title: Evaluation of the Disability-Adjusted Life Year (DALY) on a Cohort of Patients With Indolent Systemic Mastocytosis (ISM)

acronym: DALY-MAST

summary: Mastocytosis is a group of pathologies characterized by the accumulation and/or clonal proliferation of abnormal mast cells in various organs. The impact of mastocytosis on health, quality of life, the psychoaffective sphere and on professional life constitutes the burden of this disease. The DALY is the disability-adjusted life expectancy, which takes into account the life expectancy and the number of years "lost" due to illness, disability or early death. Due to the major impact of the disease this study evaluates the DALY in indolent mastocytosis patients

ReferenceCitation: Siebenhaar F, Fortsch A, Krause K, Weller K, Metz M, Magerl M, Martus P, Church MK, Maurer M. Rupatadine improves quality of life in mastocytosis: a randomized, double-blind, placebo-controlled trial. Allergy. 2013 Jul;68(7):949-52. doi: 10.1111/all.12159. Epub 2013 Jun 4.

ReferenceCitation: Siebenhaar F, von Tschirnhaus E, Hartmann K, Rabenhorst A, Staubach P, Peveling-Oberhag A, Wagner N, Martus P, Carter MC, Metcalfe DD, Church MK, Maurer M, Weller K. Development and validation of the mastocytosis quality of life questionnaire: MC-QoL. Allergy. 2016 Jun;71(6):869-77. doi: 10.1111/all.12842. Epub 2016 Feb 15.

ReferenceCitation: van Anrooij B, Kluin-Nelemans JC, Safy M, Flokstra-de Blok BM, Oude Elberink JN. Patient-reported disease-specific quality-of-life and symptom severity in systemic mastocytosis. Allergy. 2016 Nov;71(11):1585-1593. doi: 10.1111/all.12920. Epub 2016 Jun 23.

ReferenceCitation: Jennings SV, Slee VM, Zack RM, Verstovsek S, George TI, Shi H, Lee P, Castells MC. Patient Perceptions in Mast Cell Disorders. Immunol Allergy Clin North Am. 2018 Aug;38(3):505-525. doi: 10.1016/j.iac.2018.04.006.

ReferenceCitation: Jennings S, Russell N, Jennings B, Slee V, Sterling L, Castells M, Valent P, Akin C. The Mastocytosis Society survey on mast cell disorders: patient experiences and perceptions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):70-6. doi: 10.1016/j.jaip.2013.09.004. Epub 2013 Dec 3.

ReferenceCitation: Nowak A, Gibbs BF, Amon U. Pre-inpatient evaluation on quality and impact of care in systemic mastocytosis and the influence of hospital stay periods from the perspective of patients: a pilot study. J Dtsch Dermatol Ges. 2011 Jul;9(7):525-32. doi: 10.1111/j.1610-0387.2011.07638.x. Epub 2011 Mar 24. English, German.

ReferenceCitation: Sanchez-Munoz L, Morgado JM, Alvarez-Twose I, Matito A, Garcia-Montero AC, Teodosio C, Jara-Acevedo M, Mayado A, Mollejo M, Caldas C, Gonzalez de Olano D, Escribano L, Orfao A. Diagnosis and classification of mastocytosis in non-specialized versus reference centres: a Spanish Network on Mastocytosis (REMA) study on 122 patients. Br J Haematol. 2016 Jan;172(1):56-63. doi: 10.1111/bjh.13789. Epub 2015 Oct 12.

ReferenceCitation: Jackson CW, Pratt CM, Rupprecht CP, Pattanaik D, Krishnaswamy G. Mastocytosis and Mast Cell Activation Disorders: Clearing the Air. Int J Mol Sci. 2021 Oct 19;22(20):11270. doi: 10.3390/ijms222011270.

ReferenceCitation: Valent P, Horny HP, Escribano L, Longley BJ, Li CY, Schwartz LB, Marone G, Nunez R, Akin C, Sotlar K, Sperr WR, Wolff K, Brunning RD, Parwaresch RM, Austen KF, Lennert K, Metcalfe DD, Vardiman JW, Bennett JM. Diagnostic criteria and classification of mastocytosis: a consensus proposal. Leuk Res. 2001 Jul;25(7):603-25. doi: 10.1016/s0145-2126(01)00038-8.

ReferenceCitation: Afrin LB. Mast cell activation disease and the modern epidemic of chronic inflammatory disease. Transl Res. 2016 Aug;174:33-59. doi: 10.1016/j.trsl.2016.01.003. Epub 2016 Jan 18.

ReferenceCitation: Hermouet S, Bigot-Corbel E, Gardie B. Pathogenesis of Myeloproliferative Neoplasms: Role and Mechanisms of Chronic Inflammation. Mediators Inflamm. 2015;2015:145293. doi: 10.1155/2015/145293. Epub 2015 Oct 11.

location_facility: Centre de Référence des Mastocytoses, Service de Dermatologie, Hôpital Larrey, CHU Toulouse


title: Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

acronym: NORAHPI

summary:
In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) < 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative mortality/ International recommendations recommend the prescription of noradrenaline as a first-line treatment to reduce morbidity and mortality. However, excess norepinephrine or duration of exposure is also deleterious. The Acumen IQ device (Edwards Lifesciences) allows the calculation of a predictive index of arterial hypotension episodes (predictive hypotension index, HPI). HPI could improve norepinephrine weaning by preventing episodes of arterial hypotension or detecting preload dependence, thus avoiding the transient increase in norepinephrine during hypotension.

This is a single-center, prospective, open-label, randomized, controlled, 2-group, parallel, intention-to-treat study. The aim was to evaluate the superiority of a new decision algorithm, based on the HPI delivered by the Acumen IQ device, to reduce the duration of norepinephrine administration in post-cardiac surgery vasoplegic shock.

The duration of the interventional protocol is 72 hours. To evaluate the clinical impact of the protocol, the time of the study will be 30 days. Several follow-up visits will be performed (end-of-protocol day, discharge day, and at D30 of inclusion) to collect clinical, biological, and HPI monitoring data.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: Safety of Low PEEP Maneuvers During ARDS Management

acronym: DEBAS

summary:
Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Recently, recruitment to inflation ratio and airway closure have been investigated in order to help PEEP adjustment. However, ventilatory maneuvers are performed with a low level of PEEP and therefore expose to derecruitment and oxygen desaturation. So far, the risk of oxygen desaturation has not been investigated and risk factors are unknown.

The aim of this study is to evaluate the prevalence of oxygen desaturation during ventilatory maneuvers at low level of PEEP in patients with moderate or severe ARDS

study_start_date_type: Actual

status: Recruiting

study_type: Observational

time_perspective: Retrospective

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II

acronym: REF-BIP

summary:
The facial emotion recognition is a basic social skill for successful social interactions. Several meta-analyses and recent studies found impairments of the perception of facial emotions in patients with euthymic bipolar disorder. Few studies compared recognition of facial emotions impairments during euthymia in patients with bipolar disorder type 1 and 2. These studies included low population samples (N<60). There were discrepancies in results of these studies. Szanto suggested that facial emotion recognition impairments were correlated with suicidal risk and social isolation. These impairments should be taking into account regarding psycho-social treatments in patients with bipolar disorder.

This study aims to evaluate facial emotion recognition in patients with bipolar I and II disorders compared to healthy controls, using the facial emotion recognition test (TREF). The objective of the present study is to compare TREF scores in a group of patients with bipolar 1, a group of patients with bipolar 2 disorder and a group with healthy controls. In addition, the investigators will investigate the relationships between TREF scores and levels of self-esteem and mental well-being.

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

enrollment_type: Actual

collaborators: Pôle Ressource Évaluation et Réhabilitation Psycho-sociale, EPSM de l'Oise

collaborators: Centre Hospitalier Philippe Pinel, Amiens

intervention_type: Other

status_simplified: Completed


title: Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU

acronym: EIDAR

summary:
Swallowing disorders (SD) are particularly common after extubation in the ICU and may be associated with an increased risk of lung disease, increased length of hospital stay, and a higher risk of early reintubation. In contrast, early detection of SDs has been shown to be associated with a decrease in these complications. Thus, there is a need for rapid and reliable assessment of SDs in ICU patients before the withdrawal of mechanical ventilation.

Videofluoroscopy (VFS) and nasofibroscopy (NF) are the gold standard examinations for diagnosing SD. However, these two examinations are not feasible in intubated patients.

In this context, ultrasound appears to be a promising alternative to identify patients at risk of SD after extubation. This examination can be performed at the intubated patient's bedside and can be used evaluate the mobility of the structures involved in swallowing. Many studies have already shown the interest of ultrasound in the evaluation of SD but none has focused on intubated patients under respiratory assistance.

The objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting SD after extubation.

This monocentric study will take place in the Intensive Care Unit (ICU) of the Dijon University Hospital. The duration of participation in this research will be equal to the length of stay in the ICU. During their stay, patients will undergo ultrasound and nasofibroscopy. Information on the characteristics of the ICU stay will be collected at discharge.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire Dijon


type: Other Identifier

title: Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise

acronym: PENTHERE

summary: Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. While hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. The effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. What's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. A better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"

acronym: GLASS-BONA

summary:
Adult patients referred to the ENT surgery department of the Hospices Civils de Lyon with cholesteatoma that had never been operated on.

All patients will benefit from surgical management for cholesteatoma initially in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

intervention_type: Device


title: Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren - The FRENCH Study

acronym: FRENCH

summary: In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in children with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).

lead_sponsor: University Hospital, Bordeaux

intervention_type: Procedure


title: Role of Diffusion Tensor Brain MRI in the Detection of Structural Abnormality of the Apparently Normal White Substance in Patients Victims of Concussion in the Context of Sport : Prospective Comprative Study Versus Healthy Subjects

acronym: COMMOTION

summary:
Concussions in sports are a major public health problem because of their frequency, and are often underdiagnosed because of an unspecific clinical picture or sometimes masked by the concussion itself.

Support data has been constantly evolving in recent years, including the last publication of the Berlin Consensus in 2016 specifying support in the field. However, to date, there is no tool to predict the severity of a concussion or to predict when it will return to play objectively and reliably.

Brain MRI done after the head injury is most often normal. However, previous studies agree that there is a persistent electrophysiologic disturbance several weeks after the injury, and the specific pathophysiology of white matter changes after a head injury remains controversial.

Diffusion tensor imaging (DTI), in addition to morphological sequences, is capable of assessing white matter microstructure and fibrous tract integrity or not. Several parameters, such as the seemingly normal white matter fractional anisotropy (FA) coefficient, the mean diffusivity and the radial diffusivity, may be altered in the aftermath of a concussion, indicating axonal damage not visible on conventional MRI sequences.

Previous studies have evaluated these parameters with sometimes contradictory results: some have found an increase in AF in specific regions such as the cortico-spinal tract and the corpus callosum, others have found a decrease in AF.

So far, assessment of a player's condition on and off the field after a head injury has been based on clinical criteria alone, sometimes far too subjective. The player may choose to mask their symptoms to allow them to return to the game faster, or feign more than they have. Once pathologies such as bone fractures or intracranial hematomas are ruled out by conventional imaging, there is no longer any tool for a more accurate diagnosis of possible microstructural alterations of brain tissue and for monitoring of the patient.

The advent of new MRI techniques such as diffusion imaging, and particularly diffusion tensor imaging (DTI), is a promising tool to better understand white matter involvement in diffuse axonal lesions.

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Pavlovic D, Pekic S, Stojanovic M, Popovic V. Traumatic brain injury: neuropathological, neurocognitive and neurobehavioral sequelae. Pituitary. 2019 Jun;22(3):270-282. doi: 10.1007/s11102-019-00957-9.

ReferenceType: result

ReferenceCitation: Cubon VA, Putukian M, Boyer C, Dettwiler A. A diffusion tensor imaging study on the white matter skeleton in individuals with sports-related concussion. J Neurotrauma. 2011 Feb;28(2):189-201. doi: 10.1089/neu.2010.1430. Epub 2011 Jan 27.

ReferenceCitation: Lancaster MA, Meier TB, Olson DV, McCrea MA, Nelson LD, Muftuler LT. Chronic differences in white matter integrity following sport-related concussion as measured by diffusion MRI: 6-Month follow-up. Hum Brain Mapp. 2018 Nov;39(11):4276-4289. doi: 10.1002/hbm.24245. Epub 2018 Jul 2.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: open (via crossref license, author manuscript)

license: publisher-specific, author manuscript

license_normalized: publisher-specific

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

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

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Chappell MH, Ulug AM, Zhang L, Heitger MH, Jordan BD, Zimmerman RD, Watts R. Distribution of microstructural damage in the brains of professional boxers: a diffusion MRI study. J Magn Reson Imaging. 2006 Sep;24(3):537-42. doi: 10.1002/jmri.20656.

ReferenceCitation: Yin B, Li DD, Huang H, Gu CH, Bai GH, Hu LX, Zhuang JF, Zhang M. Longitudinal Changes in Diffusion Tensor Imaging Following Mild Traumatic Brain Injury and Correlation With Outcome. Front Neural Circuits. 2019 May 7;13:28. doi: 10.3389/fncir.2019.00028. eCollection 2019.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Meier TB, Bergamino M, Bellgowan PS, Teague TK, Ling JM, Jeromin A, Mayer AR. Longitudinal assessment of white matter abnormalities following sports-related concussion. Hum Brain Mapp. 2016 Feb;37(2):833-45. doi: 10.1002/hbm.23072. Epub 2015 Dec 10.

oa_colors: green other

evidence: open (via free pdf)

ReferenceCitation: Jang SH, Seo YS. Diffusion tensor tractography characteristics of axonal injury in concussion/mild traumatic brain injury. Neural Regen Res. 2022 May;17(5):978-982. doi: 10.4103/1673-5374.324825.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Gonzalez AC, Kim M, Keser Z, Ibrahim L, Singh SK, Ahmad MJ, Hasan O, Kamali A, Hasan KM, Schulz PE. Diffusion Tensor Imaging Correlates of Concussion Related Cognitive Impairment. Front Neurol. 2021 May 24;12:639179. doi: 10.3389/fneur.2021.639179. eCollection 2021.


title: Intermittent Theta Burst Stimulation of the Precuneus for the Treatment of Resistant Schizophrenia

acronym: Stim-TISiTBS

summary: The purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms.

primary_purpose: Treatment

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

lead_sponsor_type: industriel


title: Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment

acronym: AMELIAS

summary: Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective Study of Circulating Tumor DNA Kinetics Post R-CHOP Type Treatment of Diffuse Large B Cell Lymphoma

acronym: LYMPHO-CLEAR

summary: The purpose of this study is to determine the kinetics of circulating tumor DNA (ctDNA) in the hours following initial administration of immuno-chemotherapy to patients with diffuse large B cell lymphoma (DLBCL). Modelizing the short-term kinetics of ctDNA would help to determine the optimal time-point for ctDNA follow-up. The investigators hypothesize that the greater ctDNA release at this time-point compared to baseline might lead lead to the detection of novel variants compared to baseline.

lead_sponsor: Centre Henri Becquerel


title: Probing and Modulating Motor Imagery Capacities in Aphantasia

acronym: OLIPHANT

summary: The present study aims to characterize and modulate motor imagery abilities in individuals with aphantasia. The investigators will characterize the neurophysiological and physiological underpinnings of mental imagery abilities in participants with aphantasia by investigating several indices of motor imagery abilities and comparing them to participants with typical mental imagery abilities. The investigators will investigate whether non-invasive brain stimulation applied to the primary motor cortex improves mental imagery abilities in participants with aphantasia.

primary_purpose: Basic Science

lead_sponsor: Hôpital le Vinatier


title: Characterization of the Neuromuscular and Biomechanical Properties of Spastic Myopathy-affected Muscles During the Generation of Passive and Active Force: the Effect of a Management Program Based on Eccentric Exercises.

summary: The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Secondary objectives involve assessing: i) modifications in neuromuscular parameters of PF, ii) changes in muscle stiffness within PF during passive mobilization and active force generation, and iii) modifications in architectural parameters of PF.

primary_purpose: Health Services Research

ipd_sharing_description: Data will be shared upon request from researchers

lead_sponsor: Clinique Du Parc de Belleville

sponsor_collaborators:
Clinique Du Parc de Belleville
Henri Mondor University Hospital


title: Anterior Thoracic Perforating Artery (PATA); Systematization and Applications in Reconstructive Surgery of the Head and Neck

acronym: PATA-Fix

summary:
The use of cutaneous or fasciocutaneous flaps is daily in reconstructive surgery ENT in patients with cancers of the upper aero-digestive tract (AVDS). Cancers of the oral cavity require reconstructions with thin flaps in order to best preserve the functions of swallowing and phonation via patients' joints. Indeed, the flaps are inert tissues, which can only be mobilized by the residual muscles of the patients' tongue: their lightness and finesse facilitates this mobilization. The use of free flaps is regular but requires micro-surgical skill of the operator as well as a preserved general condition of the patients and appropriate post-operative care. Alternatively, there are some pedicled flaps with the appropriate thickness to reconstruct extensive loss of substances from the oral cavity in a suitable manner: the supraclavicular flap, the suprahyoid flap, the submental flap and the myo-mucosal flap pedicled on the facial artery being more limited in size. The creation of an anterior thoracic fasciocutaneous flap, pedicled on the anterior thoracic perforating artery (PATA) seems to be another suitable therapeutic option. Only one preliminary Chinese study describes it, on only eleven patients. According to the authors, it would offer a wide skin palette (up to 15x10cm). Its long pedicle (on average 9.2cm) would allow a significant axis of rotation so that the flap easily reaches the oral cavity. The authors underline the variability of the origin of this perforator, arising depending on the case from the transverse cervical trunk (9 cases) or from the supraclavicular artery (2 cases), branches of division of the thyro-cervical trunk.

However, when the PATA arises from the supraclavicular artery, its interest could be limited because the creation of a PATA perforator flap could compromise the creation of a secondary supraclavicular flap.

Thus, this study aims to clarify the feasibility of harvesting the PATA flap in the greatest number of patients. The objective is to study the variations of the anterior thoracic perforating artery necessary for the creation of this flap, by specifying its vascularization territory and its characteristics.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
mermoz hospital


title: Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy

acronym: KAPP-IMU anc

summary:
Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Locomotion can be assessed using a motion capture system that enables 3-dimensional analysis, in order to help make treatment decisions and quantify them. Although these systems are currently considered to be the gold standard, the fact remains that they cause a certain amount of patient fatigue (long set-up times) and that walking is assessed in a laboratory rather than in real life.

Today, technological advances have brought to the fore other gait analysis devices, such as inertial measurement units (IMUs). Various systems incorporating IMUs in the feet, for example, respond to these problems of analysing walking in real-life situations. The IMUs record the movements and orientation of the foot in space; the data is then processed by algorithms to recognise walking steps and calculate the spatio-temporal parameters of locomotion. Additional IMUs positioned on the body can be grafted onto this system to provide a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. However, before such devices can be used in a pathological paediatric population, they must be validated in a healthy population. This validation must be conducted using a precise method that has been widely documented in the COSMIN recommendations (Consensus-based Standards for the selection of health Measurement Instruments). The first stage will assess the safety of the IMU devices in a healthy paediatric population, and the validity of the spatio-temporal parameters. If these properties are deemed to be compliant, these same parameters will be assessed in a paediatric population with cerebral palsy in the second stage.


title: Role of Peripheral Serotonin in Oculocutaneous Albinism

acronym: SEPIAs

summary:
Serotonin (5-HT or 5-hydroxytryptamine) is a monoamine primarily known for its role as a neurotransmitter in the central nervous system (CNS). However, the functions of serotonin go beyond its role in the central nervous system: different peripheral tissues have the capacity to produce and/or use serotonin locally, forming systems called "micro-serotonergic" systems. Among the peripheral roles of serotonin, previous work by the Iron and Immunity team, INSERM U1016, Institut Cochin (Paris), was able to show that serotonin has a positive role on erythropoiesis and the survival of red blood cells, and the team's ongoing work suggests that serotonin also impacts iron metabolism.

In humans and in mouse models, several studies have suggested a role for serotonin in pigmentation. In certain syndromic forms of albinism such as Hermansky Pudlak syndrome, platelet serotonin levels are reduced in connection with a decrease in dense platelet granules (delta granules): this characteristic is even part of the diagnostic criteria.

Preliminary data from the Iron and Immunity team found:

Changes in serotonin levels in children with albinism compared to control patients,
Changes in hemoglobin level and mean corpuscular volume (MCV) in children with albinism (towards anemia and microcytosis),
Changes in the iron balance in children with albinism (towards iron deficiency).

The hypothesis of this research is that peripheral serotonin plays a role in the clinical and biological manifestations of oculocutaneous albinism.

ReferenceCitation: Amireault P, Sibon D, Cote F. Life without peripheral serotonin: insights from tryptophan hydroxylase 1 knockout mice reveal the existence of paracrine/autocrine serotonergic networks. ACS Chem Neurosci. 2013 Jan 16;4(1):64-71. doi: 10.1021/cn300154j. Epub 2012 Nov 7.

ReferenceCitation: Yabut JM, Crane JD, Green AE, Keating DJ, Khan WI, Steinberg GR. Emerging Roles for Serotonin in Regulating Metabolism: New Implications for an Ancient Molecule. Endocr Rev. 2019 Aug 1;40(4):1092-1107. doi: 10.1210/er.2018-00283.

ReferenceCitation: Fouquet G, Coman T, Hermine O, Cote F. Serotonin, hematopoiesis and stem cells. Pharmacol Res. 2019 Feb;140:67-74. doi: 10.1016/j.phrs.2018.08.005. Epub 2018 Aug 11.

ReferenceCitation: English KB, Wang ZZ, Stayner N, Stensaas LJ, Martin H, Tuckett RP. Serotonin-like immunoreactivity in Merkel cells and their afferent neurons in touch domes from the hairy skin of rats. Anat Rec. 1992 Jan;232(1):112-20. doi: 10.1002/ar.1092320112.

ReferenceCitation: Johansson O, Liu PY, Bondesson L, Nordlind K, Olsson MJ, Lontz W, Verhofstad A, Liang Y, Gangi S. A serotonin-like immunoreactivity is present in human cutaneous melanocytes. J Invest Dermatol. 1998 Dec;111(6):1010-4. doi: 10.1046/j.1523-1747.1998.00460.x.

ReferenceCitation: Lee HJ, Park MK, Kim SY, Park Choo HY, Lee AY, Lee CH. Serotonin induces melanogenesis via serotonin receptor 2A. Br J Dermatol. 2011 Dec;165(6):1344-8. doi: 10.1111/j.1365-2133.2011.10490.x. Epub 2011 Oct 17.

ReferenceCitation: Slominski A, Pisarchik A, Semak I, Sweatman T, Wortsman J, Szczesniewski A, Slugocki G, McNulty J, Kauser S, Tobin DJ, Jing C, Johansson O. Serotoninergic and melatoninergic systems are fully expressed in human skin. FASEB J. 2002 Jun;16(8):896-8. doi: 10.1096/fj.01-0952fje. Epub 2002 Apr 23.

ReferenceCitation: Slominski A, Pisarchik A, Zbytek B, Tobin DJ, Kauser S, Wortsman J. Functional activity of serotoninergic and melatoninergic systems expressed in the skin. J Cell Physiol. 2003 Jul;196(1):144-53. doi: 10.1002/jcp.10287.

ReferenceCitation: Zhou L, Cai M, Ren Y, Wu H, Liu M, Chen H, Shang J. The different roles of 5-HT1A/2A receptors in fluoxetine ameliorated pigmentation of C57BL/6 mouse skin in response to stress. J Dermatol Sci. 2018 Dec;92(3):222-229. doi: 10.1016/j.jdermsci.2018.10.002. Epub 2018 Oct 25.

ReferenceCitation: Liu L, Fu M, Pei S, Zhou L, Shang J. R-Fluoxetine Increases Melanin Synthesis Through a 5-HT1A/2A Receptor and p38 MAPK Signaling Pathways. Int J Mol Sci. 2018 Dec 25;20(1):80. doi: 10.3390/ijms20010080.

ReferenceCitation: Enkhtaivan E, Lee CH. Role of Amine Neurotransmitters and Their Receptors in Skin Pigmentation: Therapeutic Implication. Int J Mol Sci. 2021 Jul 28;22(15):8071. doi: 10.3390/ijms22158071.

ReferenceCitation: Schallreuter KU, Salem MA, Gibbons NC, Martinez A, Slominski R, Ludemann J, Rokos H. Blunted epidermal L-tryptophan metabolism in vitiligo affects immune response and ROS scavenging by Fenton chemistry, part 1: Epidermal H2O2/ONOO(-)-mediated stress abrogates tryptophan hydroxylase and dopa decarboxylase activities, leading to low serotonin and melatonin levels. FASEB J. 2012 Jun;26(6):2457-70. doi: 10.1096/fj.11-197137. Epub 2012 Mar 13.

ReferenceCitation: Maurer-Spurej E, Dyker K, Gahl WA, Devine DV. A novel immunocytochemical assay for the detection of serotonin in platelets. Br J Haematol. 2002 Mar;116(3):604-11. doi: 10.1046/j.0007-1048.2001.03302.x.

ReferenceCitation: Thompson JH. Iron absorption and serotonin (5-hydroxytryptamine) antagonism. Arch Int Pharmacodyn Ther. 1965 Aug;156(2):249-54. No abstract available.

ReferenceCitation: Amireault P, Hatia S, Bayard E, Bernex F, Collet C, Callebert J, Launay JM, Hermine O, Schneider E, Mallet J, Dy M, Cote F. Ineffective erythropoiesis with reduced red blood cell survival in serotonin-deficient mice. Proc Natl Acad Sci U S A. 2011 Aug 9;108(32):13141-6. doi: 10.1073/pnas.1103964108. Epub 2011 Jul 25.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Spasticity Multidisciplinary Management : QoL and Physical Activity Measurement With Connected Health Devices (PEPS)

acronym: PEPS

summary: PEPS is a 18 months prospective bicentric study on 30 patients with spastic foot. The main objective is to evaluate the mean daily gait perimeter modifications mesured by connected watch, 6 months after spastic equinus foot surgery versus before this surgery. Investigator will lend a connected watch during the first consultation, and the patient will use it during 10 days in order to collect his mean daily gait perimeter. A lot of other tests will be realised in order to caracterize the clinical picture of each patient. After patients will be operated and all caracteristics of the surgery will be collected. Finally, at 6 months appointment, investigator will do the same analysis than first appointment in order to comparate the data for functional prognosis.

ReferenceCitation: Sheean G. The pathophysiology of spasticity. Eur J Neurol. 2002 May;9 Suppl 1:3-9; dicussion 53-61. doi: 10.1046/j.1468-1331.2002.0090s1003.x.

ReferenceCitation: Wallace D, Duncan PW, Lai SM. Comparison of the responsiveness of the Barthel Index and the motor component of the Functional Independence Measure in stroke: the impact of using different methods for measuring responsiveness. J Clin Epidemiol. 2002 Sep;55(9):922-8. doi: 10.1016/s0895-4356(02)00410-9.

ReferenceCitation: Milligan J, Ryan K, Lee J. Demythifier la spasticite en premiere ligne. Can Fam Physician. 2019 Oct;65(10):e422-e428. French.

ReferenceCitation: Nikamp CD, Buurke JH, van der Palen J, Hermens HJ, Rietman JS. Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):798-808. doi: 10.1177/0269215516658337. Epub 2016 Jul 7.

ReferenceCitation: Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

ReferenceCitation: Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.

ReferenceCitation: Sankaranarayan H, Gupta A, Khanna M, Taly AB, Thennarasu K. Role of ankle foot orthosis in improving locomotion and functional recovery in patients with stroke: A prospective rehabilitation study. J Neurosci Rural Pract. 2016 Oct-Dec;7(4):544-549. doi: 10.4103/0976-3147.185507.

ReferenceCitation: Deltombe T, Gustin T. Selective tibial neurotomy in the treatment of spastic equinovarus foot in hemiplegic patients: a 2-year longitudinal follow-up of 30 cases. Arch Phys Med Rehabil. 2010 Jul;91(7):1025-30. doi: 10.1016/j.apmr.2010.04.010.

ReferenceCitation: King BW, Ruta DJ, Irwin TA. Spastic foot and ankle deformities: evaluation and treatment. Foot Ankle Clin. 2014 Mar;19(1):97-111. doi: 10.1016/j.fcl.2013.10.007.

ReferenceCitation: Kidd D, Stewart G, Baldry J, Johnson J, Rossiter D, Petruckevitch A, Thompson AJ. The Functional Independence Measure: a comparative validity and reliability study. Disabil Rehabil. 1995 Jan;17(1):10-4. doi: 10.3109/09638289509166622.

ReferenceCitation: Dones I, Nazzi V, Broggi G. The guidelines for the diagnosis and treatment of spasticity. J Neurosurg Sci. 2006 Dec;50(4):101-5.

ReferenceCitation: Menz HB, Latt MD, Tiedemann A, Mun San Kwan M, Lord SR. Reliability of the GAITRite walkway system for the quantification of temporo-spatial parameters of gait in young and older people. Gait Posture. 2004 Aug;20(1):20-5. doi: 10.1016/S0966-6362(03)00068-7.

ReferenceCitation: Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001 Jan;82(1):9-13. doi: 10.1053/apmr.2001.9396.

ReferenceCitation: Rene F, Casimiro L, Tremblay M, Brosseau L, Lefebvre A, Beaudouin M, Belliveau V, Bergeron LP. Une version canadienne francaise du Lower Extremity Functional Scale (LEFS) : L'Echelle fonctionnelle des membres inferieurs (EFMI), partie I. Physiother Can. 2011 Spring;63(2):242-8. doi: 10.3138/ptc.2010-11F. Epub 2011 Apr 13. French.

ReferenceCitation: Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9.

ReferenceCitation: Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4. doi: 10.3109/03790799109166684.

lead_sponsor: University Hospital, Angers


title: The Benefits of Dietary and Micro-nutritional Management for Well-being at Work

acronym: MEDEIS

summary: The aim of this observational study is to describe the benefits of this treatment, particularly in terms of changes in the well-being of participating employees in relation to their nutritional/micro-nutritional status.

lead_sponsor: Larena SAS

intervention_type: Biological


title: Evaluation de l'utilité du Monitorage du Glycacalyx Pour prédire Les Complications du Patient de Chirurgie Cardiaque

acronym: MOGLYCC

summary: This is a prospective observational study of the evolution of the microcirculation and the sublingual glycocalyx in perioperative cardiac surgery under cardiopulmonary bypass. Our main objective is to evaluate the prognostic value of the variation of the thickness of the perioperative glycocalyx for the occurrence of a major complication in the first 24 hours after surgery.

lead_sponsor: University Hospital, Rouen

sponsor_collaborators:
University Hospital, Rouen
University of Rouen Normandie


title: Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome

acronym: AFFIRMATICS

summary: The goal of this study is to evaluate the proportion of assertiveness difficulties in Tourette syndrome. Participants will complete several e-questionnaires (on assertiveness, Tourette severity, quality of life, self-esteem and comorbidities like depression, anxiety...).

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test


title: Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs

summary:
The loss of standing and walking capabilities in a paraplegic person is most often the result of damage to the spinal cord, either traumatic (accidental) or pathological and has both a somatic and a psychological impact on the quality of life, the risk of depression, and the difficulty of socio-professional reintegration in a society that is not adapted to people with disabilities.

A motorized mechanical exoskeleton is an external device intended to compensate for a muscular or neurological deficiency enabling paraplegics to stand and walk again. The Atalante exoskeleton, designed by Wandercraft company allows patients to stand upright and walk without the aid of crutches.

This early study was the first clinical investigation of the Atalante exoskeleton performed early in the development. It was used to evaluate the device design concept with respect to initial clinical safety and device functionality and guided further device modifications.

primary_purpose: Device Feasibility

lead_sponsor: Wandercraft

location_facility: CEREMH (Centre de ressources et d'innovation mobilité handicap)


title: MR-Only Based Adaptive External Beam Radiation Therapy of Cervical Cancer on Ethos

acronym: Ethos Col

summary:
Current management of patients treated with External Beam Radiation Therapy (EBRT) for cervical cancer with a classical Image-guided Radiation Therapy (IGRT) strategy involves a complex, not entirely satisfactory, treatment workflow. Indeed, in our institution, two workflows have been designed to take into account the inter-fraction motion of cervix and uterus : an Internal Target Volume (ITV)-based approach and a plan of the day strategy requiring both several planning-CT (Computed Tomography) acquisitions with variable bladder filling.The upcoming installation of a Varian Ethos therapy system in our institution will allow us to implement a less cumbersome online adaptive radiotherapy strategy (oART), which, by conforming to the daily anatomy, will enable a reduction in the Clinical Target Volume (CTV) to Planning Target Volume (PTV) margins leading to an expected reduction in dose delivered to organs at risk (OAR) .On the other hand, MR (Magnetic Resonance)-only treatment planning is playing an increasing role in radiotherapy, notably in the treatment of prostate cancer. MR-only workflows are known (a) to provide the most reliable delineation in soft tissues and (b) to decrease spatial uncertainties by suppressing the Magnetic Resonance Imaging (MRI)-CT co-registration. Regarding the management of cervical cancer, the importance of MRI is well established and its use becomes essential. Combining a MR-only workflow with an adaptative one on the Varian Ethos system, could lead to an improved management of patients treated for cervical cancer with an expected reduction in margins and volumes treated (thanks to MRI delineation and online adaptation) and therefore a reduction of OAR toxicity. Including regular multi-parametric MR imaging during and after the course of the treatment could also provide in the future an assessment of the treatment response. One of the important challenges in developing this specific workflow is to have a reliable synthetic CT (derived from MRI) to (a) provide electron or mass density for treatment planning calculations and (b) allow accurate online repositioning/deformation with Ethos Cone Beam Computed Tomography (CBCT). The other fundamental challenge is to provide a formal assessment of the clinical benefit of introducing MR-only simulation and planning in an oART workflow.

This project aims to demonstrate the feasibility of setting up an adaptive workflow on the ETHOS platform with the sole use of MR patient image.The project is divided into two parts. The first part consists in demonstrate the feasibility of the workflow on 15 patients with cervix cancer.

lead_sponsor: Recherche clinique

sponsor_collaborators:
Recherche clinique
Varian Medical Systems


title: Analysis of Mandibular Movements to Optimize Ventilatory Management of Children With Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure or Non-Invasive Ventilation.

acronym: AMANDA

summary: Obstructive Sleep Apnea is a common medical condition in children. Diagnosis is based on polysomnography . We conducted an open prospective non randomised clinical trial to assess the efficacy of a new medical device called SUNRISE.

ReferenceCitation: Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.

ReferenceCitation: Lescanne E, Chiron B, Constant I, Couloigner V, Fauroux B, Hassani Y, Jouffroy L, Lesage V, Mondain M, Nowak C, Orliaguet G, Viot A; French Society of ENT (SFORL); French Association for Ambulatory Surgery (AFCA); French Society for Anaesthesia, Intensive Care (SFAR). Pediatric tonsillectomy: clinical practice guidelines. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):264-71. doi: 10.1016/j.anorl.2012.03.003. Epub 2012 Oct 15.

ReferenceCitation: Redline S, Tishler PV, Schluchter M, Aylor J, Clark K, Graham G. Risk factors for sleep-disordered breathing in children. Associations with obesity, race, and respiratory problems. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1527-32. doi: 10.1164/ajrccm.159.5.9809079.

ReferenceCitation: Aubertin G, Schroder C, Sevin F, Clouteau F, Lamblin MD, Vecchierini MF. [Obstructive sleep apnea-hypopnea syndrome in children: Clinical diagnosis]. Arch Pediatr. 2017 Feb;24 Suppl 1:S7-S15. doi: 10.1016/j.arcped.2016.09.002. Epub 2016 Oct 18. French.

ReferenceCitation: Abrahamyan L, Sahakyan Y, Chung S, Pechlivanoglou P, Bielecki J, Carcone SM, Rac VE, Fitzpatrick M, Krahn M. Diagnostic accuracy of level IV portable sleep monitors versus polysomnography for obstructive sleep apnea: a systematic review and meta-analysis. Sleep Breath. 2018 Sep;22(3):593-611. doi: 10.1007/s11325-017-1615-1. Epub 2018 Jan 9.

ReferenceCitation: Uddin MB, Chow CM, Su SW. Classification methods to detect sleep apnea in adults based on respiratory and oximetry signals: a systematic review. Physiol Meas. 2018 Mar 26;39(3):03TR01. doi: 10.1088/1361-6579/aaafb8.

ReferenceCitation: Lapina VA, Dontsov AE, Ostrovskii MA, Emanuel' NM. [Interaction of oxygen anion radicals with eye melanins and ommochromes]. Dokl Akad Nauk SSSR. 1985;280(6):1463-5. No abstract available. Russian.

ReferenceCitation: Gray EL, Barnes DJ. Beyond the thermistor: Novel technology for the ambulatory diagnosis of obstructive sleep apnoea. Respirology. 2017 Apr;22(3):418-419. doi: 10.1111/resp.13004. Epub 2017 Feb 14. No abstract available.

ReferenceCitation: Obermeyer Z, Emanuel EJ. Predicting the Future - Big Data, Machine Learning, and Clinical Medicine. N Engl J Med. 2016 Sep 29;375(13):1216-9. doi: 10.1056/NEJMp1606181. No abstract available.

ReferenceCitation: Amaddeo A, Caldarelli V, Fernandez-Bolanos M, Moreau J, Ramirez A, Khirani S, Fauroux B. Polygraphic respiratory events during sleep in children treated with home continuous positive airway pressure: description and clinical consequences. Sleep Med. 2015 Jan;16(1):107-12. doi: 10.1016/j.sleep.2014.07.030. Epub 2014 Nov 18.

ReferenceCitation: Pepin JL, Letesson C, Le-Dong NN, Dedave A, Denison S, Cuthbert V, Martinot JB, Gozal D. Assessment of Mandibular Movement Monitoring With Machine Learning Analysis for the Diagnosis of Obstructive Sleep Apnea. JAMA Netw Open. 2020 Jan 3;3(1):e1919657. doi: 10.1001/jamanetworkopen.2019.19657.

ReferenceCitation: Martinot JB, Senny F, Denison S, Cuthbert V, Gueulette E, Guenard H, Pepin JL. Mandibular movements identify respiratory effort in pediatric obstructive sleep apnea. J Clin Sleep Med. 2015 Apr 15;11(5):567-74. doi: 10.5664/jcsm.4706.

ReferenceCitation: Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.

ReferenceCitation: Amaddeo A, Frapin A, Touil S, Khirani S, Griffon L, Fauroux B. Outpatient initiation of long-term continuous positive airway pressure in children. Pediatr Pulmonol. 2018 Oct;53(10):1422-1428. doi: 10.1002/ppul.24138. Epub 2018 Aug 1.

ReferenceCitation: Amaddeo A, Frapin A, Fauroux B. Long-term non-invasive ventilation in children. Lancet Respir Med. 2016 Dec;4(12):999-1008. doi: 10.1016/S2213-2600(16)30151-5. Epub 2016 Jul 13.

ReferenceCitation: Amaddeo A, Khirani S, Griffon L, Teng T, Lanzeray A, Fauroux B. Non-invasive Ventilation and CPAP Failure in Children and Indications for Invasive Ventilation. Front Pediatr. 2020 Oct 26;8:544921. doi: 10.3389/fped.2020.544921. eCollection 2020.

lead_sponsor: University Hospital, Grenoble


title: Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions

acronym: DERMOCOS

summary:
Cancer treatments can trigger cutaneous side-effects, as well as nail and hair toxicities. When related to drug treatment, this iatrogeny depends on the type of drug, its dosage and individual susceptibility. Although these dermatological adverse events are rarely serious, they can significantly alter patients' quality of life, and may even necessitate the introduction of curative treatment.

The impact of these side effects can be mitigated by the use of dermo-cosmetic products and aesthetic solutions. However, most of this supportive care is not reimbursed by the health insurance system, representing a source of inequalities in access to healthcare for cancer patients.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Development, Implementation and Evaluation of Interventions to Remediate the Threatening Effects of Obesity Stereotyes

summary: This project proposes to integrate a psychosocial approach into the therapeutic patient education program (TPE) at "La Vie la Santé", an innovative health promotion platform at Poitiers University Hospital. A randomized study will be set up within the active file of patients referred by the specialized obesity center of Poitou-Charentes and integrated into this patient education program (TPE) program. Patients randomized to the TPE-STEREOBES experimental cohort arm will participate for 12 months in obesity-specific adapted physical activity workshops, on the one hand, and in workshops based on "social well-being" on the other, designed as part of this study. They will be assessed when they enter the program (T0), then at 3 months (T3), 6 months (T6), 12 months (T12) and finally 6 months later (T18). Assessments at T0, T12 and T18 will be compared with those of patients in the control group, made up of patients followed up at the specialized obesity center who were not included in the TPE-STEREOBES program.

lead_sponsor: Poitiers University Hospital

intervention_type: Behavioral


title: Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of Intravenous ANT3310 Alone and in Combination With Meropenem in Healthy Subjects

summary: The purpose of this study is to evaluate the safety and tolerability of single and multiple intravenous ascending doses of ANT3310, a novel, specific, competitive inhibitor of serine β-lactamases, alone and in combination with meropenem in healthy subjects.

lead_sponsor: Antabio


title: Implicit and Explicit Assessment of Suicide Risk

acronym: MIERIS

summary: In 2007 Nock & Banaji developed a so-called implicit suicide risk measurement using a computer tool: the Implicit Association Test (IAT). This measurement, associated with traditional evaluations, makes it possible to better predict suicidal recurrence. In 2020, the Poitiers team of Tello was able to replicate these results on a French population. However, although a high IAT score predicts the onset of suicide at 1 year, there is no data on how this score changes over time nor even data concerning the measure's ability to differentiate a population with explicit suicidal ideation from a population without explicit suicidal ideation. The investigators therefore seek to demonstrate an evolution of implicit suicidal ideation over time by replicating the measurement at inclusion, at 6 months and at 12 months, for different patient profiles: Suicidal ideation vs No suicidal ideation and suicide attempt vs no suicide attempt. Patients will be recruited from the emergency-unit of CHU Amiens-Picardie and will take the suicide-IAT as well as various questionnaires.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Early Mobilisation and Relational Touch Practice on Intubated Patients of Intensive Care Unit

acronym: TORE-BDL

summary:
41.3% of patients hospitalized in intensive care express feeling anxiety when they are systematically questioned. Ventilatory weaning is one of the moments of anxiety for the patient. While being conscious he must tolerate invasive ventilation. The early mobilization of patients in intensive care must be started early, within 24-48 hours, after the patient wakes up. Early mobilization is part of the weaning process from invasive mechanical ventilation in intensive care. It is recommended to reduce it to use relaxation therapies. Several studies have assessed the impact of relational touch in conscious or unconscious patients in intensive care. The SRLF consensus conference in 2010 recommends the use of massage for anxiolytic purposes.

This study aims to assess the impact of relational touch versus standard care on anxiety during the first bedside session, in intubated intensive care patients ventilated for at least 48 hours and presenting with RASS (Richmond agitation sedation scale). ) from 0 to -1.

The study will aussi assess the impact of relational touch versus standard care on the following patient parameters:

Evaluation of caregiver anxiety with the Spielberger inventory before and after the session
Increasing the duration of the bedside session;
Variations in pain, assessed by the Behavioral Pain Scale (BPS) at the end of the session;
The level of agitation/vigilance at the beginning and at the end of the session with the Richmond agitation-sedation scale (RASS);
Induced variations in blood pressure;
Induced variations in oxygen saturation;
The variations induced on the respiratory rate;
The variations induced on the heart rate;
The need to prescribe psychotropic drugs on the day of the first bedside;
Reduction in the number of days of invasive mechanical ventilation between the first bedside session and discharge from intensive care unit (maximum D28 after the first bedside session).

This is a national, multicenter, cluster, randomized, controlled trial with 4-stage stepped-wedge design (1:1:1:1 randomization), phase III, superiority, open-label, comparing systematic practice relational touch by the paramedical team during bedside sessions, versus standard care (without relational touch).

The benefit is above all for the patient with a better experience of bedside sessions and a reduction in ventilation time, therefore bed rest, leading to a reduction in decubitus complications. The expected economic benefit involves the reduction of decubitus complications and therefore their cost and the reduction of hospitalization times in intensive care.

primary_purpose: Supportive Care

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
GIRCI IDF


title: Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia

acronym: CAT-CAP

summary:
The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting.

As the secondary objectives, the study aims

To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of:

Persistence of cure at Day 30 of antibiotic treatment
All-cause mortality rate on Day 30 of antibiotic treatment
Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment.

To compare between the 2 study arms at Day 30 of antibiotic treatment:

The duration of antibiotic treatment;
The length of hospital stay;
The frequency and severity of adverse events during the 30 days after the start of treatment.
To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.

ReferenceCitation: Dinh A, Ropers J, Duran C, Davido B, Deconinck L, Matt M, Senard O, Lagrange A, Makhloufi S, Mellon G, de Lastours V, Bouchand F, Mathieu E, Kahn JE, Rouveix E, Grenet J, Dumoulin J, Chinet T, Pepin M, Delcey V, Diamantis S, Benhamou D, Vitrat V, Dombret MC, Renaud B, Perronne C, Claessens YE, Labarere J, Bedos JP, Aegerter P, Cremieux AC; Pneumonia Short Treatment (PTC) Study Group. Discontinuing beta-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial. Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5. Erratum In: Lancet. 2021 Jun 5;397(10290):2150.

oa_host_type: publisher

license: publisher-specific-oa

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility: Infectious diseases department, Raymond-Poincaré Hospital - APHP


title: Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke, Experimental Study in Single Cases.

acronym: LUNASTROKE

summary:
Recent work on large cohorts of chronic stroke (>6 months post-stroke) have shown that intensive training of the upper limb in the chronic stroke patients can lead to substantial motor and functional gains that are maintained at 6 months post intervention.

A very prolonged (12 weeks) and very intensive (5 hours daily) training applied to chronic patients after stroke brings a substantial gain both motor and functional which is maintained at 3 months post intervention.

Robotic rehabilitation have been shown to be as effective as any other treatment used in rehabilitation. But the methods of implementation remain widely debated. At that time, most robotic therapies have tried to reproduce functional movement mainly pointing objects.

We want to demonstrate that analytic movements of the elbow and the shoulder performed with the Luna-EMG robot can replace part of usual physiotherapy treatment with at least the same effectiveness on the recovery of fluid movements of the upper limb after a stroke.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
EGZOTech


title: Symptoms of Acute Coronary Syndrome in Medical Regulation: a Retrospective Study

acronym: SCAST+

summary:
The main objective was to analyze the impact of the gender of the attending physician in the differences in the management of ST+ ACS between men and women.

This study will be conducted in partnership with the interventional cardiology team of the CHR Metz-Thionville and SAMU (emergency call center) of Moselle, which has a detailed registry of coronary angiographies at the center. A retrospective observational study will be carried out over a "typical" period outside of covid at the CHR Metz Mercy (2021-2022) based on coronary angiographies performed in the context of ST+ ACS at the CHR of patients referred by the center 15.

The patient's medical record will be analyzed, going back to his call to the 15 via tape listening. The number of subjects required being calculated at 104 men and 104 women, these patients will be selected from the database of our cardiologist colleagues and we will match one man to one woman by comparing the delays of several items (1st medical contact, time of 1st ECG, medicalization or not, delay of call to the cardiologist, delay of coronary angiography...) according to the sex of the regulator. The consequences of a difference in management will be also evaluated by analyzing in-hospital mortality, mortality at 30 days of management, and functional sequelae at discharge (grades of dyspnea, disturbance of myocardial contractility, LVEF at discharge).

This study based on the differences in questioning according to the gender of the regulating physician would allow better identification of the factors that increase the delay in the management of ST+ ACS in women, and to find avenues of correction in order to limit the loss of opportunity for patients.

The patients included who are still alive will receive a notification of non-objection by mail.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia

acronym: NYRESED

summary:
Reduction nymphoplasty is the treatment of benign hyperplasia of the labia minora. This surgery is indicated in the event of functional, aesthetic or sexual discomfort. There has been a growing demand for this surgery over the past twenty years. It is necessary to remain vigilant because a request for cosmetic surgery can also be part of an obsession with body dysmorphism, former dysmorphophobia.

Investigators wish to study the postoperative results concerning sexuality, self-esteem and obsession with body dysmorphia in a cohort of patients followed prospectively and at more than 3 years postoperatively.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Validation in French of a Quality of Life Questionnaire for Patients With Eosinophilic Esophagitis in Pediatrics

acronym: ValidEoE

summary:
Eosinophilic esophagitis is a chronic condition of the esophagus. The symptoms of eosinophilic esophagitis can affect the quality of life of affected children. There is no French scale to specifically evaluate the quality of life of these patients.

It will be a monocentric, prospective, descriptive study carried out at the Nice University Pédiatric Hospital.

The main objective of this study will be the validation of a French version of the quality of life pediatric scale (PedsQL) module for eosinophilic esophagitis. It will take place in 2 distinct parts:

The translation of the questionnaire in French.
Collection of the quality of life questionnaires

lead_sponsor: Fondation Lenval

location_facility: Hopitaux Pediatriques de Nice Chu-Lenval


title: Effects of a Personalized Physical Training to Reduce Fatigue in Chronic Fatigue Patients: a Randomized Controlled Trial.

summary:
Chronic fatigue (CF) is a pathological fatigue over at least 6 months, without improvement after rest or sleep. In primary care, it is the major complaint in 5 to 10% of the consultations. Physical activity is an efficient therapy to help reducing this fatigue in addition to the improvement of muscular and cardiorespiratory functions. However, it remains little exploited. Yet the studies focus mainly on precise chronic pathologies with general trainings, without considering the fatigue status and reveal a large heterogeneity. Personalizing the physical training appears to be the next step in order to improve chronic fatigue patients care.

The objective of this study will be to investigate the relevance and the effects of a personalized physical training to reduce fatigue in chronic fatigue patients.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Laboratoire Interuniversitaire de Biologie de la Motricité


title: Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.

summary:
Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

Secondary objectives:

Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

lead_sponsor: MED-EL Elektromedizinische Geräte GesmbH


title: Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy Catamenial Epilepsy: Status Report and Point of View of a Cohort of Patients Who for Drug-resistant Epilepsy at the TOULOUSE University Hospital

acronym: EPICAT

summary: This is a study of patients with catamenial epilepsy. Catamenial epilepsies are defined as epileptic seizures during the menstrual cycle. Today, there are no recommendations and no care pathway for these patients. The aim of this study is to assess the number of patients reporting a link between the occurrence of their epileptic seizures and their menstrual cycle.

status: Active, not recruiting

lead_sponsor: University Hospital, Toulouse


title: Behavior of the Iliofemoral Segment

acronym: BEHAVIOR

summary:
Peripheral artery diseases (PAD) are associated with an overall increased risk of mortality and morbidity, as a consequence of fatal or non-fatal vascular events, mainly due to the total or partial occlusion of the affected artery. Particularly, lower extremity occlusive arterial diseases remain a global concern, affecting more than 200 million people worldwide in 2015. Regarding the iliofemoral segment and, especially, the common femoral artery (CFA), conventional surgical approach (namely common femoral endarterectomy, CFE) is still as the gold standard despite its high morbidity rates mainly due to high rate of wound sepsis and autonomy loss . Endovascular procedures with CFA stenting have been introduced as a promising alternative for their multiple advantages such as shorter hospital stay and less perioperative complications. However, its acceptance among the vascular surgery community has been limited.

Endovascular stenting aims to reduce restenosis and improve the target lesion revascularization rates by the implementation of the stent at the level of the CFA. Nevertheless, fear of stent fracture due to hip mobility constitutes one of the main limitations to its implantation, despite the lack of widely accepted quantitative evidence of their relationship. Thus, this study aims to validate that the stresses and deformations on the iliofemoral segment during hip flexion are not a direct cause of stent fracture.

Numerical 3D models offer a non-invasive, inexpensive and personalized approach in the biomedical engineering field; thereby encouraging their use for the biomechanical study of different anatomical structures. These models are able to simulate the behavior and, additionally, quantify the forces, stresses and deformations of different organs and systems by implementing the information gathered in clinical measurements, diagnostic tests and imaging. 3D models can be reconstructed from computed tomography scans (CT scans). Specifically, CT angiography (CTA) images, offering high-quality and high-contrast images, facilitate the creation of numerical models of the vascular system (including the iliofemoral segment).

Our study will analyze the mechanical behavior of the iliofemoral segment by the creation of a numerical simulation to estimate the stresses and deformations at the level of the CFA during hip flexion. For this purpose, our project aims to use 3D models of this region reconstructed CT scans that are routinely performed preoperatively for PAD patients. Indeed CT scan are indicated for anatomical characterization of PAD lesions and guidance for optimal revascularization therapy.

The results of this study could be applied to the assessment of the treatment of lower extremities occlusive arterial diseases at the level of the CFA.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

acronym: Tirbaso

summary: his is a Phase 2, Single-Arm, Open-Label, Single Center, to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) not arising on the face or scalp

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs (ALLMED)

acronym: ALLMED

summary:
This study focuses on the experience of the military patient reporting a suspected drug allergy, with its own specificities. Suspicions of drug allergies during a mission expose the doctor to difficulties.

This study will improve understanding of the allergy patient's point of view. The end result could be a set of ideas for measures to raise awareness among these patients, and motivate them to undergo an allergological assessment.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: 15ème antenne médicale - Camp des Matelots


title: Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD, a Randomized Double Blind Sham Controlled Trial (TraumaStim)

acronym: TraumaStim

summary: A French multicenter randomized and double blinded shamed controlled study recruiting patients who present resistant PTSD. The aim of this trial is to assess the efficacy of cerebral modulation by rTMS with simultaneous reactivation of traumatic memory on the PTSD symptoms at M1.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris


title: Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill

acronym: FAT-VIB

summary: During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but this capability decreases with fatigue. STV could be minimize by improving shoe midsole hardness.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Saint-Etienne


title: Use of tDCS (Transcranial Direct Current Stimulation) Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population: a Proof-of-concept Study

acronym: tDCSDeMOStim

summary: Decision-making is a complex cognitive function that has been the subject of extensive scientific research in the fields of cognitive and computational neuroscience. It relies on a cerebral network that encompasses cortico-subcortical pathways. The orbitofrontal cortex (OFC) plays a significant role in decision-making by assigning values to guide choices. Risky decision-making is observed in several psychiatric pathologies, including depression and bipolar disorder, and it may constitute an endophenotype of suicide. In the project presented here, we propose to use transcranial direct current stimulation (tDCS) to target decision-making in patients suffering from mood disorders.

lead_sponsor: Centre Hospitalier St Anne

location_facility: GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne - CMME


title: Validation of the French Version of the Hearing Aid Benefit Measurement COSI and IOI-HA Questionnaires

acronym: AUDI-FR

summary: Estimating patient satisfaction is essential in modern day-to-day medical practice. This is particularly true in the field of audiology where evaluating the benefit of patients' devices makes it possible to improve settings and increase patient satisfaction and therefore compliance. Questionnaires measuring hearing aid benefit such as the IOI-HA (International Outcome Inventory for Hearing Aids) and the COSI (Client Oriented Scale of Improvement) are used in everyday practice and promote cooperation between researchers by providing comparable data. Unlike other countries, these questionnaires have never been validated in French by psychometric studies. The objective of this study is to validate the translation of the IOI-HA questionnaire already used in the clinic and to adapt the COSI into French and statistically validate its translation.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Neuromechanical Characterization of Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury

acronym: NEUROGAIT

summary: The retrospective study investigates the part of responsibility of neuromuscular disorders associated with chronic hemiparesis in walking impairment.

lead_sponsor: Henri Mondor University Hospital

location_facility: Laboratoire Analyse et Restauration du Mouvement


title: Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability: A Controlled and Randomized Study

acronym: PROPIU

summary: Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery


title: Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort

acronym: TOBIT

summary: HIV infection requires lifelong continuous antiretroviral (ARV) treatment. The efficacy of current ARV treatments makes it possible to propose strategies for reducing the cumulative exposure to ARVs, side effects and costs. And so improve the quality of life of people living with HIV (PLHIV). However, in the real world, less regular adherence to treatment, more heavily pre-treated patients and resistance to treatment make these dual therapies prescribed beyond the strict framework of clinical trials. This can lead to undesirable side effects. From the perspective of personalized medicine, it seems to be important to determine which patients are receiving dual ARV therapy, and which patients remain on it for a long time. Identifying prognostic factors would enable us to adapt therapeutic management.

lead_sponsor: Tourcoing Hospital


title: Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy

acronym: NENUFAR

summary:
The main aim of this study is to evaluate the contribution of fast-ripples (FR) information on the neurosurgery management of patients with drug-refractory epilepsy investigated by Stereo-ElectroEncephaloGraphy (SEEG), as measured by freedom from disabling seizures one-year post-surgery.

220 patients (for whom 4-6 usual clinical macro-electrodes will be replaced by hybrid micro-macro electrodes and for whom fast-ripples will be assessed) distributed over 5 centres and 220 control patients(who will undergo an SEEG with the usual electrodes and for whom fast-ripples will not be assessed) distributed over 6 centres. This is a controlled, non-randomized, parallel plan, prospective, multicentre exploratory study.

ReferenceCitation: Despouy E, Curot J, Reddy L, Nowak LG, Deudon M, Sol JC, Lotterie JA, Denuelle M, Maziz A, Bergaud C, Thorpe SJ, Valton L, Barbeau EJ. Recording local field potential and neuronal activity with tetrodes in epileptic patients. J Neurosci Methods. 2020 Jul 15;341:108759. doi: 10.1016/j.jneumeth.2020.108759. Epub 2020 May 7.

collaborators: Centre de recherche Cerveau et Cognition (CERCO)


title: Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease (AD)

acronym: ADAE

summary: Memories are more robust when they are multitraced. This means that the more a piece of information is mediated by different sensory inputs, the more resistant it is to being forgotten. Many works in the field of embodied cognition show that new learnings are better recalled over the long term when they are learned during body mobilization. Other works show that musical stimulation could be a good way of eliciting physiological and emotional states more favorable to the memorization of new contents. However, to date, no studies have examined the positive effects of these two tools combined in Alzheimer's disease. The investigators suggest that it is possible to optimize memory in Alzheimer's disease by referring to their motor and emotional resources. The hypothesis is that information will be better recalled with multimodal enriched learning.


title: Diagnostic Performance of Chest Computed Tomography Scan in Patients Aged 65 and Over Presenting to Emergency Room With Acute Dyspnea

acronym: CT-Dys

summary:
In acute dyspnea, the use of chest radiography is frequent and not very contributive, especially in the elderly patients.

However, early diagnosis of the cause of dyspnea in the ED is associated with a better prognosis, in particular for the identification of an infectious or cardiac origin.

Chest CT has already shown better diagnostic performances than conventional radiography in several pathologies such as low respiratory infection, and the development of so-called "low dose" scans allows to limit the irradiation during this examination.

The investigators aim to conduct a diagnostic study comparing non-injected chest CT-scan and conventional chest radiography in patients older than 65 presenting in the ED with acute dyspnea to assess whether CT-scan improves diagnosis.

location_facility: Emergency department Hospital Pitié-Salpêtrière


title: Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber

summary:
The aim of this study is to determine the optimal concentration of grass pollen allergens inducing rhinoconjunctivitis in subjects allergic to grass pollen in ALYATEC allergen exposure chamber.

Four concentrations of grass pollen allergen (Phl p 5) are tested during 3-hour exposures: 0, 30, 60 and 90 ng/m3.

lead_sponsor: Alyatec


title: Early Maladaptive Patterns as Markers of Vulnerability and Targets for Therapeutic Intervention in Burned-out Healthcare Professionals

acronym: SEMBO

summary: The purpose of this study is to compare the profiles and domains of maladaptive early schemas in care professionals with burnout symptoms with care professionals without burnout symptoms and with care non-professionals with burnout symptoms.

time_perspective: Other

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Evaluating the Contribution of a Cardiac Coherence Session to Reducing Patients' Anxiety During a Medical Magnetic Resonance Imaging Examination

acronym: RESP-IRM

summary: The present project aims at conducting a proof of concept study to explore the pertinence of a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, to reduce their level of anxiety and thus improve the course of the examination.


title: Impact of Postoperative Medical Equipment Removal/Insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

summary:
A lot of observationnal studies describe parental stressors in PICU/PCICU, but none studied, prospectively, the links between medical equipment removal/insertion and anxiety modulation.

The primary objective is to identify the impact of medical equipment removal/insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via VAS).

lead_sponsor: Claude Bernard University

collaborators: Research on Healthcare Performance Lab U1290


title: Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté

acronym: LIMBO

summary: The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study

summary:
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations.

Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.

Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.

lead_sponsor: Versailles Hospital


title: Multidisciplinary Platform Designed to Reduce and Prevent Environmental Reprotoxic Exposures in Subfertile Couples: Assessment of the Contribution of Such Platforms on the Birth Rate After In Vitro Fertilization: Randomized Open Prospective Comparative Multicentric Study

acronym: PREVENIR-FIV

summary:
The objective is to evaluate the effectiveness of an innovative personalized management strategy adapted to the level of environmental risk, in a population of infertile couples, eligible for assisted reproductive treatment (ART) by intraconjugal In Vitro Fertilization (IVF)/ Intracytoplasmic sperm injection (ICSI).

Consultation of the couple at the ARTcenter : - Prescriptions of the standard assessment of infertility to the couples eligible for ART. - Inclusion and randomization (arm A interventional vs arm B standard management) of the couples having signed the consent. - Information for each patient on a standardized online self questionnaire on environmental exposures, physical activity and stress.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assitance Publique Hôpitaux de Marseille


title: Elaboration of a Prioritization Score for Pharmaceutical Interviews in Patients Treated With Oral Anticoagulants

summary:
Oral anticoagulants have a prominent place in the strategy of prevention and treatment of thromboembolic diseases, especially in patients with atrial fibrillation. However, a study conducted by the National Fund for Health Insurance (Caisse primaire d'Assurance maladie, CPAM) in 2017 among nearly 35,000 patients with non-valvular atrial fibrillation showed that one in five patients stopped their oral anticoagulant without medical advice for at least 60 days during the first year of treatment.

In our establishment, patients hospitalized in the Cardiology departments and treated with oral anticoagulants benefit from pharmaceutical interviews on their treatment before they return at home. This activity, which exists since November 2014, is based on a team consisting on a pharmacy student, supervised by a pharmacist trained in therapeutic education.

In order to secure the management of patients treated by oral anticoagulants and to answer the requirements of Certification, the investigators wish to extend the pharmaceutical interviews to all of hospital's healthcare services. However, the large number of patients concerned, the shorter hospital stays and the difficulties to organize collective sessions in front of the diversity of treatments and diseases are parameters to be taken into account in the development of this activity. The provision of a targeting tool for patients with high risk of thromboembolism and / or hemorrhage is a prerequisite for organizing this institutional approach to support patients on anticoagulants.

In this context, the investigators want to establish a prioritization score to identify patients on oral anticoagulants with a higher drug risk.

lead_sponsor: CHU de Reims


title: Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.

acronym: FKprefPat

summary:
The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are:

What is the acceptability of new customization and connectivity technologies by patients?
Are they all at the same level of acceptability?

Participants will have to answer to a questionnaire of choice.

lead_sponsor: University Hospital, Brest


title: Randomized Study Evaluating the Value of a Pre-habilitation Stay and Digital Follow-up, Compared With Standard Management, in Anterior Cruciate Ligament Reconstruction

acronym: Préhab-LCA

summary: This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.

sponsor_collaborators: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure in Patients With Central Nervous System Injuries. A Randomized Controlled Trial in Post-stroke Patients and a Pilot Study in Spinal Cord Injured Patients.

acronym: RenfExc

summary:
Neurological disorders [such as Cerebral Vascular Accident (CVA) or Spinal Cord Injury (SCI)] are among the most costly health problems to society in industrialized countries. For those affected, they generate severe restrictions in mobility, significantly altering their quality of life.

Deterioration in motor function after stroke or BM is closely linked to the level of force produced at joint level. This is influenced by adaptations (neurological and tissue) inherent to the pathophysiology of the injury, and characterized by the presence of a spastic paresis syndrome.

A great deal of effort is devoted to motor neurorehabilitation (particularly physiotherapy) in the days and weeks following neurological injury. This so-called sub-acute rehabilitation phase is designed to have a positive impact on the patient's motor recovery (to prevent the development of spastic paresis), and to prevent future severe limitations in the long term.

Disorders observed in the chronic phase (partial recovery of strength, severe orthopedic deformities) demonstrate the limits of current therapies. In view of the results obtained in healthy subjects, eccentric training now seems to be one of the most promising physiotherapy methods for recovering muscle strength and countering neurological disorders.

However, its use in the sub-acute rehabilitation phase has never been evaluated in post-stroke or post-BM patients, either in terms of its effects on the strength developed in the strengthened muscles, or more locally on the neurological and tissue disorders found in these patients in the context of spastic paresis.

The aim of this project is to evaluate the effects of an eccentric muscle-strengthening exercise protocol on neurological patients in the sub-acute phase of their neurological impairment. The protocol will be applied to the ankle joint, given its importance for walking and the significant deficits found at this level in neurological populations.We hypothesize that the strengthening protocol will improve muscle strength at the ankle, and generate beneficial adaptations to combat the spastic paresis syndrome (improved muscle activation, increased muscle length, muscle volume, etc.).

lead_sponsor: Nantes University Hospital


title: Exome Evaluation in Patients Living With Diabetes Complicated by Charcot Neuroarthropathy.

acronym: CHARCOTEX

summary: Diabetes, like obesity, has reached worldwide proportions such that we're talking about a pandemic. These two diseases are a major cause of mortality and multiple complications. The medical and financial stakes involved make these two diseases a major public health issue. Two groups of factors contribute to these diseases: the environment and genetics. The use of next-generation sequencing (NGS) is a highly relevant tool for identifying mutations in already known genes, or new genes involved in the disease, for diagnostic purposes. This approach makes it possible to validate previously described genes and/or discover new loci linked to new signalling pathways involved in the pathophysiology of Charcot's foot in patients with diabetes

lead_sponsor: Centre Hospitalier Sud Francilien


title: Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems

summary:
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.

This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.

lead_sponsor: Societe dEtude, de Recherche et de Fabrication

location_facility: Centre Hospitalier de Rouen - Hôpital Charles Nicolle


title: Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

summary:
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF.

This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.

The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems.

Secondary objectives are to :

study long term patient satisfaction with their hip prosthesis,
confirm the long-term safety of these implants by studying the possible complications observed,
evaluate the performance of these implants using clinical scores.

sponsor_collaborators: Societe dEtude, de Recherche et de Fabrication


title: Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database

summary:
Atrial fibrillation is the most prevalent sustained arrhythmia worldwide with a great morbimortality. Some populations are more at risk to develop atrial fibrillation like patients suffering from inflammatory diseases or patients suffering from cancers. This is at least explained by the inflammatory environment related to these both conditions. Many experimental studies and clinical studies support the role of inflammation and immunity in atrial fibrillation genesis by modulating atrial action potential et by promoting fibrosis.

Immunomodulators are drugs used to stimulate or inhibit the immune system for two main indications : cancers and immune disorder diseases which both promote atrial fibrillation. Due to their interactions with inflammation and immunity, immunomodulatores may further promote the risk of atrial fibrillation, particularly in a population already at risk.

Based on the World Health Organization global database, the main objective of this study is to investigate the association between immunomodulators and the occurrence of atrial fibrillation reported in the database.

A disproportionality analysis will be performed. It will aim to assess whether immunomodulators are associated with a greater risk of atrial fibrillation.

Secondary objectives aim to describe the cases of atrial fibrillation among immunomodulators associated with atrial fibrillation in the main analysis, to describe coprescription among immunomodulators associated with atrial fibrillation in the main analysis, to analyse the role of immunomoduloators medical indication in the overrisk of atrial fibrillation, and to try to highlight some immune mechanisms promoting atrial fibrillation regarding the immunomodulators associated with atrial fibrillation in the main analysis.

ReferenceCitation: Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.

oa_host_type: closed

publisher_dissemination: Oxford University Press

ReferenceCitation: Lazzerini PE, Capecchi PL, Laghi-Pasini F. Systemic inflammation and arrhythmic risk: lessons from rheumatoid arthritis. Eur Heart J. 2017 Jun 7;38(22):1717-1727. doi: 10.1093/eurheartj/ehw208.

oa_host_type: repository

version: submittedVersion

unpaywall_oa_status: green

ReferenceCitation: Guo Y, Lip GY, Apostolakis S. Inflammation in atrial fibrillation. J Am Coll Cardiol. 2012 Dec 4;60(22):2263-70. doi: 10.1016/j.jacc.2012.04.063.

ReferenceCitation: Lazzerini PE, Laghi-Pasini F, Acampa M, Srivastava U, Bertolozzi I, Giabbani B, Finizola F, Vanni F, Dokollari A, Natale M, Cevenini G, Selvi E, Migliacci N, Maccherini M, Boutjdir M, Capecchi PL. Systemic Inflammation Rapidly Induces Reversible Atrial Electrical Remodeling: The Role of Interleukin-6-Mediated Changes in Connexin Expression. J Am Heart Assoc. 2019 Aug 20;8(16):e011006. doi: 10.1161/JAHA.118.011006. Epub 2019 Aug 19.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central;usiena-air.unisi.it

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Caen


title: Advanced DL-based T2w and DWI MR Sequences for Prostate Imaging

acronym: DLRPRO

summary:
MR prostate exam is essential for the diagnosis, workup and follow-up of prostate cancer. It allows to detect subclinical prostate cancer following an increase in the level of PSA. The investigators can score the lesion according to the PIRADS classification and obtain an estimate of lesion malignancy. To perform this classification, T2 and DWI sequences are essential.

Detection and characterization of malignant lesion is important to address appropriate patient care pathway. The purpose of this project is to evaluate novel deep learning (DL) T2-weighted TSE (T2DL) and Diffusion (DWIDL) sequences for prostate MR exam and investigate its impact on diagnostic, examination time, image quality, and PI-RADS classification compared to standard T2-weighted TSE (T2S) and standard Diffusion (DWIS) sequences.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)

acronym: TRANSPELV

summary: The research consists of adding to the usual MtF transgender patient undergoing vaginoplasty care course, static and dynamic perineo-pelvic MRI before, and at 6 and 24 months. The aim is to assess perineo-pelvic static's evolution, based on the appearance of a rectocele.

lead_sponsor: University Hospital, Limoges


title: Women's Knowledge About Endometriosis

acronym: Connaiss-Endo

summary:
In the world, 10% of women of childbearing age have endometriosis with diagnostic mostly between 25 and 30 years old.

Endometriosis is the leading cause of infertility in our country. A diagnosis delay of approximately 6.7 years is observed for endometriosis.

time_perspective: Cross-Sectional

lead_sponsor: Université de Reims Champagne-Ardenne


title: Avis-PHAGEinLYON Clinic

summary: Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 patients will be included in the study.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse