[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione IRCCS San Gerardo dei Tintori\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":133},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,76,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100645294","palmitoylethanolamideluteolin-supplementation-in-older-adults-undergoing-cardiac-surgery-100645294",false,"NCT07681063","Palmitoylethanolamide\u002FLuteolin Supplementation in Older Adults Undergoing Cardiac Surgery","Palmitoylethanolamide\u002FLuteolin for the Maintenance of Cognitive Performance in Older Adults Undergoing Cardiac Surgery","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Both genders\n* Undergoing elective aortic or mitral valve replacement\u002Freconstruction with or without coronary artery bypass grafting (CABG), at the Cardiac Surgery Unit of IRCCS San Gerardo dei Tintori Foundation (Monza, Italy)\n* Prognosis quoad vitam ≥ 3 months\n* Availability of a formal or informal caregiver who can assist the participant in taking the prescribed dose and following the visit schedule\n* Any concomitant therapy should be stable\n* Written informed consent obtained prior to randomization (from the participant or caregiver if the participant is unable to sign but clearly expresses the will to participate)\n\nExclusion Criteria:\n\n* Severe dementia diagnosis\n* Preoperative clinical diagnosis of delirium\n* Other treatments\u002Fmedications that may improve cognition\n* Current treatment with m\u002FumPEA or PEALut (Glialia®), or its use within 90 days prior to enrollment\n* Contraindications to the use of PEALut, including allergy to excipients contained in the supplement and previous adverse reactions to PEALut\n* Other clinical conditions or situations that could interfere with the study or prevent optimal participation, as judged by the researchers","ALL","65 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","Postoperative Cognitive Dysfunction (POCD) is a common complication after surgery, particularly among older adults. It is characterized by cognitive impairment, reduced functional independence, and decreased quality of life. Growing evidence suggests that neuroinflammation plays a relevant role in POCD development and persistence.\n\nPalmitoylethanolamide (PEA) is an endogenous lipid mediator involved in the regulation of neuroinflammatory processes through the modulation of non-neuronal cells, while luteolin is a flavonoid with well-known antioxidant properties. Under conditions of prolonged neuroinflammation, endogenous PEA levels may be insufficient to adequately counteract pro-inflammatory signaling, making exogenous administration necessary.\n\nIn this context, exogenous micronized and ultramicronized PEA (mPEA and umPEA) supplementation has been shown to modulate cognitive and executive functions, working memory, language, and activities of daily living. Moreover, the combination of umPEA and luteolin (PEALut) may produce synergistic effects by modulating neuroinflammation and supporting neuronal function.\n\nThis study aims to evaluate whether postoperative administration of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 mL), added to standard of care, may contribute to the mitigation of POCD in older adults undergoing elective cardiac surgery, compared to standard care alone.",[26],"Postoperative Cognitive Dysfunction",[28,29,30,26,31,32],"Neuroinflammation","Palmitoylethanolamide","Luteolin","Cardiac Surgery","Cognitive Impairment","NOT_YET_RECRUITING","2026-06-26",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":20},"2026-06",{"date":41,"type":20},"2028-06",{"name":43,"class":44},"Fondazione IRCCS San Gerardo dei Tintori","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100598872","vagal-nerve-stimulation-to-treat-disorders-of-consciousness-100598872","NCT07077135","Vagal Nerve Stimulation to Treat Disorders of Consciousness","Transcutaneous Vagal Nerve Stimulation to Treat Disorders of Consciousness","REVELATION","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* any acquired cerebral damage of any known etiology;\n* diagnosis of coma, UWS, or MCS with the corresponding basal CRS-R (Coma Recovery Scale-Revised) score performed during the screening period from 7 to 15 days since admission in ICU;\n* intact ear skin;\n* availability of the device.\n\nExclusion Criteria:\n\n* Patients with severe hemodynamic, respiratory, infectious, or neurological instability requiring active treatment requiring mechanical ventilation or vasoactive drugs or pending acute neurosurgical interventions;\n* Need for deep sedation, including general anesthetics (e.g., propofol) or a combination of central-acting sedatives;\n* Documented pregnancy;\n* Active implant (e.g., pacemaker, cochlear implant);\n* History of previous serious neurological disability before the brain injury;\n* Seizures or status epilepticus as cause sustaining the disorder of consciousness;\n* Patients already enrolled in another ongoing interventional trial.","18 Years",{"count":56,"type":20},106,[23],"This interventional study aims to assess the clinical efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) against sham stimulation on the recovery of consciousness in patients with disorders of consciousness. The main question it aims to answer is: will taVNS improve patients' behavioral scores or will it produce an improvement in the diagnosed level of consciousness? Researchers will compare the results with non-stimulated unconscious patients to see if the re-gain of consciousness is faster in the treated group.\n\nParticipants will undergo taVNS stimulation using the Parasym device or sham stimulation will be applied from the time of enrolment.\n\nActive stimulations will be carried out for 60 minutes twice daily during the acute phase and daily during the rehabilitation phase.",[60],"Disorder of Consciousness",[62,63,64,65,66],"vagal nerve stimulation","transcutaneous","auricolar","disorder of consciousness","coma","2025-07-11",{"date":69,"type":37},"2025-07-22",{"date":71,"type":20},"2025-09-01",{"date":73,"type":20},"2028-09-01",{"name":43,"class":44},11,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100577909","diagnosis-and-treatment-of-late-neurological-ischemic-deficit-in-patients-suffering-from-subarachnoid-hemorrhage-100577909","NCT06804421","Diagnosis and Treatment of Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage.","Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage: Diagnosis and Treatment","DINTESA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral artery aneurysm confirmed by cerebral angiotomography or angiography of the intracranial vessels, with the need for admission to the Intensive Care Unit\n* Signing the Informed Consent form to participate in the study according to current local regulations.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Primary diagnosis of subarachnoid hemorrhage sine materia, i.e. post-traumatic or caused by arteriovenous malformation or bleeding from a brain tumor.",{"count":85,"type":20},1400,"OBSERVATIONAL","Recent studies state that patients affected by aneurysmal subarachnoid hemorrhage (aSAH) today survive longer because they are treated early. Unfortunately, patients often develop chronic disabling neurological deficits at a rate that is still unacceptable given the progress in the specific treatment of this pathology and the volume of systems of neurological monitoring available to date in Italy.\n\nThe main cause of unfavorable neurological outcome is delayed cerebral ischemia (DCI), often resulting from symptomatic vasospasm defined as delayed neurological ischemic deficit (DIND). The incidence of DIND is not defined and is difficult to diagnose early as there is no gold standard for identifying it, nor guidelines regarding the most effective treatment.\n\nGiven these gaps, the primary objective of this study is to describe the incidence of DIND in patients affected by aSAH, collecting information regarding the diagnostic imaging (neurological symptom on clinical examination or alteration on instrumental monitoring). Secondary objectives will be to evaluate the different therapeutic strategies adopted in the different participating centers and compare these strategies to mortality and short- and long-term functional neurological outcome. Furthermore, as there are no data in the literature, the Investigators want to describe the indications, usefulness and intensity of treatment in the aSAH patient in case of monitoring of parenchymal intracranial pressure.",[89,90],"Aneurysmal Subarachnoid Haemorrhage","Delayed Ischemic Neurological Deficit","RECRUITING","2025-01-27",{"date":94,"type":37},"2025-02-03",{"date":96,"type":37},"2024-09-28",{"date":98,"type":20},"2026-10",{"name":43,"class":44},33,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100528673","phase-2-mesenchymal-stromal-cells-for-traumatic-brain-injury-100528673","NCT06163833","Mesenchymal Stromal Cells for Traumatic Brain Injury","MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury","MATRIx","Inclusion Criteria:\n\n* Age: 18-70 years\n* Clinical frailty index (CFI) \\\u003C 5\n* Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall's CT Classification \\>1)\n* Feasibility of study drug (MSC\u002Fplacebo) administration within 48 hours from TBI\n* GCS ≤ 8 at recruitment and at least one pupil reactive to light\n* ICP monitoring already inserted or planned for clinical indications\n* Weight \\\u003C 100 Kg and \\> 40 kg\n\nExclusion Criteria:\n\n* Motor GCS \\> 5 at recruitment\n* High likelihood (\\> 85%) of death in the first 48 h calculated by IMPACT calculator on early admission data\n* Bilateral mydriasis\n* Opening ICP \\> 40 mmHg\n* Known history of prior brain injury, psychiatric disorder, neurological impairment and\u002For deficit\n* Brain penetrating injury\n* Spinal cord injury\n* Previous epilepsy requiring anti-convulsant therapy\n* Severe organ failure (including PaO2\u002FFiO2\\\u003C200 and shock)\n* Recent serious infectious process\n* Cancer\n* Immunosuppression\n* Human immunodeficiency virus\n* Positive urine pregnancy test or nursing\n* Known risk\u002Fhistory of coagulopathy and thromboembolism\n* Pre-existing and severe:\n\n  * lung disease (such as asthma, chronic obstructive pulmonary disease),\n  * heart dysfunction (as heart failure and reduced cardiac output),\n  * liver insufficiency (as cirrhosis)\n  * kidney insufficiency\n  * and other organ severe abnormalities\n* Known hypersensitivity to excipients used in the formulation (Dimethyl sulfoxide (DMSO), Citrate-dextrose solution (ACD))\n* Participation in a concurrent interventional study","70 Years",{"count":111,"type":20},78,[113],"PHASE2","Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparative and regenerative processes. Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection and repair. Thus, data indicate MSCs as strong therapeutic candidate and support a clinical study in TBI.\n\nAim: the study is designed to assess the safety and the efficacy of the MSCs, intravenously administered in severe TBI patients within 48h from injury. The study will be conducted in a stepwise manner. Step 1 will enroll 36 patients (randomized 1:1:1 in arms 80 x 10\\^6 MSCs vs 160 x 10\\^6 MSCs vs placebo) to define safety, and will allow to select the most promising dose. Step 2 will enroll 30 patients (1:1 in arms MSCs selected dose vs placebo) to define the MSC activity based on the quantification of the plasmatic levels of the neurofilament light (NFL) at 14 days, as biomarker of neuronal damage.\n\nSecondary objectives are aimed to assess:\n\n1. brain injury evolution and white matter damage by longitudinal neuroimaging (at 4 days and 14 days post-TBI and at 6 months)\n2. brain immunomodulatory changes by temporal profiling of circulating biomarkers of brain damage and neuroinflammation (daily for 3 days after TBI, at day 7 and 14, and at 1, 6 and 12 months)\n3. clinical outcome by a structured clinical and neuropsychological assessment at both 6 and 12 months\n\nMethods: a multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study.\n\nDuration of the study: 36 months (24 of enrolment and 12 of follow up).\n\nFunding: Fondazione Regionale per la ricerca Biomedica, FRRB (Call \"Unmet medical needs\", proposal number 3440227) and Italian Ministry of health (Ministero della Salute, Bando di Ricerca Finalizzata 2021; proposal number RF-2021-12372642).",[116],"Traumatic Brain Injury With Loss of Consciousness",[118,119,120,121,122,123],"mesenchimal stromal cells","neuroprotection","neurogenesis","cell therapy","synaptic plasticity","inflammation","2023-12-01",{"date":126,"type":37},"2023-12-11",{"date":128,"type":37},"2023-09-19",{"date":130,"type":20},"2026-12",{"name":43,"class":44},3,""]