[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":751},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,48,72,108,148,175,201,244,273,292,329,371,405,438,464,500,528,557,582,615,638,660,684,705,728],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100635013","patient-voice-in-the-treatment-of-low-grade-gliomas-use-of-patient-reported-outcomes-vorasidenib-and-radiotherapy-compared-100635013",false,"NCT07547163","Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared","LGG PRO's","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological diagnosis of IDH mutant, grade 2 glioma\n* Consent to treatment\n* Consent to the administration of PROM questionnaires\n\nExclusion Criteria:\n\n* Cognitive impairment or mental disability.\n* Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable.\n* Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses.\n* Language barriers.\n* Inability to understand the language of the questionnaire: participants who do not speak or understand the language in which the questionnaire is written are excluded if validated translations are not available.\n* Literacy issues: participants who are unable to read or write are excluded.\n* Non-adherence or poor cooperation.\n* Refusal to complete the questionnaires: even if the patient agrees to participate in the study, the specific refusal to complete the questionnaires leads to exclusion.\n* Conditions that may influence questionnaire outcomes.\n* Use of medications that impair cognitive abilities: the use of sedatives or antipsychotics may affect the ability to provide coherent responses, compromising the validity of PROs.","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","OBSERVATIONAL","The study aims to assess the direct patient-reported perception (PROs) of individuals affected by IDH-mutant, grade 2 gliomas undergoing radiotherapy or pharmacological treatment with vorasidenib.\n\nTo evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.\n\nTo assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.",[25,26,27,28,29],"Glioma","Glioma of Brain","Low Grade Glioma of Brain","Low Grade Gliomas","IDH Mutation",[31,32,28,33,34],"Patient Reported Outcomes","glioma","grade 2 glioma","IDH mutant","RECRUITING","2026-04-17",{"date":38,"type":39},"2026-04-23","ACTUAL",{"date":41,"type":39},"2025-04-23",{"date":43,"type":21},"2027-10",{"name":45,"class":46},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":47},"100577154","study-for-the-diagnosis-and-treatment-of-drug-resistant-focal-epilepsies-100577154","NCT06794606","Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies","Multimodal Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies","EpiBesta","Inclusion Criteria:\n\n* Adult patients with focal epilepsy, long history of drug-resistant seizures, on mono- or polypharmacy antiepileptic therapy affected by known epileptogenic lesion or without lesions evident on neuroimaging investigations (cryptogenic). - - - Patients with recent onset of focal seizures, in mono- or polypharmacy, with controlled or rare seizures, or still in the absence of antiepileptic therapy affected by neoplastic lesion.\n\nExclusion Criteria:\n\n* Patients in whom the diagnosis of epilepsy is doubtful. Patients with cognitive or psychiatric disorders that prevent participation in an interview, proper understanding of informed consent, or completion of questionnaires.",{"count":57,"type":21},337,"Epilepsy is a clinical condition that affects about fifty million people worldwide, with an estimated occurrence of 16-51 new cases per 100,000 people each year. In 60% of these patients, the origin of seizures is due to a localized (focal) alteration of the brain. In about 25 percent of patients with focal epilepsy, drug treatment is ineffective, a condition defined by the International League Against Epilepsy (ILAE) as drug-resistant epilepsy ; this condition results in a drastic reduction in quality of life associated with psychosocial dysfunction and an increased risk of sudden death. A possible treatment alternative for drug-resistant patients is ablation of the epileptogenic zone through surgical methods that are effective and safe when patients are carefully selected. The percentage of patients with epilepsy who are completely cured after surgery is about 70% for temporal lobe epilepsies, and can be as high as 90% in the case of some brain malformations.\n\nPre-surgical screening and therapeutic intervention (particularly surgery) have health care costs that are amortized over 2-6 years depending on the procedures required before surgery. In the last decade, moreover, the refinement of noninvasive\u002Fmini-invasive methods such as radiosurgery, Magnetic Resonance-guided Focused Ultrasound (MRgFUS) and laser interstitial thermal therapy (LiTT) have allowed us to hypothesize a possible specific treatment of drug-resistant patients with epileptogenic areas that are difficult to reach with traditional surgery and patients with complex comorbidities for whom the risks of standard resective surgery would outweigh the possible benefits. Finally, there is a subgroup of patients with drug-resistant epilepsy who cannot undergo ablative surgery. In these patients, seizures originate from multiple areas of the brain (multifocal epilepsy) or the epileptogenic area affects functionally eloquent areas. In these cases, alternative functional treatments are proposed, which aim to decrease the frequency and intensity of seizures and the need for medication, such as: i) application of a vagal stimulator, a pulse generator that is implanted in the chest and connected to the vagus nerve, ii) implantation of deep brain stimulation devices, iii) neuromodulation. Therefore, careful selection of patients during the diagnostic\u002Fpre-surgical process is crucial. The multimodal assessments under study, proposed in support of clinical practice, aim to improve such selection by analyzing the causative factors of seizures, the location of the epileptogenic zone, and the clinical-epileptological course of patients who are candidates for surgical or functional treatment of epilepsies.",[60],"Epilepsy",[62,63],"Epilepsy surgery","drugs resistant focal epilepsy","2026-03-27",{"date":66,"type":39},"2026-04-01",{"date":68,"type":39},"2021-06-23",{"date":70,"type":21},"2041-03",{"name":45,"class":46},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100581941","disease-biosignatures-in-alsftd-spectrum-new-impactful-biological-perspectives-beyond-clinical-approaches-100581941","NCT06856850","Disease Biosignatures in ALS\u002FFTD Spectrum: New Impactful Biological Perspectives Beyond Clinical Approaches","SPECTRALS","Inclusion Criteria:\n\n* Clinical criteria for ALS (Brooks et al., 2000; de Carvalho M., 2008), FTD (GornoTempini et al., 2011; Rascovsky et al., 2011)\n\nExclusion Criteria:\n\n* na",{"count":80,"type":21},230,"Diagnosis of ALS\u002FFTD disease spectrum is challenging because it largely relies on clinical symptoms. Identifying novel biomarkers is essential for a paradigm shift towards a more precise biological-based diagnosis. To achieve this aim, having access to proper specimens and analytical methods is crucial. Our team of experts in neurology, biology, chemistry, physics, and AI will explore ALS\u002FFTD from novel perspectives using transcriptomics, proteomics, genomics and other innovative approaches to analyzing easily accessible tissues. The seed amplification assay (SAA) will be also exploited to detect pathological TDP-43. This project aims to create disease fingerprints useful for patient stratification and monitoring of disease progression, and to evaluate the therapeutic efficacy in clinical trials, thus overcoming the limits of clinical interpretation. Discovering new biomarkers and cellular pathways will improve the diagnosis and treatment of these devastating diseases.",[83,84,85,86,87,88],"ALS (Amyotrophic Lateral Sclerosis)","FTD","Neuropathic","Psychiatric Disorders","Idiopathic Intracranial Hypertension","Frontotemporal Dementia (FTD)",[90,91,92,93,94,95,96,97,98],"Amyotrophic lateral sclerosis","frontotemporal dementia","microbiota","miRNA","protein-NMR","TDP-43","endocytic disfunction","seed amplification assay","peripheral biomarker","2026-03-25",{"date":101,"type":39},"2026-03-30",{"date":103,"type":39},"2025-02-27",{"date":105,"type":21},"2026-08",{"name":45,"class":46},4,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":118,"conditions":119,"keywords":125,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100581157","exploring-the-olfactory-mucosa-blood-and-urine-for-the-identification-of-early-biomarkers-of-parkinsons-disease-atypical-parkinsonisms-and-neurocognitive-disorders-due-to-lewy-body-disease-100581157","NCT06846658","Exploring the Olfactory Mucosa, Blood and Urine for the Identification of Early Biomarkers of Parkinson's Disease, Atypical Parkinsonisms and Neurocognitive Disorders Due to Lewy Body Disease","EXTRAORDINARY","Inclusion Criteria:\n\n* PD (Postuma et al., 2015), MSA (Palma et al., 2018), DLB (McKeith et al., 2017), OND including acquired and hereditary ataxic syndrome with known etiology, progressive supranuclear palsy, corticobasal degeneration, and motor neuron disease.\n\nExclusion Criteria:\n\n* na",true,{"count":117,"type":21},180,"Clinical diagnosis of Parkinson's disease (PD), multiple system atrophy (MSA) and dementia with Lewy bodies (DLB) is challenging, especially in the early stages. Each disease is associated with distinct conformers of misfolded alpha-synuclein (maS) which form typical protein aggregates in the brain and represent key disease biomarkers. Thus, detection and characterization of intracerebral maS aggregates allow a definite diagnosis. The recent development of ultrasensitive assays enabled the detection of maS and other potential new biomarkers in peripheral tissues, although with several limitations. Here, the investigators propose to combine the expertise of leading and young researchers in the field of neurology, structural and molecular biology, biophysics and machine learning to perform ultrasensitive and multi-omics analyses of olfactory mucosa (OM), blood and urine of PD, MSA and DLB patients for detecting and characterizing key peripheral biomarkers allowing accurate disease recognition.",[120,121,122,123,124],"Parkinson Disease","MSA - Multiple System Atrophy","Lewy Body Dementia (LBD)","Neurodegenerative Disease","Healthy Subjects (HS)",[126,127,128,129,130,131,132,133,134,135,136,137,138,139,140],"Parkinson's disease (PD)","multiple system atrophy (MSA)","dementia with Lewy bodies (DLB)","misfolded alpha-synuclein","new biomarkers","peripheral tissues","Real-Time Quaking-Induced Conversion (RT-QuIC)","single-molecule array (Simoa)","circulating neurofilament light chain (NfL)","Nanoparticle Tracking Analysis (NTA)","blood-derived extracellular vesicles (EVs)","multi-omics analyses","transmission electron microscopy (TEM) and protein-NMR","protein misfolding","early diagnosis",{"date":101,"type":39},{"date":143,"type":39},"2023-10-03",{"date":145,"type":21},"2026-04",{"name":45,"class":46},3,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":158,"conditions":159,"keywords":164,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":47},"100578009","this-three-year-observational-study-involves-patients-of-all-ages-undergoing-endovascular-treatment-for-various-cerebral-or-spinal-vascular-conditions-it-aims-to-assess-pre--and-post-operative-clinical-conditions-report-complications-and-identify-preoperative-indicators-of-treatment-outcomes-pat-100578009","NCT06805721","This Three-year Observational Study Involves Patients of All Ages Undergoing Endovascular Treatment for Various Cerebral or Spinal Vascular Conditions. It Aims to Assess Pre- and Post-operative Clinical Conditions, Report Complications, and Identify Preoperative Indicators of Treatment Outcomes. Pat","OUTCOME IN NEURORADIOLOGIA INTERVENTISTICA INDICAZIONI COMPLICANZE (ONIRIC)","ONIRIC","Inclusion Criteria:\n\n* Patients of both sexes and any age, who are referred to the Department of Neurosurgery and Clinical Neurosciences and are candidates for interventional endovascular procedures for any cerebral or spinal pathology, will be included in the study.\n\nExclusion Criteria:\n\n* \u002F",{"count":157,"type":21},1000,"This three-year observational study involves patients of all ages undergoing endovascular treatment for various cerebral or spinal vascular conditions. It aims to assess pre- and post-operative clinical conditions, report complications, and identify preoperative indicators of treatment outcomes. Patients will also receive psychological support and Neuropsychological assessment. Clinical, medical, and demographic data will be recorded in a database during hospitalization and follow-up visits.",[160,161,162,163],"Aneurysm Cerebral","AVM","DAFV","ESDC",[165,166,167,161,168],"Endovascular treatment","Neurospychological assessment","Aneurysm","Psychological Outcome",{"date":64,"type":39},{"date":171,"type":39},"2023-02-06",{"date":173,"type":21},"2029-01",{"name":45,"class":46},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":198,"leadSponsor":200,"locationsCount":47},"100570965","application-of-digital-twins-technology-in-patients-who-had-a-stroke-with-moyamoya-disease-and-with-cerebral-amyloid-angiopathy-caa-during-the-secondary-prevention-phase-a-proof-of-concept-using-a-randomized-control-trial-clinical-study-6-stratif-ai-project-100570965","NCT06714097","Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)","SMART","Inclusion Criteria:\n\n* People aged ≥ 18\n* Clinical and neuroradiological diagnosis of stroke (TAC or MR); diagnosis of CAA based on Boston 2.0 criteria; diagnosis of Moyamoya disease based on diagnostic criteria 2021.\n* MOCA total score ≥ 23\n* modified Rankin Scale (mRS) ≤ 2\n* First-time patients at the Besta Institute\n* Ability to sign informed consent\n* Possibility of performing a brain MRI\n\nExclusion Criteria:\n\n* Patients with transient neurological deficits that resolve within an hour and normal brain imaging\n* Patient under legal protection or deprived of liberty by judicial or administrative decision\n* Patient whose follow-up will be impossible\n* Contraindication to magnetic resonance imaging and\u002For Digital subtraction angiography (DSA)\n* Pregnant patients\n* Known or suspected drug or alcohol abuse",{"count":183,"type":21},20,"INTERVENTIONAL",[186],"NA","The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes.\n\nThe main questions it aims to answer is: how is the patients' experience regarding the use of the STRATIF-AI platform? Researchers will compare Arm 1, who use the STRATIF-AI app in addition to standard secondary prevention, against Arm 2, who receive standard secondary prevention only, to collect feedback regarding the platform usability.\n\nParticipants in the Arm 1 will:\n\n* Complete cognitive and psychological assessments at the time of the first visit and after six months\n* Follow the indications received from the clinician for standard secondary prevention\n* Use the STRATIF-AI app daily for health management\n* Optionally, purchase wearable devices that connect to the app.\n* Participate in interviews at the six-month mark to share their experiences with the app.\n\nPatients in the Arm 2 will:\n\n* Complete cognitive and psychological assessments at the time of the first visit and after six months\n* Follow the indications received from the clinician for standard secondary prevention",[189,190,191],"Stroke","Moyamoya Disease","Cerebral Amyloid Angiopathy",[193,194,195,190,191],"stroke","secondary prevention","digital twin",{"date":101,"type":39},{"date":145,"type":21},{"date":199,"type":21},"2027-04",{"name":45,"class":46},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":211,"conditions":212,"keywords":235,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},"100571728","neurosurgical-outcome-network-100571728","NCT06724029","Neurosurgical Outcome Network","Neurosurgical Outcome Network Per la Predizione Dell'Outcome in Neurochirurgia","NEON","Inclusion Criteria:\n\n* Neuro-oncological pathology: supratentorial and subtentorial tumors, intra and extra axial tumors excluding the skull base (anterior, middle and posterior fossa; sellar and parasellar region)\n* Basicranial pathology: tumors originating from the anterior cranial fossa, middle cranial fossa and posterior cranial fossa, sellar region with or without supratentorial\u002Fparasellar development.\n* Vascular pathology: aneurysms, AVMs, cavernomas, other pathologies (Moyamoya disease, dural fistulas, nontraumatic hematomas)\n* Traumatic pathology: diffuse damage (nonvisible diffuse damage, diffuse damage, diffuse damage with edema, diffuse damage with shift) and focal damage (acute\u002Fsubacute\u002Fchronic subdural hematoma, extradural hematoma, subarachnoid hemorrhage, intraparenchymal hematoma, fractures); hydrocephalus. The inclusion criterion for chronic subdural hematoma is recent bleeding for TBI with CT finding of chronic subdural hematoma candidate for evacuation surgery.\n* Spinal pathology: degenerative cervical (anterior\u002Fposterior), myelopathic, and trauma pathology; instrumented, uninstrumented thoracolumbar pathology (disc pathology, canal pathology), and trauma pathology; oncologic spinal pathology.\n* Functional pathology: Parkinson's disease, spasticity, trigeminal neuralgia, craniofacial pain\u002Falgia, neuropathic pain, tremor, dystonias, obsessive compulsive disorder, drug-resistant epilepsies, depression. Normotensive hydrocephalus.\n* Peripheral nervous system pathology: peripheral nerve compression syndromes, peripheral nerve and plexus tumors, brachial plexus and peripheral nerve trauma (contusion and section)\n* Malformative pathology: Chiari malformation type 1 and craniostenoses including both those framed in malformative syndromes and those not framed in malformative syndromes (monosutural craniostenoses: trigonocephaly, plagiocephaly, scaphocephaly; multisutural craniostenoses). Malformative hydrocephalus.\n* For cognitive and psychological assessment: age 18 years or older; adequate understanding of Italian language; diagnosis of glioma, meningioma, vascular pathology, spinal pathology\n\nExclusion Criteria:\n\n* For cognitive and psychological assessment: patients with psychiatric diseases in history and\u002For taking psychotropic drugs; presence of overt cognitive decline (not due to the injury) in history; patients younger than 18 years old.",{"count":210,"type":21},4500,"The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a \"common language\" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.",[213,214,215,216,190,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234],"Aneurysms","Arteriovenous Malformations","Cavernomas","Skull Base Tumors","Dural Fistulas","Subdural Hematoma","Extradural Hematoma","Subarachnoid Hemorrhage","Hydrocephalus","Parkinson&Amp;#39;s Disease","Spasticity","Trigeminal Neuralgia","Craniofacial Pain","Neuropathic Pain","Tremor","Dystonias","Obsessive-compulsive Disorder","Drug-resistant Epilepsy","Depression","Normal Pressure Hydrocephalus","Tumors of Peripheral Nerves","Chiari Malformation Type 1",[236],"Neurosurgery Outcome Artificial Intelligence predictors",{"date":101,"type":39},{"date":239,"type":39},"2022-12-05",{"date":241,"type":21},"2027-06",{"name":45,"class":46},27,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":252,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":47},"100571187","multimodal-investigation-of-cortico-basal-ganglia-thalamo-cortical-network-dynamics-in-dystonic-patients-with-deep-brain-stimulation-100571187","NCT06716983","Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical Network Dynamics in Dystonic Patients With Deep Brain Stimulation","Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical (CBGTC) Network Dynamics in Dystonic Patients With Deep Brain Stimulation (DBS)","DYScover","Inclusion Criteria:\n\n* Patients diagnosed with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus\n* Patient implanted with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.\n* Age\\>12 years\n\nExclusion Criteria:\n\n* Evidence of CNS pathology or any other acquired conditions (perinatal, infective, toxic, neoplastic, vascular, psychogenic) responsible for the dystonia phenomenology,\n* Focal distribution of dystonia\n* Contraindications to brain MRI or EEG\u002FMEG\n* Adult subjects unable to express consent to inclusion in the study\n* Pregnancy, and breastfeeding.","12 Years",{"count":254,"type":21},15,"The goal of this prospective open label study is to elucidate the pathophysiology of dystonia and to understand how deep brain stimulation (DBS) influences brain networks. The investigators will enroll patients with dystonia implanted with DBS of the Globus Pallidus internus (GPi) with sensing implantable neurostimulators, capable of measuring GPi local field potentials (LFPs).\n\nThe main questions it aims to answer are:\n\n* does DBS influence pallidal LFPs in the long term?\n* how the basal-ganglia-thalamo-cortical circuit is modified after DBS?\n* do LFPs changes correlate with clinical improvement? Participants will undergo to serial clinical evaluations, magnetoencephalography (MEG) and functional Magnetic Resonance Imaging (fMRI) studies. Primarily, the data obtained from our study might help in clarifying basic pathological electrophysiological features of dystonia. These features might be secondarily used in future to provide a framework for an effective application of closed-loop DBS in Dystonia.",[257],"Dystonia",[257,259,260,261,262,263,264,265,266],"Movement disorders","Deep Brain Stimulation","DBS","Local Field potentials","biomarker","Magnetoencephalography","MEG","fMRI",{"date":101,"type":39},{"date":269,"type":39},"2023-12-28",{"date":271,"type":21},"2026-06",{"name":45,"class":46},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":281,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":47},"100378214","searching-biomarkers-cerebral-amyloid-angiopathy-seneca-100378214","NCT04204642","SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)","SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA): Italian Network for the Study of CAA","SENECA","Inclusion Criteria:\n\n* All consecutive patients ≥55 years (with the exception of genetic cases), referred to the participating centres, with a diagnosis of possible probable and definite symptomatic or asymptomatic CAA, defined according to the modified Boston neuroradiological criteria, who had undergone at least one brain MRI (mandatory requirement for inclusion of the patient in the study) will be recruited.\n\nExclusion Criteria:\n\n* evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain MRI, pregnancy and breastfeeding","55 Years",{"count":283,"type":21},500,"Cerebral amyloid angiopathy (CAA) is one of the major types of cerebral small vessel disease, and a leading cause of spontaneous intracerebral hemorrhage and cognitive decline in elderly patients. Although increasingly detected, a number of aspects including the pathophysiology, the clinical and neuroradiological phenotype and the disease course are still under investigation. The incomplete knowledge of the disease limits the implementation of evidence based guidelines on patient's clinical management and the development of treatments able to prevent or reduce disease progression.\n\nThe SENECA (SEarchiNg biomarkErs of Cerebral Angiopathy) project is the first Italian multicentre cohort study aimed at better defining the disease natural history and identifying clinical and neuroradiological markers of disease progression. By a multidisciplinary approach and the collection of a large and well phenotyped series and biorepository of CAA patients, the study is ultimately expected to improve the diagnosis and the knowledge of CAA pathophysiological mechanisms.",[191],{"date":101,"type":39},{"date":288,"type":39},"2020-06-01",{"date":290,"type":21},"2027-11-01",{"name":45,"class":46},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":302,"conditions":303,"keywords":309,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":47},"100628458","studying-nerve-function-and-structure-in-charcot-marie-tooth-disease-anti-mag-neuropathy-and-cidp-100628458","NCT07461896","Studying Nerve Function and Structure in Charcot-Marie-Tooth Disease, Anti-MAG Neuropathy and CIDP","Axonal Excitability and Ultrasound Patterns in Charcot-Marie-Tooth Disease and Other Demyelinating Disorders","CMT-NFS","Inclusion Criteria:\n\n1. The subject is ≥ 18 years old.\n\n   AND:\n2. A genetically confirmed diagnosis of one of the several CMT subtypes (i.e., CMT1A, CMT1B, CMTX1, CMT2I\u002FJ, CMT4B, CMT4D and CMT4J) OR\n3. A clinical diagnosis of either Chronic Inflammatory Demyelinating Polyneuropathy or anti-MAG polyneuropathy\n\nExclusion Criteria:\n\n1. Known neuropathy from another cause (e.g., diabetes, chronic renal insufficiency, medications, alcohol), including previous carpal tunnel syndrome surgery.\n2. History of exposure to chemotherapeutic agents (e.g., bortezomib, vincristine, cisplatin, taxol, vedotin\u002Fauromycin-conjugated antibodies), or other medications (e.g., disulfuram, thalidomide, voriconizole, chronic colchicine use) that can cause neuropathy, active alcohol abuse.\n3. History of cancer, other than skin cancer, within 5 years prior to enrollment.\n4. Pregnancy or nursing.\n5. Known systemic disease that predisposes to neuropathy.\n6. Other central nervous system diseases.",{"count":301,"type":21},39,"The project aims to perform both conventional nerve-conduction studies and axonal-excitability assessments using the TRONDF protocol in patients with selected forms of Charcot-Marie-Tooth disease, with comparison to individuals affected by dysimmune, acquired neuropathies, specifically chronic inflammatory demyelinating polyneuropathy (CIDP) and anti-MAG-neuropathy. The study further includes the analysis of nerve fibers obtained from skin biopsy in patients with CMT, as well as ultrasound evaluation of nerves (from the wrist to the axilla) and of intrinsic hand muscles. Axonal-excitability techniques involve the delivery of two electrical stimuli to the nerve under investigation; both stimuli vary in intensity, whereas only the first, known as the conditioning stimulus, varies in duration. Changes in response amplitude are then measured as these stimulation parameters are systematically adjusted. Some preliminary studies have already suggested the effectiveness of this method in distinguishing CMT1A from certain forms of acquired demyelinating disease, including acute inflammatory demyelinating polyradiculoneuropathy (AIDP) and CIDP. Despite the promising results, only a limited number of studies have so far been conducted in humans and mice, and no comprehensive and systematic study has yet been carried out describing the changes in axonal excitability in the various CMT subtypes, either in humans or in mouse models.",[304,305,306,307,308],"Charcot-Marie-Tooth","CMT1A","Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Polyneuropathy Associated With Anti-MAG Antibodies (Anti-MAG Polyneuropathy)","Anti-MAG Neuropathy",[304,310,311,312,305,313,314,315,316,317,318,319,320],"Neurophysiology","Axonal excitability","Ultrasound (US)","CMT1B","CMTX1","CMT2I\u002FJ","CMT4B2","CMT4D","CMT4J","CIDP","anti-MAG","2026-03-06",{"date":323,"type":39},"2026-03-10",{"date":325,"type":39},"2025-03-03",{"date":327,"type":21},"2026-05",{"name":45,"class":46},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":47},"100627010","heart-rate-variability-and-processed-eeg-features-as-predictors-of-postoperative-outcomes-after-cranial-neurosurgery-100627010","NCT07443072","Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery","Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery - A Prospective Observational Study in the Post-Anesthesia Care Unit","HERO-PACU","Inclusion Criteria:\n\n* Adult patients (≥18 years) scheduled for elective cranial neurosurgery.\n* Planned extubation in the PACU after surgery.\n* Ability to obtain high-quality ECG and EEG recordings intra- and postoperatively (≥60 min expected PACU monitoring).\n* Written informed consent signed preoperatively.\n\nExclusion Criteria:\n\n* Pre-existing severe cardiac arrhythmias (e.g., atrial fibrillation, frequent ectopy) or pacemaker dependence.\n* Known severe autonomic neuropathy (e.g., advanced diabetes, Parkinson's disease with autonomic failure).\n* Preoperative conditions associated with abnormal EEG (status epilepticus, uncontrolled seizures, sedative\u002Fhypnotic overdose).\n* Intraoperative or immediate postoperative events necessitating continued mechanical ventilation or ICU admission (e.g., massive bleeding, intraoperative arrest).\n* Inability to provide informed consent (e.g., cognitive impairment, language barrier without interpreter).\n* Refusal of informed consent",{"count":338,"type":21},300,"Patients undergoing cranial neurosurgery face a high-risk postoperative period, particularly during emergence from anesthesia and early recovery in the post-anesthesia care unit (PACU). Standard monitoring provides limited insight into brain and autonomic recovery processes. Heart rate variability (HRV) and processed electroencephalography (pEEG) may offer complementary markers of autonomic and cortical function, with potential to improve early detection of complications and guide individualized care.",[341],"Cranial Neurosurgery",[343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364],"HRV","heart rate variability","EEG","electroencephalography","EEG patterns","EEG signatures","pEEG","processed EEG","Neurosurgery","Monitoring","PACU","Post Anesthesia Care Unit","Autonomous Nervous System","Cortical Function","Outcome after Neurosurgery","Post Operative Period","Post Operative Monitoring","Post Operative Outcome","Anesthesia","Emergence","Awakening","Recovery",{"date":323,"type":39},{"date":367,"type":39},"2026-03-05",{"date":369,"type":21},"2027-02",{"name":45,"class":46},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":115,"sex":17,"minAge":379,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":184,"phases":382,"briefSummary":385,"conditions":386,"keywords":390,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":404},"100627577","phase-2-role-of-the-gut-vascular-barrier-and-microbiota-in-autism-spectrum-disorders-100627577","NCT07450443","Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders","Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Efficacy of Postbiotic-based Nutraceutical Treatment","DSA\u002FGVB","Inclusion Criteria:\n\n* Group 1 and 2:\n\nInclusion criteria\n\n* Diagnosis of ASD according to DSM-5 diagnostic criteria;\n* Clinical neurological evaluation by child neurologist and neuropsychologist with administration of standardized instruments such as Autism Diagnostic Observation Schedule-2 (ADOS-2) and\u002For Autism Diagnostic Interview-Revised (ADI-R) to support diagnosis;\n* Assessment of psychomotor or intellectual development (Griffiths Scales, Wechsler Scales, Leiter Scale)\n* Assessment of the following symptoms in the past three months: constipation, diarrhea, abnormal stool consistency, abnormal stool smell, flatulence, abdominal pain, unexplained daytime irritability, and nighttime awakening, and abdominal tenderness. The degree of gastrointestinal disturbances will be quantified before recruitment using an Italian version of the GI Severity Index. A score of at least 2 in a single item of gastrointestinal symptoms (item 1-6) was required for entry into the symptomatic group.\n* Signed informed consent for analysis of intestinal microbiota and metabolome and administration of nutraceutical therapy with PostbiotiX Comfort ®.\n\nGroup 3 Inclusion criteria\n\n* Males or females aged between 3 and 8 years whit typical development and absence of gastrointestinal symtomps\n* Signed informed consent for analysis of intestinal microbiota and metabolome\n\nExclusion Criteria:\n\nGroup 1 and 2\n\n* Exclusion Criteria\n* Children with syndromic ASD or defined genetic diseases;\n* Subjects with significant health problems requiring surgical treatment or continuous medical; treatment;\n* Severe gastrointestinal problems requiring immediate (life-threatening) treatment;\n* Severely underweight\u002Fmalnourished children;\n* Use of medications that may affect biomarkers assessed, for example: antibiotics and\u002For pre-, probiotics within 1 month prior to enrollment.\n\nGroup 3 exclusion criteria\n\n\\- Participants with gastrointestinal problems requiring immediate (life-threatening) treatment, or with gastrointestinal symptoms such as chronic irregular bowel movements (constipation, diarrhea), encopresis, recurrent abdominal bloating and pain, gastroesophageal reflux and vomiting, or food aversion.","3 Years","8 Years",{"count":20,"type":21},[383,384],"PHASE2","PHASE3","Recent research links gut microbiota alterations to Autism Spectrum Disorders (ASD), a neurobiological condition with multifactorial bases. In some ASD patients, altered gut flora and increased intestinal permeability are observed, influencing the central nervous system's development and function. Chronic gastrointestinal (GI) symptoms are commonly associated with ASD and correlate with its severity. This non-pharmacological interventional clinical study aims to investigate the role of gut microbiota on ASD and the effectiveness of postbiotic-based dietary supplements in children aged 3-8 years old. Gastrointestinal symptoms, behavioral profile and analysis of intestinal metagenomic and metabolomic profiles will be assessed before and after one-month treatment. The results of the study could enhance understanding of non-pharmacological therapeutic approaches in ASD and improve clinical management strategies and the behavioural functioning for children with ASD.",[387,388,389],"Autism","Autism Disorder","Autism Spectrum Disorder (ASD)",[391,392,393,394,395],"Autism Spectrum Disorders (ASD)","Microbiota","Gastrointestinal symptoms","Behaviour regulation","Sensory profile","2026-02-27",{"date":398,"type":39},"2026-03-04",{"date":400,"type":39},"2023-03-21",{"date":402,"type":21},"2027-12",{"name":45,"class":46},2,{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":413,"conditions":414,"keywords":423,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":437},"100587991","rare-but-not-alone-a-large-italian-network-to-empower-the-impervious-diagnostic-pathway-of-rare-cerebrovascular-diseases-aligned-100587991","NCT06935578","RAre, But Not aLone: a Large Italian Network to Empower the Impervious diaGNostic Pathway of Rare cerEbrovascular Diseases (ALIGNED)","ALIGNED","Inclusion Criteria:\n\n* patients with a clinical, genetic and\u002For neuroradiological diagnosis of rCVD (CADASIL, Fabry's disease, COL4A1, Sneddon's syndrome or Moyamoya arteriopathy), who have had at least one brain MRI study;\n\nExclusion Criteria:\n\n* na",{"count":283,"type":21},"Cerebrovascular diseases (CVDs) are one leading cause of morbidity and mortality worldwide. Despite intensive investigations, more than 30% of strokes remain of undetermined origin. Rare Cerebrovascular Diseases (rCVDs), including heritable (i.e., CADASIL, COL4A1 syndrome, Fabry disease) and acquired conditions (i.e., Sneddon syndrome, Moyamoya arteriopathy) account for a proportion of these strokes. However, rCVDs are often misdiagnosed since clinicians are not able to recognize them. Although rare, the identification of these stroke causes is important to establish appropriate management measures, including genetic counselling, and, if available, therapy. The lack of data on phenotype and clinical course of rCVDs, given the paucity of published series, makes the diagnosis and the development of therapies challenging. Furthermore, the molecular characterization of rCVDs is still lacking, despite progresses achieved in common stroke by applying high throughput approaches as multi-omics. Since the diagnosis and care of rCVDs require adequate expertise and instrumental tools, clinical and research activities are usually reserved to few specialized centers, mostly located in the North of Italy, leading patients to expensive trips for consultations. Therefore, the creation of a clinical and research network aimed at improving the diagnostic pathways of rCVDs is highly needed to improve the number of patients with rCVDs to better define the clinical phenotype and to transfer the knowledge on rCVDs in other centers overall Italy filling the geographical gap affecting Southern Italy.",[415,416,417,418,419,420,421,422],"CADASIL","CADASIL (Diagnosis)","Moya Moya Disease","Moyamoya","Moyamoya Syndrome","Sneddon Syndrome","Fabry Disease","COL4A1\\2",[424,425,415,426,421,420,427,428],"Rare Cerebrovascular Diseases","italian network","COL4A1 syndrome","Moyamoya arteriopathy","COL4A1\u002F2","2026-02-23",{"date":431,"type":39},"2026-02-24",{"date":433,"type":39},"2023-05-01",{"date":435,"type":21},"2026-05-19",{"name":45,"class":46},17,{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":115,"sex":17,"minAge":379,"maxAge":445,"enrollmentInfo":446,"targetDuration":4,"studyType":184,"phases":448,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":47},"100625846","omic-profile-in-autism-spectrum-disorder-from-cellular-level-towards-future-treatments-100625846","NCT07427940","Omic Profile in Autism Spectrum Disorder: From Cellular Level Towards Future Treatments","Aut_Omic","Inclusion Criteria:\n\n* Defined ASD diagnosis according to DSM-5 criteria\n* Age 3-15 years\n* Informed consent signed by the guardians\u002Flegal representatives.\n\nExclusion Criteria:\n\n* Exclusion criteria for Group 1 will be: having a defined genetic diagnosis or an overall clinical presentation strongly suggestive for a syndromic condition. For this definition we will apply the criteria ASD associated with at least one of the following: \\>=3 facial anomalies, \\>=1 major\u002F\\>=2 minor malformation (following EUROCAT classification), clinical issue affecting \\>=2 systems. Children showing such phenotypes but having no current genetic diagnosis could not be included in the study. Patients with a syndromic presentation and confirmed genetic diagnosis will be included in the Syndromic Group 2.\n* No standardized test to establish diagnosis\n* Parents refusing to complete the consent form\n* Impossible blood sample collection.","15 Years",{"count":447,"type":21},100,[186],"This is an interventional non pharmacological study in pediatric patientis affected by Autism Spectrum Disorder. It ams to create a collection of iPSCs and hiNSCs derived from deeply characterized ASD patients, to omics-characterize the cells, and to study the behavioral pattern of microglia-like cells in the onset of ASD.",[451],"Autism Spectrum Disorder",[451,453,454,455,456],"Neurodevelopmental disorders","iPSCs","hiNSCs","Microglia","2026-02-17",{"date":429,"type":39},{"date":460,"type":39},"2024-08-31",{"date":462,"type":21},"2026-08-31",{"name":45,"class":46},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":184,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":499,"locationsCount":404},"100583603","simplification-of-care-pathways-for-patients-with-rare-brain-tumors-through-artificial-intelligence-100583603","NCT06878469","SIMPLIFication of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence","SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence","SIMPLIF-AI","Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* Both sexes\n* Patients with rare brain tumors (incidence \\\u003C6 cases per 100,000 people\u002Fyear)\n* Candidates for craniotomy for rare brain tumors\n* Native Italian speakers for cognitive and psychological evaluation and neuro-cognitive rehabilitation\n\nExclusion Criteria:\n\n* Patients undergoing stereotactic\u002Fframeless biopsy\n* Patients with psychiatric disorders or on psychotropic medications\n* Patients with known cognitive decline (not due to the lesion)\n* Patients admitted on the same day as the surgery\n* Patients with severe impairments referred to rehabilitation centers\n* Patients without a Windows PC or laptop with Internet connection for neuro-cognitive rehabilitation",{"count":473,"type":21},200,[186],"This study focuses on rare brain tumors, which are heterogeneous entities with different morphological, biological, and clinical characteristics. Due to their rarity, many of these tumors fall under the RARECARE definition of rare tumors. The main objective of the study is to standardize care models and pathways for patients with rare brain tumors, using Artificial Intelligence (AI) and Machine Learning (ML) techniques to identify specific predictors of postoperative outcomes.\n\nThe study includes both retrospective and prospective phases, with the collection of clinical, cognitive, and psychological data at various time points. Patients will undergo an early neuro-cognitive rehabilitation program using the RehaCom software, which will be conducted at home. The goal is to improve the quality of life and care for patients through a multidisciplinary and innovative approach.",[477],"Brain Tumors",[479,480,481,482,483,484,485,486,487,488,489,490,491,492,493],"Rare brain tumors","neurosurgery","outcomes predictions","Machine Learning","Artificial Intelligence","neurocognitive rehabilitation","innovative models","health care pathways","Astrocytic tumors of CNS","Oligodendroglial tumors of CNS","Ependymal tumors of CNS","Neuronal and mixed neuronal-glial tumors","Choroid plexus carcinoma of CNS","Malignant meningiomas","Embryonal tumors of CNS",{"date":495,"type":39},"2026-02-19",{"date":497,"type":39},"2025-01-27",{"date":369,"type":21},{"name":45,"class":46},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":509,"conditions":510,"keywords":515,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":47},"100625277","clinical-significance-of-liquid-biopsy-in-brain-tumor-patients-a-5-ala-guided-approach-100625277","NCT07420543","Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach","FLUO-LB","Inclusion Criteria:\n\n* Inclusion Criteria (Glioblastoma Patients):\n* Patient aged 18 years or older\n* Diagnosis of supratentorial glioblastoma at its first occurrence (Grade 4, WHO 2021), confirmed through histological analysis, in a brain area that is accessible for surgical removal.\n* Ability of the patient to give informed consent.\n* Suitability for surgery with fluorescence guidance using 5-ALA.\n\nInclusion Criteria (Other Brain Tumors):\n\n* Patient aged 18 years or older\n* Ability of the patient to give informed consent.\n* Suitability for surgery with fluorescence guidance using 5-ALA.\n\nExclusion Criteria:\n\nExclusion Criteria (Glioblastoma Patients):\n\n* Presence of other systemic tumors.\n* Known allergic sensitivity or contraindications to gadolinium.\n* Contraindications to MRI, such as the presence of non-compatible implanted devices.\n* Significantly compromised renal function (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m²), and\u002For patients undergoing dialysis.\n* Conditions that contraindicate surgery with fluorescence guidance using 5-ALA.\n\nExclusion Criteria (Other Brain Tumors):\n\n* Patients suffering from systemic tumors (besides the primary of the brain metastasis).\n* Individuals with known allergies or adverse reactions to gadolinium.\n* Individuals with contraindications for MRI, including those with implants not compatible with the procedure.\n* Individuals with significantly reduced kidney function (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m²), or those undergoing dialysis.",{"count":508,"type":21},30,"Glioblastoma (GBM) is the most common and lethal primary brain tumor. Identifying blood biomarkers that reflect the tumor's status is a major unmet need for optimal clinical management. 5-ALA (5-Aminolevulinic Acid) administration leads to the accumulation of fluorescent Protoporphyrin IX (PpIX) in GBM cells, allowing identification during surgery. This project aims to leverage 5-ALA induced fluorescence to maximize the informational power of plasma liquid biopsy as a tool for diagnosis, post-treatment follow-up, and as a prognostic tool in patients with GBM.",[511,512,513,514],"Brain Tumors and\u002For Solid Tumors Including","Glioblastoma","Glioblastoma (GBM)","Glioblastoma - Category",[513,512,516,517,518,519,520],"Liquid Biopsy","GBM","5-ALA","Protoporphyrin IX (PpIX)","Fluorescence","2026-02-11",{"date":495,"type":39},{"date":524,"type":39},"2017-01-18",{"date":526,"type":21},"2027-05",{"name":45,"class":46},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":184,"phases":537,"briefSummary":538,"conditions":539,"keywords":541,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":556,"locationsCount":47},"100610931","ultrasound-guided-versus-non-ultrasound-guided-botulinum-toxin-injections-in-cervical-dystonia-custody-100610931","NCT07233993","UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]","A Randomised, Cross-over, Double-blind, Sham-Controlled Superiority Trial of UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum TOxin Injections in Cervical DYstonia","CUSTODY","Inclusion Criteria:\n\n* Minimum age 18 years old\n* Clinical diagnosis of Idiopathic Cervical Dystonia\n* On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to screening and expected to be maintained throughout the study\n* Treatment non-naïve to BoNT type A therapy for CD\n* At least 4 months have passed between the last BoNT injection at screening\n* Good clinical response to previous BoNT injections, on stable dosing and treatment scheme\n* Informed Consent as documented by signature.\n* Ability to perform study requirements (to attend assessment and treatments)\n\nExclusion Criteria:\n\n* Diagnosis of other types of Cervical Dystonia (Inherited and Acquired)\n\n  * Concomitant diagnosis of diseases that contraindicate the use of botulinum toxin, such as myasthenia gravis\n  * Known hypersensitivity or allergy to Botulinum-A Toxin\n  * Women who are pregnant or breast feeding\n  * Intention to become pregnant during the study\n  * Lack of safe contraception\n  * Other clinically significant and unstable concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).\n  * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant\n  * Participation in another study with investigational drug within the 30 days preceding and during the present study\n  * Previous enrolment into the current study",{"count":447,"type":21},[186],"Cervical dystonia is a condition that causes the neck muscles to tighten or spasm, leading to abnormal head positions and pain.\n\nThe main questions it aims to answer are:\n\n* Do ultrasound-guided BoNT injections improve quality of life more than injections without ultrasound?\n* Are ultrasound-guided injections as safe as injections without ultrasound?\n\nResearchers will compare:\n\n* BoNT injections with ultrasound guidance\n* BoNT injections without ultrasound guidance (based only on body landmarks)\n\nParticipants will:\n\n* Receive both types of injections during the study (one first, then the other)\n* Complete questionnaires about quality of life, movement, pain, and mood\n* Attend follow-up visits over about 8 months About 37 adults with cervical dystonia will take part. The study will take place at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy.",[540],"Idiopathic Cervical Dystonia",[542,543,544,545,546,547,548,549,550],"Cervical dystonia","Idiopathic cervical dystonia","Botulinum toxin","BoNT injections","Ultrasound-guided injections","Anatomical landmark","Quality of life","Motor symptoms","Non-motor symptoms",{"date":552,"type":39},"2026-02-13",{"date":554,"type":39},"2025-11-01",{"date":402,"type":21},{"name":45,"class":46},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":47},"100578010","natural-history-with-focus-on-oncological-risk-evaluation-in-pediatric-patients-with-pten-pathogenic-variants-100578010","NCT06805734","Natural History With Focus on Oncological Risk Evaluation in Pediatric Patients With PTEN Pathogenic Variants","Natural History With Focus on Oncological Risk Evaluation in Pediatric Patients With PTEN Pathogenic Variants - Observational Study","PTEN_Ped","Inclusion Criteria:\n\n* PTEN pathogenic variants (class 4\u002F5 SNV, gene deletion, intragenic duplication\u002Fdeletion)\n* Pediatric patients (\\\u003C18 years old) and their affected relatives, male\u002Ffemale, all ethnicities\n* The legal representative must agree to follow the screening protocol\n* Informed consent signed by the legal representative\n\nExclusion Criteria:\n\n* Refuse to undergo the exams of the protocol assessment at the diagnosis\n* PTEN non-pathogenic variants (VOUS or benign\u002Flikely benign vatiants)\n* No signed informed consent","17 Years",{"count":567,"type":21},50,"This is an observational study in pediatric patientis carryng PTEN pathogenic variants aimed to define oncological risk in children and provide a deeper insight of the clinical course, establishing an updated follow-up protocol.",[570],"PTEN Hamartoma Syndrome",[572,573],"PTEN","PTHS","2026-02-10",{"date":576,"type":39},"2026-02-12",{"date":578,"type":39},"2024-08-01",{"date":580,"type":21},"2029-07",{"name":45,"class":46},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":47},"100581017","fast-track-in-elective-neurosurgery-the-role-of-low-propofol-bis-nol-guided-general-anaesthesia-for-full-early-and-safe-awakening-100581017","NCT06844838","FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening","FasTrack","Inclusion Criteria:\n\n* Patients with supra- and sub tentorial neurosurgical pathology who meet the following inclusion criteria will be enrolled:\n* Age greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Psychiatric illness in history and\u002For taking psychotropic drugs\n* Glasgow Coma Score (GCS) \\\u003C 15\n* Presence of overt cognitive decline or speech disorders\n* Patients younger than 18 years of age\n* Intraoperative hypothermia (\\\u003C 36°)\n* Intraoperative hypotension (MAP \\\u003C 20% of baseline)",{"count":447,"type":21},"To evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical surgery.",[592],"Supratentorial Brain Tumor Surgery",[594,595,596,597,598,599,600,601,363,602,603,604,605,606,607,608],"General Anaesthesia","BIS","Bispectral Index","NOL","Nocipection Level","Neuroanesthesia","Target Colled Infusion TCI","Craniectomy","ERAS","Fast Track","Propofol","Remifentanil","Pain","Nociception","RASS",{"date":521,"type":39},{"date":611,"type":39},"2024-01-19",{"date":613,"type":21},"2026-02-01",{"name":45,"class":46},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":184,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":47},"100576983","psychological-and-psychiatric-assessment-in-patients-eligible-for-epilepsy-surgery-100576983","NCT06792383","Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery","PsychoSurgery","Inclusion Criteria:\n\n* Patients aged 18 or older at the time of enrollment;\n* Patients with drug-resistant focal epilepsy followed at the Institute for at least 6 months;\n* Patients with drug-resistant focal epilepsy eligible for epilepsy surgery;\n* Patients capable of providing informed consent to participate in the study and for the processing of personal data.\n\nExclusion Criteria:\n\n* Patients with evident and\u002For diagnosed cognitive or psychiatric disorders that prevent participation in an interview, proper understanding of informed consent, or completion of questionnaires.",{"count":117,"type":21},[186],"The aim of the study is to describe the socio-demographic, clinical, psychological, and psychiatric characteristics of patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes in these parameters over time after surgery. Additionally, the study seeks to describe the levels of quality of life, dissociative experiences, prevalence of various psychiatric symptoms, irritability, depressive symptoms, anxiety symptoms, and stigma perception in patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes over time after surgery.",[626],"Focal Epilepsy With and Without Secondary Generalization",[628,629,630,631],"epilepsy","quality of life","psychiatric symptoms","stigma",{"date":576,"type":39},{"date":634,"type":39},"2020-12-02",{"date":636,"type":21},"2026-12",{"name":45,"class":46},{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":647,"conditions":648,"keywords":650,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":404},"100560972","comparative-performance-of-general-purpose-models-100560972","NCT06584097","COMparative Performance of General Purpose Models","COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit","Inclusion Criteria:\n\n* Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \\> 12 hours • Requirement for an arterial line\n\nExclusion Criteria:\n\n* Pregnancy\n\n  * Known sensitivity or allergy to propofol or remifentanil\n  * Patient participating in research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority.\n  * Age \\\u003C 18 years old\n  * Patients subjected to infusion of propofol and\u002For remifentanil not delivered through TCI pumps before the inclusion\n  * Patients exposed to other sedatives (benzodiazepines, volatile anesthetics, quetiapine) before the inclusion",{"count":646,"type":21},42,"To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.",[649],"Neurosurgical Patients",[599,651,652,653],"total intravenous anesthesia","target controlled infusion","PKPD modelling",{"date":576,"type":39},{"date":656,"type":39},"2024-10-02",{"date":658,"type":21},"2026-12-31",{"name":45,"class":46},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":664,"acronym":665,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":667,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":669,"conditions":670,"keywords":672,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":683},"100617294","italian-translation-and-validation-of-the-gids-pd-scale-for-parkinsons-disease-100617294","NCT07316751","Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease","GIDS-PD_ITA","Inclusion Criteria:\n\n* Age ≥18 years;\n* Diagnosis of PD according to the Movement Disorder Society (MDS) diagnostic criteria (Postuma RB et al., 2015);\n* Italian-native patients or patients that understand Italian correctly at least;\n* Participants mentally and physically able to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Persons in the terminal phase of disease;\n* Persons with clinically relevant cognitive impairment;\n* Persons diagnosed with Parkinsonism other than PD.",{"count":668,"type":21},190,"This study aims to translate and validate the Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) into Italian to enable the assessment of gastrointestinal symptoms in Italian-speaking patients with Parkinson's disease. The psychometric properties of the translated instrument will be evaluated through a multi-phase process involving translation\u002Fback-translation, pre-testing, and large-scale validation across multiple Italian centers",[671,120],"PARKINSON DISEASE (Disorder)",[673,674,675],"Parkinson's Disease","Gastrointestinal Dysfunction","Scale Validation","2026-02-09",{"date":521,"type":39},{"date":679,"type":39},"2025-10-08",{"date":681,"type":21},"2028-11",{"name":45,"class":46},5,{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":690,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":694,"conditions":695,"keywords":698,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":699,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":47},"100614659","epigenetic-profiling-and-liquid-biopsy-perspectives-for-personalized-medicine-in-meningioma-patients---mind-100614659","NCT07282470","Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients - MIND","Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients","MIND","Inclusion Criteria:\n\nInclusion Criteria (Retrospective \\& Prospective):\n\n* Patient aged 18 years or older.\n* First diagnosis of uni-focal meningioma of the convexity.\n* Macroscopical total resection (Simpson 1-3).\n\n(Retrospective only):\n\n* Surgery performed between 2007 and 2016;\n* availability of FFPE sample and medical records.\n\nExclusion Criteria:\n\n* Genetic syndromes.\n* Diffuse Meningeal Meningiomatosis.\n* Patients who underwent experimental treatment in neo-adjuvant setting.\n\n(Prospective only):\n\n* Previous surgical\u002Fmedical treatment for another meningioma;\n* positive oncological history (e.g., breast cancer).",{"count":693,"type":21},210,"Meningiomas are the most common primary intracranial tumors. Current treatment relies on surgical resection and radiotherapy, but molecular predictors for recurrence are lacking. This study aims to investigate epigenetic features, specifically histone post-translational modifications (PTMs) and DNA methylation, to stratify patients. The study involves a retrospective cohort to define an epigenetic signature and a prospective cohort to validate it in tissues and liquid biopsies (plasma\u002FEVs).",[696,697],"Meningioma","Meningioma of Brain",[696,482],{"date":574,"type":39},{"date":701,"type":39},"2024-09-25",{"date":703,"type":21},"2026-03",{"name":45,"class":46},{"id":706,"slug":707,"hasResults":12,"nctId":708,"briefTitle":709,"officialTitle":709,"acronym":710,"eligibilityCriteria":711,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":712,"enrollmentInfo":713,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":715,"conditions":716,"keywords":719,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":723,"startDateStruct":724,"completionDateStruct":726,"leadSponsor":727,"locationsCount":47},"100610927","neuropsychological-profile-characterization-in-patients-with-migraine-cognitive-functioning-and-psychological-variables-100610927","NCT07233941","Neuropsychological Profile Characterization in Patients With Migraine: Cognitive Functioning and Psychological Variables","CogMIG","Inclusion Criteria:\n\n* Written informed consent.\n* Patients aged between 18 and 65 years.\n* Diagnosis of migraine according to the International Classification of Headache Disorders (ICHD-3) criteria.\n* Patients with a history of migraine for at least one year, to ensure the stability of the condition.\n* Stability of ongoing treatment for at least 3 months at baseline.\n* Understanding of the Italian language.\n\nExclusion Criteria:\n\n* Severe medical or psychiatric conditions (depression, schizophrenia, psychosis) documented by specific previous diagnoses.\n* A history of alcohol or drug abuse.\n* Primary sensory deficits.","65 Years",{"count":714,"type":21},150,"The overall objective is to define the neuropsychological profile of patients with migraine and evaluate its association with: psychological outcome measures (anxiety-depressive symptoms, pain catastrophizing, excessive worry, and coping strategies); the clinical profile of migraine; the prodromal, ictal, or interictal phase of the migraine attack; pharmacological therapy; and detoxification treatment in patients with migraine associated with medication overuse headache.",[717,718],"Migraine","Migraine Disease",[720,721,722],"migraine","cognition","cognitive impairment",{"date":521,"type":39},{"date":725,"type":39},"2025-09-01",{"date":526,"type":21},{"name":45,"class":46},{"id":729,"slug":730,"hasResults":12,"nctId":731,"briefTitle":732,"officialTitle":733,"acronym":734,"eligibilityCriteria":735,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":736,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":737,"conditions":738,"keywords":740,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":745,"startDateStruct":746,"completionDateStruct":748,"leadSponsor":750,"locationsCount":47},"100610928","intraoperative-use-of-iv-sodium-fluorescein-in-suspected-cns-tumors-100610928","NCT07233954","Intraoperative Use of I.V. Sodium Fluorescein in Suspected CNS Tumors","Use of i.v. Sodium Fluorescein as a Fluorescent Intra-operative Tracer in Patients With Suspected Malignant Neoplasms of the CNS","FLUOCERTUM","Inclusion Criteria:\n\n1. Patients of both genders, at any age.\n2. Patients with suspected aggressive lesion of the CNS, as suggested by pre-operative MRI or CT with i.v. contrast agent administration.\n\nExclusion Criteria:\n\n1. Impossibility to give consent due to cognitive deficits or language disorder.\n2. Known allergy to contrast agents and\u002For history of previous anaphylactic shocks.\n3. Known severe previous adverse reactions to Fluorescein\n4. Acute myocardial infarction or stroke in the last 90 days.\n5. Severe renal failure;\n6. Severe hepatic failure;\n7. Women in their first trimester of pregnancy or lactation.",{"count":447,"type":21},"The FLUO.CER.TUM study is a prospective observational clinical trial conducted at the IRCCS Foundation Neurological Institute \"Carlo Besta\" in Milan, Italy. It investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of suspected malignant tumors of the central nervous system (CNS). These tumors typically present as contrast-enhancing masses on pre-operative MRI or CT scans.\n\nMalignant brain tumors are notoriously difficult to fully resect due to challenges in distinguishing tumor margins from healthy tissue. Sodium fluorescein, a dye that accumulates in areas where the blood-brain barrier is disrupted, offers a promising solution by enhancing tumor visualization during surgery. When used with a dedicated surgical microscope equipped with a fluorescence filter, fluorescein can help surgeons identify and remove more tumor tissue, potentially improving patient outcomes.\n\nThe study aims to evaluate the effectiveness and safety of fluorescein-guided surgery in a real-world clinical setting. Approximately 800 patients of any age and gender, with suspected aggressive CNS lesions, will be enrolled. Each patient will receive 5 mg\u002Fkg of sodium fluorescein intravenously at the induction of anesthesia. Surgery will be performed using fluorescence-guided techniques, and patients will undergo pre- and post-operative imaging to assess the extent of resection. Clinical and neurological evaluations will also be conducted to monitor outcomes and any adverse effects.\n\nThe primary objective is to qualitatively assess the intraoperative fluorescence characteristics of CNS tumors. Secondary objectives include measuring the extent of tumor resection, evaluating post-operative neurological function, and documenting any side effects related to fluorescein administration.\n\nThe study adheres to ethical standards, including informed consent and approval by an ethics committee, and will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. Data will be anonymized and securely stored, with results potentially published following appropriate review and approval.",[739],"CNS",[741,742,743,744],"Neurosurgical Procedures","Malignant Neoplasms","Surgical Margins","Fluorescein",{"date":521,"type":39},{"date":747,"type":39},"2016-01-13",{"date":749,"type":21},"2027-12-31",{"name":45,"class":46},""]