title: Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.

acronym: TMS VR

summary:
Depression is a mood disorder affecting an individual in its entirety, altering its emotional and intellectual functioning . The major form of depression is the most common psychiatric disorder in Western countries. It is considered to be the most expensive psychiatric neurological disease in Europe and is currently treated by different methods.

However, almost a third of depressed patients shows no clinical improvement. Advances in neuroscience and understanding of neuromodulation have enabled the emergence of new treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of modulating the neuronal activity of a targeted brain region through a magnetic field applied by a coil. Even though this form of treatment has proven to be effective, it appears that more than half of depressed patients exhibited little to no response to it.

As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent signals, it was hypothesized that optimizing the effects of TMS with virtual reality is possible through the activation of these brain regions with sensory stimuli holding emotional valence (images, sounds) while using TMS concomitantly. Based on this new research premise, the investigators propose, in the context of an open and controlled clinical trial, to use a new media entitled virtual reality for displaying interactive virtual environments with positive emotional valence ( field of flowers, green valley) to a group of depressed patients undergoing TMS at the same time.

The study will include 66 depressed patients randomly assigned into two groups : TMS and Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two groups will be measured by questionnaires and brain functional imagery. This innovative and therapeutic approach will allow us to better understand the appropriate processes for modulating the neuronal activity in specific brain areas for treatment purposes.


title: Feasibility and Acceptability of a Web-based Multidomain Intervention With Connected Devices Made to Maintain Cognitive Function in Older Adults: a Pilot Randomised Controlled Trial

acronym: eMIND

summary: The primary purpose of the protocol is to evaluate the feasibility and acceptability of a home-based (using information and communication technologies) intervention composed of nutritional counselling, exercise and cognitive training in older adults and its potential effect on various health outcomes.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Andrieu S, Coley N, Lovestone S, Aisen PS, Vellas B. Prevention of sporadic Alzheimer's disease: lessons learned from clinical trials and future directions. Lancet Neurol. 2015 Sep;14(9):926-944. doi: 10.1016/S1474-4422(15)00153-2. Epub 2015 Jul 23. Review.

ReferenceCitation: Ngandu T, Lehtisalo J, Solomon A, Levälahti E, Ahtiluoto S, Antikainen R, Bäckman L, Hänninen T, Jula A, Laatikainen T, Lindström J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

ReferenceCitation: Vellas B, Carrie I, Gillette-Guyonnet S, Touchon J, Dantoine T, Dartigues JF, Cuffi MN, Bordes S, Gasnier Y, Robert P, Bories L, Rouaud O, Desclaux F, Sudres K, Bonnefoy M, Pesce A, Dufouil C, Lehericy S, Chupin M, Mangin JF, Payoux P, Adel D, Legrand P, Catheline D, Kanony C, Zaim M, Molinier L, Costa N, Delrieu J, Voisin T, Faisant C, Lala F, Nourhashémi F, Rolland Y, Van Kan GA, Dupuy C, Cantet C, Cestac P, Belleville S, Willis S, Cesari M, Weiner MW, Soto ME, Ousset PJ, Andrieu S. MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA. J Prev Alzheimers Dis. 2014 Jun;1(1):13-22.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults

acronym: CAMUS

summary:
P31 nuclear magnetic resonance (RMN) Spectroscopy (SRM P31) has currently being poorly used in the field of sarcopenia.

The aim of the CAMUS study is to investigate the feasibility a protocol of SRM P31 at rest, during and after a standardized physical task. The secondary objective is to compare the metabolism of tyhe skeletal muscle tissue assessed by SRM P31 in young and older individuals. A pilot study, cross-sectional study will be conducted. Ten healthy sedentary 70+ years males and 10 sedentary 25 to 30 years old male will be included.

Level of physical activity, physical performances, will be assessed at baseline. RMN (T1; tractography and SRM P31) will be performed. SRM P31 will be performed at rest, during and after an exhausting muscle task at 70% 1-RM. Feasibility will be judged on the rate of valuable variables recorded (>90%) inorganic phosphate (iP), phosphocreatine (PCr) and isoform of adenosine triphosphate (ATP : alfa, beta, gamma).

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Rolland Y, Lauwers-Cances V, Cournot M, Nourhashémi F, Reynish W, Rivière D, Vellas B, Grandjean H. Sarcopenia, calf circumference, and physical function of elderly women: a cross-sectional study. J Am Geriatr Soc. 2003 Aug;51(8):1120-4.

ReferenceCitation: Bourdel-Marchasson I, Joseph PA, Dehail P, Biran M, Faux P, Rainfray M, Emeriau JP, Canioni P, Thiaudière E. Functional and metabolic early changes in calf muscle occurring during nutritional repletion in malnourished elderly patients. Am J Clin Nutr. 2001 Apr;73(4):832-8.

ipd_sharing: No

intervention_type: Radiation

status_simplified: Unknown


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

primary_purpose: Treatment

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.

family: Forestier

full_name: R. Forestier

given: R.

sequence: first

family: Desfour

full_name: H. Desfour

given: H.

sequence: additional

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

given: C.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

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

intervention_type: Other

lead_sponsor_type: industriel


title: Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples

acronym: ARMED NEO

summary: In response to restrictions related to the use of DEHP as a plasticizer for PVC medical devices (MDs), manufacturers have resorted to alternative plasticizers. These are now integrated into many MDs such as infusion sets, extension lines, extracorporeal circuits, nutrition tubings ... etc. The ARMED project (2012-2015) funded by the ANSM, whose goal was to prioritizing the risk linked to the migration of these plasticizers from MDs, has shown that TOTM and DEHT present the best benefit / risk ratio due to lower migration and cytotoxicity. Nevertheless, it is important to evaluate the level of exposure of neonatal intensive care patients, due to the multi exposure to MD made of PVC, the frequent use of intravenous route and the vulnerability of this at-risk population to the metabolites of these plasticizers.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand


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.

status: Recruiting

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire Dijon

status_simplified: Ongoing


title: Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)

acronym: COLONPREP

summary:
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

status: Active, not recruiting

ipd_sharing_description: There is not a plan to make IPD available

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de chirurgie Colorectale / Hôpital Beaujon

intervention_type: Drug


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.

ReferenceType: derived

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.

family: Palanker

full_name: Daniel Palanker

given: Daniel

family: Le Mer

full_name: Yannick Le Mer

given: Yannick

family: Mohand-Said

full_name: Saddek Mohand-Said

given: Saddek

family: Muqit

full_name: Mahiul Muqit

given: Mahiul

family: Sahel

full_name: Jose A. Sahel

given: Jose A.

journal_name: Ophthalmology

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: acceptedVersion

repositories:
PubMed Central
UCL Discovery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Pixium Vision SA

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


title: Does the Urine Concentration of TIMP2*IGFBP7 Can Distinguish Patients Who Will Present Transient or Persistent Acute Kidney Injury During Septic Shock? A Retrospective Analysis. BIOCHECK

acronym: BIOCHECK

summary: Patients with septic shock in the intensive care unit have a high risk to develop acute kidney injury (AKI) and AKI is an independent risk factor of mortality. Given the absence of validated pharmacological treatments for limiting the progression of AKI or for accelerating recovery from AKI, early intervention and the restoration of the glomerular filtration rate (GFR) in this context of septic shock might improve the patients' prognosis. One major challenge is to determine whether or not the AKI is reversible (return to normal function KDIGO 0 within 72 hours). In this retrospective study the investigators will analyze all patients admitted for a septic shock in three French ICUs between the 1st january 2014 and 01st January 2017 who developed an AKI (KDIGO ≥1) at admission and who had a determination of the urine concentration of TIMP2*IGFBP7 at admission. The investigators will determine the best threshold of TIMP2*IGFBP7 to distinguish the population of patients who will return to normal kidney function within 72 hours (KDIGO 0).

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens


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

lead_sponsor: Marion Trousselard

intervention_type: Behavioral


title: Evaluation of Indirect Measurement of Respiratory Quotient in Non-cardiac Major Surgery as a Predictor of Anaerobic Metabolism (The BAR Study) Indirect Respiratory Quotient as a Predictor of Anaerobic Metabolism

summary: Demonstrate the ability of the RQ, measured indirectly from the anesthesia ventilator, to predict the occurrence of anaerobic metabolism in patients operated of major non-cardiac surgical operation in the operating room

time_perspective: Prospective

ReferenceCitation: Bar S, Grenez C, Nguyen M, de Broca B, Bernard E, Abou-Arab O, Bouhemad B, Lorne E, Guinot PG. Predicting postoperative complications with the respiratory exchange ratio after high-risk noncardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Nov;37(11):1050-1057. doi: 10.1097/EJA.0000000000001111.

family: Bar

full_name: Stéphane Bar

given: Stéphane

family: Grenez

full_name: Charles Grenez

given: Charles

family: Nguyen

full_name: Maxime Nguyen

given: Maxime

family: de Broca

full_name: Bruno de Broca

given: Bruno

family: Bernard

full_name: Eugénie Bernard

given: Eugénie

family: Abou-Arab

full_name: Osama Abou-Arab

given: Osama

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Lorne

full_name: Emmanuel Lorne

given: Emmanuel

family: Guinot

full_name: Pierre-Grégoire Guinot

given: Pierre-Grégoire

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


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


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.

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.


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.

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.

name: Service Universitaire de Psychiatrie de l’Enfant et de l’Adolescent, CHU de Toulouse, Toulouse, France

name: CERPOP, Université de Toulouse, Inserm, UPS, Toulouse, France

name: CIC 1436, Team PEPSS « Pharmacologie En Population cohorteS et biobanqueS », Toulouse University Hospital, France

family: Revet

full_name: Alexis Revet

given: Alexis

name: Centre de Ressource Douleur Soins Palliatifs Pédiatriques, CHU de Toulouse, Toulouse, France

family: Suc

full_name: Agnès Suc

given: Agnès

name: Unité de recherche clinique pédiatrique module plurithématique pédiatrique CIC Toulouse 1436, Hôpital des Enfants, CHU de Toulouse, Toulouse, France

family: Auriol

full_name: Françoise Auriol

given: Françoise

name: Department of Psychiatry, University Medical Centre Utrecht, Utrecht, The Netherlands

name: Department Youth – KOOS, Altrecht GGZ, Utrecht, The Netherlands

family: Djelantik

full_name: A. A. A. Manik J. Djelantik

given: A. A. A. Manik J.

family: Raynaud

full_name: Jean-Philippe Raynaud

given: Jean-Philippe

name: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA

name: Department of Psychiatry, University of Caen Normandy & Caen University Hospital, Caen, France

family: Bui

full_name: Eric Bui

given: Eric

currency_apc_doaj: GBP

journal_name: European Journal of Psychotraumatology

oa_colors: green gold

evidence: oa journal (via doaj)

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

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.


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.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


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


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


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.

family: Petit

full_name: Lolita Petit

given: Lolita

family: Lhériteau

full_name: Elsa Lhériteau

given: Elsa

family: Weber

full_name: Michel Weber

given: Michel

family: Le Meur

full_name: Guylène Le Meur

given: Guylène

family: Deschamps

full_name: Jack-Yves Deschamps

given: Jack-Yves

family: Provost

full_name: Nathalie Provost

given: Nathalie

family: Mendes-Madeira

full_name: Alexandra Mendes-Madeira

given: Alexandra

family: Libeau

full_name: Lyse Libeau

given: Lyse

family: Guihal

full_name: Caroline Guihal

given: Caroline

family: Colle

full_name: Marie-Anne Colle

given: Marie-Anne

family: Moullier

full_name: Philippe Moullier

given: Philippe

family: Rolling

full_name: Fabienne Rolling

given: Fabienne

journal_name: Molecular Therapy

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

title: Restoration of Vision in the pde6β-deficient Dog, a Large Animal Model of Rod-cone Dystrophy

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.

family: Pichard

full_name: Virginie Pichard

given: Virginie

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.

name: Universitätsspital Basel, Augenklinik, Basel, Switzerland

name: Department für Augenheilkunde, Universitätsklinik Tübingen, Tübingen, Germany

name: Institute for Research in Ophthalmology, Sion, Switzerland

name: Department of Ophthalmology, University of Lausanne; Faculty of Life Sciences, EPFL, Lausanne

name: Unité dʼoculogénétique, Hôpital ophtalmique Jules-Gonin, Lausanne, Switzerland

journal_name: Klinische Monatsblätter für Augenheilkunde

title: Novel PDE6B Mutation Presenting with Retinitis Pigmentosa – A Case Series of Three Patients

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

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.


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. 2020 Mar 24. doi: 10.1519/JSC.0000000000003432. [Epub ahead of print]

family: Bellicha

full_name: Alice Bellicha

given: Alice

family: Giroux

full_name: Caroline Giroux

family: Ciangura

full_name: Cécile Ciangura

given: Cécile

family: Menoux

full_name: Diane Menoux

given: Diane

family: Thoumie

full_name: Philippe Thoumie

family: Oppert

full_name: Jean-Michel Oppert

given: Jean-Michel

family: Portero

full_name: Pierre Portero

given: Pierre

bso_classification: Biology (fond.)

journal_name: Journal of Strength and Conditioning Research


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".

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.

family: Pauwels

full_name: Charlotte Pauwels

given: Charlotte

family: Roren

full_name: Alexandra Roren

family: Gautier

full_name: Adrien Gautier

given: Adrien

family: Linières

full_name: Jonathan Linières

given: Jonathan

family: Rannou

full_name: François Rannou

given: François

family: Poiraudeau

full_name: Serge Poiraudeau

given: Serge

family: Nguyen

full_name: Christelle Nguyen

given: Christelle

journal_name: Annals of Physical and Rehabilitation Medicine

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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


type: EudraCT Number

title: Essai de Phase II Multicentrique évaluant le Pembrolizumab Dans le Traitement de la Maladie de Kaposi Classique ou endémique

acronym: KAPKEY

summary:
Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies.

Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples have been recently reported. Our experience in classical and endemic KS supports the role of this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS lesions.

In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and endemic KS.


title: Evaluation of the Detection of B D Glucan in Peritonitis Fluid in Intensive Care Unit (ICU) Patients With Peritonitis for the Diagnosis of Fungal Peritonitis, Compared to Routine Microbiology Diagnosis Method. The PERICAND Study

acronym: PERICAND

summary:
Invasive candidiasis has a high mortality rate, around 40%. Outcome remains tightly linked to the time of treatment administration. Routine microbiological techniques give results too lately to allow prompt antifungal therapy initiation (at least 48 hours). It is important to develop diagnostic tools to initiate antifungal therapy as early as possible.

The B D glucan detection, one of the major components of the candida cell wall, can be useful for a early diagnosis.

There are several techniques on the market for the detection of glucan. In Europe and America, the most used is Fungitell (Associated of Cape Cod, Inc).

There is several studies about the use of such kits for fungemia. A number of studies are reporting evidences of a early diagnosis.

But, in medical literature, there isn't study focused on the detection of B D glucan in peritoneal fluid for Candida peritonitis diagnosis.


title: Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.

acronym: PUC NAVIO

summary:
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result.

Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved.

The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance.

The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith & Nephew).

The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.

intervention_type: Procedure


title: Diagnostic Value of 18FDG PET/CT Textural Indices in Patients With an Adrenal Lesion

acronym: ImpactTexture

summary:
Tumors are characterized by a great heterogeneity. Characterizing this intra-tumor heterogeneity is a major challenge in oncology to improve the therapeutic management and move towards personalized medicine adapted to each patient. However, intra-tumor heterogeneity remains rarely used for diagnostic purposes The discovery of an adrenal mass can occur in different circumstances. Detection of an adrenal mass can be done in a context of secreting syndrome, in the assessment of an extra-adrenal neoplasia or fortuitously when performing an imaging for another reason. The etiologies are numerous (cortical tumors, medullary tumors, metastatic lesion of a extra-adrenal neoplasia, others). The adrenal masses can be divided into two categories, depending on whether they are hyperfunctional or not. In patients without an oncological history, an adrenal mass discovered is most often a benign adenoma, but requires an endocrine assessment. In patients with known primary cancer, approximately 30% of the adrenal masses are malignant.

In all cases, the diagnostic procedure includes an imaging assessment to characterize the lesion and an endocrine assessment. CT scan performed without and after intravenous iodinated contrast agent injection is the first-line examination to assess an adrenal mass.

18F-FDG-PET may be indicated as second-line for characterizing an adrenal mass. Adrenal tumor SUVmax (Standard Uptake Value) and adrenal tumor SUVmax / liver SUVmax ratio are routinely used to determine the malignancy of a lesion. Although very useful for assessing the glucose metabolism of a given lesion, these parameters do not allow assessing the heterogeneity of tumor uptake. The texture analysis corresponds to an analysis of the spatial distribution of FDG uptake, and allows, by the calculation of many indices, an evaluation of the heterogeneity of the tumors.

The hypothesis of our study is that the texture parameters could have an additional diagnostic value to improve the performance of conventional quantitative parameters to determine the malignancy of a lesion.

The objective of this study is to investigate the diagnostic value of texture indices in a large cohort of patients presenting an adrenal lesion

lead_sponsor: University Hospital, Brest


title: FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home

acronym: FRAGIL-IT

summary: The object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. The devices transmit wirelessly the collected data to a remote server through a tablet. Data will then be available remotely for consultations by users (i.e. patients or physicians). The clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. Comprehensive assessments will be conducted to highlight the feasibility and acceptability.


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.

family: Mourad

full_name: Marc Mourad

given: Marc

family: Eliet

full_name: Jacob Eliet

given: Jacob

family: Zeroual

full_name: Norddine Zeroual

given: Norddine

family: Saour

full_name: Marine Saour

given: Marine

family: Sentenac

full_name: Pierre Sentenac

family: Manna

full_name: Federico Manna

given: Federico

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Gandet

full_name: Thomas Gandet

given: Thomas

family: Colson

full_name: Pascal H. Colson

given: Pascal H.

family: Gaudard

full_name: Philippe Gaudard

journal_name: Critical Care

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: unkown


title: Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents

acronym: IDEFIX

summary: The aim of the present study is to compare the effect of two weight loss interventions inducing the same energy deficit but one based on exercise and one using dietary restriction, on appetite control in obese adolescents. Investigator hypothesis that daily energy intake and hunger will be increased in the dietary restriction group but not in response to the exercise program.

ReferenceCitation: Roche J, Corgosinho FC, Dâmaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Túlio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.

family: Roche

full_name: Johanna Roche

given: Johanna

family: Corgosinho

full_name: Flavia C. Corgosinho

given: Flavia C.

family: Dâmaso

full_name: Ana R. Dâmaso

given: Ana R.

family: Isacco

full_name: Laurie Isacco

given: Laurie

family: Miguet

full_name: Maud Miguet

given: Maud

family: Fillon

full_name: Alicia Fillon

given: Alicia

family: Guyon

full_name: Aurore Guyon

given: Aurore

family: Moreira

full_name: Gustavo A. Moreira

given: Gustavo A.

family: Pradella-Hallinan

full_name: Marcia Pradella-Hallinan

given: Marcia

family: Tufik

full_name: Sergio Tufik

given: Sergio

family: Túlio de Mello

full_name: Marco Túlio de Mello

given: Marco

family: Gillet

full_name: Valérie Gillet

given: Valérie

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Duclos

full_name: Martine Duclos

given: Martine

family: Boirie

full_name: Yves Boirie

given: Yves

family: Masurier

full_name: Julie Masurier

given: Julie

family: Franco

full_name: Patricia Franco

given: Patricia

family: Thivel

full_name: David Thivel

given: David

family: Mougin

full_name: Fabienne Mougin

given: Fabienne

journal_name: Nutrition, Metabolism and Cardiovascular Diseases


title: Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates

acronym: BOOST-CA

summary: Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)]

ReferenceCitation: Cordoba A, Escande A, Leroy T, Mirabel X, Coche-Dequéant B, Lartigau E. Low-dose-rate interstitial brachytherapy boost for the treatment of anal canal cancers. Brachytherapy. 2017 Jan - Feb;16(1):230-235. doi: 10.1016/j.brachy.2016.07.007. Epub 2016 Sep 3.

family: Cordoba

full_name: Abel Cordoba

given: Abel

family: Escande

full_name: Alexandre Escande

given: Alexandre

family: Leroy

full_name: Thomas Leroy

given: Thomas

family: Mirabel

full_name: Xavier Mirabel

given: Xavier

family: Coche-Dequéant

full_name: Bernard Coche-Dequéant

given: Bernard

family: Lartigau

full_name: Eric Lartigau

given: Eric

journal_name: Brachytherapy

ReferenceCitation: Boukhelif W, Ferri-Molina M, Mazeron R, Maroun P, Duhamel-Oberlander AS, Dumas I, Martinetti F, Guemnie-Tafo A, Chargari C, Haie-Meder C. Interstitial pulsed-dose-rate brachytherapy for the treatment of squamous cell anal carcinoma: A retrospective single institution analysis. Brachytherapy. 2015 Jul-Aug;14(4):549-53. doi: 10.1016/j.brachy.2015.03.006. Epub 2015 Apr 29.

family: Boukhelif

full_name: W. Boukhelif

given: W.

family: Ferri-Molina

full_name: M. Ferri-Molina

given: M.

family: Mazeron

full_name: R. Mazeron

given: R.

family: Maroun

full_name: P. Maroun

given: P.

family: Duhamel-Oberlander

full_name: A.S. Duhamel-Oberlander

family: Dumas

full_name: I. Dumas

given: I.

family: Martinetti

full_name: F. Martinetti

given: F.

family: Guemnie-Tafo

full_name: A. Guemnie-Tafo

given: A.

family: Chargari

full_name: C. Chargari

given: C.

family: Haie-Meder

full_name: C. Haie-Meder

lead_sponsor: Institut Paoli-Calmettes


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

lead_sponsor: CHU de Reims


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.

intervention_type: Diagnostic Test


title: Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.

summary:
During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation.

The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter.

However, before being used extensively, such device needs to be evaluated concerning its accuracy. The aim of the present study is to assess the reliability of this device.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


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.

lead_sponsor: University Hospital, Clermont-Ferrand


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).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


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.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


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.

family: Louis

full_name: Clémence Louis

given: Clémence

family: Godet

full_name: Thomas Godet

family: Chanques

full_name: Gérald Chanques

given: Gérald

family: Bourguignon

full_name: Nathalie Bourguignon

given: Nathalie

family: Morand

full_name: Dominique Morand

given: Dominique

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

journal_name: Trials

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria


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: Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care

acronym: AGASA-SP

summary: Current recommendations do not recommend the concomitant administration of albumin after ascites puncture in patients with ascites neoplasia unlike cirrhotic ascites. The etiology of ascites in cancer patients is multifactorial, particularly by hepatic invasion that can lead to ascites loaded with albumin. Ascites punctures therefore lead to undernutrition, recurrent early ascites by decreasing the oncotic pressure by hypo albuminemia and a state of anasarca affecting the quality of life.

ReferenceCitation: Carrier P, Jacques J, Debette-Gratien M, Legros R, Sarabi M, Vidal E, Sautereau D, Bezanahary H, Ly KH, Loustaud-Ratti V. [Non-cirrhotic ascites: pathophysiology, diagnosis and etiology]. Rev Med Interne. 2014 Jun;35(6):365-71. doi: 10.1016/j.revmed.2013.12.001. Epub 2014 Jan 6. Review. French.

ReferenceCitation: Guide pratique des soins palliatifs Edition A.P.E.S. (2008)

ReferenceCitation: Ayantunde AA, Parsons SL. Pattern and prognostic factors in patients with malignant ascites: a retrospective study. Ann Oncol. 2007 May;18(5):945-9. Epub 2007 Feb 13.


title: Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation

acronym: PyroCal-greffe

summary:
Arterial calcifications (AC) are constant lesions in patients with Chronic Kidney Diseases (CKD). Renal transplantation would reduce their progression compared to dialysis. AC pathophysiology is a complex and finely regulated process that involves many local and systemic factors, both pro- and anti-calcification. The progression of the CKD is accompanied by an increase in phosphate levels as the renal excretion capacity of inorganic phosphates (Pi) decreases while their digestive absorption remains unchanged. Hyperphosphatremia is a well-identified calcifying factor contributing to ACs in the CKD. On the other hand, pyrophosphate (PPi) is an anti-calcifying factor from the hydrolysis of extracellular ATP by ectonucleotidases. While there are many factors that may contribute to a protective effect against AC progression of renal transplantation, no study has been yet analysed the role of PPi. Plasma concentration of PPi is decreased in dialysis patients compared to non-kidney failure patients.

The main objective of this monocentric, prospective and interventional pilot study will be to compare the progression of CA and [PPi]pl between a group of renal transplant patients over the past 24 months and a group of dialysis patients over the same period of time. The secondary objectives will be to compare the progression of ACs and the ratio[PPi]pl/[Pi]pl between transplanted and dialysis patients. Transplanted patients will be included within 24 (±3) months of transplant. Dialysis patients will be included at 24 (±3) months of the CT scan performed during the pre-transplant check-up. At inclusion, all patients will benefit from a CT scan without injection and a plasma dose of PPi, Pi and other factors involved in controlling calcification.

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire


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.

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.

name: Department of gynaecological surgery Montpellier University Hospital Montpellier France

family: Duraes

full_name: Martha Duraes

given: Martha

family: Crochet

full_name: Patrice Crochet

given: Patrice

name: Department of radiology Montpellier University Hospital Montpellier France

family: Pagès

full_name: Emmanuelle Pagès

given: Emmanuelle

family: Grauby

full_name: Elsa Grauby

given: Elsa

family: Lasch

full_name: Lidia Lasch

given: Lidia

family: Rebel

full_name: Lucie Rebel

given: Lucie

family: Van Meer

full_name: Frederick Van Meer

given: Frederick

family: Rathat

full_name: Gauthier Rathat

given: Gauthier

journal_name: The Breast Journal

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Surgery of nonpalpable breast cancer: First step to a virtual per‐operative localization? First step to virtual breast cancer localization

lead_sponsor: University Hospital, Montpellier


title: Database of Data Collection in Senological Surgery

summary: For several years, the Paoli-Calmettes Institute has been centralizing the retrospective collection of clinical data of patients operated on for histologically proven breast cancer.

ReferenceCitation: Houvenaeghel G, Lambaudie E, Cohen M, Classe JM, Reyal F, Garbay JR, Giard S, Chopin N, Martinez A, Rouzier R, Daraï E, Colombo PE, Coutant C, Gimbergues P, Azuar P, Villet R, Tunon de Lara C, Barranger E, Sabiani L, Goncalves A. Therapeutic escalation - De-escalation: Data from 15.508 early breast cancer treated with upfront surgery and sentinel lymph node biopsy (SLNB). Breast. 2017 Aug;34:24-33. doi: 10.1016/j.breast.2017.04.008. Epub 2017 May 3.

family: Houvenaeghel

full_name: Gilles Houvenaeghel

given: Gilles

family: Lambaudie

full_name: Eric Lambaudie

given: Eric

family: Cohen

full_name: Monique Cohen

given: Monique

family: Classe

full_name: Jean-Marc Classe

given: Jean-Marc

family: Reyal

full_name: Fabien Reyal

given: Fabien

family: Garbay

full_name: Jean-Rémy Garbay

given: Jean-Rémy

family: Giard

full_name: Sylvia Giard

given: Sylvia

family: Chopin

full_name: Nicolas Chopin

given: Nicolas

family: Martinez

full_name: Alejandra Martinez

given: Alejandra

family: Rouzier

full_name: Roman Rouzier

given: Roman

family: Daraï

full_name: Emile Daraï

given: Emile

family: Colombo

full_name: Pierre Emmanuel Colombo

given: Pierre Emmanuel

family: Coutant

full_name: Charles Coutant

given: Charles

family: Gimbergues

full_name: Pierre Gimbergues

given: Pierre

family: Azuar

full_name: Pierre Azuar

family: Villet

full_name: Richard Villet

given: Richard

family: Tunon de Lara

full_name: Christine Tunon de Lara

given: Christine

family: Barranger

full_name: Emmanuel Barranger

given: Emmanuel

family: Sabiani

full_name: Laura Sabiani

given: Laura

family: Goncalves

full_name: Anthony Goncalves

given: Anthony

journal_name: The Breast

title: Therapeutic escalation – De-escalation: Data from 15.508 early breast cancer treated with upfront surgery and sentinel lymph node biopsy (SLNB)

ReferenceCitation: de Nonneville A, Gonçalves A, Zemmour C, Classe JM, Cohen M, Lambaudie E, Reyal F, Scherer C, Muracciole X, Colombo PE, Giard S, Rouzier R, Villet R, Chopin N, Darai E, Garbay JR, Gimbergues P, Sabiani L, Coutant C, Sabatier R, Bertucci F, Boher JM, Houvenaeghel G. Benefit of adjuvant chemotherapy with or without trastuzumab in pT1ab node-negative human epidermal growth factor receptor 2-positive breast carcinomas: results of a national multi-institutional study. Breast Cancer Res Treat. 2017 Apr;162(2):307-316. doi: 10.1007/s10549-017-4136-5. Epub 2017 Feb 2.

family: de Nonneville

full_name: Alexandre de Nonneville

given: Alexandre

ReferenceCitation: Lambaudie E, Houvenaeghel G, Ziouèche A, Knight S, Dravet F, Garbay JR, Giard S, Charitansky H, Cohen M, Faure C, Hudry D, Azuar P, Villet R, Gimbergues P, de Lara CT, Tallet A, Bannier M, Minsat M, Resbeut M. Exclusive intraoperative radiotherapy for invasive breast cancer in elderly patients (>70 years): proportion of eligible patients and local recurrence-free survival. BMC Surg. 2016 Nov 15;16(1):74.

ReferenceCitation: Houvenaeghel G, Sabatier R, Reyal F, Classe JM, Giard S, Charitansky H, Rouzier R, Faure C, Garbay JR, Daraï E, Hudry D, Gimbergues P, Villet R, Lambaudie E. Axillary lymph node micrometastases decrease triple-negative early breast cancer survival. Br J Cancer. 2016 Oct 25;115(9):1024-1031. doi: 10.1038/bjc.2016.283. Epub 2016 Sep 29.

ReferenceCitation: Houvenaeghel G, Boher JM, Reyal F, Cohen M, Garbay JR, Classe JM, Rouzier R, Giard S, Faure C, Charitansky H, Tunon de Lara C, Daraï E, Hudry D, Azuar P, Gimbergues P, Villet R, Sfumato P, Lambaudie E. Impact of completion axillary lymph node dissection in patients with breast cancer and isolated tumour cells or micrometastases in sentinel nodes. Eur J Cancer. 2016 Nov;67:106-118. doi: 10.1016/j.ejca.2016.08.003. Epub 2016 Sep 16.

ReferenceCitation: Sabiani L, Houvenaeghel G, Heinemann M, Reyal F, Classe JM, Cohen M, Garbay JR, Giard S, Charitansky H, Chopin N, Rouzier R, Daraï E, Coutant C, Azuar P, Gimbergues P, Villet R, Tunon de Lara C, Lambaudie E. Breast cancer in young women: Pathologic features and molecular phenotype. Breast. 2016 Oct;29:109-16. doi: 10.1016/j.breast.2016.07.007. Epub 2016 Jul 29.

ReferenceCitation: Houvenaeghel G, Classe JM, Garbay JR, Giard S, Cohen M, Faure C, Charytansky H, Rouzier R, Daraï E, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Martino M, Fraisse J, Dravet F, Chauvet MP, Goncalves A, Lambaudie E. Survival impact and predictive factors of axillary recurrence after sentinel biopsy. Eur J Cancer. 2016 May;58:73-82. doi: 10.1016/j.ejca.2016.01.019. Epub 2016 Mar 11.

ReferenceCitation: Jauffret C, Houvenaeghel G, Classe JM, Garbay JR, Giard S, Charitansky H, Cohen M, Bélichard C, Faure C, Darai É, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Martino M, Coutant C, Dravet F, Chauvet MP, Chéreau Ewald E, Penault-Llorca F, Goncalves A, Lambaudie É. [Lobular invasive breast cancer prognostic factors: About 940 patients]. Gynecol Obstet Fertil. 2015 Nov;43(11):712-7. doi: 10.1016/j.gyobfe.2015.09.007. Epub 2015 Oct 16. French.

title: Facteurs pronostiques des carcinomes lobulaires infiltrants du sein : à propos de 940 cas

ReferenceCitation: Ziouèche-Mottet A, Houvenaeghel G, Classe JM, Garbay JR, Giard S, Charitansky H, Cohen M, Belichard C, Faure C, Chéreau Ewald E, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Tallet A, Bannier M, Minsat M, Lambaudie E, Resbeut M. Eligibility criteria for intraoperative radiotherapy for breast cancer: study employing 12,025 patients treated in two cohorts. BMC Cancer. 2014 Nov 24;14:868. doi: 10.1186/1471-2407-14-868.

ReferenceCitation: Houvenaeghel G, Classe JM, Garbay JR, Giard S, Cohen M, Faure C, Hélène C, Belichard C, Uzan S, Hudry D, Azuar P, Villet R, Penault Llorca F, Tunon de Lara C, Goncalves A, Esterni B; et al. Prognostic value of isolated tumor cells and micrometastases of lymph nodes in early-stage breast cancer: a French sentinel node multicenter cohort study. Breast. 2014 Oct;23(5):561-6. doi: 10.1016/j.breast.2014.04.004. Epub 2014 May 27.

title: Prognostic value of isolated tumor cells and micrometastases of lymph nodes in early-stage breast cancer: A French sentinel node multicenter cohort study

ReferenceCitation: Houvenaeghel G, Goncalves A, Classe JM, Garbay JR, Giard S, Charytensky H, Cohen M, Belichard C, Faure C, Uzan S, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Martino M, Lambaudie E, Coutant C, Dravet F, Chauvet MP, Chéreau Ewald E, Penault-Llorca F, Esterni B. Characteristics and clinical outcome of T1 breast cancer: a multicenter retrospective cohort study. Ann Oncol. 2014 Mar;25(3):623-628. doi: 10.1093/annonc/mdt532. Epub 2014 Jan 7.

ReferenceCitation: Houvenaeghel G, Bannier M, Nos C, Giard S, Mignotte H, Jacquemier J, Martino M, Esterni B, Belichard C, Classe JM, Tunon de Lara C, Cohen M, Payan R, Blanchot J, Rouanet P, Penault-Llorca F, Bonnier P, Fournet S, Agostini A, Marchal F, Garbay JR. Non sentinel node involvement prediction for sentinel node micrometastases in breast cancer: nomogram validation and comparison with other models. Breast. 2012 Apr;21(2):204-9. doi: 10.1016/j.breast.2011.09.013. Epub 2011 Oct 19.

title: Non sentinel node involvement prediction for sentinel node micrometastases in breast cancer: Nomogram validation and comparison with other models

ReferenceCitation: Houvenaeghel G, Nos C, Giard S, Mignotte H, Esterni B, Jacquemier J, Buttarelli M, Classe JM, Cohen M, Rouanet P, Penault Llorca F, Bonnier P, Marchal F, Garbay JR, Fraisse J, Martel P, Fondrinier E, Tunon de Lara C, Rodier JF. A nomogram predictive of non-sentinel lymph node involvement in breast cancer patients with a sentinel lymph node micrometastasis. Eur J Surg Oncol. 2009 Jul;35(7):690-5. doi: 10.1016/j.ejso.2008.10.003. Epub 2008 Nov 28.

journal_name: European Journal of Surgical Oncology (EJSO)

ReferenceCitation: Houvenaeghel G, Nos C, Mignotte H, Classe JM, Giard S, Rouanet P, Lorca FP, Jacquemier J, Bardou VJ; Groupe des Chirurgiens de la Federation des Centres de Lutte Contre le Cancer. Micrometastases in sentinel lymph node in a multicentric study: predictive factors of nonsentinel lymph node involvement--Groupe des Chirurgiens de la Federation des Centres de Lutte Contre le Cancer. J Clin Oncol. 2006 Apr 20;24(12):1814-22. Epub 2006 Mar 27.


title: Fluid Responsiveness Evaluation in Patients With Acute Circulatory Failure and Arrhythmia With Atrial Fibrillation: Indice Delta ITV / Delta RR

summary:
Fluid therapy is often used as first line treatment of acute circulatory failure, aiming an increase in cardiac output (by improving preload) and in tissue perfusion. Depending on left ventricular systolic function, fluid challenge could lead to an increase in cardiac ouput and tissue perfusion, or only detrimental consequences (by fluid overload and aggravation of lung and tissues oedema, increase of morbi-mortality). Patients are defined as responders to fluid therapy if one can observe an increase of cardiac output up to 15% after fluid therapy (500ml of crystalloids): gold standard test used in most of the studies on the subject. Literature reports on heterogenous populations a reproductible and constant response rate to this fluid challenge of 50%. It seems reasonable to dispose of indices allowing to predict fluid responsiveness without resulting in fluid intake. Statics markers have been abandonned for several years and dynamics methods have been developped.

In front of arrythmia, validated methods are scarce. Passive leg rising method appears to be the only one and it's validity seems to be less well documented than in sinusal patients. The purpose of this study is to determine a new method to assess fluid responsiveness in arrythmic patients.

In atrial fibrillation, RR interval varies widely between cardiac cylces. Systolic interval remain constant. Variations will occure at expense of diastolic interval, or ventricular filling interval. One can reliably assume that when RR is longer, preload is rising. If the patient is on the ascendant part of the Franck-Starling curve, a longer RR should cause au greater VTI (Vitess Time Integral, surrogate of cardiac output).

The evaluation by transthoracic echocardiography of the indice delta ITV / delta RR should determine the degree of fluid responsiveness in arrhythmic patients.

After decision of fluid expansion, patients will have haemodynamic and echocardiographic data measured, delta ITV / delta RR indice assessed, then passive leg rising and fluid expansion with 500 ml of cristalloids administered, with evaluation of VTI (as surrogate of cardiac output) at each time. Fluid responders will be compared to non-responders to evaluate the diagnostic performances of the indice delta ITV / delta RR.

lead_sponsor: Poitiers University Hospital


title: MRI of the Brachial Plexus and Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Assessment of DTI-derived Measurements at 3.0-T

acronym: PIDC

summary:
The main purpose of this study is to assess the clinical feasibility of diffusion tensor imaging (DTI) for the diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). For thar purpose, investigator will compare, fractional anisotropy (FA) obtained by diffusion tensor imaging (DTI) MRI 3T on brachial plexus and cervical spinal nerve roots between patients with defined Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), according to the EFNS 2010 criteria, and healthy controls.

The secondary outcomes will be to compare DTI parameters (FA, ADC or Apparent Diffusion Coefficient) between CIDP patients, healthy volunteers, and patients with Charcot Marie Tooth disease type 1a (CMT1a) and MRI morphological parameters (T1, STIR) between these groups. Moreover, investigator will investigate the possible relationship between MRI parameters, clinical indices, and electrophysiological measure.


title: Symptomatic Efficacy of Microparticle Arterial Embolization in Knee Osteoarthritis Resistant to Medical Treatment: Randomized Prospective Study Versus Placebo

acronym: EMBARGO

summary: The aim of this double-blind, randomized, single-center prospective study (patient and evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.


title: Use of the Rhytmia System for Determining the Precise Location and Potential Mechanism of Premature Ventricular Contractions

acronym: RhytmiaPVC

summary: This is a purely observational project and the objectives are to record and analyze the local potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard procedures, to highlight the advantages of the system compared to conventional mapping and to characterize optimal pace map or activation map as achieved by the Rhythmia system.

lead_sponsor: University Hospital, Toulouse


title: The French hMPV Study: Clinical Features, Outcome and Prognosis of Human Metapneumovirus (hMPV) Lower Respiratory Tract Infections in Adult Inpatients

acronym: French-hMPV

summary:
The human metapneumovirus (hMPV) was first described in 2001. It belongs to the paramyxovirus family and is genetically close to the Respiratory Syncytial Virus (RSV). hMPV has a seasonal epidemic pattern, between January to April. Clinical symptoms of hMPV infection include influenza-like illness (fever, asthenia and curvatures) associated with signs of respiratory tract infection. The incidence of hMPV infection is higher in children than in adults. In child pneumonia, hMPV is the third most frequent isolated pathogen (14 % of the subjects), after rhinovirus and RSV. In hospitalized adults, hMPV was detected in 6 to 8% of the subjects with lower respiratory tract and in 4 % of subjects with pneumonia.

Clinical, radiological and biological features, as well as evolution course of hMPV infections have been mainly described in children. Clinical presentation of in adult seems polymorph, ranging from acute bronchitis or exacerbation of COPD to pneumonia. The frequency of viral-bacterial coinfection is unknown. Intensive care unit (ICU) admission may involve almost 1 for 10 patients. Elderly and immunocompromised subjects are probably high-risk subjects.

Currently, treatment of hMPV infections is mainly symptomatic. However, several anti-RSV drugs that are currently in clinical development have demonstrated an activity against other paramyxoviridae in pre-clinical studies. Consequently, it seems necessary to better characterize hMPV infections in adult inpatients: presentation, course profile and risk factors for morbidity and mortality. These data would help clinicians to identify high risk patients, and consequently to choose those who could benefit from coming treatments.

The French hMPV Study is observational prospective multicenter clinical study. The study population includes all consecutive adult inpatients with a community-acquired acute lower respiratory tract infection and a mPCR positive for hMPV on any respiratory sample. The primary objective is to describe the prognosis. The secondary objectives are i) to characterize clinical, radiological and biological features, ii) to describe the hospital course and the rate of ICU transfer; in ICU patients, to describe organ failures and supports, and iii) to describe the viral and/or bacterial coinfections. The primary endpoint is the number of subjects with a poor outcome (defined by the requirement for invasive mechanical ventilation and/or the death during the hospital stay).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation in Intensive Care Unit: A Comparative Prospective Study

acronym: SEVOCOPD

summary:
Prospective, open-label, single-center, study to investigate the effect of sevoflurane sedation compared to a propofol-controlled arm during COPD exacerbation requiring invasive mechanical ventilation in ICU.

Primary outcome measure:

Evolution of airway resistance before and after sevoflurane in COPD patients,

Secondary outcomes measures:

Respiratory mechanics (Maximum pressure, PEEPi and PEEPtot, trapped volume), Gas exchange by the help of blood gases, The heterogeneity of alveolar ventilation by electro-impedancemetry, Evolution of pulmonary inflammation, Trophicity and contractility of the diaphragm,


title: Sexuality of the Man Whose Couple is Taken Care of in Medical Assistance to Procreation. Study of Case Witnesses

acronym: AMPlaisir

summary:
According to the World Health Organization and the World Association for Sexual Health, sexual health is directly associated with the psychological well-being and quality of life of each individual.

Infertility is a real public health problem. In recent years, there has been a clear decline in male fertility in industrialized countries, particularly in sperm quality. Male infertility may be perceived as a loss of masculinity and so men will be more reluctant to talk about their fertility problem than women. The studies published so far have focused on infertile men without any specification on the type or stage of care in Medically assisted procreation (MAP).

Through our work, we propose to evaluate the impact of the type of care in Medical Assistance with procreation on the sexuality of man. Does the type of MAP technique used (intrauterine insemination, in vitro fertilization or intra cytoplasmic sperm injection) have an impact on male sexuality? Sexual health and reproductive health are closely linked; management of sexual disorders is essential to improve the quality of life. A prevention of sexual difficulties during the care of these patients in MAP can be set up in the MAP service from Clermont-Ferrand hospital.

The main objective of our study is therefore to evaluate the perceived quality of sexuality by the man whose couple is engaged in a process of medical assistance to procreation.