[{"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:":545},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,95,0,25,[9,40,66,90,109,127,144,165,187,207,230,253,277,298,318,337,358,379,399,419,441,461,482,502,523],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053531","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-100053531",false,"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","ALL","18 Years",{"count":21,"type":22},50,"ESTIMATED","OBSERVATIONAL","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.",[26],"Ascending Aortic Aneurysm","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2026-06-28",{"date":35,"type":22},"2029-08",{"name":37,"class":38},"Centre Hospitalier Universitaire Dijon","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":39},"100644980","evaluation-of-the-effectiveness-of-ultrasound-guided-stellate-ganglion-block-in-cardiac-surgery-anesthesia-on-postoperative-recovery-a-multicenter-randomized-double-blind-trial-100644980","NCT07676487","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":48,"type":22},250,"INTERVENTIONAL",[51],"NA","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.",[54,55,56],"Undergo Elective Cardiac Surgery","Cardiopulmonary Bypass","CPB","NOT_YET_RECRUITING","2026-06-24",{"date":60,"type":31},"2026-06-30",{"date":62,"type":22},"2026-07",{"date":64,"type":22},"2028-02",{"name":37,"class":38},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":18,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"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":77,"type":22},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.",[80],"Newborn Screening Programmes for Rare Diseases","2026-06-16",{"date":83,"type":31},"2026-06-17",{"date":85,"type":31},"2025-05-05",{"date":87,"type":22},"2032-07",{"name":37,"class":38},5,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":49,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":39},"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":98,"type":22},200,[51],"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.",[102],"Cardiac Amyloidosis","2026-06-15",{"date":81,"type":31},{"date":62,"type":22},{"date":107,"type":22},"2028-07",{"name":37,"class":38},{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":39},"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":117,"type":22},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.",[120],"Developmental Abnormality",{"date":83,"type":31},{"date":123,"type":31},"2022-03-28",{"date":125,"type":22},"2029-03",{"name":37,"class":38},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":143,"locationsCount":39},"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":135,"type":22},100,"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.",[138],"Patient Scheduled for Surgery","2026-06-10",{"date":103,"type":31},{"date":62,"type":22},{"date":107,"type":22},{"name":37,"class":38},{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":162,"leadSponsor":164,"locationsCount":39},"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":152,"type":22},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.",[155,156,157,158,159],"Atrial Fibrillation (AF)","Cardiac Arrhythmia","Atrial Fibrillation Ablation","BDNF","Atrial Cardiomyopathy",{"date":103,"type":31},{"date":62,"type":22},{"date":163,"type":22},"2029-07",{"name":37,"class":38},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":172,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":49,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":39},"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":174,"type":22},55,[51],"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.",[178],"Presbyacousie","2026-06-09",{"date":181,"type":31},"2026-06-11",{"date":183,"type":31},"2025-08-02",{"date":185,"type":22},"2027-10",{"name":37,"class":38},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":194,"targetDuration":195,"studyType":23,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":39},"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":152,"type":22},"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",[198],"Acute Ischemic Stroke","2026-06-01",{"date":201,"type":31},"2026-06-03",{"date":203,"type":22},"2026-06",{"date":205,"type":22},"2031-06",{"name":37,"class":38},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":214,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":39},"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).",true,{"count":216,"type":22},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.",[219,220,221],"Mother Who Has Given Birth to a Singleton Newborn","Mother-newborn Dyad","Singleton Newborn","2026-05-26",{"date":224,"type":31},"2026-05-29",{"date":226,"type":22},"2026-05",{"date":228,"type":22},"2032-05",{"name":37,"class":38},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":39},"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","60 Years",{"count":240,"type":22},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.",[243,244],"Neuroendocrine Tumors","MEN1 Mutation","2026-05-20",{"date":247,"type":31},"2026-05-22",{"date":249,"type":31},"2024-06-13",{"date":251,"type":22},"2026-12",{"name":37,"class":38},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":261,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":49,"phases":264,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":39},"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":263,"type":22},12,[265,266],"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.",[269],"Proven Pathogenic or Probably Pathogenic TBR1 Variant","2026-05-19",{"date":247,"type":31},{"date":273,"type":31},"2025-09-12",{"date":275,"type":22},"2027-09-12",{"name":37,"class":38},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":49,"phases":288,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":297,"locationsCount":39},"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":287,"type":22},1660,[289],"PHASE3","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",[292],"Colon or Upper Rectum Adenocarcinoma",{"date":247,"type":31},{"date":295,"type":31},"2026-05-07",{"date":228,"type":22},{"name":37,"class":38},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":39},"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":306,"type":22},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",[309],"Amyotrophic Lateral Sclerosis (ALS)","2026-05-13",{"date":312,"type":31},"2026-05-15",{"date":314,"type":31},"2026-05-12",{"date":316,"type":22},"2029-05-12",{"name":37,"class":38},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":49,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":39},"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":135,"type":22},[51],"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.",[329],"Patient Under Mechanical Ventilation","2026-05-06",{"date":314,"type":31},{"date":333,"type":31},"2023-11-09",{"date":335,"type":22},"2027-06",{"name":37,"class":38},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":214,"sex":18,"minAge":19,"maxAge":285,"enrollmentInfo":345,"targetDuration":4,"studyType":49,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":355,"leadSponsor":357,"locationsCount":39},"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":346,"type":22},30,[51],"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.",[350],"Differenciation of Stromal-vascular Fraction Cells","2026-05-05",{"date":353,"type":31},"2026-05-08",{"date":203,"type":22},{"date":356,"type":22},"2028-06",{"name":37,"class":38},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":214,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":39},"100636366","the-effect-of-improved-glycemic-control-on-the-composition-and-function-of-high-density-lipoproteins-hdl-in-patients-with-type-1-diabetes-100636366","NCT07564752","The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes","Effect of Improved Glycemic Control on the Composition and Function of High-density Lipoproteins (HDL) in Patients With Type 1 Diabetes: a Prospective, Single-center Study. Comparison With Non-diabetic, Non-dyslipidemic Control Subjects. - HAGI-T1D Study","HAGI-T1D","Inclusion Criteria:\n\nControl group non-diabetic and non-dyslipidemic :\n\n* A person who has giver written consent\n* Fasting blood glucose \\\u003C 1,10 g\u002FL\n* Triglycerides \\\u003C 1,50 g\u002FL (\\\u003C 1,70 mmol\u002FL).\n* HDL cholesterol \\> 1,03 mmol\u002FL (men) or \\> 1,30 mmol\u002FL (women).\n* LDL cholesterol \\\u003C 1,60 g\u002FL.\n\nType 1 diabetes group :\n\n* A person who has giver written consent\n* Treated type 1 diabetes (regardless of the route of insulin administration).\n* HbA1c \\> 8.0% (\\> 64 mmol\u002Fmol).\n\nExclusion Criteria:\n\nAll participants :\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, tutorship)\n* A person subject to a judicial protective measure\n* Pregnant women, women in labor, or breastfeeding women\n* Adults who are legally incompetent or unable to give informed consent\n* Minors\n* Systemic inflammatory disease\n* Medications that affect lipoprotein metabolism: immunosuppressive therapy, long-term corticosteroid therapy.\n\nControl group non-diabetic and non-dyslipidemic :\n\n* Diabetes or use of an antidiabetic medication.\n* Dyslipidemia or use of lipid-lowering medication.\n* Cardiovascular disease (history of stroke, myocardial infarction, coronary artery disease).\n* Kidney disease (glomerular filtration rate CKD-EPI \\\u003C 75 mL\u002Fmin\u002F1.73 m²)\n* Presence of metabolic syndrome defined by the presence of at least three of the following criteria (NCEP-ATP III criteria):\n\n  * waist circumference \\> 102 cm in men, \\> 88 cm in women;\n  * fasting triglycerides \\> 1.70 mmol\u002FL ( \\> 1.50 g\u002FL);\n  * HDL cholesterol \\> 1.03 mmol\u002FL in men and 1.29 mmol\u002FL in women;\n  * systolic blood pressure ≥ 130 mmHg and\u002For diastolic blood pressure ≥ 85 mmHg;\n  * fasting blood glucose ≥ 6.10 mmol\u002FL (≥ 1.10 g\u002FL).\n\nType 1 diabetes group:\n\n* Diagnosis of type 1 diabetes within 12 months prior to enrollment.\n* Glomerular filtration rate (CKD-EPI) \\\u003C 60 mL\u002Fmin\u002F1.73 m².\n* Albuminuria ≥ 30 mg\u002Fg creatinine.\n* Initiation of lipid-lowering therapy within the month prior to the study.\n\nExclusion criteria:\n\nType 1 diabetes group:\n\n\\- Initiation of lipid-lowering therapy during the 3 months of the study",{"count":367,"type":22},143,"The HAGI-T1D study aims to determine the effect of improved glycemic control on the composition and function of high-density lipoproteins (HDL) in patients with type 1 diabetes (T1D). It requires the establishment of a biological plasma\u002Fserum bank.\n\nT1D patients hospitalized in the Endocrinology-Diabetology-Metabolic Diseases Department at the Dijon Bourgogne University Hospital for poorly controlled diabetes (defined by glycated hemoglobin HbA1c \\>8.0%).\n\nThe study includes a T1D group of 80 patients with unsatisfactory glycemic control, who will undergo intensified therapy in accordance with standard clinical practice (modification of insulin therapy, therapeutic education, and lifestyle and dietary guidelines). The study also includes a control group of 63 non-diabetic, non-dyslipidemic subjects enrolled based on the results of laboratory tests from the screening visit to assess whether improved glycemic control in the T1D group restores anti-atherogenic functions and HDL composition to a level comparable to that of the control group.",[370],"Type 1 Diabetes","2026-04-29",{"date":373,"type":31},"2026-05-04",{"date":375,"type":31},"2025-02-25",{"date":377,"type":22},"2027-11",{"name":37,"class":38},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":49,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":398,"locationsCount":39},"100554517","digital-mindfulness-training-programme-for-smoking-cessation-and-maintenance-100554517","NCT06500117","Digital Mindfulness Training Programme for Smoking Cessation and Maintenance","Digital Mindfulness Training Programme for Smoking Cessation and Maintenance A Mixed-method Pilot Study","HowToMind","Inclusion Criteria:\n\n* Person who has given oral consent\n* Adult aged 18 and over\n* Smoker with a smoking-related disorder according to DSM-5 criteria\n* Motivated to stop smoking\n* With daily access to a smartphone\n* Able to understand spoken and written French\n\nExclusion Criteria:\n\n* Person subject to a legal protection measure (curatorship, guardianship)\n* Persons under court order\n* People with cognitive problems that prevent mindfulness training\n* Currently using other smoking cessation treatments (burpropion, varenicline) except NRT\n* suffering from an acute psychiatric or somatic disorder requiring hospitalisation \u002F not stabilised\n* With a contraindication to nicotine replacement therapy\n* With an alcohol use disorder or using illicit substances\n* Anyone who is pregnant, breastfeeding or planning to become pregnant in the next 6 months\n* Not affiliated to national health insurance",{"count":388,"type":22},40,[51],"Although there are several effective medicinal approaches for smoking cessation, relapses are frequent and the proportion of people who remain abstinent is low (around 15-25% 6 months after withdrawal). New approaches are therefore needed to make it easier to stop smoking.\n\nMindfulness-based interventions (MBIs) are effective in depression, stress reduction and chronic pain (Goldberg et al., 2017, Khoury et al., 2015, Hilton et al., 2017). There is also evidence of efficacy in smoking cessation with a relative risk of 1.88 95% CI \\[1.04; 3.40\\] of abstinence at 17 to 24 weeks after MBI (Oikonomou, 2016).\n\nTypically, MBIs take the form of 8-week programmes with weekly group sessions. However, many patients are not able to attend a full 8-week programme. In addition, these programmes are only accessible to a small number of patients due to the lack of trained professionals and the out-of-pocket costs.\n\nIn response to these limitations, smartphone applications have been developed and evaluated, but none has been shown to be effective in smoking cessation. What's more, none of the evaluated applications offered the equivalent of a conventional 8-week MBI.\n\nFurthermore, it has now been demonstrated in the international literature that involving patients, service users and relatives in the development and conduct of health research projects has become a means of achieving effective, high-quality integration of healthcare (Fusco, 2020) as well as improving the overall quality of health research (Shen, 2017). When PUPs are involved not as research subjects but as research partners in the health research process, this can lead to \"significant changes in outcomes for patients and health systems, and the realignment of research processes and outcomes to be patient-centred\" (Bird, 2020).\n\nThe involvement of PUPs has become a requirement of many funding programmes and journals, as well as an international health policy priority.\n\nWe are therefore developing an eMind application - the first electronic MBI for smoking cessation that allows patients to follow a complete 8-week programme and that recreates the conditions of a classic MBI as closely as possible. The application will be available on the EXOLIS platform. This platform is offered by the Agence Régionale de Santé Bourgogne - Franche Comté in partnership with GRADeS (Groupement Régional d'Appui au Développement de la eSanté).\n\nThe eMind application will be co-constructed: it will be based on a research partnership involving patients. An initial version of the content has been created in the university hospital addictionology department by healthcare professionals trained in mindfulness. This first version of the application - a beta version - will be modified according to the feedback received from patients. To reward their contribution to the final version of the application, patients will be compensated in the form of a gift card. Once the changes have been taken into account, a feedback session will be organised to present the results of the study and the new version of eMind.",[392],"Smoking-related Disorder","2026-04-24",{"date":371,"type":31},{"date":396,"type":31},"2024-07-01",{"date":185,"type":22},{"name":37,"class":38},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":214,"sex":406,"minAge":407,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":416,"leadSponsor":418,"locationsCount":39},"100635818","study-of-the-hypothalamic-microglial-response-as-a-function-of-a-meals-lipid-content-in-humans-a-single-center-prospective-cohort-study-in-healthy-male-subjects-100635818","NCT07557628","Study of the Hypothalamic Microglial Response as a Function of a Meal's Lipid Content in Humans. A Single-center Prospective Cohort Study in Healthy Male Subjects","GLIPID","Inclusion Criteria:\n\n* A person who has given oral consent\n* Male\n* Body Mass Index (BMI) between 18.5 and 30 kg\u002Fm²\n* Age ≥ 20 years\n\nExclusion Criteria:\n\n* A person subject to a measure of legal protection (guardianship, tutorship)\n* A person subject to a judicial protective measure\n* A person who is not enrolled in or eligible for a social security program\n* Subject does not speak French\n* Subjects with a pacemaker or any other contraindication to MRI\n* Subjects with type 1 or type 2 diabetes\n* Subjects with a chronic inflammatory condition\n* Subjects with a neuropsychiatric condition\n* Subjects taking anti-inflammatory medication or medication that affects the central nervous system\n* Known hypersensitivity to foods provided during the study","MALE","20 Years",{"count":409,"type":22},20,"Obesity and its complications represent a growing public health problem in our society. A better understanding of the biological mechanisms involved in regulating food intake-and, more broadly, energy metabolism-should lead to improved management of this condition.\n\nRecent studies have shown that eating a single meal can rapidly trigger the activation of the immune system. This leads to a postprandial, systemic, and transient inflammatory response (Emerson SR, Adv Nutr 2017). It is found in both healthy and obese individuals. It has also been observed in rodents, enabling preclinical studies to better understand the phenomenon. This postprandial inflammation is characterized by the activation of macrophages in the gastrointestinal tract and by elevated levels of circulating pro-inflammatory markers. At the cellular level, nutrients activate an intracellular molecular sensor called the inflammasome, which is a multiprotein complex formed by the oligomerization of proteins including NLRP3 (Nod-like receptors pyrin domain-containing 3) and ASC (Apoptosis-associated Speck-like protein containing a CARD domain). This sensor activates caspase 1, an enzyme that converts pro-interleukin 1β (pro-IL-1β) into its mature and active form, IL-1β. This molecular mechanism converts the nutritional signal into an immune response.\n\nUnder physiological conditions, this acute response appears to have beneficial effects on the body. Indeed, it plays a positive role in blood glucose control by stimulating insulin secretion and glucose utilization (Dror, Nat Immunol 2017). However, in the context of chronic overeating and excessive consumption of saturated fats and simple sugars, this systemic inflammation becomes harmful, promoting adipocyte hypertrophy, insulin resistance, hepatic steatosis, and vascular damage (Hotamisligil, Nature 2017).\n\nIn mice, our team recently demonstrated the existence of a postprandial inflammatory response in the central nervous system (Cansell, Glia 2021). This response occurs specifically in the hypothalamus, a brain structure involved in regulating food intake and controlling energy metabolism. It is characterized by microglial reactivity visible as early as 3 hours after the start of the postprandial phase. This postprandial microglial activation occurs after the ingestion of a high-fat meal, whereas it is rarely or never observed after the ingestion of a standard balanced meal. It is characterized by a morphological change in hypothalamic microglia, including an increase in the length of microglial processes and their branching. This gliosis is associated with increased expression of IL-1β in microglial cells. Thus, the postprandial gliosis observed 3 hours after a high-fat meal is inflammatory. Using a targeted genetic approach that allows for the ablation of the inflammasome in microglial cells, the team demonstrates that postprandial gliosis exerts a satiating effect, limiting subsequent food intake following a high-calorie, high-fat meal. Thus, microglial inflammation appears to be an additional component in the body's arsenal of adaptive homeostatic responses aimed at limiting energy intake.\n\nOur clinical project will involve translating our basic findings in mice to humans. This will involve investigating postprandial hypothalamic gliosis in the human brain following a standard meal or a high-fat meal. The initial studies will be conducted exclusively in healthy male subjects to avoid the influence of the hormonal cycle on the hypothalamic response. The impact of physiological aging on the hypothalamic microglial inflammatory response will also be taken into account.",[412],"Pathophysiology","2026-04-22",{"date":371,"type":31},{"date":226,"type":22},{"date":417,"type":22},"2028-05",{"name":37,"class":38},{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":427,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":49,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":39},"100595010","the-benefits-of-virtual-reality-in-the-care-of-elderly-people-with-psychomotor-disadaptation-syndrome-100595010","NCT07026890","The Benefits of Virtual Reality in the Care of Elderly People With Psychomotor Disadaptation Syndrome","The Value of Virtual Reality in the Care of Elderly People With Psychomotor Disadaptation Syndrome: a Randomised Controlled Trial of Mixed Efficacy and Implementation vs. Conventional Rehabilitative Care","VIR-AGE","Inclusion Criteria:\n\n* Person who has given written consent\n* Person aged ≥ 65 years;\n* With a proven diagnosis of motor maladjustment syndrome;\n* Hospitalised in a geriatric care unit;\n* Able to understand a simple instruction and answer a closed question;\n* Ability to perform the TUG within 7 days of arriving on site\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* An adult who is incapable or unable to give consent\n* Persons with epilepsy, kinetosis or known claustrophobia Persons unable to understand simple instructions for carrying out tests\n* Anyone with a severe visual and\u002For hearing impairment\n* Any person with a behavioural disorder (agitation, aggressiveness)\n* Any person with a severe walking or balance problem that makes motor exercises unsuitable\n* Anyone with a pathology, injury, wound or severe deformity to the head or cervical spine\n* Any person suffering from severe vertigo, diagnosed at the discretion of the investigating doctor\n* Inability to use arm for pointing\n* Persons susceptible to migraines\n* Non-French speakers\n* Anyone with an inter-pupillary distance outside the range of possible helmet adjustments","65 Years",{"count":21,"type":22},[51],"Psychomotor Disadaptation Syndrome (PMDS) is characterised by a deterioration in postural function, gait and psychomotor automatisms in the elderly. It is often associated with falls and can manifest itself as retropulsion, gait abnormalities, neurological disorders and psycho-behavioural problems. For the majority of these patients, a stay in a geriatric medical and rehabilitation centre is necessary, enabling an objective assessment of these disorders and multi-professional care, including physiotherapists, occupational therapists and adapted physical activity teachers, aimed at restoring safe movement and motor independence. However, rehabilitation relies on traditional exercises that are limited, repetitive and sometimes far removed from everyday activities. Technological innovations such as virtual reality (VR) offer opportunities to improve care by creating immersive environments that reproduce real-life situations. VR could thus help to rehabilitate the motor problems associated with MS.\n\nThe aim of the VIR-AGE project is to study the clinical benefits of VR in the rehabilitation of hospitalised elderly people suffering from PMDS in terms of functional deficits, particularly motor deficits.\n\nThe study will take place at the Centre gériatrique Champmaillot of the CHU Dijon Bourgogne. A total of 50 patients with SPDM will take part.\n\nThe total duration of your participation is 5 weeks.",[432],"Psychomotor Disadaptation Syndrome","2026-04-20",{"date":435,"type":31},"2026-04-21",{"date":437,"type":31},"2025-07-16",{"date":439,"type":22},"2027-09",{"name":37,"class":38},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":214,"sex":18,"minAge":261,"maxAge":19,"enrollmentInfo":448,"targetDuration":4,"studyType":49,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":39},"100626219","metrological-properties-of-a-digital-motion-analysis-research-application-for-assessing-the-motor-abilities-and-performance-of-children-with-cerebral-palsy-100626219","NCT07432789","Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performance of Children With Cerebral Palsy","Valid-ABLE","Inclusion Criteria:\n\nCommon to both groups:\n\n* Obtaining free and informed consent from the child and at least one parent\n* Children of all genders aged 6 to 18\n* Children affiliated with or beneficiaries of a social security system\n\nFor the Cerebral Palsy group:\n\n* Medical diagnosis of CP according to the SCPE (Surveillance of Cerebral Palsy in Europe) definition;\n* Unilateral and bilateral impairment;\n* Gross Motor Function Classification System (GMFCS) = I to III;\n* No major cognitive or visual impairments that limit the performance of motor tasks\n\nFor the control group:\n\n\\- Children free from any disease\n\nOther volunteers included in the protocol (qualitative analysis only (parents and clinicians)):\n\n* Parent(s) of children with CP included in this study;\n* Healthcare professionals and researchers involved in monitoring children with CP and\u002For evaluating the research application within the framework of this study\n\nExclusion Criteria:\n\nCommon to both groups:\n\n* Participants or parent(s) of participants who do not speak French\n* Children subject to legal protection measures\n* Pregnant or breastfeeding participants\n\nFor the Cerebral Palsy group:\n\n* Presence of a cause of neuro-orthopedic disorders other than CP\n* Limiting pain\n* Surgical procedures performed less than 6 months prior to inclusion in the study\n* Any other functional medical intervention that took place 3 months prior to inclusion in the study (e.g., botulinum toxin injections, plaster casts, etc.)\n* Medical or surgical interventions planned between visit 1 and visit 2\n* Children with a condition other than cerebral palsy that affects their walking ability",{"count":306,"type":22},[51],"Cerebral palsy is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as locomotion, which has a major impact on the quality of life of affected children. It is therefore essential to characterize these functional impairments in order to guide clinical decisions and maximize the motor function of affected children.\n\nCurrently, the assessment of motor function is based on physical examinations and functional scales, such as the Gross Motor Function Classification System, which is specifically designed to assess children with CP. However, movement analysis using optoelectronic systems is considered the gold standard for this assessment, even though these systems have notable limitations (expensive installation, time-consuming use, and use only in a clinical environment, making it difficult to assess motor skills in children's everyday lives). In order to establish a comprehensive and personalized functional diagnosis, it is crucial to evaluate other fundamental motor tasks such as running, jumping, object control, and balance tasks. Recently, innovative markerless motion analysis technologies have been developed that allow analysis using smartphones or tablets outside of healthcare facilities. Therefore, developing an application dedicated to motion analysis for children with cerebral palsy that is easy to access and can be used frequently could yield many significant benefits.",[452],"Cerebral Palsy","2026-04-14",{"date":455,"type":31},"2026-04-17",{"date":457,"type":31},"2026-03-18",{"date":459,"type":22},"2028-11-16",{"name":37,"class":38},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":49,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":39},"100597837","phase-3-efficacy-of-early-argipressin-in-the-management-of-intensive-care-patients-with-norepinephrine-refractory-vasoplegic-shock-100597837","NCT07063680","Efficacy of Early Argipressin in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock","Efficacy of Early Argipressin (Arginine Vasopressin) in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock: a Multicentric Randomized, Double-blind Placebo-controlled Superiority Trial","Vaso²R","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* Vasoplegic shock defined as patient requiring vasopressor at the time of inclusion AND with a cardiac index ≥ 2.3\u002FL\u002Fmin\u002Fm² \\[32\\] (measured by echocardiography, Swan-Ganz, pulse contour analysis or thermodilution) and with hyperlactatemia \\> 2 mmol\u002Fl.\n* Vasoplegia must be primarily caused by one of the following etiologies:\n\n  * Sepsis (documented or clinically suspected infection)\n  * Post-operative vasoplegia (following cardiac or non-cardiac surgery)\n  * Post hemorrhage\n  * Sterile systemic inflammation (e.g., pancreatitis, burns, trauma)\n  * Anaphylaxis\n  * Liver failure\n  * Other causes of vasoplegia\n* Refractory shock: dose of vasopressor (express as norepinephrine base equivalent) ≥ 0.25 μg\u002Fkg\u002Fmin in order to maintain perfusion pressure within patient-defined targets (defined by the physician in charge of the patient).\n* Early intervention: Criteria for refractory AND vasoplegic shock reached for less than 12 hours.\n* Informed consent obtained from the patient or, if unable to give consent, a surrogate. If the surrogate is not available, emergency consent can be considered.\n* Covered by French national health insurance\n\nExclusion Criteria:\n\n* Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition)\n* Ongoing vasopressin treatment\n* Ongoing inotrope treatment (except norepinephrine)\n* Ongoing acute coronary syndrome, mesenteric ischemia\n* Uncontrolled active bleeding\n* Vasoplegia due to neurogenic shock\n* Vasospastic disease (Raynaud's disease, systemic scleroderma…)\n* Hyponatremia \\\u003C120 mmol l-1\n* Known hypersensitivity to Argipressin or to any of the excipients of REVERPLEG®.\n* Patient already enrolled in an interventional trial\n* Decision to limit life-sustaining treatments\n* Person under legal protection\n* Pregnant, parturient or breastfeeding women",{"count":470,"type":22},390,[289],"Acute circulatory failure (shock) is defined as insufficient oxygen transport to meet the oxygen requirements of organs and tissues. Vasoplegic shock is the most frequent cause of shock, defined by vasoplegia and a drop in arterial pressure with preserved cardiac output. The main aetiologies of vasoplegic shock are sepsis and post-operative vasoplegia. Symptomatic treatment of vasoplegic shock is based on vasopressors. The first-line vasopressor is norepinephrine. Refractory vasoplegic shock refers as high norepinephrine requirements. In patients with catecholamine-refractory vasoplegia, the use of vasopressin as a second-line treatment is proposed. The use of vasopressin could improve organ and tissue perfusion, improve renal function, accelerate shock reversal and reduce patients' exposure to catecholamines, and thus to their side effects.\n\nCurrently, there is a gap between evidence and guidelines\u002Fpractice regarding vasopressin in patients with refractory vasoplegic shock:\n\n1. There are no large randomized control trial focusing on vasopressin use in patients with refractory vasoplegic shock and data extrapolated from non-refractory shock have contradictory conclusions regarding the benefit of vasopressin in this population.\n2. In patients with vasoplegic shock, expert often recommend vasopressin as second line vasopressor and, in the case of septic shock, current international guidelines clearly position vasopressin as second-line therapy in septic shock and advocate its initiation in patients with vasoplegia refractory to norepinephrine.\n\nThe strengh of those recommendation is weak due to moderate quality of evidence highlighting the need to conduct a large randomized control trial on this topic.\n\nWe hypothesize that the use of vasopressin in patients with refractory vasoplegic shock may improve 30-day survival, decrease renal replacement therapy and reduce duration of vasopressor administration. This is the first multicentred study aiming to confirm the superiority of vasopressin in combination with norepinephrine over norepinephrine alone in this population.",[474],"Patients With Norepinephrine-refractory Vasoplegic Shock","2026-04-13",{"date":453,"type":31},{"date":478,"type":31},"2026-04-07",{"date":480,"type":22},"2029-01",{"name":37,"class":38},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":490,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":49,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":39},"100371771","efficacy-of-transcranial-direct-current-stimulation-tdcs-in-patients-suffering-from-pathological-use-of-internet-gaming-100371771","NCT04120714","Efficacy of Transcranial Direct Current Stimulation (tDCS) in Patients Suffering From Pathological Use of Internet Gaming","Efficacy of Transcranial Direct Current Stimulation (tDCS) in Patients Suffering From Pathological Use of Internet Gaming : Randomized, Controlled, Double-blind, Monocentric Pilot Study","StimNET","Inclusion Criteria:\n\n* Patient aged ≥ 12 years old\n* Patient and\u002For parents who have given oral consent\n* Patient with PUIG (DSM-5 criteria)\n* Patient that is motivated and willing to reduce or stop internet gaming\n\nExclusion Criteria:\n\n* a person who is not affiliated to or not a beneficiary of a social security scheme\n* Patient with severe chronic psychiatric comorbidity (schizophrenia, paranoia, chronic hallucinatory psychosis) and bipolar disorder types I and II\n* Patient with a gambling addiction\n* Patient who has had a recent change (\\\u003C 1 month) in the prescription of psychotropic treatment\n* Patient with an addiction to a psychoactive substance other than tobacco\n* Patient receiving psychiatric care without consent or legal protection (guardianship, curatorship)\n* Minor patient without parental consent for care\n* Patient with severe heart, kidney, liver or lung failure\n* Patient with a contraindication to the practice of tDCS: metal parts, medical devices implanted in the brain\n* Pregnancy or breastfeeding in progress (negative pregnancy test)\n* Patient unable to commit to a three-month follow-up","12 Years",{"count":21,"type":22},[51],"The Internet has grown considerably in the last twenty years, and as a result, cases of excessive iinterney use have emerged. These cases, which have clinical similarities with substance addiction, involve the various activities related to the Internet (online gambling, discussion forums, online networking, e-mail, pornography, shopping, etc.). However, to date, only the pathological use of Internet gaming (PUIG) is referenced in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, section III).\n\nIn PUIG, an individual loses control when gambling online. He\u002Fshe typically spends 8 to 10 hours on this activity, sometimes without eating or sleeping. Usual obligations, such as school or work, or family obligations are neglected. PUIG can cause great psychological and social suffering. Neurological complications (epilepsy) and deaths (cardiac arrest) related to PUIG have also been reported. These situations are all the more dramatic because they often affect adolescents and young adults. In Asia, PUIG has become a public health problem. To date, no treatment has been validated for this disorder.\n\nNon-invasive brain stimulation (NIBS) techniques can modulate neural activity in the dorsolateral prefrontal cortex (DLPFC). This modulation makes it possible to reduce addictive behaviours through different mechanisms (reduction of craving, impulsivity, and decision-making disorders). These techniques could be effective for PUIG.",[495],"Pathological Use of Internet Games","2026-04-10",{"date":475,"type":31},{"date":499,"type":31},"2020-01-06",{"date":377,"type":22},{"name":37,"class":38},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":214,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":521,"locationsCount":522},"100345089","development-of-a-device-for-evaluating-primary-hemostasis-under-whole-blood-flow-conditions-100345089","NCT03773159","Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions","INDONESIA","Inclusion Criteria:\n\n* person who has given oral consent\n* adult\n* blood donor at EFS Bourgogne Franche-Comté\n* or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon\n* or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital\n\nExclusion Criteria:\n\n* a person who is not affiliated to or not a beneficiary of national health insurance\n* person subject to court-ordered protection (curatorship, guardianship)\n* pregnant, parturient or breastfeeding woman\n* a person who is unable to consent\n* person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)",{"count":98,"type":22},"Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.\n\nAn exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).\n\nThe objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.\n\nParticipation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).",[512,513,514],"Von Willebrand Diseases","Major Constitutional Thrombopathy","Patient on Antiplatelet Drugs","2026-04-01",{"date":517,"type":31},"2026-04-02",{"date":519,"type":31},"2019-05-06",{"date":417,"type":22},{"name":37,"class":38},2,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":214,"sex":18,"minAge":530,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":49,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":39},"100526759","analysis-of-the-psychometric-properties-of-kinematic-parameters-of-locomotion-measured-by-inertial-measurement-units-validation-in-healthy-children-and-children-with-cerebral-palsy-100526759","NCT06138925","Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy","KAPP-IMU anc","Inclusion Criteria:\n\n* Children who have given their consent and whose legal representatives have given their consent\n* Age between 7 and 17 years,\n* Children able to understand simple commands and instructions.\n* Children living within a maximum radius of 50 km of the investigation site.\n* Child covered by national health insurance.\n\nPATIENT GROUP (IN ADDITION TO THOSE ABOVE)\n\n* Children with proven cerebral palsy resulting in locomotor impairment but able to move around without technical aids (cane, wheelchair).\n* Child covered by national health insurance.\n\nExclusion Criteria:\n\n* Children with a condition other than cerebral palsy that affects their ability to walk.\n* Child subject to a measure of legal protection\n* A child unable to give consent\n* Pregnant, parturient or breast-feeding participant","7 Years","17 Years",{"count":533,"type":22},80,[51],"Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Locomotion can be assessed using a motion capture system that enables 3-dimensional analysis, in order to help make treatment decisions and quantify them. Although these systems are currently considered to be the gold standard, the fact remains that they cause a certain amount of patient fatigue (long set-up times) and that walking is assessed in a laboratory rather than in real life.\n\nToday, technological advances have brought to the fore other gait analysis devices, such as inertial measurement units (IMUs). Various systems incorporating IMUs in the feet, for example, respond to these problems of analysing walking in real-life situations. The IMUs record the movements and orientation of the foot in space; the data is then processed by algorithms to recognise walking steps and calculate the spatio-temporal parameters of locomotion. Additional IMUs positioned on the body can be grafted onto this system to provide a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. However, before such devices can be used in a pathological paediatric population, they must be validated in a healthy population. This validation must be conducted using a precise method that has been widely documented in the COSMIN recommendations (Consensus-based Standards for the selection of health Measurement Instruments). The first stage will assess the safety of the IMU devices in a healthy paediatric population, and the validity of the spatio-temporal parameters. If these properties are deemed to be compliant, these same parameters will be assessed in a paediatric population with cerebral palsy in the second stage.",[452],"2026-03-23",{"date":539,"type":31},"2026-03-27",{"date":541,"type":31},"2024-01-31",{"date":543,"type":22},"2028-01",{"name":37,"class":38},""]