[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital, Lille\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":652},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,136,0,25,[9,53,83,113,143,170,197,225,250,274,299,326,351,377,401,422,447,473,498,520,536,555,578,599,626],{"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":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100492965","phase-1-individualized-or-conventional-transfusion-strategies-during-peripheral-va-ecmo-100492965",false,"NCT05699005","Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO","Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE","ICONE","Inclusion Criteria:\n\n* Age of 18 and older,\n* supported by peripheral VA-ECMO\n* for cardiogenic shock\n* Life expentency \\>90 days\n* Central venous line available ScVO2 measurement\n\nExclusion Criteria:\n\n* Pregnancy,\n* Lack of health insurance,\n* Opposition to blood transfusion,\n* Known congenital hemoglobin disease or disorder,\n* Metabolic alcaloosis with pH\\>7.8,\n* eCPR,\n* Legally incapacitated adults","ALL","18 Years",{"count":21,"type":22},236,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock.\n\nAn individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness",[28,29,30,31,32],"Cardiogenic Shock","Extracorporeal Membrane Oxygenation","Transfusion Related Complication","Anemia","Oxygen Delivery",[34,35,36,37,38,39],"ECMO","ECLS","Refractory cardiogenic shock","Transfusion","ScVO2","Outcome","RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":44},"2023-09-18",{"date":48,"type":22},"2028-12-18",{"name":50,"class":51},"University Hospital, Lille","OTHER",1,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":52},"100637069","switch-to-ofatumumab-and-level-of-immunoglobulins-100637069","NCT07625800","Switch to Ofatumumab and Level of Immunoglobulins","SOLI","Inclusion Criteria:\n\n1. Adult patients (≥ 18 years old) who had been treated with ocrelizumab for a relapsing form of Multiple Sclerosis according to the ocrelizumab marketing authorization (MA) treatment regimen for at least 18 months.\n2. Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment\\*.\n3. Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study\\*).\n4. Patients agreeing to participate to the study.\n5. Able to provide their non-opposition\n\n   * At the discretion of the investigator, if a benefit for patients is expected based on their experience and depending on patient's characteristics\n\nExclusion Criteria:\n\n1. Patients with ocrelizumab dose spacing \\> 8 months in the last 18 months before switch\n2. Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch\n3. Ongoing or planned pregnancy","65 Years",{"count":62,"type":22},115,"OBSERVATIONAL","This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up.\n\nThe primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.",[66],"Multiple Sclerosis",[66,68,69,70,71,72,73],"NIS","Ofatumumab","Kesimpta","Ocrelizumab","IgG","IgM","NOT_YET_RECRUITING","2026-05-28",{"date":77,"type":44},"2026-06-04",{"date":79,"type":22},"2026-06",{"date":81,"type":22},"2029-06",{"name":50,"class":51},{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":91,"minAge":19,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100397191","early-gestational-diabetes-mellitus-100397191","NCT04451915","Early Gestational Diabetes Mellitus","Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial","LEMA_GDM","Inclusion Criteria:\n\n* Pregnant woman\n* Singleton pregnancy\n* Early GDM defined by a fasting plasma glucose between 5.1 mmol\u002Fl and 6.1 mmol\u002F with at least one risk factor (age ≥35 years and\u002For BMI ≥ 25 kg\u002Fm2 and\u002For familial history of diabetes and\u002For personal history of GDM and\u002For personal history of macrosomia).\n* First prenatal visit prior 20 weeks of gestation at the time of randomization.\n* Signed informed consent\n\nExclusion Criteria:\n\nDiabetic follow-up started at time of inclusion\n\n* Pre-existing diabetes in pregnancy\n* Renal impairment\n* Hepatic insufficiency\n* History of bariatric surgery\n* Long time corticosteroids treatment\n* Insufficient understanding\n* Language difficulties\n* Lack of social Insurance\n* Person in emergency situation\n* Person under the protection of justice (tutelage\u002F curatorship)\n* Persons deprived of their liberty","FEMALE",{"count":93,"type":22},2010,[95],"NA","In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol\u002Fl should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.\n\nIn France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol\u002Fl, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo\u002FL is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol\u002Fl for the identification of GDM in early pregnancy is not justified by current evidence",[98],"Gestational Diabetes",[100,101,102,103,104],"Early gestational diabetes","pregnancy","fasting plasma glucose","diagnosis","prognosis",{"date":106,"type":44},"2026-06-02",{"date":108,"type":44},"2020-11-30",{"date":110,"type":22},"2027-06-30",{"name":50,"class":51},10,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":52},"100614124","phase-2-diroximel-fumarate-to-reduce-perihaematomal-oedema-in-intracerebral-haemorrhage-double-blind-randomized-clinical-trial-100614124","NCT07275515","DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL","DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL (DARLENE)","DARLENE","Inclusion Criteria:\n\n1. Patients 18 years or older (no upper age limit)\n2. Patients admitted for a first-ever or recurrent (occurred more than 1 year before) symptomatic supratentorial spontaneous ICH confirmed by brain imaging\n3. Administration of study treatment no later than 48 hours after symptom onset or since last seen normal\n4. Written consent obtained\n5. Patient with social insurance in France\n6. Patient willing to comply with all study procedures and duration\n\nExclusion Criteria:\n\n1. Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated \\> 60ml)\n2. Severe coma (Glasgow Coma Scale \\\u003C6)\n3. Pure intraventricular hemorrhage\n4. ICH suspected to result from a preceding trauma, an identified intracranial vascular malformation, venous thrombosis, tumor or hemorrhagic transformation within an infarct\n5. Patient planned for surgical evacuation of ICH before randomization (Evacuation, Decompressive hemicraniectomy, External ventricular drain)\n6. Patient with a known indication for DRF treatment (e.g. multiple sclerosis) or any other NrF2 agonist (dimethyl fumarate; Tecfidera)\n7. Patient with contraindication to DRF: patients with known hypersensitivity to DRF, or to any of the excipients of VUMERITY (patients taking dimethyl fumarate)\n8. Severe lymphopenia at admission (lymphocyte counts \\\u003C 0.5 x 109\u002FL)\n9. Medical history: Suspected or confirmed of progressive multifocal leukoencephalopathy\n10. Severe swallowing disorder and\u002For nasogastric tube required\n11. Severe pre-ICH dependency (modified Rankin score of 5)\n12. Life expectancy \\\u003C 1 year related to comorbidities\n13. Late-stage organ (acute cardiac, renal or hepatic failure)\n14. Decision already taken for palliative (end of life) care with withdrawal of active treatment\n15. Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)\n16. Adults who are deprived of their liberty by judicial or administrative decision",{"count":122,"type":22},192,[124],"PHASE2","Spontaneous intracerebral haemorrhage (ICH) is a life-threatening condition, still devoided of specific treatment. Peri-haematomal oedema (PHO) develops in the ensuing days after ICH onset and worsens functional outcome. Hence, PHO is a promising therapeutic target but until now there is no specific treatment for PHO. The occurrence and growth of PHO is mainly mediated by inflammation. We hypothesize that a modulation of inflammation is effective in reducing PHO growth, therefore improving the functional outcome of ICH patients. From animal studies to human post-mortem studies, our team has demonstrated a key role for erythroid-related nuclear factor 2 (Nrf2) in PHO. Indeed, this transcription factor promotes the protective effect of inflammation: Nrf2 activation enhances antioxidant defenses and increases rates of blood resorption. Therefore, Nrf2 emerges as a promising and innovative therapeutic target. Taking into account the prolonged time interval between de novo drug discovery and use in clinical practice, drug repurposing is an interesting option for the unmet clinical need of reducing PHO. We chose Diroximel Fumarate (DRF) which is a safe and effective Nrf2 activator widely used in multiple sclerosis (dimethyl fumarate is on the market since 2013, and DRF since 2019) to modulate inflammation and to establish the efficacy of Nrf2 activation in reducing PHO growth and, ultimately, in improving the functional prognosis after ICH.",[127],"Stroke",[129,130,131,132,133,134,135],"proof of concept","multicenter","stroke","randomization","double-blind, placebo-controlled","France","DRF group VS Placebo group","2026-05-27",{"date":75,"type":44},{"date":139,"type":44},"2026-05-19",{"date":141,"type":22},"2029-05",{"name":50,"class":51},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":52},"100589597","phase-3-prolonged-corticosteroid-treatment-or-n-acetylcysteine-for-severe-alcoholic-hepatitis-100589597","NCT06956482","PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis","PROCORNAC","Inclusion Criteria:\n\n* Patients aged 18-75\n* Alcohol consumption of more than 40g\u002Fday (women) and 50g\u002Fday (men)\n* Recent onset of jaundice (\\\u003C3 months)\n* Biopsy proven alcoholic hepatitis (transjugular liver biopsy)\n* Maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis\n* MELD score ≥ 17\n* Patients covered with social insurance\n* Patients having provided written informed consent to participate\n\nExclusion Criteria:\n\n* Hepatocellular carcinoma\n* Uncontrolled gastrointestinal bleeding\n* Previous severe allergy or hypersensitivity to N-acetylcysteine (anaphylactic shock, Quincke edema, severe urticaria)\n* Hypersensitivity to any component of the medication\n* MELD score \\\u003C17\n* Type 1 hepatorenal syndrome before the initiation of treatment\n* Severe extrahepatic disease, with life expectancy \\\u003C 6 months\n* Any malignant tumor \\\u003C 2 years (except skin carcinomas)\n* Ongoing viral or parasitic infection\n* Untreated bacterial infection\n* Tuberculosis \\\u003C 5 years\n* Positive blood PCR in patients with positive antibodies against HCV\n* Patient carrying HBV or HIV\n* Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study","75 Years",{"count":152,"type":22},477,[154],"PHASE3","Only patients suffering from a severe form of alcoholic hepatitis (Maddrey's discriminant function greater than 32) require medical treatment. Oral prednisolone for 28 days is the only treatment which has been proven to improve short-term survival over placebo in patients with severe alcoholic hepatitis. However, prednisolone alone cannot be regarded as an ideal treatment because some patients still have a bad outcome despite being treated with corticosteroids. Response to treatment can be predicted by the Lille score, a simple tool that is calculated after 7 days of prednisolone course. The ideal binary cut-off of the Lille is 0.45, responders having a Lille score \\\u003C 0.45 and non-responders having a Lille score ≥0.45. In terms of treatment management, approximately 30% of patients with severe alcoholic hepatitis do not take benefit from prednisolone and are classified as null responders by a Lille score greater than 0.56. In them, there is a consensus for stopping prednisolone after a 7-day course of treatment (Lille score is calculated after 7 days) while patients with a Lille score \\\u003C0.56 continue treatment for a total of 30 days.\n\nNumerous trials have attempted to test the impact of other strategies in association with prednisolone, but none of them has shown an improvement in survival (primary endpoint) as compared to prednisolone alone. These strategies include for instance pentoxifylline, amoxicillin-clavulanic acid and enteral nutrition.\n\nBecause oxidative stress is a major driver of liver injury during alcohol-related liver disease, antioxidants, especially N-acetylcysteine, have been tested for many years to treat alcoholic hepatitis. N-acetylcysteine alone does not seem to bring a survival benefit over placebo while it may improve outcome when combined to prednisolone.\n\nHistorically in severe alcoholic hepatitis, treatment is only given for one month. However, a significant proportion of patients still disclose impaired hepatic function after treatment has been stopped (e.g. 50% of patients still have a MELD score ≥17 after 60 days in). It is thus tempting to hypothesize that a proportion of patients will recover slowly and may take benefit from a prolonged treatment. Such strategy has been proposed in some old studies with relatively limited sample size but never tested with a rigorous approach.\n\nIn the present study, for the first time in alcoholic hepatitis, we will take into account the recent recommendations of international experts by choosing an innovative primary endpoint that does not only include mortality and evaluate this endpoint at the preferred timepoint of 90 days.\n\nAfter more than 30 years of negative trials in severe alcoholic hepatitis, the present study is aimed to evaluate two important new strategies to decrease both mortality and liver impairment.",[157],"Alcoholic Hepatitis",[159,160,161,162],"Alcoholic hepatitis","survival, prednisolone","N-acetylcysteine","liver insufficiency",{"date":164,"type":44},"2026-06-01",{"date":166,"type":44},"2026-05-22",{"date":168,"type":22},"2030-05",{"name":50,"class":51},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100337209","correction-of-nonsense-mutations-in-cystic-fibrosis-100337209","NCT03670472","Correction of Nonsense Mutations in Cystic Fibrosis","Optimization of Correcting Molecules of Nonsense Mutations in Epithelial Cells of the Upper Airways of Patients With Cystic Fibrosis With Nonsense Mutations in the CFTR Gene","Inclusion Criteria:\n\n* Male \u002F female adults and minors aged 8 years and over\n* Patients with cystic fibrosis and carry a nonsense mutation on the 2 alleles of the gene coding for the CFTR channel.\n* Patients whose genotype of patients concerning the CFTR gene is known.\n* Patients with social security\n* Major patients who have given their consent\n* Minor patients with parental authorization\n\nExclusion Criteria:\n\n* Patients who have a mutation other than nonsense in the CFTR gene\n* Patients whose CFTR gene was not sequenced on the 2 alleles\n* Patients not wishing to participate in this study or persons not giving or not able to give consent.\n* Pregnant or lactating women\n* Patients under curatorship or guardianship","8 Years",{"count":179,"type":22},85,"The presence of a nonsense mutation leads to the rapid degradation of the carrier mRNA mutation by a mechanism called NMD (nonsense-mediated mRNA decay) \\[6, 13\\]. There are currently 3 main strategies at least for correcting nonsense mutations: exon skipping, inhibition of NMD and nonsense mutation readthrough.\n\nIn the laboratory, we developed a strategy for correcting nonsense mutations combining inhibition of NMD and activation of translecture. For this purpose, we have constructed screening systems to identify NMD-inhibiting and\u002For readthrough enhancers. The molecules thus identified are then tested on cell lines and in murine models carrying a nonsense mutation.\n\nOne of our goals is to select a set of molecules that can correct effectively nonsense mutations. For this we have to test these molecules on a great diversity of nonsense mutations.\n\nThis work will:\n\n* determine if we can correct all the nonsense mutations tested with at least one of our molecules\n* determine what is common within a group of mutations corrected by a given molecule\n* be able to assign the parameters that make one mutation is corrected by one molecule and not or little by another.\n\nThis study will therefore improve our theoretical knowledge on the recognition of premature stop codons but also to propose therapeutic approaches for the correction of nonsense mutations of the CFTR gene in cystic fibrosis in a targeted way for a patient.",[182],"Cystic Fibrosis",[184,185,186,187,188],"Cystic fibrosis","nonsense mutations","CFTR gene","nasal epithelial cells","nonsense mutation readthrough","2026-05-21",{"date":166,"type":44},{"date":192,"type":44},"2016-02-03",{"date":194,"type":22},"2030-01",{"name":50,"class":51},8,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":52},"100638475","lung-disease-and-flna-mutations-100638475","NCT07592637","Lung Disease and FLNA Mutations","Prevalence and Characteristics of Lung Disease Associated With FLNA Mutations: a Multicenter Cross-sectional Study","FLN-Air","Inclusion Criteria:\n\n* Patient with an FLNA mutation (or gene alteration)\n* Patient who has given written consent to participate in the trial\n* Socially insured patient\n* Patient willing to comply with all study procedures and duration\n\nExclusion Criteria:\n\n* Patient refused or unable to give informed consent\n* Administrative reasons: inability to receive information, inability to participate in the entire study, lack of coverage by the social security system,\n* Pregnant or breastfeeding women\n* Patient under guardianship\n* Persons deprived of liberty","99 Years",{"count":207,"type":22},70,[95],"Some sparse scientific data support the hypothesis that otherwise unexplained emphysema may be associated with FLNA variants. This transversal multicentric study aimed to describe the frequency of emphysema in patients carrying an FLNA variation. Patients with FLNA variations who accept the study will benefit from a chest physician's clinical examination, respiratory function tests, a cardiac ultrasound and a chest scan. The primary endpoint is to describe emphysema's frequency in patients carrying FLNA variation. The other objectives are to describe emphysema's features in these patients, the prevalence of pulmonary hypertension and to describe their lung function abnormalities. The final goal is to confirm the association between unexplained emphysema and FLNA mutation.",[211],"Emphysema",[211,213,214,215,216],"FLNA","Filaminopathies A","Pulmonary hypertension","Asthma","2026-05-20",{"date":219,"type":44},"2026-05-26",{"date":221,"type":22},"2026-09",{"date":223,"type":22},"2029-03",{"name":50,"class":51},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100628410","phase-4-self-hanging-patient-and-hyperbaric-oxygen-therapy--siphon-study-100628410","NCT07461272","Self-hangIng Patient and Hyperbaric Oxygen Therapy _ SIPHON Study","Self-hangIng Patient and Hyperbaric Oxygen Therapy - SIPHON Study \u002F Place de l'Oxygénothérapie Hyperbare Dans la Prise en Charge Des Tentatives de Pendaison","SIPHON","Inclusion Criteria:\n\nPatients who present, following an attempted hanging, neurological distress defined by the presence of one or more of the following criteria:\n\n* Glasgow score \\\u003C 13\u002F15\n* Confusional syndrome\n* Psychomotor agitation Who most of the time require optimal neuroprotection by sedation and invasive mechanical ventilation for the purpose of protecting the airways.\n* Patient aged over 18 years,\n* Suicide attempt by hanging without cardiocirculatory arrest,\n* Patient insured socially and able to understand the information provided\n\nExclusion Criteria:\n\n* Response time exceeded by \\> 6 hours from the hanging\n* Attempted hanging with immediate return to normal consciousness\n* Refusal of consent from the family or trusted person at the time of inclusion in the study,\n* Patients and\u002For families unable to understand the information provided",{"count":234,"type":22},50,[236],"PHASE4","During an attempted hanging, patients present severe neurological distress that can lead to major neuropsychiatric sequelae. These sequelae are notably due to significant cerebral edema related to hanging. Hyperbaric Oxygen therapy is known to reduce cerebral edema and improve cerebral perfusion. The main objective of the study is to evaluate in patients who have attempted hanging without presenting cardio-respiratory arrest, the effect of one Hyperbaric Oxygen therapy session in addition to standard intensive care management on a potential reduction in short-term neurological sequelae. Patients will benefit from either standard management or standard management associated with one Hyperbaric Oxygen therapy session",[239],"Suicide",[241,242,243,244],"Hanging","Neurological sequelae","Hyperbaric oxygen therapy","Intensive care",{"date":166,"type":44},{"date":79,"type":22},{"date":248,"type":22},"2028-12",{"name":50,"class":51},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":257,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":52},"100625622","evaluation-of-an-intensified-systematic-screening-for-congenital-hypothyroidism-in-premature-newborns-100625622","NCT07425028","Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns","PREMATHYRO","Inclusion Criteria:\n\n* Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days), both female and male, of all ethnic origins, regardless of birth weight, and including all other pathologies.\n* Newborns whose parents have given their non-opposition consent.\n\nExclusion Criteria:\n\n* Newborns born who leave the region before day 15.\n* Newborns who die before 15 days of age.\n* Newborns whose parents are not affiliated with the social security system.","23 Weeks","32 Weeks",{"count":260,"type":22},1600,"Currently in France, screening for congenital hypothyroidism (CH) in premature infants is done by a single TSH assay on filter paper. However, European recommendations advise repeating the assay within the first month of life.\n\nOur primary objective is to estimate the incidence of CH in preterm infants under 32 weeks of gestational age by applying the European recommendations.",[263],"Congenital Hypothyroidism",[265,266,267],"congenital hypothyroidism","prematurity","screening",{"date":166,"type":44},{"date":270,"type":22},"2027-03",{"date":272,"type":22},"2028-03",{"name":50,"class":51},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":91,"minAge":19,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":296,"leadSponsor":298,"locationsCount":4},"100624431","autonomic-nervous-system-intrapartum-monitoring-to-prevent-neonatal-adverse-outcomes-100624431","NCT07409545","Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes","ANSINAO","Inclusion Criteria:\n\n* Pregnant woman admitted to the delivery room for childbirth\n* Fetus in cephalic presentation\n* Aged 18 to 45 years old\n* Gestational age greater than 37 weeks\n* Understanding of the French language\n* Participant who has given written consent to participate in the study.\n\nExclusion Criteria:\n\n* Hospitalization for medical termination of pregnancy\n* Death in utero\n* Heart transplant\n* Twin pregnancy\n* Open wound in an area covered or wrapped by the medical device\n* Allergy to a component of the TOCONAUTE device: polyamide, polyester, elastane, silver, other synthetic materials\n* Sensory disorders rendering the subject insensitive to pain on the skin\n* Risk of contamination (viral\u002Finfectious) of one of the materials constituting the device\n* Participant wearing an implanted medical device (pacemaker, etc.)\n* Simultaneous participation in another research study.","45 Years",{"count":283,"type":22},760,[95],"Perinatal asphyxia affects 3 to 8 newborns per 1,000 births, with moderate or severe anoxic-ischemic encephalopathy occurring in 0.5 to 1 per 1,000 births. Approximately 15 to 20% of affected newborns will die during the postnatal period, and 25 to 50% of those who survive will develop severe disabilities (epilepsy, cerebral palsy, sensory, behavioral, and psychiatric disorders).\n\nIn situations where there is a risk of perinatal asphyxia, the challenge for obstetricians is to choose between vaginal delivery or cesarean section and to determine the optimal time to induce labor in order to prevent brain damage.\n\nVisual analysis of fetal heart rate (FHR) and uterine contraction signals by cardiotocography (CTG) is the gold standard method for monitoring fetal status and is one of the most common obstetric procedures. Numerous classifications have been proposed to classify FHR and predict neonatal outcomes. Unfortunately, they have a high rate of interobserver variability and low specificity for predicting neonatal complications.\n\nThe INSERM CIC-IT 1403 unit at Lille University Hospital has previously developed an innovative heart rate variability (HRV) analysis method for assessing autonomic nervous system activity. This technology has been adapted for assessing pain and well-being in adults and newborns (ANI and NIPE® monitors) and is now distributed in more than 70 countries worldwide. Numerous studies have demonstrated the ability of this HRV analysis to study the autonomic response to painful stimuli in adults, children, and newborns. More recently, we have studied the ability of our HRV analysis method to predict acidosis and have adapted it to obtain a fetal stress index (FSI).\n\nAs proof of concept for the effectiveness of FSI in treating acidosis and adverse neonatal outcomes (i.e., brain damage) has been established in an animal model as part of the PrevAP project, we hypothesize that FSI analysis could provide an effective means of assessing acidosis in human fetuses. Such real-time analysis of fetal HRV is now possible thanks to the TOCONAUTE system, whose safety and performance have been demonstrated in a previous study.",[287],"Obstetrics",[289,290,291,292,293],"Electrocardiogram","fECG","patch","heart rate","contractions",{"date":166,"type":44},{"date":270,"type":22},{"date":297,"type":22},"2028-09",{"name":50,"class":51},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":313,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":4},"100613981","phase-3-efficacy-and-safety-of-cryotherapy-followed-by-tirbanibulin-ointment-for-actinic-keratosis-on-the-scalp-and-forehead-100613981","NCT07273656","Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead","TIRBACRYO","Inclusion Criteria:\n\n* Subject over 18 years old presenting with ≥ 8 typical actinic keratoses (AK), clinically visible or palpable, grade I or II, with at least 4 AK per hemiscalp,\n* Participants who, in the investigator's judgment, are in good general condition (ECOG ≤ 2),\n* The AK must be distributed in 2 non-overlapping areas, and of similar grades,\n* Patient capable of understanding and adhering to the study visit schedule and other protocol requirements,\n* Patient capable of understanding and voluntarily signing informed consent,\n* Patient covered by social insurance,\n* Patient willing to comply with all study procedures and duration,\n* Women of childbearing potential must:\n\nHave a negative pregnancy test at screening and during the treatment period,\n\nUse an effective contraceptive method throughout the study participation. Menopausal women (absence of menstruation for at least one year without other medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy) may be enrolled.\n\nExclusion Criteria:\n\n* Clinically atypical and\u002For rapidly evolving actinic keratoses (AK) in the treatment area, and grade 3 AK according to Olsen classification,\n* A defined treatment area that would be:\n\n  1. Located somewhere other than the scalp and\u002For forehead,\n  2. Within 5 cm of a wound that is not fully healed or a lesion suspicious for carcinoma,\n* Prior treatment with tirbanibulin,\n* Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for actinic keratoses in the treatment area or within 2 cm around this area within 6 weeks prior to the screening visit,\n* Use of the following therapies within 2 weeks prior to the screening visit:\n\n  1. Therapeutic or cosmetic procedures (e.g., liquid nitrogen application, surgical excision, dermabrasion, medium or deep chemical peeling, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area,\n  2. Therapeutic products containing acids (e.g., salicylic acid, fruit acids), topical retinoids, or light peels in the treatment area or within 2 cm around the selected treatment area,\n* Allergy to tirbanibulin or any of its components.\n* Any condition causing a risk of poor compliance,\n* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign the consent form,\n* Women of childbearing potential who refuse to use an effective contraceptive method,\n* Pregnant women, women planning to become pregnant, and breastfeeding women,\n* Persons deprived of liberty by judicial or administrative decision.",{"count":307,"type":22},59,[154],"The aim of the study is to evaluate the efficacy and safety of a combined approach of cryotherapy and tirbanibulin for the treatment of actinic keratosis of the scalp and forehead, repeated every 4 months. A higher rate of complete response is expected with this combination compared to cryotherapy alone, as well as a better response with repeated treatment cycles.",[311,312],"Keratosis","Actinic Keratoses",[314,315,316,317,318,319],"Tirbanibulin","Cryotherapy","Squamus cell carcinoma","Skin carcinoma","Actinic Keratosis","Field cancerization",{"date":166,"type":44},{"date":322,"type":22},"2026-11-30",{"date":324,"type":22},"2028-11-30",{"name":50,"class":51},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":334,"maxAge":19,"enrollmentInfo":335,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":52},"100600605","use-of-the-aortic-time-velocity-integral-via-suprasternal-ultrasound-to-search-preload-dependence-in-paediatric-surgery--kids-fluid-management-fm-100600605","NCT07099664","Use of the Aortic Time-velocity Integral Via Suprasternal Ultrasound to Search Preload Dependence in Paediatric Surgery : Kid's Fluid Management (FM)","Use of the Aortic Time-velocity Integral (VTI) Via Suprasternal Ultrasound to Search Preload Dependence in Paediatric Surgery : Kid's Fluid Management (FM)","Kid's FM","Inclusion Criteria:\n\n* Patient under 18 admitted to paediatric operating room for a surgical intervention, an endoscopy, an interventional radiology procedure or an imagery and needing a general anaesthesia.\n\nExclusion Criteria:\n\n* Condition preventing a suprasternal ultrasound (tracheostomy, spinal immobilization, suprasternal bandage)\n* Pathology disturbing respiratory variation of left ventricular stroke volume (PAH, constrictive pericarditis, pericardial effusion, right ventricular dysfunction, complex congenital heart disease, aortic coarctation, patent ductus arteriosus\n* Every medical condition where Berry's rule of fasting compensation could be unsafe (anuric kidney failure, oedema, heart failure with reduce left ventricular ejection fraction, patient under vasoactive drugs\n* Opposition to the participation in the study\n* Pregnant women\n* Patient with no security coverage\n* Inability to determine baseline cardiac output","0 Years",{"count":336,"type":22},90,"After major surgery, fluid overload is associated with an increase of morbidity and mortality.\n\nFluid administration should therefore be given wisely. However, there is a paucity of monitor to predict preload dependence in paediatric anaesthesia.\n\nThe aim of this study is to determine if VTI variation, measured through the suprasternal window, with a cardiac doppler probe, can predict preload dependence.\n\nIndeed, cardiac probe are present in most operating room and suprasternal window is reachable in most surgical case, which should allow VTI monitoring for the vast majority of our patient.",[339],"Hemodynamic",[341,342,343,344],"Suprasternal doppler","paediatric anaesthesia","hemodynamic","fluid management",{"date":166,"type":44},{"date":347,"type":44},"2025-10-03",{"date":349,"type":22},"2026-08",{"name":50,"class":51},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":359,"sex":18,"minAge":360,"maxAge":19,"enrollmentInfo":361,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":52},"100490504","engagement-in-physical-activities-and-sports-in-adolescents-with-diaphragmatic-hernia-100490504","NCT05666986","Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia","Identification of Obstacles and Facilitators to the Engagement in Physical and Sports Activities in a Population of Adolescents Operated on for a Diaphragmatic Hernia","CHASAM","Inclusion Criteria:\n\n* Child\u002Fadolescent having undergone surgery for CDH in the first month of life, aged 12 to 18 years; absence of polypathology (i.e. diaphragmatic hernia not associated with another pathology); follow-up at the CDH reference centre, Lille site\n* Written consent from both parents allowing the collection of data from the child\u002Fadolescent\n* Written consent from the parent(s) agreeing to participate in the study by answering the questionnaires and the individual interview, for themselves and for their child\n* Possibility of accessing equipment to conduct a video-conference interview if necessary.\n\nExclusion Criteria:\n\n* Parents or child\u002Fadolescent not understanding French\n* Parents under guardianship or child under legal protection",true,"12 Years",{"count":362,"type":22},20,"The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the hindering factors as well as the factors facilitating these practices.\n\nBased on self-questionnaires and semi-structured interviews, this research is a qualitative research in the field of human and social sciences.\n\nThe qualitative survey will make it possible to report on the experience of the disease of children and parents; in parallel, a complete medical evaluation of the subjects (clinical and para-clinical) will be carried out.\n\nThe analysis of the verbatim of the self-questionnaires and interviews with regard to the real physical capacities of the subjects, will be discussed.",[365],"Congenital Diaphragmatic Hernia",[367,368,369,370,371],"CDH","physical activity and sports","childhood and adolescence","environment sociological","psychological clinical",{"date":166,"type":44},{"date":374,"type":44},"2022-05-19",{"date":270,"type":22},{"name":50,"class":51},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":91,"minAge":19,"maxAge":281,"enrollmentInfo":385,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":400,"locationsCount":52},"100486611","long-term-ovarian-fertility-in-patients-treated-for-lymphoma-100486611","NCT05616325","Long-term Ovarian Fertility in Patients Treated for Lymphoma.","Long-term Follow-up of Ovarian Function and Fertility in Young Lymphoma Patients Treated by Chemotherapy","FERTILymph","Inclusion Criteria:\n\n* Patients with a history of lymphoma treated with chemotherapy\n* followed in the fertility observatory of the Jeanne de Flandre Hospital at the University Hospital of Lille (project \"she will heal and then want a child\"), who are at least at 5 years since the end of chemotherapy\n* Patients having been informed and having given their written consent to participate in the study.\n* Beneficiary of a social security system.\n\nExclusion Criteria:\n\n* Patient not followed in the fertility observatory.\n* Inability of the patient to undergo the medical follow-up of the trial for geographical, social or psychological reasons.\n* Patient opposed to her participation in the study.\n* Patient under guardianship or curatorship.",{"count":386,"type":22},270,"This is an observational, single-center, longitudinal cohort study. In order to evaluate the gonadotoxicity of chemotherapy, an AMH monitoring was initiated in 2006 in our fertility observatory in young patients with lymphoma before, during and after chemotherapy. This study is part of the project \"She will get better and then want a child\" and is supported by the ARS hauts de France (n° DOS\u002FSDES\u002FAR\u002FFIR\u002F2019\u002F282). Our first study published in 2010 shows that AMH decreases sharply during chemotherapy, regardless of the chemotherapy protocol. At the end of chemotherapy, AMH recovery profiles differ according to the protocol received. This follow-up is therefore essential in order to adapt our practices and our preservation strategies, particularly to the type of chemotherapy. Patients are primarily concerned about their chances of subsequent pregnancy, and there is little evidence in the literature about the impact of chemotherapy on ovarian reserve and long-term fertility.\n\nThe fisrt objective of our study is to evaluate, at distance from chemotherapy, the evolution of ovarian function in patients treated for lymphoma by evaluating follicular reserve parameters (AMH and antral follicle count) at 5 and 10 years after the end of chemotherapy compared with the initial workup performed before chemotherapy and the workup performed at 12 months after the end of chemotherapy.",[389],"Lymphoma, Follicular",[391,392,393,394,395],"Ovarian reserve","chemotherapy, antimüllerian hormone, lymphoma, fertility, follicle","antimüllerian hormone, lymphoma, fertility, follicle","lymphoma","follicle",{"date":166,"type":44},{"date":398,"type":44},"2023-08-22",{"date":223,"type":22},{"name":50,"class":51},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":150,"enrollmentInfo":409,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":421,"locationsCount":52},"100483600","blood-screening-for-adult-colorectal-cancer-100483600","NCT05577143","Blood Screening for Adult Colorectal Cancer","Evaluation of the Discriminatory Role of Blood TFPI-1 and TFPI-2 in Adult Colorectal Cancer","BACCHUS","Inclusion Criteria:\n\n* Patients with suspected colorectal cancer for which colonoscopy is indicated.\n* Patients between 50 and 75 years old, asymptomatic from the digestive point of view (for example referred for colonoscopy as part of a pre-operative check-up of an inguinal hernia or 3 months after an episode of complicated sigmoiditis), for whom a follow-up colonoscopy is indicated.\n\nNote.\n\n* If the post-inclusion colonoscopy is normal, no biopsy will be performed and patients will be assigned to the control group.\n* If the colonoscopy performed after inclusion is abnormal (presence of at least one mucosal lesion), patients will be assigned to the \"colorectal cancer\" group or to the \"polyps\" group depending on the results of the anatomopathological analysis of the lesion(s)\n\nExclusion Criteria:\n\n* All clinical situations outside of CRC that could increase TFPI-1 or 2 blood levels: acute coronary syndrome (unstable angina, acute myocardial infarction), severe sepsis, decompensated cirrhosis, pregnancy, chronic inflammatory bowel disease (Crohn's or ulcerative colitis), colitis or radiation rectitis.\n* Endoscopic polypectomy without prior histological confirmation.\n* Emergency (occlusion or peritonitis)\n* Minor patients.\n* Persons of full age under legal protection or unable to express their consent\n* Persons not affiliated to a social security system or beneficiaries of such a system.\n* Pregnant women, women in labor or nursing mothers.",{"count":410,"type":22},303,"Multicenter, inter-regional, case-control study with the primary objective of evaluating the discriminative power of the blood biomarker TFPI-1 to separate patients with histologically proven CRC from an asymptomatic control population between 50 and 75 years of age with normal colonoscopy.",[413],"Cancer Colorectal",[415,416],"Oncology","Biology",{"date":166,"type":44},{"date":419,"type":44},"2023-03-23",{"date":270,"type":22},{"name":50,"class":51},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":430,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":4},"100476981","performance-for-french-pediatric-intensive-care-units-100476981","NCT05491018","Performance for French Pediatric Intensive Care Units","Creation of a Composite Indicator of Clinical and Economic Performance for French Pediatric Intensive Care Units","QUAL-REAPED","Inclusion Criteria:\n\n* All patients under 18 years of age admitted to the 14 pediatric intensive care units and voluntarily participating in the project will be included in the study.\n\nExclusion Criteria:\n\n\\- Children of age of reason or parents\u002Flegal guardians of children refusing participation in this project will be excluded from the study.",{"count":431,"type":22},13270,"Introduction. The measurement of severity scores in adult and pediatric resuscitation provides a tool for evaluating the clinical performance of resuscitation services. No pediatric studies have investigated the association between current procedure and diagnostic cost indices with pediatric ICU patient severity and mortality.\n\nObjectives. The main objective of this project in real-life situations, in 14 French pediatric intensive care units, is to validate the recently available PIM3 and PRISM IV severity scores, which take into account the clinical dimension of performance in pediatric intensive care.\n\nThis project is a French multicenter prospective observational research project involving 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP). All patients under 18 years of age admitted to the 14 pediatric intensive care units affiliated with the GFRUP and voluntarily participating in the project will be included in the study.\n\nExpected outcomes are: Validation of PIM3 and PRISM IV scores in a French population to assess clinical performance. To develop a predictive model of mortality and a predictive model of cost in French pediatric intensive care units.",[434],"Severity of Illness Index",[436,437,438,439,440],"Pediatric","intensive care","Severity of Illness","economic","scoring system",{"date":166,"type":44},{"date":443,"type":22},"2027-01",{"date":445,"type":22},"2027-10",{"name":50,"class":51},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":359,"sex":18,"minAge":455,"maxAge":456,"enrollmentInfo":457,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":459,"conditions":460,"keywords":463,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":52},"100470452","biomarkers-for-invasive-mucormycosis-100470452","NCT05406037","Biomarkers for Invasive Mucormycosis","Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera","BIM","Inclusion Criteria:\n\n* Men and women\n* Age : Children and adults from 3 to 64 years old (18 to 64 for controls)\n* In patients whose consent has been collected after information. In the case of children, information on the study will be given to the holders of parental authority and then to the child to obtain their consent.\n* Patient social insured\n* Specific medical conditions :\n\n  1. For the case group :\n\n     Any patient hospitalized in one of the departments of the University Hospital of Lille, in which the diagnosis of mucormycosis was conducted on the following criteria:\n     * Conventional mycology data and \u002F or\n     * Positivity of q-PRC and \u002F or\n     * Anatomopathologic diagnosis Associated with a compatible clinical situation\n  2. For the control group 1 Patient assessed for hematopoietic stem cell transplantation, considered at risk for IFI but for whom the pre-transplantation review will have excluded an ongoing infection\n  3. For control group 2 Any patient hospitalized in a department of Lille University Hospital, in which the diagnosis of disseminated candidiasis or invasive pulmonary aspergillosis has been made according to specific classifications (EORTC\u002FMSG criteria, AspICU criteria)\n\nExclusion Criteria:\n\n* Patients for whom the inclusion criteria are not met\n* Co-infection mucormycosis\u002Fother IFI","3 Years","64 Years",{"count":458,"type":22},100,"Mucormycosis (MM) is one of the main invasive fungal infection (IFI), and is determined by filamentous fungi belonging to the order of Mucorales, with a mortality rate ranging from 20 to 60% according to localization. Prompt initiation of adequate antifungal therapy is critical for treating mucormycosis. Early diagnostic is therefore essential. The presence in the Mucorales' cell wall of uncommon monosaccharides open interesting perspectives for the development of specific diagnostic biomarkers.\n\nThis study evaluate a diagnostic test for mucormycosis in a cohort of patients with MM and in control groups (high-risk patients without MM and patients with another IFI).",[461,462],"Mucorales Infection","Mucormycosis",[462,464,465,466],"Invasive fungal infection","Cell wall oligo\u002Fpolysaccharides","Biomarkers",{"date":166,"type":44},{"date":469,"type":44},"2023-11-29",{"date":471,"type":22},"2026-07",{"name":50,"class":51},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":496,"locationsCount":497},"100460246","mobility-disorders-assessment-in-patients-with-mild-cognitive-disorders-100460246","NCT05273125","MOBility Disorders Assessment in Patients With Mild COGnitive Disorders","Multimodal and Longitudinal Assessment of MOBility Disorders in Patients With Mild COGnitive Disorders","COG-MOB","Inclusion Criteria:\n\n* Patient being diagnosed with MCI, according to the 2011 criteria\n* Able to walk 4 meters with or without technical assistance\n* Comprehension of French language allowing the realization of the neuropsychological assessment\n\nExclusion Criteria:\n\n* Severe visual or hearing impairment that does not allow the assessment\n* Severe pathology that makes follow-up impossible\n* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security insurance, refusal to sign consent form\n* Under legal protection (guardianship, curatorship, safeguard of justice)",{"count":482,"type":22},417,"Mild cognitive impairment (MCI) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. Sixteen percent of community-dwelling older people (over 65 years) live with MCI. They are both cognitively and physically vulnerable. From a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. From a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with MCI. Falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. In the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with MCI.\n\nThe research goals of this project are 1) to identify specific predictors for falls in clinic attendees with MCI in preparation for a definitive, fully powered study across France, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in MCs, whatever its setting and location.\n\nWe aim to prospectively follow-up people diagnosed with MCI and aged above 65 years old in four MCs in France (three in the North (one community-based MC), and one in the Centre) for one year.",[485],"Cognitive Dysfunction",[487,488,489,490,491],"Mild Cognitive Impairement","Falls","Predictive factors","Elderly","Gait disorders assessment.",{"date":166,"type":44},{"date":494,"type":44},"2022-09-09",{"date":221,"type":22},{"name":50,"class":51},2,{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":359,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":52},"100411598","genetic-fronto-temporal-dementia-initiative-in-lille-100411598","NCT04639622","GENetic Fronto Temporal Dementia Initiative in Lille","GENFI-LILLE","Inclusion Criteria:\n\n* The participant must be 18 years old or older.\n* The participant must be a member of a family with a known pathogenic mutation in the GRN or MAPT genes, or with a pathogenic expansion in the C9orf72 gene :\n\n  * An affected member is one who has been clinically diagnosed by a neurologist as having frontotemporal dementia or a disorder in the FTD spectrum.\n  * An at-risk member is one who is a first-degree relative of a family member affected with the disease.\n  * Pathogenicity of a GRN or MAPT mutation is defined by those included within the GENFI list of FTD mutation. If a novel mutation is discovered that is likely to be pathogenic and has not yet been included within the FTD mutation database then the GENFI Genetics Core will decide on inclusion. Please send an email to the GENFI Trials Team at genfi@ucl.ac.uk.\n  * A pathogenic C9orf72 expansion is defined as greater than 30 repeats. Intermediate expansions are not considered pathogenic.\n  * Participants from one of the small number of families around the world in which 2 (or more) pathogenic mutations have been found should not be included in GENFI.\n* If the participant is demented or cognitively impaired there must be an available caregiver that can escort them.\n* The participant must have an identified informant.\n* The participant must be fluent in the language of their country of assessment.\n* The participant accepts that genetic analysis will be carried out on his\u002Fher blood samples, and that no results will be available neither for the investigator nor for the participant.\n\nExclusion Criteria:\n\n* Participant has another medical or psychiatric illness that would interfere in completing assessments.\n* Contraindications to FDG-PET (allergy to FDG…)\n* Participant is pregnant.",{"count":362,"type":22},[95],"GENFI Lille is a French cohort that belongs to the international initiative GENFI2, a five year longitudinal biomarker cohort study of genetic FTD and its associated disorders (including MND\u002FALS) investigating members of families with a known mutation in GRN or MAPT or an expansion in C9orf72 (including those affected with the disorder as well as at-risk members of families).",[509],"Frontotemporal Dementia",[509,511,512,513],"Biomarker","Social cognition","Genetic mutation",{"date":166,"type":44},{"date":516,"type":44},"2019-04-23",{"date":518,"type":22},"2027-04-23",{"name":50,"class":51},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":535,"locationsCount":52},"100403241","blood-concentration-in-lorazepam-and-treatment-in-adult-catatonia-100403241","NCT04530734","Blood Concentration in Lorazepam and Treatment in Adult Catatonia","PHARMAPREDICAT","Inclusion Criteria:\n\n* catatonia according DSM-5\n\nExclusion Criteria:\n\n* Subject is less than 18 years of age\n* Subject is pregnant at the time of the study\n* Subject\u002Flegal guardian unwilling to participate in the study",{"count":458,"type":22},"Catatonia is a severe form of psychomotor disturbance with a heterogenous presentation. It affects approximately 10% of acute psychiatric inpatients. According to the fifth edition of DSM-5 the diagnosis of catatonia can be made when three or more symptoms from the twelve following are present : catalepsy, waxy flexibility, stupor, agitation, mutism, negativism, posturing, mannerisms, stereotypies, grimacing, echolalia, echopraxia. It can occur in various psychiatric diseases, including mood disorders or schizophrenia, but also in various non-psychiatric disorders \\[metabolic disturbances, viral infections (including HIV), typhoid fever, heat stroke, and autoimmune disease\\].\n\nBenzodiazepines, especially LORAZEPAM, are the most common initial treatment, with a remission rate of approximately 70-80 %, regardless of the cause or the clinical manifestations. This first line treatment is titrated gradually according to the therapeutic response over a few days up to 20-25 mg per day. Electroconvulsive therapy (ECT) is initiated on patients with catatonia who do not respond to benzodiazepines.\n\nInterestingly, pharmacogenetic variants can alter the metabolism of lorazepam (e.g., the UGT2B15 \\* 2 allele slows it down).\n\nThe main objective of this study is to assess the link between clinical response to lorazepam, residual plasma concentrations of lorazepam after 72 hours of fixed dosage, and the existence of genetic polymorphisms modifying the metabolism of lorazepam. Our hypothesis is that non-responding patients have lowered blood concentrations of lorazepam associated to a genetic profile of rapid metabolism. Evaluating the predictive factors of the response to treatment would allow early and precise identification of non-responder patients in order to adapt their first-line treatment.",[530],"Catatonia",{"date":166,"type":44},{"date":533,"type":44},"2020-01-01",{"date":443,"type":22},{"name":50,"class":51},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":150,"enrollmentInfo":544,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":52},"100393252","study-of-alcohol-related-liver-disease-in-europe-100393252","NCT04400604","Study of Alcohol-related Liver Disease in Europe","Evaluation of the Natural History of Alcoholic Liver Disease According to Baseline Severity","SALVE","Inclusion Criteria:\n\n* Active alcohol excessive consumption defined as \\> 210 g per week for men and\\> 140 g per week for women during the previous year.\n* Patients with high risk of alcoholic-related liver disease can be included only if the following assessment were available: Abdominal Ultrasound \u002F Ultrasound elastography pulse (FibroScan®) \u002F FibroTest®, AshTest® and LCR1-LCR2® (cost will be supported by Biopredictive) \u002F Non-patented methods: Forns Index; Fib-4, Hepascore®\u002F Absolute values should be provided for all these methods.\n\nFor patient in whom liver stiffness measurements were uninterpretable (unavailable results) only those with FibroTest® and LCR1 and LCR2 measurements can be included.\n\nResults of FibroScan® were considered unavailable based on following criteria: When no value was obtained after at least 10 shots (valid shot=0) OR If SR (Success Rate), the ratio of valid shots to the total number of shots at least 60% OR IQR (InterQuartil Range reflecting variability of measurements) less than 30% of the median LSM (Liver Stiffness Measure) value (IQR≤LSM≤30%).\n\n* Patients must provide written informed consent and agree to have blood stored for the study and tissue stored for those in whom physicians performed liver biopsy according their clinical practice.\n* Patients should agree to participate for at least 5-year follow-up.\n* Patients with social insurance\n\nExclusion Criteria:\n\nFor all study groups, the following exclusion criteria will be applied:\n\n* Evidence of other forms of known chronic liver disease including:Positive test result at baseline for hepatitis B surface antigen or positive serology of hepatitis C virus infection (regardless PCR results)\u002F Autoimmune liver disease \u002F Known or suspected HCC\n* Any previous episode of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding before current hospitalization and\u002For inclusion in the study\n* Known positivity for human immunodeficiency virus infection.\n* Terminal extrahepatic illness defined as: All conditions evolved into a clinical stage to limit the patient's functional status (e.g.: heart failure, renal failure, neurological or respiratory diseases, or any other disabling diseases etc. …).\n* Other medical conditions that may diminish life expectancy to \\\u003C2 years.\n* Known extra-hepatic cancers with the exception of basal cell skin cancer.\n* Any other condition that, in the opinion of the Investigator, would impede completion of the study (eg: Homeless, non-compliant patients…).\n* Mental instability or incompetence, such that the validity of informed consent is uncertain.\n* Lack of informed consent or refusal to participate for follow up evaluation.\n* A condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.\n* Pregnant or lactating women",{"count":545,"type":22},7500,"Alcohol-induced liver injury is made up of fatty liver, fibrosis and alcoholic hepatitis (AH), elementary lesions that may occur separately, simultaneously or sequentially in a same patient. Among these histological features, alcoholic hepatitis, a necro-inflammatory process is associated with the fastest fibrosis progression leading to cirrhosis in 40% of cases and a pivotal lesion driving increased risk of liver decompensation.\n\nThe non-invasive methods for the diagnosis of fibrosis open new perspectives for a better understanding of the natural history of disease-progression from early injury to the cirrhotic stage, for the identification of subgroup patients at risk of developing cirrhosis at medium term and for proposing a strategy of screening of patients with extensive cirrhosis at risk of liver-threatening events. There is an urgent need to perform studies in asymptomatic heavy drinkers in order to identify cut-offs associated with significant risk of development of cirrhosis at medium term. Such objectives require large-scale screening of heavy drinkers. Each of non-invasive methods have been tested to predict with of extensive fibrosis with a high predictive performance as shown below.\n\nA screening policy cannot be accepted without answering the following questions: a) are the requirements of public health screening fulfilled? b) Is the group of patients undergoing screening defined? c) is there a reliable method for of testing? Indeed, the detection of a disease is subject to certain public health requirements and may be proposed to health authorities only if it modifies the management of subjects screened. In the specific case of mass screening of liver fibrosis in heavy drinkers, only the detection of extensive fibrosis could fulfill this criterion because of the potential survival benefit resulting from the screening of hepatocellular carcinoma (HCC) in patients with extensive fibrosis. Indeed, recent studies have found that the probability of receiving curative treatment of HCC was significantly higher in patients who received a six-month surveillance ultrasound. Therefore, the detection of extensive fibrosis seems reasonable in the light of these studies when considering that the yearly risk of development of HCC in the subgroup of heavy drinkers with extensive fibrosis is approximately 3%.\n\nTaking into account the above scientific arguments, the most recent EASL clinical practical guidelines on ALD recommend longitudinal studies using non-invasive tools to evaluate screening of extensive fibrosis and disease progression in heavy drinkers.",[548],"Alcoholic Liver Disease",{"date":166,"type":44},{"date":551,"type":44},"2021-03-03",{"date":553,"type":22},"2032-03",{"name":50,"class":51},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":564,"conditions":565,"keywords":567,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":576,"locationsCount":577},"100377426","signature-of-the-risk-profile-of-mortality-in-a-hospital-cohort-of-patients-with-metabolic-diseases-100377426","NCT04194372","Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases","INTEGRA","Inclusion Criteria:\n\n* Diabetic: antecedent - treatment - or glycemia\\> = 1.26 g \u002F dl - or HbA1C\\> = 6.5% and or\n* Obese: BMI\\> = 30 and or\n* Metabolic syndrome defined AND\n* Patient having given written consent to participate in the study or collection of the consent of the witness\n* Social insured patient (excluding AME)\n* Patient willing to comply with all procedures of the study and its duration AND\n\nPatient also presenting a pathology among:\n\n* Cardiology:\n\n  * Coronary patient(history of myocardial infarction, coronary bypass, or coronary angioplasty or stenosis greater than 50% on an epicardial vessel documented on coronary angiography)\n  * Patient with systolic or diastolic heart failure\n  * Patient with atrial fibrillation\n  * Patient with aortic stenosis (Vmax\\> 2.5 m \u002F s)\n  * Patient with high blood pressure\n* neurology:\n\n  * ischemic stroke\n  * intracerebral hemorrhage\n  * transient ischemic attack\n* diabetology:\n\n  * Obesity without diabetes\n  * Diabetes T2\n  * T1 diabetes\n  * Monogenic Diabetes \u002F MODY\n  * African Diabetes\n  * Diabetes secondary to pancreatopathy \u002F liver cirrhosis\n  * Diabetes post transplantation \u002F post immunotherapy\n  * Diabetes associated with Steinert's disease\n* hepatology: hepatological pathology\n* nephrology: nephrology\n\nExclusion Criteria:\n\n* Unscheduled hospitalization less than 3 months old\n* Ongoing treatment :\n\n  * Cytotoxic chemotherapy\n  * Radiotherapy\n* HIV and \u002F or HCV and \u002F or active HBV infection\n* OMS score\\> = 2\n* Pregnant woman",{"count":563,"type":22},10000,"Epidemiological studies are usually conducted in the general population in adults without complications or pathology at baseline. The results obtained are therefore often better designed for primary prevention use. The prediction of mortality risk in patients with complications and requiring hospital follow-up is less well known.\n\nThe study purpose is to determine a mortality risk profile in a hospital cohort of patients with pathologies associated with metabolic diseases.\n\nToday the \"multimaker\" scores based on a panel of biomarkers - have significantly improved the discriminating power of prediction models existing in many pathologies. It is no longer a single biomarker that can improve risk prediction but a complete and cross-sectional profile that is sought after. We aim to establish a personalised mortality risk profile by combining clinical and biological parameters including metabolomics, genetics, transcriptomics and epigenomics by high throughput screening of biological samples.",[566],"Metabolic Disease",[568,569,570,571],"Diabetic","CardioVascular Disease","morbi-mortality","Hospital Cohort",{"date":166,"type":44},{"date":574,"type":44},"2019-12-20",{"date":194,"type":22},{"name":50,"class":51},3,{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":52},"100345145","comparison-of-inflammatory-profiles-and-regenerative-potential-in-alcoholic-liver-disease-100345145","NCT03773887","Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease","TargetOH","Inclusion Criteria:\n\n* group A: patients with acute alcoholic hepatitis\n* Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (\\> 60 g per day for men and\\> 40 g per day for women)\n* Moderate elevation of transaminases (less than 500 U \u002F L) with a typical ASAT \u002F ALAT ratio of 2: 1\n* Bilirubin\\> 50 mg \u002F l\n* Absence of autoimmune liver disease (ANA \\\u003C1\u002F80, AML \\\u003C1\u002F80, LKM1 neg, AAM neg)\n* Absence of hepatitis B and C and HIV infection (negative anti-HIV antibodies, negative HBsAg, negative HCV PCR)\n* Patients with other acute complications than alcoholic hepatitis may be included (eg, digestive hemorrhage, acute renal failure, infection, etc.)\n* Because there is no validated noninvasive tool for the diagnosis of alcoholic hepatitis, histological confirmation is required in all patients (preferably by transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histological characteristics: Hepatocellular lesions (ballooning, Mallory body)\u002F Inflammatory infiltrate with polymorphonuclear neutrophils\n* group B1: patients with alcoholic cirrhosis\n* Decompensated or non-decompensated alcoholic cirrhosis, defined according to the HAS guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments (www.has-sante.fr)\n* group B2: patients free from chronic liver disease\n* Justification of blood and liver sampling for the management of a pathology other than chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy liver)\n\nExclusion Criteria:\n\n* For groups A and B1:\n* Patients with hepatocellular carcinoma of progressive non-hepatic cancer\n* Presence of HBsAg\n* Presence of anti-HCV antibodies by positive PCR\n* Presence of antibodies to HIV 1 +2\n* Pregnancy\n* for group B2:\n* Alcoholic liver disease\n* Presence of HBsAg\n* Presence of anti-HCV antibodies by positive PCR\n* Presence of antibodies to HIV 1 +2\n* Pregnancy","70 Years",{"count":587,"type":22},450,[95],"The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease",[591,592],"Liver Diseases","Acute on Chronic Hepatic Failure",{"date":166,"type":44},{"date":595,"type":44},"2014-12-25",{"date":597,"type":22},"2027-09",{"name":50,"class":51},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":91,"minAge":607,"maxAge":150,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":614,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":625},"100344544","laparoscopic-preventive-prerectal-mesh-100344544","NCT03766048","LAparoscopic Preventive PRErectal Mesh","Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse","LAPREM","Inclusion Criteria:\n\n* Women with a urogenital prolapse (anterior wall and\u002For uterus or vaginal apex) stage = 2 (Ba and\u002For C points ≥ - 1 cm using the POP-Q system),\n* without significant posterior vaginal wall prolapse (Bp \\\u003C -1 cm when apical prolapse is reduced using a retractor leaving the posterior vaginal wall free),\n\nExclusion Criteria:\n\n* Previous surgical repair for Pelvic Organ Prolapse\n* Any associated prolapse requiring any non-authorized additional surgical repair (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy, salpingectomy, myomectomy, or suburethral vaginal tape.)\n* Wish for future pregnancy\n* Lack of health insurance\n* Woman not reading French or unable to consent\n* Woman under law protection","40 Years",{"count":609,"type":22},834,[95],"Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%).\n\nThe benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 LS with double-mesh (anterior \\& posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p\\\u003C0,01), and total recurrence rates 16.2 vs. 43.8% (p\\\u003C0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since).\n\nOn the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.",[613],"Urogenital Prolapse",[615,616,617,618],"Urogenital prolapse","laparoscopic sacropexy","mesh","medico-economic study",{"date":166,"type":44},{"date":621,"type":44},"2019-09-11",{"date":623,"type":22},"2026-12",{"name":50,"class":51},9,{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":637,"conditions":638,"keywords":641,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":625},"100341627","von-willebrand-factor-point-of-care-testing-to-improve-minimally-invasive-tavi-outcomes-100341627","NCT03728049","Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes","Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI","WITAVI-REAL","Inclusion Criteria:\n\n* All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.\n* Symptomatic aortic stenosis scheduled to undergo TAVI\n* TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia\u002Fconscious sedation; no TEE guidance.\n* All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted\n\nExclusion Criteria:\n\n* TAVI through non-transfemoral approach\n* TAVI with concomitant percutaneous coronary intervention\n* TAVI performed under general anesthesia\n* TAVI performed under TEE guidance\n* Valve-in-valve procedure\n* Inability to provide informed consent\n* Associated ≥ moderate mitral regurgitation\n* Peri-procedural treatment with ticagrelor or prasugrel treatment \u002F direct oral anticoagulant",{"count":635,"type":22},944,[95],"Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.\n\nThe hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).",[639,640],"Aortic Valve Stenosis","Aortic Valve Insufficiency",[642,643,644,511,645,646],"Transcatheter Aortic Valve Replacement","Paravalvular regurgitation","Point-of-care test","Aortic stenosis","Von willebrand Factor",{"date":166,"type":44},{"date":649,"type":44},"2019-12-18",{"date":623,"type":22},{"name":50,"class":51},""]