title: Impact of the DROP (Drug Related Problems in Oncology Practice) Program of Pharmaceutical Interventions of the French Society of Oncological Pharmacology Versus Usual Care on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors

acronym: DROP-SFPO

summary:
The rise of oral anticancer drugs favors outpatient care but exposes patients to new risks compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. Latrogenic risk of these treatments is reinforced in older patients with frequent comorbidities, taking multiple pharmaceutical treatments for long periods and followed by several prescribers.

The literature reports an emergence of drug related problems (DRP) in more than 90% of patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced efficacy and potentiation of toxicity) are all the more important that outpatient monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings.

Medical care and prevention of these DRP are difficult because of a lack of information and tools shared between hospital and liberal actors. Experiments are developed according to different organizational models, frequently focused on the pharmaceutical analysis of prescriptions, the detection of DRP and their control, but they stay still undervalued. In this context, the French Society of Oncological Pharmacology (SFPO - Société Française de Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien website and proposes to assess the impact of a program of pharmaceutical interventions named DROP. The hypothesis of the study is that the DROP program will secure the medical care of patients with oral anticancer drugs compared to the usual care.

location_facility: Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud


title: Diagnostic Accuracy Study of an Answer Reliability Assessment Tool for Aphasic Patients

acronym: YNQ

summary: Quality of care depends strongly on oral communication with patients. Stroke patients, who have language disorders, have understanding difficulties, but also have difficulties in expressing their needs and in being understood. Available tools do not allow a professional consensus on the assessment of patients' ability to answer reliably to questions asked by caregivers. The investigators propose an answer reliability assessment tool based on yes or no questions. The goal of the present study is to define an optimal score for defining the test positivity, as a compromise between sensitivity and specificity, and by emphasizing the negative predictive value.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Completed


title: Quality of Life and Neurocognitive Functioning in Diffuse Low-grade Glioma (TEMOIN)

acronym: TEMOIN

summary: Studying QoL in patients DLGG receiving TMZ is complex because of the multiples interactions between tumor characteristics, neurocognitive functioning, treatments, environment and psychopathological context in which these patients experience symptoms. It is, however, important to accurately evaluate these aspects in consideration of the young age, generally preserved QoL at the time of diagnosis, possible implications of the disease on the professional (DLGG patients are often still active), social and familial domain, and relatively long survival of these patients. In the absence of a curative treatment for DLGG, preserving patients' QoL is indeed a major goal.

study_type: Interventional

primary_purpose: Treatment

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

location_facility: Institut regional du Cancer - Val d Aurelle

intervention_type: Other

lead_sponsor_type: industriel


title: Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer

acronym: IDEASEIN

summary: Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

primary_purpose: Prevention

ipd_sharing: No

location_facility: Institut régional du Cancer de Montpellier

intervention_type: Biological


title: Filling and Emptying Cystometries: a Feasibility and Validation Study in Order to Simplify the Manometric Follow-up of Overactive Detrusor in Neurological Patients Under Anticholinergic or Botulinum Toxin Injections.

summary: This study evaluate the feasibility and the accuracy of an emptying cystometry in order to simplify the manometric follow-up of overactive detrusor in neurological patients under anticholinergic or botulinum toxin injections.

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of Neuro-urology, Tenon hospital


title: Defining Use and Misuse of BIoMarkers Dosage and Trends in Observed Concentration Over Time: a BIg Data Analysis

acronym: rUBIDIuM

summary:
The investigators conducted a retrospective analysis of all measured concentrations performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th, in adults over 20 years old.

The investigators are aimed at studying physicians' use and eventually misuse of biomarkers dosage and the characteristics of a broad population based on some biomarkers concentrations.

time_perspective: Retrospective

ipd_sharing_description: Only aggregated data are available

lead_sponsor: Hospital Avicenne


title: Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)

acronym: RCMIGI

summary:
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment.

The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Jereczek-Fossa BA, Orecchia R. Evidence-based radiation oncology: definitive, adjuvant and salvage radiotherapy for non-metastatic prostate cancer. Radiother Oncol. 2007 Aug;84(2):197-215. doi: 10.1016/j.radonc.2007.04.013. Epub 2007 May 29.

ReferenceCitation: Zaorsky NG, Harrison AS, Trabulsi EJ, Gomella LG, Showalter TN, Hurwitz MD, Dicker AP, Den RB. Evolution of advanced technologies in prostate cancer radiotherapy. Nat Rev Urol. 2013 Oct;10(10):565-79. doi: 10.1038/nrurol.2013.185. Epub 2013 Sep 10.

ReferenceCitation: Budaus L, Bolla M, Bossi A, Cozzarini C, Crook J, Widmark A, Wiegel T. Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature. Eur Urol. 2012 Jan;61(1):112-27. doi: 10.1016/j.eururo.2011.09.027. Epub 2011 Oct 6.

ReferenceCitation: Ohri N, Dicker AP, Showalter TN. Late toxicity rates following definitive radiotherapy for prostate cancer. Can J Urol. 2012 Aug;19(4):6373-80.

ReferenceCitation: Pardo Y, Guedea F, Aguilo F, Fernandez P, Macias V, Marino A, Hervas A, Herruzo I, Ortiz MJ, Ponce de Leon J, Craven-Bratle J, Suarez JF, Boladeras A, Pont A, Ayala A, Sancho G, Martinez E, Alonso J, Ferrer M. Quality-of-life impact of primary treatments for localized prostate cancer in patients without hormonal treatment. J Clin Oncol. 2010 Nov 1;28(31):4687-96. doi: 10.1200/JCO.2009.25.3245. Epub 2010 Oct 4. Erratum In: J Clin Oncol. 2011 Feb 20;29(6):779.

ReferenceCitation: de Crevoisier R, Fiorino C, Dubray B. [Dosimetric factors predictive of late toxicity in prostate cancer radiotherapy]. Cancer Radiother. 2010 Oct;14(6-7):460-8. doi: 10.1016/j.canrad.2010.07.225. Epub 2010 Aug 24. French.

ReferenceCitation: Valdagni R, Rancati T, Fiorino C. Predictive models of toxicity with external radiotherapy for prostate cancer: clinical issues. Cancer. 2009 Jul 1;115(13 Suppl):3141-9. doi: 10.1002/cncr.24356.

ReferenceCitation: Yu JB. Hypofractionated Radiotherapy for Prostate Cancer: Further Evidence to Tip the Scales. J Clin Oncol. 2017 Jun 10;35(17):1867-1869. doi: 10.1200/JCO.2017.72.7016. Epub 2017 Mar 29. No abstract available.

ReferenceCitation: Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20. Erratum in: Lancet Oncol. 2016 Aug;17 (8):e321.

ReferenceCitation: Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4.

ReferenceCitation: Incrocci L, Wortel RC, Alemayehu WG, Aluwini S, Schimmel E, Krol S, van der Toorn PP, Jager H, Heemsbergen W, Heijmen B, Pos F. Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1061-1069. doi: 10.1016/S1470-2045(16)30070-5. Epub 2016 Jun 20.

ReferenceCitation: Arcangeli G, Saracino B, Arcangeli S, Gomellini S, Petrongari MG, Sanguineti G, Strigari L. Moderate Hypofractionation in High-Risk, Organ-Confined Prostate Cancer: Final Results of a Phase III Randomized Trial. J Clin Oncol. 2017 Jun 10;35(17):1891-1897. doi: 10.1200/JCO.2016.70.4189. Epub 2017 Mar 29.

ReferenceCitation: Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.

ReferenceCitation: Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouvière O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.

ReferenceCitation: Rodin D, Tawk B, Mohamad O, Grover S, Moraes FY, Yap ML, Zubizarreta E, Lievens Y. Hypofractionated radiotherapy in the real-world setting: An international ESTRO-GIRO survey. Radiother Oncol. 2021 Apr;157:32-39. doi: 10.1016/j.radonc.2021.01.003. Epub 2021 Jan 14.

ReferenceCitation: Chapet O, Decullier E, Bin S, Faix A, Ruffion A, Jalade P, Fenoglietto P, Udrescu C, Enachescu C, Azria D. Prostate hypofractionated radiation therapy with injection of hyaluronic acid: acute toxicities in a phase 2 study. Int J Radiat Oncol Biol Phys. 2015 Mar 15;91(4):730-6. doi: 10.1016/j.ijrobp.2014.11.027.

ReferenceCitation: Palombarini M, Mengoli S, Fantazzini P, Cadioli C, Degli Esposti C, Frezza GP. Analysis of inter-fraction setup errors and organ motion by daily kilovoltage cone beam computed tomography in intensity modulated radiotherapy of prostate cancer. Radiat Oncol. 2012 Apr 2;7:56. doi: 10.1186/1748-717X-7-56.

ReferenceCitation: Tanyi JA, He T, Summers PA, Mburu RG, Kato CM, Rhodes SM, Hung AY, Fuss M. Assessment of planning target volume margins for intensity-modulated radiotherapy of the prostate gland: role of daily inter- and intrafraction motion. Int J Radiat Oncol Biol Phys. 2010 Dec 1;78(5):1579-85. doi: 10.1016/j.ijrobp.2010.02.001. Epub 2010 May 14.

ReferenceCitation: Nguyen NP, Davis R, Bose SR, Dutta S, Vinh-Hung V, Chi A, Godinez J, Desai A, Woods W, Altdorfer G, D'Andrea M, Karlsson U, Vo RA, Sroka T; International Geriatric Radiotherapy Group. Potential applications of image-guided radiotherapy for radiation dose escalation in patients with early stage high-risk prostate cancer. Front Oncol. 2015 Feb 2;5:18. doi: 10.3389/fonc.2015.00018. eCollection 2015.

ReferenceCitation: Crehange G, Martin E, Supiot S, Chapet O, Mazoyer F, Naudy S, Maingon P. [Image-guided radiotherapy in prostate cancer: concepts and implications]. Cancer Radiother. 2012 Sep;16(5-6):430-8. doi: 10.1016/j.canrad.2012.07.183. Epub 2012 Aug 23. French.

ReferenceCitation: Bernchou U, Agergaard SN, Brink C. Radiopaque marker motion during pre-treatment CBCT as a predictor of intra-fractional prostate movement. Acta Oncol. 2013 Aug;52(6):1168-74. doi: 10.3109/0284186X.2012.747698. Epub 2012 Dec 17.

ReferenceCitation: Badakhshi H, Wust P, Budach V, Graf R. Image-guided radiotherapy with implanted markers and kilovoltage imaging and 6-dimensional position corrections for intrafractional motion of the prostate. Anticancer Res. 2013 Sep;33(9):4117-21.

ReferenceCitation: Tong X, Chen X, Li J, Xu Q, Lin MH, Chen L, Price RA, Ma CM. Intrafractional prostate motion during external beam radiotherapy monitored by a real-time target localization system. J Appl Clin Med Phys. 2015 Mar 8;16(2):5013. doi: 10.1120/jacmp.v16i2.5013.

ReferenceCitation: Das S, Liu T, Jani AB, Rossi P, Shelton J, Shi Z, Khan MK. Comparison of image-guided radiotherapy technologies for prostate cancer. Am J Clin Oncol. 2014 Dec;37(6):616-23. doi: 10.1097/COC.0b013e31827e4eb9.

ReferenceCitation: Foster RD, Pistenmaa DA, Solberg TD. A comparison of radiographic techniques and electromagnetic transponders for localization of the prostate. Radiat Oncol. 2012 Jun 21;7:101. doi: 10.1186/1748-717X-7-101.

ReferenceCitation: Korreman S, Rasch C, McNair H, Verellen D, Oelfke U, Maingon P, Mijnheer B, Khoo V. The European Society of Therapeutic Radiology and Oncology-European Institute of Radiotherapy (ESTRO-EIR) report on 3D CT-based in-room image guidance systems: a practical and technical review and guide. Radiother Oncol. 2010 Feb;94(2):129-44. doi: 10.1016/j.radonc.2010.01.004. Epub 2010 Feb 12.

ReferenceCitation: Santanam L, Malinowski K, Hubenshmidt J, Dimmer S, Mayse ML, Bradley J, Chaudhari A, Lechleiter K, Goddu SK, Esthappan J, Mutic S, Low DA, Parikh P. Fiducial-based translational localization accuracy of electromagnetic tracking system and on-board kilovoltage imaging system. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):892-9. doi: 10.1016/j.ijrobp.2007.10.005.

ReferenceCitation: Langen KM, Willoughby TR, Meeks SL, Santhanam A, Cunningham A, Levine L, Kupelian PA. Observations on real-time prostate gland motion using electromagnetic tracking. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1084-90. doi: 10.1016/j.ijrobp.2007.11.054. Epub 2008 Feb 14.

ReferenceCitation: Willoughby TR, Kupelian PA, Pouliot J, Shinohara K, Aubin M, Roach M 3rd, Skrumeda LL, Balter JM, Litzenberg DW, Hadley SW, Wei JT, Sandler HM. Target localization and real-time tracking using the Calypso 4D localization system in patients with localized prostate cancer. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):528-34. doi: 10.1016/j.ijrobp.2006.01.050.

ReferenceCitation: Mayyas E, Chetty IJ, Chetvertkov M, Wen N, Neicu T, Nurushev T, Ren L, Lu M, Stricker H, Pradhan D, Movsas B, Elshaikh MA. Evaluation of multiple image-based modalities for image-guided radiation therapy (IGRT) of prostate carcinoma: a prospective study. Med Phys. 2013 Apr;40(4):041707. doi: 10.1118/1.4794502.

ReferenceCitation: Noel C, Parikh PJ, Roy M, Kupelian P, Mahadevan A, Weinstein G, Enke C, Flores N, Beyer D, Levine L. Prediction of intrafraction prostate motion: accuracy of pre- and post-treatment imaging and intermittent imaging. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):692-8. doi: 10.1016/j.ijrobp.2008.04.076. Epub 2008 Aug 7.

ReferenceCitation: Zhu M, Bharat S, Michalski JM, Gay HA, Hou WH, Parikh PJ. Adaptive radiation therapy for postprostatectomy patients using real-time electromagnetic target motion tracking during external beam radiation therapy. Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):1038-44. doi: 10.1016/j.ijrobp.2012.08.001. Epub 2012 Sep 25.

ReferenceCitation: Su Z, Zhang L, Murphy M, Williamson J. Analysis of prostate patient setup and tracking data: potential intervention strategies. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):880-7. doi: 10.1016/j.ijrobp.2010.07.1978. Epub 2010 Oct 8.

ReferenceCitation: Kupelian P, Willoughby T, Mahadevan A, Djemil T, Weinstein G, Jani S, Enke C, Solberg T, Flores N, Liu D, Beyer D, Levine L. Multi-institutional clinical experience with the Calypso System in localization and continuous, real-time monitoring of the prostate gland during external radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1088-98. Epub 2006 Dec 21.

ReferenceCitation: Klayton T, Price R, Buyyounouski MK, Sobczak M, Greenberg R, Li J, Keller L, Sopka D, Kutikov A, Horwitz EM. Prostate bed motion during intensity-modulated radiotherapy treatment. Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):130-6. doi: 10.1016/j.ijrobp.2011.11.041. Epub 2012 Feb 11.

ReferenceCitation: Mantz C. A Phase II Trial of Stereotactic Ablative Body Radiotherapy for Low-Risk Prostate Cancer Using a Non-Robotic Linear Accelerator and Real-Time Target Tracking: Report of Toxicity, Quality of Life, and Disease Control Outcomes with 5-Year Minimum Follow-Up. Front Oncol. 2014 Nov 14;4:279. doi: 10.3389/fonc.2014.00279. eCollection 2014.

ReferenceCitation: Sandler HM, Liu PY, Dunn RL, Khan DC, Tropper SE, Sanda MG, Mantz CA. Reduction in patient-reported acute morbidity in prostate cancer patients treated with 81-Gy Intensity-modulated radiotherapy using reduced planning target volume margins and electromagnetic tracking: assessing the impact of margin reduction study. Urology. 2010 May;75(5):1004-8. doi: 10.1016/j.urology.2009.10.072. Epub 2010 Feb 13.

ReferenceCitation: Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33.

ReferenceCitation: Azria D, Betz M, Bourgier C, Jeanneret Sozzi W, Ozsahin M. Identifying patients at risk for late radiation-induced toxicity. Crit Rev Oncol Hematol. 2012 Dec;84 Suppl 1:e35-41. doi: 10.1016/j.critrevonc.2010.08.003. Epub 2010 Sep 24.

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: Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30.

ReferenceCitation: Nyaga VN, Arbyn M, Aerts M. Metaprop: a Stata command to perform meta-analysis of binomial data. Arch Public Health. 2014 Nov 10;72(1):39. doi: 10.1186/2049-3258-72-39. eCollection 2014.

intervention_type: Radiation

status_simplified: Ongoing


title: Impact of Early Intervention on Neurocognitive Profile of Children With Autism Spectrum Disorder

acronym: IDEAEYE

summary:
The Early start Denver model (Rogers, 2010; Dawson, 2010) is a developmental and behavioral model that aim to enhance socio-comunicative abilities and also global development of children with Autism spectrum disorder (ASD). The purpose of this study is to identify changes in neurocognitive profile of children population with ASD receiving Early Start Denver Model (ESDM) applied 12 hours per week in comparison to children receiving other interventions. That is a study proposed to children with ASD and their families that participate already to a randomized control study called IDEA registered on clinicaltrials.gov NCT02608333.

the investigators hypothesized that ESDM would increase social cognition, reduce shifting attention time and increase preference for unpredictable stimuli.

status: Terminated

lead_sponsor: Hôpital le Vinatier

intervention_type: Behavioral

status_simplified: Unknown


title: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer

acronym: CYTO-CHIP

summary: Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median survival of less than one year. Systemic chemotherapy including targeted agents has not been found to significantly increase the survival in Gastric cancer associated peritoneal carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal recurrences in many randomised trials in Asian countries; as a definitive treatment in established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is the only therapeutic modality that has resulted in long-term survival in select groups of patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still evolving and needs larger studies before it is accepted as a standard of care.

ReferenceType: derived

ReferenceCitation: Bonnot PE, Piessen G, Kepenekian V, Decullier E, Pocard M, Meunier B, Bereder JM, Abboud K, Marchal F, Quenet F, Goere D, Msika S, Arvieux C, Pirro N, Wernert R, Rat P, Gagnière J, Lefevre JH, Courvoisier T, Kianmanesh R, Vaudoyer D, Rivoire M, Meeus P, Passot G, Glehen O; FREGAT and BIG-RENAPE Networks. Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer With Peritoneal Metastases (CYTO-CHIP study): A Propensity Score Analysis. J Clin Oncol. 2019 Aug 10;37(23):2028-2040. doi: 10.1200/JCO.18.01688. Epub 2019 May 14.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Chirurgie Générale et Digestive - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

intervention_type: Procedure


title: Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.

summary:
Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid.

The present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

lead_sponsor: Claude Bernard University

location_facility: Centre Lyonnais d'Enseignement par la Simulation en Santé

intervention_type: Device


title: Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)

acronym: HYPNOSEIN

summary: Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.

ReferenceCitation: Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.

location_facility: Institut réginal du Cancer de Montpellier


title: Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin

acronym: NIPOX

summary: This study determine the maximal tolerate dose

intervention_type: Drug


title: Cerebrospinal Fluid Biomarkers Value: Exploratory and Prospective Study in Leptomeningeal Metastases of Breast Cancer (LCS Bio Sein)

acronym: LCS Bio Sein

summary: Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system (CNS). Several prognostic factors have been identified, including the age at diagnosis, the functional and neurological status, the delay between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6 months in most published series. Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in several neurological diseases including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation of a clinico-biological collection seems to be of high value in order to investigate future biomarkers of interest


title: Radiation-induced Late Side-effects: Predictive Role of New Biomarkers for Selecting Hypersensitive Patients to Ionizing Radiation in Breast Cancer (BIORISE)

acronym: BIORISE

summary: To confirm the protein expression level in radiation-induced late effects patients and to determine the performance value, in particular the positive predictive value, of a blood test based on the dosage of a panel of five proteins, it is necessary to validate these preliminary results by a prospective study on a large cohort of patients.

status: Unknown status

enrollment_type: Anticipated


title: Contribution of Stereography in the Quantification of Malunions Femoral Shaft Fractures Operated by Centromedullary Nailing. A Case Serie of 40 Patients

acronym: FEOS

summary: This observational study is a collection of clinical and imaging data of patients with a femoral shaft fracture treated by nails. The aim of this research is the contribution of the EOS imaging system in the quantification of malunions.

lead_sponsor: University Hospital, Grenoble

location_facility: Orthopedic and Trauma Department, University Hospital, Grenoble Alpes


title: Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes

acronym: TRAUMPO

summary: The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.

lead_sponsor: Rennes University Hospital

location_facility: Pediatric and orthopedic surgery division


title: Phenotypic Characterization of Alveolar Macrophages 2016

acronym: Caract-Aires

summary: The aim of the study is to investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from patients with non-infectious lung diseases.


title: Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

summary: The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.


title: Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?

acronym: PAINLESS

summary:
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.

Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.

Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.

The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.

primary_purpose: Supportive Care

lead_sponsor: Poitiers University Hospital


type: Other Identifier

title: Physiologic Pilot Study: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in Post-surgical Period Alternatively in Conventional Ventilation (Pressure Controlled) and in NAVA (Neurally Adjusted Ventilatory Assist) Ventilation.

acronym: NAVA-DIAPH

summary: Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a synchronized proportional assisted ventilation. This technique has already been used in the newborn, especially premature and has shown many benefits. Only one study in the literature shows its feasibility in newborns with CDH. This technique seems interesting in the context of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating the clinical benefits, it seems important to describe the effects on the respiratory physiology, in particular on work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is an innovative physiologic pilot study with the objective to describe work of breathing in neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation using an esophageal transducer. It will provide the clinician with a physiological justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of these patients. This study is a prerequisite for the realization of studies demonstrating the clinical benefit of NAVA ventilation on reduction of duration of ventilation and more generally on morbidity and mortality in the population of neonate with CDH.

primary_purpose: Other

location_facility: Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon


type: Registry Identifier

title: Role of the Endothelium in Stroke-like Episode Among CDG Patients

acronym: PECDG

summary: The aim of the study is to evaluate the role of the endothelial barrier in the occurrence of stroke-like episode. And to study the protein C system on the surface of the endothelium.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Medical Ericksonian Hypnosis on Patients Treated With Adjuvant Chemotherapy for Breast Cancer at the ICM Val d'Aurelle - Montpellier: a Feasibility Study

acronym: HYPNOVAL

summary: The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

location_facility: Institut régional du Cancer de montpellier


title: Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

summary: Based in an embodied approach of cognition, several studies have highlighted a direct link between perception of an object or an emotion and the associated motor responses. This study investigated in patients suffering from bipolar affective disorders whether the perception of emotional words involves an automatic sensorimotor simulation of approach and avoidance behaviors, and whether the perception of an object involves an automatic sensorimotor simulation of object prehension (affordance). We hypothesize that, in this pathology, low level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will be recruited. The main objective is the emergence of sensorimotor compatibility effects in approach-avoidance task with emotional stimuli (gain between compatible vs incompatible conditions).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis

acronym: HAQ-II

summary: The purpose of the study is to develop a validated French version of the HAQ-II questionnaire for rheumatoid arthritis.


title: Study Assessing the Changes in Markers of Calcium Vitamin Metabolism of Patients Taken in Charge by Chemotherapy for Breast Cancer Adjuvant

acronym: CALCIOBS

summary: This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast cancer.


title: Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)

acronym: ECMO PFA-100

summary: The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.


title: A Multicenter Non-inferiority Randomized Trial Comparing Cloxacillin Versus Cefazolin Efficacy for the Treatment of Bacteremia Caused by Methicillin-susceptible Staphylococcus Aureus (MSSA)

acronym: CLOCEBA

summary:
"Methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia remains a major cause of community- or hospital-acquired bloodstream infections with an overall mortality estimated around 25%. Anti-staphylococcal penicillins (APs) such as oxacillin or cloxacillin are recommended as first-line agents. With the exception of first-generation cephalosporin (1GC) such as cefazolin, no alternative has yet proven a similar efficacy. Due to an unfavourable safety profile for high doses used in severe infection, an uneasy dosing schedule in patients with renal failure and possible recurrent stock-out events for APs, alternative to APs are needed. This led to propose an open-label, randomized, controlled parallel groups, phase IV, non-inferiority trial comparing the efficacy, the safety, and the ecological impact of cefazolin versus cloxacillin for the treatment of MSSA bacteremia in adults.

The primary objective is to compare the therapeutic efficacy of cefazolin vs cloxacillin at day 90 after the inclusion. "

status: Recruiting

ReferenceCitation: Burdet C, Loubet P, Le Moing V, Vindrios W, Esposito-Farèse M, Linard M, Ferry T, Massias L, Tattevin P, Wolff M, Vandenesch F, Grall N, Quintin C, Mentré F, Duval X, Lescure FX; CloCeBa study group. Efficacy of cloxacillin versus cefazolin for methicillin-susceptible Staphylococcus aureus bacteraemia (CloCeBa): study protocol for a randomised, controlled, non-inferiority trial. BMJ Open. 2018 Sep 1;8(8):e023151. doi: 10.1136/bmjopen-2018-023151.


title: Value of Fusion of 3D Images With 2D Images, Associated With Calcification Raising During Trans Aortic Valve Implantation Procedures

acronym: TAVI

summary:
Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve implantation (TAVI) has been developed since 2002, first to treat rejected patients from conventional surgery, then to treat high surgical risk patients and nowadays probably intermediate surgical risk patient. TAVI related complications are still recurrent and the investigators are searching a way to decrease them.

One of them could be image fusion, since it may decrease radiation exposure and contrast agent use. It may also improve valve placement position leading to decreased complications.

40 prospective and consecutive patients will be included. Participants will be divided into two groups: the 20 first included will be control group, the 20 following patients will be the fusion group. For control group TAVI procedure will be the usual one, for fusion group the procedure will be the usual one with addition of computed tomography 3D images fusion with fluoroscopy 2D images.

Main evaluation criteria will be radiation exposure, measured by dose area product (DAP). Secondary evaluation criterion will be procedural as contrast agent volume used, procedure duration, subjective usefulness of image fusion or procedure failure evaluated immediately after procedure. The investigators will also evaluated procedure induced complications as de novo pacemaker implantation, de novo left bundle branch, vascular complication, major bleeding, acute kidney failure, significant aortic regurgitation. These complications occurrence will be evaluated after 1 month follow up, during the usual following consultation.

status: Withdrawn

lead_sponsor: Nantes University Hospital


title: Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin During Bone and Joint Infections: a Prospective, Randomized, Open-label, Monocentric Crossover Study.

acronym: CLOXA Continue

summary: Our objective is to establish pharmacological equivalence of intermittent and continuous infusion of cloxacillin during methicillin-susceptible Staphylococcus aureus (MSSA) bone and joint infections (BJI). Twelve patients suffering MSSA BJI will receive both administration modalities and serum concentrations of cloxacillin will be determined after 3 days of II and 3 days of continuous infusion in a prospective, randomized, open-label, monocentric crossover study design.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Spirituality, Experience of Disease and Quality of Life in Cancer Patients

acronym: SPIQOL

summary:
The general aim of research is to identify and analyze the impact and role of spirituality (as a search for meaning and understanding of the meaning of existence) in the experience of cancer. For this purpose, the main objective of this study is to measure the "existential" component in the trajectory of the disease. It is a question of observing its potential contribution to the improvement of the quality of life of the patients and to define if this variable can be translated into a strategy of adjustment for the patients. This research has a double interest: (a) clinical interest in better managing patients' needs; (B) an interest in research in the field of health by combining a measure of spirituality with other psycho-social variables.

The project is a prospective non-randomized mono-centric study by questionnaire and research interview. It is a study that seeks to identify the role of spirituality in the experience of illness (i.e. representations, adjustments, emotional distress) and as a determinant of the quality of life of subjects with cancer pathology.

The interviews will be conducted by a psychologist to qualitatively collect the elements of the lived experience of the disease in connection with the spiritual elements of the "quest for meaning" type.

The population covered by the project is in and out patients coming to the Department of Medical Oncology and Palliative Care at the CHU de la Timone.

The realization of this project will allow investigators to explore the specificity of the existential / spiritual dimensions of patients confronted with cancer, to assess the patients' needs for this type of approach within the hospital, to link the existential component / Spiritual with psycho-social variables

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation

acronym: MERAIODE

summary: This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease

acronym: ACTIPARK

summary: Our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation. In addition, the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide interesting data from this population.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Analysis of the Impact of HCV Treatment by Last Generation Direct Antiviral Agents (DAA) on Antiviral Immunity and HIV DNA Reservoir in Coinfected HIV-HCV Patients

acronym: HCURE

summary:
Spontaneous recovery of patients infected with HCV is related to the development of a cytotoxic immune response that is executed by specialized white blood cells, the CD8+ T cells, which develop a virus-specific response. In addition, the natural killer (NK) cells provide a first-line innate cytotoxic response, which is pivotal for the spontaneous clearing of HCV. In patients where HCV infection settles chronically, CD8+ T lymphocytes and NK cells fall into a state of anergy induced by chronic viral challenge. This anergic state is also found in the case of HIV infection and exacerbated by HIV-HCV coinfection. The first therapeutic strategies against HCV were based on a treatment with interferon alpha, which had an antiviral but also immunosuppressive effect. In fact, this therapeutic strategy was unable to help the recovery of the patient's immune system that would be expected after HCV cure. However, interferon-free therapeutic strategies combining first generation direct antiviral agents (DAA) showed a positive effect on HCV antiviral immunity, by enhancing the proliferative response of CD8+ T cells and the cytotoxic and proinflammatory responses of NK cells in HCV monoinfected patients (4, 5). Since HCV-targeted therapies based on combinations of the latest generation of DAA have nearly 100% cure rates and enable faster viral suppression over shorter treatment times, a positive impact of these regimens on antiviral immunity is plausible. This possibility would be particularly interesting in HIV-HCV co-infected patients, where reactivation of the innate antiviral immunity may contribute to immune defenses against both viruses. Moreover, it has been previously reported a moderate but significant and sustained decline of HIV-1 DNA in CD4 T cells from HIV-1/hepatitis C virus-coinfected patients receiving highly active antiretroviral therapy and treated with IFN alpha/ribavirin.

To date, the real impact on antiviral immunity of treatment as well as on HIV reservoir with the latest generation of DAA was not measured in HIV-HCV co-infected patients.

The aim of this study is to analyze the impact of the cure of hepatitis C on the HIV DNA reservoir and antiviral function of CD8+ and NK cells in a subgroup of patients receiving the latest generation DAAs for treatment of HCV infection, as part of a program for a reduction of the prevalence of chronic hepatitis C patients co-infected HIV-HCV set up within the Immuno-Hematology Service of the Sainte Marguerite Hospital (Research in routine care-Ethics committee Approval Sud- Méditerranée I ID RCB 2015-A01913-46/ Principal Investigator: Dr I Poizot-Martin).

The analysis of HIV DNA, NK and CD8+ T lymphocyte antiviral immune response prior, during and after anti-HCV treatment will need the collection of a biobank. Indeed, 25 mL peripheral blood will be collected at treatment initiation, during an interim assessment, at the end of treatment and six months post-treatment, for a total of 100 ml of additional blood collection. These analyzes will be performed by Dr C Tamalet for HIV DNA IHU-Méditerranée Infection, and the team of Prof. E Vivier, DHU- Marseille Immunopole for NK and CD8+ T lymphocyte antiviral immune response.


title: Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease

acronym: DREPAMUSCLE

summary:
Background : Sickle cell patients have profound remodeling of their muscle microcirculation networks with signs of amyotrophy. However, the consequences of these muscle alterations on the functional status of muscles are unknown. In addition, whether the poor physical fitness of sickle cell patients can be attributed, at least partly, to an hypothetical muscle dysfunction has never been tested.

Purpose : this study will compare the muscle function of legs between sickle cell patients (SS and SC genotypes) and healthy individuals (AA genotype) before, during and after a short localized muscle endurance exercise.

Abstract : Very recently, a study reported large differences between the muscle microcirculation networks of sickle cell patients compared to healthy individuals with decreased capillary density and higher proportion of large capillaries in the former population. In addition, the same study showed signs of amyotrophy in sickle cell patients. However, the muscle function of sickle cell patients has not been investigated and one may suggest that muscle dysfunction could participate in the decrease of physical fitness, in association with the hematological and hemorheological disorders, already reported in this population. The hypothesis is that muscle fatigue during a short localized muscle endurance exercise should be higher in sickle cell patients compared to healthy individuals, due to a greater recruitment of glycolytic fibers and a faster decrease of muscle oxygenation during exercise.


title: Clock'N' Test: Development and Validation (in a Control Population) of a Test Based on Time Estimations and Aiming to Evaluate Emotional Disorders

acronym: Clock'N'test

summary:
This study concerns the validation of a clinical test that aims to reveal "first level" emotional disorders in neurological diseases.

In order to bring to light such disorders, it is necessary to begin by establishing reference values in healthy individuals. This test is based on the priming effect and time estimations. The test procedure has two successive phases. The first phase aims to determine the judgement of time inherent to each participant and then to assess whether or not this judgement varies during the second phase with the introduction of emotional priming. First, we set out to look for and to calibrate video stimuli able to activate emotions. To this end, we used a battery of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined their degree of physiological activation by measuring the electrodermal response at the laboratory for the exploration of the nervous system in Dijon. These measurements also allowed us to define and refine our paradigm, notably by deciding at what moment the time estimation task should be done and by eliminating the influence of attention. We decided to select only seven video sequences because we noticed a reduction in the measurement effect on time estimations due to habituation of the subject. We also conducted pre-tests in a control population made up of twenty men and women aged from 20 to 60 years.

This brought to light a warp in time estimation opposite to that we found using olfactory stimuli. This first finding suggests that there are two types of emotion, one which is anticipative and the other immediately experienced.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration

acronym: QUASAR

summary: Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.


title: Characterization of Normal and Pathological Oocyte Cohort After Controlled Ovarian Stimulation: Example of Endometriosis

acronym: EndOvo

summary:
The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the follicular fluid. This evaluation will be completed by a transcriptomic analysis from the cumulus cells of the oocyte.

The normal and pathological oocyte cohort after controlled ovarian stimulation will be also characterized by identifying the oocyte leading to live birth.


title: Prospective Assessment of the Quality of the Image and the Usability of the C-ARM ARCO FP-Rk521S Used in Surgical Conventional Practice

summary: THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and its ability to be used during surgery.


acronym: QUALANGIO

summary: This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles

summary:
Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate with modification of protease-antiprotease and oxidant-antioxydant balances. Local modifications are associated with systemic changes. Many occupational factors have been associated with an excess of COPD in epidemiological studies, however without identification of any specific clinical or biological phenotype.

Pathophysiological pathways involved in COPD might be different according to etiologic agents. Therefore, it is important to focus research on blood biomarkers associated with some well-characterized occupational COPD.

The objectives of MB2PROF project are:

To build the first multicentric cohort of cases of occupational COPD, with collection of plasma and DNA samples,
To study the evolution of clinical and lung function parameters of occupational COPD in comparison with non occupational COPD during a follow-up study,
To identify biological phenotypes of COPD associated to a given etiological agent.

The methodology includes:

The constitution of a cohort with a clinical and biological follow-up during 5 years. Subjects will be recruited in 7 occupational diseases departments, with the collaboration of Pneumology departments.

Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60 subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical data, lung function parameters, occupation history and blood samples will be collected.

The identification of biomarkers, using proteomic and genomic approaches according to subgroups (with different etiologies) of occupational COPD,
The study of molecular pathways identified in these subgroups, with in vitro and in vivo studies The MB2PROF project is an original and ambitious multidisciplinary and translational project. The constitution of well-characterized COPD cases cohort should allow the identification of biomarkers and molecular pathways associated with some subgroup of subjects, and improve the knowledge of mechanisms involved.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Arterial pH Selectively Predicts ICU Transfer in Obese Patients With Acute Dyspnea Presenting to the Emergency Department: a Prospective Comparative Cohort Study

summary: This study evaluates the prognostic value of arterial blood gas analysis in a cohort of Emergency Department patients presenting with shortness of breath of any cause, comparing obese and non-obese patients.

lead_sponsor: Association pour la Formation du Personnel à la Medecine d'Urgence


title: Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? A Prospective, Randomized Study

acronym: PEDI-PDS

summary: To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.


title: Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant

acronym: vaLIDLIver

summary:
The study is a prospective observational mono center study

Primary objective :

Study the anti-HLA antibodies frequency preformed before liver transplantation and the kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver transplantation.

Secondary objective :

Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)

Impact of DSA on:

Graft and patients survivals
Onset of allograft rejection (acute, late-onset, chronic)
Unexplained liver graft dysfunction
Unexplained liver enzymes abnormalities
Liver fibrosis development (liver stiffness study using fibroscan©)

lead_sponsor: University Hospital, Lille


type: EudraCT Number

title: Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .

acronym: CATHEPAT

summary:
Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an epidural haematoma formation following the epidural analgesia, "gold standard" in major abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local anesthetics constitute so an alternative.

The study will compare the continuous infiltration of local anesthetics and rachianalgesia in terms of decreased postoperative morphine consumption and incidences of chronic postoperative pain at 3 and 6 months after hepatic surgery compared to the control group.


title: A Phase IV, Prospective, Open-label, Multicentre, Single Arm, 3-month Proof of Concept Study to Assess the Effect of IKERVIS® Eye Drops Administered Once Daily on the Quality of Vision in Dry Eye Disease (DED) Patients With Severe Keratitis

lead_sponsor: Santen SAS

source: euctr

summary: The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.


title: Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial

acronym: MAGMAT

summary:
Thrombotic Thrombocytopenic Purpura (TTP) is a potentially life-threatening thrombotic microangiopathy caused by a severe deficiency of ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif member 13). Decreased ADAMTS13 activity leads to an accumulation of ultralarge von Willebrand factor (vWF) multimers which induce aggregation of platelets and microthrombi. These microthrombi may involve the brain, heart, kidneys and lead to life-threatening organ failures.

In experimental models, magnesium sulfate increases cleavage of newly released vWF by ADAMTS13, decreases the endothelial secretion of ultralarge vWF and inhibits the interaction of vWF with platelets. In another thrombotic microangiopathy, magnesium sulfate has been shown to reduce the risk of seizures in women with severe pre-eclampsia. In analogy with its evidence-based therapeutic application in pre-eclampsia and based on a strong rationale for magnesium supplementation in TTP, we propose a phase 3, double blind, placebo controlled, and randomized study to evaluate the efficacy of magnesium sulfate in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis in patients with Thrombotic Thrombocytopenic Purpura.


title: Study of Association Between Clinical Criteria Collected at the SAMU Regulation Centre Call and the Hospital Orientation of Patients With Suspected Sepsis State

summary: Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit

ipd_sharing_description: No IPD sharing plan is planned

lead_sponsor: Hôpital Necker-Enfants Malades


title: Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study

acronym: CAPE

summary: To study the association between several exposures of interest and the occurrence of infectious loco-regional complications of pharyngitis in children.


title: Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome: an Interventional, Prospective, Monocentric Study.

acronym: Marfanpower

summary:
Marfan syndrome (MFS) is a rare genetic disease (1/5000) characterized by the association of ocular impairment, cardiovascular disease and musculoskeletal disease.

In some chronic conditions, physical activity and training have been shown to be effective in improving muscle strength and functional abilities but also fatigue and quality of life. We hypothesize that the implementation of a personalized exercise rehabilitation program (Personalized Training Program) in children and young adults with MFS, by improving muscle mass, physical endurance, muscle strength, bone mass and quality of life of these patients. In order to test this hypothesis, investigators wish to carry out an interventional, prospective, monocentric study for the first time in children and young adults (<25 years old) presenting an MFS.

ReferenceCitation: Judge DP, Dietz HC. Marfan's syndrome. Lancet. 2005 Dec 3;366(9501):1965-76. Review.

ReferenceCitation: De Paepe A, Devereux RB, Dietz HC, Hennekam RC, Pyeritz RE. Revised diagnostic criteria for the Marfan syndrome. Am J Med Genet. 1996 Apr 24;62(4):417-26.

ReferenceCitation: Loeys BL, Dietz HC, Braverman AC, Callewaert BL, De Backer J, Devereux RB, Hilhorst-Hofstee Y, Jondeau G, Faivre L, Milewicz DM, Pyeritz RE, Sponseller PD, Wordsworth P, De Paepe AM. The revised Ghent nosology for the Marfan syndrome. J Med Genet. 2010 Jul;47(7):476-85. doi: 10.1136/jmg.2009.072785.

ReferenceCitation: Bathen T, Velvin G, Rand-Hendriksen S, Robinson HS. Fatigue in adults with Marfan syndrome, occurrence and associations to pain and other factors. Am J Med Genet A. 2014 Aug;164A(8):1931-9. doi: 10.1002/ajmg.a.36574. Epub 2014 Apr 9.

ReferenceCitation: Giske L, Stanghelle JK, Rand-Hendrikssen S, Strøm V, Wilhelmsen JE, Røe C. Pulmonary function, working capacity and strength in young adults with Marfan syndrome. J Rehabil Med. 2003 Sep;35(5):221-8.

ReferenceCitation: Percheron G, Fayet G, Ningler T, Le Parc JM, Denot-Ledunois S, Leroy M, Raffestin B, Jondeau G. Muscle strength and body composition in adult women with Marfan syndrome. Rheumatology (Oxford). 2007 Jun;46(6):957-62. Epub 2007 Feb 28.

ReferenceCitation: Behan WM, Longman C, Petty RK, Comeglio P, Child AH, Boxer M, Foskett P, Harriman DG. Muscle fibrillin deficiency in Marfan's syndrome myopathy. J Neurol Neurosurg Psychiatry. 2003 May;74(5):633-8.

ReferenceCitation: Haine E, Salles JP, Khau Van Kien P, Conte-Auriol F, Gennero I, Plancke A, Julia S, Dulac Y, Tauber M, Edouard T. Muscle and Bone Impairment in Children With Marfan Syndrome: Correlation With Age and FBN1 Genotype. J Bone Miner Res. 2015 Aug;30(8):1369-76. doi: 10.1002/jbmr.2471. Epub 2015 May 14.

ReferenceCitation: Burks TN, Andres-Mateos E, Marx R, Mejias R, Van Erp C, Simmers JL, Walston JD, Ward CW, Cohn RD. Losartan restores skeletal muscle remodeling and protects against disuse atrophy in sarcopenia. Sci Transl Med. 2011 May 11;3(82):82ra37. doi: 10.1126/scitranslmed.3002227.

ReferenceCitation: Peters KF, Horne R, Kong F, Francomano CA, Biesecker BB. Living with Marfan syndrome II. Medication adherence and physical activity modification. Clin Genet. 2001 Oct;60(4):283-92.

lead_sponsor: University Hospital, Toulouse


title: Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells: A Confirmatory, Randomized, Double Blinded Trial

acronym: DLI-Boost

summary:
The investigators have previously shown the absence of toxicity of Treg-depleted-DLI and the possibility to triggering alloreactivity (GVHD/GVT) in relapsing patients dealing with hematological malignancies who had never shown any signs of GVHD after transplant or after one or more DLI.

The Investigators, we plan to demonstrate the benefit of Treg-depleted DLI as compared to the reference treatment of relapse in hematological malignancies after allogeneic HSCT which is currently based on standard DLI

ReferenceCitation: Maury S, Lemoine FM, Hicheri Y, Rosenzwajg M, Badoual C, Cheraï M, Beaumont JL, Azar N, Dhedin N, Sirvent A, Buzyn A, Rubio MT, Vigouroux S, Montagne O, Bories D, Roudot-Thoraval F, Vernant JP, Cordonnier C, Klatzmann D, Cohen JL. CD4+CD25+ regulatory T cell depletion improves the graft-versus-tumor effect of donor lymphocytes after allogeneic hematopoietic stem cell transplantation. Sci Transl Med. 2010 Jul 21;2(41):41ra52. doi: 10.1126/scitranslmed.3001302.


title: Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes

acronym: CEREAL

summary: The investigators focused on patients with refractory acute leukemia or MDS and designed a phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided myeloablative busulfan doses. This scheme allows combining different optimization of RTC experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine analog cladribine) to approach a specific platform to treat refractory diseases.

lead_sponsor: Institut Paoli-Calmettes


title: Pilot Study Investigating the Effects of Cathodal Transcranial Direct Current Stimulation (tDCS) on Executive Functions of Patients With Autism Without Mental Retardation. TRANSFEX Study

acronym: TRANSFEX

summary:
It's an interventional, prospective and monocentric pilot study concerning adult patients with autism without mental retardation.

The primary outcome is to assess the effects of cathodal transcranial direct current stimulation (tDCS) on the left dorsolateral prefrontal cortex (DLPFC) on the executive functions of patients with autism without mental retardation or with Asperger syndrome.

The secondary outcomes are to evaluate the safety of this treatment and to evaluate its impact on impaired social communication and on restricted or repetitive behaviors.

lead_sponsor: Centre Hospitalier du Rouvray


title: Validation of MotionPODTM a Device for Measuring Physical Activity, in Free-living Conditions

summary: In this study, the investigators propose to assess the validity in measuring physical activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope) with an automatic activity/posture recognition algorithm and an activity-specific multilinear prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns will be compared to those of two existing activity or movement monitors: the triaxial accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the cost of a calibration of the heart-rate/EE relationship that limits its use in large population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years of both gender and with broad range of body mass index and physical activity level. The subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total of 14 days in everyday life conditions and complete a physical activity diary. In half of the subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW. The other 60 subjects will be studied twice, one month apart, to test the reproducibility of the measures.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud


title: Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.

acronym: SEXODREP

summary: Evaluation of knowledge about contraception in sickle cell adolescents.

lead_sponsor: Adele CARLIER-GONOD

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia

acronym: NUCLARA

summary: Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and consolidation. Standard chemotherapy combination for induction treatment associates cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About 60-70% of patients achieved complete remission after this standard chemotherapy. As cytarabine competes with endogenous nucleotides to exert its activity, the aim of this protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of the induction treatment. Thus, intracellular nucleotides levels will be determined in peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment, and results will be compared with the efficacy of the treatment. This parameter will be assessed by the achievement of complete remission.

location_facility: Service d'hématologie - Centre Hospitalier Lyon Sud - Hospices Civils de LYON


title: Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)

acronym: UF-Plaques

summary: Unstable plaques are characterized by lower segmental stiffness and intimal neovascularization compared to stable plaques. Our objective is to determine the capacity of the elastographic parameters obtained by the UF to discriminate the unstable to the stable plaques. We hope to improve the stroke prediction in asymptomatic patients with carotid stenosis.

primary_purpose: Diagnostic

ReferenceCitation: Goudot G, Sitruk J, Jimenez A, Julia P, Khider L, Alsac JM, El Batti S, Bruneval P, Amemyia K, Pedreira O, Mortelette H, Calvet D, Tanter M, Mirault T, Pernot M, Messas E. Carotid Plaque Vulnerability Assessed by Combined Shear Wave Elastography and Ultrafast Doppler Compared to Histology. Transl Stroke Res. 2022 Feb;13(1):100-111. doi: 10.1007/s12975-021-00920-6. Epub 2021 Jun 28.

lead_sponsor: French Cardiology Society


title: Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention

summary:
Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major foetal pathology and impact growth.

Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and water.

Through a prevention program, the investigators tried to warned pregnant women on endocrine disruptors exposition risks. The goal here is to assess the effectiveness of this program on their fresh products consumption.

ReferenceCitation: Ouazzani HE, Rouillon S, Venisse N, Sifer-Riviere L, Dupuis A, Cambien G, Ayraud-Thevenot S, Gourgues AS, Pierre-Eugene P, Pierre F, Rabouan S; DisProSE Group, Migeot V, Albouy-Llaty M. Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy-PREVED study: study protocol for a randomized controlled trial. Trials. 2021 Dec 4;22(1):876. doi: 10.1186/s13063-021-05813-5. Erratum In: Trials. 2021 Dec 29;22(1):968.

lead_sponsor: Poitiers University Hospital

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Electrophysiological and Bioenergetic Study of Variations in Cognitive and Physical Performance in Healthy Humans: EEG Monitoring for PERFormance Anticipation

acronym: MEEGAPERF

summary: Identify, characterize and then validate electrophysiological markers linking electrophysiological cerebral activity and performance in cognitive and physical fatigability in humans. To do this, noninvasive explorations of electroencephalography (EEG) and magnetoencephalography (MEG) will be carried out under two conditions of different experiments, the first one that induces a cognitive fatigability and the second one that induces physical fatigability.


title: Evaluation of an E-learning to Prevent Drug Errors in Anesthesia.

acronym: ELPdrug

summary: The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid medication errors during anesthesia.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of an E-learning to Prevent Wrong Site Surgery in Anesthesia.

acronym: ELPSite

summary: The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid wrong site surgery during anesthesia.


title: French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)

acronym: MoCATEL

summary: The aim of the study is to validate a french version of the 5 minutes version of the Montreal Cognitive Assessment as compared to the french full version of this test.


title: Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.

acronym: AMYLCAR

summary: To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.


title: HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

acronym: MICROSTEM

summary: This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft


title: Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria: PHAGO- BMR

acronym: PHAGO-BMR

summary:
This research focuses on antibiotic resistant bacteria that may reside in the digestive tract (intestinal flora) of everyone.

When we develop an infection, the bacteria in question is, often, already present in our flora. Face to the growing phenomenon of multi-resistance, which is a public health problem, it is essential to follow the frequency of these bacteria but also to find new strategies and effective means to fight against their spread.

It has been discovered long time ago that it exists viruses able of destroying bacteria: they have been called bacteriophages .They was used before the arrival of antibiotics for the treatment of various infections (phagotherapy). Today, with the problems of resistance, phagotherapy could become a good way to fight against infections with bacteria very resistant but also a way to remove the resistant bacteria that are present in our digestive flora.

Moreover, it is known that these viruses of bacteria are present everywhere in the environment (waters, soils, human digestive tract and animal), it is important to check their presence in our digestive tract. Our objective is to study if the presence of these phages prevents resistant bacteria from set up in our digestive flora.

To answer the question, it is planned to include 460 people hospitalized in intensive care unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of resistant bacteria is carried out regularly during the hospitalization. Three resuscitation services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool samples collected at different times of the stay (admission and then during the stay), we will look for 2 types of bacteria and viruses capable of destroying them.

ReferenceCitation: Adhya S, Merril CR, Biswas B. Therapeutic and prophylactic applications of bacteriophage components in modern medicine. Cold Spring Harb Perspect Med. 2014 Jan 1;4(1):a012518. doi: 10.1101/cshperspect.a012518. Review.

ReferenceCitation: Balcazar JL. Bacteriophages as vehicles for antibiotic resistance genes in the environment. PLoS Pathog. 2014 Jul 31;10(7):e1004219. doi: 10.1371/journal.ppat.1004219. eCollection 2014 Jul.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: réanimation médicale Hôpital Saint Antoine


title: Prospective Multicentric Study for the Diagnostic Performance of CArdiac MAgnetic REsonance Imaging Used First for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction

acronym: CAMAREC

summary: When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is performed. In this situation, the investigators aim to evaluate a strategy with CMR as the front line exam, and invasive coronary angiography performed only in case of ischemic scar on CMR


title: Study of the Links Between Suicidal Intentionality and Acute Alcoholism

acronym: ISA

summary:
There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. However why the alcohol consumption increase the suicidal risk is unknown.

The hypothesis of this study is that the alcohol consumption induced disinhibition and facilitates the suicide attempt without premeditation


title: Determination of the Root Causes of Obstructions of Catheters in Patients With Type 1 Diabetes Treated by Insulin Implanted Pumps

acronym: CATS

summary:
During this study, the investigators will perform a collection of biological and device samples (blood, catheters, insulin) in order to investigate the causes of catheter obstructions in patients with type 1 diabetes treated by implanted insulin pumps using intra-peritoneal delivery.

This multi-centre study is interventional with minimal constraints. After an inclusion visit, blood samples and an insulin sample from pump reservoir will be collected. During the following year, if a peritoneal catheter is blocked or changed, the explanted catheter and new blood and insulin samples will be collected for examination of the catheter obstruction and search for patient- or insulin-related reasons for obstructions.

In this study, 140 patients will be investigated.


title: Prevalence and Characteristics of Fabry Disease (FD) in Patients With Stroke or Small Fiber Neuropathy

acronym: FABRY

summary:
FD is pan-ethnic. Its reported annual incidence of 1 in 100,000 may underestimate the true prevalence of the disease. Indeed, recently, in addition with affected males FD developing a "classic" phenotype, " cardiac variant " and " renal variant " have been reported for FD patients with predominant or exclusive cardiac or renal involvement. " Neurologic variant " could exist.

Nervous system can be affect by FD leading to cerebrovascular diseases (ischemic or haemorrhagic strokes, TIA (Transient Ischemic Attacks) or peripheral neuropathy (acroparesthesias and pain).

Aims will be to determine the prevalence of Fabry disease in patients with stroke or small fiber neuropathy, and their characteristics

location_facility: CHU de Bicêtre, UNSIV (neurovascular stroke unit)


title: Anesthesia Management in Endovascular Therapy for Ischemic Stroke: A Multicenter Randomised Study

acronym: AMETIS

summary: Objective of the study: to assess whether pharmacological sedation or general anesthesia for treatment of anterior circulation ischemic stroke with endovascular mechanical thrombectomy is associated with difference in morbidity (neurological outcome and peri-procedural complications).

ReferenceCitation: Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum in: N Engl J Med. 2015 Jan 22;372(4):394.

ReferenceCitation: Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.

ReferenceCitation: Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.

ReferenceCitation: Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Román L, Serena J, Abilleira S, Ribó M, Millán M, Urra X, Cardona P, López-Cancio E, Tomasello A, Castaño C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Pérez M, Goyal M, Demchuk AM, von Kummer R, Gallofré M, Dávalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

ReferenceCitation: Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.

ReferenceCitation: Berkhemer OA, van den Berg LA, Fransen PS, Beumer D, Yoo AJ, Lingsma HF, Schonewille WJ, van den Berg R, Wermer MJ, Boiten J, Lycklama À Nijeholt GJ, Nederkoorn PJ, Hollmann MW, van Zwam WH, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW, Roos YB; MR CLEAN investigators. The effect of anesthetic management during intra-arterial therapy for acute stroke in MR CLEAN. Neurology. 2016 Aug 16;87(7):656-64. doi: 10.1212/WNL.0000000000002976. Epub 2016 Jul 15.

ReferenceCitation: Schönenberger S, Uhlmann L, Hacke W, Schieber S, Mundiyanapurath S, Purrucker JC, Nagel S, Klose C, Pfaff J, Bendszus M, Ringleb PA, Kieser M, Möhlenbruch MA, Bösel J. Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy: A Randomized Clinical Trial. JAMA. 2016 Nov 15;316(19):1986-1996. doi: 10.1001/jama.2016.16623. Erratum in: JAMA. 2017 Feb 7;317(5):538.

ReferenceCitation: Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; American Heart Association Stroke Council. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Oct;46(10):3020-35. doi: 10.1161/STR.0000000000000074. Epub 2015 Jun 29.

ReferenceCitation: Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7:CD013690. doi: 10.1002/14651858.CD013690.pub2. Review.

ReferenceCitation: Chabanne R, Begard M, Cazenave L, Pereira B. New paradigm shift in perioperative medicine: General anaesthesia finally better than procedural sedation for anterior circulation stroke thrombectomy? Anaesth Crit Care Pain Med. 2019 Dec;38(6):585-587. doi: 10.1016/j.accpm.2019.10.005.

ReferenceCitation: Chabanne R, Fernandez-Canal C, Degos V, Lukaszewicz AC, Velly L, Mrozek S, Perrigault PF, Molliex S, Tavernier B, Dahyot-Fizelier C, Verdonk F, Caumon E, Masgrau A, Begard M, Chabert E, Ferrier A, Jaber S, Bazin JE, Pereira B, Futier E; ANARLF Network and the AMETIS study group. Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol. BMJ Open. 2019 Sep 13;9(9):e027561. doi: 10.1136/bmjopen-2018-027561.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial

acronym: NO for LP

summary: Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot single-center study, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this multi-center trial is to confirm these results in a larger and more heterogeneous group of patients having a LP.

study_start_date_type: Anticipated


title: Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects

acronym: PEGASE

summary:
The aim of the study is to compare several parameters in three distinct groups of subjects: persons with obesity, persons with obesity and diabetes and persons with neither obesity nor diabetes:

the electrical activity in response to a sweet solution, measured before and after a standard meal, using gustatory evoked potentials (recording explained below)
blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin: measured in blood samples)
levels of activity and quantity of an enzyme present in the saliva, amylase, which is able to break down ingested starch into several molecules of glucose.

All of these parameters will be correlated to determine whether the results are different in the 3 groups of subjects in the study.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation

summary:
Cancer is a well known complication about long term transplantation. Cancer outcomes are due to the immunosuppressive treatment that prevents transplanted people from rejection. By lowering the effectiveness of the immune system, immune cells are no longer able to seek and destroy cancer cells.

The goal here is to study immunes cells population of people that were transplanted 10 years ago and are now treated either by a corticosteroid - azathioprine association, or only by cyclosporine A.


title: Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cheese Products in Elderly People

acronym: AlimaSSenSLait

summary:
The aim of this study is to understand how dairy products enriched in minerals and proteins are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and formation of the food bolus during the consumption of enriched cheese, that is to say the way in which the food is broken down to be swallowed.

The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4 months. These two sessions will allow investigators to characterise the chewing behaviour of the subjects and their salivation, and the structure of the food bolus formed when eating the four products of the project.

For each of the four foods in each session:

Two samples of saliva will be taken
A video will be made of subjects eating one of the study products
Subjects will chew the study foods and spit them out.


title: Evaluation of the Link Between the Characteristics of Oral Physiology and Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People Via a Modelling Approach.

summary:
The aim of this study is to understand how foods such as Sponge cake or Brioche are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and (i) formation of the food bolus during the consumption of Sponge cake or Brioche, that is to say the way in which the food is broken down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning the sensations that participant feel when they eat these products.

The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3 months. The first session will allow us to characterise the chewing behaviour of the subjects and their salivation, and will enable us to train them in the instructions for the following sessions. The 6 other sessions will allow us to study the structure of the food bolus while being formed and the mouthfeel of the foods in the project.

In the first session:

Two samples of saliva will be taken
A video will be made of subjects eating Sponge cake or Brioche
Subjects will be trained in exercises for the following sessions - this will consist in chewing the study foods and spitting them out on the experimenter's signal.

During the 6 other sessions, subjects will be asked to:

Chew one of the study foods and spit it out on the signal of the experimenter.
Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different questions. This test will be done during 4 of the 6 sessions.


title: Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects

summary:
Risperidone at low dosage is often used as treatment of acute anxiety symptom. However, patients may be either responder or not. Here we hypothesized that the early response to a low dose of risperidone is predictive to risperidone efficiency.

Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone prescription would be proposed to be enrolled in the study. A check-up is made at D0, then the subjects begin the treatment (0.5mg risperidone). The same check-up is carried out on the following day (D1). The subjects fulfil a last check-up 12 week after the beginning of treatment (W12). During the D1-W12, the psychiatrist may changes the treatment.

lead_sponsor: Marion Trousselard


title: Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016

acronym: ABC-NEO

summary:
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas cord blood were introduced in our maternity ward.

The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main factors including second line strategy introduction, systematic umbilical cord acid-base implementation and improvement in antenatal risk factor screening for asphyxia. The investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was improved with systematic early after birth EEG evaluation, allowing early treatment and surveillance.

location_facility: Department of obstetrics, Femme Mère Enfant Hospital


title: An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder

acronym: PREDICTage

summary: The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins.

acronym: VARIABLE

summary:
The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning intervention. It allows a long-term treatment of this arrhythmia with a success rate of about 80%. There are, nevertheless, some recidivism.

Risk factors for recidivism are poorly codified and need further research. Indeed the identification of factors of poor prognosis could lead to not propose this procedure to the patients who present them and at least to inform them of an increased risk of failure.

To date, aortic stiffness has not been studied in the context of assessing the risk factors for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic dysfunction and increased left atrial size. That may constitute a substrate for FA recurrence.

In the literature, aortic stiffness can be measured in several ways:

Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner or transesophageal Echography (ETO).
Measuring of the Pulse Wave Velocity.
Measurement of aortic calcifications.

The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA 6 months after ablation procedure performed in the Croix-Rousse cardiology's department.

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


title: Prospective Clinical Trial to Assess the Performance of a Cyto-selective Cryotherapye "CRYOBEAUTY MAINS ET DECOLLETE" Compared With Liquid Nitrogen Cryotherapy in the Treatment of Solar Lentigines in 30 Patients

summary:
This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines.

The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices:

CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.
Liquid nitrogen is a comparator device.

lead_sponsor: Cryobeauty


title: Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).

acronym: IMMUNONIVO

summary: This is an open bi-centric prospective non-randomized study in patients with metastatic melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and identify the differences between responder and non-responder patients.

location_facility: Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)


title: Study on Communication Comprehension in the Schizophrenic Spectrum

acronym: SKYPROVERB

summary: The purpose of the present study is to evaluate the effect of emotional prosody on the perception of emotional discourse in the schizophrenic spectrum. The investigators hypothesize that participant may use emotional prosody as an emotional cue to understand the emotional content of discourse.

ReferenceType: result

ReferenceCitation: Brazo P, Beaucousin V, Lecardeur L, Razafimandimby A, Dollfus S. Social cognition in schizophrenic patients: the effect of semantic content and emotional prosody in the comprehension of emotional discourse. Front Psychiatry. 2014 Sep 10;5:120. doi: 10.3389/fpsyt.2014.00120. eCollection 2014.

ReferenceCitation: Edwards J, Jackson HJ, Pattison PE. Emotion recognition via facial expression and affective prosody in schizophrenia: a methodological review. Clin Psychol Rev. 2002 Jul;22(6):789-832. Review. Erratum in: Clin Psychol Rev. 2002 Nov;22(8):1267-85.

ReferenceCitation: Beaucousin V, Lacheret A, Turbelin MR, Morel M, Mazoyer B, Tzourio-Mazoyer N. FMRI study of emotional speech comprehension. Cereb Cortex. 2007 Feb;17(2):339-52. Epub 2006 Mar 8.

lead_sponsor: Centre Hospitalier René Dubos


title: Acute Pain Memory Among Former Burned: Exploration of Functional Magnetic Resonance Imaging (fMRI).

acronym: EXPLO-DMA

summary: Pain is complex phenomenon misunderstood in spite of medical progress and neurosciences. That's why the relief of chronic pain is only partial for a lot of infection as arthrosis, chronic back pain, headaches or neuropathic pain. Certain situations bring to relive pain sensation. Investigators were interested to former burned. They wonder about somatic memory and unconscious of acute.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Brain Plasticity in Stroke Patients : Functional and Anatomical Connectivty

acronym: MAPPY

summary: The investigators believe that the initial cerebral connectivity as well as its evolution immediate post-stroke could be correlated to the amount of motor recovery. Therefore a cohort of 21 people early post-stroke, and 6 weeks post standard routine rehabilitation will be analyzed. Clinical, kinematic and imaging (MRI) data will be compared with 12 healthy controls. Kinematic movement information has been collected within the fMRI. By integrating multi-modal clinical, kinematic and MRI, the study aims to identify biomarkers of recovery to improve patient specific evaluation post-stroke in order to adapt rehabilitation protocols accordingly and to improve functional gain.