title: Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment

acronym: VALS

summary:
Assessment of the effect of spa treatment on the functional severity of arthrosis.

Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment.

Primary outcome measure:

Measuring the effect of spa treatment on functional severity of arthrosis

Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference)

Secondary outcome measures

Quantitative evaluation of pain

Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after

Quantitative evaluation of WOMAC

Comparison of mean WOMAC between enrollment and 6 months after

Impact of spa treatment on the patient's metabolism

Height and Weight (BMI calculation)
Blood pressure
Heart rate

Quality of life

36-Item Short Form (SF36) at enrollment, 3 months and 6 months
EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months

Opinion of doctor and patient

Semi-quantitative scale collected at enrollment, 3 months and 6 months
Treatment follow-up

Self-evaluation of pain

Self-evaluation of pain with VAS pain scale every 6 week

ReferenceCitation: Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8.

ReferenceCitation: Constant F, Collin JF, Guillemin F, Boulangé M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.

ReferenceCitation: Elkayam O, Ophir J, Brener S, Paran D, Wigler I, Efron D, Even-Paz Z, Politi Y, Yaron M. Immediate and delayed effects of treatment at the Dead Sea in patients with psoriatic arthritis. Rheumatol Int. 2000;19(3):77-82.

ReferenceCitation: Franke A, Reiner L, Pratzel HG, Franke T, Resch KL. Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up. Rheumatology (Oxford). 2000 Aug;39(8):894-902.

ReferenceCitation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31.

ReferenceCitation: Konrad K, Tatrai T, Hunka A, Vereckei E, Korondi I. Controlled trial of balneotherapy in treatment of low back pain. Ann Rheum Dis. 1992 Jun;51(6):820-2.

ReferenceCitation: Leplège A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23.

ReferenceCitation: Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9.

ReferenceCitation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005 Jan;64(1):34-7. Epub 2004 May 6.

ReferenceCitation: van Tubergen A, Landewé R, van der Heijde D, Hidding A, Wolter N, Asscher M, Falkenbach A, Genth E, Thè HG, van der Linden S. Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2001 Oct;45(5):430-8.

ReferenceCitation: Van Tubergen A, Boonen A, Landewé R, Rutten-Van Mölken M, Van Der Heijde D, Hidding A, Van Der Linden S. Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2002 Oct 15;47(5):459-67.

ReferenceCitation: Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Knipschild PG. Balneotherapy for rheumatoid arthritis and osteoarthritis. Cochrane Database Syst Rev. 2000;(2):CD000518. Review. Update in: Cochrane Database Syst Rev. 2003;(4):CD000518.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

lead_sponsor: Le Syndicat Intercommunal pour le Thermalisme et l'Environnement


title: Interest of Concentrations in Meconium of Drugs Used for Treatment of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Abstinence Syndrome

acronym: SUBOPGEST

summary: The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Caen

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Corticospinal and Neuromuscular Plasticity Induced by Real and Imaginary Contractions.

summary: Physical activity is considered a therapeutic strategy in its own right in a vast majority of disabling chronic disorders. It leads to an increase in physical and probably cognitive capacity, thanks to its effects on both metabolism (muscle hypertrophy, improvement in oxidative metabolism) and the nervous system (neuroplasticity). Nonetheless, even though there is a consensus on the positive effects of physical exercise (PE) on cerebral plasticity, the physiological mechanisms by which PE affects neuroplasticity, in particular depending on the mode of muscle contraction, are still hypothetical. Moreover, several recent studies have shown that mental learning (ML) by motor imagery improves motor performance, thus making it of interest in a context of rehabilitation, in particular in situations where PE is transient of definitively impossible. Yet, the mechanisms and brain structures involved in motor learning by ML have not been established so far. Finally, on the basis of clinical observations concerning the key role of sensory input in motor function, the hypothesis that increased demand on this input by electrical stimulation (ES) as a means to improve motor function has been proposed. However, the mechanisms by which this type of stimulation could induce neuroplasticity is still to be elucidated.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Other

status_simplified: Ongoing


title: Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration

acronym: PRIMA FS

summary: In this study, the principle functionality of the device will be tested in humans for the first time. The study will evaluate the extent to which patients with atrophic dry age related macular degeneration (AMD) have evoked light perception using the implant.

status: Active, not recruiting

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Palanker D, Le Mer Y, Mohand-Said S, Sahel JA. Simultaneous perception of prosthetic and natural vision in AMD patients. Nat Commun. 2022 Jan 26;13(1):513. doi: 10.1038/s41467-022-28125-x.

ReferenceCitation: Palanker D, Le Mer Y, Mohand-Said S, Muqit M, Sahel JA. Photovoltaic Restoration of Central Vision in Atrophic Age-Related Macular Degeneration. Ophthalmology. 2020 Aug;127(8):1097-1104. doi: 10.1016/j.ophtha.2020.02.024. Epub 2020 Feb 25.

ipd_sharing: No

lead_sponsor: Pixium Vision SA

location_facility: Fondation Ophtalmologique A. De Rothschild/ Hopital des Quinze Vingts/

intervention_type: Device

lead_sponsor_type: industriel


title: Retrospective and Prospective Observational Study of MRI Changes in Bone and Visceral Lesions of Patients With Type 1 Gaucher Disease Treated With VPRIV® (Velaglucerase Alfa)

acronym: EIROS

summary:
This study with standardized reading MRIs, will provide for the first time objective and quantified data on organomegaly (liver and spleen volumes) as well as bone alteration (Bone Marrow Burden11) of French patients treated with VPRIV®. These data will help to better assess the impact of this treatment on these parameters.

The result of this study will also answer in part to the request of the French Transparency Commission (CT: Commission de Transparence) of the French National Health Authority to provide them with data of French patients treated with VPRIV®.

time_perspective: Cross-Sectional

lead_sponsor: CEN Biotech


title: Post Traumatic Stress Disorder (PTSD): Benefits of Diving Practice on Patient Quality of Life

acronym: Dive-Hope

summary: within the components of Scuba diving there are similarities with meditation and mindfulness techniques. PTSD and emotion dysregulation are known to be involved by meditation training This study evaluates the benefits of scuba diving on quality of life and mindful functioning comparing the benefits of diving training using a clinical trial protocol

design_allocation: Randomized

ipd_sharing: Undecided

lead_sponsor: Marion Trousselard

intervention_type: Behavioral


title: Comparison of Two Strategies for the Prevention of Endotracheal Tube Cuff Underinflation During Invasive Mechanical Ventilation: Intermittent Versus Continuous Cuff Pressure Control - A Randomised Controlled Study

acronym: CONTIPRESS

summary: During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.

ReferenceCitation: Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, Lakhal K. Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study. Anaesth Crit Care Pain Med. 2020 Jun;39(3):435-441. doi: 10.1016/j.accpm.2020.04.007. Epub 2020 May 4.

lead_sponsor: Nantes University Hospital


title: Phase II Randomized Trial Comparating Two Concomitant Administration of Radiotherapy With Cisplatin in Patients With Not Operated or Inoperable HNSCC or With Recurrence High Risk in Adjuvant Postoperative Treatment

acronym: CisFRad

summary: The general aim is to compare the cumulative dose of cisplatin administered concomitantly with radiotherapy in reference arm A (cisplatin 100 mg / m2 day 1 every 21 days) and in the experimental arm B (Cisplatin split 25 mg / m2 / J D1 to D4 all 21 days).

ipd_sharing: Yes

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

intervention_type: Radiation


title: Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child

acronym: ASTS

summary:
The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis.

The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

ReferenceType: background

ReferenceCitation: Noordeen HM, Shah SA, Elsebaie HB, Garrido E, Farooq N, Al-Mukhtar M. In vivo distraction force and length measurements of growing rods: which factors influence the ability to lengthen? Spine (Phila Pa 1976). 2011 Dec 15;36(26):2299-303. doi: 10.1097/BRS.0b013e31821b8e16. Erratum in: Spine (Phila Pa 1976). 2012 Mar 1;37(5):432. Al Mukhtar, Mohannad [corrected to Al-Mukhtar, Mohannad].

ReferenceCitation: Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12.

ReferenceCitation: Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003 Nov-Dec;3(6):329-41.

ReferenceCitation: Akbarnia BA, Marks DS, Boachie-Adjei O, Thompson AG, Asher MA. Dual growing rod technique for the treatment of progressive early-onset scoliosis: a multicenter study. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S46-57.

ReferenceCitation: Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H, Boachie-Adjei O, Karlin LI, Canale S, Poe-Kochert C, Skaggs DL. Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am. 2010 Nov 3;92(15):2533-43. doi: 10.2106/JBJS.I.01471. Epub 2010 Oct 1.

ReferenceCitation: Lucas G, Bollini G, Jouve JL, de Gauzy JS, Accadbled F, Lascombes P, Journeau P, Karger C, Mallet JF, Neagoe P, Cottalorda J, De Billy B, Langlais J, Herbaux B, Fron D, Violas P. Complications in pediatric spine surgery using the vertical expandable prosthetic titanium rib: the French experience. Spine (Phila Pa 1976). 2013 Dec 1;38(25):E1589-99. doi: 10.1097/BRS.0000000000000014.

ReferenceCitation: Krieg AH, Speth BM, Foster BK. Leg lengthening with a motorized nail in adolescents : an alternative to external fixators? Clin Orthop Relat Res. 2008 Jan;466(1):189-97. doi: 10.1007/s11999-007-0040-3. Epub 2008 Jan 3.

ReferenceCitation: Baumgart R. The reverse planning method for lengthening of the lower limb using a straight intramedullary nail with or without deformity correction. A new method. Oper Orthop Traumatol. 2009 Jun;21(2):221-33. doi: 10.1007/s00064-009-1709-4.

ReferenceCitation: den Uil CA, Bezemer R, Miranda DR, Ince C, Lagrand WK, Hartman M, Bogers AJ, Spronk PE, Simoons ML. Intra-operative assessment of human pulmonary alveoli in vivo using Sidestream Dark Field imaging: a feasibility study. Med Sci Monit. 2009 Oct;15(10):MT137-141.

ReferenceCitation: Kanter KR, Haggerty CM, Restrepo M, de Zelicourt DA, Rossignac J, Parks WJ, Yoganathan AP. Preliminary clinical experience with a bifurcated Y-graft Fontan procedure--a feasibility study. J Thorac Cardiovasc Surg. 2012 Aug;144(2):383-9. doi: 10.1016/j.jtcvs.2012.05.015. Epub 2012 Jun 13.

ReferenceCitation: Kerimaa P, Ojala R, Sinikumpu JJ, Hyvönen P, Korhonen J, Markkanen P, Tervonen O, Sequeiros RB. MRI-guided percutaneous retrograde drilling of osteochondritis dissecans of the talus: a feasibility study. Eur Radiol. 2014 Jul;24(7):1572-6. doi: 10.1007/s00330-014-3161-6. Epub 2014 Apr 17.

ReferenceCitation: Flynn JM, Emans JB, Smith JT, Betz RR, Deeney VF, Patel NM, Campbell RM. VEPTR to treat nonsyndromic congenital scoliosis: a multicenter, mid-term follow-up study. J Pediatr Orthop. 2013 Oct-Nov;33(7):679-84. doi: 10.1097/BPO.0b013e31829d55a2.

lead_sponsor: University Hospital, Toulouse


title: Risk Factors for Complicated Grief After a Death From Cancer or an Other Cause: A Longitudinal and Prospective Study Among Children and Their Parents

acronym: CAPS

summary: The purpose of this study is to identify risk factors of Complicated Grief (CG) among children and adolescents who lost a parent to cancer or from an other cause.

design_allocation: Non-Randomized

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Revet A, Suc A, Auriol F, Djelantik AAAMJ, Raynaud JP, Bui E. Peritraumatic distress predicts prolonged grief disorder symptom severity after the death of a parent in children and adolescents. Eur J Psychotraumatol. 2021 Jun 28;12(1):1936916. doi: 10.1080/20008198.2021.1936916. eCollection 2021.

location_facility: Psychiatrie de l'enfant et de l'adolescent


title: Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane

acronym: PROCATMER

summary: The prevalence of idiopathic epiretinal membranes (ERM) in people over 50 is estimated at 6 to 19%. Even though most cases show very few symptomats, they may induce alterations of the underlying retina and lead to visual impairment likely to greatly diminish quality of life in patients. Thanks to the ever-improving quality of vitreo-retinal surgery, ablation of these membranes is a frequent and safe procedure allowing a functional gain in the majority of cases. Given the increasing prevalence in the population concerned and the accelerated ageing of the lens after vitrectomy, cataract surgery is often associated with removal of the membrane. On the basis of a study in 142 patients, it was possible to identify clinical and morphological prognostic factors and to inclure them in a score to assess the chances of complete functional recovery at one year following the procedure . Age of the patient, the duration of symptoms, initial visual acuity and the quality of the junction between external and internal segments of photoreceptors in optic coherence tomography (OCT) appeared as significantly related to visual results. Using this score in a new prospective cohort would allow the investigators to make it a reliable and easy-to-use tool at the service of ophthalmologist surgeons and their patients and would provide scientific confirmation of the interest of earlier surgery in this disease. It would also allow the investigators to define in a validated and reproducible manner, a threshold for an ndication for ERM surgery, which is currently based on relatively subjective criteria mostly related to visual acuity.


title: Neuro-Orthopedic Registry of the University Hospital of Toulouse

summary: Neuro-orthopedics corresponds to the evaluation and therapeutic management of the orthopedic consequences of damage to the central or peripheral nervous system. In case of neurological impairment, there may be joint, motor, sensory and cognitive impairments that limit the patient's activities. The management of these orthopedic problems falls within the specific framework of neuro-orthopedics because in the presence of neurological, problems are different and more complex than in classical orthopedics. In this context, a well-conducted evaluation is a prerequisite for appropriate treatment.


type: Other Identifier

title: Evaluation of Peripheral Intravenous Catheter and Urinary Catheters Present on Admission to the "Maladies Infectieuses aiguës" Department.

summary:
A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to MIA with an intravenous and/or a urinary catheter.

the investigators analyzed:

the demographic characteristics of the patient
the final diagnosis
the patient's severity and the patient outcome after discharge from MIA
the justification of the venous and or a urinary catheter
the duration of the prescription of the device Evaluation on admission of the need to maintain an intravenous or urinary catheter. Adjusting the prescription in terms of duration or withdrawal of the device in order to limit their complications (lymphangitis, superficial thrombophlebitis, bacteremia related to health care, urinary tract infection).

Hypothesis:

Limit the length of stay and reduce the cost of hospitalization.

status: Unknown status

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

status_simplified: Unknown


title: Effects of Variation of Sodium Dialysate in ICU Acute Kiney Injury

acronym: NADIRA

summary: Intermittent hemodialysis/diafiltration is a current renal replacement therapy (RRT) institued for ICU patients with AKI. For a better clinical tolerance, iinternational guidelines advise to use cold dialysate, increase duration session, decrease blood and dialysate flows, and increase level of sodium dialysate concentration (≥ 145mmol/l). Indeed, the use of a Na concentration dialysate > 145 mmol/l improves intradialytic hemodynamic tolerance but it may also induce fluid overload by the transfert of sodium from the dialysate compartment to the blood. Yet, fluid overload has been strongly associated with mortality in critically ills. The investigators hypothesized that the use of a level in sodium dialysate at 140 mmol/l with slow low efficiency daily dialysis-filtration (SLEDD-f) will permit a fair intradialytic hemodynamic tolerance without the adverse effect of intradiaclytic Na loading from the dialysate. Two randomized groups of ICU AKI patients treated by SLEDD-f will be compared in terms of intradialytic hemodynamic tolerance and overload accordong to 140 or 145 mmol/l of Na in the dialysate

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Drug


title: A Prospective, Multicenter, Randomized,Controlled Study to Compare the Safety and Performance of Cellular Matrix Device (Combination of Autologous Platelet-rich Plasma and Non-crosslinked Hyaluronic Acid) to Those of Synvisc-One (Crosslinked Hyaluronic Acid) for the Treatment of Mild to Moderate Knee Osteoarthritis

summary: This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to moderate knee osteoarthritis (particularly pain on walking) compared to hyaluronic acid only (Synvisc®-One).

lead_sponsor: Regen Lab SA


intervention_type: Biological

title: Safety and Efficacy of a Unilateral Subretinal Administration of HORA-PDE6B in Patients With Retinitis Pigmentosa Harbouring Mutations in the PDE6B Gene Leading to a Defect in PDE6ß Expression

lead_sponsor: Coave Therapeutics

type: EudraCT Number

source: euctr

ReferenceCitation: Petit L, Lhériteau E, Weber M, Le Meur G, Deschamps JY, Provost N, Mendes-Madeira A, Libeau L, Guihal C, Colle MA, Moullier P, Rolling F. Restoration of vision in the pde6β-deficient dog, a large animal model of rod-cone dystrophy. Mol Ther. 2012 Nov;20(11):2019-30. doi: 10.1038/mt.2012.134. Epub 2012 Jul 24.

ReferenceCitation: Pichard V, Provost N, Mendes-Madeira A, Libeau L, Hulin P, Tshilenge KT, Biget M, Ameline B, Deschamps JY, Weber M, Le Meur G, Colle MA, Moullier P, Rolling F. AAV-mediated Gene Therapy Halts Retinal Degeneration in PDE6β-deficient Dogs. Mol Ther. 2016 May;24(5):867-76. doi: 10.1038/mt.2016.37. Epub 2016 Feb 9.

ReferenceCitation: Palmowski-Wolfe A, Stingl K, Habibi I, Schorderet D, Tran HV. Novel PDE6B Mutation Presenting with Retinitis Pigmentosa - A Case Series of Three Patients. Klin Monbl Augenheilkd. 2019 Apr;236(4):562-567. doi: 10.1055/a-0811-5480. Epub 2019 Jan 15.

summary: The study is a Phase I/II, monocentric, open-label, dose-ranging safety and efficacy gene therapy intervention by subretinal administration of AAV2/5-hPDE6B. At least twelve patients 18 years of age or older, within four consecutive cohorts of patients, will be recruited.


title: Evolution of Dark Ideas When Introducing or Switching an Antidepressant: Hetero-evaluation and Use of a Smartphone Application in the Monitoring of Depression

acronym: DEPASSE

summary: Depression is a frequent disease and a serious public health problem, of which suicide is the most severe complication. Its treatment is based on the introduction of antidepressant which not only proposes a significant delay in the relief of symptoms but also by the phenomenon of lifting of inhibition can increase the suicidal risk during the initiation phase. Therefore there is a major interest in proposing a monitoring of these dark and suicidal ideas, immediately after the implementation of such treatment as well as other symptoms of depression. Thus, the aim of this study is to identify the mechanisms underlying this increase in dark and suicidal ideas in this context.

status: Terminated


title: Description of the Interdigitation Retinal Area by SD-OCT (Spectral Domain Optical Coherence Tomography): An Exploratory Study (ODIGIT)

acronym: ODIGIT

summary: Improvement of retinal medical imaging opens new perspectives for exploring the retinal structures. Optical coherence spectral domain (SD-OCT), which has been widely used in the last ten years, is certainly the most advanced device. In the analysis of patients without retinal disease using SD-OCT, granulations in the interdigitation area were observed. These granulations have never been described with this device. They could correspond either to the degradation products of the external segments of the photoreceptors or to melanosomes. A descriptive study of these granulations at different examination times and in different lighting situations would allow us to obtain essential information for a better understanding of this area. Based on the results, larger studies could explore this area more finely in retinal pathologies involving dysfunctions of photoreceptors or of the pigmentary epithelium.

primary_purpose: Basic Science

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Determination of Coronary Flow Reserve by Dynamic Myocardial Perfusion Scintigraphy

acronym: ERCAD

summary: Because of its availability, non-invasiveness, and high diagnostic performance, myocardial perfusion tomoscintigraphy has become a standard tool for the detection, characterization and monitoring of coronary artery disease. Standard analysis, based on the reversibility of regional myocardial hypoperfusion between stress (physiological or pharmacological) and rest, has good sensitivity and negative predictive value in the search for myocardial ischemia. However, two major obstacles persist. First, because of the relative nature of the normalization of cardiac activity, this approach may underestimate the extent of the damage, especially when the territory with the most activity is itself pathological. Thus myocardial perfusion scintigraphy can only detect 40 to 50% of tri-truncal patients. To overcome these disadvantages, several indexes have been proposed to improve the diagnostic performance of perfusion scintigraphy in multi-truncal patients based in particular on kinetic analysis. Secondly, the review does not provide any guarantee as to the quality and reproducibility of use of the coronal reserve during stress, in particular during submaximal stress tests and pharmacological stress, the latter being easily antagonized by xanthine derivatives contained in tea and coffee in particular (abstinence of at least 12 to 24 hours being recommended). In recent years and thanks to the advent of CZT semiconductor cameras dedicated to cardiology - to perform a dynamic tomographic acquisition - a study of the coronal reserve is feasible by perfusion tomoscintigraphy in current practice. This study of the coronary reserve mainly consists of a computer post-processing of the myocardial perfusion scintigraphy data and does not therefore require any additional irradiation (the only difference with respect to the old protocols is the start of the images at the time of publication. injection of the radiotracer). However, the diagnostic benefit gained from the coronary reserve study compared to conventional stress / rest perfusion scintigraphy has not been clearly studied, particularly in the multi-truncal patients.

lead_sponsor: Hospices Civils de Lyon

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


title: Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery

acronym: FAMOUS

summary: This study aims to describe the effects of sleeve gastrectomy, the most commonly performed bariatric procedure worldwide, on functional capacity, habitual physical activity, physical fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese subjects undergoing bariatric surgery. Functional capacity, physical activity, physical fitness and gait parameters will be objectively assessed and compared among candidates seeking sleeve gastrectomy and 6 months after sleeve gastrectomy.

ReferenceCitation: Bellicha A, Giroux C, Ciangura C, Menoux D, Thoumie P, Oppert JM, Portero P. Vertical Jump on a Force Plate for Assessing Muscle Strength and Power in Women With Severe Obesity: Reliability, Validity, and Relations With Body Composition. J Strength Cond Res. 2022 Jan 1;36(1):75-81. doi: 10.1519/JSC.0000000000003432.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study

summary:
Localized cutaneous squamous cell carcinoma (CSCC) is usually treated by radical surgery with or without radiotherapy. The cure rate is high around 90% of cases (1). Unresectable CSCC represents less than 10% of all CSCC. The prognosis of these advanced forms is poor, without any proven treatment option. The number of studies investigating systemic treatment of advanced or metastatic CSCC is limited, mostly based on phase II trials or case reports. Systemic treatment includes cytotoxic chemotherapy such as cisplatin and 5-Fluoro-uracil (5FU), immunotherapy (interferon alpha) or retinoic acid (13CRa) (1,2). Recently, epidermal growth factor receptor (EGFR) targeting agents have been explored (1,2). The anti-EGFR monoclonal antibody Cetuximab has shown some clinical efficacy in advanced CSCC alone or concomitant with radiotherapy or chemotherapy (3-5). A recent phase II study aimed at investigating the role of Cetuximab in 36 patients with unresectable CSCC (6). The authors reported a disease control rate at 6 weeks of 69% (95% CI, 52% to 84%). The best responses were eight partial responses and two complete responses. There were no Cetuximab-related deaths. There were three related serious adverse events: two grade 4 infusion reactions and one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients and was associated with prolonged Progression Free Survival (PFS) (6). The authors concluded that regarding the Cetuximab therapeutic index it could be interesting in this particular situation mainly for elderly patient. Unfortunately, the small number of patient included not allowed to draw definitive conclusion. It was interesting to note that the Disease rate control (DRC) with Cetuximab increased of 15% comparatively of DRC with chemotherapy. Additionally it seems that in case of efficacy the functional improvement of Cetuximab-sensitive patients occurred after very few infusions.

Taking these data together it seemed logical to design a larger retrospective clinical trial to confirm these results in "real life patients".

time_perspective: Retrospective

lead_sponsor: Centre Antoine Lacassagne


title: Barriers and Facilitators to a Home-based Cycling Program Tailored to Patients' Preferences in Lumbar Spinal Stenosis Using Connected Ergometric Bicycles: a 3-month Open Pilot Study

acronym: FLEXCAL Pilot

summary: The purpose of this study is to determine whether a home-based cycling program for patients with lumbar spinal stenosis is a feasible and acceptable

ReferenceCitation: Pauwels C, Roren A, Gautier A, Linières J, Rannou F, Poiraudeau S, Nguyen C. Home-based cycling program tailored to older people with lumbar spinal stenosis: Barriers and facilitators. Ann Phys Rehabil Med. 2018 May;61(3):144-150. doi: 10.1016/j.rehab.2018.02.005. Epub 2018 Feb 27.

location_facility: Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis


title: Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients

summary:
Introduction: Nearly 1% of the population is currently treated with long-term corticosteroid therapy. When corticosteroids are introduced, patient information concerning the adverse effects and the modalities of prevention by the lifestyle changes is usually proposed. However, studies have shown an imperfect acquisition of this information about treatment and prevention of adverse effects, as well as a difficult implementation on diet and physical activity advices. In this study, the investigators aimed to evaluate the difficulties encountered by patients with dietary advice in the context of long-term corticosteroids use in order to optimize care, drug adherence and the quality of life of patients.

Methods: the investigators will recruite adult patients from general medicine and rheumatology practice and treated by long-term corticosteroids (≥ 3 months, ≥ 5mg/day). the investigators will perform a qualitative analysis in a semi-directed interview.


title: A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System

summary:
Anxiety is an emotional disorder. It's a painful concern caused by uncertainty. It is a complex phenomenon misunderstood in spite of medical progress. Relaxation is a technical for reduce anxiety and is effective and safe. Previous study demonstrated the impact of session relaxation on the autonomous nervous system by the heart rate variability.

Primary objective of this new study is to demonstrate a link between heart rate variability and reduced anxiety during relaxation session.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of a Training in Therapeutic Education on the Relation Between Care Givers and Their Patients

acronym: METIS

summary:
This study aims to describe the impact of a training in therapeutic education on the relation between a caregiver and his/her patients.

Subjects are recruited among health professionals attending a training in therapeutic education. Then they are asked to identify up to 5 of their patients to be contacted by the researcher for an interview.

Individual semi-structured interviews are conducted with 20 duo "caregivers / patients" before the training, 1 month and 6 months after the training.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. An Open, Randomised, Multicentre Study Versus Artificial Sphincter.

acronym: PROSPECT

summary:
Few surgical methods to treat male stress urinary incontinence have been assessed in comparative, randomised interventional studies.

Ustrap is a new adjustable-pressure 4-arm device. The artificial sphincter is currently considered the gold standard device in this field.

The aim of this randomised prospective international study is to assess the efficacy and safety of the Ustrap® device comparatively with an artificial sphincter (AMS800) in the treatment of stress urinary incontinence following prostate removal in cancer patients.

ReferenceCitation: Herschorn S, Bruschini H, Comiter C, Grise P, Hanus T, Kirschner-Hermanns R, Abrams P; Committee of the International Consultation on Incontinence. Surgical treatment of stress incontinence in men. Neurourol Urodyn. 2010;29(1):179-90. doi: 10.1002/nau.20844. Review.

lead_sponsor: Quanta Medical


title: Impact of Cognitive, Psychological and Psychiatric Factors in Pathogenesis of Diabetic Foot and Recurrence : Study in Diabetic Patients

acronym: Diapepsy

summary:
It is estimated that approximately 20-25% of diabetic patients will have at least one trophic disorder during their period. The appearance of a trophic disorder in a diabetic patient is a serious complication, indicating that diabetes is often complicated. The consequences are serious for the patient with an impairment of his quality of life, but also for society with a high cost in terms of health care costs.

It should also be noted that diabetes remains the main cause of non-traumatic amputation in most developed countries, with amputation often preceded by a trophic disorder. In addition, 20% of amputees are re-amputated at least once a year. Thus, the consequences of diabetic foot injuries are important in human, social and health terms and are the subject of increased health care spending.

Many studies have shown that diabetes is a risk factor for dementia, whether it is Alzheimer's disease, Alzheimer's disease or the vascular component or pure vascular dementia.

However, an understanding of the cognitive mechanisms involved in the management of diabetes and in particular in the diabetic foot and its recurrence remains partial and no study has integrated the severity of the risk of the foot (evaluated by the podological risk) Specific implication of some Cognitive abilities, especially in relation to episodic memory, and social cognition integrating decision-making abilities. These specific disorders could have a major impact in diabetes follow-up, therapeutic adherence and the risk of developing recurrent trophic disorders.

Thus, the coexistence of diabetes with a mental pathology makes the management of the subject more complex and exposes it to more complications.

In the management of chronic diabetic disease, adherence to treatment is essential. It is therefore important to detect the specific effects of this type of personality on the prognosis of diabetes and the appearance of foot wounds.


title: Validation of End-tidal CO2 for Transplumonary Blood Flow Monitoring During PVA-ECMO

acronym: CAPNOECMO

summary: Cardiogenic shock, the most severe form of acute heart failure, is a critical situation where the body cells lack of oxygen because of cardiac dysfunction. The failure of pharmacological therapy to maintain adequate perfusion has led to attempts to improve the circulation by the use of mechanical circulatory support devices. Peripheral veno-arterial support (PVA-ECMO) is the most frequently used device. It consists of extracorporeal circulatory support. Venous blood is aspirated via the right atrium and reinjected into the descending aorta via the femoral artery. As a consequence of this by-pass, pulmonary artery flow and residual left ventricle ejection can fall drastically until zero in the most severe patients. A minimal transpulmonary blood flow is crucial to avoid left heart cavities and pulmonary artery and left heart cavities thrombosis. The gold standard technique to monitor transpulmonary blood flow is right-heart cavities catheterism (Swan-Ganz catheter) but it represents major limits: invasive technique, limited duration of utilization because of septic risk, physical limit of flow measurement (under 1 liter/minute). End-tidal pressure carbon dioxide (Pet CO2) monitoring (or capnography) is a routine and non-invasive measure in ventilated patients. Previous studies have shown that changes in PetCO2 can measure changes in cardiac output in anesthetized patients and that PetCO2 is a useful index of pulmonary artery blood flow during separation from cardiopulmonary bypass. The aim of this study is to demonstrate that PetCO2 is correlated to transpulmonary blood flow in patients under PVA-ECMO and that exhaled CO2 can provide an on-line, continuous, and noninvasive monitor of residual outflow from the heart during PVA-ECMO.

ReferenceCitation: Mourad M, Eliet J, Zeroual N, Saour M, Sentenac P, Manna F, Molinari N, Gandet T, Colson PH, Gaudard P. Pulse pressure and end-tidal carbon dioxide for monitoring low native cardiac output during veno-arterial ECLS: a prospective observational study. Crit Care. 2020 Sep 22;24(1):569. doi: 10.1186/s13054-020-03280-z.

ipd_sharing_description: unkown


title: Influence of the Modulation of the Posterior Parietal Cortex (rTMS) on a Pointing Movement With the Paretic Upper Limb After Stroke

acronym: PPCstim

summary:
This study evaluates the effect of a unique session of inhibitory rTMS (cTBS) over the contralesional posterio parietal cortex (PPC) on the spatio-temporal parameters of a pointing movement performed by stroke patients with their paretic upper limb. It will also assess the effects on the resting motor threshold of both hemispheres and on parietopremotor connectivity.

To achieve theses aims, the real cTBS stimulation will be randomly counterbalanced with a SHAM stimulation (in a second session) in a crossover design. Assessments will be performed before and after each stimulation session.

lead_sponsor: University Hospital, Lille


title: Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy Volunteers

summary:
the main objectives are

to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and
to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients.

The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.


title: Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability

summary:
Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.

High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.

To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.

The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.

This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.

study_start_date_type: Anticipated

lead_sponsor: CHU de Reims


title: Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims

acronym: SUIVIPROCHE

summary: Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.


title: Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited

acronym: DGP-CeliacDis

summary:
Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small bowel mucosa, triggered by the ingestion of gluten-containing grains.

The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper endoscopy. Since 1990, the availability of serological tests has contributed to a different perception of the disease. Serological testing is now considered fundamental for celiac disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and anti-reticulin antibodies. Recently, several studies showed that deamidated products of gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced into the wide spectrum of serological tests for celiac disease.


title: Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients

summary: Bullous pemphigoid affects mainly elderly patients. It is often associated with neurologic disorders, which represent a major risk factor of the disease


title: Impact of Nuclear Quality of Human Sperm on Embryonic Development Kinetics Evaluated by Time Lapse Primovision®

acronym: PRIMOSPERMO

summary: To date, none study shows the impact of human spermatozoa nuclear alteration on embryonic development kinetic with morpho-kinetics tools. In this study, Investigator analyze the possible influence of sperm nuclear quality on embryonic development kinetics. Moreover, Investigator will evaluate possible new sperm biomarkers and try to better understand the pathophysiology of male infertility.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test


title: Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography

acronym: NERVWATCH

summary: The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Molecular Characterization of Primary Mucosal Melanoma

acronym: MELMUQ

summary:
Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. " The identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with MPM.

The principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of MPMs based on the population of a French region.

intervention_type: Genetic


title: OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN

acronym: OKAPI

summary: The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.

ReferenceCitation: Corriger A, Voute M, Lambert C, Pereira B, Pickering G; OKAPI Consortium. Ketamine for refractory chronic pain: a 1-year follow-up study. Pain. 2022 Apr 1;163(4):690-701. doi: 10.1097/j.pain.0000000000002403.


title: Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay

summary: Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia

summary: Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).


title: Evaluation of Copeptin in Patients With Cirrhosis and Ascites

acronym: CIRCOPEP

summary:
Copeptin is a glycopeptide released by the post-pituitary gland. In case of decrease in blood volume or blood pressure, it is secreted in the serum in an equimolar quantity to arginine vasopressin (AVP) . Unlike AVP, copeptin is readily assayable in serum and its prognostic value has been recently observed during cirrhosis. However, the pathophysiological relationships between serum copeptin concentrations and indirect markers of inflammation are unknown.

The main objective of this multicenter pilot study is to study the relationship between serum copeptin and markers of inflammatory stress in cirrhotic patients with ascites. It is indeed in this population with high-risk of complications that most need biomarkers of events (like death) are needed. The main secondary objective is to evaluate the prognostic interest at 6 months of the variation of copeptin between day 0- day15.


title: Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device

acronym: BASILE

summary:
Ceftobiprole is a very active new cephalosporin on staphylococci resistant to methicillin (SEMR: Staphylococcus epidermidis Resistant to Meticillin, SAMR: Staphylococcus aureus Resistant to Meticillin) and / or vancomycin; it is also very active on pneumococci resistant to penicillin and / or 3rd generation cephalosporins. This new drug has AMM in nosocomial respiratory infections, Animal work shows the efficacy of ceftobiprole in gram negative bacillus meningeal infections.

The rationale of this study is based on the antibacterial spectrum of ceftobiprole, which would therefore be useful in the treatment of staphylococcal bacterial meningitis resistant patients (SEMR or SAMR) encountered in intensive care and / or neurosurgery and in the treatment of pneumococcal meningitis.

To validate these possibilities, it is necessary to know the concentrations of ceftobiprole in the meningeal space.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)

summary: The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients

ReferenceCitation: Louis C, Godet T, Chanques G, Bourguignon N, Morand D, Pereira B, Constantin JM; AZUREA network. Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial. Trials. 2018 Jun 4;19(1):307. doi: 10.1186/s13063-018-2656-x.


title: Adverse Renal Effects of Immune Checkpoints Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) in Clinical Practice: a Large Monocentric Prospective Study

acronym: ImmuNoTox(INT)

summary:
Renal toxic events related to Immune Checkpoints Inhibitors therapy (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) have been recently reported. These were immune-allergic acute interstitial nephritis.

However, no systematic study has ever focused on renal adverse effects. The investigators study here the evolution of renal function and the occurrence of nephrological events in a large monocentric cohort of patients treated with Immune Checkpoints Inhibitors in the Centre Hospitalier Lyon Sud. Nephrological parameters based on Serum Creatinine (SCr), estimate Glomerular Filtration Rate (eGFR) and urinary sediment are monitored. The aim of the study is to determine the incidence of renal events due to Immune Checkpoint Inhibitor treatment, particularly Acute Kidney Injury, (AKI) and identify the clinical presentation, histological description and risk factors.

time_perspective: Other

location_facility: Department of Nephrology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon


title: Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study

acronym: ARISTOTE

summary:
Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter aortic valve replacement [TAVR]) in severe AS, as soon as symptoms or left ventricular (LV) dysfunction occur, in order to improve clinical outcome and achieve LV mass (LVM) regression. The highest amount of LVM regression is obtained during the first year. Nevertheless, there is heterogeneity in LV remodeling and residual LV hypertrophy is associated with poorer postoperative improvement in cardiac function and morphology. Incomplete regression of LV hypertrophy at 12 months after SAVR is a powerful predictor of adverse outcome. Yet, the use of specific pharmacological therapy to improve postoperative LVM regression could be an appealing therapeutic option after aortic valve intervention.

Renin-angiotensin-aldosterone system blockers (RAASb) and more particularly angiotensin-II receptor blockers (ARBs) are efficient in reducing LVM in hypertensive patients, as emphasized by several meta-analyses. In addition, ARBs improve myocardial relaxation, diastolic function, decreased hypertrophy and may have anti-fibrotic effects. In a recent retrospective study from our group, RAASb prescription after SAVR was associated with increased survival, but confirmation through a randomized trial is mandatory. In a prospective randomized single-center study, the use of candesartan was associated both with LV and LA remodeling as compared to the conventional management. Nevertheless, these results are based on echocardiographic data, which is not the gold standard for the assessment cardiac remodeling, and no placebo or active comparator was tested to control the impact of ARBs in these patients.

The primary objective of this Phase II study is to investigate the efficacy of valsartan, introduced postoperatively, as compared to placebo, on 1-year changes in indexed LVM, as assessed by CMR, in patients undergoing aortic valve intervention (SAVR or TAVR) for AS.

The secondary objectives are to compare the efficacy of valsartan vs. placebo in terms of one-year changes (difference from baseline) in cardiac function and in cardiac morphology, one-year exercise capacity and one-year changes in biomarkers related to cardiac function. In addition, the assessment of the safety of valsartan will also be considered as secondary objective.

The ARISTOTE trial is a multicenter prospective phase II, randomized, double-blind study including patients with the diagnosis of severe AS and indication for valve intervention.

The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist.

Patients will be randomized between 2 groups (valsartan versus placebo) and the treatment will be initiated (80 mg daily) at 5±4 days following aortic valve intervention. The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group.

The patients will be cautiously monitored and any adverse events will be collected. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study. The tolerance will be regularly assessed and dose adjusted according to a pre-specified algorithm.

status: Not yet recruiting

lead_sponsor: University Hospital, Limoges


title: Feasibility of PET-scan Carried Out at Day 1 of Brachytherapy for Patients With Locally Advanced Cervical Cancer Treated Initially by Concomitant Radio-chemotherapy

acronym: TEP-Curie

summary: Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan

lead_sponsor: Centre Oscar Lambret


title: Effect of Need to Void on Parkinsonian Gait

summary: This study evaluates the effect of the need to void on parkinsonian gait

lead_sponsor: Pierre and Marie Curie University


title: Obstetrical Analgesia in the Estaing Hospital Maternity. A Prospective Database to Study the Determinants of Labor Pain and the Resulting Maternal Non Satisfaction.

acronym: AOMHE

summary: There is a trend to offer personalized care in many medical domains. In the field of labor pain, it appears that maternal satisfaction about care is multifactorial, and that labor pain is only one of its determinants, competing with psychological and sociological factors. Furthermore, labor pain is also multifactorial, depending on predisposition to pain, the way analgesia is conducted, and other environmental factors. We wish to develop predicting models of maternal satisfaction, in order to offer in the future a better tailored analgesia.


title: A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer

acronym: ODENZA

summary: To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: A Feasibility Study (ROLL-I) of Indocyanine Green (ICG) Fluorescence Mapping for Non-palpable Breast Cancers

summary:
Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and their small size encourage the investigators for finding methods simpler and more efficient to treat them by breast-conserving surgery with acceptable cosmetic results.

The pre-operative detection of the tumor lesion is currently carried out by two methods: the radioactive seed localization and guidewire technique. Each has its disadvantages: the guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid requires a specialized and complex organization around this radioactive product.

Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in breast cancer and seems promising.

In this study, investigators evaluate the feasibility and performance of indocyanine green fluorescence in non-palpable tumor detection in comparison with radioactive seed localization (ROLL)

Secondary objectives are evaluate the feasibility of the location by the radiologist, feasibility of detection by the surgeon, study of the product and the probe.

primary_purpose: Prevention

ReferenceCitation: Francini S, Rathat G, Manna F, Pages E, Rebel L, Perrochia H, Taourel P, Ranisavljevic N, Duraes M. Occult lesion localization by indocyanine green fluorescence for nonpalpable breast cancer. Breast J. 2020 May;26(5):1101-1103. doi: 10.1111/tbj.13760. Epub 2020 Jan 28.

ReferenceCitation: Duraes M, Crochet P, Pagès E, Grauby E, Lasch L, Rebel L, Van Meer F, Rathat G. Surgery of nonpalpable breast cancer: First step to a virtual per-operative localization? First step to virtual breast cancer localization. Breast J. 2019 Sep;25(5):874-879. doi: 10.1111/tbj.13379. Epub 2019 Jun 9.

lead_sponsor: University Hospital, Montpellier


title: Effects of a Cocktail XXS-2A/Omega-3 on Insulin Sensitivity and Oxidative Stress During a 20-day Period of Physical Inactivity: a Controlled, Randomized Pilot Study on 20 Healthy Men

summary:
This experiment consists on a 20-day reduction in daily step in free-living active individuals to induce physical inactivity. This will be used to test the efficacy of the anti-oxidant cocktail we aim to test as a new countermeasure in 2016 during the 60-d bed rest planed by ESA/CNES.

The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the glucose intolerance and improve oxidative defenses induced by 20 days of physical inactivity through daily step reduction

Although physical inactivity is reported to affect glucose tolerance within days of inactivity, we selected a period of 20 days for the effect of the cocktail to take place and assess secondary molecular mechanisms. The effect of this short period of inactivity on metabolism will moreover be boosted during the last 10 days by taking fructose, a sugar found in abundance in fruits, honey and juices, which is known to quickly trigger metabolic deregulation.

ReferenceCitation: Adams GR, Caiozzo VJ, Baldwin KM. Skeletal muscle unweighting: spaceflight and ground-based models. J Appl Physiol (1985). 2003 Dec;95(6):2185-201. Review.

ReferenceCitation: Alibegovic AC, Højbjerre L, Sonne MP, van Hall G, Stallknecht B, Dela F, Vaag A. Impact of 9 days of bed rest on hepatic and peripheral insulin action, insulin secretion, and whole-body lipolysis in healthy young male offspring of patients with type 2 diabetes. Diabetes. 2009 Dec;58(12):2749-56. doi: 10.2337/db09-0369. Epub 2009 Aug 31.

ReferenceCitation: Alibegovic AC, Sonne MP, Højbjerre L, Bork-Jensen J, Jacobsen S, Nilsson E, Faerch K, Hiscock N, Mortensen B, Friedrichsen M, Stallknecht B, Dela F, Vaag A. Insulin resistance induced by physical inactivity is associated with multiple transcriptional changes in skeletal muscle in young men. Am J Physiol Endocrinol Metab. 2010 Nov;299(5):E752-63. doi: 10.1152/ajpendo.00590.2009. Epub 2010 Aug 24.

ReferenceCitation: Bakker GC, van Erk MJ, Pellis L, Wopereis S, Rubingh CM, Cnubben NH, Kooistra T, van Ommen B, Hendriks HF. An antiinflammatory dietary mix modulates inflammation and oxidative and metabolic stress in overweight men: a nutrigenomics approach. Am J Clin Nutr. 2010 Apr;91(4):1044-59. doi: 10.3945/ajcn.2009.28822. Epub 2010 Feb 24.

ReferenceCitation: Bergouignan A, Momken I, Lefai E, Antoun E, Schoeller DA, Platat C, Chery I, Zahariev A, Vidal H, Gabert L, Normand S, Freyssenet D, Laville M, Simon C, Blanc S. Activity energy expenditure is a major determinant of dietary fat oxidation and trafficking, but the deleterious effect of detraining is more marked than the beneficial effect of training at current recommendations. Am J Clin Nutr. 2013 Sep;98(3):648-58. doi: 10.3945/ajcn.112.057075. Epub 2013 Jul 31.

ReferenceCitation: Bergouignan A, Momken I, Schoeller DA, Normand S, Zahariev A, Lescure B, Simon C, Blanc S. Regulation of energy balance during long-term physical inactivity induced by bed rest with and without exercise training. J Clin Endocrinol Metab. 2010 Mar;95(3):1045-53. doi: 10.1210/jc.2009-1005. Epub 2010 Jan 8.

ReferenceCitation: Bergouignan A, Rudwill F, Simon C, Blanc S. Physical inactivity as the culprit of metabolic inflexibility: evidence from bed-rest studies. J Appl Physiol (1985). 2011 Oct;111(4):1201-10. doi: 10.1152/japplphysiol.00698.2011. Epub 2011 Aug 11. Review.

ReferenceCitation: Bergouignan A, Trudel G, Simon C, Chopard A, Schoeller DA, Momken I, Votruba SB, Desage M, Burdge GC, Gauquelin-Koch G, Normand S, Blanc S. Physical inactivity differentially alters dietary oleate and palmitate trafficking. Diabetes. 2009 Feb;58(2):367-76. doi: 10.2337/db08-0263. Epub 2008 Nov 18.

ReferenceCitation: Biensø RS, Ringholm S, Kiilerich K, Aachmann-Andersen NJ, Krogh-Madsen R, Guerra B, Plomgaard P, van Hall G, Treebak JT, Saltin B, Lundby C, Calbet JA, Pilegaard H, Wojtaszewski JF. GLUT4 and glycogen synthase are key players in bed rest-induced insulin resistance. Diabetes. 2012 May;61(5):1090-9. doi: 10.2337/db11-0884. Epub 2012 Mar 8.

ReferenceCitation: Biolo G, Agostini F, Simunic B, Sturma M, Torelli L, Preiser JC, Deby-Dupont G, Magni P, Strollo F, di Prampero P, Guarnieri G, Mekjavic IB, Pisot R, Narici MV. Positive energy balance is associated with accelerated muscle atrophy and increased erythrocyte glutathione turnover during 5 wk of bed rest. Am J Clin Nutr. 2008 Oct;88(4):950-8.

ReferenceCitation: Blanc S, Normand S, Ritz P, Pachiaudi C, Vico L, Gharib C, Gauquelin-Koch G. Energy and water metabolism, body composition, and hormonal changes induced by 42 days of enforced inactivity and simulated weightlessness. J Clin Endocrinol Metab. 1998 Dec;83(12):4289-97.

ReferenceCitation: Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.

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lead_sponsor: Centre National d'Etudes Spatiales

intervention_type: Dietary Supplement


title: Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)

acronym: I-RECANAL

summary:
Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia.

Small studies have highlighted the value of cerebral MRI (Magnetic Resonance Imaging) in CRAO with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a correlation between anomalies in diffusion sequence and the probability of a pathology with a high risk of recurrence (carotid stenosis or emboligenic cardiopathy). But there are usually few radiological signs that allow a direct positive diagnosis of CRAO, an etiologic diagnosis or a prognosis. This descriptive study will focus on CRAO at the diagnostic and post-treatment phases in the short and medium term, in order to (i) identify imaging etiologic signs of CRAO with specific sequences from a 3 Tesla MRI, (ii) identify positive diagnostic signs of CRAO with the same specific sequences, (iii) correlate these signs with the visual prognosis one month after the CRAO.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting Programmed Cell Death 1 (PD-1)

summary:
Prospective, monocentric clinical study. Patients selected for nivolumab therapy in AP-HM for melanoma and non-small cell lung cancer will be eligible. Do not include patients with conditions that do not allow MRI, prior cardiovascular disease with LVEF<50%, cardiomyopathy, history of cardiac arrhythmia, history of cardiovascular toxicity under anticancer therapy, coronary artery disease or stroke less than 3 months Therapeutic management will not be modified and treatment will be administrated as usual.

Cardiovascular follow up will be identical to that recommended and realized in current care in the Cardio-Oncology unit of AP-HM. It will include clinical, biological (BNP and troponin) and trans-thoracic echocardiography (TTE) at baseline and then at 1, 3 and 6 months. Auto-antibodies against troponin I assay will be performed to avoid false negatives of normal blood level of troponin I at baseline and then at 6 months. Cardiac MRI will be performed as well at baseline and at the end of the study (6 months). MRI is the gold standard for ventricular function evaluation.

Primary endpoint will be left ventricular function evolution evaluated by global longitudinal strain (GLS, 2D speckles tracking) in TTE. Secondary endpoints will be left and right ventricular function parameters: LEVF by TTE and MRI, left ventricular indexed volumes by TTE and MRI, right ejection ventricular function and indexed volumes by TTE and MRI, systolic pulmonary arterial pressure by TTE, serum troponin I and BNP, arrhythmias and conduction disorders on the electrocardiogram (ECG).

Number of required subjects: GLS is recommended for following up left ventricular function under anticancer treatments. Based on the hypothesis of a significant GLS decrease (15%) in 20% of cases with alpha risk of 0.05 and accuracy of 0.12 which means expected confidence interval of 0.08-0.32, then the number of required subjects is 50 patients.

The inclusion period will be 18 months with a follow up if 6 months, ie a total duration of the study of 24 months.

primary_purpose: Diagnostic

ReferenceCitation: Cadour F, Cautela J, Rapacchi S, Varoquaux A, Habert P, Arnaud F, Jacquier A, Meilhac A, Paganelli F, Lalevée N, Scemama U, Thuny F. Cardiac MRI Features and Prognostic Value in Immune Checkpoint Inhibitor-induced Myocarditis. Radiology. 2022 Jun;303(3):512-521. doi: 10.1148/radiol.211765. Epub 2022 Mar 1.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma

acronym: IMMUQ

summary: The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years


title: Study of the Diaphragmatic Function by Transient Elastography : Comparison With Mechanical and Electrophysiological Variables

acronym: ELASTODIAPH

summary: The study of diaphragmatic function is usually measured by the pressures and volumes generated by contraction of the diaphragm, which is often difficult (cumbersome technique, difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically analyze the diaphragm compared to other accessory respiratory muscle groups). In this study, the investigators aimed at analysing diaphragmatic function by measuring the shortening, stiffness, strain and thickening of the diaphragm by ultrasound.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil


title: Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells

acronym: GAMAIT

summary:
Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. Corticosteroid therapy is the reference treatment for GCA. This treatment is highly effective but must be maintained for 12 to 24 months to avoid relapses, which causes the onset of numerous adverse effects in this elderly population.

Currently clinicians have no way to estimate this risk of relapse during the treatment of GCA.

Invariant T lymphocytes associated with the mucous membrane (MAIT), whose role in vasculitides has recently been shown and which produce IL-17 and IFN-γ, two key cytokines in the pathophysiology of GCA could be implicated in the pathophysiology of GCA and could constitute a predictive marker of relapse.

Our hypothesis is that blood MAIT are recruited in the artery wall in patients with GCA and that the number of circulating MAIT in the blood falls and then returns to normal if the corticoids are effective.

Given that it will be necessary to include a large number of patients to show that the persistence of a low number of circulating MAIT in patients treated with corticoids is a predictor of relapse, we propose, as the first step, to carry out a pilot study to obtain preliminary data on these new markers.

The study is classified as interventional because a lot of blood samples are taken


title: Effects of Augmented Reality Glasses on Muscle Activity, Balance, Physical and Mental Fatigue

summary: Nowadays, augmented reality (AR) has gained attention but little is known concerning its repercussion in individuals when considering some mental and physiological aspects. Therefore, the aim of this study was to investigate the effects of AR glasses on some cognitive and physiological functions in an attempt to determine its safety for workers.

ReferenceCitation: Babault N, Païzis C, Deley G, Guérin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.

lead_sponsor: University of Burgundy

location_facility: Centre d'Expertise de la Performance - Université de Bourgogne


title: Asthma, Smoking, Emotional Deficits

acronym: ASTADEM

summary: The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Pneumologie Hôpital de la Croix-Rousse


title: First Study Evaluating Efficiency and Safety of a Compressive Device to Prevent Keloid Scars Recurrence After Surgery

acronym: SCARWARS

summary: SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis

acronym: HYPOGRAFT

summary: The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.

lead_sponsor: University Hospital, Toulouse


title: Pilot Study on the ADherence to Oral Antibiotics in Patients With BONE and Joint Infections (ADABONE)

acronym: OBSAIO

summary:
Bone and joint infection (BJI) are bacterial infections that can occur after surgery (nosocomial infections) or de novo. They constitute a public health problem in Western Countries . These infections are often difficult to treat, with a high rate of re-hospitalizations (19.5%) caused by relapses or recurrences. The treatment of Bone and joint infection can be surgical and / or pharmacological . Drug treatment is based on the use of parenteral and / or oral antibiotics. It is a curative therapy in most cases, with a prolonged duration ranging from 6 weeks to several months depending on the lesions .

Medication adherence, is a patients' behavior defined as drug intake with optimal attendance and regularity, as prescribed and explained by the physician. It is a key factor in the success of any drug therapy, as drugs don't work in patients who don't take them..

To the knowledge of investigators, there are no published data on the adherence to antibiotic therapy in patients treated for Bone and joint infection. In addition to its prolonged duration, the antibiotic treatment of the Osteoarticular Infections may require several daily drug intakes and may be responsible for severe adverse effects, these three factors being known to adversely affect adherence.

Prevalence, adherence patterns over time and determinants of adherence in this patient population are not known. Currently, drug adherence is not routinely evaluated and is not considered in the treatment of Bone and joint infection in the Regional Center for Complex Bone and joint infection of the investigators.

A specific study evaluating adherence to antibiotic therapy in patients treated for Bone and joint infection appears to be justified.

location_facility: Centre de référence des infections ostéo-articulaires de Lyon


type: Registry Identifier

title: Study of the Immunological Profile of Archival Formalin-fixed Paraffin-embedded Solid Tumors Sample

summary:
It has become clear in the recent year that the nature of the immune cells infiltrate within a tumor was essential in the control of the tumor growth. This so-called immune contexture does vary between cancer types and in response to treatments. In this context, this trial is a non-interventional, mono-centric in patients with solid tumors. Samples in paraffin-embedded material block of biopsies or surgical pieces (either primitive tumor or metastases) will be analysed. For each sample, clinically relevant data associated with treated cancer and needed for characterization of tumor microenvironment will be documented.

This trial is, through accessing to well documented selected archival tumor materials, to validate selected biomarker for early phase trial.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Toxicological Screening by GC-MS Among Children Admitted for a First Afebrile Seizure (CASTox): a Pilot Study

acronym: CASTox

summary:
Before the age of 14 years, 1% of the paediatric population will develop a seizure. The only systematically required complementary examination is an electroencephalogram (EEG). Additional biological or radiological examinations depend on the circumstances, the past medical history of the patient and other associated symptoms or clinical signs. A seizure can be the first sign of acute intoxication and represents a severity criterion. Failure to detect the toxic cause of a seizure can lead to a delay in the access or administration of an antidote if applicable. This can lead to target organ toxicity due to the absence of specific treatment. In the current French guidelines for a first seizure, a toxicological analysis is recommended if there is a possibility of exposure to toxic medications or products. However, this screening is often missing, unless a witness suggests that the child may have been exposed to a toxin.The recognition of a paediatric toxidrome is low among paediatricians, paediatric neurologists or emergency physicians. This is due to a lack of knowledge in clinical toxicology and the screening for toxic aetiology is not frequently or irrelevantly prescribed. There is an increasing number of proconvulsive molecules on the market. These molecules are not targeted in classic toxic screening. As result, a toxic cause of a seizure may be missed unless specific screening is performed. For all these reasons, little is known about the prevalence of toxic causes after a first episode of non-febrile seizure and probably under estimated in the paediatric population, especially in young children. New technologies for toxic detection like chromatography combined with mass spectrometry allow wide screening on different matrix. Initially dedicated to forensic analysis, they are more widely accessible for the exploration of the patients. The CASTox study is based on this context.

The first aim will be to evaluate the prevalence of a toxicological cause by a systematic blood and urine screening of children admitted to Toulouse paediatric emergency unit for a first afebrile seizure. Moreover, secondary aim will be to describe the effect of the systematic screening on the management of the children.

primary_purpose: Screening

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title: Comparison Between Two Strategies of Induction in Case of Unfavourable Cervix After 12 Hours of Premature Rupture of Membranes (PROM) at Term: Cook Cervical Ripening + Oxytocine From 6 Hours Versus Dinoprostone Vaginal Insert

acronym: RUBAPRO

summary: The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women.

ReferenceCitation: Devillard E, Delabaere A, Rouzaire M, Pereira B, Accoceberry M, Houlle C, Dejou-Bouillet L, Bouchet P, Gallot D. Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments. BMJ Open. 2019 Jun 20;9(6):e026090. doi: 10.1136/bmjopen-2018-026090.