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.

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.


title: Recurrent S. Aureus Infections in Osteoarticular Infections

acronym: RELAPSTAPH

summary:
Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side.

The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Study of the Inflammatory Response to Enterovirus Meningitis in Newborns, Infants and Children, as Assessed by Cytokine Levels in Blood and Cerebrospinal Fluid. Case-control Comparison Using an Existing Cohort.

acronym: Bledi-Cytokine

summary:
Enteroviruses (EV) are the most frequent cause of acute meningitis in the paediatric population. Detection of enterovirus in cerebrospinal fluid (CSF) specimens by Polymerase Chain Reaction (PCR) is the gold standard diagnostic test. Recently, our laboratory published the BLEDI study which highlighted the interest of detecting EV in the blood of the paediatric population : (i) EV was found in more than a quarter of cases in the blood of infants admitted to hospital with isolated fever and (ii) detection of EV was more frequent in the blood than in CSF in neonates and infants with isolated fever, sepsis or meningitis. However, the pathophysiology of EV infections is poorly understood and little work has been done on the inflammatory response to these infections. In EV meningitis, the inflammatory response has been studied primarily in children infected with enterovirus A71 (EV-A71). Indeed, in these children, inappropriate cytokine secretion (cytokine storm) leads to severe neurological and cardiopulmonary damage, which can progress to death. The study of the inflammatory response during meningitis due to other types of EV remains poorly

The objective of BLEDI-CYTOKINES (ancillary study of the BLEDI study) is to study the inflammatory response during EV meningitis in neonates, infants and children, as assessed by cytokine levels in blood and cerebrospinal fluid, by comparing case-controls from an existing cohort.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceType: background

ReferenceCitation: Lafolie J, Labbé A, L'Honneur AS, Madhi F, Pereira B, Decobert M, Adam MN, Gouraud F, Faibis F, Arditty F, Marque-Juillet S, Guitteny MA, Lagathu G, Verdan M, Rozenberg F, Mirand A, Peigue-Lafeuille H, Henquell C, Bailly JL, Archimbaud C; Blood Enterovirus Diagnosis Infection (BLEDI) in paediatric population study team. Assessment of blood enterovirus PCR testing in paediatric populations with fever without source, sepsis-like disease, or suspected meningitis: a prospective, multicentre, observational cohort study. Lancet Infect Dis. 2018 Dec;18(12):1385-1396. doi: 10.1016/S1473-3099(18)30479-1. Epub 2018 Oct 30.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Biological


title: Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery

summary: The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. During different phases, all patients received a Passive Leg Raising (PLR) maneuver for preload status evaluation using the PICCO system, a Lung Recruitment Maneuver (LRM) and an echographic evaluation of the right cardiac function. 20 patients were analyzed. Incomplete Lung Recruitment Maneuver (LRM) can predict fluid responsiveness at phase 1, pre-operatively, with a sensitivity of 0.57 and specificity of 0.62. Performance of an incomplete Magnetic Resonance Angiography (MRA) to predict right cardiac dysfunction based on TAPSE post-operatively provides a sensitivity and specificity of respectively 0.33 and 0.17 Tolerance to a stepwise lung recruitment maneuver can not be used to evaluate reliably the preload responsiveness and guide fluid therapy except pre-operatively. The use of a lung recruitment maneuver can be a promising method for right cardiac dysfunction screening but further studies need to be done with different echographic tools for right cardiac dysfunction evaluation.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

status_simplified: Completed


title: Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

acronym: HEMEP

summary: The clonal hematopoiesis of indetermined prognosis (CHIP) has been described as risk factor for juvenile atherosclerosis. Moreover, some of CHIP genes are responsible of myeloproliferative disorders. Venous thrombosis are frequent in these disorders. The purpose of this project is to determine if CHIP is frequent in unprovoked pulmonary embolism and could be part of the pathophysiology.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire, Amiens


type: Registry Identifier

title: Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality

acronym: PACAH-UCA HV

summary: The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP


title: Comparison of Extubation Delay After Prolonged Sedation With Inhaled Isoflurane Using the MIRUS® Device or Continuous Intravenous Midazolam in Patients With Septic Shock in Intensive Care

acronym: ISOREA

summary:
This monocentric, prospective, controlled, randomized, single-blind study will be conducted in surgical resuscitation at the Rouen University Hospital. The aim of our research project is to evaluate the extubation time after sedation with inhaled isoflurane compared to conventional intravenous sedation with midazolam, in patients who require prolonged sedation (3 to 28 days) in a context of septic shock. This population is particularly at risk of hypnotic accumulation due to the prolonged duration of use and the increased risk of developing renal or hepatic impairment in connection with septic shock.

Based on data from the literature on shorter durations of up to 96 hours of sedation, the investigators expect a decrease in the time to extubation in patients sedated with isoflurane as well as a better quality of awakening with a decrease in resuscitation delirium. This shortened duration of mechanical ventilation could have beneficial effects on the morbidity associated with prolonged sedation and ventilation: reduction of pneumopathies acquired under mechanical ventilation, reduction of the length of stay in resuscitation and hospitalization.

primary_purpose: Treatment

lead_sponsor: University Hospital, Rouen

intervention_type: Drug


title: Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation

acronym: COMPAR-MI

summary: To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to procedures performed without EndoNaut.

ReferenceType: derived

ReferenceCitation: Caradu C, Stenson K, Houmaïda H, Le Ny J, Lalys F, Ducasse E, Gheysens B. EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease. J Vasc Surg. 2022 Feb;75(2):651-659.e1. doi: 10.1016/j.jvs.2021.08.069. Epub 2021 Sep 10.

lead_sponsor: Therenva

intervention_type: Procedure

lead_sponsor_type: industriel


type: Other Identifier

title: Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial

acronym: IMPROVED

summary:
Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications.

The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou


type: EudraCT Number

title: A Randomized, Open-label, 3-period, Single-dose, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of GLPG3970 Given as an Oral Tablet Formulation Versus the Oral Solution Formulation of GLPG3970 and to Assess the Effect of Food on the Oral Tablet Formulation.

summary: This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and tolerability of a single dose of GLPG3970.

lead_sponsor: Galapagos NV


title: Protocol for the Collection of Clinical Samples for Evaluation and Implementation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

acronym: SeroCOV

summary:
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months.

In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.

primary_purpose: Diagnostic

intervention_type: Diagnostic Test


title: MRI Exploration of Meningeal Inflammatory Disease

acronym: EIME

summary:
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which two additional sequences of 6 minutes duration will be added.

The MRI of routine care includes at least the following sequences:

3D T1 TFE 1.0 isotropic (2 minutes)
T2 TSE (2 minutes)
3D FLAIR pre-injection (opt) (3 minutes)
3D FLAIR post-injection (3 minutes)

As part of the research, the following sequences will be acquired:

FABIR pre-injection (3 minutes)
FABIR post-injection (3 minutes)

Patients hospitalized for a foreseeable duration of at least 24 hours will be offered participation in the longitudinal tab of the study, for which four non-injected MRI examinations will be performed. The examinations will be carried out remotely from the injected MRI (1h, 2h, 12h-15h, 24h-36h). These exams dedicated to research will include the following sequences for a maximum of 8 minutes:

3D T1 TFE 1.0 isotropic (2 minutes)
3D FLAIR (3 minutes)
FABIR (3 minutes)

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild

intervention_type: Device


title: Comparison of the Performance of an Optimized 3D EPI SWI Sequence and a Non-EPI QSM SWI Sequence in Detecting the Central Vein Sign in Patients With Multiple Sclerosis

acronym: COPEQ-MS

summary:
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which four additional 20-minute sequences will be added.

MRI of routine care in the context of MS includes at least the following sequences:

3D T1 TFE (2 minutes)
T2 TSE (2 minutes)
3D FLAIR (3 minutes)
SWI EPI 0.6 iso (7 minutes)

The sequences added by the search are:

SWI non EPI QSM 6 echo (10 minutes)
SWI EPI in resolution equivalent to non-EPI SWI (3 minutes)
SWI EPI to TR equivalent to SWI non EPI (6 minutes)

These sequences will be acquired before or after the injection of gadolinium (if present in the examination of routine care). For examinations carried out with injection, the order of carrying out the 4 post-injection SWI sequences will be random.


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


title: Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors

acronym: PRIS

summary:
In radiotherapy, Magnetic Resonance Imaging (MRI) is used as a complement to the CT scanner because it provides better tissue contrast and therefore more precise delineations without the need for additional irradiation. However, MRI does not allow the definition of the electronic densities of the tissues necessary for dose calculation.

In this work, we sought to measure the feasibility of a method for generating CT-synthetic images from MRI in terms of dosimetric and geometrical precision for the purpose of MRI workflow alone (see diagram). The cerebral sphere and the prostate are the two tumor locations considered. All patients will have a planning CT (reference) and an MRI in the treatment position. The contours of the structures will be contoured by a radiotherapist on both the MRI and the reference CT. Synthetic CTs will be generated from the MRI with the method of automatic assignment of densities in five classes. The volumes bypassed and the dosimetries performed will be compared. A study of the quality of the images generated from MRI for dose calculation and images for the verification of per-treatment positioning will be performed.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"

acronym: ESPACE

summary: Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer

primary_purpose: Other

lead_sponsor: Clinique Bizet


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.


title: Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

acronym: PWV follow-up

summary:
The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

ReferenceCitation: Bironneau V, Tamisier R, Trzepizur W, Andriantsitohaina R, Berger M, Goupil F, Joyeux-Faure M, Jullian-Desayes I, Launois S, Le Vaillant M, Martinez MC, Roche F, Pépin JL, Gagnadoux F. Sleep apnoea and endothelial dysfunction: An individual patient data meta-analysis. Sleep Med Rev. 2020 Aug;52:101309. doi: 10.1016/j.smrv.2020.101309. Epub 2020 Mar 13. Review.

lead_sponsor: University Hospital, Grenoble


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


title: Latest Imaging SPECT System Evaluation Phase 1

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

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

intervention_type: Radiation


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


title: Evaluate the Therapy of Large Ovarian Endometrioma

acronym: ENDOKYSTE

summary:
Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve.

Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve.

In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy.

This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above.

The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone

lead_sponsor: University Hospital, Lille


title: Colorimetric Comparison of Email Defects Using Spectrophotometric and Computer Techniques and Biological, Structural and Physico-chemical Analyses of Teeth or Pathological Enamel

acronym: COLOEMAIL

summary:
The study focuses on the analysis of enamel defects grouping together hypomineralization and hypoplasia. It focuses on 3 very characteristic enamel pathologies that are most often encountered in dental consultations: Molar Incisor Hypomineralization (MIH), dental fluorosis (FD) and amelogenesis imperfecta (AI). The research focuses on the use of a spectrophotometer for measuring tooth colors: the Zfx SpectroShade® (MHT) and its software as a means of early diagnosis of pre-eruptive enamel abnormalities. The main objective of the study is to analyze the color parameters of teeth affected with one of the 3 enamel abnormalities for use of the spectrophotometer as a non-invasive diagnostic tool for enamel defects.

The secondary objective is focused on the biological, structural and physicochemical characterizations of these different enamel pathologies from extracted teeth or enamel biopsies that must be ground to achieve a restoration.

location_facility: Service d'odontologie, Hôpital Pitié-Salpêtrière


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.

ReferenceCitation: Bellier A, Labarère J, Putkaradze Z, Cavalie G, Carras S, Pelen F, Paris A, Chaffanjon P. Effectiveness of a multifaceted intervention to improve interpersonal skills of physicians in medical consultations (EPECREM): protocol for a randomised controlled trial. BMJ Open. 2022 Feb 15;12(2):e051600. doi: 10.1136/bmjopen-2021-051600.


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.

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lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of the Performance of COVIDISC Rapid Test for Diagnosis of SARS-CoV-2

acronym: COVIDISC

summary:
The Covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. Moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (RT-PCR) on a nasopharyngeal sample taken by swab. This technique is expensive (54€) and its production time is several hours.

Alternative methods are in progress, including, rapid diagnostic tests. The MEMS microfluids and nanostructures (MMN) laboratory, in partnership with the Institut Chimie Biologie Innovation (CBI) (Paris, 75005), have developed a portable test "COVIDISC", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (RT-LAMP).

The "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic RT-PCR (sensitivity of 7 copies per μl, specificity 100%).

The objective of this study is to validate the in vitro diagnostic medical device, COVIDISC, with the standard nasopharyngeal RT-PCR test.

status: Terminated

lead_sponsor: CMC Ambroise Paré

status_simplified: Unknown


title: Neonatal Precursors of Neurodevelopment

acronym: NEOPRENE

summary: The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.

lead_sponsor: University Hospital, Caen

intervention_type: Behavioral


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: Modifications Electrophysiologiques et de la Pulsatilité Cérébrale à la détection de Stimuli Nouveaux (Electro-PulCe)

acronym: Electro-Pulce

summary:
The oddball paradigm is one of the most widely used methods of brain exploration for the study of attentional processes. It allows the measurement, by means of an Electro-Enchephalogram (EEG), of evoked potentials reflecting the electrophysiological reactivity to the detection of novel stimuli within a stream of standard stimuli.

Other studies have recently suggested that, in addition to neuronal activation, certain other physiological processes related to cerebrovascular reactivity, such as the Brain Tissue Pulsatility (BTP), could also be sensitive to various cognitive processes and in particular to attentional processes.

In one of the latest studies published in collaboration with our group, it was shown that the amplitude of the electrophysiological response classically associated with attentional activity (P300 wave) was significantly correlated with the amplitude of BTP, suggesting the involvement of cerebrovascular processes in attentional functions. Nevertheless, in this study, the two methods of EEG and Tissue Pulsatility Imaging (TPI) were not synchronized, since TPI was performed at rest and not during the oddball task itself, and to date no study has sought to couple the methods of EEG and ultrasound TPI in an oddball paradigm, for a simultaneous characterization of neuronal and cerebrovascular responsiveness during attentional processes.

The general objective of this study will be to evaluate changes in BTP during the detection of novel stimuli in an oddball task in healthy volunteers, in which the two methods of TPI and EEG will be coupled and synchronized.

location_facility: Paedopsychiatry department, University Hospital, Tours


title: Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders

acronym: DEMUse

summary:
Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.

However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.

lead_sponsor: Hospices Civils de Lyon


title: Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty

acronym: game-ready

summary: The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint


title: Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding

acronym: HEMOCC

summary:
The etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients).

One of the complications of radiation cystitis is persistent hematuria. There is currently no curative treatment for this hematuria. There are few treatment options with a random probability of improvement of this symptomatology. These haematurias are rarely resolved spontaneously and most of the time involve emergency room management with +/- invasive procedures, sometimes by hospitalisation, always with a significant psychological impact on the patient.

Furthermore, lifetime anticoagulant treatment considerably increases the likelihood of bladder bleeding. This is the case of patients being followed for Atrial Fibrillation Cardiac Arrhythmia (AFCA), which by definition carries a major cardioembolic risk, and who will be of particular interest in this study.

In recent years, cardiologists have developed an alternative to anticoagulants: left atrial appendage closure or left atrial occlusion (LAO) . This procedure consists of inserting a nitinol prosthesis in the left atrium, the site of more than 90% of thrombi formation in non-valvular atrial fibrillation. This minimally invasive procedure lasts about 15 minutes and is performed during a 48-hour hospitalization. Anticoagulants are stopped the day after the setting up procedure. Several studies have shown non-inferiority of atrial closure and anticoagulants to thromboembolic events in non-valvular atrial fibrillation. In addition, LAO allows the permanent discontinuation of anticoagulants, associated with the cessation of anticoagulant bleeding adverse events.

While studies have been conducted on the impact of this technique on patients monitored in cardiology, no studies evaluate the value of LAO in anticoagulated patients with a hematuric radiation cystitis. This tprocedure is already used in routine care for patients followed in urology, and has shown encouraging results, since 8 out of 10 patients saw a significant reduction in the number of haematurias, but it has never yet been scientifically proven to be effective, hence the aim of this study.

The interest of this study will therefore be :

To evaluate the potential benefit of left atrial appendage closure on the number of episodes of hematuria.
To evaluate the economic benefit in reducing the number of hospitalizations, surgeries and complications for hematuria as well as the discontinuation of anticoagulants.

As the patient's data must be retrieved regardless of the patient's subsequent management (with or without a cardiac procedure) within the framework of the HEMOCC protocol, it will be proposed to the patient as soon as he or she is consulting for haematuria on radiation cystitis. The patient will be followed for 3 years.

The mainly descriptive analyses will be collected in the form of a register and carried out by a biostatistician from Clermont-Ferrand University Hospital.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Extracellular Vesicles as Biomarkers for Chronic Renal Failure

acronym: VE-IRC

summary: The recent discovery of extracellular vesicles (EV) as a mechanism of intercellular communication has made it possible to develop a new field of health research and could bring new information on the pathological mechanisms of renal diseases. Definition of physiologic and pathologic values of urinary extracellular vesicles (EVu) between healthy subjects and chronic kidney diseases (CKD) patients could be a new tool for follow up of renal diseases. EV are found in all biological fluids including urine, that's why they are increasingly analyzed in renal pathologies. The main objective of this study is to determine the physiological values and the pathological thresholds of EVu.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


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.

lead_sponsor: University Hospital, Montpellier


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.

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.

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.

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.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


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: Comparison of Two NGS Phasing Techniques of Parental Haplotypes for NIPD of Triplet Expansion Diseases

summary: The purprose of this study is to develop and validate an analytical NIPD test for triplet repeat disesases by NGS analysis from maternal blood, searching for the familial mutation in families at risk of having one of the following triplet repeat diseases: Huntington's disease, Myotonic dystrophy, Fragile X syndrome.. A comparison of two 3rd generation long fragment DNA sequencing techniques will be performed. These methods are based of the phasing techniques of parental haplotypes without the proband.

status: Active, not recruiting

ReferenceCitation: Liautard-Haag C, Durif G, VanGoethem C, Baux D, Louis A, Cayrefourcq L, Lamairia M, Willems M, Zordan C, Dorian V, Rooryck C, Goizet C, Chaussenot A, Monteil L, Calvas P, Miry C, Favre R, Le Boette E, Fradin M, Roux AF, Cossée M, Koenig M, Alix-Panabière C, Guissart C, Vincent MC. Noninvasive prenatal diagnosis of genetic diseases induced by triplet repeat expansion by linked read haplotyping and Bayesian approach. Sci Rep. 2022 Jul 6;12(1):11423. doi: 10.1038/s41598-022-15307-2.

ipd_sharing_description: NC

intervention_type: Genetic


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.

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


title: BREGS - IL-2 Signaling and Polarization of Regulatory LBs: Involvement in Multiple Sclerosis

acronym: BREGS

summary:
Multiple sclerosis (MS) has long been considered a disease mediated primarily by CD4+ T cells. However, recent clinical trials demonstrating significant efficacy of B-lymphocyte depletive therapies have highlighted the major role of this cell population in the development of MS. Among B-Ls, regulatory ("anti-inflammatory") B-Ls (Bregs) have protective functions in autoimmune diseases including MS, however the mechanisms that regulate the development and function of Bregs are poorly characterized. In our research laboratory (INSERM UMR1236), one of the lines of research focuses on the role of interleukin-2 (IL-2) signaling in the fate of the B lymphocyte. Numerous studies conducted in both human and mouse models of MS demonstrate the major role of this IL-2/IL2R signaling pathway in the pathogenesis of autoimmune diseases.

The hypothesis is that IL-2/IL2R pathway could contribute, by a mechanism intrinsic to B lymphocytes, to the development of autoimmune diseases such as MS.

While a defect in IL-2 signaling plays a critical role in the pathogenesis of MS, the impact of this defective signaling on regulatory B lymphocyte populations, which has been shown to play a protective role in the development of the disease, has never been studied. This study could help establish a new mechanism predisposing patients to develop the disease.

lead_sponsor: Rennes University Hospital


title: Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)

acronym: FNIRS

summary:
Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants.

Hemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS.

The use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.


title: Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal 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: Rapid Screening for Olfactory Disorders in Covid-19 Infection

acronym: OLFASCAN

summary:
Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions.

The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.

lead_sponsor: Centre Hospitalier Universitaire de Nice


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: Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)

acronym: AVATAR

summary: Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

time_perspective: Cross-Sectional


title: Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis

acronym: Psyllium

summary:
Familial amyloidosis is a rare disease that mainly affects the nerves and heart, but also more rarely the eyes and kidneys. This disease is due to a mutation in the gene encoding the synthesis of transthyretin, resulting in a modification of the translated protein. This abnormal protein and its derivatives are deposited in the form of a toxic "amyloid" substance in tissues and organs, altering their functions, particularly in the gastrointestinal tract.

From a gastrointestinal perspective, different treatments can be proposed in the absence of specific recommendations for familial amyloidosis. The hygienic and dietary measures consist of avoiding tobacco, alcohol and carbonated drinks, limiting fatty meals rich in poorly digestible fibers, and splitting meals. If this fails, metoclopramide and domperidone are suggested. As a second-line erythromycin, can be used with caution because of cardiac risks and drug interactions. Polyethylene glycol-based osmotic laxatives can be used to treat constipation. Alternating diarrhea and constipation can be treated with ispaghul-based laxatives, aiming at transit regulation. Finally, refractory diarrhea can be treated with the administration of loperamide. If this fails, treatment with a somatostatin analogue may be offered.

However, all these treatments can present significant side effects, therefore natural alternatives are often sought. Psyllium in particular regulates transit by normalizing stool consistency: it is effective against digestive disorders such as constipation, but it is also effective in the event of diarrhea. It allows the formation of a viscous gel by the hydrophilicity of polysaccharides macromolecules, increasing the fecal bowl which stimulates peristalsis and facilitates defecation. The WHO has recognized that Psyllium is superior to wheat bran in the treatment of irritable bowel syndrome.

The main objective of the study is to assess the effect of daily Psyllium administration on digestive quality of life in familial amyloidosis patients who suffer from digestive disorders.


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: Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging

acronym: OPM

summary:
This research is a feasibility study on a new generation of brain magnetic activity sensor which should allow the development of this modality, until now limited by its cost to a few large university centers.

The measurement of magnetic activity allows the detection and localization of abnormal activities such as paroxysmal events occurring between seizures in patients with epilepsy as well as research into brain function. It is the only one, along with EEG and related techniques, to provide data related to the speed of the brain. MEG, by virtue of the properties of magnetic fields, has a greater potential than EEG for the detection and localization of the neuronal sources which cause it.

The MEG sensors used until now use Superconducting Quantum Interference Devices (SQUID) components that are extremely sensitive but require complex instrumentation and only operate under superconducting conditions, resulting in prohibitive maintenance and cost.

The alternative could come from a new magnetic activity sensor: the optical pumping magnetometers of the alkaline type.

This preliminary study proposes to compare SQUID sensors with MPO He4 sensors for their ability to detect abnormal activities recorded in epileptic patients. Measurements that cannot be recorded simultaneously Two types of measurement will be compared with the reference that constitutes in-depth recording (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.

The expected results are a capacity of this type of sensors to detect epileptic activities equivalent to that of SQUIDs.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM


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: Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method

summary: We aim at finding prognostic factors of long term (after growth) function outcome in patient with clubfoot treated by ponseti method, based on a very complete prospective recording of treatment variables and outcome

status: Unknown status


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.


title: Adaptation française Des échelles AIDA (Assessment of Identity Development in Adolescence) et LoPF-Q (Levels of Personnality Functioning Questionnaire), Designed to Assess Personality Development in Adolescence.

summary:
The main objective of this study is to develop the French version of the two questionnaires AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology.

To participate in the study, patients will have to complete online or paper versions of the questionnaires AIDA-LoPF and other assessments of personality and general psychopathology (BB5, SDQ). Parents will have to answer complete the parent version of the SDQ questionnaire. The BPFSC-11, which is a clinician-rated assessment, will be completed in a subgroup of patients, by the same healthcare professional, in order to assess the concurrent validity. The investigators will also add the clinical diagnoses according to ICD-10 found in the medical record.


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: Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With

summary: Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).


title: Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"

acronym: CHRMICI

summary:
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. In addition, patients with IBD (Crohn's or RectoColitis Haemorrhagic, UC) may have rectal involvement. In both cases, hemorrhoidal surgery can be harmful to the anorectal level. However, recent data from the literature has proven to be reassuring. Indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with IBD, especially when the disease is quiescent.

The main objective is to assess the morbidity of hemorrhoidal surgery in IBD patients who have been operated on at our center. Postoperative complications will be the main elements sought in the study.

The secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with IBD. This requires an exhaustive collection of clinical data.

ReferenceCitation: Cracco N, Zinicola R. Is haemorrhoidectomy in inflammatory bowel disease harmful? An old dogma re-examined. Colorectal Dis. 2014 Jul;16(7):516-9. doi: 10.1111/codi.12555. Review.

ReferenceCitation: Jeffery PJ, Parks AG, Ritchie JK. Treatment of haemorrhoids in patients with inflammatory bowel disease. Lancet. 1977 May 21;1(8021):1084-5.

ReferenceCitation: McKenna NP, Lightner AL, Habermann EB, Mathis KL. Hemorrhoidectomy and Excision of Skin Tags in IBD: Harbinger of Doom or Simply a Disease Running Its Course? Dis Colon Rectum. 2019 Dec;62(12):1505-1511. doi: 10.1097/DCR.0000000000001524.

ReferenceCitation: Lightner AL, Kearney D, Giugliano D, Hull T, Holubar SD, Koh S, Zaghiyan K, Fleshner PR. Excisional Hemorrhoidectomy: Safe in Patients With Crohn's Disease? Inflamm Bowel Dis. 2020 Aug 20;26(9):1390-1393. doi: 10.1093/ibd/izz255.


title: EXOMEDIANE - Retrospective Study Using High Throughput Sequencing (HTS) on Biological Samples to Improve Genetic Counseling for Patients With Previously Explored Craniofacial Midline Defects.

acronym: EXOMEDIANE

summary:
Holoprosencephaly, or HPE, is the most common congenital cerebral malformation in humans and the most severe of a group of pathologies related to a deficiency of the SHH signalling pathway (Sonic Hedgehog SHH-D). It is characterized by severe cerebral and craniofacial abnormalities.

The regulation of SHH concentration is therefore crucial for correct craniofacial development.

Despite the recent identification of about 20 genes, 70% of cases of EHPE and craniofacial midline abnormalities of genetic origin do not have a molecular diagnosis. It is therefore important to continue the search for new candidate genes to improve the understanding of brain and facial development and to improve genetic counseling for these families.

The development of Next-Generation Sequencing (NGS) technologies opens up the possibility of studying the exome or even the genome in a single manipulation. The latter type of analysis is particularly well suited to the discovery of new genes and will therefore improve the care of patients and their families.


title: Cerebal Hemodynamics and Oxygenation in Critically Ill Patients : Characterization and Effects of Therapeutics

summary: Critically-ill patients frequently experience marked changes in mean arterial pressure and carbon dioxide partial arterial pressure, the two major determinants of the cerebral blood flow. In addition, many therapeutics (fluids, vasopressors or inotropes administration, blood transfusion, prone positioning...) can influence these two determinants of cerebral blood flow and thus cerebral blood flow, especially in patients with altered cerebral autoregulation. Nevertheless, cerebral hemodynamics and oxygenation, as well as the effects of the different therapeutics on it have been poorly studied in critically-ill patients. In addition, it has been suggested that impaired cerebral blood flow and impaired cerebral microcirculation may be involved in the pathophysiology of septic encephalopathy in patients with sepsis and/or septic shock. In this study, we aimed to characterize and investigate the effects of different therapeutics on cerebral hemodynamics and oxygenation in critically-ill patients.

ipd_sharing_description: no data sharing plan is planned


title: The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.

acronym: e-CONSULT

summary: Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

lead_sponsor: Centre Francois Baclesse


title: Biological Material Bank for Studies Related to Organ Transplantation

summary:
This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :

i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)


title: Effect of Neurodynamic Mobilization Techniques on Knee Extension Range of Motion of Asymptomatic Young Students: a Prospective, Comparative Study.

acronym: SPEAKER

summary:
Background: The neurodynamics technique seems interesting for increased lower limb flexibility of the lower limbs in healthy subjects. The objective of this study is to assess the physiological effects of the SLUMP sliding technique on the range of knee extension during the SLUMP test.

Methods: 60 physiotherapy students perform measurements during three tutorials. The first involves training in evaluation techniques. The second involves mobilizing the knee, out of the SLUMP position. The third tutorial includes neuronal mobilization in SLUMP.

Knee extension in SLUMP position is measured immediately after completing techniques. The mobilization amplitudes (degrees) will be compared between the techniques by a Student test on paired series, each subject being his own control.

Discussion: The results of this study will provide evidence for the physiological effect of SLUMP sliding techniques performed by physiotherapy students on the range of knee extension during the SLUMP test in asymptomatic subjects.

lead_sponsor: University Hospital, Rouen


title: Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial

acronym: COMBIELEC

summary:
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.

Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.

Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.

A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Brest


title: Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

acronym: IODIAB

summary: Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease: a Pilot Study

acronym: SCM-PARK

summary:
Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia.

Evaluation of gait and motor symptoms will be performed with and without stimulation, after a 3-month period for each of the stimulation conditions.This is a pilot, single centre, prospective, randomized, double blinded, cross-over study.

lead_sponsor: University Hospital, Grenoble


title: Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.

acronym: CoDoRéa

summary:
Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Defining the Severe Paediatric Asthma Endotype: an Integrated Approach Combining Phenotypic Analyses Related to Immune, Metabolomics and Microbial Features

acronym: SevAsthma

summary: The primary objective of this project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses. This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients : ProCOVRA

acronym: ProCOVRA

summary: COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.


title: Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat

summary:
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC).

The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.

lead_sponsor: Alyatec