[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre Hospitalier Universitaire Dijon\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":550},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,99,0,25,[9,45,71,94,117,140,160,182,202,221,241,263,287,306,323,339,360,382,402,424,446,470,490,510,529],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651066","integration-of-new-generation-multi-omics-analyses-for-the-diagnosis-of-genetic-neurodevelomental-disorders-100651066",false,"NCT07755098","Integration of New Generation Multi-omics Analyses for the Diagnosis of Genetic Neurodevelomental Disorders","NEXTOMIX","Inclusion Criteria:\n\n* Index case (minor or adult) with severe to profound intellectual disability or syndromic neurodevelopmental disorder without an identified molecular diagnosis. - Index case with a negative srGS result.\n* Sample collection possible from the index case (blood and skin biopsy) and their biological parent(s) (blood) if material is not otherwise available.\n* Signed consent from the adult index case, or from the legal representatives or guardian (as applicable) of a minor index case, and from their parent(s).\n\nExclusion Criteria:\n\n* \\- Index case or parent(s) not affiliated with or not covered by a social security scheme.\n* Diagnostic hypothesis considered highly probable, for which an available targeted molecular test costs less than the proposed strategy.\n* Suspicion of an acquired cause for the symptoms.\n* Minor parent(s).\n* Parent subject to a legal protection measure, or incapacitated or otherwise unable to provide informed consent.\n* Pregnant, birthing, or breastfeeding woman.\n* Participant (index case or parent) who has previously undergone allogeneic hematopoietic stem cell transplantation, rendering blood sample analysis uninformative.","ALL",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"NA","Neurodevelopmental disorders (NDDs), including intellectual disability (ID), represent the most common indication for genetic testing. Affecting up to 3% of the general population, NDDs are characterized by significant clinical and genetic heterogeneity. Although short-read genome sequencing (srGS) has driven major advances through the France Genomic Medicine 2025 Plan (PFMG2025), a substantial proportion of patients still lack a molecular diagnosis.\n\nThese results are partly explained by the limitations of short-read genome sequencing (srGS). Although effective in many cases, this technology performs poorly in detecting complex structural rearrangements, anomalies within repetitive or GC-rich regions, epigenetic variations, and certain intronic variants. Furthermore, srGS does not allow for the direct assessment of the functional impact of genetic variations on splicing or gene expression. Following a negative srGS result, periodic reanalysis of sequencing data via the PFMG2025 laboratories (AURAGEN and SeqOIA) is the only diagnostic option currently available in routine practice. However, these reanalyses are constrained by financial and staffing limitations as well as strict eligibility criteria, making it difficult for many patients-particularly those with stable neurodevelopmental disorders (NDDs)-to obtain a diagnosis. Moreover, they often consist merely of a data review without bioinformatic updates, and the turnaround times-frequently exceeding one year-contribute to the diagnostic odyssey. Utilizing updated pipelines tailored to the specific characteristics of NDDs for the re-examination of srGS data could serve as an initial source of new diagnoses.\n\nComplementary technologies-such as messenger RNA sequencing (mRNA-seq), optical genome mapping (OGM), and long-read genome sequencing (lrGS)-are available and offer solutions to overcome the limitations of short-read genome sequencing (srGS). In particular, they enable the identification of complex structural variants and the assessment of the functional impact of point variants. Despite their potential, their routine use remains limited due to cost and technical complexity.\n\nOur study proposes a combined strategy to address the limitations of current approaches and improve the diagnosis of neurodevelopmental disorders (NDDs) that remain unresolved after short-read genome sequencing (srGS). It begins with a re-analysis of sequencing data using customized bioinformatics pipelines tailored to the patients' specific clinical profiles. In cases of inconclusive results, innovative multi-omics analyses (mRNA-seq, OGM, and long-read genome sequencing\u002FlrGS) will be employed to investigate complex genetic variants. As multi-omics approaches are not currently integrated into the PFMG2025 framework, the project's findings will be crucial in demonstrating their added value for NDD diagnosis and could pave the way for their inclusion in a future PFMG. By anticipating these developments, NextOmix will help define the diagnostic strategies of the future, aligned with technological advancements and patient needs.",[26,27,28,29,30,31],"Intellectual Disability","Neurodevelopmental Disorder (Diagnosis)","srGS","lrGS","Short-read Genome Sequencing","Long-read Genome Sequencing","NOT_YET_RECRUITING","2026-08-05",{"date":35,"type":36},"2026-08-10","ACTUAL",{"date":38,"type":20},"2026-09",{"date":40,"type":20},"2029-03",{"name":42,"class":43},"Centre Hospitalier Universitaire Dijon","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100650522","chorioretinal-imaging-vascular-biomarkers-and-ultra-trail-a-pilot-study-100650522","NCT07748936","Chorioretinal Imaging, Vascular Biomarkers, and Ultra-Trail: A Pilot Study","UTMA-RETINA","Inclusion Criteria:\n\n* Participant who has given free, informed, and verbal consent\n* Participant of legal age\n* Participant registered for the UTMA 100 km solo ultra-trail race (for the \"ultra-trail\" group)\n* Active subject not exposed to intense physical exertion (\\>6 hours of exercise) within the 7 days prior to the enrollment visit (for the \"active control\" group)\n* Participant with an estimated physical activity level of 4-6 hours per week (for the \"active control\" group)\n* Participant agreeing to undergo ophthalmological examinations on the same schedule as the ultra-trail group (for the \"active control\" group)\n\nExclusion Criteria:\n\n* Myopia \\> 6 diopters\n* Type 1 or Type 2 diabetes\n* Protected individuals: Minors, individuals under legal protection (guardianship, conservatorship, court order), individuals unable to give informed consent\n* Individuals not enrolled in a social security program\n* Pregnant or breastfeeding women\n* Participants with a systemic or inflammatory vascular condition and cardiovascular risk\n* Participants with an ocular condition or ophthalmological history likely to impair retinal\u002Fchoroidal microcirculation or the quality of imaging (vascular and degenerative macular conditions, cataracts)\n* Participants being treated with vasoconstrictors\n* Tobacco use within 4 hours prior to enrollment\n* Caffeine consumption within 1 hour prior to enrollment",true,"18 Years",{"count":55,"type":20},40,[23],"Retinal and choroidal microcirculation is a relevant biomarker of systemic vascular health and lies at the heart of eye-heart interactions. Noninvasive retinal imaging, particularly OCT angiography (OCT-A), now makes it possible to examine retinal and choroidal microvascularization in vivo and to study its relationship with systemic cardiovascular and neurovascular mechanisms.\n\nUltra-endurance activities, such as ultra-trail races, induce significant systemic hemodynamic changes, including dehydration, variations in perfusion pressure, prolonged sympathetic activation, and redistribution of blood flow. These physiological adaptations could lead to acute and reversible changes in retinal and choroidal vascular parameters as measured by retinophotography and OCT angiography.\n\nSeveral studies suggest that intense physical exercise may be accompanied by significant changes in retinal and choroidal microvascular perfusion. In particular, a significant decrease in the vascular density of the superficial retinal plexus has been observed following intense exercise in a healthy population, suggesting a transient change in retinal microcirculation. Similarly, following a marathon, a decrease in the retinal vascular density index (RVDI) has been reported, likely related to exercise-induced vasoconstriction and a transient reduction in retinal blood flow. This decrease may also be exacerbated by the drop in systemic blood pressure and the relative dehydration observed after the race. More broadly, intense endurance exercise is accompanied by cardiovascular and neurohormonal adaptations, particularly through activation of the renin-angiotensin-aldosterone system, which may modulate ocular perfusion. Scott et al. demonstrated, following a 160-km ultramarathon, significant alterations in left ventricular function and a major elevation in NT-pro-BNP, indicating systemic cardiovascular stress that was markedly greater than that observed after a standard marathon. Furthermore, a multi-omics study conducted during the Ultra-Trail du Mont-Blanc (171 km) revealed systemic oxidative stress, marked inflammation with elevated IL-6 levels, and profound metabolic changes affecting red blood cells-mechanisms recognized as being involved in microvascular dysfunction. However, these variations primarily reflect functional changes in perfusion related to hemodynamic status and autonomic tone, rather than true structural microvascular remodeling or angiogenesis. Metrics derived from OCT angiography, such as vascular density or perfusion density, are in fact sensitive to systemic variations in circulating volume, perfusion pressure, and the quality of the acquired signal.\n\nIn this context, the effects of ultra-endurance exercise on the eye remain poorly characterized. Research in this area is necessary to better understand the acute physiological adaptations of ocular microcirculation and to highlight the value of retinal imaging as a tool for cardiovascular research and prevention within an integrated eye-heart approach.",[59,60,61,62],"OCT Angiography","Retinal Microcirculation","Choroidal Microcirculation","Physical Exercion","2026-07-31",{"date":65,"type":36},"2026-08-06",{"date":67,"type":20},"2026-10",{"date":69,"type":20},"2027-02",{"name":42,"class":43},{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100506640","phase-3-unipolar-versus-bipolar-interlocking-in-humeral-shaft-fractures-in-adults-100506640","NCT05877014","Unipolar Versus Bipolar Interlocking in Humeral Shaft Fractures in Adults","UNILOCH","Inclusion Criteria:\n\n* Patient with written consent\n* Patient ≥18 years of age with a diagnosis of humeral shaft fracture (all types in the AO classification) requiring surgical treatment with intramedullary nailing\n\nExclusion Criteria:\n\n* Person not affiliated to national health insurance\n* Patient unable to attend all study visits\n* Patient with a pathologic fracture\n* Patient with a post-traumatic brachial plexus injury at the time of inclusion\n* Patient under court protection, guardianship or legal guardianship\n* Pregnant, parturient or breastfeeding woman\n* Patient admitted for revision surgery of a humerus fracture (insufficient healing or complication)\n* Patient with an acute or chronic, unstable or poorly controlled disease that may interfere with the evaluation of the study objective, as determined by the investigator.",{"count":79,"type":20},390,[81],"PHASE3","Shaft fractures account for 20% of humeral fractures and 3% of all adult fractures in France, with an estimated incidence of 13 to 20\u002F100,000 people. Men aged 21 to 30 years and women aged 60 to 80 years are particularly affected. Intramedullary nailing is among the standard treatments for humeral shaft fractures (when surgery is required). Once inserted, the nail is locked in order to limit stress on the fractured bone, as well as possible secondary rotational displacements or malunion. Bipolar interlocking (BI) is typically performed on both sides (proximal and distal) of the fracture site. This procedure is performed under radiological control, exposing the patient and care team to radiation (during the entire procedure). The objective of the treatment is to obtain consolidation of the fracture within 12 months, and to limit the occurrence of irreversible complications such as malunion or nonunion (2-10% at 12 months post-surgery). The \"unipolar interlocking\" (UI) technique has recently been introduced. In this technique, locking is performed only on the proximal side of the fracture site. By avoiding the distal approach, potential complications such as radial nerve damage, with the risk of irreversible paralysis (3.8-14.2% in studies of the BI technique in this indication) or the risk of infection on the distal side can be avoided. It also reduces operative time, and consequently the radiation received by patients and caregivers. However, the UI may be poorly positioned, resulting in malunion that requires revision surgery.\n\nDespite the absence of recommendations due to the lack of existing data, several teams use the UI in routine care. In this context, a descriptive cohort of 121 patients operated on at the Dijon University Hospital5 showed similar rates of consolidation between the 2 techniques (93.8% for UI versus 95.2% for BI, p=0.64), functional scores, and complications, as well as a significant 29% decrease in operating time in the UI group (mean + SD: 63.1±21.3 min versus 88.0±30.1 min for VB, p\\\u003C0.01). These encouraging results, although limited by the retrospective and observational nature of the data, justify a prospective randomized trial comparing these two techniques.",[84],"Humeral Shaft Fracture","RECRUITING","2026-07-29",{"date":88,"type":36},"2026-07-30",{"date":90,"type":36},"2023-07-03",{"date":92,"type":20},"2027-09",{"name":42,"class":43},{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":53,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":44},"100564515","evaluation-of-the-impact-of-psychological-profile-on-diabetic-foot-wound-healing-100564515","NCT06630182","Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing.","Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing. Prospective, Monocentric Study","BORTNER PIED 2","Inclusion Criteria:\n\n* Person who has given his non-opposition\n* Person over 18 years of age\n* Person with type 2 diabetes\n* Person referred for management of a new diabetic foot wound\n\nExclusion Criteria:\n\n* Person subject to a legal protection measure (curatorship, guardianship)\n* Person subject to a legal protection measure\n* Pregnant women, women in labour or breastfeeding mothers\n* An adult who is incapable or unable to give consent\n* Minors\n* Person unable to complete self-questionnaires",{"count":103,"type":20},308,"OBSERVATIONAL","Foot wounds in patients with diabetes are one of the most frequent complications associated with diabetes. Despite the progress made in its management in recent years, the risk of amputation remains high in cases of diabetic foot wounds.\n\nSeveral studies have highlighted the value of analyzing the psychological profile A or B, defined by self-questionnaire using Bortner's method. The A personality profile is characterized by hyperactivity, combativeness and exaggerated ambition, while the B profile is characterized by less sensitivity to stress and reduced combativeness.\n\nType A personality profile is associated with reduced cardiovascular mortality in type 1 diabetes. Type B personality profiles have also been shown to be associated with inflammation in both type 1 and type 2 diabetes.\n\nOur group showed that patients with diabetes and a foot wound were more likely to have a type B psychological profile than patients with diabetes and no foot wound.\n\nHowever, to our knowledge, it has never been determined whether the psychosomatic profile type A or B assessed by the Bortner self-questionnaire influenced wound healing and the risk of amputation.\n\nThe aim of this study is to determine whether type A or B psychosomatic profile influences wound healing in diabetic feet.\n\nThis study will be carried out in the endocrinology, diabetology and nutrition department of the Dijon Bourgogne University Hospital. 308 patients will be included in the study.",[107,108],"Type 2 Diabetes","Foot Wound","2026-07-23",{"date":111,"type":36},"2026-07-24",{"date":113,"type":36},"2024-09-11",{"date":115,"type":20},"2028-09",{"name":42,"class":43},{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":44},"100644980","evaluation-of-the-effectiveness-of-ultrasound-guided-stellate-ganglion-block-in-cardiac-surgery-anesthesia-on-postoperative-recovery-100644980","NCT07676487","Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery","Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery: A Multicenter, Randomized, Double-Blind Trial","ECLAIR","Inclusion Criteria:\n\n* Individuals who have provided their free and informed written consent\n* Age ≥18 years\n* Patients scheduled to undergo elective cardiac surgery (≥24 hours) with cardiopulmonary bypass (CPB): valve surgery, aorto-coronary bypass surgery, or combined surgery (\\>2 procedures)\n\nExclusion Criteria:\n\n* Adult under guardianship\n* Patient not enrolled in a social security program\n* Patient who has previously been included in the study (e.g., repeat surgery)\n* Patient with hypersensitivity to local anesthetics or to any of the excipients in the products used\n* Preoperative AC\u002FFA\n* Hypovolemia\n* Severe hypotension\n* Acute porphyria\n* Pregnant, laboring, or breastfeeding women",{"count":126,"type":20},250,[23],"Heart surgery is a complex and delicate procedure that affects more than one million people worldwide each year. Patients who undergo this surgery are generally elderly and have multiple comorbidities, which places them in high-risk categories (ASA III or IV). This frailty, combined with a loss of physiological reserve, makes these patients particularly vulnerable to postoperative complications, which can range from cardiovascular disorders to neurological, respiratory, renal, gastrointestinal, infectious, and hematological complications.\n\nIn this context, the quality of postoperative recovery is crucial because it reflects the patient's postoperative health status. The quality of recovery encompasses several dimensions, such as pain, return to independence, sleep quality, and mental state. Optimal anesthesia-which goes beyond simply minimizing pain-requires proactive management of all these dimensions. Current research in cardiac surgery focuses on optimizing anesthesia strategies, particularly the choice between opioid and non-opioid anesthesia, as well as the complementary use of regional analgesia. However, studies providing clear recommendations on these topics are still limited.\n\nAmong the techniques explored, the ultrasound-guided stellate ganglion block (SGB) stands out due to its numerous positive clinical effects. This block, which involves the ultrasound-guided injection of a local anesthetic into the stellate ganglion, produces a temporary sympathetic block that reduces the activity of the autonomic nervous system during surgery. Several studies suggest that SGB could significantly improve the quality of postoperative recovery, particularly in terms of pain reduction, sleep quality, and a lower incidence of cardiac arrhythmias. A meta-analysis has shown that SGB promotes the recovery of gastrointestinal function following various surgical procedures. In major thoracic surgery, it has been observed that SGB reduces the incidence of perioperative atrial and ventricular fibrillation.\n\nAlthough these results are promising, data from randomized trials in cardiac surgery are still limited. A pilot study demonstrated the feasibility and safety of SGB in this type of surgery, with a reduced incidence of atrial fibrillation. However, further studies are essential to confirm these results and assess the impact of SGB on the quality of recovery following anesthesia in cardiac surgery.\n\nThe hypothesis of this study is that performing a stellate ganglion block during general anesthesia improves the quality of recovery in all its aspects (pain, well-being, sleep, etc.). This hypothesis warrants in-depth exploration to optimize postoperative care and improve long-term outcomes for patients undergoing complex cardiac surgery.",[130,131,132],"Undergo Elective Cardiac Surgery","Cardiopulmonary Bypass","CPB","2026-07-21",{"date":109,"type":36},{"date":136,"type":20},"2026-07",{"date":138,"type":20},"2028-02",{"name":42,"class":43},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100600175","exploratory-functional-assessment-after-lower-limb-amputation-locomotion-balance-energy-performance-and-strategies-for-adapting-to-orthopaedic-devices-100600175","NCT07094074","Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices","AMILOCO","Inclusion Criteria:\n\n* Person who has given oral consent\n* Patient able to understand simple commands and packaging instructions\n* Male or female patient over 18 years of age\n* Patient with a lower limb amputation, at tibial or femoral level\n\nExclusion Criteria:\n\n* Person not affiliated to or not benefiting from a social security scheme\n* Person subject to a legal protection measure (curatorship, guardianship)\n* Person subject to a judicial protection measure\n* Pregnant women, women in labour or breastfeeding mothers\n* Adults who are incapable or unable to give their consent\n* Subjects with disarticulated hips\n* Subjects with serious associated pathologies having an impact on walking (other than amputation)",{"count":148,"type":20},100,[23],"The general aim of this exploratory study is therefore to investigate and quantify the functional capacities of patients with lower limb amputations (transtibial and transfemoral), with no change in their management, and to describe any changes in these capacities. The volunteers included in this study will be testing new equipment, all of which will be CE-marked, and will therefore meet all the safety and performance conditions required for use by these patients (equipment that is likely to be prescribed as standard). These devices could benefit from current technological advances that could improve these patients' functional abilities. They will be chosen and adapted according to the volunteer's activity and current equipment.\n\nThis is a local project of the CHU Dijon Bourgogne which will take place on the Technological Investigation Platform located at the Centre de Rééducation et de Réadaptation of the CHU Dijon Bourgogne.\n\nA maximum of 100 patients will take part in the study, divided into two sub-groups of between 5 and 50 patients, depending on the type of brace worn and the level of amputation.\n\nAfter the inclusion visit, each volunteer will undergo 2 assessment visits (the order of assessment of the devices will depend on randomisation) separated by 3 to 6 weeks. Follow-up is for a maximum of 14 weeks.",[152],"Lower Limb Amputation","2026-07-16",{"date":155,"type":36},"2026-07-17",{"date":38,"type":20},{"date":158,"type":20},"2032-01",{"name":42,"class":43},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":181,"locationsCount":44},"100647439","a-study-of-taste--and-olfactory-evoked-potentials-in-patients-with-visual-impairment-taste-smell-and-vision-100647439","NCT07707219","A Study of Taste- and Olfactory-Evoked Potentials in Patients With Visual Impairment: Taste, Smell, and Vision","GOUSTAVIS","Inclusion Criteria:\n\n* Adult: ≥ 18 years and ≤ 60 years\n* Individual who has given oral consent\n* Individual who has been fasting (no food, drink, or tobacco) for at least 1 hour prior to PEG and PEO measurement\n* No cognitive complaints and normal neurological examination.\n* Group of patients with visual impairment:\n\nA. Central: documented bilateral macular dystrophy (e.g., Stargardt disease, Best disease) with confirmed central scotoma (CV 24.2, 10.2, or 30.2).\n\nB. Peripheral: documented bilateral peripheral retinal dystrophy with confirmed peripheral involvement (CV 30-2 or 24-2).\n\n• Control group: a person with normal vision and no known ophthalmological abnormalities (normal visual acuity and fundus examination) who is precisely matched by sex and smoking status (former smoker who has quit vs. nonsmoker), and approximately matched by age (± 5 years) to a visually impaired participant included in the study.\n\nExclusion Criteria:\n\nFor this group: patients with visual impairments:\n\n* Individuals who are not enrolled in or eligible for a social security program\n* Individuals subject to a legal protective measure (guardianship, conservatorship)\n* Individuals subject to judicial safeguard measures\n* Adults who are legally incapacitated or unable to give informed consent\n* Documented COVID-19 infection within the 6 months prior to enrollment\n* Active smokers (≥1 cigarette per day) or users of any other inhaled substances (water pipe, cannabis, etc.)\n* Participants following a sugar-free diet\n* Participants with diabetes, of any type\n* Participants taking medication (ongoing during the study) that interferes with taste perception • Pregnant or breastfeeding women\n* Individuals with neurodegenerative diseases (Parkinson's, Alzheimer's)\n* Individuals with braids, dreadlocks, or any other hairstyle that prevents electrodes from being placed in sufficiently precise locations on the scalp.\n* Overweight subjects with a BMI ≥ 35 kg\u002Fm²","60 Years",{"count":169,"type":20},50,[23],"Visual impairment, whether central or peripheral, may influence the plasticity of other sensory modalities, such as taste and smell. Taste-evoked potentials (TEPs) and smell-evoked potentials (SEPs)-methods for analyzing brain activity in response to taste and smell stimuli-allow for the objective assessment of these interactions. This approach has already demonstrated its value in the study of cognitive disorders. This study aims to demonstrate an enhancement of taste and smell capabilities that could compensate for specific visual impairments, particularly in situations involving food choices.",[173,174,175,176],"Central Visual Impairment","Peripherical Visual Impairment","Macular Retinal Dystrophy","Peripherical Macular Dystrophy","2026-07-15",{"date":153,"type":36},{"date":38,"type":20},{"date":115,"type":20},{"name":42,"class":43},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":44},"100645906","a-study-of-lipid-metabolism-and-mitochondrial-function-in-myeloid-cells-and-total-aortic-tissue-in-patients-with-ascending-thoracic-aortic-aneurysm-ata-and-bicuspid-ba-or-tricuspid-ta-aortic-valves-100645906","NCT07695545","A Study of Lipid Metabolism and Mitochondrial Function in Myeloid Cells and Total Aortic Tissue in Patients With Ascending Thoracic Aortic Aneurysm (ATA) and Bicuspid (BA) or Tricuspid (TA) Aortic Valves.","A Prospective, Single-center, Open-label Study of Lipid Metabolism and Mitochondrial Function in Myeloid Cells and Total Aortic Tissue in Patients With Ascending Thoracic Aortic Aneurysm (ATA) and Bicuspid (BA) or Tricuspid (TA) Aortic Valves.","PROMETA","Inclusion Criteria:\n\n* Individuals who have given their consent\n* Patients with an ascending aortic aneurysm for which surgical replacement is indicated\n* Age \\> 18 years\n* Scheduled surgery\n* Preoperative ultrasound confirmation of the heart valve architecture (bicuspid or tricuspid valve)\n\nExclusion Criteria:\n\n* A person subject to a legal protective measure (guardianship, conservatorship)\n* A person subject to a judicial safeguard measure - A pregnant woman, a woman in labor, or a breastfeeding woman\n* Adults who are legally incapacitated or unable to give consent\n* Emergency surgical procedures\n* Patients with uncontrolled inflammatory or autoimmune conditions\n* Patients with a history of recent acute infection (within the last 3 months or still undergoing treatment)\n* Patients with a condition requiring immunosuppressants - Patients with a confirmed or suspected genetic aneurysm (Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome, etc.)\n* Patients with a history of cardiac surgery",{"count":169,"type":20},"Ascending aortic aneurysms (AAAs) are serious conditions that can lead to aortic dissections or ruptures, carrying a high risk of mortality. Their pathophysiology is based on complex mechanisms involving inflammatory and metabolic processes, as well as alterations in mitochondrial function. The presence of a bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) significantly influences the progression and severity of aneurysms. Bicuspid aortic valve (BAV) patients often develop aortic aneurysms earlier, as early as age 40-50, whereas tricuspid aortic valve (TAV) patients generally present with a degenerative condition that appears later (after age 50). The objective of this study is to compare the inflammatory, metabolic, and transcriptomic signatures of myeloid cells and total aortic tissue between BAV and TAV patients. These analyses will help identify specific molecular mechanisms, potential biomarkers, and therapeutic targets. To ensure pathophysiological homogeneity, patients with aneurysms of genetic origin (Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome, etc.) will be excluded.",[193],"Ascending Aortic Aneurysm","2026-07-10",{"date":196,"type":36},"2026-07-13",{"date":198,"type":36},"2026-06-28",{"date":200,"type":20},"2029-08",{"name":42,"class":43},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":44},"100514963","pilot-study-of-the-contribution-of-fractional-exhaled-nitric-oxide-as-a-prognostic-marker-of-response-to-anti-pd-l1-immunotherapy-in-non-small-cell-lung-cancer-100514963","NCT05985330","Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer","FENOTYPE","Inclusion Criteria:\n\n* Patients with metastatic NSCLC\n* Patient not previously treated\n* PD-L1 tumor expression \\> 50%, to be treated with immunotherapy alone after validation by a multidisciplinary consultation meeting.\n* Patients over 18 years of age\n* Patient having given his\u002Fher non-opposition\n* Patient who speaks and reads French\n\nExclusion Criteria:\n\n* Patients previously treated for NSCLC\n* Patient with oncogene addiction or a first-line targetable rearrangement\n* Patient not suitable for immunotherapy alone\n* Patient having received corticosteroid treatment in the 15 days prior to FeNO.\n* Patient on inhaled corticosteroid at time of inclusion.\n* Blood eosinophilia \\> 500 \u002Fmm3\n* Patient on 24-hour oxygen therapy\n* Contraindication to immunotherapy\n* Inability to perform FeNO measurement manoeuvres\n* Pregnant, parturient or breast-feeding women\n* Person under judicial protection (curatorship, guardianship)\n* Person subject to limited judicial protection\n* Adult unable to express their non-opposition\n* Patient refusing to participate in the study",{"count":210,"type":20},56,"Based on the use of the patient's natural defences, immunotherapy mobilizes the immune system to recognize and destroy cancer cells, and it has revolutionized the treatment of lung cancer.\n\nHowever, the effectiveness of immunotherapy varies from patient to patient. At present, we have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a given individual.\n\nCurrent scientific data identifies a number of molecules produced by the cancer cells and their environment which can be detected by various means (blood tests, breath analysis, etc.).\n\nThe aim of this study is to understand whether the amount of nitric oxide (NO) present in the breath is a more accurate predictor of response to immunotherapy.\n\nParticipation in this study involves breath testing (to measure FeNO (Fractional exhaled Nitric Oxide)) before receiving the first infusion of immunotherapy, and at the follow-up visit after the 4th course of immunotherapy.",[213],"Metastatic Non-small Cell Lung Cancer","2026-07-09",{"date":194,"type":36},{"date":217,"type":36},"2023-09-26",{"date":219,"type":20},"2030-09",{"name":42,"class":43},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":44},"100371770","phase-3-circulating-tumor-dna-based-decision-for-adjuvant-treatment-in-colon-cancer-stage-ii-100371770","NCT04120701","CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II","CIRCULATE","Inclusion Criteria:\n\n* Signed written informed consent obtained prior to any study specific procedures\n* Age ≥ 18 years and ≤ 75 years\n* Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 12 cm from the anal verge by endoscopy and\u002For above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent. Pathology report must be faxed to CRGA just after patient's randomization.\n* At least 12 lymph nodes analyzed\n* Patient with MSI + tumors can be included\n* All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy\n* No metastatic disease on CT-Scan and\u002For liver MRI done within 3 months before randomization.\n* Randomization planned up to 7 weeks after curative R0 resection\n* WHO performance Status \\\u003C 2\n* No prior chemotherapy for colo-rectal cancer\n* No prior abdominal or pelvic irradiation for colo-rectal cancer\n* Life expectancy of ≥ 5 years\n* Adequate haematological function: with neutrophils ≥ 1,500 \u002Fmm3, platelet count ≥ 100,000\u002Fmm3, hemoglobin ≥ 9 g\u002FdL (5,6 mmol\u002Fl)\n* Total bilirubin ≤ 1.5 x ULN (upper limit of normal)\n* ASAT and ALAT ≤ 2.5 x ULN\n* Alkaline phosphatase ≤ 2.5 x ULN\n* Serum creatinine ≤ 120 µmol\u002FL or creatinine clearance ≥50 ml\u002Fmin according MDRD (Modification of Diet in Renal Disease)\n* Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period)\n* Negative pregnancy test for registration(for women of childbearing age)\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* T4b tumors\n* Peripheral neuropathy \\> grade 1\n* Comorbidity influencing the 5 year patients' survival including clinically relevant cardiovascular disease,\n* Ischemic myocardial infarction in the last year and\u002For unstable ischemic cardiopathy,\n* Participation to another interventional study for postoperative therapy\n* Partial or complete DPD deficiency\n* Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to finish the study\n* Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,\n* Lack of effective contraception in patients (men and\u002For women) of childbearing age, pregnant or breastfeeding women. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy and at least 30 days after discontinuation of 5-fluorouracil. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil.","75 Years",{"count":230,"type":20},1980,[81],"The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.",[234],"Patients With Resected Stage II Colon Cancer",{"date":194,"type":36},{"date":237,"type":36},"2020-01-17",{"date":239,"type":20},"2032-03",{"name":42,"class":43},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":260,"leadSponsor":262,"locationsCount":44},"100646765","a-study-of-the-value-of-trio-genome-sequencing-in-the-etiological-evaluation-of-early-onset-andor-atypical-psychiatric-disorders-without-intellectual-disability-or-congenital-anomalies-100646765","NCT07686653","A Study of the Value of Trio Genome Sequencing in the Etiological Evaluation of Early-Onset and\u002For Atypical Psychiatric Disorders Without Intellectual Disability or Congenital Anomalies","PSYGEN","Inclusion Criteria:\n\n* Index case with one or more psychiatric disorders confirmed by a psychiatrist and\u002For child psychiatrist, whose evaluations may be supplemented as needed as part of their care, and who meets at least ONE of the following criteria for atypicality:\n* Early age of onset\n* Unusual course of the disorder (polymorphic\u002Ffluctuating)\n* Treatment resistance\n* Disorder classified as \"unspecified\" by the DSM-5 with significant functional impact\n* Index case aged 3 to 50 years, inclusive\n* Consent signed by the biological parents and by the \"index case, if of legal age\"\n* Index case and their parents enrolled in or eligible for a social security program\n* Sample collection possible from the index case and their two known biological parents\n\nExclusion Criteria:\n\n* Genetic testing previously performed (CGH array, targeted gene testing, gene panel, etc.)\n* Parent(s) and\u002For the index case subject to a court-ordered protective measure\n* The index case and his or her parents have a condition that, in the investigator's opinion, would contraindicate the subject's participation in the study\n* Presence of an intellectual developmental disorder confirmed by a neuropsychological test or strongly suspected clinically in the index case and\u002For their parents\n* Index case with a clear syndromic diagnosis\n* Index case with a psychiatric disorder already covered by a pre-indication under PFMG2025.","3 Years","50 Years",{"count":251,"type":20},255,"According to the World Health Organization, one in eight people worldwide has a mental disorder, defined as a significant impairment in thinking, emotional regulation, or behavior. These disorders are classified according to the DSM-5. These psychiatric disorders may be atypical in terms of their age of onset, course of the illness, unusual response to treatment, or classification (significant impact but classified as a \"disorder not otherwise specified\" by the DSM-5). These disorders can occur sporadically or run in families.\n\nIn France, there are no genetic testing recommendations for these patients. A CGH-array analysis may be ordered as part of patient care, as may testing for Fragile X syndrome, depending on the clinical context.\n\nThe main hypothesis is that atypical psychiatric disorders result from multifactorial inheritance, involving a combination of common genetic variations and environmental factors. Pangenomic association studies and twin studies have already demonstrated heritability in these psychiatric disorders. It has now been shown that some neurodevelopmental disorders (NDDs) and psychiatric disorders-such as autism spectrum disorders or schizophrenia, for which similar hypotheses were proposed in the past-may result from monogenic inheritance. Furthermore, preliminary indications now allow for the prescription of genome sequencing on the platforms of the France Genomic Medicine Plan 2025.\n\nTo date, no study has evaluated the role of high-throughput sequencing in an etiological approach to atypical, non-syndromic psychiatric disorders. Through this study, we aim to assess whether genome sequencing (GS) could be relevant for atypical, non-syndromic psychiatric disorders, which would be the case if it leads to an etiological diagnosis in at least 12% of cases.\n\nThe establishment of the GénoPsy network (Centers of Excellence for Behavioral Disorders in Developmental Disorders) creates an environment that is highly conducive to the development of this project.",[254,255],"Genetic","Diagnostic Strategies","2026-06-30",{"date":258,"type":36},"2026-07-07",{"date":38,"type":20},{"date":261,"type":20},"2029-05",{"name":42,"class":43},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":271,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100583343","a-pilot-study-to-assess-the-feasibility-and-acceptability-of-newborn-screening-using-in-silico-panel-based-solo-genome-sequencing-in-france-100583343","NCT06875089","A Pilot Study to Assess the Feasibility and Acceptability of Newborn Screening Using in Silico Panel-based Solo Genome Sequencing in France","A Pilot Study to Assess the Feasibility and Acceptability of Newborn Screening Using in Silico Panel-based Solo Genome Sequencing in France PERIGENOMED-CLINICS 1 (PGC1 Study)","PGC1","Inclusion Criteria:\n\nFor satisfaction study about the information \\& identification of determinants of acceptability :\n\nInclusion criteria for parents\u002Flegal guardians :\n\n* All future parents approached for whom the unborn child will be cared for in the participating maternity unit\n* At least one parent\u002Flegal guardian who received information about the study\n* Future parents\u002Flegal guardian who do not object to the use of their data\n* Parent(s) or legal guardian(s) affiliated to a social security system or beneficiaries of such a system\n\nFor pGS-NBS :\n\nInclusion criteria for newborn :\n\n* All babies born in one of the participating centers or born by chance outside the maternity but whom care will be carried out in the participating center\n* Newborn who are less than 28 days at the date of the collection of PGC1 blotting paper\n\nInclusion criteria for parents\u002Flegal guardians\n\n* At least one biological parent who received information about the study\n* Parent(s) or legal guardian(s) who do not object to \"conventional\" NBS\n* At least one parent\u002Flegal guardian able to provide consent for testing the infant\n* Informed consent signed by at least one parent\u002Flegal guardian\n* Agreement of the second parent\u002Flegal guardian for testing the infant (unless he is unknown or loss of contact) obtained from the first parent\u002Flegal guardian if his written informed consent has not been obtained\n* Parent(s) or legal guardian(s) affiliated to a social security system or beneficiaries of such a system\n\nExclusion Criteria:\n\nNon inclusion criteria for satisfaction studies and pGS-NBS :\n\nNon-inclusion criteria for parents\u002Flegal guardians :\n\n* Parent(s) or legal guardian(s) under legal protection (guardianship, tutorship) or to a court order Non-inclusion criteria for newborn\n* Babies born under anonymous birth according to the French law, known as \"nés sous X\"","0 Days","28 Days",{"count":274,"type":20},5000,"Newborn Screening (NBS) based on genome sequencing (GS) is currently the subject of particular attention at both European and international levels. Over the past three years, several publications have discussed the opportunities and challenges of using GS for NBS. To date, only two Chinese programs have published their results, the first on a series of 29,601 healthy newborns and the second on a series of 10,334 healthy newborns and 668 high-risk infants. Globally, more than twenty pilot projects are underway, although none has been initiated within the French context thus far. Across the different pilot projects, various study designs are used. Most have opted for a targeted GS-based analysis to screen for pediatric-onset diseases. Some projects focus solely on diseases for which effective drugs or interventions exist to prevent or reduce symptoms. In contrast, others offer parents the option to screen their newborns for diseases without current treatment options, but for which a treatment is underdevelopment, or with interest in early management, a choice exercised by most parents. Indeed, early diagnosis of these diseases can help to introduce treatments or interventions when they become available, to participate in research trials on new treatments and to receive early management and genetic counseling.\n\nIn France, the national NBS program has long been recognized worldwide for its organizational quality and comprehensiveness, although, until recently, it has one of the lowest numbers of diseases screened in Europe. As of mid-2024, the French NBS only includes 14 serious diseases. Recently, the French bioethics law has evolved to allow the use of genetic testing as a first-line procedure for NBS. At the same time, the development and efficiency of genomic techniques and the rapid increase in the number of treatable rare diseases (RDs) raise questions about the acceptability and relevance of these genomic methods for NBS and its possible extension. The extension of NBS to many RDs of early onset represents a real public health challenge as RDs, 80% of which are of genetic origin, account for 10% of deaths before the age of 5.\n\nThe FHU TRANSLAD has elaborated the PERIGENOMED Project, a large-scale project which aims to assess the relevance of pGS-NBS in France (analytical and clinical validity, clinical utility and psychosocial, ethical and organizational issues).\n\nThe pGS-NBS (also known as in silico panel-based GS, i.e. an analysis carried out entirely using informatic tools) consists of bioinformatics filtering steps that return only selected variants and\u002For rare variants from targeted genes issued from GS. So, even if the source data comes from the GS, it is possible to configure the pipeline to return only those variations known to be responsible for specific RDs.\n\nthe PERIGENOMED Project will be led in two steps. The first pilot step (PERIGENOMED-CLINICS 1 - PGC1 Study), presented in this protocol, aims to evaluate the feasibility and acceptability of pGS-NBS France. This pilot study plans to screen 2,500 newborns using pGS-NBS targeting two lists of genes (1 corresponding to genes variables responsible of treatable rare diseases, 2 including genes variation leading to actionable rare diseases). In both lists only RDs of early onset are considered. PGC1 study will be carried in 5 healthcare centers in France, with results expected to be returned to clinicians within less than 4 weeks. It will also provide an understanding of the optimal information and analytical pathways, and the possible organizational repercussions of pGS-NBS as well as a first insight about the validity of the pGS-NBS and about the clinical course of newborns screened positive and with a confirmed RD Two studies in humanities and social sciences (HSS) will also be linked to PGC1 Study. The first will focus on the reasons given by decliners and on the medical and socio-economic characteristics (at the individual and contextual level) of decliners versus participants. The second will assess the psychosocial impact of result disclosure on families of positive newborns, comparatively of negative ones.\n\nThese initial results will provide the first outcomes before the launch of a second larger phase PERIGENOMED-CLINICS 2 (PGC2 Study - 22,000 newborns), designed for studying the implementation of such pGS-NBS in routine on a regional level.",[277],"Newborn Screening Programmes for Rare Diseases","2026-06-16",{"date":280,"type":36},"2026-06-17",{"date":282,"type":36},"2025-05-05",{"date":284,"type":20},"2032-07",{"name":42,"class":43},5,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":303,"leadSponsor":305,"locationsCount":44},"100642081","prevalence-of-cardiac-thrombi-in-cardiac-amyloidosis-100642081","NCT07648303","Prevalence of Cardiac Thrombi in Cardiac Amyloidosis","CATICA","Inclusion Criteria:\n\n* Individuals with a diagnosis of cardiac amyloidosis (AL diagnosed by echocardiography and\u002For MRI combined with histological evidence; or ATTR diagnosed in the presence of typical cardiac abnormalities on echocardiography and\u002For MRI with cardiac hyperintensity)\n* Individuals who have had at least one consultation related to their cardiac amyloidosis at the Dijon University Hospital during the year prior to enrollment\n* Adults\n\nExclusion Criteria:\n\n* Individuals with an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Anyone with a known allergy to iodinated contrast agents\n* Overt thyrotoxicosis\n* Uncontrolled asthma\n* Individuals with a known history of cardiac thrombus\n* Individuals with a history of percutaneous or surgical closure of the left atrial appendage\n* Individuals not enrolled in or not eligible for a social security program\n* Individuals under legal guardianship\n* Individuals under conservatorship\n* Pregnant or breastfeeding women",{"count":295,"type":20},200,[23],"Cardiac amyloidosis (CA) is an infiltrative disease characterized by deposits of amyloid proteins of genetic or acquired origin (often in elderly patients), leading to heart failure and arrhythmias. More than 98% of currently diagnosed cases of cardiac amyloidosis result from fibrils composed of monoclonal immunoglobulin light chains (AL) or transthyretin (ATTR), in its hereditary (ATTRv) or acquired (ATTRwt) form.\n\nIts prevalence is rising sharply due to an aging population and improved diagnostic techniques. Atrial fibrillation is responsible, in particular, for heart failure, arrhythmias, conduction disorders, and ischemic strokes, and is associated with significant morbidity and mortality. These patients have a much higher-than-normal risk of stroke because they are in a procoagulant state in the left atrium, even in the absence of atrial fibrillation. Intracardiac thrombi (ICTs) are present in 28% of patients with AC requiring cardioversion, compared with 2.5% of patients without AC, 50% of whom are on anticoagulants.\n\nIt has also been shown that the CHA2DS2-VASc score is not effective in predicting thromboembolic risk, and that direct oral anticoagulants (DOACs) are as effective as vitamin K antagonists (VKAs) in preventing embolisms.\n\nThe prevalence and factors associated with the development of intracardiac thrombi in patients with cardiac amyloidosis are unknown, as the available retrospective studies focused only on selected high-risk patients. Furthermore, tafamidis is now available to stabilize the course of cardiac amyloidosis and improve prognosis, but its effect on thromboembolic risk remains unknown.",[299],"Cardiac Amyloidosis","2026-06-15",{"date":278,"type":36},{"date":136,"type":20},{"date":304,"type":20},"2028-07",{"name":42,"class":43},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":322,"locationsCount":44},"100473702","the-diagnostic-observatory-combating-diagnostic-wandering-and-impasse-within-the-anddi-rares-network-100473702","NCT05448326","The Diagnostic Observatory: Combating Diagnostic Wandering and Impasse Within the AnDDI-Rares Network","Obs du Diag","Inclusion Criteria:\n\nWP1:\n\n\\- Children or adult patients who did not obtain a diagnosis after consulting for a developmental abnormality (that may include isolated or multiple, minor or major malformations, facial dysmorphia associated or not with learning disabilities and\u002For intellectual disability). These patients had a diagnostic evaluation over the 2 weeks randomly drawn from 2012 and 2022.\n\nPatients agreeing to resume a diagnostic approach requiring new blood samples. For genome sequencing through the platforms of the France Genomic Medicine Plan, when they correspond to the criteria of existing preindications, the parents' sample will be proposed.\n\n\\- Patients (adults or their parents) affiliated to national health insurance or beneficiaries of such a system\n\nWP2:\n\nFor the identification of patients eligible for reanalysis (Part 1 Lab) :\n\n* Patients, children or adults with developmental anomalies with or without neurodevelopmental disorders,\n* Patients in whim a de novo CNV of unknown significance of more than 1 Mb has been detected since the implementation of the CGH array platforms\n* The CNV remained of unknown significance or classified as (probably) benign after reanalysis\\* \\*reanalysis other than that performed in the context of the diagnostic observatory\n\nFor reanalysis, in addition to the previous inclusion criteria (Part 2 Clinical):\n\n* CNV remained of unknown significance or classified as (probably) benign after reanalysis\\*\\*\n* Patients and\u002For their parents agreeing to resume diagnostic testing\n* Patients (adults or their parents) affiliated to national health insurance or beneficiaries of such a system \\*\\* After reanalysis in the framework of the diagnostic observatory\n\nWP3:\n\n* Patients (children or adults) with a syndrome that corresponds to the study criteria:\n* Established clinical diagnosis for one of the characteristic syndromes of the AnDDI-Rares pipeline (list may be revised in the future): Noonan syndrome, CHARGE syndrome, Kabuki syndrome, Cornelia de Lange syndrome, Rubinstein-Taybi syndrome ;\n* Known gene(s) but patient's molecular diagnosis is negative.\n* Patients and at least one parent agreeing to a new blood sample for genome ± RNA sequencing and\u002For skin biopsy for conditions where gene transcription is not satisfactory from RNA extracted from blood; or agreeing to perform these analyses from previously stored samples (recommended trio - trio may include other family members);\n* Parents of legal age who are affiliated with national health insurance or who are beneficiaries of such a system;\n* Signed informed consent from both biological parents and\u002For the index case if they are of legal age;\n* Ability of both biological parents to understand correctly.\n\nExclusion Criteria:\n\nWP1:\n\n* Patients without a developmental abnormality ;\n* Patients with a previously identified diagnosis at the time of consultations on the weeks drawn randomly from 2012 and 2022.\n\nWP3:\n\n* Unlikely clinical diagnosis ;\n* Family not wishing to pursue molecular investigations;\n* Index case having already benefited from the investigations through another research project.\n* The parents of the index case are under court protection ;\n* Families where both parental authority holders are not the biological parents",{"count":314,"type":20},1280,"The Direction Générale de l'Organisation des Soins (DGOS) and the Banque Nationale de Données Maladies Rares (BNDMR) have launched a call for a letter of commitment for the implementation of a diagnostic observatory in order to fight against diagnostic wandering and impasse. In this context, the AnDDI-Rares network proposes 3 work packages (WP) to respond to the missions entrusted to it.\n\nWork package 1 of the diagnostic observatory includes a retrospective and prospective study to evaluate how diagnostic wandering and impasse has evolved within the network, with regard to the integration of new technologies, and the expectations of patients and their families.\n\nWork package 2 of the diagnostic observatory includes a reassessment of sporadic copy number variations (CNV) of unknown significance of more than 1 Mb obtained since the beginning of CGH array analyses in the territory.\n\nWork package 3 of the diagnostic observatory aims to help put an end to diagnostic wandering for patients with certain emblematic syndromes by proposing genome and RNA analysis, which provides a certain diagnosis and negative targeted molecular study.",[317],"Developmental Abnormality",{"date":280,"type":36},{"date":320,"type":36},"2022-03-28",{"date":40,"type":20},{"name":42,"class":43},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":337,"leadSponsor":338,"locationsCount":44},"100642576","evaluation-of-pupillometry-as-a-predictor-of-pain-intensity-upon-withdrawal-of-sedation-in-the-postoperative-period-following-cardiac-surgery-a-prospective-cohort-study-100642576","NCT07648342","Evaluation of Pupillometry as a Predictor of Pain Intensity Upon Withdrawal of Sedation in the Postoperative Period Following Cardiac Surgery: A Prospective Cohort Study","PUPREA","Inclusion Criteria:\n\n* A person who has given verbal consent\n* An adult patient\n* A patient scheduled for heart surgery\n\nExclusion Criteria:\n\n* A person who is not enrolled in or eligible for a social security program\n* A person subject to a legal protective measure (guardianship, conservatorship)\n* Person subject to a judicial safeguard measure\n* Pregnant, laboring, or breastfeeding woman\n* Adult who is legally incapacitated or unable to give consent\n* Minor\n* Patient with preoperative cognitive impairment (MMS)",{"count":148,"type":20},"Postoperative pain is a significant issue following surgery, and pain that is either inadequately treated or, conversely, overtreated can increase morbidity. For example, severe chest pain following cardiac or pulmonary surgery impairs the patient's respiratory rehabilitation, which can lead to fluid retention and, consequently, pneumonia. Conversely, overtreatment through excessive use of opioids can cause drowsiness and respiratory depression. Currently, planning postoperative pain management for intubated, ventilated, and sedated patients relies on indirect signs of pain assessed using scales, and on the clinician's subjective judgment. It is only after sedation is discontinued that the actual level of pain can be assessed, once the patient becomes communicative, which then allows analgesic treatment to be adjusted to the pain. This approach inevitably results in a period of discomfort and pain for the patient. In addition to semi-quantitative and subjective scales, a number of analgesia monitoring tools have been developed.\n\nAmong these, the use of pupillometry and the Pupillary Pain Index (PPI) during surgeries (gynecological, pediatric, cardiac) has been associated with a reduction in intraoperative opioid doses and a decrease in postoperative pain. In our department, pupillometry is routinely used to assess analgesia in intubated, ventilated, and sedated patients undergoing painful procedures. This method is integrated into standard care in the operating room in accordance with the PUCCAR study algorithm, as well as in the intensive care unit according to a specific departmental protocol, in addition to standard assessment scores. We hypothesize that performing pupillometry with a PPI score is predictive of pain intensity at extubation. If our hypothesis is confirmed, this would allow us to tailor analgesic management for each patient prior to discontinuing sedation.",[333],"Patient Scheduled for Surgery","2026-06-10",{"date":300,"type":36},{"date":136,"type":20},{"date":304,"type":20},{"name":42,"class":43},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":44},"100642550","association-between-circulating-bdnf-levels-and-atrial-cardiomyopathy-in-patients-undergoing-ablation-for-persistent-atrial-fibrillation-100642550","NCT07648329","Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation","METAPROFIL 2","Inclusion Criteria:\n\n* Participants who have provided written consent\n* Patients aged 18 years or older.\n* Patients scheduled to undergo their first ablation procedure for persistent atrial fibrillation at the Dijon Bourgogne University Hospital\n\nExclusion Criteria:\n\n* A person who is not enrolled in or eligible for a social security program\n* A person subject to a legal protective measure (guardianship, conservatorship)\n* Person subject to a judicial safeguard measure\n* Pregnant or breastfeeding woman\n* Adult who is legally incapacitated or unable to give consent\n* Ablation of paroxysmal AF with or without electroanatomical mapping",{"count":347,"type":20},150,"trial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and its prevalence continues to rise. AF is associated with serious complications, including embolic strokes, heart failure, and mortality. Characterized by rapid, irregular, and weakened contractions of the atria, AF is considered one of the \"visible\" electrophysiological manifestations of a broader condition known as atrial cardiomyopathy (ACM). Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, predisposes to thrombus formation. Once dislodged from the atrial cavity and migrating to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for ACI\u002FAF are metabolic syndrome and aging. CMA is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, we aim to address this challenge by approaching CMA through one of its complications: persistent atrial fibrillation. Indeed, CMA can be assessed using electroanatomical mapping during atrial fibrillation ablation (AFA) procedures. During radiofrequency ablation of AF, electroanatomical mapping of the left atrium is performed to measure left atrial voltage, which serves as an indirect marker of the presence of atrial fibrosis, strongly associated with CMA. Other parameters relevant to the identification of CMA can be assessed during this procedure, such as conduction velocities and specific electrographic characteristics.\n\nWe plan to include 150 patients undergoing ablation for persistent atrial fibrillation at the Dijon Bourgogne University Hospital and to correlate circulating levels of BDNF (brain-derived neurotrophic factor) with electroanatomical mapping data of the left atrium. The electrical remodeling of the left atrium, including low-voltage areas and conduction velocity, as well as left atrial morphology assessed by pre-procedural cardiac computed tomography using the ADAS3 Galgo LA Module software, will be correlated with BDNF levels. Blood samples for BDNF assessment will be collected before or at the start of the ablation procedure, prior to any catheter insertion into the vessels.\n\nWhile investigating the association between BDNF levels and CMA characteristics during AF ablation, thereby confirming the pathophysiological relationship with atrial remodeling, our objective is also to evaluate the prognostic role of BDNF levels in clinical and rhythm outcomes following AF ablation. Thus, we will compare changes in BDNF levels after AF ablation at one-year follow-up, correlating them with the evolution of CMA-based on left atrial parameters assessed by echocardiography or cardiac computed tomography-autonomic nervous system balance and heart rhythm obtained via Holter monitoring, as well as clinical outcomes.",[350,351,352,353,354],"Atrial Fibrillation (AF)","Cardiac Arrhythmia","Atrial Fibrillation Ablation","BDNF","Atrial Cardiomyopathy",{"date":300,"type":36},{"date":136,"type":20},{"date":358,"type":20},"2029-07",{"name":42,"class":43},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":367,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":44},"100537805","study-of-the-effect-of-rhythmic-and-non-rhythmic-musical-priming-on-the-syntax-capacity-of-presbyacoustic-older-adults-100537805","NCT06282601","STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS","AMORCAGE MUSIC","Inclusion Criteria:\n\n* No objection to participation in the study\n* Men and women aged ≥ 70 years\n* Patients diagnosed with presbyacusis (age-related bilateral and symmetrical sensorineural hearing loss, all stages combined), with or without the use of a bilateral hearing aid.\n* If they use a hearing aid: hearing must have an average free-field fitted tonal threshold of 40 dB max and free-field fitted speech discrimination without lip-reading of 90-100% at 60dB in silence.\n* MMSE score ≥ 24\u002F30\n\nExclusion Criteria:\n\n* Person under legal protection (curatorship, guardianship)\n* Person under court order\n* Adult unable to provide consent\n* Person with a neurocognitive disorder (post-stroke, dyslexia, dyspraxia) or neuro-psychiatric disorder (dementia, autism)\n* Severe sensorineural hearing loss with mean free-field threshold \\> 40 dB and free-field speech discrimination without lip-reading of \\\u003C 90-100% at 60dB in silence\n* Asymmetrical sensorineural hearing loss due to an additional cause of hearing loss on one side.\n\nSecondary exclusion criteria:\n\nPerson with syntax disorder (discovery of sentence comprehension or production disorders during syntax test)","70 Years",{"count":369,"type":20},55,[23],"Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.\n\nHowever, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.\n\nIn this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.\n\nThis study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children.",[373],"Presbyacousie","2026-06-09",{"date":376,"type":36},"2026-06-11",{"date":378,"type":36},"2025-08-02",{"date":380,"type":20},"2027-10",{"name":42,"class":43},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":389,"targetDuration":390,"studyType":104,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":44},"100640936","association-between-circulating-bdnf-levels-and-cardioembolic-strokes-in-patients-treated-for-ischemic-stroke-100640936","NCT07624396","Association Between Circulating BDNF Levels and Cardioembolic Strokes in Patients Treated for Ischemic Stroke","METAPROFIL 1","Inclusion Criteria:\n\n* Individuals who provided informed consent\n* Diagnosis of acute ischemic stroke confirmed by brain imaging (CT or MRI)\n* Patient admitted to the USINV of the Department of General, Vascular, and Degenerative Neurology at the Dijon Bourgogne University Hospital during the inclusion period\n* Underwent a combined cardiac and brain CT scan within 24 hours of admission for stroke\n\nExclusion Criteria:\n\n* A person subject to a legal protective measure (guardianship, conservatorship)\n* A person subject to a judicial safeguard measure\n* A pregnant woman, a woman who has recently given birth, or a breastfeeding woman\n* An adult who is legally incapacitated or unable to give consent,\n* A minor",{"count":347,"type":20},"36 Months","Atrial fibrillation (AF) is associated with serious complications, including embolic strokes, heart failure, and mortality. Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, increases the risk of thrombus formation. Once dislodged from the atrial cavity and traveling to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for atrial cardiomyopathy (ACM) and AF are metabolic syndrome and aging.\n\nACM is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, the investigators aim to address this challenge by examining ACM through the lens of one of its complications: cardioembolic stroke. BDNF (Brain-Derived Neurotrophic Factor) is a neurotrophic factor involved in inflammatory and metabolic processes that may play a key role in the development of these complications.\n\nThis study explores the association between circulating levels of BDNF and the morphological and metabolic characteristics of ACM, as assessed by cardiac and brain imaging studies",[393],"Acute Ischemic Stroke","2026-06-01",{"date":396,"type":36},"2026-06-03",{"date":398,"type":20},"2026-06",{"date":400,"type":20},"2031-06",{"name":42,"class":43},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":52,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":44},"100640031","olfactory-communication-in-the-first-days-of-life-from-chemical-mechanisms-to-improved-breastfeeding-100640031","NCT07616076","Olfactory Communication in the First Days of Life: From Chemical Mechanisms to Improved Breastfeeding","OD-ALL","Inclusion Criteria:\n\n* Regarding mothers:\n\n  * Individuals who have provided their consent (studies 1, 2, and 3) as well as that of their child (studies 1 and 3).\n  * Adults.\n  * Birth of a singleton newborn.\n  * Breastfeeding woman (studies 1 and 2).\n  * Absence of any infectious risk and any prior morbidity during pregnancy, childbirth, and breastfeeding (determined by medical staff).\n* Regarding newborns:\n\n  * Absence of medical problems during pregnancy, at delivery (full-term birth: 37-42 weeks of amenorrhea, Apgar score \\> 7 at 1 and 10 minutes; birth weight \\> 2500 g), or during the neonatal period.\n\nExclusion Criteria:\n\n* Regarding mothers:\n\n  * Any mother with an infectious disease (HIV, hepatitis A or B) or under special medical supervision.\n  * Mothers taking medication that may alter body odor (e.g., corticosteroids, progestins, antidepressants).\n  * Mothers who smoke.\n  * Mothers suffering from chronic (confirmed congenital anosmia) or acute impairments of the sense of smell (nasal congestion due to infection or allergy).\n  * Mothers subject to legal protective measures (guardianship, conservatorship).\n  * Mothers subject to judicial protective measures.\n* Regarding newborns:\n\n  * Any child who experienced medical problems during pregnancy, childbirth, or the neonatal period (Apgar score \\\u003C 7 at 1, 5, and 10 minutes).\n  * Congenital anosmia (if this information is noted in the medical record; for example, in cases of Du Morsier-Kallman syndrome).",{"count":410,"type":20},364,"For a newborn, locating and latching onto the mother's breast is the foundational social interaction. This pivotal moment not only influences the newborn's survival but also determines the mother's physiological (lactation) and psychological (attachment) engagement, as well as the long-term health of both the child and the mother. However, according to the WHO, three out of five newborns are not exclusively breastfed for the recommended 6 months, and several recent studies point to suboptimal rates of breastfeeding initiation in the maternity ward, partly due to difficulties with oral latching, insufficient sucking, or refusal of the breast. This situation compromises the initial intake of colostrum\u002Fmilk, as well as the establishment of early emotional bonds. A wealth of research data from biology, psychology, and pediatrics shows that neonatal and maternal sensory experiences play a central role in the initiation of breastfeeding. However, our understanding of the sensory and behavioral mechanisms at play remains unclear. While visual and auditory interactions have been extensively documented, other sensory modalities-touch, chemoreception, and kinesthesia-remain largely overlooked, even though their critical role has been documented in other mammals. The inves will focus on the role of olfaction in organizing the adaptive responses of the newborn to the mother's breast and of the mother to her baby.\n\nA wealth of research data from biology, psychology, and pediatrics shows that neonatal and maternal sensory experiences play a central role in the initiation of breastfeeding. However, our understanding of the sensory and behavioral mechanisms involved remains unclear. While visual and auditory interactions have been extensively documented, other sensory modalities-touch, chemoreception, and kinesthesia-have received little attention, even though their critical role has been documented in other mammals. Here, the investigators will focus on the role of olfaction in organizing the adaptive responses of the newborn to the mother's breast and of the mother to her baby.\n\nResearch data in humans show that: 1) several mammary secretions (colostrum\u002Fmilk, areolar secretions) emit odorous compounds, and 2) newborns respond to them in a stereotypical and repeatable manner. These odors, which are specific to the mammary gland, serve to facilitate the very first mother-infant interactions. However, the source of these odorous compounds remains unclear, and their chemical nature is unknown. Without precise chemical identification, it is difficult to fully understand the mechanisms by which odors influence the newborn's behavior toward the mother's breast at the start of breastfeeding. Conversely, the newborn's body odors could also convey information about its emotional or metabolic state and influence maternal motivation and behavior.\n\nBased on research conducted on other mammals, as well as studies focused on our own species, the investigators know that: 1) postpartum mothers are highly receptive to the body odor of their newborns, and 2) newborns emit odor compounds that are appreciated by mothers (even if the infants are not their own) . It cannot therefore be ruled out that human mothers react, even unconsciously, to these infant odors and that these odors could help regulate maternal psychophysiology (particularly that underlying lactation and the related chemocommunication mechanisms).\n\nThe OD-ALL project aims to unravel the chemical basis of the olfactory interactions that lead to the establishment of the breastfeeding relationship between each member of the mother-newborn dyad. To this end, the investigators will apply an innovative technology, proton transfer reaction time-of-flight mass spectrometry (PTR-ToF-MS), which has previously been used to monitor volatile organic compounds (VOCs) in the environment. Unlike conventional techniques (such as gas chromatography coupled with mass spectrometry; GC-MS), which allow only sporadic and somewhat disruptive measurements, PTR-ToF-MS records odor emissions in real time, without any disruption to the natural interactions taking place. It is capable of providing a true \"chemical video\" of the dynamic variations in VOCs of mammary or infant origin (whereas conventional GC-MS provides only a \"chemical snapshot\"). These fluctuations can thus be correlated with the behaviors and physiological responses of mothers and newborns, which will be recorded concurrently. This approach opens up entirely new avenues for understanding the chemosensory foundations of early human interactions, particularly those that occur during the initiation of breastfeeding. Alongside this fundamental approach, the OD-ALL project aims to raise awareness among healthcare professionals, the general public and health policy makers regarding the role of smell in early interactions between mother and newborn.",[413,414,415],"Mother Who Has Given Birth to a Singleton Newborn","Mother-newborn Dyad","Singleton Newborn","2026-05-26",{"date":418,"type":36},"2026-05-29",{"date":420,"type":20},"2026-05",{"date":422,"type":20},"2032-05",{"name":42,"class":43},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":167,"enrollmentInfo":432,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":44},"100549131","study-of-the-value-of-hpg80-circulating-progastrin-for-the-diagnosis-of-neuroendocrine-tumours-in-patients-with-an-men1-mutation-100549131","NCT06430021","Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an MEN1 Mutation","Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an NEM1 Mutation: the Progastrin-NEM1 Study","PRO-NEM1","Inclusion Criteria:\n\n* Patients with proven MEN1, symptomatic or not, confirmed on the basis of the following international criteria (Thakker et al.):\n* patients with an MEN1 mutation;\n* patients belonging to an identified MEN1 family in which at least one first-degree relative has been affected and has at least one MEN1-related lesion;\n* patients without a positive genetic test or a family history of the disease, but with at least two of the three main MEN1 lesions (parathyroid adenomas, duodenopancreatic NETs and pituitary tumours).\n* Majors patients,\n* Patients who have undergone thoracoabdominal imaging (MRI, and\u002For CT and\u002For somatostatin receptor imaging (PET or octreotide scan)) within 3 months prior to inclusion or are due to undergo imaging within 3 months of inclusion to document the presence of NETs,\n* Regardless of the treatment they are receiving (treatment naïve or treated patient),\n* Regardless of the type of disease associated with MEN1 (presence or absence of NET, adenoma....),\n* Patients who did not object to taking part in the study.\n\nExclusion Criteria:\n\n* Person not affiliated to national health insurance\n* Person subject to a measure legal protection (curatorship, guardianship, family empowerment) or a court order\n* Pregnant, parturient or breastfeeding mothers",{"count":433,"type":20},297,"Multiple Endocrine Neoplasia type 1 (MEN1) is an autosomal dominant disease with a high degree of penetrance (\\>80% of patients). It is caused by the presence of the MEN1 mutation located on chromosome 11q13. The prevalence of this mutation is estimated at approximately 1\u002F30,000. This hereditary syndrome is characterized by the presence of tumours of the endocrine system (adenoma of the parathyroid, pituitary and adrenal glands, neuroendocrine tumors - NETs - of the endocrine pancreas, duodenum, lung or thymus), which threaten the health of these patients. Other malignant tumors such as breast cancer are also more common in patients with MEN1.\n\nThe clinical manifestations of MEN1 are linked to the location of the adenomas and NETs and their secretory products. Indeed, most NETs produce and secrete numerous peptide hormones (in the case of Insulinomas, Gastrinomas, VIPomas, Glucagonomas or PPomas for example). This causes a specific clinical syndrome, which can be detected in the blood serum. However, most NETs are \"non-functional\" tumors, which do not have specific secretions.\n\nAmong general tumor markers, chromogranin A (CgA) is widely used as a biomarker for monitoring NETs. CgA is a secretory protein released into the blood by neuroendocrine cells. However, the performance of CgA as a diagnostic biomarker is too limited to be used for the early identification of NETs, particularly in patients with MEN1.\n\nThis is why patients with MEN1 undergo regular biological and morphological examinations, at least once a year, to screen for the development of adenomas and NETs. However, CgA or hormone secretions assays, and imaging examinations (MRI, CT scan, or duodenopancratic endoscopic ultrasound (EUS)) are tedious and stressful for patients; in addition, they all have their limitations (poor performance for biological tests; irradiation for CT scan; need for anesthesia for endoscopic ultrasound, etc.). Consequently, there is a need for new markers to identify NETs in this population as early as possible.\n\nProgastrin is a pro-hormone that, under physiological conditions, is matured into gastrin in the G cells of the antrum of the stomach. The role of gastrin is to stimulate gastric acid secretion during digestion. It also plays an important role in regulating cell growth in the gastric mucosa. In pathological situations, it has been shown that the GAST gene, which codes for progastrin, is over-expressed in human tumor cells of different origins, leading to the accumulation of progastrin within them. Tumor cells that are unable to mature progastrin into gastrin, either because the maturation enzymes are not expressed or are inhibited, will secrete it. This circulating progastrin is then called hPG80 (to differentiate it from intracellular progastrin) and is detectable in patient blood. hPG80 is a new biomarker for the detection of different types of cancer. It appears to be elevated in the early stages of the disease, potentially more so than other biomarkers such as circulating tumor DNA (ctDNA) or NETest. In addition, hPG80 is easily measured in plasma using the DxPG80.Lab ELISA (Progastrin Manufacturing). The analytical characteristics of this CE-marked in vitro diagnostic test have been published in the Analytical Methods journal. It has been validated in numerous studies of various cancers, including NET patients. In addition, a study conducted by the team at Progastrin Manufacturing (formerly ECS-Progastrin) showed that hPG80 was unequivocally present in the peripheral blood of patients with 11 different types of cancer, with a concentration significantly higher than that found in blood donors considered to be healthy. We therefore hypothesize that hPG80 could also be a biomarker for NETs in MEN1.",[436,437],"Neuroendocrine Tumors","MEN1 Mutation","2026-05-20",{"date":440,"type":36},"2026-05-22",{"date":442,"type":36},"2024-06-13",{"date":444,"type":20},"2026-12",{"name":42,"class":43},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":454,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":44},"100575789","phase-1-a-study-evaluating-24-months-of-lithium-carbonate-treatment-in-patients-with-tbr1-related-neurocognitive-disorder-100575789","NCT06776848","A Study Evaluating 24 Months of Lithium Carbonate Treatment in Patients With TBR1-related Neurocognitive Disorder","A Pilot, Multicentre, Controlled, Open-label Study Evaluating 24 Months of Lithium Carbonate Treatment in Patients With TBR1-related Neurocognitive Disorder","ESALIT","Inclusion Criteria:\n\n* Written informed consent from the patient, parent or legal representative\n* ≥6 years old at the time of consent\n* Proven pathogenic or probably pathogenic TBR1 variant (SNV confirmed by Sanger sequencing or CNV including only TBR1)\n* If applicable: Stable concomitant psychoactive medication regimen (dose and schedule) ≥2 months prior to lithium initiation\n* Affected individuals able to take tablet \u002Fcapsules orally\n* Highly effective method of contraception in affected female individuals of childbearing age (Combined hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system or abstinence) during treatment and for at least 3 months after the final dose of lithium\n* Highly effective method of contraception in affected men individuals of childbearing age (condom or abstinence) during the treatment and for at least 5 days after the final dose of lithium\n* 1 available parent\u002Fguardian able to attend all visits having acceptable reading skills\n\nExclusion Criteria:\n\nCriteria related to associated pathologies leading to particular risks:\n\n* Renal\u002Fliver insufficiency (disturbed liver function, abnormal creatinine clearance)\n* Unbalanced thyroid or diabetic pathology\n* Long QT\u002FBrugada syndrome or familial antecedent of Brugada syndrome, cardiac insufficiency\n* Addison disease, dehydration, sodium restriction\n* Non-stabilized epileptic disease.\n\nCriteria related to contra-indication to treatment:\n\n* Patient with concomitant diseases for which the experimental treatment by lithium could alter the tolerance\n* Hypersensitivity to lactose, lithium or one of its excipients\n* Patient with a wheat allergy (other than celiac disease)\n* Pregnant or breastfeeding woman\n\nCriteria related to treatments\u002Fprocedures:\n\n* Parent\u002Fguardian incapable of expressing consent\n* Person not affiliated to a national health insurance scheme\n* Person subject to a court order\n* Cognitivo-behavioural therapy focused on ASD in 6 weeks previous to inclusion\n* Other genetic pathogenic variant associated to neurocognitive disorders\n* Any introduction of psychotropic molecules within 2 months prior to the trial, including neuroleptics, monoamine oxidase inhibitors, stimulants, antidepressants.\n* Concomitant use of Angiotensin-Converting Enzyme (ACE) inhibitor, angiotensin II receptor antagonists, Nonsteroidal anti-inflammatory drugs, diuretics.\n* Current lithium treatment\n* Severe behavioural disorder or refusal to take drug treatment not allowing for compliance with medication;\n* Impossibility to perform blood tests to check the lithiaemia when the patient is included.\n* Participation in another therapeutic trial","6 Years",{"count":456,"type":20},12,[458,459],"PHASE1","PHASE2","TBR1 is a human gene encoding a brain-specific transcription factor, principally expressed in the excitatory neurons of the neocortex. It regulates development of axonal projection and expression of numerous genes involved in autism spectrum disorders (ASD) and intellectual disability (ID). Recent progress in detection and analysis of rare variants allowed to identify group of genes with strong statistical evidence for association with ASD risk, of which TBR1. Numerous studies on mice showed that TBR1 heterozygous mice display autistic traits as deficiencies in social interaction, in cognitive flexibility, and in associative memory. Functional analyses on human cell lines have demonstrated that de novo truncating variants in TBR1 identified in patients with sporadic ASD disrupt transcriptional repression activity, localization, homodimerization of TBR1 product.\n\nIn 2019, only 12 single nucleotide variants (SNVs) and few copy number variations (CNVs) involving TBR1 have been reported in the literature and clinical descriptions were poor. To provide details on the phenotype linked to TBR1 mutations, we and others gathered 25 new individuals with de novo TBR1 SNV and CNV, complemented by a review of individuals previously reported in the literature. On 38 individuals, all presented developmental delay (DD)\u002FID, ranging from mild to severe, and 76% of them presented autistic traits. Additional behaviour disorders were observed in 85% of individuals, mainly attention deficit and aggressive behaviour. However, the natural history of patients with TBR1 variations is not well known.\n\nDevelopment of RNA-Seq allowed a better understanding of its transcription factor role and revealed that Tbr1 promotes expression of layer 6 markers as Wnt7b. In heterozygous and homozygous TBR1 mutant mice, Fazel Darbandi et al (1), observed that Wnt7b expression is reduced in cortical layer 6 and that neurons have reduced excitatory and inhibitory synaptic density. They showed that lithium chloride and lithium carbonate, WNT-signalling agonists, rescue the dendritic spines, the synaptic and the axonal defects in Tbr1layer5, Tbr1layer6 and Tbr1 constitutive (Tbr1+\u002F-) mutant mice. They also observed an improvement of social interactions in mice after treatment by lithium. These results suggest an important and novel biological mechanism underlying ASD that may have implications for the treatment of patients with TBR1 variants.\n\nMoreover, lithium treatment has already been evaluated in patients with neurocognitive disorders not linked to TBR1 showing an improvement in the adaptative behaviour and cognition function.\n\nAs of today, only symptomatic treatments are available. As lithium increase neuronal activity in mice, and may thus improve the symptoms of this disorder, we propose a clinical trial to study the security and efficacy of lithium carbonate targeting the patients with TBR1-related disorders, with specific and adapted endpoints. Lithium carbonate treatment will be administered after an observation period of 6 to 12 months, allowing to ascertain the stability of neurocognitive abnormalities.",[462],"Proven Pathogenic or Probably Pathogenic TBR1 Variant","2026-05-19",{"date":440,"type":36},{"date":466,"type":36},"2025-09-12",{"date":468,"type":20},"2027-09-12",{"name":42,"class":43},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":21,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":489,"locationsCount":44},"100531256","phase-3-investigate-the-efficacy-of-chemotherapy-in-patients-with-positive-ctdna-after-surgery-and-adjuvant-chemotherapy-for-a-stage-iii-colorectal-cancer-100531256","NCT06197425","Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer","Phase III Multicentric, Open-label, Randomized Study to Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer (PRODIGE 88)","CIRCULATE PAC","Inclusion Criteria:\n\n* Fully resected stage III or high-risk stage II colon or upper rectum adenocarcinoma previously treated by standard adjuvant chemotherapy or peri-operative chemotherapy (FOLFOX or CAPOX) for either 3 or 6 months based on local multidisciplinary meeting, and on TNCD recommendations\n* Positive ctDNA screening (methylation) and confirmation (NGS) on samples collected at the 3- or 6 months follow-up visit post-adjuvant chemotherapy\n* Patients ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is \\>14 for patients 70 years or older)\n* Subjects with WHO performance status \\\u003C 2\n* No documented disease using TAP CT-scanner and liver MRI in the case of contra-indication to dye contrast (or TEP-scanner may be also used in addition depending on physicians' choice and local availabilities).\n* Adequate haematological function: with neutrophils ≥ 1,500 \u002Fmm3, platelet count ≥ 100,000\u002Fmm3, hemoglobin ≥ 9 g\u002FdL (5,6 mmol\u002Fl)\n\nTotal bilirubin ≤ 1.5 x ULN (upper limit of normal) ASAT and ALAT ≤ 2.5 x ULN Alkaline phosphatase ≤ 2.5 x ULN Creatinine clearance ≥50 ml\u002Fmin according MDRD (Modification of Diet in Renal Disease)\n\n* Available tumor sample for NGS analysis\n* Signed written informed consent obtained prior to any study specific procedures\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Patients already treated with trifluridine tipiracil or irinotecan in the past 5 years\n* Uncontrolled intercurrent illness\n* Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 3 years\n* Pregnant or breastfeeding women, women of childbearing age not having had a negative pregnancy test\n* Any known specific contraindication or allergy to the treatments used in the study†\n* Total or partial dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia \\> 16ng\u002Fml)\n* Known Gilbert's disease (UGT1A1\\*28 genotype)\n* In case of concomitant use with St John's Wort related to irinotecan\n* In case of bowel obstruction according related to irinotecan\n* In case of recent concomitant treatment with brivudine, related to fluorouracil.\n* Participation to another interventional study for postoperative therapy\n* Persons deprived of liberty or under guardianship or incapable of giving consent\n* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.","80 Years",{"count":480,"type":20},1660,[81],"Phase III multicentric, open-label, randomized study\n\nThe main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma",[484],"Colon or Upper Rectum Adenocarcinoma",{"date":440,"type":36},{"date":487,"type":36},"2026-05-07",{"date":422,"type":20},{"name":42,"class":43},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":44},"100562810","influence-of-olfacto-gustatory-sensoriality-on-the-nutritional-status-of-patients-with-amyotrophic-lateral-sclerosis-100562810","NCT06608004","Influence of Olfacto-gustatory Sensoriality on the Nutritional Status of Patients With Amyotrophic Lateral Sclerosis","GOUSLA","Inclusion Criteria:\n\nInclusion criteria\\*:\n\n* Incident cases of definite or probable ALS according to El-Escorial criteria (3) followed up at the participating regional centre of competence\n* Patient aged over 18\n* Patient fluent in French\n* Patient having given oral consent\n\nExclusion Criteria:\n\n* Patients with an acute infection undergoing antibiotic treatment at the time of inclusion\n* Patients with psychiatric, cognitive or neurological disorders making it impossible to assess food preferences\n* Patient with a known food allergy\n* Patients with excessive alcohol consumption (≥ 10 standard drinks per week)\n* Patients who have stopped smoking for less than 1 month\n* Patients with severe bulbar involvement from the outset, preventing swallowing, patients with aphagia or patients eating exclusively via a gastrostomy\n* Patient with severe diaphragmatic impairment requiring NIV from the outset\n* Person not affiliated to or not benefiting from a social security scheme\n* Person under legal protection (curatorship, guardianship)\n* Persons subject to a legal protection measure\n* Pregnant women, women in labour or breastfeeding mothers\n* An adult who is incapable or unable to give consent\n* Minors",{"count":498,"type":20},60,"Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterised by progressive diffuse muscular paralysis due to the inexorable loss of motor neurons in the primary motor cortex, the corticospinal tract, the brain stem and the spinal cord.\n\nOver the course of the disease, when the phrenic motor neurons are involved, diaphragmatic weakness develops, leading to restrictive respiratory failure, which is the main cause of morbidity and mortality. Non-invasive ventilation (NIV) compensates for diaphragm failure and corrects the associated symptoms, and has been shown to prolong patient survival and improve quality of life.\n\nUndernutrition is another recognised prognostic factor. Several mechanisms have been described, foremost of which are a state of hypermetabolism and a reduction in food intake secondary to chewing difficulties, dysphagia, a loss of dexterity in the upper limbs, a disturbance in salivary secretion or psychological disorders. In addition, diaphragmatic dysfunction plays a direct role in the onset of undernutrition, as compensatory contraction of the accessory neck muscles increases resting energy expenditure.\n\nHowever, the hedonic sensations triggered by a meal play a role in controlling food intake beyond the simple energy balance between calorie intake and energy expenditure. Olfacto-gustatory sensoriality could therefore play a role in the nutritional status of patients suffering from ALS.\n\nDiaphragmatic dysfunction may also influence nutritional status by other mechanisms. For example, the reduction in inspiratory capacity associated with diaphragmatic insufficiency reduces olfaction in a group of tetraplegic patients. Central sensory impairment could exacerbate this phenomenon. Although it is conventionally considered that there are no sensory manifestations during the course of ALS, minor but diffuse abnormalities of the nerves and sensory action potentials have been observed. A central alteration in olfacto-gustatory sensoriality could be part of the neurological manifestations of ALS. In addition, olfactory deficits occur in other neuromuscular diseases with central involvement, such as myasthenia, Parkinson\\'s or Alzheimer\\'s disease, in the absence of concomitant cognitive or diaphragmatic impairment.\n\nOur hypothesis is that impaired olfacto-gustatory function favours the onset of undernutrition in ALS.\n\nCurrent nutritional management consists of ensuring adequate calorie intake by prescribing oral food supplements or inserting a gastrostomy. Taking personalised account of food preferences during dietary advice or of a potential olfacto-gustatory deficit, by reinforcing smells or tastes during food consumption, would be an interesting additional therapeutic avenue for improving patients\\' nutritional status, quality of life and prognosis",[501],"Amyotrophic Lateral Sclerosis (ALS)","2026-05-13",{"date":504,"type":36},"2026-05-15",{"date":506,"type":36},"2026-05-12",{"date":508,"type":20},"2029-05-12",{"name":42,"class":43},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":21,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":44},"100510103","use-of-ultrasound-for-early-identification-of-patients-at-risk-of-swallowing-disorders-acquired-in-the-icu-100510103","NCT05922085","Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU","EIDAR","Inclusion Criteria:\n\nPatient:\n\n* Major (≥18)\n* On mechanical ventilation for at least 48 hours\n* Affiliated to national health insurance\n\nExclusion Criteria:\n\nPatient:\n\n* Under legal protection (curatorship, guardianship, safeguard of justice)\n* Pregnant, parturient or breastfeeding woman\n* Refusal to participate by the patient or their proxy (or an immediate family member)\n* Cognitive disorders incompatible with the understanding of instructions\n* Previously diagnosed swallowing disorders\n* With a neurological condition at the origin of the SD (stroke, ALS...)\n* Treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy)\n* presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements\n* Patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit\n* With one or more contraindications to performing NF:\n\n  * Anatomical features not compatible with NF: mainly deviation of the nasal septum.\n  * Risk of significant otorhinolaryngological bleeding",{"count":148,"type":20},[23],"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.\n\nVideofluoroscopy (VFS) and nasofibroscopy (NF) are the gold standard examinations for diagnosing SD. However, these two examinations are not feasible in intubated patients.\n\nIn 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.\n\nThe objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting SD after extubation.\n\nThis 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.",[521],"Patient Under Mechanical Ventilation","2026-05-06",{"date":506,"type":36},{"date":525,"type":36},"2023-11-09",{"date":527,"type":20},"2027-06",{"name":42,"class":43},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":478,"enrollmentInfo":537,"targetDuration":4,"studyType":21,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":549,"locationsCount":44},"100636561","a-study-using-human-abdominal-adipose-tissue-biopsies-to-characterize-the-role-of-endocannabinoids-in-adipocyte-differentiation-100636561","NCT07567287","A Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation","A Basic Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation","ECTADIF","Inclusion Criteria:\n\n* Control group :\n\n  * Men or postmenopausal women aged 18 to 80\n  * Individuals who have provided their free and informed written consent\n  * Individuals scheduled to undergo abdominal surgery\n* Non-diabetic obese individuals :\n\n  * Men or postmenopausal women aged 18 to 80\n  * BMI \\> 30 - Individuals who have provided written, free, and informed consent\n  * Scheduled to undergo abdominal surgery\n* Obese individuals with diabetes :\n\n  * Men or postmenopausal women aged 18 to 80 with type 2 diabetes not treated with insulin or a GLP-1 agonist\n  * BMI \\> 30\n  * Individuals who have provided written, free, and informed consent and are scheduled to undergo abdominal surgery\n\nExclusion Criteria :\n\n* Control group :\n\n  * Individuals not enrolled in or eligible for a social security program\n  * Individuals subject to legal guardianship (curatorship, guardianship)\n  * Individuals subject to judicial protective measures\n  * Pregnant women, women in labor, or breastfeeding women\n  * Adults who are legally incapacitated or unable to give consent\n  * Minors\n  * BMI \\> 30\n  * Diabetes\n  * Chronic inflammatory disease\n  * Cancer undergoing chemotherapy or having undergone chemotherapy within the past year\n  * Gastrointestinal cancer with recent weight loss and\u002For malnutrition\n  * Known metastatic cancers\n  * Cancers undergoing long-term hormonal therapy\n  * Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen testing, or testing for antibodies against the hepatitis C virus (HCV) with a positive HCV RNA test.\n* Non-diabetic obese individuals :\n\n  * Individuals not enrolled in or eligible for a social security program\n  * Individuals subject to legal guardianship (curatorship, guardianship)\n  * Individuals subject to judicial protective measures\n  * Pregnant women, women in labor, or breastfeeding women\n  * Adults who are legally incapacitated or unable to give consent\n  * Minors\n  * Diabetes\n  * Chronic inflammatory disease\n  * Cancer undergoing chemotherapy or having undergone chemotherapy within the past year\n  * Gastrointestinal cancer with recent weight loss and\u002For malnutrition\n  * Known metastatic cancers\n  * Cancers undergoing long-term hormonal therapy,\n  * Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or antibodies to hepatitis C virus (HCV) with a positive HCV RNA test.\n* Obese individuals with diabetes\n\n  * Individuals not enrolled in or not eligible for a social security program\n  * Individuals subject to legal guardianship (curatorship, guardianship)\n  * Individuals subject to judicial protective measures\n  * Pregnant women, women in labor, or breastfeeding women\n  * Adults who are legally incapacitated or unable to give consent\n  * Minors\n  * Diabetes\n  * Chronic inflammatory disease\n  * Cancer undergoing chemotherapy or having undergone chemotherapy within the past year\n  * Gastrointestinal cancer with recent weight loss and\u002For malnutrition\n  * Known metastatic cancers\n  * Cancers undergoing long-term hormonal therapy,\n  * Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or antibodies against hepatitis C virus (HCV) with a positive HCV RNA test.",{"count":538,"type":20},30,[23],"Abdominal obesity and type 2 diabetes are associated with hyperactivation of the endocannabinoid system. Several animal and human studies indicate that circulating endocannabinoid levels correlate with body fat mass. Thus, adipose tissue, which possesses the enzymatic machinery of the endocannabinoid system, may be the primary producer of plasma endocannabinoids.\n\nToday, it is well established that stimulation of the endocannabinoid system, through the activation of cannabinoid receptor 1 (CB1R) located in the brain, leads to increased food intake and weight gain. Furthermore, peripheral CB1R present in adipose tissue are also directly involved in energy storage processes. Indeed, activation of the endocannabinoid system in adipose tissue is associated with stimulation of pathways leading to the uptake of carbohydrates and fatty acids, as well as their storage in the form of triglycerides.\n\nAdipose tissue consists primarily of mature adipocytes, and activation of the endocannabinoid system appears to play a key role in increasing fat mass by promoting the hypertrophy of these adipocytes through the stimulation of lipogenesis. However, the vascular stromal fraction also contains stem cells capable of generating new adipocytes, and an autocrine action of endocannabinoids on progenitor cells could also contribute to its expansion by promoting hyperplasia.\n\nThat is why, in this project, the investigators aim to study the impact of endocannabinoids on the differentiation of stem cells from the stromal-vascular fraction into adipocytes. In particular, the investigators will seek to compare the impact of endocannabinoids on the differentiation capacity of stem cells derived from adipose tissue collected from patients with obesity, with or without diabetes, compared to controls.\n\nThese data, combined with those obtained in parallel in mice, could help determine whether adipose tissue (visceral and\u002For subcutaneous) is a priority target for the development of CB1R-blocking molecules (such as rimonabant) with exclusively peripheral action (which do not cross the blood-brain barrier to avoid psychiatric side effects) for the treatment of metabolic obesity and type 2 diabetes.",[542],"Differenciation of Stromal-vascular Fraction Cells","2026-05-05",{"date":545,"type":36},"2026-05-08",{"date":398,"type":20},{"date":548,"type":20},"2028-06",{"name":42,"class":43},""]