title: Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fall Apprehension and Risk: A Randomized Controlled Trial

summary: This study evaluates the effects of an adapted physical activity with an interactive gaming platform on fall apprehension and risks. Half of the participants will receive a rehabilitation program using the Medimoov gaming program, the other half will receive the standard rehabilitation program.

ReferenceCitation: Dargent-Molina P, Cassou B. Prévention des chutes chez les personnes âgées de plus de 75 ans vivant à leur domicile: analyse des interventions efficaces et perspectives de santé publique. Bull Épidémiologique Hebd. 2017;16-17:336-43.

ReferenceCitation: Tallon G, Seilles A, Melia G, et al. Intérêt du serious game Medimoov pour améliorer l'autonomie fonctionnelle chez la personne âgée institutionnalisée. Montpellier, 2015.

ReferenceCitation: Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.

ReferenceCitation: Skjæret N, Nawaz A, Morat T, Schoene D, Helbostad JL, Vereijken B. Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy. Int J Med Inform. 2016 Jan;85(1):1-16. doi: 10.1016/j.ijmedinf.2015.10.008. Epub 2015 Oct 28. Review.

ReferenceCitation: Melia G, Seilles A, Tallon G. Évaluation d'un jeu sérieux thérapeutique. 2025; 4.

ReferenceCitation: Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98.

ReferenceCitation: Siegrist M. Test-Retest Reliability of Different Versions of the Stroop Test. J Psychol. 1997; 131: 299-306.

ReferenceCitation: Hauer KA, Kempen GI, Schwenk M, Yardley L, Beyer N, Todd C, Oster P, Zijlstra GA. Validity and sensitivity to change of the falls efficacy scales international to assess fear of falling in older adults with and without cognitive impairment. Gerontology. 2011;57(5):462-72. doi: 10.1159/000320054. Epub 2010 Oct 22.

ReferenceCitation: Freire AN, Guerra RO, Alvarado B, Guralnik JM, Zunzunegui MV. Validity and reliability of the short physical performance battery in two diverse older adult populations in Quebec and Brazil. J Aging Health. 2012 Aug;24(5):863-78. doi: 10.1177/0898264312438551. Epub 2012 Mar 15.

ReferenceCitation: Wagner S, Helmreich I, Dahmen N, Lieb K, Tadic A. Reliability of three alternate forms of the trail making tests a and B. Arch Clin Neuropsychol. 2011 Jun;26(4):314-21. doi: 10.1093/arclin/acr024. Epub 2011 May 15.

ReferenceCitation: Lapierre N, Um Din N, Igout M, Chevrier J, Belmin J. Effects of a Rehabilitation Program Using a Patient-Personalized Exergame on Fear of Falling and Risk of Falls in Vulnerable Older Adults: Protocol for a Randomized Controlled Group Study. JMIR Res Protoc. 2021 Aug 26;10(8):e24665. doi: 10.2196/24665.

lead_sponsor: Joel Belmin

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université


title: Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study ScanRach Study

acronym: SCANRACH

summary: Investigators team propose to evaluate the impact of the use of intraoperative scanning coupled with Stryker navigation, compared to the conventional fluoroscopy technique, on the accuracy of pedicle screws, in instrumented spinal surgery, by a randomised prospective study, in terms of pedicular screw accuracy. We will also evaluate the radiation exposure of the neurosurgical team and the patient in these two techniques.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Ramsay Générale de Santé

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Unknown


title: Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D. 3D-HAM Study.

summary: The automated TALAS measurement tool, working with the Cone Beam 3D scanner under load, provides a reproducible measurement of the Foot Ankle Offset (FAO). It is possible to determine an average value and the standard deviation of FAO in the relevant population. And to differentiate significantly the populations with a neutral alignment, varus or valgus.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

intervention_type: Diagnostic Test

status_simplified: Completed


title: Promoting Fall Prevention Workshops for Individuals Aged 60 and Over: an Exploratory Study.

summary: Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation resulting in PA approaches designed to prevent falls actually only benefiting a limited number of elderly subjects.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

lead_sponsor_type: academique


title: Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection: Search for Acquired Thrombophilia and Interferon-alpha Signature

summary:
Spectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Chilblains are sometimes associated with Raynaud's phenomenon or acrocyanosis. Dermatological features may present pathophysiological similarities with the inflammatory and respiratory vascular disturbances, which makes all the gravity of this disease, or even with other organs. Indeed, genetic conditions such as familial lupus chilblains, linked to a mutation of TREX1 gene, and SAVI (Sting associated vasculopathy with onset on infancy) have similar clinical presentations. In particular, SAVI associates both acral skin and lung damage, and auto-antibodies. They have recently been identified as type I interferonopathies. Hallmark is interferon signature, i.e. hyperexpression of type I interferon in the blood.

The investigators hypothesize Covid-19 may lead to similar skin involvement as in type I interferonopathies. The interferon pathway is involved in anti-viral defense. Covid-19 could cause excessive activation of this pathway. In addition, hyperactivation of the type I interferon pathway leads to modulation of the adaptive immune response. Production of autoantibodies, in particular antiphospholipid antibodies, have thrombogenic properties. Searching for acquired hemostasis disorders and high level of interferon secondary Covid-19 virus infection, could explain this new and misunderstood skin disorder. Then, targeted therapies, both treating and preventing, could be considered.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families: A Randomized Trial. Famiréa - FCS

acronym: Famirea - FCS

summary: This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

study_start_date_type: Anticipated

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Behavioral


title: Prevalence and Clinical Evolution of Olfactory and Taste Disorders in Patients Infected by SARS-CoV-2

summary: A novel coronavirus SARS-CoV-2 HAS arose in 2019 in Wuhan, China. Beside the classical semiology of this infection, numerous patients described olfactory and teste disorders. These symptoms are not described in this coronavirus, neurotropism of coronaviridae has been documented before. The aim of the study is to evaluate prevalence of anosmia and dysgeusia (olfactory and taste disorders) in coronavirus diagnosed patients and compare with different clinical conditions. The second endpoint is to evaluate the duration of these symptoms in order to better understand the semiology of this infection.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Association of Lung Microbiota With Intensive Care Unit Mortality in ARDS Patients: MicrA Study

acronym: MicrA

summary: Acute respiratory distress syndrome (ARDS) is due to diffuse and severe lung inflammation. Despite intensive research, few therapeutics have emerged and treatment is still mostly symptomatic. As lung microbiota seems to be associated with lung inflammation in numerous chronic respiratory diseases, this study aims to analyse the correlation between lung microbiota and mortality.

lead_sponsor: University of Bordeaux

location_facility: Medical intensive care unit, Pellegrin hospital


title: A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer

acronym: XenoBreast

summary: Patient derived xenografts (PDX) from mammary tumors are usually made from metastatic tumors. Indeed, PDX from primitive mammary tumors or after neoadjuvant treatment are still rare. However, the realization of such PDX (from primitive mammary tumors or after neoadjuvant treatment) would make it possible to have a better knowledge of the tumor heterogeneity to the therapeutic response, to explore the models of tumor evolution during metastatic progression and also observe the mechanisms of tumor resistance in the case of non-metastatic tumors. It therefore seems necessary to develop PDX from primitive tumors in order to observe firstly the success rate of PDX; on the other hand, the drift of the initial heterogeneity, measured by comparison of the histomolecular profile of the tumors with that of the PDXs. It aims to develop xenografts from tumor samples from surgical specimens of patients with triple negative or luminal B breast cancer.

status: Recruiting

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Veyssière H, Passildas J, Ginzac A, Lusho S, Bidet Y, Molnar I, Bernadach M, Cavaille M, Radosevic-Robin N, Durando X. XENOBREAST Trial: A prospective study of xenografts establishment from surgical specimens of patients with triple negative or luminal b breast cancer. Version 3. F1000Res. 2020 Oct 9 [revised 2021 Jan 1];9:1219. doi: 10.12688/f1000research.26873.3. eCollection 2020.

lead_sponsor: Centre Jean Perrin

intervention_type: Biological

status_simplified: Ongoing


type: Registry Identifier

title: Analysis of the Ligamentization Process in the Anatomical Ligamentoplasty of the Lateral Ankle Plane to the Hamstrings

acronym: LIGANALYS

summary:
This is a prospective bi-centric study, which evaluate the evolution of RMI signal of transplant till 12 months after ligament plasty surgery.

As the primary objective, the study aims to define the post-operative timeframe needed to obtain an optimal quality of repair, especially in their restarting of sportive activities, by analysis of RMI signal and biomechanic features modifications.

As secondary objectives, the study aims to:

study the correlation between the RMI signal of plasty and the Young's modulus;
study the evolution of RMI of plasty at M3, M6 and M12;
study the evolution of Young's modulus at M3, M6 and M12;
evaluate the reproductibility between 2 lector of RMI measurements;
evaluate the reproductibility between 2 lector of elastography measurements of LTFA;
evaluate the optimal delay of return to sport after ligament plasty surgery of ankle;
develope a score of type SNQ for ankle ligament plasty surgery;
evolution of AOFAS and EVA scores.

location_facility: Orthopaedic Surgery Department, Ambroise Paré hospital, APHP


title: Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN

acronym: DIA-RAMADAN

summary: The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa

ReferenceType: result

ReferenceCitation: Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, Rudijanto A, Shaltout I, Fariduddin M, Mohd Izani Wan Mohamed W, Al Awadi F, Alessa T; DIA-RAMADAN study investigators. A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN. Diabetes Res Clin Pract. 2020 May;163:108154. doi: 10.1016/j.diabres.2020.108154. Epub 2020 Apr 21.

ReferenceCitation: Hassanein M, Al Sifri S, Shaikh S, Raza SA, Akram J, Rudijanto A, Shaltout I, Fariduddin M, Mohamed WMIBW, Al Awadi F, Durocher A, Cortese V, Alessa T. Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN. Diabetes Ther. 2021 Jun;12(6):1703-1719. doi: 10.1007/s13300-021-01067-1. Epub 2021 May 11.

lead_sponsor: Servier Affaires Médicales


title: Assessment of Agreement Between Two Measurement Methods of Left Ventricular Outflow Tract (LVOT) Velocity Time Integral (VTI) : Automatic Versus Manual, in Critically Ill Patients in Acute Circulatory Failure

acronym: AUTO-VTI

summary: Acute circulatory failure (ACF) is a common cause of admission in intensive care unit (ICU). Echocardiography is a widespread tool nowadays for the initial assessment and the hemodynamic monitoring. An interesting data from this exam is the Left ventricular outflow tract (LVOT) velocity time integral (VTI), reflecting stroke volume, and therefore cardiac output. A new tool for automated recording has been developped on the VENUE GE echograph. This study aims at assessing this automated measurement of LVOT VTI compared with the classic manual method.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Device


type: Other Identifier

title: An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients

acronym: SEPAS

summary: Urinary disorders (UD) are common in Multiple Sclerosis (MS) and can necessitate using Intermittent Self Catheterisation (ISC). It is well experienced by patients, has little impact on daily life and improves quality of life. However, studies are lacking on long-term adherence to this treatment as well as on discontinuation factors. Our main objective is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.

status: Active, not recruiting

lead_sponsor: University Hospital, Toulouse


title: Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.

acronym: LTR

summary:
Childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions.

RéPPOP is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes.

Short and medium-term assessments of Rhône RéPPOP care for overweight and obese children show encouraging results. Long-term assessment is needed to confirm these results.

The present study aims to assess the long-term efficiency of Rhône RéPPOP care for overweight and obese children by comparing BMI Z-scores at the start and the end of RéPPOP care to the current BMI. This data will be collected through a telephonic questionnaire by the scientific manager.

The study's secondary objectives are to evaluate patients and their families' lifestyle changes and to improve RéPPOP practices.

time_perspective: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices civils de Lyon, Endocrino-pediatric service


title: "Follow-up of Midlines Placed Outside the Intensive Care Unit: What Happens Next, What Side Effects? A Multicenter Observational Study"

acronym: MidDATA

summary: Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. The Midline catheter is poorly described in scientific literature; therefore, the aim of the study is to determinate the incidence of adverse events (Infections and thrombosis) and risk factors for patients with this device.

lead_sponsor: Nantes University Hospital


title: Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)

acronym: AURIX

summary:
While invasive vagal stimulation has proven its therapeutic effectiveness over the past 20 years, particularly in the treatment of epilepsy or depression, its implementation is hampered by the high cost, high technicality and sometimes significant side effects. Non-invasive vagal stimulation, most often electric, is a less expensive therapeutic alternative and easier to implement, although the level of evidence is lower than that of invasive stimulation.

Some so-called traditional therapies, such as acupuncture, also stimulate certain parts of the ear by mechanical means, most often by puncturing the ear or the concha. In these traditional therapies, more than one hundred stimulation points have been described, each precisely positioned according to an empirical topography.

However, electrical non-invasive stimulation recognizes only three areas of interest on the ear, which are the areas of sensitive innervation, namely the afferences of the vagus nerve in the concha, which is the only one used in practice, the large occipital nerve on the lobe and part of the helix, and the auriculotemporal nerve on the rest of the auricular flag.

In this study, we would like to explore the justification for the topographic precision, adopted by traditional therapies, for non-invasive vagal stimulation on the concha.

status: Terminated

lead_sponsor: Hôpital Européen Marseille


title: Preliminary Study to Evaluate the Effect of an EEG-proprioceptive Neurofeedback on Cortical Excitability and Motor Function of the Upper Limb After Stroke

acronym: HANDS

summary: Interventional study with minimal risks and constraints, prospective, monocentric.

ReferenceCitation: Le Franc S, Bonan I, Fleury M, Butet S, Barillot C, Lécuyer A, Cogné M. Visual feedback improves movement illusions induced by tendon vibration after chronic stroke. J Neuroeng Rehabil. 2021 Oct 30;18(1):156. doi: 10.1186/s12984-021-00948-7.

lead_sponsor: Rennes University Hospital


title: Integration of Clinical Pharmacy Along the Entire Care Pathway of Patients Implanted With a PICC-line

acronym: CLIPICC

summary:
Clinical pharmacy is a patient-centered discipline and improves significantly the safety of drug management. Regarding medications, clinical pharmacy is efficient. The investigator hypothesize that clinical pharmacy applied to medical devices could be as effective as in the medication field.

The main objective of this study is to assess the effectiveness of clinical pharmacy activities during entire care pathways of patients implanted with a PICC line, in preventing complications.

design_allocation: Non-Randomized

primary_purpose: Prevention

ReferenceCitation: Pouget AM, Civade E, Cestac P, Rouzaud-Laborde C. From hospitalisation to primary care: integrative model of clinical pharmacy with patients implanted with a PICC line-research protocol for a prospective before-after study. BMJ Open. 2021 Apr 7;11(4):e039490. doi: 10.1136/bmjopen-2020-039490.


title: Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies

acronym: HCM-Vein

summary:
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies. However, the relation between obstruction and endothelial and venous dysfunctions has not been previously studied.

The main objective is to investigate the relations between endothelial and venous dysfunctions and symptomatic left ventricular outflow-tract obstruction in HCM patients.

lead_sponsor: University Hospital, Bordeaux


title: High Resolution and High Speed Multimodal Ophthalmic Imaging

acronym: IMA-MODE

summary:
Knowledge of the pathogenesis of ocular conditions, a leading cause of blindness, has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems are limited in resolution, speed, or access to certain structures of the eye.

The use of a high-resolution imaging system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many microstructures of the eye: photoreceptors, vessels, nerve bundles in the retina, cells and nerves in the cornea.

The use of a high-speed acquisition imaging system makes it possible to detect functional measurements such as the speed of blood flow. The combination of data from multiple imaging systems to obtain multimodal information is of great importance for improving the understanding of structural changes in the eye during a disease.

The purpose of this project is to observe structures that are not detectable with routinely used systems.

ReferenceCitation: Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Localizing in the Brain the Areas of Time to Contact Perception During an Awake Surgery

acronym: BRAIN-TIME

summary: During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. The present project aims at testing the patient in this awake phase to determine the brain areas implied in time to contact (TTC) perception, a function that allows determining the arrival time of moving objects and used in many tasks of our daily life.


title: PSYCHIatric Disorders and Covid-19 (PSYCHIC) : Observatory of the Psychiatric, Somatic and Pharmacological Impacts of the COVID-19 Pandemic on Patients Hospitalized for Psychiatric Disorders and Suspected to be Infected by COVID-19

acronym: PSYCHIC

summary: Given the possible risks and complications of a comorbidity between psychiatric disorder and coronavirus disease 2019 (COVID-19), it seems particularly important to specify the impact of the COVID-19 pandemic in patients with psychiatric disorders and suspected of infection, hospitalized in a specific unit, at the psychiatric, somatic and pharmacological level.


title: Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

acronym: Covid-Thelium

summary: The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.

lead_sponsor: University Hospital, Rouen


title: Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth

acronym: PELVPUNCTURE

summary:
During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present.

After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. The patient's participation in the study ends when she leaves the labour room after the birth.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience

acronym: FOR-HYPO

summary:
Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy.

The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.

location_facility: Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant


primary_purpose: Treatment

acronym: LILIADE-COVID

intervention_type: Drug

title: Low Dose of IL-2 In Acute Respiratory DistrEss Syndrome Related to COVID-19

type: EudraCT Number

source: euctr

location_facility: Service Anesthésie Réanimation - Groupe Hospitalier Pitié-Salpêtrière

summary: The purpose is to demonstrate the efficacy of low-dose interleukin 2 (Ld-IL2) administration in improving clinical course and oxygenation parameters in patients with SARS-CoV2-related ARDS.


title: Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI

acronym: PulmoVasc

summary:
Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent pulmonary disease providing major morbidity and mortality. Bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known.

Improving knowledge on pulmonary vascular adaptive skills in COPD patients could allow for better understanding disease exacerbations, evolution towards chronic pulmonary hypertension (PH) and therapeutics to be offered to the patients.

Magnetic resonance imaging (MRI) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. This work aims at identifying pulmonary vascular impairment in COPD patients using functional MRI.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Prediction and Unraveling of Delayed Cerebral Ischemia in Patients With Subarachnoid Hemorrhage Using Early Dynamic 18F-FDG PET/CT Assessment of Cerebral Glucose Uptake (PREDISP)

acronym: PREDISP

summary: A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral glucose uptake reflecting microperfusion.

ipd_sharing: Yes

lead_sponsor: University Hospital, Montpellier

location_facility: Département d'Anesthésie-Réanimation Gui de Chauliac 80 Av Augustin.Fliche


title: Validation Study of a Rapid Screening Test of Food Addiction in Patients Suffering From Obesity and Healthy Volunteer

acronym: FAST - FR

summary: Food addiction (FA) is a behavioral addiction characterized by a high consumption of palatable foods, which markedly activate the reward system, despite adverse consequences. FA was first described in 1956 but remains controversial. The Yale Food Addiction Scale (YFAS), developed by Gearhardt et al. in 2009, is currently regarded as the "Gold Standard" for FA screening. In a previous study, we established a Food Addiction Screening Test using artificial intelligence. The main objective of the present study is to validate the sensitivity, specificity and precision for FA diagnosis in a sample of patient suffering from obesity and healthy volunteers.


title: Long Term Physical Functional Performance in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation: a Multicentric Observational Study

summary:
Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations.

Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management.

Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.

lead_sponsor: CHU de Reims


title: Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations

summary:
The identification of the operative site of lumbar ductal stenosis and lumbar disc herniation is classically done by radioscopy, thus inducing irradiation of the patient.

The use of ultrasound in spine surgery is little studied and poorly mentioned in the scientific literature. However, it is commonly used for other types of scouting (especially anesthetics). Thus, in the absence of consensus and clear recommendations, some practitioners perform ultrasound scans . Methodological developments also validate the feasibility of the ultrasound approach.

The double benefit of an ultrasound identification is firstly a lack of exposure to X-rays for both the patient and the operating team and secondly a lower cost than a conventional radiography.

The main objective is to demonstrate the interest of the ultrasound identification of the surgical site in the intervention of lumbar ductal stenosis and lumbar disc herniations in terms of concordance of the operating site between ultrasound and fluoroscopy.

lead_sponsor: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale


title: International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery

summary:
Cerebrospinal fluid (CSF) leak is a rare condition. When it involves the ventral skull base, a surgical closure may be achieved using endoscopic skull base surgery techniques. The major principles remain in achieving a watertight closure that can also support the brain (and avoid brain sagging) in case of extensive skull base defects. Surgical techniques are well described. Many clinical factors may influence the successful rate of the reconstruction. However, there is a lack of clinical study on perioperative management of CSF leaks. The purpose of this study is to gather the opinion of skull base surgeons on the post-operative management of patients to avoid CSF leak recurrence.

•Methods: The investigators will collect data from skull base surgeons using an electronic survey questionnaire (Google Form, Google, Mountain View, California, U.S.A.) submitted by e-mail to the members of the French Association of Rhinology, to the European Rhinologic Society, to the French college of neurosurgeons, to the Italian skull base society members, and to the former students of the European endoscopic skull base diploma. This is an anonymous 60-items survey. Questions were classified in eight sections: general questions, material used at the end of the surgical procedure, post-operative resting position, drugs, CSF depletion, post-operative advices, explorations in case of early recurrence of the rhinorrhoea, and follow-up modalities.

•Discussion: The investigators aim to understand the actual practice of skull base surgeons after closure of ventral skull base CSF leaks. This can serve as a basis for conducting clinical studies in the future.


title: Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care : DIPREA

acronym: DIPREA

summary: Currently about 90 cases of infection in children are reported every year in pediatric intensive care, a disease considered to be the main cause of hospitalization of children. 16% of invasive pneumococcal infections are linked to a genetic abnormality in immunity. Herpetic encephalitis has become a model of genetic infectious disease, with new mutations identified in the TLR3 pathway. Severe infections are no longer the result of chance and can be the way to reveal a primary immune deficiency. In this context, the investigators propose to evaluate the incidence of hereditary immune deficiency after a systematic immunological screening in children admitted for a severe infection in pediatric intensive care unit (ICU).


title: Oral Health Perception and Difficulties Encountered by Parents in the Implementation of Oral Hygiene of Children Under 6, Qualitative Study.-

summary:
A qualitative analysis was carried out on 15 participants, in 3 different places: the Montpellier health center, a pediatric odontology practice in Nîmes and a dentistry practice in Marseille.

Two methods of analysis were chosen: thematic analysis and word counting.


title: Impact of Confinement on the Treatment of Spondyloarthritis.

summary: Evaluate the impact of confinement on treatment use in spondyloarthritis. Study hypothesis that with the confinement, subjects will stop their treatment. The main objective is to study the impact of confinement on treatment. And secondly to look for for specific psychological profile linked to the interruption of the treatment. the study population consists of patients with spondyloarthritis and belonging to a patient association (ACS). All patients over 18 are included. A mailing questionnaire will be send to all patients. data on diseases activity and treatment will be collected

ipd_sharing_description: no data sharing plan has been established

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Diagnosis of RSTS: Identification of the Acetylation Profiles as Epigenetic Markers for Assessing Causality of CREBBP and EP300 Variants.

acronym: GENEPI

summary:
Rubinstein-Taybi syndrome (RSTS) is a rare and severe congenital developmental disorder characterized by congenital anomalies and intellectual disability with a long term memory deficit. The main challenge is to improve the intellectual and memory efficiency of these patients. CREBBP and EP300 are the two genes known to cause RSTS. Both paralogs play a major role in chromatin remodeling and encode for transcriptional co-activators interacting with many proteins.

The aim of this pilot study is to characterize the histone acetylation profiles in order to identify specific acetylation markers during normal and pathological neuronal differentiation of cortical and pyramidal neurons in RSTS.

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus

summary: The Covid-19 pandemic is a major public health issue. Potential treatments are essential to control the infection. Hydroxychlorquine is currently tested in several clinical trials to evaluate its efficiency.The objective of this study was to evaluate the symptoms related to COVID-19 occuring in patients with systemic lupus erythematosus (SLE)


title: Impact on Mortality of Cardiovascular Treatments Interruption in a Medical Intensive Care Unit

acronym: TRAM

summary: Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified. The question of the study is to investigate wether such treatment interruption might be responsible for prognosis modifications.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Medical Intensive Care Unit, Brest University Hospital


title: Evolution of Maxillofacial Trauma Activity During COVID-19 Containment Measures: a French Multicentric Comparative Observational Study

acronym: Traumax

summary:
The COVID-19 global pandemic has led to a major professional and social national reorganization: professional because it involves a redeployment of medical staff and material resources, and social because it imposes prolonged containment measures on an entire population.

The maxillofacial trauma activity is mainly linked to sports or leisure accidents, fights and road accidents.

It seems to appear since the beginning of containment measures a significant drop in maxillofacial trauma activity at the national level, which, if it is demonstrated in a significant way in several French hospital centers, would allow to redeploy the material and human resources related to this activity on sectors in tension due to the pandemic.


title: Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy

acronym: KYSINDO

summary: To evaluate the feasibility of using Indocyanine Green in the laparoscopic surgical treatment of benign organic ovarian cysts (dermoid, serous, mucinous and endometriotic) in patients with a short-term desire for pregnancy. The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. To do so, the fluorescence scores (indocyanine green staining) need to be compared to the ovarian reserve of the patient, previously verified intraoperatively and postoperatively at M6 and M12, these scores being determined according to the vascularization visualized in laparoscopy and established both by a double visual notation (Likert scale) and by a computer software (METAMORPH) objective notation. This procedure would, in patients with fertility disorders or wishing for pregnancy in the short run, reassure them about their reproductive potential immediately after the intervention. In the event of poor staining, if correlated by a decrease in ovarian reserve, the concerned patients could be referred to a MPA treatment facility much earlier in the postoperative period or, if no desire for immediate pregnancy, towards fertility preservation methods.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Plasma Oxalate in Patient With Short Bowel

acronym: OXAGO

summary: Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.

location_facility: Nephrology Department, Edouard Herriot Hospital


title: Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis

acronym: UVE-FAS

summary: The study aims at defining the role of soluble CD95 Ligand in the physiopathology of the non-infectious uveitis. Soluble CD95 Ligand might have a prognostic interest as well as potential for the discovery of new therapeutic strategies


title: Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients

summary:
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.

The objectives of this study are :

To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.
To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.
To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.


title: Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta

acronym: MOVE-OI

summary:
Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low bone mass. It is conceivable that children and adolescents with OI are less active than healthy peers because of frequent fractures, immobilization,functionals limitations and no adapted physicals activity(APA). The hypothesis is that an Adapted physique activity could improve access of activity for patients with Osteogenesis Imperfecta (OI).

The aim of the study is to evaluate benefice of APA,improve aerobic capacity, cardiovascular and bone benefits, and gain of quality of life.

Children with OI between 6 and 18 years old will have a program of supervised "adapted training program" during one year. The program is adapted at each individual and without risk for the patient.

location_facility: Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant


title: Benefit of Tin Filter in Regards to Image Quality and Radiation Dose in CT Scan

summary: Main objective: to demonstrate that the diagnostic quality associated with the acquisition mode with tin filter, evaluated in a subjective way, is not inferior to that associated with the acquisition mode without filter.

primary_purpose: Device Feasibility

lead_sponsor: Ramsay Générale de Santé


title: Reliability of Gastric Suctioning Compared to Gastric Ultrasound for Residual Gastric Volume Monitoring in Intensive Care Unit Pediatric Patients

acronym: GASTRIPED

summary:
It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation.

Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP).

Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding.

Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP.

This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients.

Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients.

This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.

location_facility: Service Anesthésie réanimation - Centre Hospitalier Hôpital Femme Mère Enfant Groupement Hospitalier Est - Hospices Civils de Lyon


title: Assessment of Muscular Respiratory Involvement in Systemic Sclerosis

acronym: SIROCO

summary:
Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability.

Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors.

Diffuse fibrosing myopathy of bad prognosis have been reported in ScS.To now, muscular respiratory involvement has not been evaluated in ScS. Therefore, ScS patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (PFT).

This project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in ScS and to evaluate a screening strategy of this involvement.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital


title: Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire (Diagnosis of Facet Joint Origin Lumbago).

acronym: Rhizolyse

summary:
Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications.

A previous study has selected functional and physical signs selected by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.

The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.


title: Comparison of the Proportion of Covid19 Seroconversion of Caregivers Working or Not in the COVID Sector

acronym: CoSigS

summary:
According to recent publications, the percentage of caregivers infected with COVID 19 is evaluated between 10 and 30% . This great variability is due, on the one hand to the intensity of the influx of covid plus patients and, on the other hand, to the disparity in the preparation of caregivers in the face of this emergency. Indeed, we can understand that the strict application of hygiene rules can be faulted in the face of the volume of patients, the lack of protective equipment and the lack of specific training for caregivers in this area. As a result, within healthcare teams, there are many questions that generate anxiety: will I be able to provide care properly while protecting myself from the risk of contamination? This anxiety is also present and sometimes manifests itself aggressively in the entourage or in the vicinity of caregivers, due to lack of scientific data adapted to the local ecology of the crisis.

Thus, the aim of this study is to show that the risk for caregivers of being contaminated by COVID in an area dedicated to COVID positive patients is no higher than being a caregiver in a non-COVID area that he either in the adult or pediatric sector.

lead_sponsor: University Hospital, Limoges


title: Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

acronym: PB-USTE

summary:
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity.

BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time.

Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months.

Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.


title: Psychological Impact of Quarantine in Chronic Pain Patient During COVID-19 Outbreak

acronym: DolPsyCOVID

summary: In the context of quarantine with COVID-19, we will study the experience and psychological impact of pain in adult patients living with chronic pain. We will evaluate the link between the question of physical and psychological confinement in the experience of pain in this particular situation

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Lille


title: Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire

summary:
A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.

The objective of the study is to validate the translation of the SN-5 questionnaire in French.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome

acronym: TIPEX-VOLTEX

summary: Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.

ReferenceType: background

ReferenceCitation: Casserly B, McCool FD, Saunders J, Selvakumar N, Levy MM. End-Expiratory Volume and Oxygenation: Targeting PEEP in ARDS Patients. Lung. 2016 Feb;194(1):35-41. doi: 10.1007/s00408-015-9823-6. Epub 2015 Dec 8.

ReferenceCitation: Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801.

ReferenceCitation: Olegård C, Söndergaard S, Houltz E, Lundin S, Stenqvist O. Estimation of functional residual capacity at the bedside using standard monitoring equipment: a modified nitrogen washout/washin technique requiring a small change of the inspired oxygen fraction. Anesth Analg. 2005 Jul;101(1):206-12, table of contents.

ReferenceCitation: Sahetya SK, Goligher EC, Brower RG. Fifty Years of Research in ARDS. Setting Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1429-1438. doi: 10.1164/rccm.201610-2035CI. Review. Erratum in: Am J Respir Crit Care Med. 2018 Mar 1;197(5):684-685.

ReferenceCitation: Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.

lead_sponsor: Centre Hospitalier Intercommunal Aix-Pertuis


title: Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy: Prospective Randomized Study.

acronym: COMPTAMAF

summary:
Prospective mono-centric randomized open-label study (randomization 1: 1, 2 groups) comparing a group of patients who received conventional information to a group of patients who had been sensitized to a fetal active movement count technique.

The study will take place at the University Hospital Center of Saint-Etienne in the gynecology-obstetrics department.

An information brochure on the study will be handed over at the end of the term consultation to 41+0 weeks of gestation. After collecting the consent of the patient, the distribution between the two groups will be done by randomization. Thus, for the fetal active movement count group, fetal active movement count education will be proposed during the term consultation with the submission of an information brochure. The "control" group will also receive a simple information pamphlet with, in writing, what patients currently receive orally: definition of active fetal movements, and the need to consult if the patient perceives less movements of her fetus .The principal objective is to compare perinatal morbidity in relation with the sensation of decrease active fetal movements in case of late pregnancy, according to the fact if the patients use or not the AFM's count.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Does Preprocedural Ultrasound Exam of Lumbar Spine Increase the First-pass Success Rate of Epidural Space Identification Among Obese Parturients: A Randomized Controlled Open Trial

summary: Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients.

ReferenceCitation: Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French.

lead_sponsor: University Hospital, Caen


title: High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - (IRIR)

acronym: IRIR

summary:
The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters.

The investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of VKA or EPO, metabolic parameters (HbA1c, NFS, reticulocytes, BNP, lipid balance, phosphocalcic balance).


title: Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study- Fluomet Study

acronym: Fluomet

summary: Few studies have evaluated the use of fluorescein sodium for the resection of brain tumours (especially glioblastomas) but also cerebral metastases. We therefore propose to evaluate the technique of fluorescence guided microsurgery (fluorescein sodium) compared to the conventional microsurgical technique in the resection of cerebral metastases in adults in order to specify, by a prospective and randomised study, the assistance provided by this technique in the quality of resection and the gain in terms of overall survival and local control of brain disease.


title: Evaluation of Knowledge About Contraception and Pregnancy Planning Among Type 1 and Type 2 Diabetes Women

acronym: DMPKA

summary:
Diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as preeclampsia, congenital malformations and macrosomia.

Preconception care is all methods to assess the best prognostic for a diabetic pregnancy. Among these methods, contraception is very important to plan the pregnancy on a chosen moment.

The content of the preconception care is well established. However, information of diabetic women concerning contraception and giabetic pregnancy has been little studied.

ReferenceCitation: Feutry L, Barbe C, Marquet-Dupont A, Fèvre A, Lukas-Croisier C, Vitellius G, Delemer B, Barraud S. Contraception use and knowledge related to pregnancy in diabetic women. Ann Endocrinol (Paris). 2022 Apr;83(2):88-94. doi: 10.1016/j.ando.2022.01.007. Epub 2022 Feb 7.


title: Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events: Randomized Controlled Trial of Non-inferiority (TONIC)

acronym: TONIC

summary:
Traditionally, patients are asked to fast prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this.

Hypothesis/Objective :

To show that allowing unrestricted oral intake before a coronary interventional procedure is not inferior to imposing a pre-procedural fasting period, in terms of adverse events, in patients requiring coronary angiography or a planned or semi-urgent percutaneous coronary intervention.

Method:

The study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms. The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm. In order to keep the blind, the medical and paramedical staff of the interventional cardiology room will not inquire about the fasting status of patients included in the study.

Patients are randomized either to the pre-procedural fasting arm or to the absence of pre-procedural fasting.

No intervention: Pre-procedural fasting is defined by the absence of ingestion of fluids or solid food for at least 6 hours before the examination.
Experimental: free feeding and drinking until the procedure.

Patients are followed for 4 hours after the end of the procedure at the hospital for adverse events (vagal discomfort, nausea, vomiting or hypoglycaemia).

Then a follow-up will be done at day 7 after the procedure (by telephone for outpatients or discharged from the hospital and in the cardiology department for patients still hospitalized on D7) to look for the occurrence of acute renal failure or pneumonia

status: Not yet recruiting

ipd_sharing_description: data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study

acronym: TAVIWOP

summary: The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.


title: Comparative Study of the Results of Anterior and Posterior Arthrodesis in Degenerative Lumbar Pathology

acronym: ECALAP

summary: To compare the functional results through the improvement of the Oswestry medium-term score of the lumbar arthrodesis performed to treat patients with lumbago and/or lumbar-radicular pain due to degenerative lesions of the lumbar spine: degenerative disc disease, osteoarthritis spondylolisthesis or adult dislocation scoliosis.


title: Promote Personalized Medicine Based on Diagnostic Genomic Tools in Order to Innovate in the Early Detection of Child Deafness in the SUDOE Space (European International Project)

acronym: GHELP

summary: To assess the diagnostic value of NGS screnning in prelingually deafned children using a new designed chip, and to evaluate its interest in a the neonatal screening program for ddetecting congenitally deafned children.

lead_sponsor: Clinica Universidad de Navarra, Universidad de Navarra


title: Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections

acronym: PK-plèvre

summary:
The incidence of pleural infection is increasing worldwide since the last two decades. Antibiotics are one of the cornerstones of the treatment of this disease and must be associated to a correct evacuation of the pleural effusion.

Data concerning the pleural diffusion of antibiotics currently used in community acquired pleural infection are scarce. The main objective of this study is to evaluate the pleural pharmacokinetic of amoxicillin and clavulanic acid in patients with a complicated pleural infection (patients who need a chest tube insertion).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: French Study in Real Life Evaluating Xybilun: Convenience and Erection Induction Related to a New Administration in Orodispersible Film

acronym: XY-FILM

summary: Collecting Xybilun (Viagra's generic) efficacity, tolerance, convenience and patients/doctors satisfaction's data at different doses (50-75-100 mg), is the aim of the study.

lead_sponsor: Laboratoires Genévrier


title: Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

acronym: MAB IN SITRO

summary: Multicentric interventional prospective study with collection of biological samples as part of a routine care research

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: COgilus Remediation in Alzheimer Patients

acronym: CORA

summary: This study evaluates the usability of a new tablet PC application to stimulate cognitive functions. Patients hospitalized in a geriatric ward (day or complete hospitalisation) but also their informal and professional caregivers will assess the usability of the application using a structured survey.

lead_sponsor: University Hospital, Angers


title: ASSESSMENT OF COMPLEXITY AND TECHNICAL DIFFICULTIES IN LIVER TRANSPLANTATION: INTERNATIONAL SURVEY OF EXPERTS

summary: The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification.

ReferenceCitation: Lee MK 4th, Gao F, Strasberg SM. Perceived complexity of various liver resections: results of a survey of experts with development of a complexity score and classification. J Am Coll Surg. 2015 Jan;220(1):64-9. doi: 10.1016/j.jamcollsurg.2014.09.017. Epub 2014 Oct 15.

ReferenceCitation: Lee MK 4th, Gao F, Strasberg SM. Completion of a Liver Surgery Complexity Score and Classification Based on an International Survey of Experts. J Am Coll Surg. 2016 Aug;223(2):332-42. doi: 10.1016/j.jamcollsurg.2016.03.039. Epub 2016 Apr 9.

ReferenceCitation: Manceau G, Benoist S, Panis Y, Rault A, Mathonnet M, Goere D, Tuech JJ, Collet D, Penna C, Karoui M. Elective surgery for tumours of the splenic flexure: a French inter-group (AFC, SFCD, FRENCH, GRECCAR) survey. Tech Coloproctol. 2020 Feb;24(2):191-198. doi: 10.1007/s10151-019-02143-2. Epub 2020 Jan 14.

ReferenceCitation: Reames BN, Blair AB, Krell RW, Groot VP, Gemenetzis G, Padussis JC, Thayer SP, Falconi M, Wolfgang CL, Weiss MJ, Are C, He J. Management of Locally Advanced Pancreatic Cancer: Results of an International Survey of Current Practice. Ann Surg. 2021 Jun 1;273(6):1173-1181. doi: 10.1097/SLA.0000000000003568.

lead_sponsor: Pitié-Salpêtrière Hospital


title: Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study.

acronym: Achalaglie

summary:
Achalasia is a primary esophageal motility disorder characterized on high-resolution manometry (HRM) studies by 100% failed peristalsis and elevated integrated relaxation pressure of the lower esophageal sphincter. It is further divided into 3 sub-types according to the Chicago classification v3.01. The pathophysiology of achalasia is poorly understood; however, the NGEU is increasingly recognized as playing a key role in the development of this disorder. Similarly, the esophageal muscle tissue is probably involved, but its sampling remained challenging until the recent advent of the POEM procedure. Indeed, it is now possible, easy and safe to take biopsies of the muscle tissue during POEM. Therefore, POEM not only represents an innovative and effective treatment for achalasia, but also an opportunity to better understand its underlying pathophysiological mechanisms. Currently available treatments for achalasia (pneumatic dilation (PD), Heller's myotomy (HM), botox injections, POEM) are "palliative" procedures that do not restore normal contractile function of the esophagus, but a better understanding of the pathophysiological mechanisms underlying this disorder could potentially help developing curative, or even preventative treatments.

To date, muscle tissue sampled during a POEM has only been characterized qualitatively (normal, atrophic, hypertrophic) with no assessment of the enteric nervous system. Moreover, there has been no studies of the mucosal or NGEU anomalies on biopsies taken during a minimally invasive procedure for achalasia such as a POEM.

This study aims to evaluate the feasibility of the assessment of NGEU and esophageal muscle tissue in biopsies taken during a POEM for achalasia. It also aims to determine whether specific biomarkers within the NGEU and muscle tissue can predict a better therapeutic response to a POEM. The goal is to include 30 patients within 12 months. Given that approximately 100 new cases of achalasia are diagnosed each year at the included centers, and that about 50% of treatment-naive patients are offered and accept to undergo a POEM, recruitment should be completed relatively rapidly. All POEMs will be performed at the CHU de Nantes by a single endoscopist who has already performed more than 100 procedures. Other than the complications related to the POEM itself, the addition of 14 esophageal biopsies required for our study is a very low-risk intervention. Biopsy sampling extends the length of the procedure by only 4-5 minutes and has not been associated with an increased risk of complications in a previous study.

Patients will be evaluated at five time points: preinclusion visit (up to four months before the POEM), inclusion visit (day of the POEM), post-POEM phone calls (3-6, 9-12, 22-26 months after POEM). During the preinclusion visit, relevant information regarding inclusion/exclusion criteria, consent, HRM and pH impedance results, past medical history, and pregnancy status (if applicable) will be gathered. At each time point, current medical history, Eckhardt score2 and pH impedance results (if available) will be documented. The patient will also answer the quality of life (SF36)3 and nutritional status questionnaires and will undergo blood sampling for albumin and prealbumin levels. Additionally, on the day of the POEM, there will be another blood sampling for complete blood count, PT, APTT, serum electrolytes and CRP level. Finally, at each post-POEM phone calls, the occurrence of adverse events will be reported.

Our primary hypothesis is that the analysis of mucosal and muscle tissue biopsies taken safely during a POEM will allow better characterization of transcriptomic and molecular remodeling of the mucosa (especially the NGEU) and the muscularis propria in achalasia. We also hypothesize that these anomalies could eventually serve as treatment targets and as a way of better stratifying patients according to achalasia type and treatment (in our case, POEM) response.

ReferenceCitation: Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.

ReferenceCitation: Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8.

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

lead_sponsor: Nantes University Hospital


title: Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection

acronym: LoPreCol

summary: The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.

lead_sponsor: Institut Paoli-Calmettes


title: COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study

acronym: COCORICO

summary: Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization.

lead_sponsor: Société Française d'Endoscopie Digestive


title: Dermatologic Clinical Patterns Study of Tuberous Sclerosis Complex Patients Related With Their Somatic Mutation

summary:
Tuberous Sclerosis is a rare genetic disorder that affects about one in 15,000 individuals. It is part of the phacomatoses: a germline mutation of the gene Tuberous Sclerosis Complex 1 (TSC1) or TSC2 causes a protein dysfunction, hamartin and tuberin respectively, leading to mTOR signaling pathway activation, thus tumors rise on the skin but also brain, eyes, kidneys, heart.

Thanks to the advent of sequencing techniques of the human genome, genes involved were found twenty years ago. Most commonly, these are de novo private mutations and autosomal dominant Mendelian transmission. About 15% of patients have a phenotype corresponding to the disease but no mutation is found.

Although the initial clinical description was in 1880, publications regularly describe new signs in Tuberous Sclerosis, especially for skin.

Cutaneous manifestations are important in the diagnostic criteria of the disease and often even the first sign of appeal. However, no data is available on the relationship between genotype and dermatological phenotype.

Therefore the investigator intend to review all cutaneous finding in Tuberous Sclerosis patient and try to link with their mutation.

lead_sponsor: University Hospital, Montpellier


title: Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement

acronym: ASOPHA

summary:
Opioid-free anesthesia (ATO) is a multimodal anaesthesia combining different analgesic and anesthetic modalities thus excluding opiates as an intraoperative. Recent studies have found a benefit from the ATO on postoperative rehabilitation and reduced length of hospitalization.

Periarticular infiltration with a local anesthetic is one of the measures proposed in OFA during the PTH.

PTH remains a painful procedure and the occurrence of morphinic-related side effects in sometimes elderly patients is often observed.

The main objective of this study is to assess the feasibility of ATO in anterior hip replacement under general anesthesia with the primary endpoint of morphine consumption measured 24 hours after surgery.

lead_sponsor: Hôpital Privé Sévigné


title: Assessment of 4 Bone Turnover Markers (C-terminal Telopeptides of Type I Collagene (CTX), Amino-terminal Telopeptide of Type 1 Collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in Multiple Myeloma Patients Treated With Intravenous Bisphosphonate

acronym: AMBROBiMM

summary: The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.

location_facility: Necker Hospital, Adult haematology department


title: Exploration of the Transfer of Barium From Thermal Mud (T2BT Study)

summary: It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urine following applications of thermal mud. The main objective is to highlight an increase in serum barium level of at least twice.

ReferenceCitation: Roques CF, Trèves R, Queneau P, Bontoux D. Avis de l'académie nationale de médecine relatif à l'évaluation des risques sanitaires liés à la présence de baryum dans des argiles constitutives des boues thermales et à l'absence de contrôle sanitaire des boues thermales. Bull Acad Ntle Méd., , 201: 13-38, 2017.

ReferenceCitation: Ainouche R, Tabone W, Bouvier CE, Renaud V. Usage thérapeutique (des boues thermales), panorama du thermalisme français en 2013. Bulletin de l'AFTH (Association Française des Techniques Hydrothermales), 2014, n° 25, Symposium Utilisation des boues en établissement thermal, Enghien les Bains, Novembre 2013, pp. 7-11

ReferenceCitation: Gomes C, Carretero MI, Pozo M, Maraver F, Cantista P et al. Peloids and pelotherapy : historical evolution, classification and glossary. Applied clay science 75-76:28-38, 2013.

ReferenceCitation: Liu H, Zeng C, Gao SG, Yang T, Luo W, Li YS, Xiong YL, Sun JP, Lei GH. The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2013 Oct;41(5):1418-25. doi: 10.1177/0300060513488509. Epub 2013 Sep 5.

ReferenceCitation: Roques CF. Mud Therapy. Data of clinical evidence. Balnea 10:57-62, 2015.

ReferenceCitation: Xiang J, Wu D, Li J. Clinical Efficacy of Mudpack Therapy in Treating Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Studies. Am J Phys Med Rehabil. 2016 Feb;95(2):121-31. doi: 10.1097/PHM.0000000000000354.

ReferenceCitation: Roques CF, Queneau P. [SPA therapy for pain of patients with chronic low back pain, knee osteo-arthritis and fibromyalgia]. Bull Acad Natl Med. 2016 Mar;200(3):575-86; discussion 586-7. Review. French.

ReferenceCitation: World Health Organization (WHO) - 2001 - IPCS (International Programme on Chemical Safety) - Concise international chemical assessment document 33 - barium and barium compounds. 57 pp

ReferenceCitation: Conseil canadien des Ministres de l'environnement - Recommandations canadiennes pour la qualité des sols - environnement et santé humaine. Le baryum. Feuillet d'information 2013, 1 doc 11 pp

ReferenceCitation: Kravchenko J, Darrah TH, Miller RK, Lyerly HK, Vengosh A. A review of the health impacts of barium from natural and anthropogenic exposure. Environ Geochem Health. 2014 Aug;36(4):797-814. doi: 10.1007/s10653-014-9622-7. Epub 2014 May 21. Review.

ReferenceCitation: INRS - base de données de fiches toxicologiques. Baryum et composés. Fiche toxicologique complète n°125. 1 doc 12 pp, 2012

ReferenceCitation: Ding C, Pan Y, Zhang A, Zhu C, Liu D, Xu G, Zheng Y, Yan H. [Distribution of rubidium, cesium, beryllium, strontium, and barium in blood and urine in general Chinese population]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2015 Dec;33(12):894-9. doi: 10.3760/cma.j.issn.1001-9391.2015.12.004. Chinese.

lead_sponsor: Association Francaise pour la Recherche Thermale


title: Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine

acronym: ERIEAS

summary: The study is a realistic evaluation of the Expériences Animées school-based programme. The aim is to precisely characterize i) the effects in terms of alcohol and cannabis consumption, the use of health professionals in case of problematic use of those two substances; ii) the context and underpinning mechanisms triggered by the program in terms of changes of alcohol and cannabis representations and life skills development. This evaluation could allow to produce the key functions of the programme: how the intervention works, in which conditions.

ReferenceCitation: Martin-Fernandez J, Affret A, Martel E, Gallard R, Merchadou L, Moinot L, Termote M, Dejarnac V, Alla F, Cambon L. Realist evaluation of a theory-based life skills programme aiming to prevent addictive behaviours in adolescents: the ERIEAS study protocol. BMJ Open. 2020 Jun 29;10(6):e034530. doi: 10.1136/bmjopen-2019-034530.

lead_sponsor: University Hospital, Bordeaux

location_facility: CIC1401-EC - CHU de Bordeaux Centre Inserm U1219


title: Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening

acronym: DiVHeB

summary: The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.

lead_sponsor: University Hospital, Grenoble


title: Study of PtiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients With Intracranial Refractory Hypertension Treated With Targeted Temperature Control

acronym: TODAY

summary:
Serious head trauma is a common and pathology and responsible of high morbidity and mortality. The major challenge, from the very first hours, is to limit cerebral ischemia by controlling secondary brain injury factors.

These parameters must be integrated early in order to guide the better cerebral resuscitation. Brain monitoring is multimodal:transcranial Doppler, intracranial pressure sensor, cerebral tissue pressure in O2.

In the case of refractory intracranial hypertension to well-conducted medical treatment, targeted temperature control showed its efficacy on the control of intracranial pressure.

There are few data in the literature on PbtO2 modifications during therapeutic hypothermia.

PbtO2 monitoring is now commonly used according to literature data, showing the benefit of the latter but the interpretation of its values during the phase of targeted temperature control is not known. Due to the lack of data on the variation of values of PbtO2 during the hypothermia phase, values falsely comfortable or falsely weak could lead respectively to a lack of support of an episode of tissue hypoxia or the introduction of unjustified aggressive therapeutics.

lead_sponsor: University Hospital, Brest


title: Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin: Retrospective Study in Patients Followed at the CHRU of Brest

acronym: MAP

summary: Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest

ReferenceCitation: Bernat AL, Oyama K, Hamdi S, Mandonnet E, Vexiau D, Pocard M, George B, Froelich S. Growth stabilization and regression of meningiomas after discontinuation of cyproterone acetate: a case series of 12 patients. Acta Neurochir (Wien). 2015 Oct;157(10):1741-6. doi: 10.1007/s00701-015-2532-3. Epub 2015 Aug 12.

ReferenceCitation: S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.

location_facility: Département de Nutrition - CHRU de Brest


title: Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack

acronym: TIA

summary: Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the literature. score ABCD3-I1. Several studies have shown that brain microhemorrhages are associated with the risk of early stroke in patients with TIA. Data on white matter hypersignals on the T2-weighted sequence or FLAIR (FLuid Attenuated Inversion Recovery) are more conflicting. The global microangiopathic load, including the gaps, the hypersignals of the white matter, the perivascular spaces visible on MRI in the basal ganglia, especially when they are very numerous (> 20) and the gaps, have recently been described as being associated with stroke risk within 2 to 3 years of TIA or ischemic stroke. To date, the predictive value of global microangiopathic burden on early stroke risk in the course of TIA is not known.

lead_sponsor: Hospices Civils de Lyon


title: Randomised Study of Noninferiority Comparing a TransversusAbdominis Plane Block Surgical (c-TAP Block) to the Ultrasound-guided Abdominis Plane Block Transversus (Us-TAP Block) in Postoperative Analgesia After Laparoscopy or Laparotomy

acronym: CHIRTAP

summary: Interventional, randomised, prospective, multicentric study

status: Suspended

lead_sponsor: Institut Jean-Godinot


title: Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient

acronym: ULD OSLER

summary:
Hereditary hemorrhagic telangiectasia (HHT) is linked to a dysregulation of angiogenesis leading to the formation of arteriovenous malformations (AVM): cutaneo-mucous telangiectasia and visceral shunts. The diagnosis is clinical and based on Curaçao criteria: recurrent epistaxis, cutaneo-mucous telangiectasia, hereditary signs and presence of visceral AVM.

Pulmonary AVMs (PAVM) expose patients to many potentially life-threatening complications, such as strokes or brain abscesses due to the right-left shunt created and the lack of filtration barrier of the pulmonary capillary within the AVM. These patients should therefore have regular monitoring throughout their life by a chest CT scanner every 5 to 10 years in the absence of PAVM at the initial scan or more often if PAVMs are present. The management of PAVMs is based on their early detection and embolization in interventional radiology during which is set up within the afferent artery of the PAVM an embolizing agent, the coil.

However, the risk of cumulative irradiation exposure from thoracic scanners and repeated thoracic embolizations over time could be reduces by a decrease of X-rays dose.

A new thoracic CT imaging protocol validated in the United States in the primary screening of lung cancer, the ultra-low dose protocol, is a CT scanner acquired at an irradiation dose equivalent to that of a frontal chest x-ray and in profile. The dose reduction is of 40 times the usual dose of a chest CT scanner.

The lung parenchyma has a high natural contrast on thoracic CT images and there are few adjacent attenuating structures allowing a drastic reduction of dose. However, from this dose, the image quality is degraded with an increase of the image noise. The diagnostic performances have to be confirmed with qualitative and quantitative measurements.

Thus, the objective of this study is to compare the sensitivity and the specificity of the current scanner and the ultra-low dose scanner to reduce the exposure to X-rays.

location_facility: Hospices Civils de Lyon - Hopital Louis Pradel

intervention_type: Radiation


title: Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorder in Female Adolescents With Anorexia Nervosa: a Randomized, Controlled Superiority Study

acronym: ANO-TERV

summary:
Anorexia nervosa is defined in DSM V as a quantitative and qualitative dietary restriction resulting in significant weight loss, intense fear of weight gain, altered weight and body shape perception (body dysmorphic disorder) and low self-esteem influenced by weight or body shape. Body dysmorphic disorder is the most difficult symptom to manage in anorexia nervosa and its persistence is a factor associated with relapse.

Virtual reality exposure therapy has proven its effectiveness in the management of post-traumatic stress disorder in the military and is a widely used therapy. The effectiveness of this treatment using new technologies has not yet been studied for the treatment of body dysmorphic disorder in anorexia nervosa and is not used routinely. It could represent an interesting alternative to the physical approach in psychomotor therapy, traditionally offered to patients suffering from anorexia nervosa. It is important to evaluate the effectiveness of virtual reality exposure therapy in the management of body dysmorphic disorder in patients with anorexia nervosa by comparing these two care techniques.

lead_sponsor: CHU de Reims


title: Metabolic, Functional and Nutritional Responses to Weight Cycling in Athletes: The WAVE Study

acronym: WAVE

summary:
Many elite athletes are submitted to frequent rapid weight loss periods to meet their competition weight category and then experience weight cycling (lowing and gaining weight regularly). This weight cycling induce severe temporary energetic and metabolic changes and when repeated over time can lead to permanent metabolic adaptations that might favor metabolic disorders, body weight gain and body composition changes (favoring fat mass). The exact effects of this weight cycling are not clear yet, especially in terms of metabolic, energetics, nutritional functional and psychological impacts. Better understand these adaptations and their variations during weight loss and weight gain in regular weight cycler is of main importance to prevent these athletes for future health issues.

The aim of the present project if to assess these metabolic, functional, energetic and nutritional adaptations during weight loss, weight stable and weight gain periods in athletes experiencing regular weight cycling.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Randomized Study of the Effect of Vocal Exercises With Straw on Aerodynamic Parameters of Voice (Pressure, Flow) in Dysodic Singers With Nodules

acronym: DYSODIE

summary:
Singers are over-represented in phoniatric consultations; they present increased risk of developing voice disorders. The most common lesion found in singers is nodule. It comes from vocal straining characterized by the use of a pressed phonation mode, resulting in an increase subglottal pressure and a decrease flow rate. Voice therapy aims to restore a more relaxed phonation. There is a growing interest in semi-occluded vocal tract exercises with a straw in therapy; they have positive effects, particularly in terms of aerodynamic parameters such as subglottal pressure and oral airflow. After these exercises, subglottal pressure decreases and oral airflow increases. In other words, patient adopts a more relaxed phonation mode. Several studies have investigated the effect of these straw exercises on dysphonic patients i.e. on speaking voice; no study to date has explored the effect of these exercises on dysodic subjects i.e. on singing voice.

The aim of this study is to evaluate the impact of straw exercises compared to open-mouth exercises on aerodynamic parameters in dysodic women singers with nodules.


title: Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops

acronym: KALICORT

summary:
Following corneal graft, local steroids with a gradually decreasing dose for 12 months are prescribed to reduce the graft rejection risk (maximum incidence of 20% for the first 12 months). The validated KaliJAR® device is a box for single-dose eye drops collection. This innovative tool will make it possible to objectify the compliance of patients with a corneal graft.

Unlike the field of glaucoma, no specific compliance data are available for corneal grafts, although it is important because graft rejection is the most important cause of corneal graft failure.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Clinical, EEG and Radiological Initial and Evolutive Characterisation of LGI1-antibody Patients

summary:
Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders.

This disease is rare and its clinical, EEG and radiological characterisation is not sufficiently established. The investigators will evaluate these three aspects for the anti-LGI1 cohort of patients of the National Reference Center of autoimmune encephalitis.

location_facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes


title: Immunogenetic Characteristics in Autoimmune Encephalitis and Related Disorders: HLA Analysis

acronym: ICARE

summary:
Autoimmune encephalitis (AE) are characterized by subacute onset of memory deficits, altered mental status or psychiatric symptoms, frequently associated with seizures, inflammatory cerebrospinal fluid and in cases with prominent limbic involvement, typical magnetic resonance imaging. Several autoantibodies (Ab) may be detected in AE, although its detection is not mandatory to establish a diagnosis. These Ab mainly recognize different synaptic and cell-surface proteins in the central nervous system, and are thought to be pathogenic as they alter the normal location or function of its antigens.

The primary trigger of the immune response is unknown for most of AE. In addition to acquired susceptibility, genetic predisposition may also be important in the pathogenesis of AE. Human leukocyte antigen (HLA) is the genetic factor most frequently associated with autoimmune diseases, due to its genetic complexity and key role in the adaptive immune response. The aim of the study is to describe HLA profile in three groups of autoimmune encephalitis and related disorders: anti-LGI1, anti-CASPR2 and anti-GAD neurological diseases.


title: Neuromuscular Plasticity in Response to Obesity: Effects of Mechanical Overload, Metabolic Disorders and Age

acronym: PLANEUROB

summary: Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of torque production during repeated contractions. Our previous studies on "healthy" obese adolescents (i.e without inflammation or metabolic disorder) suggests that obesity has positive effects on the neural and muscular factors responsible for torque production, with chronic overload acting as a strength training . However, this high torque level is associated with higher fatigability. These results are in contrast with the data obtained on adult obese patients (young and elderly), in whom torque production and fatigability appear to be more impaired, probably due to the development of metabolic disorders associated with obesity (inflammation, insulin resistance and lipid infiltration in muscle) and aging. The respective effects of mechanical overload, metabolic disorders (insulin resistance and lipid infiltration) and aging on neural and muscular factors of torque production and neuromuscular fatigue etiology are not currently known in young adult obese of elderly. Their relationship to the clinical symptoms of mobility troubles is also unknown. However, this knowledge is crucial for designing physical activity programs tailored and adapted to the level of metabolic impairment and age of obese patients. The hypothesis is that mechanical overload associated with obesity has positive effects on torque production in the absence of metabolic alteration and the effect of aging but negative effects on fatigability, mainly due to muscular factors; the insulin resistance increases peripheral fatigue (due to an alteration in the excitability of the sarcolemma during fatiguing exercise), central fatigue, and slows recovery; the development of inflammation and lipid infiltration, which are more pronounced in obese subjects, further affect torque production through inhibition of the nervous control and alteration of contractile properties and muscle architecture, all these phenomena leading to a decrease in torque production and increased fatigability, cumulating with the effects of the ageing (sarcopenia).


title: Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse Measured by Diaphragmatic Echogaphy

acronym: PIRD-DRA

summary:
The diaphragm is a fine striated muscle with both extra respiratory and respiratory functions. It does most of the breathing work in interaction with the accessory respiratory muscles, the rib cage and the abdomen. Its activity can be measured by the transdiaphragmatic pressure generated by the magnetic stimulation of phrenic nerves (gold standard). It has been shown in the literature that diaphragmatic ultrasound, via the measurement of diaphragmatic excursion and especially the thickening fraction, is an easily accessible, non-invasive, reproducible and relevant technique for evaluating acute diaphragmatic dysfunction in resuscitation patients.

The objective of this project is to evaluate the prevalence of diaphragmatic dysfunction at admission in patients hospitalized in intensive care / respiratory intensive care unit for hypercapnic and/or hypoxic acute respiratory distress and requiring ventilatory support by non-invasive ventilation or high flow oxygen therapy. A subgroup analysis will then be carried out on 3 populations:

Hypercapnic exacerbation of chronic obstructive pulmonary disease
Hypoxic acute respiratory distress on infectious lung disease
Acute pulmonary edema

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: STUDY OF THE EFFECTIVENESS OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON OBSESSIVE COMPULSIVE DISORDER

acronym: EFFI-STOC

summary:
The usual management of Obsessive Compulsive Disorders is based on cognitive-behavioural psychotherapy, as well as the use of serotonergic antidepressants. Nevertheless, a significant proportion of patients (40% to 60%) are non-responders to these conventional therapies, and remain severely handicapped.

transcranial Direct current stimulation (tDCS) has already proven its effectiveness, in addition to drug approaches, in various clinical settings, such as depression or acoustic-verbal hallucinations. This technic appears to be an extremely interesting alternative This is a non-invasive neuromodulation technique (application of a low intensity direct current (1 to 2 mA) between two electrodes positioned on the scalp) that allows the neural activity of different brain areas to be modulated simultaneously. It is a simple and inexpensive technique with excellent tolerance.


title: A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children

acronym: KID SSQ12

summary:
Deafness significantly affects several auditory tasks of everyday life in children: understanding speech in quiet and noisy environments, spatial location of sounds ...

These difficulties in locating sound sources are often ignored by parents and underestimated by children. Nowadays we there is specific tools to evaluate these problems in children. Indeed, there is a validated French questionnaire (Speech and Spatial Questionnaire SSQ) for adults that evaluates auditory abilities, including sound localization, in different tasks of daily life. Although robust, this questionnaire includes 49 questions and is too long for daily use in consultation. For this reason, Moulin et al validated in 2018 a short version of the SSQ questionnaire for adults with only 15 items.

Based on this model, the aim of this study is to develop and test a paediatric questionnaire with 12 items to assess more specifically auditory difficulties in deaf children. This questionnaire will follow the validated frame of the adult SSQ questionnaire and will consist of three subscales: speech hearing (4 items), spatial hearing (4 items), and qualities of hearing (4 items). These 3 subscales are identical to those defined in long and short form pf the adult SSQ questionnaire.

location_facility: ENT departement, Edouard Herriot Hospital