type: EudraCT Number

title: Phase I, Open-label, Multicenter Study to Evaluate the Imaging Performance, Safety, Biodistribution and Dosimetry of [68Ga]-FF58 in Adult Patients With Selected Solid Tumors Expectedto Overexpress αvβ3 and αvβ5 Integrins.

summary: This is a First-In-Human (FIH) study of [68Ga]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of [68Ga]-FF58 in adults with relapsed or refractory (r/r) glioblastoma multiforme (GBM) or Human Epidermal growth factor Receptor 2 positive (Her2+) breast cancer that has metastasized to the brain expected to overexpress alpha-v beta 3 (αvβ3) and alpha-v beta 5 (αvβ5) integrins.

lead_sponsor: Novartis Pharmaceuticals


type: Other Identifier

title: tDCS and Prismatic Adaptation: Roles of the Cerebellum and the Primary Motor Cortex in the Transfer of After-effects to a Non-exposed Task.

acronym: TRANSTIM

summary:
Human beings are able to produce precise and smooth movements despite varying demands thank to the nervous system plasticity. Primastic exposure is a method that allows to easily study these sensorimotor plasticity processes in a laboratory context. In a typical protocol, participants wear prismatic goggles that induce a lateral deviation of the visual field while performing a goal directed motor task (e.g. pointing). During the first trials, participants make errors in the direction of the deviation and correct them trial-by-trial. Finally, participants go back to baseline performances after a few dozen of trials. Upon goggles removal, participants make mistakes toward the direction opposition to the initial prismatic deviation. These after-effects reflect adaptive processes that occurred to counteract the perturbation. The way that these after-effects can be transferred to other situations which have not been exposed to the prismatic perturbation bring crucial information about the nature of the processes involved. Additionally, these transfer properties might be of great interest in the field of neuro rehabilitation. In fact, the purpose of therapeutic strategies is to induce compensations that can be transferred to daily life situations.

In previous studies, the investigator showed that expertise on the exposed had a notable influence on transfer properties. However, these studies did not allow to identify the cerebral regions involved in transfer.

The cerebellum is described as a major area implied during motor adaptation and the occurrence of after-effects, while the primary motor cortex might play a crucial role in the formation of motor memory. As such, these two regions are likely to be involved in transfer properties.

The objective of this project is to identify the roles of the cerebellum and the primary motor cortex in the transfer of visuomotor compensations acquired during prism exposure to task that has not been practiced under the perturbation. To do so, the investigator will use transcranial direct current stimulation (tDCS) which is a non-painful and non-invasive functional brain stimulation method. Several groups will be constituted to test if stimulation (inhibitory and excitatory) of the cerebellum or the primary motor on the transfer of prism acquired compensations to a non-exposed task. More precisely, the investigator aim to study the influence of different stimulation modalities (cerebellum vs MA, inhibitory vs excitatory vs sham) on the error reduction during prism exposure, on the amount of after-effects and on the amount on transfer to the non-exposed task.

On a fundamental level, this project will allow a better understanding of the sensorimotor plasticity processes involved to counteract a perturbation and about mechanisms underlying transfer properties. Future results would allows to shed light on the conditions necessary to give rise to transfer as well as the implied brain regions. On longer-term these results will be used to optimize rehabitation strategies in motor function recovery in order to favour the transfer of acquired compensations to daily life situations.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Neuroscience de Lyon INSERM U1028, Equipe ImpAct

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Healthy-related Quality of Life and Physical Activity of Children With Inherited Cardiac Arrhythmia or Inherited Cardiomyopathies: the Prospective Multicentre Controlled QUALIMYORYTHM Study

acronym: QUALIMYORYTHM

summary: The QUALIMYORYTHM trial is a multicentre controlled study, aiming to assess health-related quality of life (HRQoL) of 107 children aged 6 to 18 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathies (hypertrophic, dilated, or restrictive cardiomyopathy), and to compare the results to those of 107 age and gender-matched healthy subjects. The secondary objective is to assess, in this population, the HRQoL according to disease characteristics, level of physical activity, exercise capacity, and socio-demographic data. Participants will wear a fitness tracker for 2 weeks.

study_start_date_type: Actual

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6.

family: Amedro

full_name: Pascal Amedro

given: Pascal

sequence: first

family: Werner

full_name: Oscar Werner

given: Oscar

sequence: additional

family: Abassi

full_name: Hamouda Abassi

given: Hamouda

family: Boisson

full_name: Aymeric Boisson

given: Aymeric

family: Souilla

full_name: Luc Souilla

given: Luc

family: Guillaumont

full_name: Sophie Guillaumont

given: Sophie

family: Calderon

full_name: Johanna Calderon

given: Johanna

family: Requirand

full_name: Anne Requirand

given: Anne

family: Vincenti

full_name: Marie Vincenti

given: Marie

family: Pommier

full_name: Victor Pommier

given: Victor

family: Matecki

full_name: Stefan Matecki

given: Stefan

family: De La Villeon

full_name: Gregoire De La Villeon

given: Gregoire

family: Lavastre

full_name: Kathleen Lavastre

given: Kathleen

family: Lacampagne

full_name: Alain Lacampagne

given: Alain

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Beyler

full_name: Constance Beyler

given: Constance

family: Delclaux

full_name: Christophe Delclaux

given: Christophe

family: Dulac

full_name: Yves Dulac

given: Yves

family: Guitarte

full_name: Aitor Guitarte

given: Aitor

family: Charron

full_name: Philippe Charron

given: Philippe

family: Denjoy-Urbain

full_name: Isabelle Denjoy-Urbain

given: Isabelle

family: Probst

full_name: Vincent Probst

given: Vincent

family: Baruteau

full_name: Alban-Elouen Baruteau

given: Alban-Elouen

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon


title: Covert Saccade Triggers in Bilateral Vestibular Hypofunction

acronym: CS-TRIGGER

summary: Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The triggering of these covert-saccade is still not known. They could be of visual origin but the short latency is unusual. The objective of this study is to evaluate the potential role of visual trigger in 12 patients with chronic bilateral areflexia, using different visuo-vestibular conditions. The latency of simple visually guided saccades will also be tested in the group of patients and a group of 12 healthy controls.

primary_purpose: Basic Science

intervention_type: Other


title: Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

acronym: RAACHYS

summary: It is an observational study, prospective in order to assess the impact of the implementation of an early rehabilitation program on post-operative recovery. this is measured by the qOR15 questionnaire in patients operated on for a programmed hysterectomy, it takes place in the gynecology department of the CHR Metz-Thionville hospital.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Reliability and Competing Validity of the FeetMe Monitordevice® Measurement of the Spatial-temporal Parameters of the gaitRite System® in Healthy Subjects

summary:
The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals.

At D0 and D7, the volunteer is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Healthy volunteers have two measurements 7 days apart. The volunteer repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the volunteer.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: FeetMe

location_facility: Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: industriel

status_simplified: Completed


title: Clinical and Molecular Aspects of Early Osteoarthritis

summary:
The etiology of osteoarthritis is varied, ranging from multifactorial, environmental to monogenic. In individuals in whom osteoarthritis appears earlier than in the general population, it is called early osteoarthritis. To our knowledge, there are no large-scale genetic studies on people with early osteoarthritis. The investigators therefore sought to study the causes of monogenic osteoarthritis in people suffering from early non-syndromic osteoarthritis.

Material and method From 2013 to 2019, experts in constitutional bone disease sent patients with non-syndromic early osteoarthritis for genetic analysis to our center of competence for constitutional bone diseases. The sequencing of a panel of genes was carried out by NGS.

time_perspective: Other

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Phase I-II Study of Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma

acronym: NIVOGLIO

summary:
Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, safety run study in nine patients. In case of safety issue a -1 dose level will be tested.

Phase II : Open label, non randomized, efficacy study of nivolumab in addition to radiotherapy and temozolomide. This phase will start when the RP2D has been defined after the last patients evaluable for DLT achieved the first 6 weeks of treatment (the radio-chemotherapy period) with a DLT rate below 30% during the the phase I study.

primary_purpose: Treatment

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Radiation


title: FeetMe® Monitor Connected Insoles Are a Valid and Reliable Alternative for the Evaluation of Gait Speed After Stroke

summary:
The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite for a pathologic gait. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals.

At D0 and D7, the patient is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Hemiparetic patients have two measurements 7 days apart. The patient repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the patient.


title: Adrenocorticotropic Hormone Stability on Whole Blood

acronym: STABACT

summary:
ACTH is a peptide secreted by pituitary gland and plays an important role in regulating cortisol secretion. ACTH is determined in plasma by immunoassays using specific antibodies. Its determination is difficult because of instability in whole blood. Several factors which influence ACTH stability in blood before analysis have been identified: temperature, hemolysis, time to centrifugation and presence of protease inhibitors. Published results on ACTH whole blood stability seem contradictory.

The objective of this study is to evaluate the effect of aprotinin in 10 healthy volunteers. ACTH measurements will be performed on cobas e602 (Roche Diagnostics, Mannheim, Germany).

lead_sponsor: University Hospital, Rouen

intervention_type: Biological


title: Emergency Departement (ED) Hypernatremia. Prognostic Factors and Epidemiology. About a Single-center Prospective Study

acronym: NATSAU

summary: This study evaluate the 1-month mortality of patients who proceed a blood sample while in the ED with an hypernatremia (>145 mmol/l). This prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients

acronym: DOREPAR

summary: Pain is one of the non-motor symptoms of Parkinson's disease still poorly known and misdiagnosed and its management is complex. This encourage to explore new non-drug therapeutic paths, such as foot reflexology (FR). the present study proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of FR on pain, compared to sham massage.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


title: E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain

acronym: E-lombactifs

summary:
The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients.

Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months.

A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain.

The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

acronym: STIMADHD

summary: Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurodevelopmental disorder in childhood. Patients with ADHD present inattention, impulsivity and hyperactivity causing severe impairments on academic achievement, social and professional life and daily functioning. Medications are effective in a majority of children with ADHD, but about 30% do not respond or tolerate stimulants, and some parents refuse pharmacological treatments.Transcranial Direct Current Stimulation is a safe and non-invasive technique of brain stimulation used in several neurological and psychiatric disorders, and recently in ADHD. In patients with ADHD, tDCS stimulations targeted frontal regions improve executive and attentional functioning and daily life symptoms. The objective of this project is to evaluate the efficacy of tDCS (vs sham) during cognitive-remediation exercises on ADHD symptoms (inattention, impulsivity and hyperactivity as defined by DSM-5) in children with ADHD between 7 and 14 years of age.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations

summary: This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris


title: Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care

acronym: COMEBAC

summary: To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia

time_perspective: Retrospective


title: Latest Imaging SPECT System Evaluation Phase 1

summary: Monocentric study for the evaluation of a whole body CZT scintigraphy system.

ReferenceType: background

ReferenceCitation: Garcia EV, Faber TL, Esteves FP. Cardiac dedicated ultrafast SPECT cameras: new designs and clinical implications. J Nucl Med. 2011 Feb;52(2):210-7. doi: 10.2967/jnumed.110.081323. Epub 2011 Jan 13. Review.

ReferenceCitation: Garcia EV. Are SPECT measurements of myocardial blood flow and flow reserve ready for clinical use? Eur J Nucl Med Mol Imaging. 2014 Dec;41(12):2291-3. doi: 10.1007/s00259-014-2924-2.

ReferenceCitation: Slomka PJ, Berman DS, Germano G. New cardiac cameras: single-photon emission CT and PET. Semin Nucl Med. 2014 Jul;44(4):232-51. doi: 10.1053/j.semnuclmed.2014.04.003. Review.

ReferenceCitation: Bani Sadr A, Testart N, Tylski P, Scheiber C. Reduced Scan Time in 123I-FP-CIT SPECT Imaging Using a Large-Field Cadmium-Zinc-Telluride Camera. Clin Nucl Med. 2019 Jul;44(7):568-569. doi: 10.1097/RLU.0000000000002554.

ReferenceCitation: Salerno M, Beller GA. Noninvasive assessment of myocardial perfusion. Circ Cardiovasc Imaging. 2009 Sep;2(5):412-24. doi: 10.1161/CIRCIMAGING.109.854893. Review.

ReferenceCitation: Mowatt G, Vale L, MacLeod A. Systematic review of the effectiveness of home versus hospital or satellite unit hemodialysis for people with end-stage renal failure. Int J Technol Assess Health Care. 2004 Summer;20(3):258-68. Review.

ReferenceCitation: Loong CY, Anagnostopoulos C. Diagnosis of coronary artery disease by radionuclide myocardial perfusion imaging. Heart. 2004 Aug;90 Suppl 5:v2-9. Review.

ReferenceCitation: Roach PJ, Gradinscak DJ, Schembri GP, Bailey EA, Willowson KP, Bailey DL. SPECT/CT in V/Q scanning. Semin Nucl Med. 2010 Nov;40(6):455-66. doi: 10.1053/j.semnuclmed.2010.07.005. Review.

ReferenceCitation: Valotassiou V, Malamitsi J, Papatriantafyllou J, Dardiotis E, Tsougos I, Psimadas D, Alexiou S, Hadjigeorgiou G, Georgoulias P. SPECT and PET imaging in Alzheimer's disease. Ann Nucl Med. 2018 Nov;32(9):583-593. doi: 10.1007/s12149-018-1292-6. Epub 2018 Aug 20. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins

acronym: SESAME

summary: Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.

lead_sponsor: University Hospital, Tours

location_facility: Department of Dermatology, Hospital University of Tours


type: Registry Identifier

title: Diagnostic Accuracy of Electrochemical Skin Conductance Measurement in Paediatric Small Fibre Neuropathy Following Neurotoxic Chemotherapy

acronym: SUDOPED

summary: The purpose of this study is to determine the diagnostic accuracy of a newly developed tool (Electrochemical Skin Conductances (ESC) measurement) easy-to-perform, non-invasive, highly reproductible and not requiring specific training, to identify pediatric chemotherapy-induced-peripheral-neuropathies (CIPN). CIPN are a frequent (20 to 75% depending on the drug), early and potentially severe long-lasting and dose limiting adverse effect of treatments in immuno-hematology and cancerology. The pathophysiology, the chronology of injury (ie small then large sensory nerve fiber or vice-versa) and the age-related short/long-term impact on peripheral nerves remain largely not understood. Clinical signs of CIPN are highly heterogenous, often under-recognized and include diverse sensory symptoms and pain. Persistent loss of sensation and strength as well as neuropathic pain may have a short/long-term impact in term of functional limitations and quality of life. There is a lack of specific and sensitive measurement tools for CIPN in the pediatric population. Neurophysiological tools (except electro-neuro-myography allowing only the assessment of large myelinated nerves) are not implemented in the pediatric oncology-hematology everyday practice: they are often invasive and/or poorly reproducible, not accessible for "bedside" follow-up, and lacking normative values, thus often dedicated only to research. ESC may provide an early and quantitative assessment of small fiber dysfunction in children, a prerequisite for the identification of additional preventive or curative approaches in CIPN.

ReferenceCitation: Kandula T, Farrar MA, Kiernan MC, Krishnan AV, Goldstein D, Horvath L, Grimison P, Boyle F, Baron-Hay S, Park SB. Neurophysiological and clinical outcomes in chemotherapy-induced neuropathy in cancer. Clin Neurophysiol. 2017 Jul;128(7):1166-1175. doi: 10.1016/j.clinph.2017.04.009. Epub 2017 Apr 25. Review.

ReferenceCitation: Kandula T, Farrar MA, Cohn RJ, Mizrahi D, Carey K, Johnston K, Kiernan MC, Krishnan AV, Park SB. Chemotherapy-Induced Peripheral Neuropathy in Long-term Survivors of Childhood Cancer: Clinical, Neurophysiological, Functional, and Patient-Reported Outcomes. JAMA Neurol. 2018 Aug 1;75(8):980-988. doi: 10.1001/jamaneurol.2018.0963. Erratum in: JAMA Neurol. 2018 Aug 1;75(8):1028.

ReferenceCitation: Gilchrist LS, Tanner L. The pediatric-modified total neuropathy score: a reliable and valid measure of chemotherapy-induced peripheral neuropathy in children with non-CNS cancers. Support Care Cancer. 2013 Mar;21(3):847-56. doi: 10.1007/s00520-012-1591-8. Epub 2012 Sep 20.

ReferenceCitation: Gibbons CH, Wang N, Freeman R. Capsaicin induces degeneration of cutaneous autonomic nerve fibers. Ann Neurol. 2010 Dec;68(6):888-98. doi: 10.1002/ana.22126.

ReferenceCitation: Castro J, Miranda B, Castro I, de Carvalho M, Conceição I. The diagnostic accuracy of Sudoscan in transthyretin familial amyloid polyneuropathy. Clin Neurophysiol. 2016 May;127(5):2222-7. doi: 10.1016/j.clinph.2016.02.013. Epub 2016 Feb 27.

ReferenceCitation: Lefaucheur JP, Wahab A, Planté-Bordeneuve V, Sène D, Ménard-Lefaucheur I, Rouie D, Tebbal D, Salhi H, Créange A, Zouari H, Ng Wing Tin S. Diagnosis of small fiber neuropathy: A comparative study of five neurophysiological tests. Neurophysiol Clin. 2015 Dec;45(6):445-55. doi: 10.1016/j.neucli.2015.09.012. Epub 2015 Nov 17.

ReferenceCitation: Leclair-Visonneau L, Bosquet T, Magot A, Fayet G, Gras-Le Guen C, Hamel A, Péréon Y. Electrochemical skin conductance for quantitative assessment of sweat function: Normative values in children. Clin Neurophysiol Pract. 2016 Jul 27;1:43-45. doi: 10.1016/j.cnp.2016.07.001. eCollection 2016.

intervention_type: Diagnostic Test


title: Effectiveness of a Multifaceted Program to Improve Interpersonal Skills of Physicians in Medical Consultations. A Randomized Controlled Trial (EPECREM)

acronym: EPECREM

summary: To determine whether the implementation of a multifaceted training program relying on the conceptual framework of the Four Habits Model improved the communication and interpersonal skills for hospital physicians during consultations compared with control physicians receiving no intervention, the investigators will conduct a prospective randomized, controlled, open-label, two parallel arms, superiority interventional trial. The unit of randomization is the physician.

ReferenceCitation: Bellier A, Chaffanjon P, Krupat E, Francois P, Labarère J. Cross-cultural adaptation of the 4-Habits Coding Scheme into French to assess physician communication skills. PLoS One. 2020 Apr 16;15(4):e0230672. doi: 10.1371/journal.pone.0230672. eCollection 2020.

ReferenceCitation: Fossli Jensen B, Gulbrandsen P, Dahl FA, Krupat E, Frankel RM, Finset A. Effectiveness of a short course in clinical communication skills for hospital doctors: results of a crossover randomized controlled trial (ISRCTN22153332). Patient Educ Couns. 2011 Aug;84(2):163-9. doi: 10.1016/j.pec.2010.08.028. Epub 2010 Nov 2.

ReferenceCitation: Krupat E, Frankel R, Stein T, Irish J. The Four Habits Coding Scheme: validation of an instrument to assess clinicians' communication behavior. Patient Educ Couns. 2006 Jul;62(1):38-45. Epub 2005 Jun 17.

lead_sponsor: University Hospital, Grenoble


title: Pilot Study on the Assessment of Motor Imaging Skills in Patients With Complex Regional Pain Syndrome (CRPS)

acronym: ImagNimes

summary: Medical functional imagery seems to demonstrate that patients suffering from complex regional pain syndrome (CRPS) have cortical modifications that alter their motor (or mental) imagery capacities. Nowadays, the use of motor imagery exercises are used in conventional rehabilitation treatments. But, in clinical practice, no study has verified if patients with CRPS desmonstrate problems in their motor imagery capacities. The MIQ-RS (Motor Imagery Questionnaire - Revised Second) is a valid, reliable and translated into French questionnaire to measure patients' capacities to do mental imagery. In this study, we compare 3 groups of 50 patients : healthy patients, patients with CRPS and patients with musculoskeletal disorder without CRPS. Every patient will take the MIQ-RS for the right and left body side. We hypothesis that patients with CRPS have more deficit than the 2 others to realise motor imagery.

primary_purpose: Screening

ReferenceCitation: Birklein F, O'Neill D, Schlereth T. Complex regional pain syndrome: An optimistic perspective. Neurology. 2015 Jan 6;84(1):89-96. doi: 10.1212/WNL.0000000000001095. Epub 2014 Dec 3. Review.

ReferenceCitation: Boesch E, Bellan V, Moseley GL, Stanton TR. The effect of bodily illusions on clinical pain: a systematic review and meta-analysis. Pain. 2016 Mar;157(3):516-529. doi: 10.1097/j.pain.0000000000000423. Review.

ReferenceCitation: Breivik H, Allen SM, Stubhaug A. Mirror-therapy: An important tool in the management of Complex Regional Pain Syndrome (CRPS). Scand J Pain. 2013 Oct 1;4(4):190-197. doi: 10.1016/j.sjpain.2013.07.019.

ReferenceCitation: Butler AJ, Cazeaux J, Fidler A, Jansen J, Lefkove N, Gregg M, Hall C, Easley KA, Shenvi N, Wolf SL. The Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Is a Reliable and Valid Tool for Evaluating Motor Imagery in Stroke Populations. Evid Based Complement Alternat Med. 2012;2012:497289. doi: 10.1155/2012/497289. Epub 2012 Feb 28.

ReferenceCitation: Cacchio A, De Blasis E, De Blasis V, Santilli V, Spacca G. Mirror therapy in complex regional pain syndrome type 1 of the upper limb in stroke patients. Neurorehabil Neural Repair. 2009 Oct;23(8):792-9. doi: 10.1177/1545968309335977. Epub 2009 May 22.

ReferenceCitation: de Souza NS, Martins AC, Bastos VH, Orsini M, Leite MA, Teixeira S, Velasques B, Ribeiro P, Bittencourt J, Matta AP, Filho PM. Motor Imagery and Its Effect on Complex Regional Pain Syndrome: An Integrative Review. Neurol Int. 2015 Dec 31;7(3):5962. doi: 10.4081/ni.2015.5962. eCollection 2015 Dec 29. Review.

ReferenceCitation: de Vries S, Tepper M, Feenstra W, Oosterveld H, Boonstra AM, Otten B. Motor imagery ability in stroke patients: the relationship between implicit and explicit motor imagery measures. Front Hum Neurosci. 2013 Nov 19;7:790. doi: 10.3389/fnhum.2013.00790. eCollection 2013.

ReferenceCitation: Deconinck FJ, Smorenburg AR, Benham A, Ledebt A, Feltham MG, Savelsbergh GJ. Reflections on mirror therapy: a systematic review of the effect of mirror visual feedback on the brain. Neurorehabil Neural Repair. 2015 May;29(4):349-61. doi: 10.1177/1545968314546134. Epub 2014 Aug 26. Review.

ReferenceCitation: den Hollander M, Heijnders N, de Jong JR, Vlaeyen JWS, Smeets RJEM, Goossens MEJB. EXPOSURE IN VIVO VERSUS PAIN-CONTINGENT PHYSICAL THERAPY IN COMPLEX REGIONAL PAIN SYNDROME TYPE I: A COST-EFFECTIVENESS ANALYSIS. Int J Technol Assess Health Care. 2018 Jan;34(4):400-409. doi: 10.1017/S0266462318000429. Epub 2018 Jul 26.

ReferenceCitation: Duong S, Bravo D, Todd KJ, Finlayson RJ, Tran Q. Treatment of complex regional pain syndrome: an updated systematic review and narrative synthesis. Can J Anaesth. 2018 Jun;65(6):658-684. doi: 10.1007/s12630-018-1091-5. Epub 2018 Feb 28.

ReferenceCitation: Elsamadicy AA, Yang S, Sergesketter AR, Ashraf B, Charalambous L, Kemeny H, Ejikeme T, Ren X, Pagadala P, Parente B, Xie J, Lad SP. Prevalence and Cost Analysis of Complex Regional Pain Syndrome (CRPS): A Role for Neuromodulation. Neuromodulation. 2018 Jul;21(5):423-430. doi: 10.1111/ner.12691. Epub 2017 Sep 29. Review.

ReferenceCitation: Ezendam D, Bongers RM, Jannink MJ. Systematic review of the effectiveness of mirror therapy in upper extremity function. Disabil Rehabil. 2009;31(26):2135-49. doi: 10.3109/09638280902887768. Review.

ReferenceCitation: Gregg M, Hall C, Butler A. The MIQ-RS: A Suitable Option for Examining Movement Imagery Ability. Evid Based Complement Alternat Med. 2010 Jun;7(2):249-57. doi: 10.1093/ecam/nem170. Epub 2007 Dec 26.

ReferenceCitation: Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Schlereth T, Chont M, Vatine JJ. Development of a severity score for CRPS. Pain. 2010 Dec;151(3):870-876. doi: 10.1016/j.pain.2010.09.031. Epub 2010 Oct 20.

ReferenceCitation: Harden RN, Oaklander AL, Burton AW, Perez RS, Richardson K, Swan M, Barthel J, Costa B, Graciosa JR, Bruehl S; Reflex Sympathetic Dystrophy Syndrome Association. Complex regional pain syndrome: practical diagnostic and treatment guidelines, 4th edition. Pain Med. 2013 Feb;14(2):180-229. doi: 10.1111/pme.12033. Epub 2013 Jan 17.

ReferenceCitation: Harris JE, Hebert A. Utilization of motor imagery in upper limb rehabilitation: a systematic scoping review. Clin Rehabil. 2015 Nov;29(11):1092-107. doi: 10.1177/0269215514566248. Epub 2015 Jan 20. Review.

ReferenceCitation: Lorey B, Pilgramm S, Bischoff M, Stark R, Vaitl D, Kindermann S, Munzert J, Zentgraf K. Activation of the parieto-premotor network is associated with vivid motor imagery--a parametric FMRI study. PLoS One. 2011;6(5):e20368. doi: 10.1371/journal.pone.0020368. Epub 2011 May 31.

ReferenceCitation: Loison B, Moussaddaq AS, Cormier J, Richard I, Ferrapie AL, Ramond A, Dinomais M. Translation and validation of the French Movement Imagery Questionnaire - Revised Second Version (MIQ-RS). Ann Phys Rehabil Med. 2013 Apr;56(3):157-73. doi: 10.1016/j.rehab.2013.01.001. Epub 2013 Jan 29.

ReferenceCitation: Maihöfner C, Baron R, DeCol R, Binder A, Birklein F, Deuschl G, Handwerker HO, Schattschneider J. The motor system shows adaptive changes in complex regional pain syndrome. Brain. 2007 Oct;130(Pt 10):2671-87. Epub 2007 Jun 15.

ReferenceCitation: Maihöfner C, Forster C, Birklein F, Neundörfer B, Handwerker HO. Brain processing during mechanical hyperalgesia in complex regional pain syndrome: a functional MRI study. Pain. 2005 Mar;114(1-2):93-103. Epub 2005 Jan 26.

ReferenceCitation: Maihöfner C, Handwerker HO, Neundörfer B, Birklein F. Patterns of cortical reorganization in complex regional pain syndrome. Neurology. 2003 Dec 23;61(12):1707-15.

ReferenceCitation: Marchesotti S, Bassolino M, Serino A, Bleuler H, Blanke O. Quantifying the role of motor imagery in brain-machine interfaces. Sci Rep. 2016 Apr 7;6:24076. doi: 10.1038/srep24076.

ReferenceCitation: Marinus J, Moseley GL, Birklein F, Baron R, Maihöfner C, Kingery WS, van Hilten JJ. Clinical features and pathophysiology of complex regional pain syndrome. Lancet Neurol. 2011 Jul;10(7):637-48. doi: 10.1016/S1474-4422(11)70106-5. Review.

ReferenceCitation: McCabe CS, Haigh RC, Ring EF, Halligan PW, Wall PD, Blake DR. A controlled pilot study of the utility of mirror visual feedback in the treatment of complex regional pain syndrome (type 1). Rheumatology (Oxford). 2003 Jan;42(1):97-101.

ReferenceCitation: McInnes K, Friesen C, Boe S. Specific Brain Lesions Impair Explicit Motor Imagery Ability: A Systematic Review of the Evidence. Arch Phys Med Rehabil. 2016 Mar;97(3):478-489.e1. doi: 10.1016/j.apmr.2015.07.012. Epub 2015 Aug 5. Review.

ReferenceCitation: Meugnot A, Almecija Y, Toussaint L. The embodied nature of motor imagery processes highlighted by short-term limb immobilization. Exp Psychol. 2014;61(3):180-6. doi: 10.1027/1618-3169/a000237.

ReferenceCitation: Meugnot A, Toussaint L. Functional plasticity of sensorimotor representations following short-term immobilization of the dominant versus non-dominant hands. Acta Psychol (Amst). 2015 Feb;155:51-6. doi: 10.1016/j.actpsy.2014.11.013. Epub 2014 Dec 30.

ReferenceCitation: Moseley GL. Is successful rehabilitation of complex regional pain syndrome due to sustained attention to the affected limb? A randomised clinical trial. Pain. 2005 Mar;114(1-2):54-61. Epub 2005 Jan 26.

ReferenceCitation: Moseley GL, Zalucki N, Birklein F, Marinus J, van Hilten JJ, Luomajoki H. Thinking about movement hurts: the effect of motor imagery on pain and swelling in people with chronic arm pain. Arthritis Rheum. 2008 May 15;59(5):623-31. doi: 10.1002/art.23580.

ReferenceCitation: Oostra KM, Oomen A, Vanderstraeten G, Vingerhoets G. Influence of motor imagery training on gait rehabilitation in sub-acute stroke: A randomized controlled trial. J Rehabil Med. 2015 Mar;47(3):204-9. doi: 10.2340/16501977-1908.

ReferenceCitation: Pervane Vural S, Nakipoglu Yuzer GF, Sezgin Ozcan D, Demir Ozbudak S, Ozgirgin N. Effects of Mirror Therapy in Stroke Patients With Complex Regional Pain Syndrome Type 1: A Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Apr;97(4):575-581. doi: 10.1016/j.apmr.2015.12.008. Epub 2015 Dec 23.

ReferenceCitation: Pleger B, Ragert P, Schwenkreis P, Förster AF, Wilimzig C, Dinse H, Nicolas V, Maier C, Tegenthoff M. Patterns of cortical reorganization parallel impaired tactile discrimination and pain intensity in complex regional pain syndrome. Neuroimage. 2006 Aug 15;32(2):503-10. Epub 2006 Jun 6.

ReferenceCitation: Ramachandran VS, Altschuler EL. The use of visual feedback, in particular mirror visual feedback, in restoring brain function. Brain. 2009 Jul;132(Pt 7):1693-710. doi: 10.1093/brain/awp135. Epub 2009 Jun 8. Review.

ReferenceCitation: Hall M. Opportunity in health visiting. Br Med J. 1978 Dec 9;2(6152):1646.

ReferenceCitation: Santos-Couto-Paz CC, Teixeira-Salmela LF, Tierra-Criollo CJ. The addition of functional task-oriented mental practice to conventional physical therapy improves motor skills in daily functions after stroke. Braz J Phys Ther. 2013 Nov-Dec;17(6):564-71. doi: 10.1590/S1413-35552012005000123. Epub 2013 Nov 1.

ReferenceCitation: Sato K, Fukumori S, Matsusaki T, Maruo T, Ishikawa S, Nishie H, Takata K, Mizuhara H, Mizobuchi S, Nakatsuka H, Matsumi M, Gofuku A, Yokoyama M, Morita K. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study. Pain Med. 2010 Apr;11(4):622-9. doi: 10.1111/j.1526-4637.2010.00819.x. Epub 2010 Mar 1.

ReferenceCitation: Selles RW, Schreuders TA, Stam HJ. Mirror therapy in patients with causalgia (complex regional pain syndrome type II) following peripheral nerve injury: two cases. J Rehabil Med. 2008 Apr;40(4):312-4. doi: 10.2340/16501977-0158.

ReferenceCitation: Smart KM, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2016 Feb 24;2:CD010853. doi: 10.1002/14651858.CD010853.pub2. Review.

ReferenceCitation: Solodkin A, Hlustik P, Chen EE, Small SL. Fine modulation in network activation during motor execution and motor imagery. Cereb Cortex. 2004 Nov;14(11):1246-55. Epub 2004 May 27.

ReferenceCitation: Sullivan MJ, Thorn B, Haythornthwaite JA, Keefe F, Martin M, Bradley LA, Lefebvre JC. Theoretical perspectives on the relation between catastrophizing and pain. Clin J Pain. 2001 Mar;17(1):52-64. Review.

ReferenceCitation: Thieme H, Morkisch N, Rietz C, Dohle C, Borgetto B. The Efficacy of Movement Representation Techniques for Treatment of Limb Pain--A Systematic Review and Meta-Analysis. J Pain. 2016 Feb;17(2):167-80. doi: 10.1016/j.jpain.2015.10.015. Epub 2015 Nov 6. Review.

ReferenceCitation: Trojan J, Speck V, Kleinböhl D, Benrath J, Flor H, Maihöfner C. Altered tactile localization and spatiotemporal integration in complex regional pain syndrome patients. Eur J Pain. 2019 Mar;23(3):472-482. doi: 10.1002/ejp.1321. Epub 2018 Nov 12.

ReferenceCitation: Vladimir Tichelaar YI, Geertzen JH, Keizer D, Paul van Wilgen C. Mirror box therapy added to cognitive behavioural therapy in three chronic complex regional pain syndrome type I patients: a pilot study. Int J Rehabil Res. 2007 Jun;30(2):181-8.

ReferenceCitation: Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0. Review.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Post Operative Quality of Life Assesment After Patulous Eustachian Tube Surgical Treatment

summary:
Patulous eustachian tube (ET) is a usually asymptomatic poorly known ET pathology. When it becomes so and thus impairs the eardrum (retraction pockets, cholesteatoma) or patients' quality of life (QoL), therapeutic management is proposed. The surgical treatment has diversified in recent years but remains dominated by filling spaces around the ET (autologous fat and/or septal cartilage grafting). Efficiency is traditionally objectivized by dynamic otoscopy, tubomanometry and audiometry, but QoL must also be taken into account and its postoperative assesment was the objective of this work.

Materials and Methods This is a unicentric retrospective study conducted from November 2016 to March 2019 on all patients with a disabling patulous ET, single or bilateral, managed surgically by autologous fat and/or septal cartilage grafting in investigators ENT department. Patients for whom a concomitant procedure was performed were excluded from the study.

The post-operative QoL assessment was performed using the Glasgow Benefit Inventory (GBI), postoperative self-administered questionnaire validated in ENT, including a general, physical and social evaluation. Predictive factors for QoL improvement were investigated among pre-, per- and post-operative clinical data.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Institut Universitaire de la Face et du Cou


title: Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies

acronym: GEN-HEMO-INF

summary:
Patients with monoclonal gammopathies either benign or malignant may develop inflammatory symptoms such as Schnitzler syndrome. We proposed to name those cases as monoclonal gammopathy of inflammatory significance, or MGIS.

The aim of the study is to search for inflammatory pathway that may be activated in case MGIS and to search if the genetic of tumoral cell could explain those activations.


title: Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT)

acronym: Ev-NIRT

summary:
Parkinson's disease has only pharmacological (essentially dopaminergic) and surgical treatment (essentially high-frequency deep brain stimulation), that are symptomatically effective. none of them is curative, and has the ability to slow down the disease and to protect dopaminergic neurons from death by neurodegeneration. Experimental results, based on preclinical studies, suggest that brain illumination in the Near-InfraRed (NIR) range is likely to slow down this neurodegenerative process.

Thus, a medical device system (called Ev-NIRT) has been developed for 670 nm intracerebral illumination of the substantia nigra pars compacta (SNpc), and is planned to be tested for the treatment of Parkinson's disease.

In this pilot study the investigators will evaluate the feasibility and tolerance of surgery and brain illumination thanks to the Ev-NIRT medical device, in a group of 7 de novo Parkinson's patients implanted with the innovative medical device. Patients will be monitored for 4 years.

ReferenceCitation: Chabardès S, Carron R, Seigneuret E, Torres N, Goetz L, Krainik A, Piallat B, Pham P, David O, Giraud P, Benabid AL. Endoventricular Deep Brain Stimulation of the Third Ventricle: Proof of Concept and Application to Cluster Headache. Neurosurgery. 2016 Dec;79(6):806-815.

ReferenceCitation: Darlot F, Moro C, El Massri N, Chabrol C, Johnstone DM, Reinhart F, Agay D, Torres N, Bekha D, Auboiroux V, Costecalde T, Peoples CL, Anastascio HD, Shaw VE, Stone J, Mitrofanis J, Benabid AL. Near-infrared light is neuroprotective in a monkey model of Parkinson disease. Ann Neurol. 2016 Jan;79(1):59-75. doi: 10.1002/ana.24542. Epub 2015 Dec 12.

ReferenceCitation: Moro C, El Massri N, Darlot F, Torres N, Chabrol C, Agay D, Auboiroux V, Johnstone DM, Stone J, Mitrofanis J, Benabid AL. Effects of a higher dose of near-infrared light on clinical signs and neuroprotection in a monkey model of Parkinson's disease. Brain Res. 2016 Oct 1;1648(Pt A):19-26. doi: 10.1016/j.brainres.2016.07.005. Epub 2016 Jul 7.

ReferenceCitation: Reinhart F, Massri NE, Chabrol C, Cretallaz C, Johnstone DM, Torres N, Darlot F, Costecalde T, Stone J, Mitrofanis J, Benabid AL, Moro C. Intracranial application of near-infrared light in a hemi-parkinsonian rat model: the impact on behavior and cell survival. J Neurosurg. 2016 Jun;124(6):1829-41. doi: 10.3171/2015.5.JNS15735. Epub 2015 Nov 27.

ReferenceCitation: Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Front Neurosci. 2016 Jan 11;9:500. doi: 10.3389/fnins.2015.00500. eCollection 2015. Review.


title: Effect of Tai Chi Protocol on Global Physical Activity in Patients With Spondyloarthitis in Comparison With a Control Group

acronym: TaiChiSpA

summary: Our hypothesis is that tai chi sessions would increase physical activity of patients with Spondyloarthitis. The main objective is to study the effect of tai chi sessions (16 vs.0) on global physical activity of Spondyloarthitis patients, compared to a control group without tai chi.


title: Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction

acronym: MeDIAGSTOLE

summary: The MeDIAGSTOLE project aims to develop diagnostic tools for heart failure with preserved ejection fraction (IC / FEp), a pathology that is difficult to diagnose and to manage clinically in the absence of targeted treatment . The IC / FEp concerns the elderly population with comorbidities such as hypertension, obesity, anemia and atrial fibrillation. In the absence of specific biomarkers, clinical diagnosis is based on serum markers of heart failure with reduced ejection fraction (IC / FEr). The identification of new biomarkers, genetic and / or cellular, specific for IC / FEp would be an important innovation.


title: Effect of the Duration of Pre-oxygenation (3 Minutes vs 6 Minutes) on Apnea Tolerance in Obese Patients (BMI> 30 kg / m2) During the Induction of General Anesthesia

summary:
The occurrence of arterial oxygen desaturation (hypoxemia) during the induction of general anesthesia remains one of the main causes of complications and mortality in anesthesia. In a healthy patient breathing in ambient air [Inspired O2 fraction (FiO2) = 21%] before the onset of narcosis, a drop in arterial O2 saturation (SpO2) occurs within 1 to 2 minutes. When pre-oxygenation is performed for 3 minutes in healthy subjects with FiO2 = 100%, SpO2 is less than 97% after 7.9 minutes of apnea and arterial O2 desaturation (SpO2 <93%) occurs after 8 to 9 minutes. For this reason and "in order to prevent arterial desaturation during tracheal intubation or supraglottic device insertion maneuvers", it is recommended "to systematically perform a pre-oxygenation procedure (3 min / 8 deep breaths) , including in the context of an emergency ". Tolerance to apnea is conditioned by the amount of O2 stored during the pre-oxygenation phase. Oxygen is transported to different tissues in 2 forms: combined with hemoglobin (Hb) and in dissolved form. In ambient air, the quantity of O2 transported by the Hb is much greater than the part transported in dissolved form. However, when the patient breathes a gas enriched in O2, all the molecules of Hb are quickly saturated (SpO2 = 100%), while the content of dissolved O2 increases constituting a reserve allowing to increase the tolerance to apnea.

Under usual conditions (3 minutes pre-oxygenation with FiO2 = 1), tolerance to apnea is shorter in obese subjects. Arterial O2 desaturation occurs after 2-3 minutes of apnea in patients with grade III obesity [Body Mass Index (BMI)> 35 kg / m2]. In addition, arterial O2 desaturation is faster the higher the BMI is. In fact, in obese patients, the lung volumes that can be mobilized in the supine position are modified compared to the non-obese subject: decrease in vital capacity, decrease in expiratory reserve volume, increase in airway resistance, decrease in thoracic compliance. These changes are, in part, explained by the weight of tissue on the rib cage and abdomen leading to compression of the lungs and diaphragm. In addition, there is also an increase in oxygen consumption in patients with a BMI> 40.

Different techniques have been proposed to increase apnea tolerance in obese patients. For Dixon et al., The desaturation of the morbidly obese subject (BMI> 40 kg / m2) is less rapid after 3 minutes of pre-oxygenation carried out with the patient in a half-seated position at 25 °: 201 seconds against 155 seconds in the Control group. This additional time seems to correlate with the value of the arterial pressure in O2 (PaO2) measured at the end of the pre-oxygenation (442 vs 360 mmHg). Likewise, the proclive position (30 ° reverse Trendelenburg) during the pre-oxygenation phase seems effective in limiting the occurrence of desaturation after induction.

The O2 reserve is usually assessed by measuring the partial pressure of O2 in the arterial blood. A value greater than 100 mmHg indicates that an amount of O2 is "in reserve", increasing tolerance to apnea. In practice, this examination is not feasible in current practice because it requires the performance of an invasive procedure, cannot be measured continuously and the rendering of the result is delayed by several minutes. In recent years, a technology based on spectrophotometry has been developed to measure the saturation of Hb in O2 in non-pulsatile blood. By algorithmic transformation, an Oxygen Reserve Index (ORI) is calculated. Its value varies from 0 to 1 and covers a data range between 100 and 200 mmHg of blood pressure in O2 (moderate hyperoxia). This data is obtained continuously and non-invasively from a sensor (RD Rainbow SET R Sensors; Masimo) placed on the 3rd or 4th finger of the hand. When a patient receives an O2 enriched gas mixture, the value of ORI increases rapidly and reaches a plateau. When the patient is in apnea, the drop in the ORI value precedes the drop in SpO2 by several tens of seconds. In a pilot study observing the kinetics of ORI in non-obese (BMI <25 kg / m2) or obese (BMI> 30 kg / m2) anesthetized patients, we observed that the time required to reach the plateau of l The ORI was longer (133 ± 30 seconds) in "obese" patients compared to "non-obese" patients (89 ± 28 seconds). Thus, one hypothesis to explain the poorer tolerance to apnea in obese patients would be that the duration of 3 minutes of pre-oxygenation as recommended in the recommendations is insufficient.

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.

family: Cook

full_name: T.M. Cook

family: Woodall

full_name: N. Woodall

given: N.

family: Frerk

full_name: C. Frerk

given: C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: Anaesthesia †

ReferenceCitation: Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28. Review.

family: Tanoubi

full_name: Issam Tanoubi

given: Issam

family: Drolet

full_name: Pierre Drolet

given: Pierre

family: Donati

full_name: François Donati

given: François

journal_name: Canadian Journal of Anesthesia/Journal canadien d'anesthésie

evidence: open (via free pdf)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Optimizing preoxygenation in adults

ReferenceCitation: Gambee AM, Hertzka RE, Fisher DM. Preoxygenation techniques: comparison of three minutes and four breaths. Anesth Analg. 1987 May;66(5):468-70.

ReferenceCitation: Jense HG, Dubin SA, Silverstein PI, O'Leary-Escolas U. Effect of obesity on safe duration of apnea in anesthetized humans. Anesth Analg. 1991 Jan;72(1):89-93.

ReferenceCitation: Berthoud MC, Peacock JE, Reilly CS. Effectiveness of preoxygenation in morbidly obese patients. Br J Anaesth. 1991 Oct;67(4):464-6.

ReferenceCitation: Tsymbal E, Ayala S, Singh A, Applegate RL 2nd, Fleming NW. Study of early warning for desaturation provided by Oxygen Reserve Index in obese patients. J Clin Monit Comput. 2021 Aug;35(4):749-756. doi: 10.1007/s10877-020-00531-w. Epub 2020 May 18.

family: Tsymbal

full_name: Ekaterina Tsymbal

given: Ekaterina

family: Ayala

full_name: Sebastian Ayala

given: Sebastian

family: Singh

full_name: Amrik Singh

given: Amrik

family: Applegate

full_name: Richard L. Applegate

given: Richard L.

suffix: II

family: Fleming

full_name: Neal W. Fleming

given: Neal W.

journal_name: Journal of Clinical Monitoring and Computing

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)


title: Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)

acronym: STEPPER

summary: The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients

lead_sponsor: Lille Catholic University


title: Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI

acronym: FLOWHAND

summary:
Allotransplants of vascularized composite tissues are subject to chronic vascular rejection, which can lead to graft loss. Currently, no imaging technique allows a reproducible quantitative exploration of the arterial trees of the hand, and therefore a satisfactory monitoring of transplants. Since 2014, flow MRI has been applied to the analysis of small-calibre arteries by the Image Processing Team at the Amiens-Picardie University Hospital. Between 2015 and 2017, several acquisitions were made in 3 patients who received facial allotransplantation, and the team recently developed a flow MRI protocol dedicated to the study of arterial trees in the hand.

The main objective is to measure vascular flows of radial, ulnar and interdigital arterial trees in normal (healthy volunteers) and pathological situations (patients with radial forearm flap reconstruction and patients with hand allotransplantation) using the specifically developed flow MRI protocol.

primary_purpose: Diagnostic


title: Prospective Collection of Biological Samples From Patients With Rare Neurological Diseases

acronym: EXPLAINEUR

summary: The aim of this project is to improve biological collections of patients presenting rare neurological disorders with known or suspected autoimmune origin. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.


title: Post-Stroke Medication Relay

acronym: REMEDIPA

summary:
Prior to discharge from hospital and return home, patients managed for ischemic stroke will receive a pharmaceutical interview to discuss their discharge prescription (indication, method of administration, precautions, and possible side effects).

Improvements in the use of medications in the community and in hospital follow-up.

Telephone interviews or teleconsultations will make it possible to assess the patient's knowledge of his or her treatment and to re-explain it if necessary to improve patient compliance with treatment.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie Vasculaire, Unité 201 Hôpital Neurologique Pierre Wertheimer, HCL


title: An Open Label, Randomized Controlled Study to Compare Healing of Severe Diabetic Foot Ulcers and Forefoot Amputations in Diabetics With and Without Moderate Peripheral Arterial Disease Treated With Kerecis Omega3 Wound and SOC vs. SOC Alone

acronym: Odinn

summary: This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.

ReferenceCitation: Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003 Dec 1;115(8):627-31.

ReferenceCitation: Barshes NR, Sigireddi M, Wrobel JS, Mahankali A, Robbins JM, Kougias P, Armstrong DG. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013 Oct 10;4. doi: 10.3402/dfa.v4i0.21847. Review.

lead_sponsor: Kerecis Ltd.


title: Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal Advanced Squamous Cell Carcinoma: CTCO (Circulating Tumor Cells in the Oropharynx)

acronym: CTCO

summary:
Head and neck cancers (HNSCC) are primarily squamous cell cancers represented by tumors of the upper aerodigestive tract. Locally advanced stages (stages III and IV) account for 50 to 70% of all presentations. The three main risk factors are smoking, alcohol and oropharyngeal infection with human papilloma virus (HPV).

Apart from HPV status, there is no biomarker for the prognosis in HSNCC patients. Circulating Tumor Cells (CTCs) can provide "real-time" information on tumor behavior and are already used in various cancers (colon, lung). Their detection has limited sensitivity and biomarkers cannot be used for early diagnosis, but may be useful during follow-up to assess local, regional or metastatic early tumor recurrence.

By using blood samples at different times (at diagnosis, after initial treatment and during follow-up), we will be able to measure the variation in quantification and establish a predictive role of these CTCs for the response to treatment.

Our hypothesis is that CTCs may have a key role, in addition to clinical and radiological examination, in detecting early tumor relapse.

We believe that the joint consideration of clinical parameters, treatment strategy and quantification of CTCs could optimize patient follow-up and management.

The CTC extraction system, ClearCell® FX from Biolidics, is an automated microfluidic enrichment system. It has the advantage of recovering fully intact and viable CTCs from a standard blood sample. The gentle sorting principle allows to preserve cell integrity and thus the expression of surface antigens. The CTCs thus isolated can then be re-cultured or analyzed by immunostaining. This high-performance technique, in operation since December 2017 in the Biochemistry Department of Pr Claire Rodriguez-Lafrasse (HCL), has demonstrated its usefulness in lung cancer.

Transcriptomic analysis of CTCs can be performed at the scale of a cell after isolation of the CTCs. CTCs can then be sequenced in RNAseq either in bulk (pool of cells) or cell by cell on our Illumina (Nextseq) sequencer, in order to define the heterogeneity of the tumor. Transcriptome analysis then provides information on the state of the cell as to its position in the epithelio-mesenchymal transition thanks to a molecular signature by phenotype. A priori-free characterization is therefore possible thanks to the RNAseq single-cell. This highly sensitive and innovative technique will allow the study of the gene expression profile of CTCs.

location_facility: Service ORL Chirurgie Cervico-faciale (Pr Philippe CERUSE)


title: Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)

summary:
The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts).

The secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.

lead_sponsor: Adeline BLOT

intervention_type: Dietary Supplement


title: Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma

acronym: SIMILY

summary:
This trial is a translational, prospective, open-label, monocentric research.

The study will be conducted in a population of 60 patients with diffuse large B-cell lymphoma (DLBCL) for whom first-line treatment with R-CHOP is planned as part of their standard of care.

SIMILY program aims at identifying biomarkers and/or molecular signatures related to immuno-phenotypic and -genotypic characteristics of the tumor and immune microenvironment, at the time of diagnosis, during R-CHOP, and at 24 months or time of progression.

Each patient will be followed during 2 years.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: Anti-IL5 and Other Biotherapies in Cystic Fibrosis in French CF Centers : MAB-CF Cohort

acronym: MAB-CF

summary:
Our project is to describe retrospectively and prospectively CF patients treated with biotherapy in French CF centers.

Main objective: To describe the clinical and paraclinical course of CF patients before and after treatment with anti-IL5 and other biotherapies since 2019.

Secondary objective: To describe adverse events potentially related to the biotherapies.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Muscle Function at Discharge From ICU: Evaluation of the Correlation Between Manual Muscle Testing, Dynamometric and Peripheral Ultrasound Parameters

acronym: DYNAMIQUE

summary:
The objective of intensive care therapists is to be able to detect as early as possible the muscle weakness acquired in intensive care, in order to implement curative strategies such as adapted nutrition and early rehabilitation. Various diagnostic tools are available for this purpose. To evaluate muscle mass, CT and MRI remain the gold standard but are difficult to implement in routine practice in ICU and are extremely expensive and can generate radiation for the patient.

Functional muscle evaluation is based on different voluntary tests which are not all able to predict muscle weakness acquired in ICU. In addition, some of the voluntary tests are expensive and require expert staff for practice and interpretation of results.

In addition, a muscle test such as MRC, although having an intraclass coefficient of 0.94, has little predictive value on clinical parameters such as mechanical ventilation duration and is not associated with mortality in the ward. However, it remains the test of choice to define a ICUAW with a threshold value of 48/60 points.

Dynamometry is a tool for measuring muscle strength. The patient is asked to perform a short and intense maximal muscular effort against manual or instrumental resistance. The limb segments must not move, it is an isometric effort. The most common measurement in intensive care units is the dynamometric grip force, called "handgrip".

In ICU, the patient may have touble with awareness, arousal or even comprehension, which will lead to biases in the evaluation of the motor force.

Ultrasound is a tool available in ICU and the muscle component can be assessed qualitatively or quantitatively without the patient's participation. Several studies have also demonstrated that muscle ultrasound is capable of reliably detecting pathological changes, particularly when repeated. Muscle ultrasound could thus help identify patients at higher risk of prolonged complications. Nevertheless, this technique lacks standardization and normative criteria (patient position, probe position, type and number of measurements, target muscle, etc.).

The main objective is to show that the dynamometric force relative to ultrasound thickness of several muscle groups (arm flexors/knee extensors/foot lifters) is correlated with manual MRC testing in intensive care unit (ICU) patients

ReferenceCitation: Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. Review.

ReferenceCitation: Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19:274. doi: 10.1186/s13054-015-0993-7. Review.

ReferenceCitation: Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matté A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. Epub 2006 Jun 8.

ReferenceCitation: Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.

ReferenceCitation: Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93.


title: Comparative Study of Two Cognitive Stimulation Approaches Using the Non-verbal Communication on People With Alzheimer's Disease and/or Related Diseases at a Moderate to Advanced Stage of Evolution

acronym: GEMAN

summary:
Cognitive impairements in Alzheimer's and apparented disorders may lead to the decreased engagement in activities, spetially in moderate and advanced stages of evolution. The lack of stimulation for people with dementia is associated with the risk of challenging behaviors, depressives symptoms, sleeping disorders or faster cognitive deterioration. Those challenges may lead to the increased administration of pharmacological treatments, though the risks of neurleptics use in this population are currently known. In this context, non-pharacological interventions hold a significant place in dementia care.

This research focuses on cognitve stimulation activities. More precisly, our study compares two aproaches using the reading groups. The first type (" usual " reading group) is based on the principle of stimulating those cognitive functions which dicreases with the evolution of dementia. The second (Montessori reading group) approach relies on the idea to use preserved capacities in order to compensate the cognitive impariments.

The aim of our study is to compare the impact of these two non-pharmalogical interventions on non-verbal communication. The collected datas will help analyzing and understanding the internal and behavioral states of people living with dementia. Our study will also extend relfexions about cognitive stimulation groups in care institutions.


title: Pro-inflammatory Cytokines as Potential Therapeutic Target in Type 1 Facioscapulohumeral Muscular Dystrophy: Pilot Study

acronym: CYTOKINE-FSH

summary: The facial-glenohumeral muscular dystrophy type 1 (DMFSH1) is characterized by a selective and asymmetrical involvement of the facial muscles, the shoulder girdle and the anterolateral lodge legs. Genetically, the disease is transmitted in an autosomal dominant manner and is caused by a pathogen contraction of repeat units (UR) say D4Z4 localized to the telomeric portion of chromosome 4qA. The loss of UR causes hypomethylation of DNA and chromatin relaxation of the region that lead to inappropriate expression of DUX4 retrogene highly toxic. The inappropriate expression induces a T cell reaction inflammatory response that participate and increase muscle damage. In favor of this hypothesis, several muscle MRI studies have shown that atrophy and fibro-adipose degeneration (hyper signal in T1) were preceded by the appearance of muscle inflammation (hyper signal T2STIR) confirmed on histologically and dysregulation of genes involved in adaptive and innate immunity. scientific hypothesis and potential benefits: the investigateur hypothesize that in patients of DMFSH1, the immune system cells may participate in the pathophysiology of the disease through changes in serum secretion of one or more cytokines and / or a modification of the response of inflammatory cells in some cell damage stimuli. Design: this is a single-center pilot study, interventional. In this study, the investigator will assay the serum cytokines and changes in peripheral blood cells of the expression of cytokines in response to some stimuli in 20 patients with Type 1 DMFSH genetically confirmed at an intermediate stage of clinical disease (kept walking, but at least one muscle of lower limbs reached) and compare with controls from the CYTOKINAGE study. The investigator will also carry patients clinical testing (MMT sum score) and functional (6minute test march MFM) and a MRI not injected whole body (T1 sequences + and T2STIR) to study the relationship between these parameters and secretion cytokines or serum in response to certain stimuli Main objective: to compare serum levels of IL-6 in patients with DMFSH and controls.


title: Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients

acronym: MODEX

summary: This project aims to (1) define and characterize brain networks of cognitive flexibility amongst patients with frontal lesions; (2) quantify the effects of ecological cognitive trainings and brain stimulation on behavioral performance and brain networks; (3) identify predictive markers of effective rehabilitation (patients)

location_facility: Universty hospital of Toulouse (Rangueil)

intervention_type: Behavioral


title: Analysis of Mandibular Kinematics of a Group of Asymptomatic Subjects Recorded With the Modjaw® Device

summary:
In oral rehabilitation, the integration into the digital flow of mandibular movements and the patient's individual reference planes optimizes the functional adaptation of prosthetic elements whose design is computer aided. The innovative Modjaw® device allows you to record and then virtually simulate mandibular movements.

This retrospective study aims to: 1) Test the reliability of the Modjaw® device; 2) Measure the condylar displacements of asymptomatic subjects for the arbitrary programming of simulators.

Kinematic recordings of 22 healthy volunteers (15F / 7H; mean age: 22.2 years) were analyzed. Two recording sessions were carried out within one month of each other, by three different operators; each subject was followed by the same operator during the first (E1) and the second (E2) recording. The values of sagittal condylar inclination (SCI) obtained in opening, protrusion, right-left mediotrusion were calculated at 3 and 5 mm of condylar displacement. The transverse condylar inclination (TCI) was calculated at 4mm.

ipd_sharing_description: No data sharing is planned


title: Impact of Executive Functions and Language on Social Cognition in Pediatric Epilepsy

acronym: TOMEPI

summary: The purpose of this study is to investigate the development of social cognition skills in pediatric epilepsy compared to healthy children. There are evidences indicating that children with epilepsy have executive dysfunctions and language problems. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. Moreover, the literature regarding development of non epileptic children, with ordinary development indicates that executive functions and language are linked to the emergence of social cognition. Then, the investigators asked if children with epilepsy, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Children with epilepsy and a control group of healthy volunteers will be compared to identify relationships between executive functions, language and social cognition.

lead_sponsor: CHU de Reims


title: Pulvinar Stimulation in Epilepsy: a Pilot Study

acronym: PULSE

summary:
Deep brain stimulation (DBS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated, and vagal nerve stimulation (VNS) demonstrated no efficacy. Benefits such as reduction of seizure frequency have been shown for thalamic stimulation of the anterior thalamic nucleus (ANT), however it has limited efficacy and non-optimal neurocognitive outcome, making the search for other targets crucial in this context. We propose a novel target for DBS stimulation in drug-resistant epilepsy namely the medial pulvinar thalamic nucleus (PuM).

This target has been chosen based on previous retrospective studies demonstrating that PuM is involved during focal seizures and in loss of consciousness and seizure termination. PuM stimulation also showed potential encouraging results based on the feasibility and safetu studies recently published.

The main objective is to obtain a significant percentage of seizure reduction after 12 months of PuM stimulation compared to baseline period. Quality of life and the relationship with psychiatric and cognitive comorbidities will also be assessed.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Liquid Biopsies (Blood, Gastric Fluid) for the Personalized Management of Patients With Hereditary Diffuse Gastric Cancer: a Pilot Project

acronym: LISA-HDGC

summary: Activating somatic mutations and methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper G-I endoscopy.

ipd_sharing_description: Data entry and management under the responsibility of Dr Patrick Benusiglio investigator coordinating the study

intervention_type: Genetic


title: Observatory of Drug-Related Problems: Impact of the Age and the Presence of Diabetes

acronym: DRP-AD

summary:
Drug-Related Problems (DRP) are a variety of events or circumstances that can interfere with the expected results of a treatment. They may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... When these situations result in harm, they are referred to as adverse drug events (ADEs). DRP and particularly ADE represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs.

DRPs are largely preventable and actions can be set up to detect and correct them. It is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. In our institution, the investigators have implemented several activities in different care services, including

medication reconciliation,
an ADE detection. These activities have interesting and encouraging results in terms of impact on the prevention of DRP. However, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. The investigators therefore need tools to prioritize our activities on the most at-risk patients.

In this study, the investigators seek to identify DRP risk factors and develop DRP risk scores, with the objective to improve the detection and even prevention of DRP.

Translated with www.DeepL.com/Translator (free version)


title: Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients

acronym: ACTIODERM

summary:
MOBIDERM® demonstrated his interest through clinical studies on the treatment of lower or upper limb lymphedema (Mestre et al 2017; Quéré et al. 2014). This CE (Conformity European)-marking device is well established both in ambulatory and hospitalisation. Nevertheless, the mechanism of action of this device had never been confirmed and no experimental clinical studies had been performed. The hypothesis is that the MOBIDERM system creates a pressure differential between the contact zone underneath the foam cubes composing the system and their surrounding area, leading to a shear effect on the subcutaneous tissues treated.

The aim of this study is thus to assess the mechanism of action of MOBIDERM on the lymphatic system by evaluating quantitative and qualitative effects of this medical device on lymphatic system, oedema volume and cutaneous parameters in 10 lymphoedema patients during their hospitalisation for reduction phase.

ReferenceCitation: Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.

ReferenceCitation: Quéré I, Presles E, Coupé M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

lead_sponsor: Thuasne


title: Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room

acronym: VERAPOP

summary:
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention.

A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.

status: Unknown status

lead_sponsor: University Hospital, Bordeaux

location_facility: Plateau technique Centre François-Xavier Michelet

status_simplified: Unknown


title: FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

acronym: NEFAPA

summary:
st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (> 5 mm).
nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels

acronym: CELSIOR-TGV

summary:
Celsior® is an organ preservation solution used for the harvesting and the preservation of solid organs. Its use as a crystalloid cardioplegia solution has been established recently. Its main advantage is the long duration of myocardial protection. Compared to the other cardioplegia solutions, it allows a reduced amount of solution administered during the surgery and fewer interruptions during the intervention for the administration of supplemental doses of cardioplegia for long and complex operations.

The objective of this register is to compare the safety and the efficacy of Celsior® to the old cardioplegia solution Saint-Thomas used as cardioplegia solution in surgery of the transposition of great vessels, the arterial switch operation.

location_facility: : Hôpital Louis Pradel - Service de Chirurgie Cardiaque C

intervention_type: Drug


title: Prospective Evaluation of the Predictive Criteria of Severity Related to Patient Calling Emergency Centre for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID-19.

acronym: COPREG

summary: Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.

lead_sponsor: University Hospital, Toulouse


title: Assessment of Personal, Psychosocial, Work, and Economic Burden in Patients With Mast Cell Disorders,

acronym: MCD&BuDi

summary:
The symptoms caused by mast cell disorders can have a significant impact on the state of health of individuals, constituting a real burden for them, and consequently altering their quality of life. It therefore seems important to clarify the impact on the quality of life, on the psycho-affective sphere, on professional life and on the direct and indirect costs caused by the disease, as well as on the "patient's remaining burden". It seems possible by a longitudinal study (patient follow-up over 1 year).

Primary objective is Assessment of quality of life in adult patient with mast cell diseases at M0.


title: Comparison of Preoperative 3D Spine Reconstruction With the EOS System and Peroperative 3D Spine Reconstruction With SURGIVISIO

acronym: Spine-PDCA-OR

summary:
The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system.

The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.

ReferenceCitation: Dubousset J. Scoliosis and its pathophysiology: do we understand it? Spine (Phila Pa 1976). 2001 May 1;26(9):1001.

ReferenceCitation: Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3. Review.

ReferenceCitation: Courvoisier A, Garin C, Vialle R, Kohler R. The change on vertebral axial rotation after posterior instrumentation of idiopathic scoliosis. Childs Nerv Syst. 2015 Dec;31(12):2325-31. doi: 10.1007/s00381-015-2891-3. Epub 2015 Sep 4.

ReferenceCitation: Merloz P, Tonetti J, Cinquin P, Lavallée S, Troccaz J, Pittet L. [Computer-assisted surgery: automated screw placement in the vertebral pedicle]. Chirurgie. 1998 Nov;123(5):482-90. French.

ReferenceCitation: Merloz P, Tonetti J, Pittet L, Coulomb M, Lavallée S, Troccaz J, Cinquin P, Sautot P. Computer-assisted spine surgery. Comput Aided Surg. 1998;3(6):297-305.

ReferenceCitation: Merloz P, Troccaz J, Vouaillat H, Vasile C, Tonetti J, Eid A, Plaweski S. Fluoroscopy-based navigation system in spine surgery. Proc Inst Mech Eng H. 2007 Oct;221(7):813-20.

ReferenceCitation: Prod'homme M, Cavalié G, Kerschbaumer G, Valmary-Degano S, Boudissa M, Tonetti J. T1 Vertebra Pedicular Osteoid Osteoma: Minimally Invasive Surgical Resection Aided by New Integrated Navigation to 3D Imaging Device. Case Rep Orthop. 2019 Mar 18;2019:7626454. doi: 10.1155/2019/7626454. eCollection 2019.

ReferenceCitation: Ferrero E, Mazda K, Simon AL, Ilharreborde B. Preliminary experience with SpineEOS, a new software for 3D planning in AIS surgery. Eur Spine J. 2018 Sep;27(9):2165-2174. doi: 10.1007/s00586-018-5591-3. Epub 2018 Apr 24.

ReferenceCitation: Stindel E, Merloz P, Graf P, Massin P, Gruber P, Robert H, Moineau G, Colmar M. [Computer assisted orthopedics surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2007 Jun;93(4 Suppl):2S11-32. French.


title: REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19. The Non-randomized, Non-controlled, Pilot, Open, Mono-centric REHSCU Study

acronym: REHSCU

summary: The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short half-life) in the critical care units of Nantes University Hospital during the COVID-19 pandemic.

lead_sponsor: Nantes University Hospital


title: Prevalence of Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery

acronym: PRATHYC

summary: This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. This study will describe the relationship between amyloid deposition observed on the transverse carpal ligament and the presence of cardiac involvement.


title: Effect of COVID-19 Related COntainment in ChildreN

acronym: E-COCCON

summary: The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020

ReferenceCitation: Claudet I, Marchand-Tonel C, Ricco L, Houzé-Cerfon CH, Lang T, Bréhin C. During the COVID-19 Quarantine, Home Has Been More Harmful Than the Virus for Children! Pediatr Emerg Care. 2020 Sep;36(9):e538-e540. doi: 10.1097/PEC.0000000000002205.

family: Claudet

full_name: Isabelle Claudet

family: Marchand-Tonel

full_name: Claire Marchand-Tonel

given: Claire

family: Ricco

full_name: Lucas Ricco

given: Lucas

family: Houzé-Cerfon

full_name: Charles-Henri Houzé-Cerfon

given: Charles-Henri

family: Lang

full_name: Thierry Lang

given: Thierry

family: Bréhin

full_name: Camille Bréhin

given: Camille

journal_name: Pediatric Emergency Care

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: Immunological Follow-up of Patients With Basedow's Orbitopathy : SIPO

acronym: SIPO

summary:
Graves' disease is characterized by the combination of anti-TSH receptor antibodies (Thyroid-Stimulating Hormone or thyroidotropic hormone), specific to this disease, with inconsistent symptoms such as hyperthyroidism, orbitopathy, goiter, or myxedema dermatological involvement. The activation of TSH receptors (RTSH) by these antibodies (known as "TRAK") causes the secretion of thyroid hormones as well as the development of the thyroid gland, responsible for a goiter. The cellular infiltrate responsible for the goiter consists mainly of T-lymphocytes but also of activated B lymphocytes secreting TRAK. Although Graves' disease is antibody mediated, cytokine secretion by Th1 therefore seems essential to pathogenesis. The treatment of orbitopathy requires primarily euthyroidism and the discontinuation of smoking. Despite these measures, moderate to severe attacks may require immunomodulatory treatment to limit local inflammation. This treatment is currently based on a first-line corticosteroid treatment (per os or preferably by weekly intravenous infusions). In the context of inadequate response, the therapeutic strategy is not very well established since some immunosuppressive treatments targeting B-cells or T- cells have been studied but with little benefit.

Many new concepts concerning immune tolerance and autoimmunity have emerged in recent years, particularly in Graves' disease, with sometimes complex cellular interactions. Certain mechanisms could occur either independently or in combination: i) modulation of T cell activation, differentiation and apoptosis; ii) inhibition of BL maturation and immunoglobulin production; iii) alteration of the balance between T helper (Th)-17 and T regulatory lymphocytes (Treg), by promoting Treg differentiation and inhibiting Th17 differentiation.


title: Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy

acronym: MuciLight

summary: This is a monocentric, prospective, non-comparative phase II study with minimal risks and constraints. The study will aim to assess the curative treatment of radio-induced mucositis by photobiomodulation using LED lamp.

lead_sponsor: Centre Oscar Lambret


title: Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018

acronym: PAROMIP

summary: A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as non-invasive samples of subgingival plaque and crevicular gingival fluid (CGF). The subgingival plaque samples will be analyzed to define the microbiotic profiles of the patients and the CGF determined to define their inflammatory expression profiles. These results will then be linked to the diagnosis of severity of periodontitis.


title: Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery

acronym: NICOLE

summary: Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. However, additional clinical validation studies in humans are required to better define the typologies of patients for whom this monitoring could be proposed routinely. Lung surgery is defined as an intermediate or high risk surgery regarding postoperative cardiac complications. However, surgical patients rarely benefit from continuous monitoring of cardiac output, the available methods being considered too invasive or insufficiently reliable in daily practice. Thoracic bio-reactance (Non Invasive Cardiac Output Monitor (NICOM) Starling SV) has not been studied in this subgroup of clinically relevant patients.


title: Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19

summary:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Even if in the vast majority of viral infection results in a mild illness, it can also progress to a severe form with sometimes fatal consequences.

Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been widely described since the start of the pandemic. This manifests itself at the biological level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers, sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).

At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic management targeting these cytokines are currently underway in COVID-19.

Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ and IL-6 seem to be key mediators of hyperinflammation.

Plasma ferritin is a biological marker of inflammation, long known, associated with various infectious, hematological and immunological conditions. An increase in ferritin levels has in particular been associated with an unfavorable development in certain infections such as influenza and certain authors have moreover shown an association between plasma ferritin and the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool for SAM, and could make it possible to differentiate the latter from severe sepsis in intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or CRS.

The plasma dosage of ferritin, associated with that of its glycosylated fraction, could therefore be a diagnostic (difference between SAM and severe sepsis in intensive care), prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected with SARS-CoV-2.

The objective of this study is to retrospectively assess the prognostic value of ferritin and glycosylated ferritin in SARS-CoV-2 infection in hospitalized.


title: Effect of Milk Consumption, Containing A2 β-caseins Only, on Digestive Comfort. A Randomized and Double-blind Study

summary:
Lactose, naturally present in milk, can cause digestive discomfort. Delactosed milk is currently the only one alternative to cow's milk for intolerant people. As some of them do not digest milk, it was completely remove from their diet. However, are they really intolerant to lactose or intolerant to milk (or to another of its compounds)? Do β-caseins play a role in this intolerance? β-caseins are proteins naturally present in milk. Two types of β-caseins were identified: A1 and A2. These types differ according to the genetic profile of the cow and depend on the breed. The rare clinical studies interested in this topic suggest that:

consumption of milk A1 versus consumption of milk A2 can lead to: softer stools, delayed transit, as well as pro-inflammatory effects in some individuals,
consumption of A2 milk significantly reduces gastrointestinal symptoms and improves digestive comfort in lactose intolerant people.

Thus, it would be interesting to be able to assess the effect of a consumption of A2A2 milk type compared to A1A2 milk type, both on the parameters of digestive comfort and on inflammatory parameters.

lead_sponsor: Institut Pasteur de Lille


title: Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors

acronym: BIOPSAR

summary: This is a prospective multi-center interventional study that will be performed in an effort to assess the diagnostic accuracy performance of preoperative vaginal ultrasound-guided biopsy (VUGB) to detect the exact histology of uterine tumors and thereafter triage cases being eligible for morcellation during laparoscopic resection. Ten tertiary French centers will participate in the present study.

lead_sponsor: Institut Bergonié


title: Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

acronym: SOHO

summary: First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

lead_sponsor: Poitiers University Hospital


title: Assessment of the Lived Experience of the Disease of the Patients Followed at the CHU of Gui de Chauliac for a Keratoconus and Their Habit of Eye Rubbing

acronym: Rub'Cornea

summary: Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction habits

status: Withdrawn


title: Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study

acronym: DELTA

summary:
The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit.

Two of those strategies are based on electrical impedance tomography (EIT) monitoring.

lead_sponsor: University Hospital, Angers


title: A Kinetic Study of Lipoprotein in Humans for a Better Understanding of Lipoprotein(a) Metabolism Under PCSK9 Variations (Hu-La-u-P Study)

acronym: HuLaUP

summary: The aim is to study the relationship between lipoprotein(a) [Lp(a)] and PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9) in humans with a kinetic study of lipoproteins in patients with dramatic increase of Lp(a) and controls.