[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione Don Carlo Gnocchi ETS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":190},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,89,115,140,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100649276","home-based-exergame-motor-cognitive-rehabilitation-for-traumatic-brain-injury-100649276",false,"NCT07733336","Home-Based Exergame Motor-Cognitive Rehabilitation for Traumatic Brain Injury","Effectiveness of Home-Based Exergame Motor-Cognitive Rehabilitation Versus Outpatient Multidisciplinary Rehabilitation in Individuals With Traumatic Brain Injury: A Pilot Controlled Trial","HOME-TBI","TBI patients Inclusion Criteria\n\n* Discharge from intensive inpatient post-acute rehabilitation following a first traumatic brain injury (TBI).\n* Level of Cognitive Functioning Scale (LCF) score ≥ 6, indicating appropriate and goal-directed cognitive responses.\n* Ability to walk at least 30 meters, with or without an assistive device.\n* Ability to maintain an unsupported standing position for at least 3 minutes.\n* Provision of written informed consent.\n\nTBI patients Exclusion Criteria\n\n* Diagnosis or suspected diagnosis of a neurodegenerative disorder.\n* Previous history of traumatic brain injury.\n* History of major psychiatric disorders (e.g., schizophrenia or bipolar disorder), primary sleep disorders, or epilepsy.\n* Severe visual or auditory impairment that could interfere with study assessments or participation in the rehabilitation program.\n* Severe expressive and\u002For receptive aphasia.\n* Language barriers preventing reliable cognitive assessment or informed consent procedures.\n* Current pregnancy.\n\nHealthy Subjects - Exclusion Criteria\n\n* Presence of any neurological, sensrory, cognitive, psychiatric, cardiopulmonary, or musculoskeletal condition that may affect study participation or outcome measures\n* Language barriers preventing reliable cognitive assessment or informed consent procedures.\n* Current pregnancy.",true,"ALL","18 Years","75 Years",{"count":22,"type":23},30,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this clinical trial is to evaluate the effectiveness of a home-based cognitive-motor telerehabilitation program in individuals with traumatic brain injury (TBI) following discharge from intensive inpatient neurorehabilitation.\n\nThe main questions it aims to answer are:\n\n* Does home-based cognitive-motor telerehabilitation improve functional independence, cognitive performance, mobility, and quality of life in individuals with TBI?\n* Are the effects of home-based cognitive-motor telerehabilitation superior to those achieved with standard outpatient rehabilitation?\n\nThe study will compare a home-based cognitive-motor telerehabilitation program with standard outpatient rehabilitation to determine their relative effects on functional recovery.\n\nParticipants will:\n\n* Receive either home-based cognitive-motor telerehabilitation or standard outpatient rehabilitation, according to the assigned treatment pathway. Both rehabilitation programs consist of 20 sessions lasting 45 minutes each, three times per week.\n* Undergo clinical, cognitive, and motor assessments at predefined study time points: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).\n* Be evaluated for changes in functional independence, cognitive functioning, mobility, quality of life, and caregiver burden.",[29],"Traumatic Brain Injury",[31,32,33,34,35],"Traumatic Brain Injury;","Telerehabilitation","motor function","cognitive function","multidisciplinary rehabilitation","NOT_YET_RECRUITING","2026-08-07",{"date":39,"type":40},"2026-08-11","ACTUAL",{"date":42,"type":23},"2026-11-03",{"date":44,"type":23},"2029-03-31",{"name":46,"class":47},"Fondazione Don Carlo Gnocchi ETS","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100649253","prevalence-of-mild-cognitive-impairment-and-dementia-in-patients-admitted-to-non-neurological-rehabilitation-wards-100649253","NCT07731334","Prevalence of Mild Cognitive Impairment and Dementia in Patients Admitted to Non-neurological Rehabilitation Wards","COGinREHAB","Inclusion Criteria:\n\n* Age ≥45 years\n* Hospitalization for at least 7-10 days for a non-neurological condition, in cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units\n* Adequate fluency in the Italian language\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Illiteracy\n* Severe, uncorrected visual impairment and\u002For hearing loss\n* Severe verbal communication deficit\n* Inability to remain seated for the duration of the assessment\n* Inability to use the dominant upper limb\n* Altered state of consciousness or alertness (e.g., delirium)\n* Severe scalp skin lesions or dermatitis precluding electrode application for neurophysiological recordings\n* Previous or current history of severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder, severe major depressive disorder with psychotic symptoms, current suicidal risk, or other psychiatric conditions judged by the investigator to interfere with study participation, procedural compliance, or interpretation of results)\n* Previous history or current presence of clinically relevant neurological pathologies other than cognitive impairment (e.g., epilepsy, stroke, neurodegenerative diseases such as Parkinson's disease or multiple sclerosis, moderate-to-severe traumatic brain injury, brain tumors, central nervous system infections, or other neurological conditions that may influence cognitive, behavioral, or neurological functioning, or otherwise compromise the study objectives)","45 Years",{"count":58,"type":23},384,[26],"Cognitive impairment is common among older adults hospitalized for non-neurological conditions but often goes unrecognized, particularly in rehabilitation settings where clinical attention is mainly focused on physical recovery. The COGinREHAB study is a multicenter, prospective, longitudinal interventional study conducted at three rehabilitation centers of the Fondazione Don Carlo Gnocchi in Italy (Florence and Milan).\n\nThe study will enroll 384 patients aged 45 years or older who are hospitalized for at least 7-10 days in cardiac, pulmonary, or orthopedic intensive rehabilitation units, or in intermediate care units, for conditions unrelated to the nervous system.\n\nAt admission, all participants undergo a clinical and cognitive screening visit. Patients whose screening results suggest possible cognitive impairment then undergo a more extensive neuropsychological evaluation. In those with confirmed cognitive impairment, additional blood tests are performed to measure biomarkers of neurodegeneration (GFAP, neurofilament light chain, and phosphorylated tau-217), together with APOE genotyping and a non-contrast brain CT scan. In a subset of these patients, resting-state EEG, auditory event-related potentials, actigraphy, and overnight polysomnography are also performed. Patients with confirmed cognitive impairment are invited to a follow-up visit 12 months later to assess whether their cognitive profiles and biological markers have changed.\n\nThe main purpose of the study is to estimate how frequently cognitive impairment occurs among patients admitted to non-neurological rehabilitation units, including how often it was previously undiagnosed. The study will also describe the clinical, biological, and neurophysiological profile of these patients and examine how cognitive impairment evolves over one year.",[62,63,64,65,66],"MCI","Mild Cognitive Impairment (MCI)","Mild Cognitive Impairment","Cognitive Deficit","Cognitive Decline",[64,68,69,70,71,72,73,74,75,76,77,78],"Cognitive Screening","Multimodal Assessment","Cognitive Trajectories","Dementia","Non-Neurological Rehabilitation","Plasma Biomarkers","Neurodegeneration","Neurophysiological Measures","Longitudinal Study","APOE Genotype","MoCA","RECRUITING","2026-08-05",{"date":82,"type":40},"2026-08-10",{"date":84,"type":40},"2026-01-20",{"date":86,"type":23},"2028-12",{"name":46,"class":47},3,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":24,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100558185","rehabilitation-with-and-without-robot-and-allied-digital-technologies-in-stroke-patients-100558185","NCT06547827","Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients","Rehabilitation With and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-organizational Sustainability of RADTs From Subacute to Chronic Phase","StrokeFit4","Inclusion Criteria:\n\n* First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging;\n* Age 18 years and over;\n* Time since the event equal to or less than 6 months;\n* Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and\u002For mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and\u002For mild to severe impairment of balance (Berg Balance Scale ≤ 45);\n* Clinical stability allowing transfer to the gym and execution of the planned treatments.\n\nExclusion Criteria:\n\n* Clinical instability;\n* Behavioral\u002Fcognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment \\\u003C10);\n* Rigidity or hypertonia (Modified Ashworth Scale \\> 3) in the plegic\u002Fparetic limb;\n* Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and\u002For robotic devices;\n* Pregnant women;\n* Refusal to sign the informed consent.",{"count":98,"type":23},596,[26],"Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes.\n\nThis multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.",[102],"Stroke",[104,105],"rehabilitation","robotics","2026-07-23",{"date":108,"type":40},"2026-07-24",{"date":110,"type":40},"2024-08-12",{"date":112,"type":23},"2026-11-30",{"name":46,"class":47},27,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":24,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100648580","new-diagnostic-approaches-in-the-management-of-inflammatory-lung-diseases-100648580","NCT07723638","New Diagnostic Approaches in the Management of Inflammatory Lung Diseases","ALPI","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), or combined pulmonary fibrosis and emphysema (CPFE), established according to current international diagnostic guidelines.\n* Ability and willingness to provide written informed consent.\n* Willingness to provide blood and saliva samples for biomarker analyses.\n* Willingness and ability to undergo clinical assessments and scheduled follow-up visits.\n* Willingness and ability to use study monitoring devices, including environmental monitoring devices and, where applicable, telemedicine tools.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* Inability or unwillingness to provide written informed consent.\n* Inability to comply with study procedures or scheduled follow-up.\n* Presence of any medical, psychiatric, or cognitive condition that, in the opinion of the investigator, would interfere with study participation or interpretation of the study results.\n* Participation in another interventional clinical trial that, in the opinion of the investigator, could interfere with the objectives of this study.",{"count":123,"type":23},200,[26],"Inflammatory lung diseases, including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), are major causes of morbidity and mortality worldwide. Their development and progression are influenced by environmental exposures, such as cigarette smoking and air pollution, as well as genetic susceptibility. Despite advances in disease management, early diagnosis, accurate differential diagnosis, personalized treatment, and continuous monitoring remain significant clinical challenges.\n\nThis project aims to improve the management of inflammatory lung diseases through the development and validation of innovative diagnostic, monitoring, and therapeutic approaches. The study will identify and validate multi-omics biomarkers for the differential diagnosis and prognosis of COPD, IPF, and related respiratory diseases, using machine learning techniques to develop diagnostic and prognostic biochips. Environmental determinants, including indoor and outdoor exposome factors, will be assessed to better understand their contribution to pulmonary inflammation and disease progression. The project will also develop nanotechnology-based therapeutic formulations combined with precision inhalation devices and integrate a telemedicine platform for real-time monitoring of clinical and environmental data, enabling the early detection of exacerbations and supporting personalized disease management.\n\nThe expected outcomes include improved diagnostic accuracy, enhanced risk stratification, personalized therapeutic strategies, reduced disease exacerbations, and improved quality of life for patients with inflammatory lung diseases.",[127,128],"Chronic Obstructive Pulmonary Disease (COPD)","Idiopathic Pulmonary Fibrosis",[130,131,132],"Biomarkers","COPD","IPF","2026-07-21",{"date":106,"type":40},{"date":136,"type":23},"2026-09-01",{"date":138,"type":23},"2027-11-13",{"name":46,"class":47},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":24,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100647384","identification-of-diagnostic-and-prognostic-biomarkers-in-the-pathological-continuum-of-bronco-chronic-obstructive-pulmonary-disease-idiopathic-pulmonary-fibrosis-and-pulmonary-neoplasia-100647384","NCT07707245","Identification of Diagnostic and Prognostic Biomarkers in the Pathological Continuum of Bronco Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Pulmonary Neoplasia","RESPIRO","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of: Chronic Obstructive Pulmonary Disease (COPD), current or former smokers; and\u002For Idiopathic Pulmonary Fibrosis (IPF), current or former smokers; and\u002For Resectable lung adenocarcinoma (Stage I-III, according to clinical indication for surgical resection).\n* Ability to comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent.\n* Active respiratory infection or acute exacerbation of COPD or IPF at the time of enrollment.\n* Previous or concomitant malignant disease (except non-melanoma skin cancer) that could interfere with study objectives.\n* Prior systemic immunosuppressive or anti-inflammatory therapy that may significantly alter immune profiling within a defined washout period (if applicable per protocol).\n* Severe comorbid conditions limiting life expectancy or ability to complete follow-up (e.g., advanced heart failure, severe renal or hepatic disease).\n\nInadequate biological sample quality or impossibility to obtain required blood samples.",{"count":148,"type":23},120,[26],"Primary Objective:\n\nTo evaluate the association between inflammatory, immunological, genetic, and epigenetic biomarkers measured at enrollment and the clinical, functional, and phenotypic characteristics of patients with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and lung cancer.\n\nSecondary Objective:\n\nTo assess the prognostic value of the identified biomarkers by evaluating their ability to predict clinical outcomes at 12 months.\n\nPrimary Outcome Measure:\n\nAssociation between baseline inflammatory, immunological, genetic, and epigenetic biomarkers and disease-specific clinical, functional, and phenotypic characteristics assessed at enrollment, including:\n\nCOPD: current or former smokers, stratified according to the predominant phenotype (emphysema or bronchiolitis); IPF: rapid progressors, slow progressors, and patients with combined pulmonary fibrosis and emphysema (CPFE); Lung cancer: current smokers, former smokers who quit less than 15 years before enrollment, former smokers who quit 15 years or more before enrollment, and never-smokers.\n\nSecondary Outcome Measure:\n\nPredictive performance of baseline inflammatory, immunological, genetic, and epigenetic biomarkers for 12-month clinical outcomes.",[131,152,153],"Idiopathic Pulmonary Fibrosis (IPF)","Lung Cancer","2026-07-15",{"date":156,"type":40},"2026-07-16",{"date":158,"type":40},"2026-04-22",{"date":160,"type":23},"2028-10-30",{"name":46,"class":47},1,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100540913","spontaneous-eye-blinking-in-disorders-of-consciousness-100540913","NCT06323031","Spontaneous Eye Blinking in Disorders of Consciousness","Spontaneous Eye Blinking as a Diagnostic and Prognostic Marker in Patients With Disorders of Consciousness After Severe Acquired Brain Injury","Blink-DoC","Inclusion Criteria:\n\n* clinical diagnosis of DoC (UWS, MCS minus, MCS plus) following repeated clinical evaluation (at least four CRS-R in a week)\n* age ≥ 18 years\n* time post-onset ≤6 months\n* Previous sABI of any etiology (traumatic, vascular, anoxic, mixed, etc.)\n* Negative anamnesis for neurological or psychiatric disorders.\n\nExclusion Criteria:\n\n* unstable clinical conditions (e.g. respiratory failure, fever, status epilepticus, etc.);\n* ophthalmic diseases, or clinically detected peripheral damage in eyelid motility (e.g. orbital fracture);\n* intake of sedative drugs in the preceding 24 hours;\n* additional brain event following admission (e.g., stroke).",{"count":172,"type":23},70,"OBSERVATIONAL","Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and\u002For sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).\n\nThis is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months.",[176],"Disorders of Consciousness",[176,178,179,180,104],"blinking","diagnosis","prognosis","2026-07-10",{"date":183,"type":40},"2026-07-13",{"date":185,"type":40},"2025-05-08",{"date":187,"type":23},"2026-12-31",{"name":46,"class":47},8,""]