, Biard-Piechaczyk M. Brief Report: Impaired CD4 T-Cell Response to Autophagy in Treated HIV-1-Infected Individuals. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):201-205. doi: 10.1097/QAI.0000000000001201.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)

acronym: ESPT-PP

summary: The purpose of this study is to estimate the prevalence of post-traumatic stress disorder (PTSD) at one month in women who have given birth at the University Hospital of Angers over a period of 1 year.


title: Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds

acronym: Bortner Pied

summary:
Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness.

It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene.

Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology.

It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Prediction of Patient-specific Outcomes After Interventional Neuroradiology Procedures

acronym: PREDICTNRI

summary:
Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of irreversible brain damage, it is an absolute medical emergency.

An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain. It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There will then be a neurological deficit (paralysis) more or less important corresponding to the affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a part of the body (upper or lower limb) and sometimes is associated with facial paralysis and/or language disorders.

A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also occur later in life due to illness, head injury, oral contraceptives or certain lifestyle habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress or strenuous exercise can serve as a trigger.

Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using imaging to perform the medical procedure and thereby limit openings and their associated risks. This specialty has a growing place in modern medicine.

In order to improve the quality of care, patient safety and functional outcomes, it is necessary to keep patient information. A database storing patient data from the NRI department will make it possible to track patients since their arrival at the Brest University Hospital. Thanks to this structured database, clinical studies will be facilitated, making it possible to advance knowledge of the pathology and its treatments.

From the bibliographical research, we can conclude as to the current state of the facts: there is currently no method for predicting the functional results of the interventional neuroradiologist's patient based on automated learning.

A strategy based on an innovation programme is therefore being implemented over several years, the first stage of which is the retrospective data study which was approved by the ethics committee on 12/09/2019 and the second stage is the prospective data study.

This innovation program requires the most complete and homogeneous data possible.

lead_sponsor: University Hospital, Brest


title: Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols

acronym: EXECO

summary:
Understanding how to delay age-related physical and mental declines is an issue for aging research. It has been shown that isolated aerobic, coordination and cognitive training improve brain functions and cognitive performances. Moreover, the combination of them leads to greater effects. Different combination modalities are possible: training programs demanding cognitive resources within the activity performed in a natural environment like Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training where training components are systematically combined and their intensity controlled. The aim of this study is to compare three training programs: a Nordic walking one (NW), and two conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT) exercises, while CT-fit characterized by cognitive charge embodied in the movements through the use of technology. An improvement in physical, motor, and cognitive functions is expected by all three groups. However, our primary hypothesis is that the CT-fit will impact executive functions more.

45 healthy independent living community dwellers participants aged 65 to 80 will be recruited. Participants will be included after a general medical examination (geriatric screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of cognitive impairment, (MMSE <26/30), and physical impairments. Participants will be randomly divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour 3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task, Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance test, walking speed and size of the base of support, Timed Up & Go, Chair sit and reach test and Four square stepping test) and physical assessment (10 m incremental shuttle walking test, maximal handgrip force, 30s chair rise stand).

Improving cognitive functions by adding new technology embodied in a systematically combined training (exergame), would result to be the best solution to optimize training for aging people.

lead_sponsor: Aix Marseille Université

location_facility: Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)


title: Pulmonary and Ventilatory Effects of End-expiratory Positive Pressure Optimization in Intubated ICU Patients With Healthy Lungs or Acute Respiratory Distress Syndrome. A Randomized Controlled Trial

acronym: PEEP-Réa

summary: PEEP titration is a recommended during invasive mechanical ventilation of ICU patients. However, little is known about the right way to conduct this titration. PEEP titration can be conducted by a stepwise increase in PEEP level, or following an ARM and a consecutive stepwise decrease in PEEP level. Those 2 methods will be explored in intubated ICU patients either with healthy lung or ARDS lungs. Physiological exploration will include end-expiratory lung volume measurements, driving pressure, compliance and electro-impedance tomography at each PEEP level.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences

acronym: BARO-AF

summary:
Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium is covered by an extensive network belonging to the autonomic nervous system that can be damaged during the ablation. The involvement of the autonomous nervous system in the genesis and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a non-invasive method assessing autonomous nervous system activity.

The rate of atrial fibrillation recurrence after ablation is currently high and a better understanding of the mechanisms associated with recurrence is essential to improve selection of the patients who will benefit the most from this procedure.

The aim of this study is to evaluate the association between the baroreflex sensitivity and atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex measurement compared to other published criteria.

lead_sponsor: Poitiers University Hospital


title: Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients

acronym: PHYSIOHAND

summary:
The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands.

Secondary objectives:

To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers,
To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger),
To assess pain due to mobilization in stroke patients.

status: Terminated

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace


title: Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study

acronym: Fungi-up

summary: Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients. This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles. This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients. Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU). This will help to identify which patients are the more prone to antifungal under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.

location_facility: Hospices Civils de Lyon, Croix-Rousse Hospital


title: Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients

acronym: STADIA

summary: The objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.

lead_sponsor: Lille Catholic University


title: Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique

acronym: OMEDIA

summary: The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

intervention_type: Dietary Supplement


title: Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial

acronym: QuITO

summary:
Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.

The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.

The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.

ReferenceCitation: Marty P, Chassery C, Rontes O, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Ferré F, Naudin C, Joshi GP, Delbos A. Combined proximal or distal nerve blocks for postoperative analgesia after total knee arthroplasty: a randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):427-434. doi: 10.1016/j.bja.2022.05.024. Epub 2022 Jun 28.

lead_sponsor: Clinique Medipole Garonne


title: Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma

acronym: MEMO-GCAO

summary:
Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline, magnesium and Gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already shown results on the preservation of the vision of glaucomatous patients.

The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis Treated With Subcutaneous Biologic DMARDs

summary:
There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.

The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.

lead_sponsor: Hôpital Cochin


title: Methodology of " CoCo 20 ": a Longitudinal Follow-up Study of the Paediatric Population and Their Families During and After the Coronavirus Pandemic and the Confinement

summary:
In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations.

After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems.

The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term

ReferenceCitation: Gindt M, Fernandez A, Richez A, Nachon O, Battista M, Askenazy F. CoCo20 protocol: a pilot longitudinal follow-up study about the psychiatric outcomes in a paediatric population and their families during and after the stay-at-home related to coronavirus pandemic (COVID-19). BMJ Open. 2021 Apr 8;11(4):e044667. doi: 10.1136/bmjopen-2020-044667.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19

acronym: EPI CV COVID

summary: The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as coronary artery disease, which significantly increase the risk of mortality in patients infected with SARS-CoV2. Investigators have recently studied the complex links between respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the investigators investigated whether COVID-19-related sepsis and/or respiratory failure could be an underlying mechanism of MI2.


title: MYocardial DOmmages Related to COVID-19

acronym: DOMY COVID

summary: Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation of cardiac biomarkers could be linked to the occurrence of myocarditis.


title: Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study)

acronym: SignCov

summary: Metabolomics is the analysis of small molecules in a biological sample (cells, tissues or biological fluids). It can potentially detect very sensitively any change related to a pathology or exposure to a toxic agent. The analyses are fast, inexpensive and therefore applicable in routine, particularly in health care. Given the emergence of this new disease, COVID-19, there is a real need to better understand the pathophysiological mechanisms of SARS-CoV-2 infection. In this context, metabolomics could have a place and could lead to the development of interesting diagnostic or prognostic tools. The objective of this study is to identify, through the analysis of biological samples (blood and urine), whether there is a metabolomic signature in patients with COVID-19.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Using Tele-evaluation and Teleconsultation Instead of Classical Consultation for the Follow-up of Obese Patients After Bariatric Surgery : a Pilot Study.

acronym: TELECHIRO

summary: An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. To design a large randomized clinical trial (RCT) comparing teleevaluations and teleconsultations to classical follow, aiming to prove that the quality of the follow-up is maintained and the patient-experience is improved, at a lower cost in people living far from the reference centre, this pilot study aims at describing the distribution of the collected criteria.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Toulouse