[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital, Rouen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":562},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,99,0,25,[9,43,75,99,127,148,168,192,213,233,256,276,294,314,333,351,370,388,412,431,451,471,491,517,541],{"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":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100593807","alloreactive-memory-b-lymphocytes-and-anti-hla-sensitization-100593807",false,"NCT07011238","Alloreactive Memory B Lymphocytes and Anti-HLA Sensitization","Alloreactive Memory B Lymphocytes and Anti-HLA Sensitization in Kidney Transplantation","ALLO-BMEM","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Rouen University Hospital patient monitored in the Nephrology and Kidney Transplantation Department, registered on the national kidney transplant waiting list\n* Carrier of HLA antibodies, including at least anti-HLA2, identified during the last screening\n* Notion of classic immune-promoting events including at least one previous transplant or pregnancy, or absence of a known immune-promoting event (naïve patient group)\n* Incompatible graft rate (IGR)\n\n  * IGR ≥ 85% (hyperimmunized patient group with anti-HLA polyreactivity) or\n  * IGR between 50% and 85% (immunized patient group with a more restricted repertoire of HLA reactivities) or\n  * IGR \\\u003C 50% (naïve patient group with no known history of immune-promoting events)\n* Person who has read and understood the information letter and does not object Not participating in the study\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Patients who have received rituximab in the previous year (B-cell depleting therapy)\n* Patients undergoing an HLA desensitization protocol using plasmapheresis and\u002For rituximab\n* Patients with an active infection\n* Persons deprived of their liberty by an administrative or judicial decision or persons placed under judicial protection\u002Fguardianship or curatorship","ALL","18 Years",{"count":21,"type":22},51,"ESTIMATED","1 Day","OBSERVATIONAL","In transplantation, B lymphocytes are major cellular players in the alloreactive humoral response through the production of antibodies targeting allogeneic HLA molecules expressed by the transplant. In subjects sensitized to HLA antigens, the contribution of pre-existing alloreactive memory B lymphocytes (Bmem) to allograft rejection phenomena after transplantation is now recognized. It has been proposed that the identification of these Bmem during the pre-transplant period could contribute to a better assessment of post-transplant immunological risk, allowing optimization of strategies to prevent humoral rejection. However, knowledge regarding the phenotypic and functional heterogeneity of Bmem as well as their clonal diversity is still extremely limited, not allowing discrimination between pathogenic and non-pathogenic alloreactive humoral responses. Such discrimination requires a better understanding of the modalities of differentiation of alloreactive B lymphocyte responses. To this end, this study aims to characterize the clonal, phenotypic and functional properties of alloreactive Bmem in subjects awaiting renal transplantation and sensitized to HLA antigens.",[27],"Kidney Transplant",[29],"B lymphocytes","RECRUITING","2026-06-17",{"date":33,"type":34},"2026-06-22","ACTUAL",{"date":36,"type":34},"2023-04-17",{"date":38,"type":22},"2028-06-17",{"name":40,"class":41},"University Hospital, Rouen","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100579319","phase-3-fosfomycin-for-male-urinary-tract-infection-100579319","NCT06822751","FOsfomycin for Male Urinary Tract Infection","Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care","FOMUTI","Inclusion Criteria:\n\n* Men aged 18 years or older.\n* Consulting in a primary care setting.\n* Suspected of having a male urinary tract infection (MUTI) by the investigating physician and presenting at least one recent acute symptom (\\\u003C 3 months) from the following:\n\n  * Lower urinary tract symptoms: dysuria, urgency, frequency, hematuria.\n  * Pelvic pain unrelated to urination: suprapubic, perineal, or urethral pain.\n* Patient has read and understood the information letter and signed the informed consent form.\n* Affiliation with a social security system or beneficiary of such a system.\n* No history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him\u002Fher from giving informed consent\n\nExclusion Criteria:\n\n* Presence of one or more criteria for severity of infection\n\n  * Severe sepsis or septic shock defined by a qSOFA score ≥ 2\n  * or\u002Fand systolic BP less than 100 mmHg: non-inclusion criterion\n  * or\u002Fand temperature \\\u003C 36°C or \\> 38°C\n  * or\u002Fand diagnosis of pyelonephritis (pain on lumbar percussion)\n  * or\u002Fand presence of abdominal guarding\u002Fcontraction\n  * or\u002Fand presence of a bladder globe above the pubic bone: (suspected acute retention of urine)\n  * or\u002Fand known immunosuppression: any immunosuppressive treatment (including corticosteroid therapy \\> 10 mg\u002Fd for more than 5 days), neutropenia (PNN \\\u003C 500\u002FmL) severe malnutrition (albumin \\\u003C 30 and\u002For BMI \\\u003C 16),\n* No diagnosis of male urinary tract infection in the last 3 months,\n* No ongoing chronic prostatitis,\n* Known urinary tract abnormality: urinary tract lithiasis, vesico-ureteral reflux, prostate or urinary tract cancer, prostate adenoma treated medically or surgically, urinary tract malformation (including single kidney and urethral stricture).\n* Acute retention of urine and indication for surgical or interventional drainage\n* Hyperalgesic form\n* Urinary tract infection associated with care, on urinary catheter or suprapubic catheter\n* Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation less than 3 months old\n* Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation less than 3 months old\n* Severe disease or high probability of death within 3 months,\n* Hypersensitivity to fosfomycin trometamol or to any of the excipients (notable excipients: sucrose, dextrose (source of glucose), maltodextrin (source of glucose), orange yellow colouring S (E110)),\n* End-stage renal disease (creatinine clearance \\\u003C10 mL\u002Fmin),\n* Patients with glucose and galactose malabsorption syndrome or sucrase\u002Fisomaltase deficiency (rare hereditary disease)\n* Antibiotic taken within 72 hours of diagnosis of male urinary tract infection,\n* Major cognitive impairment,\n* Person deprived of liberty by an administrative or judicial decision or person placed under court protection \u002F sub- guardianship or curatorship\n* Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent the subject from giving informed consent.\n* Known non-adherence to treatment,\n* Simultaneous participation in another interventional clinical study,\n* Cannot be taken orally (vomiting)","MALE",{"count":53,"type":22},138,"INTERVENTIONAL",[56],"PHASE3","Male urinary tract infections (MUTI) are often less recognised compared to those in women. French clinical guidelines practices recommend the use of antibiotics called fluoroquinolones, which are highly effective in treating MUTIs. However, these antibiotics can lead to rare but serious side effects, such as tendonitis or heart rhythm disturbances. Additionally, fluoroquinolones can contribute to the development of bacterial resistance, making their use inadvisable within six months of treatment.\n\nIn response to these concerns, we aim to explore a well-established alternative, fosfomycin trometamol (known by the brand name MONURIL®). This antibiotic has a strong track record in treating UTIs in women, with well-documented benefits and minimal associated risks.\n\nThe primary goal of this study is to assess the effectiveness of fosfomycin trometamol in treating urinary tract infections in men, as well as to evaluate any potential treatment failures.",[59,60,61],"Urinary Tract Infection","Prostatitis","Cystitis",[63,61,59,64,65],"Men","Anti-infective agents, urinary","Fosfomycin","NOT_YET_RECRUITING","2026-06-11",{"date":69,"type":34},"2026-06-12",{"date":71,"type":22},"2026-07",{"date":73,"type":22},"2029-10",{"name":40,"class":41},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":42},"100634150","prospective-exploration-of-vascular-complications-associated-with-the-use-of-immune-checkpoint-inhibitors-100634150","NCT07535944","Prospective Exploration of Vascular Complications Associated With the Use of Immune Checkpoint Inhibitors","Prospective Exploration of Vascular Complications Associated With the Use of Immune Checkpoint Inhibitors in Cancer Treatment: a Multidimensional Study of a Patient Cohort","ICI-Vasc","Inclusion Criteria:\n\n* Patient treated with an ICI (nivolumab, pembrolizumab, atezolizumab, ipilimumab, cemiplima, or any novel antibody directed against PD-1, PD-L1, CTLA-4, or LAG-3) as monotherapy or in combination with another ICI or with radiotherapy,\n* Patient over 18 years of age,\n* WHO performance status: 0 to 2,\n* Oral informed consent,\n* Patient affiliated with or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* History of ICI treatment,\n* History of chemotherapy or targeted therapy within the last 4 weeks,\n* Stage 4 PAD,\n* Severe Raynaud's syndrome,\n* Removal of both hands and\u002For both feet,\n* Removal of the right hand\u002Fleft foot or the left hand\u002Fright foot,\n* Patient deprived of liberty by an administrative or judicial decision or patient under legal protection, guardianship, or curatorship,\n* Pregnant or breastfeeding woman,\n* Patient unable to understand the study for any reason or to comply with the trial requirements (language barrier, psychological, geographical, etc.).",{"count":84,"type":22},200,"The development of immune checkpoint inhibitors (ICIs) has revolutionized the management of many oncological diseases, and their use continues to increase. ICIs are monoclonal antibodies that target immune checkpoints such as PD-1 (programmed cell death protein 1, as seen in nivolumab, pembrolizumab, and cemiplimab), PD-L1 (programmed cell death protein 1 ligand, as seen in atezolizumab, avelumab, and durvalumab), CTLA-4 (cytotoxic T-lymphocyte antigen 4, as seen in ipilimumab and tremelimumab), or LAG-3 (lymphocyte-activating gene 3, as seen in relatlimab), which play a crucial role in immune tolerance to cancer cells.\n\nHowever, the surge in ICI prescriptions has been accompanied by the occurrence of numerous side effects, some of which are severe or even fatal. ICIs have a different toxicity spectrum than conventional chemotherapy, and most toxicities result from excessive immunity against different organs.\n\nThis immune-mediated toxicity can affect various organ systems, including the heart and blood vessels. Pharmacovigilance data from clinical trials conducted by Bristol-Myers Squibb, which marketed ipilimumab (anti-CTLA-4) and nivolumab (anti-PD1), revealed 18 cases (0.09%) of myocarditis among 20,594 subjects.\n\nWhile cardiac complications induced by immune checkpoint inhibitors (ICIs), particularly autoimmune myocarditis, are widely described, the impact of these treatments on the vascular system remains poorly understood. However, a variety of vascular complications have been reported, ranging from vasculitis of large, medium, and small vessels to a possible increase in arterial thrombotic events, ischemic strokes, and acute coronary syndromes.\n\nThe incidence of vasculitis appears to be between 1% and 2% of patients treated with immune checkpoint inhibitors (ICIs). This is emerging as a significant signal in various pharmacovigilance studies, suggesting the involvement of immune checkpoint derepression in the pathophysiology of vasculitis. A translational study demonstrated the major role of CTLA-4 in the pathophysiology of giant cell arteritis (GCA), although the precise mechanisms involved remain to be determined. Therefore, a specific immune environment could promote the development of vasculitis, a phenomenon reproduced by ICI administration.\n\nThe increase in arterial thrombotic vascular events was primarily observed in a matched cohort study, which showed a threefold increased risk of arterial thrombotic vascular events following the initiation of ICI therapy. These thrombotic events would coincide with the acceleration of atherosclerosis in patients treated with ICIs. This \"accelerated\" atherosclerosis could be linked to inflammatory changes within the plaques, causing plaque destabilization or rupture. It is also unreasonable to rule out the possibility that the accelerated atherosclerosis is related to the development of vasculitis in these patients.",[87],"Vascular Complications",[89,90],"immune checkpoint inhibitors","cancer therapy","2026-06-08",{"date":93,"type":34},"2026-06-10",{"date":95,"type":22},"2026-06-01",{"date":97,"type":22},"2031-06-01",{"name":40,"class":41},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":19,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":42},"100604573","impact-of-ehlers-danlos-syndrome-on-gynaecological-health-100604573","NCT07151274","Impact of Ehlers-Danlos Syndrome on Gynaecological Health","Impact of Ehlers-Danlos Syndrome on Gynaecological Health: Focus on the Prevalence of Dysmenorrhoea","GYNESED","Inclusion Criteria:\n\n* Women aged 18 or over.\n* Willing to participate voluntarily in the study via an online questionnaire.\n* Of childbearing age.\n* Reporting a diagnosis of EDS (all types) or not having EDS (control group) and being part of a database of healthy volunteers.\n\nExclusion Criteria:\n\n* Minors (\\\u003C 18 years old).\n* Menopausal women\n* People who do not understand French well enough to complete the questionnaire.\n* Uncertain diagnosis of EDS (exclusion of participants who suspect EDS but without medical confirmation).",true,"FEMALE","50 Years",{"count":111,"type":22},156,"Dysmenorrhea is a common problem in gynaecology, significantly impacting patients' quality of life. Ehlers-Danlos syndrome (EDS) is associated with joint hypermobility, tissue fragility and chronic pain. Some studies suggest an increased prevalence of gynaecological disorders, including dysmenorrhea, in patients with EDS. However, data remain limited and few studies have compared the intensity and characteristics of dysmenorrhea in women with EDS. There is also little data on the prevalence of other gynaecological conditions in women with EDS.\n\nThis study therefore aims to compare the severity of dysmenorrhea in patients with EDS and a control group in order to better characterise the gynaecological impact of EDS. It will also compare the prevalence of other gynaecological conditions between women with EDS and women without EDS.",[114],"Ehlers-Danlos Syndrome (EDS)",[116,117,118,119,120],"gynaecological disorder","dysmenorrhea","menorrhagia","dyspareunia","endometriosis",{"date":93,"type":34},{"date":123,"type":34},"2025-07-07",{"date":125,"type":22},"2026-08-01",{"name":40,"class":41},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":107,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100559046","determine-the-frequency-of-variants-in-the-gbapsap-genes-in-patients-with-mm-or-mgus-100559046","NCT06559033","Determine the Frequency of Variants in the GBA\u002FPSAP Genes in Patients With MM or MGUS","Determine the Frequency of Variants in the GBA\u002FPSAP Genes in Patients With Multiple Myeloma (MM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)","GAMY","Inclusion Criteria:\n\n* Major patients with multiple myeloma (MM) (defined by clonal proliferation of tumour plasma cells (\\>10%), presence of a monoclonal peak in serum or urine (excluding non-secretory myeloma) and organ involvement secondary to bone marrow invasion) or with MGUS (defined as bone marrow plasmacytosis of less than 10%, associated with a monoclonal protein of less than 30g\u002FL and no clinical involvement).\n* Membership of a social security scheme\n* Adult having read and understood the information letter and signed the consent form\n\nExclusion Criteria:\n\n* Person deprived of liberty by an administrative or judicial decision or person placed under court protection \u002F sub-guardianship or guardianship",{"count":136,"type":22},300,"No effective specific treatment is currently available for the management of Multiple Myeloma (MM) and Monoclonal Gammopathy of Undetermined Significance (MGUS). A better understanding of the pathophysiological mechanisms would make it possible to propose treatments specifically targeting the deregulated pathways.",[139,140],"Monoclonal Gammopathy of Undetermined Significance","Myeloma Multiple",{"date":93,"type":34},{"date":143,"type":34},"2025-10-07",{"date":145,"type":22},"2027-04-01",{"name":40,"class":41},2,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":107,"sex":18,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":147},"100553732","overview-of-the-mental-health-of-adolescents-in-therapeutci-educational-and-pedagogical-facilities-in-france-100553732","NCT06489912","Overview of the Mental Health of Adolescents in Therapeutci, Educational and Pedagogical Facilities in France","Etat Des Lieux de la santé Mentale Des Adolescents Suivis Par Les Dispositifs ITEP en France","PsyPreDi","Inclusion Criteria:\n\n* Adolescent aged 12 to 16\n* In a DITEP for at least 15 days\n* Minor who has been informed and has not objected to the research (according to his\u002Fher capacity)\n* At least one person exercising parental authority who has read and understood the information note and has not objected to the research OR\n* For a minor under guardianship: legal representative who has read and understood the information note and has not objected to the research.\n\nExclusion Criteria:\n\n* Minor and\u002For person(s) exercising parental authority who do not understand French\n* Holder of parental authority opposed to the search\n* Minor opposed to search","12 Years","16 Years",{"count":84,"type":22},"Assess the prevalence of various psychiatric disorders in adolescents aged 12 to 16 receiving support from therapeutic, educational and pedagogical institutes.",[161],"Mental Health Disorder",{"date":93,"type":34},{"date":164,"type":34},"2024-12-20",{"date":166,"type":22},"2026-12-31",{"name":40,"class":41},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":54,"phases":178,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100626894","evaluation-of-the-efficacy-of-ischemic-preconditioning-to-protect-against-acute-kidney-injury-after-open-surgery-for-juxtarenal-abdominal-aortic-aneurysm-100626894","NCT07441564","Evaluation of the Efficacy of Ischemic Preconditioning to Protect Against Acute Kidney Injury After Open Surgery for Juxtarenal Abdominal Aortic Aneurysm","EPAKI","Inclusion Criteria:\n\n* Patients aged 18-85 years\n* Patients with juxtarenal abdominal aortic aneurysms scheduled for open surgery\n* Patients with juxtarenal abdominal aortic aneurysms, which require suprarenal aortic cross clamping\n* Patients with juxtarenal abdominal aortic aneurysms, which are of atheromatous etiology or which developed after aortic dissection\n* Affiliation with, or beneficiary of a Social security (national health insurance) scheme\n* Adult having read and understood the information letter and signed the consent form\n* Women of childbearing potential with effective contraception according WHO definition (estrogen-progestin contraception or intrauterine device or male condom) since at least 1 month with a negative blood pregnancy test by b-HCG at inclusion.\n* Women surgically sterile (absence of ovaries and\u002For uterus or tubal ligation)\n* Postmenopausal women: confirmation of non-medically induced amenorrhea since at least 12 months prior to the inclusion visit\n\nExclusion Criteria:\n\n* Patients dependent from dialysis\n* Patients with aortic aneurysms, which require reconstruction of the visceral arteries\n* Patients with aortic aneurysms, which require supra-visceral aortic cross clamping\n* Patients with wall thrombus or calcification of inter- and suprarenal aorta\n* Patients with septic aortitis\n* Patients with aneurysm requiring stent graft (EVAR) explantation\n* Patients requiring emergency surgery\n* Patients receiving treatments that may interact with preconditioning: Nicorandil and Glibenclamide\n* Pregnant or parturient or breastfeeding woman or absence of proven contraception\n* Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or curatorship\n* Person participating to another trial during the month before randomization\n* Medical history or psychological or sensorial abnormality prone to inhibit the subject to understand the conditions required for his\u002Fher participation to the protocol or unable to give an informed consent","85 Years",{"count":177,"type":22},206,[179],"NA","Juxta-renal abdominal aortic aneurysms (AAA) are challenging to treat with standard endovascular techniques (EVAR) due to their proximity to the renal arteries. Open surgical repair continues to be used in patients unsuitable for EVAR but carries a high risk of acute kidney injury (AKI), up to 24%. Postoperative AKI is a strong predictor of both short- and long-term cardiovascular mortality. The KDIGO criteria are used to better define and stage AKI. Pharmacological prevention strategies have shown limited effectiveness, prompting interest in ischemic preconditioning (IPC). Remote IPC has shown mixed results in cardiac and vascular surgery, depending on patient risk and protocols used. Local IPC, applied directly near the renal arteries, has shown promising renal protection in animal models. However, this technique has never been clinically tested in humans. We propose here a randomized trial to assess the efficacy of local IPC before suprarenal aortic clamping during open repair of juxta-renal AAA to reduce postoperative AKI.",[182],"Aneurysm Aortic","2026-06-05",{"date":185,"type":34},"2026-06-09",{"date":187,"type":22},"2026-09-01",{"date":189,"type":22},"2029-12-01",{"name":40,"class":41},7,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":54,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":147},"100617212","understanding-and-treating-severe-and-resistant-pathological-aggression-using-deep-brain-stimulation-to-treat-resistant-aggression-100617212","NCT07315685","Understanding and Treating Severe and Resistant Pathological Aggression: Using Deep Brain Stimulation to Treat Resistant Aggression","STAR","Inclusion Criteria:\n\n* Aged between 18 and 70 inclusive\n* Patients who have been in isolation in a secure psychiatric unit for at least 50% of the time over a period of more than 6 months prior to inclusion\n* A GAF score \\\u003C21\n* An ICAP score \\\u003C40\n* Other stable medical conditions\n* No contraindications to brain imaging (MRI and CT)\n* No contraindications to taking medication for travel (loxapine and diazepam)\n* No contraindications to surgery\n* Adult who has read and understood the information letter and signed the consent form. A psychiatrist, independent of the study and treatment, will examine the patient and determine their ability to read and understand the consent form before signing. If this is not the case, authorisation may be given by the guardianship judge in accordance with Article L. 1111-6.\n* An adult assisted by their guardian or by the judge who has read and understood the information letter and signed the consent form (if the patient is under guardianship). If the guardian does not wish to give an opinion or make a decision for the patient, the guardianship judge may be consulted in accordance with Article L1223-1.\n* Patients covered by social health insurance (except AME)\n* Women of childbearing age (a woman is considered to be of childbearing age, i.e. fertile, after menarche and until she reaches menopause, unless she is permanently infertile) using at least minimally effective contraception (i.e. at least: oral progestogen-only contraception, where inhibition of ovulation is not the primary mode of action, male or female condoms with or without spermicide, diaphragm, diaphragm or sponge with spermicide) for at least 1 month and throughout the study, as well as a negative urinary pregnancy test for β-HCG at inclusion.\n* Surgically sterile women (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)\n* Menopausal women: Post-menopausal status is defined as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the post-menopausal interval may be used to confirm post-menopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhoea, a single FSH measurement is insufficient.\n\nFor schizophrenic patients\n\n* All previous treatments have failed, including the combination of clozapine (for at least 6 months with clozapine levels \\> 350 ng\u002FmL) + ECT (minimum 20 sessions)\n* Have had at least two clozapine potentiations among the following: lithium, valproic acid, beta-blockers, other antipsychotics.\n\nFor ASD patients with or without intellectual disability\n\n\\- All recommended psychoeducational measures must have been attempted with failure of the following treatments: risperidone, aripiprazole, clozapine, naltrexone, beta-blockers given for at least three months at the maximum tolerated dose.\n\nExclusion Criteria:\n\n* Minors\n* Contraindications to surgery and anaesthesia\n* Contraindications to the use of the Medical Device (diathermy, certain magnetic resonance imaging procedures, transcranial magnetic stimulation (TMS), (see section 'Contraindications' in the 'Information for Prescribers' manual for the implanted neurostimulator)\n* Contraindications to MRI and CT scans (cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, pregnancy, claustrophobia, cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, etc.)\n* Other medical problems interfering with the protocol and surgery\n* Pregnant women","70 Years",{"count":201,"type":22},6,[179],"Physical aggression can be defined as the use of force with the intention of causing physical injury, psychological damage or death. Pathological aggression may be associated with various psychiatric disorders. This symptom can often be improved by prescribing medication, implementing psychoeducational strategies or even electroconvulsive therapy. However, some patients exhibit such severe pathological aggression that they must be institutionalised because they pose a danger to themselves or others. These patients are then hospitalised in a unit for difficult patients (UMD) for enhanced therapeutic care. Despite this maximum level of care, the pathological aggression of a minority of patients persists, leading to a therapeutic impasse, confining the patient to the UMD for many years with social isolation, a collapsed quality of life, and major repercussions for the family. The aim of this project is to use deep brain stimulation, a controlled, reversible, adaptable and low-morbidity neurosurgical method, in six patients with pathological aggression suffering from either schizophrenia (n=3) or autism spectrum disorders (n=3). We hypothesise that the effects of deep brain stimulation (DBS) of the Sano triangle will significantly control the pathological aggression of these six patients.\n\nThis is a pilot study with randomised, crossover, double-blind evaluation. It will also provide answers regarding the safety of using SCP for this indication.",[205,206],"Autism Spectrum Disorder","Schizophrenia Disorder",{"date":91,"type":34},{"date":209,"type":22},"2026-07-13",{"date":211,"type":22},"2029-05-08",{"name":40,"class":41},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":54,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100611970","impact-of-reventilation-after-one-lung-ventilation-in-thoracic-surgery-olvreexp-100611970","NCT07247500","Impact of Reventilation After One-Lung Ventilation in Thoracic Surgery (OLVREEXP)","OLVREEXP","Inclusion Criteria:\n\n* ASA score ≤ 3.\n* Undergoing a scheduled video-assisted or robot-assisted lobectomy or segmentectomy.\n* Patient has read and understood the information sheet and signed the informed consent form.\n* For women of childbearing potential, effective contraception and confirmation of the absence of an ongoing pregnancy by a negative blood or urine pregnancy test are required.\n* Postmenopausal women (spontaneous, non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).\n* Patient affiliated with a social security system.\n\nExclusion Criteria:\n\n* Patients with a BMI \\> 40 kg\u002Fm².\n* Patients with severe chronic respiratory failure (COPD grade 3, FEV₁\u002FFVC \\\u003C 0.7 and FEV₁ \\\u003C 50% - according to the GOLD 2025 classification).\n* Patients with severe chronic renal failure (GFR \\\u003C 30 mL\u002Fmin).\n* Patients at high risk of conversion to thoracotomy.\n* Patients with a history of acute respiratory distress syndrome (ARDS) within 3 months prior to surgery.\n* Patients with a known history of severe hepatic failure (Child-Pugh class B or C).\n* Patients with a history of heart failure (NYHA class ≥ II).\n* Patients with a history of pulmonary resection.\n* Patients with uncontrolled asthma.\n* Pregnant or breastfeeding women.\n* Patients deprived of liberty by administrative or judicial decision, as well as those under legal protection, guardianship, or curatorship.",{"count":221,"type":22},350,[179],"Lung cancer is a common disease, and more than 8,000 patients in France undergo lobectomy or pulmonary segmentectomy each year. This surgery remains associated with significant postoperative pulmonary complications, whose incidence ranges from 15% to 49% depending on the study (1). The main complication is pulmonary atelectasis, which provides a favorable setting for the development of postoperative pneumonia.\n\nIn thoracic surgery, the operated lung is excluded, and one-lung ventilation is performed on the contralateral lung. During surgery, several strategies exist to prevent atelectasis during one-lung ventilation, known as protective ventilation strategies (2). At the end of the procedure, reventilation allows re-expansion of the previously excluded lung.\n\nHowever, pulmonary reventilation induces the release of pro-inflammatory cytokines and causes endothelial dysfunction, which may lead to pulmonary edema, thereby negating the benefits of intraoperative protective ventilation. Conversely, insufficient re-expansion may result in persistent postoperative atelectasis, whereas excessive re-expansion can cause volutrauma, alveolar trauma, and\u002For barotrauma to the operated lung (3).\n\nSeveral reventilation techniques are currently used, but to our knowledge, the impact of reventilation itself has never been specifically studied. The first, empirical technique, consists of reventilating both lungs using the accessory circuit and the adjustable pressure-limiting (APL) valve, manually bagging the patient over several respiratory cycles (4). The main drawback of this method is the lack of monitoring of insufflated volumes and pressures.\n\nThe second, more recent technique, consists of reventilating the patient using the anesthesia machine circuit in controlled ventilation mode, which allows for precise monitoring of pressures and insufflated volumes (5). This approach provides real-time monitoring of lung re-expansion and could therefore be less harmful than the empirical method.\n\nThus, the objective of this study is to compare postoperative pulmonary complications between patients who underwent lung re-expansion using the accessory circuit and those who underwent lung re-expansion using the anesthesia machine circuit in controlled ventilation mode.",[225],"Lung Surgery",{"date":185,"type":34},{"date":228,"type":22},"2026-07-01",{"date":230,"type":22},"2028-08-01",{"name":40,"class":41},5,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":54,"phases":244,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100559176","implementation-of-a-personalised-health-plan-php-on-patient-quality-of-life-score-at-2-year-follow-up-100559176","NCT06560723","Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score at 2-year Follow-up","Identifying and Managing Frailty in the Elderly in a Multiprofessional Health Home","FRAPA","Inclusion Criteria:\n\n* Patient ≥ 70 years\n* Autonomous patient (ADL ≥ 5)\n* Patient identified as frail according to the Gérontopôle de Toulouse GFST grid\n* Patient whose primary care physician is in the MSPs of Charleval or Romilly sur Andelle for the intervention group, and in the MSPs of Gaillon and Pont de l'Arche for the control group.\n* Patient living at home or in an RPA\n* Understanding of the French language\n* Patient having read and understood the information letter and signed the consent form\n* Affiliation with a social security scheme\n\nExclusion Criteria:\n\n* Hospital geriatric follow-up\n* Geriatric assessment already carried out\n* Person deprived of liberty by an administrative or judicial decision, or placed under court protection \u002F sub-guardianship or curatorship\n* History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.","100 Years",{"count":243,"type":22},120,[179],"\"Healthy ageing\" is not limited to the absence of disease, but implies the \"development and maintenance of the functional skills that enable the elderly to enjoy a state of well-being\": (for example : the ability to walk, go out, engage in leisure activities, memorize...) It is interesting to study whether the implementation of a Personal Health Plan (PHP) in a Multiprofessional Health Home improves the quality of life of frail elderly people.",[247],"Elderly, Frail",[249],"identifying",{"date":185,"type":34},{"date":95,"type":22},{"date":253,"type":22},"2030-06",{"name":40,"class":41},4,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":54,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":42},"100550398","phase-3-de-scalation-or-switch-of-treatment-according-to-circulating-tumor-dna-variation-after-2-cycles-of-doublet-chemotherapy-plus-targeted-agent-in-metastatic-unresectable-colorectal-cancer-100550398","NCT06446557","De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer","De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer (DIAMOND Study): A Randomized Phase III of PRODIGE Intergroup","DIAMOND","Inclusion Criteria:\n\n* Histologically proven diagnosis of RAS WT or mutant, MSS, BRAFV600E non-mutated colorectal cancer.\n* Left side or rectal cancer\n* An unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.\n* At least one measurable lesion according to RECIST criteria version 1.1.\n* Age ≥ 18 years.\n* ECOG PS ≤ 1\n* Neutrophils ≥ 1.5 x 10\\^9\u002FL, Platelets ≥ 100 x 10\\^9\u002FL, Hb \\> 9 g\u002Fdl.\n* Total bilirubin ≤ 1.5 time the upper-normal limits (UNL) and ASAT (SGOT) and\u002For ALAT (SGPT) ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases.\n* Creatinine clearance \\> 50 mL\u002Fmin or serum creatinine ≤ 1.5 x UNL.\n* The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis.\n* Adequate coagulation function \\[International Normalized Ratio (INR) ≤1.5 and Partial. Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x ULN.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Right side colon cancer\n* First-line chemotherapy +\u002F- biologic agents for mCRC before C1\n* Radiotherapy to any site within 4 weeks before C1\n* Adjuvant oxaliplatin-based treatment completed less than 6 months before relapse.\n* Treatment with any investigational drug within 30 days prior to C1\n* Known allergy to any of the study treatment components.\n* Dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Documented and\u002For symptomatic brain or leptomeningeal metastases.\n* Patient with active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.\n* Uncontrolled or poorly controlled hypertension despite standard medical management.\n* Severe renal or hepatic failure\n* Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to C1\n* Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start.\n* Infection with the human immunodeficiency virus.\n* Symptomatic peripheral neuropathy grade 1 according the NCI CTC.\n* Acute or subacute bowel obstruction or history of chronic diarrhea, which is considered clinically significant in the opinion of the investigator.\n* Chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg\u002Fday) is permitted.\n* Pregnant or lactating women.\n* Patient with active psychiatric illness or social situation that would severely limit compliance with study requirements.",{"count":265,"type":22},408,[56],"Background : In unresectable mCRC, a de-escalation strategy using maintenance or chemotherapy (CT) discontinuation in selected cases is considered as a valid option in non-progressive patients after a first-line induction of doublet CT + targeted agent (TA) (1-7).\n\nIn this context, circulating tumor DNA (ctDNA) is considered very promising to optimize decision making. Indeed, ctDNA harbour the same main alterations of the tumor and has been recognized as biologically relevant to reflect tumor dynamics and therapeutic efficacy (8).\n\nAs reported in mCRC, that early variation of ctDNA during CT may be relevant to predict outcome (9-11). Indeed, patients with a ctDNA decrease from the first (C1) to the third (C3) cycles of CT (∆≥80% or ctDNA\\\u003C0.1 ng\u002Fml at C3) or without ctDNA detectable at C1 and C3 have significant better survival as compared to patients with less decrease or with ctDNA increase (10). ctDNA monitoring had never been prospectively evaluated to guide early adaptation in the treatment strategy in mCRC.\n\nAim: A randomized phase III, open label, strategy trial of the superiority in overall survival (OS) adjusted on quality of life of an early treatment adaptation guided by ctDNA variation versus a standard management in unresectable left-side, MSS-BRAFV600E non-mutated mCRC treated by first-line doublet CT + TA.\n\nPatients and methods :\n\n-Main inclusion criteria will be (i) unresectable left-side and non-pre-treated mCRC (ii) MSS and non-mutated BRAFV600E tumor (iii) at least one measurable lesion (iv) ECOG 0-1 and adequate biological functions for first-line doublet CT + TA (antiEGFR if RAS WT, bevacizumab (BV) if RAS MUT).\n\nRandomization (1:1) between an experimental strategy guided by ctDNA variation with de-escalation (Arm A1 or A2) or switch of treatment (Arm A3) versus standard strategy (Arm B). The analysis of variation of ctDNA from C1-C3 will be centralized and detected using Digital PCR targeting hypermethylation of WIF1\u002FNPY genes (10) in real-time in arm A and in second step in arm B.\n\nRandomization in Arm A: after 4 cycles of doublet + TA, non-progressive patients will be allocated to a strategy according to ctDNA value and variation from C1-C3:\n\nArm A1: CT discontinuation (ctDNA normalization \\\u003C 0.1 ng\u002Fml or ctDNA not detectable) Arm A2 : maintenance with fluoropyrimidine + TA (ctDNA ≥ 0.1 ng\u002Fml and ∆ctDNA≥ 80%).\n\nArm A3 : ctDNA non-responders (∆ctDNA \\\u003C 80% or increase) : switch of CT +\u002F- TA.\n\nRandomisation in Arm B: at least 8 cycles of doublet CT + TA before adaptation of sequence at physician choice.\n\nStatistical considerations : with an expected median OS at 32 months (mean 37.6 months), a mean QoL at 70.0% in first-line mCRC, corresponding to 0.700 x 37.6 = 26.3 QALM or 2.19 QALY (SD 1.18 QALY), 408 patients are required (randomization 1:1) to show a gain of 4 months of quality-adjusted OS (4 QALM or 0.33 QALY) in experimental ctDNA strategy versus standard strategy (5% two-sided type I error rate, 81% power and 1.18 QALY SD).\n\nThe secondary objectives will be:\n\n* To compare strategies (standard vs ctDNA guided) overall and in the subgroups of ctDNA response on 18, 24 and 36-months restricted mean of QoL-adjusted OS, OS, PFS, response rate, toxicity, Quality of Life and cost utility.\n* Bio-collection for further ctDNA analysis. Only cost of samples collection and their transportation to the resource center is requested. Further ancillary analysis will be subject to independent funding requests to evaluate :\n* ctDNA kinetics during the induction and its impact on outcome in overall population and in each arm\n* ctDNA changes between time points during de-escalation arms to determine thresholds of variations predictive of clinical and\u002For radiological progression.\n\nConclusion: DIAMOND is a randomized phase III strategy trial to show the superiority in OS adjusted on quality of life of an early treatment adaptation guided by ctDNA versus a standard management in unresectable left-side, MSS-BRAFV600E non-mutated mCRC treated by first-line doublet CT + TA.",[269],"Metastatic Colon Cancer",{"date":185,"type":34},{"date":272,"type":22},"2026-06",{"date":274,"type":22},"2032-06-01",{"name":40,"class":41},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":54,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":292,"leadSponsor":293,"locationsCount":42},"100550397","functional-residual-capacity-and-alveolar-recruitment-in-single-lung-ventilation-a-randomized-study-100550397","NCT06446544","Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study","OLVEELV","* Adult patient aged 18 to 75 years inclusive\n* Patient requiring lobectomy or segmentectomy by video or robot-thoracoscopy\n* Patient having read and understood the information letter and signed the consent form\n* Patient affiliated to a social security system\n* Women :\n\n  * Of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy))\n\n    * using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device (IUD), male or female condoms) for at least 4 weeks before inclusion and during the study And,\n    * Presenting a negative urine pregnancy test at inclusion;\n  * Menopause: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\nExclusion Criteria:\n\n* Patients aged 76 and over\n* COPD patients (Gold stage 3 or 4 of the 2023 Gold classification)\n* Patients with a history of ischemic coronary artery disease\n* Patients with a history of pulmonary emphysema bubbles on the ventilated lung\n* Tracheostomized patient\n* Obese patients (\\>30 kg\u002Fm²)\n* Patients with a history of pulmonary resection\n* ASA patients ≥4\n* Patient benefiting from a pre-operative rehabilitation protocol with physiotherapy\n* Pregnant or parturient or breastfeeding woman or proven absence of contraception\n* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection\u002Funder guardianship or curatorship\n* History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent\n* Patient refusing to give consent.","75 Years",{"count":285,"type":22},44,[179],"In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.\n\nStrategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.\n\nThe General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.\n\nThe effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and\u002For more intensive respiratory rehabilitation program with the physiotherapy team.",[289],"Lung Injury",{"date":185,"type":34},{"date":228,"type":22},{"date":230,"type":22},{"name":40,"class":41},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":283,"enrollmentInfo":302,"targetDuration":4,"studyType":54,"phases":303,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":42},"100538456","phase-4-comparison-of-the-effects-of-belatacept-and-anticalcineurins-on-endothelial-function-in-renal-transplant-patients---belafendo-100538456","NCT06291077","Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - \u003CBELAFENDO>","Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients \u003CBELAFENDO>","BELAFENDO","Inclusion Criteria:\n\nFor the Belatacept group:\n\n\\- Patients who have undergone a graft biopsy due to impaired renal function finding criteria for chronic toxicity of anticalcineurins leading to the introduction of Belatacept.\n\nFor the anticalcineurin group:\n\n* Renal transplant patients treated with anticalcineurins for more than a year.\n* Stable renal function (defined by a creatinine level in µmol\u002Fl stable for 3 months (variation +\u002F-20%)\n\nFor both groups:\n\n* Date of kidney transplant greater than 1 year\n* Age between 18 and 75 years inclusive\n* Patient having received clear information from one of the investigators, having read and understood the information letter and signed the consent form\n* Women :\n\n  * of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy)\n\n    * using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device (IUD), male or female condoms) for at least 4 weeks before inclusion and during the study And,\n    * presenting a negative urine pregnancy test at inclusion;\n  * menopausal: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n* Patient benefiting from a social protection scheme\n\nExclusion Criteria:\n\n* Stage 5 chronic renal failure (defined by a CKD-EPI GFR\\\u003C15 ml\u002Fmin\u002F1.73m²)\n* Dialysis patient\n* History of myocardial infarction or stroke less than 6 months old\n* Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF \\\u003C30%\n* BMI\\>35 kg\u002Fm²\n* Severe hepatic insufficiency (Child-Pugh class C)\n* Contraindication to NATISPRAY 0.30 mg\u002Fdose, solution for oral spray (and in particular hypersensitivity to nitrates in accordance with the SPC (Summary of Product Characteristics) of NATISPRAY)\n* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship\n* Previous or current treatment with Belatacept\n* Severe high blood pressure (DBP ≥ 110 mm Hg and\u002For SBP ≥ 180 mm Hg)\n* Presence or history of functional or ligated or thrombosed bilateral arteriovenous fistula, preventing explorations\n* Pregnant, breastfeeding woman, or absence of proven effective contraception\n* Excessive alcohol consumption (no more than 10 drinks per week)\n* Active smoking with a daily consumption of more than 21 mg of nicotine per day or taking nicotine substitutes with a dose greater than 21 mg\u002F24 hours\n* Drug addiction or suspected illicit drug use\n* Patient participating or having participated in the 4 weeks preceding inclusion in a clinical trial",{"count":285,"type":22},[304],"PHASE4","Kidney transplantation is the standard treatment for patients with end-stage renal failure.\n\nHowever, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction.\n\nBelatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage.",[307],"Kidney Diseases",{"date":185,"type":34},{"date":310,"type":34},"2026-04-30",{"date":312,"type":22},"2029-02-01",{"name":40,"class":41},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":54,"phases":323,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":255},"100538459","phase-2-safety-of-rotigotine-in-patients-with-autosomal-dominant-polycystic-kidney-disease-100538459","NCT06291116","Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease","ETERNAL-PKD","Inclusion Criteria:\n\n* ADPKD patients aged 18 to 60 years\n* Normotensive or hypertensive patients treated controlled (SBP\u002FDBP on daytime ABPM \\\u003C135\u002F85 mmHg less than 3 months old)\n* Patient having read and understood the information letter and signed the consent form\n* Effective contraception in women of childbearing age (for postmenopausal women, a confirmatory diagnosis should be obtained)\n* Patient benefiting from a social protection scheme\n\nExclusion Criteria:\n\n* Stage 4 or 5 renal insufficiency (GFR CKD-EPI \\\u003C30 ml\u002Fmin)\n* Renal transplant patients\n* Dialysis patients\n* History of myocardial infarction or stroke less than 6 months old\n* Severe hepatic insufficiency (Child-Pugh class C)\n* Patients currently being treated or treated in the 6 months preceding the trial with a dopamine agonist or antagonist\n* Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF \\\u003C30%\n* Orthostatic hypotension (decrease \\> 20 mm Hg)\n* Pregnant, breastfeeding woman, or proven absence of contraception\n* Excessive alcohol consumption (greater than 20 g\u002Fday)\n* History of addictive behavior, particularly gambling, compulsive purchasing or hypersexuality\n* Drug addiction or suspected illicit drug use\n* Taking other sedative medications or other central nervous system depressants (benzodiazepines, antipsychotics, antidepressants or neuroleptics with antiemetic intent)\n* Hypersensitivity to the active ingredient, rotigotine, or to one of its excipients\n* Known allergy to sulphites\n* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship.","60 Years",{"count":243,"type":22},[324],"PHASE2","Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease and is caused by mutations in the PKD1 or PKD2 genes, which encode polycystins 1 and 2. Patients develop renal cysts associated with a progressive decline in kidney function, ultimately leading to end-stage renal disease in approximately one third of cases. ADPKD is also characterized by early-onset hypertension and cardiovascular complications, notably intracranial aneurysms.\n\nThis phenotype is related to abnormal polycystin function in the primary cilia of renal epithelial and vascular endothelial cells, resulting in impaired mechanotransduction of shear stress induced by urinary and blood flow and subsequent alterations in multiple cellular functions. Experimental studies have suggested that stimulation of dopamine receptor type 5 (DR5) may restore endothelial mechanosensitivity. This hypothesis is supported by our preliminary results showing that local administration of dopamine improves endothelial function in patients with ADPKD through restoration of nitric oxide (NO) release in response to increased blood flow.\n\nConsistent with these findings, the IMPROVE-PKD study recently demonstrated similar beneficial effects on endothelial function and hemodynamics using rotigotine, a dopamine agonist administered via transdermal patches for two months at a low dose (4 mg\u002F24 h). Dopaminergic stimulation may also prevent renal abnormalities related to polycystin deficiency. We therefore hypothesize that rotigotine could slow the progression of ADPKD at both the renal and cardiovascular levels.\n\nThis phase 2 study aims to evaluate the long-term tolerability of rotigotine in patients with ADPKD and to collect preliminary data on its effects on renal outcomes.",[307],{"date":185,"type":34},{"date":329,"type":34},"2026-05-12",{"date":331,"type":22},"2030-07-01",{"name":40,"class":41},{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":54,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":348,"leadSponsor":350,"locationsCount":42},"100538458","phase-2-screening-for-subclinical-antibody-mediated-rejection-and-efficacy-of-belatacept-in-the-context-of-de-novo-donor-specific-antibody-after-kidney-transplantation-bela-m-r-100538458","NCT06291103","Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)","BELA-M-R","Inclusion Criteria:\n\n1. Screening inclusion criteria:\n\n   * Kidney transplant recipient\n   * Adult\n   * De novo DSA (MFI \\> 1000 using the Luminex single antigen beads assay or positive with the manufacturer criteria according to the Luminex assay) absent on the day of kidney transplantation and in the sera prior to kidney transplantation\n   * No clinical graft dysfunction at time of DSA detection (\\\u003C 20 % variation of eGFR compared to last 3 months before detection and \\\u003C 0,5 g\u002Fg proteinuria\u002Fcreatinuria ratio)\n   * Affiliation with, or beneficiary of a Social security (national health insurance) category\n   * Person having read and understood the information letter and signed the consent form\n   * Women of childbearing potential with effective contraception\u002Fvery-effective contraception (Cf. CTFG) (oestro-progestatives or intra-uterine device or tubal ligation) and a negative blood pregnancy test.\n   * Women surgically sterile (absence of ovaries and\u002For uterus)\n   * Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)\n2. Randomization inclusion criteria:\n\n   * Patients with active sABMR, according Banff 2019 classification, with very slight transplant glomerulogathy (cg = 0 or 1).\n\nExclusion Criteria:\n\n1. Screening exclusion criteria:\n\n   * Minor\n   * Specific treatment for DSA occurrence before kidney graft biopsy: IVIG or rituximab or plasmapheresis or immunoabsorption\n   * ABO incompatible kidney transplantation\n   * Combined transplantation\n   * Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.\n   * Hypersensitivity to the active substance or to any of the excipients - Pregnant or parturient or breastfeeding woman or absence of contraception\n   * Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision\n   * Person consenting to the research participating to another trial\n   * Medical history or psychological or sensorial abnormality prone to inhibit the subject to understand the conditions required for his\u002Fher participation to the protocol or unable him\u002Fher to give an informed consent\n   * No signed ICF\n2. Randomization exclusion criteria:\n\n   * No sABMR or chronic active sABMR (cg \\> 1) on initial biopsy\n   * History of severe opportunistic infection before randomization\n   * Acute or chronic infection with HBV, HCV or HIV\n   * EBV negative serology\n   * History of post-transplant lymphoproliferative disorder.",{"count":341,"type":22},290,[324,56],"Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and\u002For proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, a retrospective multicenter study was published, within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI \\> 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, no effect of standard of care treatment in active sABMR was observed. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. It was conclude that the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, the current proposal is to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.\n\nThe monitoring of dnDSA after KT and an indication graft biopsy in case of appearance, even in the absence of graft dysfunction, is not part of a routine clinical practice in all KT centers. This strategy could be a valuable option, in order to begin treatment of ABMR before graft dysfunction occurs, and therefore to improve prognosis associated with phenotype 2 ABMR. Parajuli et al.4 suggested that early diagnosis and treatment of sABMR with SOC, using DSA monitoring may improve outcomes after KT, but this is a retrospective and no-randomized study. This study will be the first prospective randomized study in the context of de novo DSA. The objective is to evaluate a new combination of treatment for ABMR in the context of dnDSA with subclinical lesions and in the same time may help to determine the real incidence of sABMR in KT recipients with subclinical dnDSA. The use of belatacept in the context of sABMR to improve the non-adherence and to decrease the endothelial toxicity had never been evaluated in a prospective way.",[345],"Kidney Transplant Rejection",{"date":185,"type":34},{"date":228,"type":22},{"date":349,"type":22},"2032-08-01",{"name":40,"class":41},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":54,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":367,"leadSponsor":369,"locationsCount":42},"100525548","phase-3-postoperative-anti-infective-strategy-following-pancreaticoduodenectomy-in-patients-with-preoperative-biliary-stent-100525548","NCT06123169","Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent","FRENCH24 ANIS","Inclusion Criteria:\n\n* Planned pancreaticoduodenectomy for periampullary neoplasms\n* Endoscopic or radiological pre-operative biliary drainage\n* Age ≥ 18 years old\n* Patient able to comply with the study protocol, in the investigator's judgment\n* Patient affiliated with, or beneficiary of a social security (national health insurance) category\n* Person of full age having read and understood the information letter and signed the consent form\n* Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) with hightly effective contraception (Cf. CTFG) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) since 1 month and during the duration of the study and a negative blood pregnancy test by beta-HCG at inclusion.\n* Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n* Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\nExclusion Criteria:\n\n* Contraindication to PIPERACILLIN\u002FTAZOBACTAM PANPHARMA 4g \u002F 500mg powder for solution for injection in accordance with its SmPC\n* Patients allergic to beta-lactam antibiotics\n* Others pancreatic resection\n* Absence of preoperative biliary drainage\n* Surgical or anaesthesiological contra-indications:\n* non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled AHT (SBP \\>160 mm or DBP \\> 100 mm, despite optimal drug treatment), long QT\n* major non-controlled infection\n* severe liver failure\n* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent\n* Any significant disease, which, in the investigator's opinion, would exclude the patient from the study\n* Pregnant or parturient or breastfeeding woman or absence of contraceptionn\n* Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision\n* Simultaneous participation in another interventional research with the same primary endpoint.",{"count":359,"type":22},326,[56],"The main objective of the study is to compare 2 broad-spectrum antibiotic (Piperacillin \u002F Tazobactam) treatment modalities, following pancreaticoduodenectomy in patients with preoperative biliary stent, to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)",[363,364],"Pancreaticoduodenectomy","Antibiotherapy",{"date":185,"type":34},{"date":71,"type":22},{"date":368,"type":22},"2028-09",{"name":40,"class":41},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":283,"enrollmentInfo":377,"targetDuration":4,"studyType":54,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":385,"leadSponsor":387,"locationsCount":42},"100489343","phase-3-efficacy-and-tolerance-of-baricitinib-a-jak-inhibitor-in-the-treatment-of-refractory-non-infectious-non-anterior-uveitis-100489343","NCT05651880","Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis","JAKUVEITE","Inclusion Criteria:\n\n* Patient with diagnosis of non-anterior non-infectious uveitis, refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab)\n* Need to stop biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressive drugs (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date\n\nExclusion Criteria:\n\n* 1\\. Isolated anterior uveitis. 2. Infectious uveitis. 3. Severe uveitis threatening the visual prognosis and requiring emergency treatment with intravenous corticosteroids.\n\n  4\\. Initial visual acuity \\> 1.3 LogMAR in at least one eye. 5. Corneal or lens opacity that prevents fundus visualization or may require cataract surgery during the study.\n\n  6\\. Contraindication to baricitinib (OLUMIANT 2 and 4 mg film-coated tablets) : Hypersensitivity to the active substance or to any of the excipients.\n\n  7\\. Contraindication to mydriasis. 8. Refractory glaucoma in either eye. 9. Monophthalmic patient. 10. Previous treatment with JAK inhibitors. 11. Intraocular corticosteroid injection (subconjunctival or laterobulbar) within 1 month prior to inclusion or intravitreal corticosteroid implant within 3 months prior to inclusion.\n\n  12\\. Need for treatment with a biotherapy (anti-IL6, anti-IL6 receptor, anti-IL1, anti-IL12\u002FIL23 anti-IL17, anti-BAFF) for extra-ocular involvement, during the entire study period.\n\n  13\\. Treatment with OAT3 inhibitors with high inhibitory potential such as probenecid, leflunomide, teriflunomide 14. 14. Vaccination with a live or live attenuated vaccine within 15 days prior to inclusion 15. History of cancer within the previous 5 years, except non-metastatic squamous cell and basal cell carcinoma of the skin.\n\n  16\\. Personal history of venous thromboembolic disease.",{"count":378,"type":22},33,[56],"The aim of the study is to evaluate the efficacy of Baricitinib, a JAK1 and 2 inhibitor, in the management of non-infectious non-anterior uveitis refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab) after 6 months of treatment",[382],"Active Non-anterior Non-infectious Uveitis",{"date":91,"type":34},{"date":71,"type":22},{"date":386,"type":22},"2029-12",{"name":40,"class":41},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":396,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":54,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":42},"100593605","myt1l-syndrome-a-rare-paediatric-genetic-syndrome-responsible-for-a-neurodevelopmental-disorder-100593605","NCT07008612","MYT1L Syndrome: a Rare Paediatric Genetic Syndrome Responsible for a Neurodevelopmental Disorder","Characterisation of Language and Prosody Disorders, Cognitive Functioning and Behavioural Problems in MYT1L Syndrome","MYT1L","Inclusion Criteria:\n\nMYT1L Group Patients\n\n* Minimum age for inclusion: 6 years\n* Maximum age for inclusion: no upper age limit\n* Language: French\n* Consent of parents or legal guardian\n* Social security coverage required\n\nProsody Group Patients\n\n* Unaided visual or hearing impairment making assessments impossible\n* Non-French speaking patients\n* Patients with a dual molecular genetic diagnosis also causing a neurodevelopmental disorder\n* Acquired neurological disorder\n\nExclusion Criteria:\n\nMYT1L Group patients\n\n* Unaided visual or hearing impairment making assessments impossible\n* Non-French speaking patients\n* Patients with a dual molecular genetic diagnosis also causing a neurodevelopmental disorder\n* Acquired neurological disorder\n\nProsody Group Patients\n\n* Patients with molecularly confirmed MYT1L syndrome.\n* Nonverbal patients","6 Years",{"count":398,"type":22},50,[179],"MYT1L syndrome is a rare genetic syndrome, recently described in 2011, with paediatric onset, responsible for a neurodevelopmental disorder combining psychomotor retardation, learning difficulties and\u002For intellectual development disorders, epilepsy, overweight and eating disorders. The Rouen genetics department is currently positioned as a clinical expert in this disease.\n\nThe study published in 2020 by our team (Coursimault J et al., Hum Genet. 2022, PMID: 34748075) has enabled us to describe 40 new individuals worldwide, to gain a better understanding of this disease, to specify the genotype-phenotype relationships and to describe new clinical signs. We were able to confirm the presence of a neurodevelopmental disorder in 100% of patients, which includes: language delay, impaired orality, global and facial hypotonia, prosodic features and behavioural problems. This will be the first study in the world to characterise the neuropsychological, language and prosodic profiles of MYT1L patients.",[402],"MYT1L Syndrome",[404],"combination of symptoms and physical features which are found together in a person and are all due to the same underlying cause","2026-06-04",{"date":91,"type":34},{"date":408,"type":34},"2025-02-04",{"date":410,"type":22},"2027-11-01",{"name":40,"class":41},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":54,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":42},"100548764","evaluation-of-the-influence-of-aromatherapy-and-music-therapy-on-stress-during-the-management-of-cerebral-arteriography-100548764","NCT06425237","Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography","HERMES","Inclusion Criteria:\n\n* Adult (≥ 18 years old)\n* Patient who is scheduled for a cerebral arteriography with local anaesthesia\n* Patient who capable to read and understand the patient information and consent.\n* Patient capable to read and sign the consent form\n* Patient with social insurance\n* Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)\n* Negative urine pregnancy test\n\nExclusion Criteria:\n\n* Patients who have had a previous cerebral arteriogram\n* Patient with allergy to iodinated contrast medium\n* Patient with severe renal insufficiency\n* Patient requiring sedation and artificial ventilation\n* Patient who is deaf and\u002For hard of hearing\n* Patient with a known allergy to essential oils\n* Patient with anosmia\n\n  * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship,\n  * Pregnant or breastfeeding woman",{"count":420,"type":22},224,[179],"Cerebral arteriography is a reference examination in medical imaging. This examination is performed to allow the diagnosis and therapeutic management of patients with vascular pathologies.\n\nIt is most often accompanied by a situation of stress, anxiety and apprehension related to the course of the examination or the announcement of the results.\n\nThese situations generate physiological reactions in patients, making the performance of cerebral arteriography more complex. In order to improve the quality of care for patients undergoing this invasive examination, it is proposed to use two non-medicinal techniques known for their soothing and relaxing properties: aromatherapy and music therapy alone or in combination. These two techniques will help to establish a common thread from the preparation of the patient before the examination to his return to the post-interventional surveillance room.",[424],"Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes",{"date":183,"type":34},{"date":427,"type":34},"2024-11-04",{"date":429,"type":22},"2027-11-04",{"name":40,"class":41},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":108,"minAge":19,"maxAge":199,"enrollmentInfo":439,"targetDuration":4,"studyType":54,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":147},"100513744","phase-3-effect-of-preventive-analgesia-by-injection-of-a-local-anesthetic-before-vaginal-incision-for-hysterectomy-by-vnotes-approach-100513744","NCT05969457","Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach","Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study","ANOTES","Inclusion Criteria:\n\n* Adult patients aged 18 to 70 inclusive\n* Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).\n* Person having read and understood the information letter and signed the consent form\n* Person affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Suspicion of malignant pathology\n* History of rectal surgery\n* History of pelvic inflammatory disease\n* Suspicion of recto-vaginal endometriosis\n* Virginity\n* Contraindication to NAROPEINE 7.5 mg\u002FmL, solution for injection in ampoule\n* Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection\n* Patients on a low-salt diet\n* History of more than 2 caesarean sections\n* Estimated uterine size \\> 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound). a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3\n* BMI \\> 35\n* Contraindication to analgesic molecules in intraoperative and postoperative protocols.",{"count":440,"type":22},108,[56],"The research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to create a paracervical block at the beginning of surgery, while the patient is already under general anesthesia.\n\nThis injection will take place 3 minutes before the vaginal incision, via 4 injection points. Injections are made 3 mm deep into the vaginal cul de sac.\n\nRandomization takes place before surgery by vNOTES:\n\n* Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg\u002FmL, i.e. 150mg) and general anesthesia\n* Control group: Injection of 20mL of placebo (saline) and general anesthesia\n\nIn both groups, systematic intraoperative and postoperative analgesia will be identical.",[444],"Hysterotomy; Affecting Fetus",{"date":91,"type":34},{"date":447,"type":34},"2025-09-16",{"date":449,"type":22},"2029-09-01",{"name":40,"class":41},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":108,"minAge":19,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":54,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":470},"100488058","effectiveness-of-a-hip-abductor-training-in-women-with-stress-urinary-incontinence-100488058","NCT05635175","Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence","PROTOGLUT","Inclusion Criteria:\n\n* Women ≥ 18 ans\n* patient with urinary incontinence according to the ICS criteria \\[3\\]\n* having received a prescription for perineal rehabilitation\n* affiliated to french health care insurance\n* Patient having read and understood the information letter and signed the consent form\n* Effective contraception in women of childbearing age (negative urine pregnancy test). For postmenopausal women, a confirmatory diagnosis must be obtained (amenorrhea for at least 12 months before the inclusion visit)\n\nExclusion Criteria:\n\n* Bladder pathologies (cyst, tumour, interstitial cystitis)\n* Neurological pathologies (multiple sclerosis, Parkinson's desease, etc.)\n* Pregnant or parturient or breastfeeding woman or absence of proven contraception\n* Person deprived of liberty by administrative or judicial decision or a person placed under the safeguard of justice, or guardianship or curatorship\n* Physical inability to perform hip abductors exercises (unable to walk or stand independently)\n* Women having scheduled continence surgery before the end of physiotherapy sessions at the time of randomization\n* Women having at least one of the continence-specific anticholinergic treatments prescribed before the end of the physiotherapy sessions at the time of randomization",{"count":459,"type":22},78,[179],"Urinary incontinence (UI) is estimated to affect 25% à 45 % women all over the world. UI is associated with a poor Quality of life, with a strong level of certainty. Stress urinary incontinence (SUI) is the second more prevalent type of UI . First-line treatment for SUI is conservative, non-drug and non-surgical treatment. Among these techniques, physiotherapist-supervised pelvic floor muscle (PFM) training (PFMT) as a first-line treatment; however, only half of women with SUI are cured with PFMT.\n\nBrain imaging shows that PFMs (involved in continence mechanisms) and gluteal muscles can activate the same cortical region. This synergy is found if the gluteal muscles are voluntarily activated, but not if the PFMs are volontary activated alone . In women, hip abductor physiotherapy is a common practice which has already been the subject of a very extensive literature and has largely shown its effectiveness in the quality of lumbo-pelvic control, balance, quality of life and risk of fall prevention. This rehabilitation is based on exercises that induce solicitation of the hip abductors by synergistic reflex activation during a range of well-known exercises. Recent work has shown the effect of hip abductors on the activation of the PFMs . Until today, there is no literature evaluating the effectiveness of a hip abductors training program without associated voluntary contraction of the PFMs (PPM) on UI. The hypothesis of this work will be to demonstrate that a complementary training focused on the hip abductor, complementary to concomitant PFMT, would benefit from a more significant improvement in continence, and also in physical abilities and quality of life. Because balance seems involved in UI, we therefore propose to to observe the effects on the frontal balance of the pelvis. As the investigators have already done in previous studies, to identifying factors that predict the success of our interventions, investiagtors have planned to evaluate the observance and adherence of our patients .Complementary, the investigators planned to evaluate the effect of both intervention on pelvic floor muscles and hip abductors strength and endurance, pelvic organ prolapse symptoms and quality of life. For this objective, the investigators intend to compare two randomized parallel groups: Group A follow a 12 sessions supervised PFMT + home based PFMs exercices. Group B follow a 12 sessions supervised PFMT + home based hip abductor exercices.",[463],"Women With Stress Urinary Incontinence",{"date":91,"type":34},{"date":466,"type":34},"2023-09-28",{"date":468,"type":22},"2026-09-23",{"name":40,"class":41},3,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":54,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":201},"100447707","phase-3-immediate-prescription-of-a-hypouricemic-treatment-febuxostat-compared-to-its-delayed-administration-100447707","NCT05109936","Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration","Non-inferiority Study of a New Therapeutic Strategy for Gout: Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration - FEFACRIGOU Trial","FEFACRIGOU","Inclusion Criteria:\n\n1. Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).\n2. Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s):\n\n   * Either a first crisis,\n   * Either a new attack of a gout not treated with a hypo-uricemic or for which the hypo-uricemic treatment has not been taken for at least 6 months.\n3. Uricemia ≥ 420 µmol \u002F l, including under a diuretic (dosage carried out within 10 days before inclusion),\n4. Age ≥ 18 years old,\n5. Patient with a creatinine clearance ≥ 30 ml \u002F min (dosage carried out within 10 days before inclusion),\n6. Patient having read and understood the information letter and signed the consent form,\n7. Affiliation to a social security scheme,\n8. Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestins or intrauterine device or tubal ligation for more than 1 month and to be continued for at least 5 weeks after the last dose of the drug. ) and a negative urine pregnancy test on inclusion and throughout the duration of the study Where Postmenopausal woman: amenorrhea not medically induced for at least 12 months before the inclusion visit.\n\nExclusion Criteria:\n\n1. Patients under the age of 18,\n2. Stop taking a hypouricemic agent for less than 6 months,\n3. Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients,\n4. Renal failure defined by creatinine clearance \\\u003C30 ml \u002F min,\n5. Hepatic disease defined by an increase to more than 2 times the normal of transaminases, alkaline phosphatases, to more than 3 times the normal of gamma-GT,\n6. Non-weaned alcoholism,\n7. Crisis more than 5 days old,\n8. Patient who has received an organ or marrow transplant,\n9. Person on Naproxen, mercaptopurine, azathioprine, Glycuronidation inhibitors and inducers, theophylline, macrolides, HMG Co-A reductase inhibitors and \u002F or diuretic in combination with an ACE inhibitor or ARAII,\n10. Person with rare hereditary disorders of galactose intolerance, lactase deficiency or glucose \u002F galactose malabsorption\n11. Poor understanding of the project due to neurological disease or lack of French practice,\n12. Pregnant woman or likely to be in the absence of effective contraception (Women of childbearing age should have a negative urine pregnancy test),\n13. Breastfeeding woman\n14. Any history of pre-existing major cardiovascular disease (myocardial infarction, stroke, unstable angina, etc.), metabolic, endocrine, psychiatric or cancerous in uncontrolled development,\n15. Person deprived of liberty by an administrative or judicial decision,\n16. Person placed under judicial protection, guardianship or curatorship,\n17. Participating patient who participated in the month preceding inclusion in another interventional drug trial.",{"count":480,"type":22},128,[56],"Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (\\> 360umol \u002F l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is responsible for joint destruction. It becomes a vector of renal failure and is associated with cardiovascular morbidity and a reduction in life expectancy. It is cured if a long-term treatment such as febuxostat leading to the normalization of the uric acidemia is administered.\n\nHowever, the frequency of this disease is increasing in industrialized or emerging countries. The causes are numerous, particularly food, but also related to flaws in therapeutic care. Studies show that this treatment is not taken in particular because, after the acute attack, the patient who has become asymptomatic again no longer consults. Currently, in a traditional way and according to European recommendations, it is not prescribed until several weeks after the acute attack in order to avoid early relapses, which would then be more numerous. Nevertheless, even if the hypouricemic agent is prescribed late , the attacks can be repeated and become rare for several months after obtaining a uricemia below 360umol \u002F l; they eventually disappear. Lack of knowledge of this disease largely affects the hazards of disease-modifying treatment, which alone can prevent the progression to chronic inflammatory disease and its cardiovascular and renal impact and on mortality. One of the causes of not taking a hypouricemic agent is its delayed administration.\n\nThis study is proposed to assess the relevance of early initiation versus delayed administration of such treatment.",[484],"Gout",{"date":91,"type":34},{"date":487,"type":34},"2023-08-02",{"date":489,"type":22},"2027-01-01",{"name":40,"class":41},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":54,"phases":501,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":516},"100408919","role-of-protective-stoma-after-primary-anastomosis-for-generalized-peritonitis-due-to-perforated-diverticulitis-100408919","NCT04604730","Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis","Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial","DIVERTI2","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients operated for purulent or fecal peritonitis (Hinchey grade III and IV) secondary to perforated diverticulitis of the left colon and treated by resection with primary anastomosis\n3. Person informed and having signed his consent. If the patient is unable to sign his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned) (Article L1122-1-1 of the CSP). In this case, consent to continue the study will subsequently be requested from the patient. --\\> In addition, due to the vital urgency represented by hospitalisation in intensive care for purulent or fecal peritonitis, inclusion without prior collection of the consent of the patient or his\u002Fher representative is possible in the case where the patient is not capable of giving consent and his\u002Fher representative is not present at the time of inclusion (Article L1122-1-3 of the CSP). In this case, the patient or his\u002Fher representative will be informed as soon as possible and his\u002Fher written consent will be requested for the possible continuation of this research and the use of the data concerning him\u002Fher.\n4. Patient able to comply with the study protocol, in the investigator's judgment\n5. Patient affiliated with, or beneficiary of a social security (health insurance) category\n\nNon-inclusion Criteria:\n\n1. Physical states that prevent patient participation (e.g. septic shock or multivisceral failure)\n2. Steroid treatment \\> 20 mg daily\n3. Prior pelvic irradiation\n4. Immunocompromised status\n5. Known progressive cancer\n6. American Society of Anesthesiologists grade IV\n7. Peritonitis secondary to perforated diverticulitis of the right colon\n8. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study\n9. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)\n10. Simultaneous participation in another interventional research\n\nExclusion Criteria:\n\n1\\. Failure to obtain the consent of the patient or the patient's representative",{"count":500,"type":22},204,[179],"This study is designed to be a multicentre, prospective, comparative, randomised trial, evaluating the efficacy of two surgical strategies for the treatment of generalised peritonitis due to perforated diverticulitis. Results will be analysed according to an intention to treat principle (after selection and patient consent). Immediately before surgery, the patient will be randomly assigned to sigmoidectomy with primary anastomosis or to sigmoidectomy with primary anastomosis and diverting stoma. Sigmoidectomy will be performed through a midline laparotomy or laparoscopically according to the standard technique. In the control arm, a protective stoma will be performed at the end of surgery. A stoma reversal operation will be performed at least 3 months after the first operation and after performing a cologram by water soluble contrast between 4 and 8 weeks to check for the absence of fistula or stenosis at the level of the anastomosis. Stoma reversal will be performed with a trephine incision.\n\nPost-stoma closure follow-ups will be planned and all morbidity\u002Fmortality will be recorded. All patients will be examined at 6, 12, and 24 weeks after the initial surgery, in the surgical department where they were operated; a final study visit will be carried out 12 months (evaluation of primary endpoint) after surgery. The parameters explored at medical examinations will be: • Occurrence of complications • Quality of life assessment",[504],"Peritonitis",[506,507,508,509],"peritonitis","perforated diverticulitis","primary anastomosis","protective stoma",{"date":91,"type":34},{"date":512,"type":34},"2021-06-11",{"date":514,"type":22},"2026-12-01",{"name":40,"class":41},20,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":4,"enrollmentInfo":525,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":527,"conditions":528,"keywords":531,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":42},"100608703","evaluation-of-the-link-between-carotid-arterial-wall-viscosity-and-major-neurocognitive-disorders-100608703","NCT07205003","Evaluation of the Link Between Carotid Arterial Wall Viscosity and Major Neurocognitive Disorders","Evaluation of the Link Between Carotid Arterial Wall Viscosity and Major Neurocognitive Disorders of Vascular Origin or Linked to Alzheimer's Disease","VISCOG","Inclusion Criteria:\n\n* Age over 70\n* Memory consultation consultant (neurology or geriatrics)\n* Brain MRI less than one year old or planned as part of the cognitive assessment performed.\n* Patient diagnosed with Alzheimer's disease according to DSM-5 criteria or vascular dementia according to DSM-5 criteria, or presenting a memory complaint without evidence of a dementia-related condition.\n* No objection from the patient or their caregiver.\n* Patient covered by a health insurance plan\n\nExclusion Criteria:\n\n* Known unilateral or bilateral carotid stenosis or history of carotid surgery\n* Permanent CA\u002FAF\n* Patient presenting with confusion\n* Known psychiatric illness (severe depression, psychosis, etc.)\n* Non-vascular, non-Alzheimer's dementia (e.g., Lewy Body Dementia, Parkinsonian Dementia, Progressive Supranuclear Palsy)\n* Refusal to participate\n* MMS less than or equal to 10\n* Contraindication to performing an MRI\n* Any acute decompensated pathology\n* Patient under guardianship or curatorship",{"count":526,"type":22},140,"The mechanical behavior of conductance arteries is viscoelastic. While the elastic component has been extensively studied, the viscous component has often been neglected for methodological reasons and also because it was considered weak.\n\nUnlike a purely elastic solid, which exhibits instantaneous deformation\u002Frelaxation upon application\u002Fdiscontinuation of a force, a viscoelastic solid is characterized, from a mechanical point of view, by a delay between the application or discontinuation of the force and deformation. Thus, at the arterial level, the elasticity of the arterial wall allows the internal diameter to increase proportionally to the blood pressure during systole. The viscous component will induce a delay in diameter restoration, resulting in a larger diameter at each pressure level during the diastolic phase compared to the systolic phase. This results in a shift between the systolic and diastolic curves of the pressure-diameter relationship, creating a hysteresis loop. From a thermodynamic point of view, while a purely elastic material fully restores the energy stored during the loading phase, viscoelastic arteries will incompletely restore this energy. Thus, the surface of the hysteresis loop reflects the energy dissipated during each cardiac cycle (WV), and the area under the loading phase curve represents the energy stored by the arterial wall (WE) during the latter. Thus, arterial wall viscosity (APV) can be expressed either as the absolute value of WV or as a function of the stored energy (WV\u002FWE). Physiologically, this energy loss is low. Its increase could be accompanied by excessive energy dissipation, leading to increased cardiac work and cardio-circulatory decoupling. Conversely, low parietal viscosity could lead to damage to peripheral organs by excessive transmission of pulsatile energy to the periphery due to lack of damping.",[529,530],"Neurocognitive Disorders","Alzheimer's Disease",[532],"carotid arterial wall viscosity","2026-05-21",{"date":535,"type":34},"2026-05-22",{"date":537,"type":34},"2022-02-15",{"date":539,"type":22},"2028-05-15",{"name":40,"class":41},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":18,"minAge":23,"maxAge":548,"enrollmentInfo":549,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":147},"100392721","a-pilot-study-for-systematic-neonatal-screening-for-lysosomal-storage-diseases-using-tandem-mass-spectrometry-100392721","NCT04393701","A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry","LysoNeo","Inclusion Criteria:\n\n* Newborn in a Normandy maternity hospital\n* Newborn participating in the National Neonatal Screening Program\n* Holder(s) of parental authority having read and understood the information letter and signed the informed consent form\n\nExclusion Criteria:\n\nThere are no criteria for non-inclusion in this study. Participation in the study, such as participation in the National Neonatal Screening Program, is not mandatory.","4 Days",{"count":550,"type":22},100000,"The study will include all newborns in Normandie region for 3 years (about 105,000 births) for whom signed consent by one (or two) parents will be collected. Based on our previous pilot study (2011) assessing MCAD and PKU using tandem mass spectrometry-based method in Normandie region in which informed consents have been signed for all newborns (43,000) but we are expecting a great willingness to participate to this project. Thus, we are aiming to include 100,000 newborns, and the study will be continued until we reach at least this target.\n\nThe primary objective is to evaluate the epidemiology of MPS1 and Pompe disease using dried blood samples in the first cohort of neonates tested in France (Normandie region).",[553,554],"Neonatal Screening","Lysosomal Storage Diseases",{"date":556,"type":34},"2026-05-27",{"date":558,"type":34},"2021-03-08",{"date":560,"type":22},"2026-12-08",{"name":40,"class":41},""]