[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital, Tours\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":622},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,53,84,108,133,162,189,215,236,260,282,302,323,346,371,392,417,440,461,484,505,525,549,574,595],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100644125","phase-3-inhaled-amikacin-versus-placebo-in-patients-with-ventilator-associated-tracheobronchitis-100644125",false,"NCT07665788","Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis","A Multicentre, Double-blind, Randomized Controlled Trial of Inhaled Amikacin Versus Placebo in Critically Ill Patients With Ventilator-associated Tracheobronchitis","AMIVAT","Inclusion criteria:\n\n* Age ≥ 18 years\n* Admission to a participating intensive care unit (ICU)\n* Invasive mechanical ventilation \\> 48 hours\n* First episode of ventilator-associated tracheobronchitis during the ICU stay defined using the following criteria: (i) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate ≥10.5 colony-forming unit (CFU)\u002FmL or on bronchoalveolar lavage ≥10.4 CFU\u002FmL or on plugging telescopic catheter ≥10.3 CFU\u002FmL\n* Coverage by the French health insurance system (Social Security)\n* Written informed consent obtained from the patient, or, if the patient is not able to give written consent, from his or her legally designated representative (trusted person designated by the patient or, failing that, a family member) or, failing that, inclusion performed by the investigator within the therapeutic window (in such cases, informed consent will be sought by the investigator from the patient, or his or her legally designated representative, whichever is sooner). In all cases, the patient's written informed consent will be obtained as soon as possible.\n* For woman of childbearing potential: negative pregnancy test result at the time of inclusion\n\nExclusion criteria:\n\n* Previous ventilator-associated pneumonia due to the pathogens responsible for ventilator-associated tracheobronchitis during the same ICU stay\n* On-going antimicrobial therapy fpr ventilator-associated pneumonia\n* Ventilator-associated tracheobronchitis due to pathogens with intrinsic amikacin resistance (e.g. Stenotrophomonas maltophilia)\n* On-going therapy with intravenous amikacin or another aminoglycoside\n* Acute kidney injury stage 2 or 3 of the Kidney Disease Improving Global Outcomes (KDIGO) classification and\u002For advanced chronic kidney failure (glomerular filtration rate \\\u003C30 mL\u002Fmin), except in patients under renal replacement therapy\n* Grade B or C cirrhosis (Child-Pugh classification)\n* Scheduled extubation within 24h\n* Prior tracheotomy\n* Administration of inhaled antibiotics within the 7 preceding days\n* Known hypersensitivity to amikacin, another aminoglycoside, or any of the excipients\n* Myasthenia gravis\n* Contraindication to nebulization\n* On-going treatment with ataluren\n* Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship).\n* Moribund patient\n* End-of-life decision\n* Previous inclusion in the present study\n* Participation to another interventional study\n* Inability of the patient, or the person providing consent, to understand all aspects of the research\n* Patient being a relative of the investigator or a relative of someone from the team directly involved in the trial, including doctors and pharmacists","ALL","18 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The primary objective of the AMIVAT trial is to assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the incidence of progression to ventilator-associated pneumonia (VAP) at day 28 in intensive care unit (ICU) patients with ventilator-associated tracheobronchitis (VAT). Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT.",[28,29],"Ventilator-Associated Pneumonia","Ventilator-Associated Tracheobronchitis",[31,32,33,34,35,36,37,38,39],"Ventilator-associated tracheobronchitis","Ventilator-associated pneumonia","Inhaled antimicrobial therapy","Mechanical ventilation","Hospital-acquired infection","Ventilator-associated lower respiratory tract infection","ICU-acquired infection","Aminoglycoside","Amikacin","NOT_YET_RECRUITING","2026-06-18",{"date":43,"type":44},"2026-06-24","ACTUAL",{"date":46,"type":22},"2026-06-01",{"date":48,"type":22},"2029-09-01",{"name":50,"class":51},"University Hospital, Tours","OTHER",17,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100644438","phase-2-acetylsalicylic-acid-versus-placebo-as-an-add-on-treatment-to-local-non-steroidal-anti-inflammatory-drug-for-the-management-of-thrombotic-episodes-in-superficial-venous-malformations-in-children-aged-6-to-17-years-100644438","NCT07663825","Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years.","Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years: a Controlled Randomised, Double-blind, Cross-over, Multicenter Trial","ASPIRIN","Inclusion Criteria:\n\n* Patients aged 6 to 17 years\n* Weight ≥ 20 kg\n* Isolated or combined superficial venous malformation, confirmed by imaging, with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis\n* Complicated by acute thrombotic episodes (2 or more in the previous 12 months)\n* Written consent of the child's legal representatives or of the participant if over 18 years of age\n* Affiliation of a social security scheme\n* Highly effective contraception for young women of childbearing age\n\nExclusion Criteria:\n\n* Patients with deep or syndromic venous malformation\n* Patients with known G6PD deficiency\n* Patients with known mastocytosis\n* History of hemarthrosis\n* Simultaneous participation in another biomedical study\n* Constitutional or acquired haemostasis pathology\n* Current treatment affecting haemostasis (anticoagulants, platelet anti aggregants, oral NSAIDs)\n* Frequent bleeding (epistaxis, other) requiring management\n* Basic treatment of venous malformation (mTOR inhibitor)\n* Active neoplasia or infection (altered coagulation balance)\n* Known allergy to acetylsalicylic acid\n* Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds\n* Pregnant and breastfeeding women\n* Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency\n* Methotrexate ≥ 20 mg\u002Fweek","6 Years","17 Years",{"count":64,"type":22},34,[66],"PHASE2","Superficial venous malformations (SVMs) are rare congenital anomalies that present as bluish masses. These masses may be focal, with limited skin involvement, or segmental, with more extensive involvement. They may be associated with syndromic conditions such as blue rubber nevus syndrome.\n\nSVMs are characterised by a progressive worsening course, with repeated episodes of superficial venous thrombosis occurring. These episodes become more frequent over time, causing acute, intense and often highly debilitating pain.\n\nTo limit progression and in cases of functional impairment, long-term treatments may be offered. These include venous compression, targeted therapies such as mTOR inhibitors, and, where possible, surgical treatment or sclerotherapy.\n\nHowever, the management of intra-SVM superficial venous thrombosis is not currently standardised, especially in the pediatric population. This study aims to evaluate the benefits of Acetylsalicylic acid (ASA) as an add-on treatment to local non-steroidal anti-inflammatory drug for the management of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years.",[69,70],"Venous Malformation, Low Flow","Venous Malformations",[72,73,74],"superficial venous thrombosis","superficial venous malformations","acetylsalicylic acid","2026-06-16",{"date":77,"type":44},"2026-06-23",{"date":79,"type":22},"2026-09",{"date":81,"type":22},"2030-10-31",{"name":50,"class":51},6,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":18,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100545475","phase-2-efficacy-of-emono-as-an-add-on-therapy-to-conventional-antidepressants-for-the-treatment-of-depressive-symptoms-in-nursing-home-residents-with-neurocognitive-disorders-a-randomized-controlled-trial--100545475","NCT06382389","Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial-","Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial","PROTO-EHPAD","Inclusion Criteria:\n\n* Men and women aged 60 and over living in nursing home\n* Diagnosis of major neurocognitive disorder according to DSM-V for at least 6 month\n* MMSE \\\u003C= 20\u002F30\n* NPI depression \\>= 4\u002F12\n* Patient, family and legal representive consent where applicable Person affiliated to a social security schem\n\nExclusion Criteria:\n\n* NPI agitation \\> 6\u002F12\n* Unstable somatic pathology (in particular unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA) and any unexplained recent neurological abnormality.\n* Contraindications to the use of MEOPA\n* Patients who have already been treated with MEOPA in the 6 months prior to inclusion, for example for painful treatment\n* Sub-physiological plasma vitamin B12 or B9 concentration (below the lower limit of the laboratory value).\n* A person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation\n* Personne participant à une étude clinique médicamenteuse ou en période d'exclusion de toute étude clinique du fait d'une précédente participation","60 Years",{"count":94,"type":22},96,[66],"Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects.\n\nRecent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes.\n\nThe principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure.",[98,99],"Depression","Neurocognitive Disorders",[101],"Nitrous Oxide",{"date":103,"type":44},"2026-06-17",{"date":79,"type":22},{"date":106,"type":22},"2028-09",{"name":50,"class":51},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100470777","phase-3-chronic-anticoagulation-with-a-reduced-dose-regimen-of-rivaroxaban-in-end-stage-renal-disease-patients-100470777","NCT05410275","Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients","Chronic Anticoagulation in End-stage Renal Disease Patients: Pharmacokinetics and Pharmacodynamic of a Reduced Dose Regimen of Rivaroxaban","CARD-AXA","Inclusion Criteria:\n\n* Adult patient ≥ 18 years of age,\n* Chronic hemodialysis patient for at least 3 months,\n* Affiliated or beneficiary of a social security plan,\n* Having signed a written and informed consent.\n\nExclusion Criteria:\n\n* Any indication for long-term oral anticoagulation (atrial fibrillation, venous thromboembolic disease, mechanical valve prostheses, intracardiac thrombosis, etc.)\n* Double anti-platelet aggregation for any reason or an aspirin dose greater than 160 mg\u002Fday\n* Uncontrolled hypertension (BP \\> 180\u002F110 mmHg)\n* Ischemic stroke within 30 days prior to inclusion\n* History of major unprovoked hemorrhage (leading to hospitalization or transfusion) regardless of age\n* Surgery within 30 days prior to inclusion\n* High-risk bleeding condition in addition to renal failure (such as known coagulation disorder, thrombocytopenia (\\\u003C 100G\u002FL), active neoplasia of the digestive or urinary tract, or presence of intracranial vascular malformation)\n* Severe hepatic impairment\n* Use of strong CYP3A4 inducers, including rifampin, St. John's Wort, carbamazepine, phenytoin, phenobarbital\n* Non-compliant patients\n* Pregnant or breastfeeding women, women of childbearing age without effective contraception\n* Contraindication to the administration of an anticoagulant treatment such as anti-phospholipid antibody syndrome\n* Known allergy to rivaroxaban or to one of its excipients (lactose monohydrate)\n* Patients under guardianship or conservatorship\n* Patients already participating in an ongoing study or who have participated in a study that ended less than 30 days prior to the inclusion date.",{"count":117,"type":22},10,[25],"Atrial fibrillation is the most frequent cardiac rhythm disorder and its prognosis is essentially marked by the risk of embolic events. Its treatment is based on long-term oral anticoagulant therapy according to the risk of embolic events assessed by risk scores such as the CHA2DS2-Vasc score, but this prescription is associated with a risk of hemorrhagic events that must be taken into consideration when deciding on the treatment for a given patient. There are two categories of validated oral anticoagulant treatments for the prevention of embolic events in atrial fibrillation: antivitamin K agents, which have long been the reference treatment but are restrictive and difficult to use because of a narrow therapeutic window, and direct oral anticoagulants, which are now the first-line treatment but have not been evaluated in phase II and III studies in patients with severe renal failure. End-stage renal disease (clearance \\\u003C15 mL\u002Fmin\u002F1.73m2), particularly at the dialysis stage, is a risk factor for cardiovascular disease in its own right, and a significant number of patients develop atrial fibrillation. Given the co-morbidities associated with renal failure, in particular hypertension, patients with renal failure undergoing dialysis and suffering from atrial fibrillation are generally at a higher risk of embolism than patients without renal failure, but also at a higher risk of bleeding. Thus, if the indication for prescribing oral anticoagulant therapy is clear in this population, the associated bleeding complications are also more frequent and more serious in these patients who have regular vascular accesses in the context of hemodialysis. There is thus a real need for reliable therapeutic alternatives with a better benefit\u002Frisk ratio than antivitamins K.\n\nTranslated with www.DeepL.com\u002FTranslator (free version)",[121],"Chronic Hemodialysis Patients",[123,124],"Kidney Diseases","Therapeutic drug monitoring","RECRUITING",{"date":41,"type":44},{"date":128,"type":44},"2025-01-08",{"date":130,"type":22},"2027-01-30",{"name":50,"class":51},2,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100468872","phase-3-induction-in-sensitized-kidney-transplant-recipients-without-pre-existing-donor-specific-antibodies-100468872","NCT05385432","Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies","Induction in Sensitized Kidney Transplant Recipients Without Preexisting Donor-specific antiboDies: a Randomized Multicentre Trial Between a Lymphocyte Depleting and Basiliximab.","INSTEAD","Inclusion Criteria:\n\n* Patients aged between 18-79\n* Registered on the transplant waiting list\n* At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000 (MFI threshold in agreement with French kidney allocation system.)\n* Graft incompatibility rate (TGI) \\\u003C 85%\n* Ability for participant to comply with the requirements of the study\n* Written informed consent obtained from the participant\n* Participants covered by or entitled to social security.\n\nExclusion Criteria:\n\n* DSA (negative virtual crossmatch with MFI threshold at 1000)\n* Combined transplantation\n* Usual contraindications to a kidney transplantation such as morbid obesity (BMI \\> 40 kg\u002Fm2), active drug abuse, uncontrolled psychiatric disease, or decompensated heart failure\n* Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)\n* Incompatible ABO transplantation\n* Leukopenia lower than 3000\u002Fmm3\n* Thrombocytopenia (platelets \\\u003C 50G\u002FL)\n* Donor EBV Positive \u002F Recipient EBV Negative\n* Active HIV infection (positive viral charge)\n* History of solid cancer (\\\u003C 5 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma).History of some solid cancer (prostate, breast) can be reduced (\\\u003C2 years), depending on the prognosis for cancer recurrence as assessed by the oncologist.\n* History of lymphoma\n* Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin greater than 3 times normal\n* Known hypersensitivity or contra-indication to rabbit proteins, basiliximab including the product excipients\n* Contra-indication to tacrolimus,mycophenolic acid ans steroids\n* Pregnant or breastfeeding woman, or woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed for inclusion.\n* Patient under judicial protection, deprivation of liberty\n* Participation in other interventional research with an investigational drug or medical device.","79 Years",{"count":143,"type":22},244,[25],"Induction therapy decreases the rate of acute allograft rejection in kidney transplant recipients (KTRs) and is strongly recommended. Polyclonal lymphocyte-depleting antibodies and interleukin-2 receptor (IL2R) antagonists are therefore widely used around the world, with a leading position for rabbit anti-thymocyte globulin (rATG, Thymoglobulin®) and basiliximab (Simulect®), respectively. The actual immunological risk of the sensitized KTRs without donor specific antibodies (DSAs) is still debated. The benefit-risk equation of lymphocyte depleting antibodies (versus IL2R antagonists) is not known in sensitized KTRs without DSAs. This clinical trial will compare the efficacy and safety of basiliximab and rATG in sensitized KTR without pre-existing DSAs detected by Luminex.",[147,148],"Renal Transplant Rejection","Induction Therapy",[150,151,152,153,154],"Kidney transplantation","Basiliximab","ATG","induction","rejection",{"date":41,"type":44},{"date":157,"type":44},"2023-11-07",{"date":159,"type":22},"2030-12-30",{"name":50,"class":51},1,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100434452","efficacy-and-safety-of-non-invasive-vagal-stimulation-to-prevent-chemotherapy-induced-nausea-100434452","NCT04937309","Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea","Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy","SILENCE","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) status 0 to 2\n* patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy\n* informed consent\n* compliance expected\n* social security affiliation\n\nExclusion Criteria:\n\n* nausea or vomiting 24h or less, before inclusion\n* Antiemetic drug intake in the last 72h before inclusion\n* Central nervous system metastasis\n* Daily alcohol intake\n* Prior chemotherapy\n* Cardiac arrythmia, severe heart failure\n* Device for sleep apnea\n* History of arterial or venous thrombosis, or thrombophlebitis\n* Vagotomy\n* Vagal stimulation ongoing\n* Skin disease on the stimulation zone\n* Cochlear implant next to the stimulation zone\n* Unable to use the vagal stimulation device due to left ear unusual shape\n* Pregnant or breastfeeding women, or women of childbearing age without effective contraception\n* Documented allergy or contraindication to one of the antiemesis drugs required in the study\n* Protected adults (individuals under guardianship by court order)\n* Unable to read or write",{"count":171,"type":22},338,[173],"NA","Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life.\n\nNon invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea.\n\nThis study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.",[176],"Breast Cancer",[178,179,180,181],"nausea","non invasive vagal stimulation","chemotherapy","breast cancer",{"date":103,"type":44},{"date":184,"type":44},"2022-06-23",{"date":186,"type":22},"2028-09-30",{"name":50,"class":51},8,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":196,"sex":18,"minAge":61,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":161},"100634691","individual-neurophysiological-sensory-profiles-in-people-with-and-without-neurodevelopmental-disorders-100634691","NCT07542977","Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders","SensAUry","Inclusion Criteria:\n\n* Social security affiliation\n* Free and written informed consent from the participants (Neurotypical Adults, NDD Adults without judicial protective measures), or their tutor or legal representant(s) (other participants)\n* Age between 6 and 12 years included (Children) or between 18 and 45 years included (Adults)\n* For NDD participants: NDD diagnosis by a qualified medical professional, according to DSM-4, DSM-5, ICD-10 or ICD-11 criteria\n\nNon-inclusion Criteria:\n\n* Psychotropic medication perturbing EEG recording\n* Drugs pertubing peripheral neurophysiological measures\n* Non-corrected visual or auditory troubles\n* Known neurological or psychiatric conditions (at the exclusion of NDD for NDD participants)\n* Epilepsy\n* Inclusion in another ongoing medical protocol\n* For Neurotypical participants: NDD diagnosis\n* For NDD participants: anticipated psychological or physical risk at participating, at the investigator's discretion\n\nExclusion Criteria:\n\n* Participants with no data to evaluate Outcome 1",true,"45 Years",{"count":199,"type":22},200,"OBSERVATIONAL","The goal of this observational study is to evaluate intra-individual neurophysiological variability in children and adults with and without NeuroDevelopmental Disorders (NDD), for several sensory modalities and types of stimulation. The main hypotheses are:\n\n* NDD participants and children exhibit higher intra-individual variability than other participants\n* intra-individual neurophysiological variability is correlated to behavioral, psychological and learning profiles\n\nParticipants in this study will:\n\n* be recorded for EEG and other neurophysiological parameters while exposed to sensory stimulations, to quantify sensory neurophysiological variability\n* perform behavioral tests and fill out questionnaires, to establish the behavioral and psychological profile\n* train for perceptual learning, to measure learning abilities\n\nThese evaluations will be split in 3 visits spread on a maximum of 3 months, and training for learning will be done at home in between 2 visits.",[203],"Neurodevelopmental Disorders",[205,206,207],"Sensory","Neurophysiology","Profile","2026-06-12",{"date":75,"type":44},{"date":211,"type":44},"2026-05-07",{"date":213,"type":22},"2028-06-15",{"name":50,"class":51},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100565489","phase-3-bevacizumab-based-chemotherapy-adapted-to-bevacizumab-pharmacokinetics-in-1st-line-treatment-100565489","NCT06642844","Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment","Bevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer: a Randomized, Multicenter, Double-blind Phase 3 Study","PHARBEVACOL","Inclusion Criteria:\n\n* Patients aged ≥18 years.\n* Histologically proven metastatic colorectal adenocarcinoma (on primary tumor and\u002For metastases) inoperable, well documented, i.e. not compatible with complete oncological resection at inclusion.\n* For whom treatment with bevacizumab is indicated.\n* For women of childbearing age: effective contraception.\n* ECOG Performance status (PS) 0-2.\n* No prior treatment of metastatic disease (in the case of adjuvant treatment, interval between the end of chemotherapy and relapse \\> 6 months if fluoropyrimidine alone or \\> 12 months if FOLFOX).\n* At least one evaluable or measurable lesion assessed by computed tomography (CT) according to RECIST v1.1 criteria.\n* Life expectancy greater than 3 months.\n* Adequate hematological, renal and hepatic biological parameters: neutrophils ≥ 1.5x109\u002FL; platelets ≥ 100x109\u002FL; hemoglobin ≥ 9 g\u002FdL; serum creatinine \\\u003C150 μmol\u002FL; bilirubinemia ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase \\\u003C 5xULN; proteinuria \\\u003C 2+ (urine dipstick) or ≤ 1 g\u002F24h.\n* Written informed consent signed by the patient.\n* Patient affiliated to a French social security system.\n\nRandomization criteria in the experimental phase:\n\n\\- Serum concentration of bevacizumab on D14 ≤ 15.5 mg\u002FL (measured just before the 2nd infusion of bevacizumab).\n\nExclusion Criteria:\n\nLess than 6 months from the end of any prior chemotherapy, radiotherapy or adjuvant surgery.\n\n* Patient with a known non-indication or contraindication to first-line chemotherapy based on bevacizumab.\n* Cardiovascular contraindication to the prescription of bevacizumab: heart failure, cardiovascular event within 6 months, NYHA ≥ 2 (New York Heart Association), poorly controlled arterial hypertension, history of hypertensive crisis or hypertensive encephalopathy; Grade 3\u002F4 anterior venous thromboembolism (NCI-CTCAE)\n* Inadequate hematological, hepatic and renal function\n* Urine test strip for proteinuria ≥ 2+ unless proteinuria \\\u003C 1 g \u002F 24 hours is demonstrated.\n* Current or recent (within 10 days of study enrollment) use of aspirin (\\>325 mg\u002Fday) or clopidogrel (\\>75 mg\u002Fday).\n* Current or recent use (within 10 days before the first dose of bevacizumab) of oral or parenteral therapeutic anticoagulants or thrombolytic agents for therapeutic purposes.\n* Untreated CNS metastases or treatment of brain metastases, either by surgical or radiological techniques, must have been completed more than 4 weeks before the first study treatment.\n* Surgical procedure (including open biopsy, surgical resection, wound revision, or other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to study enrollment or anticipation of study need for major surgery during the study.\n* Serious non-healing wound, active ulcer or untreated bone fracture.\n* Other neoplasias (previous or current), except:\n\n  * i\u002F carcinoma in situ of the cervix adequately treated,\n  * ii\u002F basal cell or squamous cell carcinoma of the skin,\n  * iii\u002F cancer in complete remission for more than 5 years.\n* Other illnesses, which, according to the doctor, are life-threatening to the patient and\u002For which are uncontrolled.\n* Primary tumor in place and symptomatic (occlusion, hemorrhage).\n* Pregnant or breastfeeding women.\n* Patients unable to give consent.\n* Patients under guardianship, curatorship or legal protection.","99 Years",{"count":143,"type":22},[25],"Bevacizumab is a standard drug for metastatic colorectal cancer (mCRC) in combination with cytotoxic chemotherapy. However, inter-individual pharmacokinetic variability was observed for bevacizumab and an exposure-response relationship for efficacy was described for bevacizumab in mCRC patients treated with 1st-line bevacizumab-based chemotherapy.",[228],"Unresectable Metastatic Colorectal Cancer",{"date":75,"type":44},{"date":231,"type":44},"2025-03-04",{"date":233,"type":22},"2029-03-04",{"name":50,"class":51},4,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":196,"sex":18,"minAge":19,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":161},"100547371","collection-of-primary-human-100547371","NCT06407102","Collection of Primary Human","Collection of Primary Human Nasal Epithelial Cells","BIONOSE","Inclusion Criteria:\n\n* Adult patients (age \\> 18 years) whose native language is French, or who understands French.\n* Affiliation with a French social security system (CMU accepted).\n* Informed consent, written and signed by the participant.\n* Planned rhinological surgery (meatotomy, septoplasty or turbinoplasty for example, but other surgeries as well)\n\nExclusion Criteria:\n\n* Patients under court protection, guardianship or curatorship.\n* Pregnant or breast-feeding women (positive pregnancy test for women of childbearing age).\n* Patients presenting a major alteration of the mucosa or a malignant rhinosinus pathology.","90 Years",{"count":246,"type":22},100,[173],"Treatment and prevention of respiratory infections are of great interest in many medical areas. Create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. In this context the aim of this project is to create a collection of primary cells from the human nasal epithelium.\n\nThis collection will be realised during programmed surgery, thanks to a specific device dedicated to collect nasal cells. Then the cells will be sent to the lab in order to grow at the air-liquid interface, which is an excellent 'ex vivo' model for their study.",[250],"Nasal Disease",[252,253],"nasal cells","Respiratory epithelium",{"date":75,"type":44},{"date":256,"type":44},"2024-12-06",{"date":258,"type":22},"2028-05-02",{"name":50,"class":51},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":161},"100563963","effectiveness-of-the-skills-program-in-the-management-of-psychiatric-disorders-100563963","NCT06622993","Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders","Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders: a Pilot Randomized Controlled Trial","P-SKILLS","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Have at least one diagnosis of a psychiatric disorder\n* Be able to carry out psychotherapy sessions\n* Have been on stable psychiatric medication for 30 days\n* Written informed consent obtained from the participant\n* Be affiliated to a social security scheme or equivalent\n\nExclusion Criteria:\n\n* Cognitive deficits marked by a score above the 10th percentile for one or more tests in the assessment history.\n* Persons deprived of liberty by judicial or administrative decision; Persons under legal protection: guardianship or curatorship\n* Presence of a severe depressive episode\n* Be engaged in psychotherapeutic work elsewhere\n* Presence of a state of excessive deficit, making psychotherapy impossible\n* Presence of psychic decompensation (e.g. delusions) making psychotherapy impossible","100 Years",{"count":270,"type":22},60,[173],"Epidemiological studies show that one person in eight suffers from at least one psychiatric disorder. Mental health is therefore a major public health issue, and care for these disorders must continue to be improved.\n\nThe management of mental disorders has long followed the traditional categorical approach of developing a treatment for a given disorder. However, researchers have recently pointed out the limits of this approach in the field of mental health. They highlight the large number of co-morbidities, the existence of aspecific disorders and the intra-diagnostic heterogeneity of patients. These factors have led them to develop a transdiagnostic approach, which focuses on the mechanisms common to the various disorders in order to treat them at the same time and thus reduce the cost of treatment.",[274],"Psychiatric Disorders","2026-06-11",{"date":208,"type":44},{"date":278,"type":44},"2024-11-14",{"date":280,"type":22},"2026-11",{"name":50,"class":51},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":268,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":299,"leadSponsor":301,"locationsCount":161},"100558293","phase-3-evaluation-of-efficacy-and-safety-of-rituximab-and-mycophenolate-mofetil-combination-in-patients-with-interstitial-lung-disease-related-to-systemic-sclerosis-100558293","NCT06549231","Evaluation of Efficacy and Safety of Rituximab and Mycophenolate Mofetil Combination in Patients With Interstitial Lung Disease Related to Systemic Sclerosis","Evaluation of Efficacy and Safety of Rituximab and Mycophenolate Mofetil Combination in Patients With Interstitial Lung Disease Related to Systemic Sclerosis: a Multicentre Double-blind Placebo-controlled Randomized Trial.","EVER-ILD 3","Inclusion criteria\n\n1. Male and female 18 years and older who meet the American College of Rheumatology\u002FEUropean League Against Rheumatism collaborative initiative (ACR\u002FEULAR) classification criteria 2013 for systemic scleroderma.\n2. Who are eligible for a treatment with MMF (up to 1500 mg twice daily if tolerated) for the management of SSc-ILD adapted from the French PNDS (revised may 2022) \\[9\\]:\n\n   * Severe ILD at the baseline assessment i. with an extensive ILD on HRCT ≥20% according to Goh classification \\[10\\] ii. or with forced vital capacity of the predicted value (% FVC) ≤ 70%.\n   * or ILD regardless of HRCT extension and at high risk of progression (age \\> 60 years, male gender, early cutaneous diffuse SSc (≤ 5 years), Afro-American or Afro-Caribbean ethnicity, anti-SCL70\u002FTopoisomerase I autoantibody, or biological inflammation with CRP \\>= 5 mg\u002FL).\n   * or ILD regardless of HRCT extension and with progression criteria in the past 6-24 months before the initial assessment (based on INBUILD study): i. relative decline in the forced vital capacity of the predicted value (% FVC) \\>=10% ii. or relative decline in FVC of 5-10% associated with a relative decline in DLCO \\>= 15% iii. or relative decline in FVC of 5-10% associated with worsening of dyspnea or extension of ILD lesion on HRCT iv. or worsening of dyspnea with extension of HRCT opacities\n3. Person affiliated to a French social security system or equivalent\n4. Written informed consent obtained from participant with a specific check box on the Consent form of the study, understanding the risk for men and women treated with mycophenolate mofetil. And additional written consent on the care and contraception agreement form for women of childbearing potential because of use of mycophenolate\n5. Ability for subject to comply with the requirements of the study.\n\n   Exclusion Criteria:\n6. Known diagnosis of significant respiratory disorders (asthma, tuberculosis, aspergillosis, cystic fibrosis, idiopathic pulmonary fibrosis, sarcoidosis, smoking-related ILD), severe cardiomyopathy or a known severe heart failure as considered by the investigator\n7. Known diagnosis of group 1 precapillary pulmonary hypertension (mean pulmonary artery pressure (mPAP) \\> 20 mmHg and pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg and pulmonary vascular resistance \\> 2 UWood and FVC ≥ 70% theoretical) or group 3 severe precapillary pulmonary hypertension (mPAP \\> 20 mmHg and PAWP ≤ 15 mmHg and pulmonary vascular resistance \\> 5 UWood, whatever the FVC)\n8. Concomitant medical or surgical disease, clinically significant as considered by the investigator, serious or unstable, acute or chronically progressive, or any condition that could affect the safety of the patient, in the opinion of the investigator\n9. Patient who cannot walk more than 100 meters\n10. Known MMF intolerance\n11. Initiation of a new therapy for SSc-ILD or with interruption \u002F modification of therapy dosage within 4 weeks prior to baseline assessment\n12. Patient having already received a rituximab or MMF-based treatment line for SSc-ILD\n13. Known hypersensitivity to rituximab, to murine proteins, other excipients or sulphonamide antibiotics.\n14. Concomitant immunosuppressive treatments: \\>15 mg\u002Fday corticosteroids, azathioprine, cyclophosphamide, methotrexate, cyclosporine, tacrolimus, JAK inhibitors within 4 weeks prior to inclusion\n15. Treatment with monoclonal antibodies (such as, but not limited to, etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, tocilizumab) within 6 months prior to inclusion\n16. Patients on a lung transplant list\n17. Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship). Also, women of child-bearing potential (including female partners of sexually active men treated with mycophenolate) not using two reliable contraceptive methods and men not using a contraceptive method (condom), or women and men having a pregnancy project during the year following randomization\n18. Patients at high risk of infectious complications: Human Immunodeficiency Virus (HIV) positive or other known immunodeficiency syndromes, hepatitis B and C (HBV, HCV), COVID (within 3 month) or other known viral infection, infection requiring anti-infective treatment within 4 weeks of inclusion\n19. Patients with incomplete anti-SARS-CoV-2 vaccine regimen (according to current recommendations) and in this case, patient who has not receive treatment with anti SARS CoV2 therapeutic antibodies (ex : tixagévimab\u002Fcilgavimab).\n20. Concomitant participation in other interventional research with an investigational drug or medical device.",{"count":291,"type":22},102,[25],"The goal of this clinical trial is to evaluate the efficacy on lung function after 24 weeks of rituximab + MMF combination comparatively to placebo + MMF combination in patients with SSc-ILD severe at the initial assessment or at high risk of progression.",[295],"Interstitial Lung Disease With Systemic Sclerosis","2026-06-10",{"date":208,"type":44},{"date":128,"type":44},{"date":300,"type":22},"2029-01-08",{"name":50,"class":51},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":132},"100452418","use-of-immersive-virtual-reality-to-train-the-multisensory-processing-capacities-of-children-aged-8-to-16-years-old-with-an-autism-spectrum-disorder-single-center-randomized-pilot-study-in-parallel-groups---sevire-sensory-virtual-reality-100452418","NCT05171244","Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)","SEVIRE","Inclusion Criteria:\n\n* Child \u002F adolescent aged 8 to 16 years, diagnosed with ASD (DSM-5, ADOS, ADI-R criteria).\n* Without intellectual delay (QNV\\> 70, WISC-IV or V, WAIS-III or IV).\n* Benefiting from a treatment program at the University Center for Child Psychiatry (CHRU Bretonneau-Tours).\n* Schooled in the ordinary school context (primary school, middle school, high school, ULIS).\n* Having expressed their agreement to participate in the study.\n\n  * Whose parents or legal representatives have signed written consent.\n  * Whose parents or legal representatives are affiliated or beneficiaries of a social security scheme.\n\nExclusion Criteria:\n\n* Neuromotor disorders.\n* Uncorrected visual disorders.\n* Hearing impairment.\n* Known epilepsy.\n* Anxiety syndromes identified.\n* Hyper ADD \u002F H type activity.\n* Treatment with methylphenidate. - Rare genetic syndrome.","8 Years","16 Years",{"count":312,"type":22},50,[173],"Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with \"noisy\" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.\n\nThus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.\n\nThe investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.",[316],"Autism Spectrum Disorder",{"date":275,"type":44},{"date":319,"type":44},"2022-03-03",{"date":321,"type":22},"2028-08",{"name":50,"class":51},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":268,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":4},"100627066","comorbidity-between-attention-deficit-hyperactivity-disorder-and-fibromyalgia-100627066","NCT07443800","Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia","Comorbidity Between Attention Deficit Hyperactivity Disorder (ADHD) and Fibromyalgia: Cross-prevalence in Patients Treated for ADHD Who Are naïve to Methylphenidate, ADHD Treated With Methylphenidate, or Fibromyalgia, and Associated Metabolomic Factors","HYPERPAIN","Inclusion Criteria:\n\nFor patients with fibromyalgia :\n\n* Men or women aged 18 or over\n* Diagnosis of fibromyalgia\n* Affiliated with a social security scheme\n* Having signed an informed consent form\n\nFor patients with ADHD treated with methylphenidate\n\n* Men or women aged 18 or over\n* ADHD diagnosis\n* Current treatment with extended-release methylphenidate for at least 1 month, with stable dosage for at least 2 weeks\n* Affiliated with a social security scheme\n* Having signed an informed consent form\n\nFor patients with ADHD but not treated with methylphenidate\n\n* Men or women aged 18 or over\n* ADHD diagnosis\n* Affiliated with a social security scheme\n* Having signed an informed consent form\n\nExclusion Criteria:\n\n* For patients with fibromyalgia: existence of another condition explaining chronic pain\n* Severe cognitive impairment\n* Difficulties in understanding self-administered questionnaires\n* Difficulties in assessing pain intensity\n* Acute psychiatric disorder impacting the validity of self-report questionnaire data collection\n* Inability to take biological samples\n* Persons covered by Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, persons subject to legal protection measures: guardianship or curatorship).",{"count":246,"type":22},[173],"The overall objective of the research project presented here is to assess the prevalence of fibromyalgia in patients being treated for ADHD, the prevalence of ADHD in patients being treated for fibromyalgia, and the neurobiological correlates of ADHD-fibromyalgia comorbidity.",[335,336,337],"ADHD - Attention Deficit Disorder With Hyperactivity","Fibromyalgia (FM)","Chronic Pain","2026-06-02",{"date":340,"type":44},"2026-06-04",{"date":342,"type":22},"2026-07-01",{"date":344,"type":22},"2028-07-01",{"name":50,"class":51},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":370},"100630228","multiomics-approach-in-adult-patients-with-phenylketonuria-100630228","NCT07484945","Multiomics Approach in Adult Patients With Phenylketonuria","Relationships Between the Genome and Metabolomic and Phenomic Signatures in Adult Patients With Early-Treated Phenylketonuria: a Multicenter Cross-sectional Study","GENOPHEN","Inclusion Criteria:\n\n* PKU patients over the age of 18,\n* diagnosed through the newborn screening program,\n* patients who participated in the final visit of the ECOPHEN study,\n* affiliation with a health insurance plan,\n* informed consent dated and signed by patients for DNA analysis (saliva sample)\n\nExclusion Criteria:\n\n* Patients whose PKU diagnosis was not detected during neonatal screening,\n* Patients who have not signed a dated informed consent form,\n* Patients who are unable to provide a saliva sample.",{"count":355,"type":22},149,"The GENOPHEN study aims to explore the links between the genome, metabolomic profile, and clinical phenotype in adults with early-treated PKU.",[358],"Phenylketonuria (PKU)",[360,361],"saliva","genetics","2026-04-29",{"date":364,"type":44},"2026-05-06",{"date":366,"type":44},"2026-03-23",{"date":368,"type":22},"2028-03",{"name":50,"class":51},15,{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":380,"studyType":200,"phases":4,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":235},"100627147","improving-the-prognosis-for-cerebral-hemorrhage-a-study-of-clinical-biological-and-imaging-markers-100627147","NCT07444853","Improving the Prognosis for Cerebral Hemorrhage A Study of Clinical, Biological, and Imaging Markers","TIPITCH","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Emergency admission to a participating center, with spontaneous intracerebral hemorrhage confirmed by the first brain imaging (CT or MRI) performed at the time of initial treatment;\n* Obtaining non-opposition\n\nExclusion Criteria:\n\n* First brain imaging performed outside a center participating in the study (e.g., peripheral center not recruiting);\n* Intracerebral hemorrhage secondary to another identified condition, including:\n\n  * vascular malformation (aneurysm, arteriovenous malformation, cavernoma, etc.);\n  * intracranial tumor;\n  * hemorrhagic transformation of a cerebral infarction;\n  * recent head trauma.\n* Patient under legal protection;\n* Patient under guardianship or conservatorship.",{"count":379,"type":22},10000,"2 Years","This study will establish a prospective, multicenter national cohort of patients with spontaneous intracerebral hemorrhage (ICH). A standardized multimodal database integrating clinical, biological, and imaging data will be collected.\n\nThe study aims to better characterize ICH patient phenotypes, identify diagnostic and prognostic biomarkers, and describe adherence to evidence-based acute management strategies, including the proportion of patients managed according to the care bundle validated in the INTERACT 3 study.\n\nThe cohort is also intended to provide a structured platform for translational research and the preparation of future stratified interventional clinical trials in spontaneous ICH.",[383],"Intracerebral Hemorrhage (ICH)",[385],"diagnostic and prognostic biomarkers",{"date":364,"type":44},{"date":388,"type":44},"2026-04-09",{"date":390,"type":22},"2036-04",{"name":50,"class":51},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":402,"conditions":403,"keywords":406,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":161},"100614925","transcranial-ultrasound-assessment-of-cerebral-pulsatility-in-shunt-decision-making-for-suspected-idiopathic-normal-pressure-hydrocephalus-a-prospective-cohort-study-100614925","NCT07285928","Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study","Contribution of Cerebral Pulsatility Assessment by Transcranial Ultrasound to the Decision-making for Cerebrospinal Fluid Shunting in Patients With Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study","HYDROPULSE","Inclusion Criteria:\n\n* Adult\n* Suspected iNPH (= at least 1\u002F3 of the triad symptoms + ventriculomegaly on brain imaging)\n* Hospitalised at Tours University Hospital for 'hydrocephalus assessment'\n* Patient who has provided written and signed consent\n\nNon-inclusion criteria\n\n* Individuals who objected to data processing\n* Walking assessment by the physiotherapy team impossible AND cognitive assessment by the speech therapy team impossible\n\nExclusion criteria\n\n* Patients already fitted with a CSF shunting system (VPS)\n* Suspicion of obstructive hydrocephalus (aqueduct stenosis, tumour, etc.)\n* Patients under legal protection (guardianship, curatorship, judicial protection).",{"count":401,"type":22},110,"This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization in the neurosurgery department, followed by a second ultrasound assessment either at one year after surgery for operated patients, or at one year after the initial ultrasound assessment for non-operated patients. This ultrasound evaluation will be integrated into the routine work-up, which is already systematically performed in cases of suspected idiopathic normal pressure hydrocephalus (iNPH).\n\nThe neurosurgical team's decision to perform cerebrospinal fluid (CSF) shunting will be made blinded to the ultrasound measurements and based solely on the standard clinical protocol.\n\nThe primary objective of the study is to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) prior to subtractive lumbar puncture is significantly higher in patients who show clinical improvement 12 months after CSF shunting compared with those who do not, with a type I error risk (alpha) of 0.05.\"",[404,405],"Brain Pulsatility","Idiopathic Normal Pressure Hydrocephalus (INPH)",[407,408,409],"transcranial ultrasound","cerebral pulsatility","idiopathic normal pressure hydrocephalus (iNPH),",{"date":411,"type":44},"2026-04-30",{"date":413,"type":22},"2026-05",{"date":415,"type":22},"2029-05",{"name":50,"class":51},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":161},"100587803","prospective-validation-of-a-pharmacological-biomarker-for-low-dose-rituximab-in-rheumatoid-arthritis-100587803","NCT06933134","Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis","PROLOD-RA","Inclusion Criteria:\n\n. Age ≥ 18 years\n\n* Diagnosis of rheumatoid arthritis meeting ACR\u002FEULAR 2010 criteria.\n* Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.\n* In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.\n* If corticosteroids are co-prescribed, the dose should be ≤ 10 mg\u002Fd and stable for 3 months.\n\nExclusion Criteria:\n\n* Other associated targeted disease-modifying therapy\n* Sjögren's syndrome or other associated inflammatory rheumatism\n* Fibromyalgia or other pathology having an impact on the assessment of disease activity\n* Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).\n* Opposition to data processing\n* No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, etc.).",{"count":425,"type":22},30,"Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.",[428],"Rheumatoid Arthritis (RA)",[430,431,432,433],"pharmacological biomarker","rituximab","retreatment","low dose",{"date":411,"type":44},{"date":436,"type":44},"2026-04-23",{"date":438,"type":22},"2028-11",{"name":50,"class":51},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":447,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":161},"100559488","development-standardisation-and-standardisation-project-for-a-new-memory-assessment-100559488","NCT06564779","Development, Standardisation and Standardisation Project for a New Memory Assessment","NEM","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Ability to understand judged sufficient by the assessor;\n* Amnesic MCI profile (Petersen, 2003) during the 1st medical consultation prior to the assessment being prescribed.\n\nExclusion Criteria:\n\n* Severe auditory and\u002For visual sensory impairment not compatible with neuropsychological assessment;\n* Judged fit to take the test by the assessor;\n* Patient under guardianship, curatorship or family guardianship;\n* Opposition to data processing.","50 Years",{"count":449,"type":22},150,"Episodic memory (EM) is a neuropsychological marker of Alzheimer's disease (AD) (Thomas-Anterion, 2006). Current tests for its assessment do not take into account the identity and emotional aspects of memory (Van der Linden et al., 2018). However, there are models that integrate links with identity, self-awareness and experience. Pause et al. (2013) propose criteria to create ecological tools, including consideration of the emotional valence of memories and the spatio-temporal context of acquisition. In line with these criteria, we have developed a new tool: the NEM (New evaluation of Episodic Memory). Preliminary studies show different response profiles on the NEM among patients (Launay et al., 2023). We now want to evaluate the relevance of this tool in the differential diagnosis of AD.",[452],"Memory Disorders",[454,455],"Alzheimer","Episodic memory",{"date":411,"type":44},{"date":458,"type":44},"2024-11-22",{"date":438,"type":22},{"name":50,"class":51},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":470,"conditions":471,"keywords":476,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":161},"100534193","detection-of-rheumatoid-arthritis---interstitial-lung-disease-by-thoracic-ultrasound-100534193","NCT06235645","dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound","EARLIER","Inclusion Criteria:\n\n* Adult patient (age \\> 18 years) followed at CHU of Tours\n* Diagnosis of rheumatoid arthritis validated according to ACR 2010 criteria, EULAR classification, regardless of time since diagnosis\n* Patient who has had or will have a thoracic CT scan and PFT performed as part of routine care in the 6 months preceding or following inclusion\n* Patient with at least two risk factors for developing RA-ILD among :\n\n  * Male sex or\n  * Active or former smoker assessed at 20 pack-year or\n  * Age \\> 60 years or\n  * Levels of RF≥3N (rheumatoid factor) and\u002For anti-CCP≥3N (antibodies against cyclic citrullinated peptides) at diagnosis or at any time during the course of the disease or\n  * High RA activity score (DAS28\\>3.2)\n\nExclusion Criteria:\n\n* Diagnosis of congenital lung disease\n* Diagnosis of another autoimmune pathology associated with RA (overlap syndrome) linked to the development of ILD (interstitial lung disease) (systemic sclerosis, myositis, dermatomyositis, mixed connectivitis, systemic lupus erythematosus or other ANCA vasculitis, with the exception of secondary Gougerot-Sjögren's syndromes).\n* Current or operated lung cancer\n* Thoracic irradiation\n* Thoracic transplant patients\n* Previous invasive thoracic procedures\n* Pathologies responsible for pleural thickening (silicosis, asbestosis, known pleural plaque, pleural sequelae of tuberculosis)\n* Pregnant or breast-feeding women\n* Patient under legal protection (guardianship, curatorship or safeguard of justice)\n* Patient who has objected to data processing\n* Parenchymal infection current or less than one month old prior to LUS examination\n* Liquid or gaseous pleural effusion",{"count":469,"type":22},280,"Rheumatoid arthritis is an autoimmune disease that can affect various organs, including the lungs, and lead to rheumatoid arthritis-interstitial lung disease (RA-ILD).\n\nRA-ILD is responsible for increased mortality in rheumatoid arthristis (RA) patients.\n\nThe prevalence of RA-ILD varies according to the screening tool used.\n\nThe current gold standard is chest CT, but this is an expensive, time-consuming and irradiating examination, and recommendations on when and how often it should be performed are not clearly established.\n\nLung ultrasound (LUS) is an emerging tool for the detection of lung parenchymal damage, particularly in systemic scleroderma and idiopathic pulmonary fibrosis (IPF).\n\nLUS is a non-irradiating, non-expensive examination that can be performed rapidly.\n\nThe aim of our study is to evaluate LUS as a screening tool for RA-ILD, in patients with risk factors for developing RA-ILD.",[472,473,474,475],"Rheumatoid Arthritis","Interstitial Lung Disease","Thoracic Ultrasound","Lung Ultrasound",[477,472,473],"Lung ultrasound",{"date":411,"type":44},{"date":480,"type":44},"2024-11-18",{"date":482,"type":22},"2027-03",{"name":50,"class":51},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":196,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":493,"conditions":494,"keywords":497,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":161},"100505271","study-of-neonatal-igg-fc-receptor-expression-in-natural-killer-t-cells-expressing-an-invariant-t-receptor--implication-in-the-pathophysiology-of-systemic-lupus-100505271","NCT05859191","Study of Neonatal IgG Fc Receptor Expression in Natural Killer T Cells Expressing an Invariant T Receptor : Implication in the Pathophysiology of Systemic Lupus","Study of Neonatal Immunoglobulin G (IgG) Fc Receptor (FcRn) Expression in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT): Implication in the Pathophysiology of Systemic Lupus","FiNKLUPUS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of definite systemic lupus which may be associated with secondary antiphospholipid syndrome and\u002For secondary Gougerot-Sjögren's\n* Lupus patient, newly diagnosed or known, untreated or in relapse\n* Lupus patient considered stable by the treating practitioner\n* Requiring blood sampling for follow-up\n\nExclusion Criteria:\n\n* Main autoimmune disease other than lupus\n* Patient under legal protection, guardianship or curators\n* Opposition to data processing",{"count":312,"type":22},"This study evaluates the variation of expression of the neonatal Fc receptor (FcRn) in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT) and monocytes along with the surface expression of Fc gamma type II receptor (RII) and RIII in active or newly diagnosed lupus patients compared to inactive lupus patients.",[495,496],"Systemic Lupus Erythematosus","Physiopathology",[498],"lupus",{"date":411,"type":44},{"date":501,"type":44},"2023-07-21",{"date":503,"type":22},"2030-07",{"name":50,"class":51},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":161},"100449182","cognitive-disorders-and-brain-pulse-100449182","NCT05129150","Cognitive Disorders and Brain Pulse","COG-PULCE","Inclusion Criteria:\n\n* Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions\n\nExclusion Criteria:\n\n* Refusal of TPI ultrasound examination\n* Patients who opposed to data processing\n* Patients under judicial protection",{"count":513,"type":22},300,"Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and\u002For consultations with a MRRC doctor.",[99],[517,518],"Brain pulse","ultrasound",{"date":364,"type":44},{"date":521,"type":44},"2022-03-31",{"date":523,"type":22},"2032-03",{"name":50,"class":51},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":531,"maxAge":532,"enrollmentInfo":533,"targetDuration":534,"studyType":200,"phases":4,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":548},"100345009","assessment-and-follow-up-of-surgical-treatment-of-hemivertebra-in-children-100345009","NCT03772119","Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children","Inclusion Criteria:\n\n* Child from 3 to 10 years old\n* with a vertebral malformation requiring surgery for hemivertebras\n\nExclusion Criteria:\n\n* Child previously operated on the spine\n* Different procedure of a surgical resection of vertebral malformation\n* Absence of medical follow-up\n* Parents refusal concerning data storage","3 Years","10 Years",{"count":449,"type":22},"15 Years","The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).",[537],"Hemivertebra",[539,537,540,541],"Vertebral Malformation","Surgical resection","SOFOP",{"date":411,"type":44},{"date":544,"type":44},"2019-02-04",{"date":546,"type":22},"2039-02",{"name":50,"class":51},13,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":558,"conditions":559,"keywords":561,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":573},"100612280","communication-enhancement-among-ventilated-patients-in-intensive-care-100612280","NCT07251530","Communication Enhancement Among Ventilated Patients in Intensive Care","Communication Enhancement Among Ventilated Patients in Intensive Care : Feasibility of Implementing \"JIB-TourS cARe\" High Technology Device With Eye Tracker","CESAR","Inclusion Criteria:\n\n* Intubated ventilated ICU patient\n* Hospitalized patient with an inflated cuff tracheostomy\n* conscious patient, able to open and close eyes on demand\n* of-age patient\n* French speaking\n\nExclusion Criteria:\n\n* Patient with uncorrected visual impairment or hearing deficiency\n* Known guardianship or trusteeship at the time of inclusion\n* Known pregnant women at the time of inclusion and lactating patients\n* opposed to the processing of personal data",{"count":270,"type":22},"Intensive care is a unit that admits ventilated patients. Hospitalization is extremely challenging for these patients. Their vital prognosis is at stake, and they often have difficulty moving due to pain, edema, neuromyopathy, or the presence of monitoring cables. They are also hindered in their communication: they cannot speak because of the presence of the intubation tube between their vocal cords or the tracheostomy cannula with the inflated cuff. Every day, in each intensive care unit, about 50% of ventilated patients are conscious and face communication difficulties. They describe this difficulty as a \"nightmare.\" This leads to challenges in care management and increases the anxiety caused by hospitalization in the intensive care unit. A large proportion of patients will develop post-intensive care syndrome. The tools currently used are not efficient. Moreover, many patients have comprehension difficulties due to the medications administered to them (sedatives) or due to the initial or secondary pathologies related to their hospitalization (confusional syndrome, ICU delirium).\n\nOur objective is to implement an adapted and personalized communication tool for ventilated patients in intensive care.",[560],"Critical Care, Intensive Care",[562,563,564],"communication","critical care","Augmentative and Alternative Communications Systems","2026-04-28",{"date":567,"type":44},"2026-05-04",{"date":569,"type":44},"2026-03-19",{"date":571,"type":22},"2027-06-01",{"name":50,"class":51},3,{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":594},"100590353","awake-prone-positioning-of-patients-suffering-community-acquired-pneumonia-requiring-nasal-high-flow-therapy-100590353","NCT06966310","Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy","Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19","PRONECAP","Inclusion Criteria:\n\n* Adult patients admitted to an intensive care unit or intermediate care unit\n* Suspicion of community acquired pneumonia (at least one of the 3 criteria): fever, cough, purulent expectoration\n* And abnormalities suggestive of pneumonia by chest X-ray or CT-scan\n* PaO2\u002FFiO2 ratio \\\u003C300 mmHg (or equivalent SpO2\u002FFiO2 i.e. \\\u003C 315 mmHg) under a minimum gas flow of 30 L\u002Fmin.\n* Person affiliated to a French social security system or equivalent\n* Informed consent.\n\nExclusion Criteria:\n\n* Positive SARS-COV2 test within the last 30 days\n* Indication for immediate intubation\n* Patients for whom a \"do not intubate\" decision has been made\n* Chest trauma or other contraindication to prone position\n* Patients with formal indication for non-invasive ventilation: exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary oedema.\n* Pregnant or breastfeeding woman\n* Subjects who are under legal protection measure\n* More than 8h awake prone positioning prior to inclusion\n* More than 48h since intensive care unit or intermediate care unit admission.",{"count":583,"type":22},1078,[173],"Community acquired pneumonia, in particular when requiring oxygen therapy because of acute hypoxemic respiratory failure and meeting acute respiratory distress syndrome (ARDS) criteria frequently leads to tracheal intubation and poor outcome.\n\nAmong invasively mechanically ventilated patients with ARDS and presenting a PaO2\u002FFiO2 ratio (arterial partial pressure of oxygen to inspired fraction of oxygen) of less than 150 mmHg, the prone position significantly reduces mortality and represents standard care (Guérin 2013). Among non-intubated COVID-19 patients, a subtype of viral community acquired pneumonia, a recent study showed that awake prone positioning reduces the composite outcome of intubation or death among patients requiring nasal high flow therapy. Furthermore, it favored weaning of nasal high flow therapy.\n\nProne position in patients with non-COVID ARDS treated with high nasal flow was evaluated in 20 patients with predominantly viral pneumonia (Ding 2020) and was associated with improved oxygenation.\n\nCoordinating investigator hypothesize that prone positioning of patients suffering non-COVID community acquired pneumonia and undergoing nasal high flow therapy can significantly improve outcome by reducing the need for intubation and associated therapies such as sedation and muscle relaxation.",[587],"Community-acquired Pneumonia",{"date":567,"type":44},{"date":590,"type":44},"2025-11-30",{"date":592,"type":22},"2034-10",{"name":50,"class":51},38,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":606,"conditions":607,"keywords":609,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":7},"100635200","phase-4-prophylaxis-of-recurrent-erysipelas-in-lower-limbs-compression-therapy-vs-antibiotics-and-compression-therapy-100635200","NCT07549594","Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy.","Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy. A Non-inferiority, Multicentre, Randomized Clinical Trial.","PRESENT","Inclusion Criteria:\n\n* Male or female\n* ≥ 18 years of age\n* At least 2 episodes of recurrent erysipelas at the same leg within the previous 52 weeks, and no more than five episodes of erysipelas in the same areas of the lower limbs during the year before randomization\n* The last recurrent erysipelas have to be diagnosed within the previous 3 months\n* BMI \\\u003C 40 kg\u002Fm2 (no morbid obesity)\n* Able to apply the compression alone or with a helper (e.g., nurse, household member)\n* Affiliated with a social security regimen\n* Able to consent and written informed consent obtained from the participant\n* Able to understand the aims of the study and to comply with the requirements of the study\n* Able to participate and be followed up during the study period\n\nExclusion Criteria:\n\n* Any causes of immunosuppression: known HIV+ infection, organ transplantation, bonemarrow transplantation, immunosuppressive regimens for any disease, malignancy or lymphoproliferative disorder\n* Receiving antibiotic treatment for erysipelas\n* Received antibiotic prophylaxis for recurrent erysipelas in the year before randomization\n\n  \\_ Received short- or long-term antibiotic therapy for a condition other than erysipelas\n* Already wore effective compression therapy (worn at least 5 days a week) in the 3 months before randomization\n* Contraindication to compression therapy (ie heart failure, arterial occlusive disease,including obliterative peripheral arterial disease with a systolic pressure index \\\u003C 0.6, advanced diabetic microangiopathy for compression \\> 30 mmHg, phlegmasia cerulea dolens, and septic thrombosis)\n* History of known hypersensitivity to beta-lactamines or contraindications to Phenoxymethylpenicillin (Oracilline) or to any of the other components of the medicine as per its SmPC\n* Contraindications to the emollient cream in accordance with its SmPC\n* Diabetic foot and fractures\n* Woman of childbearing potential not using a highly effective method of contraception\\*, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed in all woman of childbearing potential\n* Persons covered by articles L1121-5 to L1121-8 of the Code de Santé Publique (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship).\n* Participation in another interventional research with an investigational drug or medical device.\n* Mental state rendering the person giving consent incapable of understanding the trial;\n* Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinator.",{"count":199,"type":22},[605],"PHASE4","Erysipelas (superficial cellulitis) is a frequent streptococcal bacterial infection. Each episode of erysipelas may worsen preexisting lymphedema and evolve to life-threatening necrotizing soft-tissue infection. Moreover, each attack of cellulitis may worsen lymphatic damage and therefore favour additional attacks. Recurrence is frequent: 10-30% of cases and even up to 50%. In this context, at least 2 episodes of erysipelas in the same limb during a 1-year period defines recurrent erysipelas requiring prophylaxis. Such prophylaxis is based usually on penicillin therapy. Compression was evaluated only in a monocentric randomized controlled trial, and was never compared to antibioprophylaxis.\n\nThe investigators hypothesized that compression therapy alone might represent a single intervention for prophylaxis of erysipelas recurrence as efficient as long-term antibiotic prophylaxis with compression therapy combined.\n\nThis study is a multicenter, parallel groups, assessor-blinded, non-inferiority, randomized clinical trial. Main objective is to evaluate whether supervised compression therapy alone is non-inferior to supervised compression therapy + oral penicillin in controlling relapse of recurrent erysipelas. Secondary objectives are to assess time to first recurrence ; to assess the severity of the recurrence ; to assess the safety of the intervention to assess the quality of life during the prophylaxis phase ; to assess the adherence of patients with the intervention and to assess, in a joint analysis, that supervised compression therapy is both not inferior in terms of QALY and not more expensive at 1 year than supervised compression therapy + antibiotic.\n\nThe study will included male or female adults who have had at least 2 episodes of recurrent erysipelas at the same leg within the previous 52 weeks, and no more than five episodes of erysipelas in the same areas of the lower limbs during the year before randomization. Experimental group is supervised compression therapy + emollient cream during 12 months and control group is supervised compression therapy + emollient cream + oral penicillin (phénoxyméthylpénicilline) during 12 months Main outcome is the proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by an assessor-blinded.\n\nPatients will be identified in a hospital setting, or referred by physicians servicing the local region, or by direct advertising through patients' associations. If the patient gives consent to participate, at the end of a inclusion visit (V0), the randomization will be performed via the e-CRF. Prescriptions will then be issued on inclusion. Control group who will start antibiotic treatment at inclusion. A run-in period of 7 ±2 days will be planned between V0 and the beginning of the compression therapy for the both group, in order to get the prescribed elastic stockings, and to train the nurse in charge of the compression supervision. A nurse trained in the study will supervise the first applications of the compression in the patient's home. After inclusion visit (V0), a home visit by the liberal IDE will be planned at M1 for to check daily adherence (use of ATB or\u002Fand wearing compression and application of emollients). A patient diary must be completed from inclusion and during the follow-up period. Two telemedicine clinic were scheduled at M3 and M9 and two study visits were scheduled at M6 and M12 with a complete physical examination. All the evaluations will be performed by a blinded evaluator investigator. Supplementary telemedicine clinic(s) in case of potential recurrence of erysipelas will be done by the blinded evaluator in the presence of the nurse who will be at bedside of patient.\n\nThe organization and design of the study will be realistic, and thus is designed to facilitate its feasibility and generalizability of results. In case of demonstration of non-inferiority of supervised compression therapy, patients with recurrent erysipelas will be spared of antibiotics first-line, and therefore suppress the impact of both long-term antibiotics on gut microbiota individuals and health burden of antibiotics at the population level.",[608],"Recurrent Erysipelas",[610,611,612,613],"Supervised compression","Oral penicillin","Controlling relapse of erysipelas","Randomized non-inferiority clinical trial","2026-04-17",{"date":616,"type":44},"2026-04-24",{"date":618,"type":22},"2026-04-01",{"date":620,"type":22},"2030-04-01",{"name":50,"class":51},""]