[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Istituti Clinici Scientifici Maugeri SpA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":645},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,44,77,100,124,150,175,196,213,233,254,279,307,335,357,383,405,426,453,480,506,533,569,594,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100429766","sonification-techniques-for-gait-training-100429766",false,"NCT04876339","Sonification Techniques for Gait Training","Sonification Techniques for Gait Training: a Pilot Multicentric Randomized Controlled Trial","SonicWalk","Inclusion criteria (stroke patients)\n\n* Age \\\u003C 80\n* Mini Mental State Examination \\> 24\n* Modified Rankin Scale: 1-3\n* Single hemisphere lesion\n* Stabilized disease (\\> 6 months after the acute event)\n* Impairment in gait parameters (e.g. velocity, perceived fatigue etc)\n* Motor independence during walking (without orthotic devices and aids) but with pathological pattern (spasticity level: Ashworth \\\u003C 2)\n\nInclusion criteria (patients with Parkinson's disease)\n\n* Age \\\u003C 80\n* Mini Mental State Examination \\> 24\n* Unified Parkinson Disease Rating Scale score (Parte III): \\\u003C 28\n* Stabilized disease and drug therapy\n* Altered gait patterns\n* Motor independence during walking (without orthotic devices and aids) but with pathological pattern\n\nInclusion criteria (patients with multiple sclerosis):\n\n* Age \\\u003C 60\n* Mini Mental State Examination \\> 24\n* Expanded Disability Status Scale score: 3-5\n* Stabilized disease in the last 6 months (without relapse or disability progression)\n* Altered gait patterns (i.e., careening, slowing down, spasticity: Ashworth \\\u003C 2, etc.)\n* Motor independence during walking\n\nExclusion Criteria (stroke patients)\n\n* Multiple or bilateral lesions\n* Neglect\n* Equinism\n* Spasticity: Ashworth \\>2\n* Structured (non-elastic) Achilles tendon retraction\n* Neurotoxin in the 3 months prior to the study\n* Baclofen introduced or modified in the week before the start of the study\n* Previous or concurrent diseases disabling the lower limb functions\n* Rehabilitative treatments with music in the year before the study\n\nExclusion criteria (patients with Parkinson's disease):\n\n* Previous or concurrent diseases disabling the lower limb functions\n* Changes of drug therapy during the study\n* Rehabilitative treatments with music in the year before the study\n\nExclusion criteria (patients with multiple sclerosis):\n\n* Previous or concurrent diseases disabling the lower limb functions\n* Neurotoxin in the 3 months prior to the study\n* Baclofen introduced or modified in the week before the start of the study\n* Spasticity: Ashworth \\>2\n* Structured (non-elastic) Achilles tendon retraction\n* Rehabilitative treatments with music in the year before the study","ALL","80 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","Music therapy is widely used in relational and rehabilitation settings. In addition to Neurologic Music Therapy and other music-based techniques, \"sonification\" approaches were recently introduced in the field of rehabilitation. The \"sonification\" can be defined as a properly selected set of sonorous-music stimuli are associated with patient movements mapping. In fact, the auditory-motor feedback can replace damaged proprioceptive circuits with a consequent improvement of the rehabilitation process. Interventions with \"sonification\" facilitate sensorimotor learning, proprioception and movements planning and execution improving global motor parameters. This study proposes the use of musical auditory cues which includes the melodic-harmonic component of the music. This kind of sonification makes the feedback pleasant and predictable as well as potentially effective. The investigators propose to apply and assess the effectiveness of this kind of sonification on gait training and other secondary outcomes in stroke, Parkinson's disease and multiple sclerosis population. Also, the investigators will assess the impact of \"sonification\" on the level of fatigue perceived during the rehabilitation process and on the quality of life. The study is a multicenter randomized controlled trial and will involve 120 patients that will undergo standard motor rehabilitation or the same rehabilitation but with the sonification support. The interventions will be evaluated at the baseline, after 10 sessions, after 20 sessions and at follow-up (one month after the end of the treatment). The assessment will include functional, motor, fatigue and quality of life evaluations. The collected data will be statistically processed.",[28,29,30],"Parkinson Disease","Stroke","Multiple Sclerosis","RECRUITING","2026-07-01",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2021-01-18",{"date":39,"type":22},"2027-06-30",{"name":41,"class":42},"Istituti Clinici Scientifici Maugeri SpA","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100627695","effects-of-oxygen-supplementation-during-the-6-minute-walk-test-in-chronic-respiratory-failure-or-exertional-hypoxemia-100627695","NCT07451977","Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia","Evaluation of the Effects of the Oxygen Supplementation During 6-minute Walking Test in Patients With Chronic Respiratory Failure or Exertional Hypoxiemia","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosis of chronic respiratory disease admitted for pulmonary rehabilitation\n* One of the following conditions at discharge:\n* Chronic obstructive pulmonary disease with exertional hypoxemia\n* Chronic obstructive pulmonary disease with chronic respiratory failure requiring long-term oxygen therapy\n* Interstitial lung disease with chronic respiratory failure requiring long-term oxygen therapy\n* Clinically stable condition for at least one month\n* Optimized medical therapy during hospitalization\n* Ability to perform the 6-minute walk test\n* Signed informed consent\n\nExclusion Criteria:\n\n* Lung diseases other than chronic obstructive pulmonary disease or interstitial lung disease\n* Resting oxygen flow requirement greater than 4 liters per minute\n* Orthopedic, neurological, or cognitive conditions that may limit walking performance\n* Recent cardiovascular or cerebrovascular events within the previous 3 months","18 Years",{"count":53,"type":22},114,[25],"The aim of this multicenter crossover trial is to describe the effect of adding a therapeutic dose of exertional oxygen therapy, in terms of exercise performance, gas exchange, heart rate, symptoms perception and subjective easiness of performance, in a cohort of subjects hospitalized in specialized pulmonary rehabilitation centers with a diagnosis of chronic respiratory failure and\u002For exertional hypoxemia due to chronic obstructive pulmonary disease or interstitial lung disease.\n\nResearchers will compare the walking performance during 6-minute walk test performed with the liters of oxygen administered as prescribed at rest (for patients with chronic respiratory failure) or in room air (for patients with exertional hypoxemia only), to the performance during a 6-minute walk test performed with the double the flow rate prescribed at rest, or with 2 L\u002Fmin for patients with exertional hypoxemia only. The two tests will be performed in random order, at least 3 hours apart and no later than 24 hours apart from each other.\n\nThe main outcome will be the difference between the distance walked in the two 6-minute walk test in the two conditions. Furthermore, will be also collected and compared: the oxygen saturation and heart rate every minute, the initial and final dyspnea and fatigue, as assessed by Borg scale, and the easiness of performance through a dedicated questionnaire. The estimated sample size will be 114 patients.\n\nThis study will provide some basis for a more accurate prescription of exercise-related oxygen therapy, offering insights into the phenotype of patients who may derive the greatest benefit from this intervention. It will also stimulate discussion regarding the optimal timing and dosing of oxygen administration during exertion in patients with respiratory failure.",[57,58,59,60],"Chronic Respiratory Failure","Hypoxemia","Chronic Obstructive Pulmonary Disease (COPD)","Interstitial Lung Disease",[62,63,64,65,66,67],"oxygen supplementation","6-minute walk test","chronic respiratory failure","exertional hypoxemia","pulmonary rehabilitation","exercise tolerance","2026-06-19",{"date":70,"type":35},"2026-06-23",{"date":72,"type":35},"2026-04-02",{"date":74,"type":22},"2028-09-30",{"name":41,"class":42},6,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":51,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"100519844","circulating-tumour-cells-characterization-in-breast-cancer-patients-100519844","NCT06048835","Circulating Tumour Cells Characterization in Breast Cancer Patients","Ultrasensitive BIOsensing Platform for Multiplex CELLular Protein PHEnotyping at Single-cell Level","BioCellPhe","Inclusion Criteria:\n\n* female patients with diagnosis of metastatic breast cancer, confirmed by clinical practice staging exams.\n* female patients with biopsy-confirmed diagnosis of early-breast cancer candidate for primary surgery after multidisciplinary evaluation.\n* patients not affected by any neoplastic disease.\n\nExclusion Criteria:\n\n* Diagnosis of any neoplastic disease",true,"FEMALE","90 Years",{"count":89,"type":22},80,"OBSERVATIONAL","In the current scenario, a reliable liquid biopsy method for predicting outcomes in solid tumors, especially among breast cancer patients, is lacking. Circulating Tumor Cells (CTCs) serve as crucial indicators of metastasis, and their early detection could significantly enhance patient stratification and facilitate the customization of personalized treatments. However, detecting CTCs in breast cancer patients presents complexities due to their substantial phenotypic heterogeneity and typically low concentration.\n\nNumerous approaches have been developed for CTC detection. Nonetheless, the currently available technologies remain intricate, time-consuming, and costly. The BioCellPhe Project is dedicated to the development of a novel device capable of isolating and characterizing individual CTCs. This innovative device relies on the identification of specific cell membrane proteins with remarkable precision, achieved through the application of novel orthogonal techniques.\n\nOn one hand, engineered bacteria are utilized to precisely bind to membrane proteins of interest on CTCs. On the other hand, Surface Enhanced Raman Spectroscopy (SERS) is employed for the detection of individual molecules. Specifically, the BioCellPhe Project focuses on comprehensively studying CTCs in breast cancer patients, encompassing both metastatic and non-metastatic cases.",[93],"Breast Cancer",{"date":70,"type":35},{"date":96,"type":35},"2022-12-01",{"date":98,"type":22},"2028-12-31",{"name":41,"class":42},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":122,"locationsCount":123},"100493691","effect-of-combined-endurance-training-on-adl-and-walking-in-copd-patients-100493691","NCT05708443","Effect of Combined Endurance Training on ADL and Walking in COPD Patients","Effect of Combined Upper and Lower Extremity Endurance Training Versus Lower Extremity Training Alone on ADL and Walking in COPD Patients","Inclusion Criteria:\n\n* GOLD class 2-3 COPD\n* Forced Expiratory Volume in the first second (FEV1) between 30% and 70% of the predicted value\n* ability to walk and climb stairs without assistance\n* stable clinical condition (pH \\> 7.35)\n\nExclusion Criteria:\n\n* chronic respiratory insufficiency on long-term oxygen therapy (LTOT)\n* severe orthopedic, neurological or cardiological comorbidities\n* cognitive impairment\n* recent exacerbation (within 15 days) requiring a change in therapy\n* presence of lung disease other than COPD\n* terminality",{"count":108,"type":22},36,[25],"Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability. Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load.\n\nThe primary aim of this study is to evaluate whether the combined \"arm and leg\" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test).",[112],"COPD",[114,112,115,116],"ADL","Glittre Test","exercise",{"date":118,"type":35},"2026-06-24",{"date":120,"type":35},"2023-01-10",{"date":39,"type":22},{"name":41,"class":42},3,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":43},"100612500","effects-of-trans-auricular-vagal-stimulation-on-neuromotor-recovery-in-subacute-stroke-during-technological-and-traditional-training-100612500","NCT07254390","Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training","Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery Post-Stroke in the Subacute Phase During Training With the Khymeia Technological Device and Traditional Rehabilitation","Inclusion Criteria:\n\n* Patients with hemiplegia following ischemic or hemorrhagic stroke occurred within the previous 6 months, clinically stable\n* Age ≥ 18 years\n* Single cortical or subcortical lesion documented on neuroimaging, corresponding to the motor deficit\n* Cognitively able to understand and follow therapeutic instructions\n* Upper limb weakness confirmed by a Motricity Index score below maximum\n* Spasticity, if present, compatible with limb function (Modified Ashworth Scale ≤ 2)\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Multiple brain lesions on neuroimaging\n* Severe spasticity (Modified Ashworth Scale 3-4)\n* Aphasia preventing comprehension of verbal instructions\n* Cognitive decline or behavioral disorders interfering with collaboration during training\n* Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training",{"count":132,"type":22},48,[25],"This randomized pilot clinical study aims to investigate the effects of trans-auricular vagus nerve stimulation (tVNS) on neuromotor recovery in patients in the subacute phase after stroke. Participants admitted for intensive rehabilitation at ICS Maugeri Centers (Montescano, Pavia, Nervi) will be randomized into four groups receiving either traditional or technological rehabilitation (Khymeia device), combined with active or sham tVNS.\n\nThe Parasym® device (CE 0197) delivers non-invasive stimulation of the auricular branch of the vagus nerve at the left ear for 60 minutes daily.\n\nThe primary outcome is the improvement in upper limb motor function, assessed by the Fugl-Meyer scale. Secondary outcomes include other clinical, cognitive, and psychological measures, as well as neurophysiological and cardiovascular autonomic parameters.\n\nThe study hypothesizes that coupling tVNS with rehabilitation enhances cortical plasticity and accelerates motor recovery. Adverse effects are expected to be minimal, with previous studies reporting only mild transient skin irritation. The results may provide new insights into the neurophysiological mechanisms of recovery and support the integration of non-invasive neuromodulation in post-stroke rehabilitation.",[29],[137,138,139,140,141],"Transcutaneous vagus nerve stimulation (tVNS)","Stroke rehabilitation","Neuroplasticity","Upper limb motor recovery","Non-invasive neuromodulation","2026-05-07",{"date":144,"type":35},"2026-05-12",{"date":146,"type":35},"2025-01-08",{"date":148,"type":22},"2027-04-03",{"name":41,"class":42},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":43},"100498791","unconscious-processing-in-decision-making-100498791","NCT05774847","Unconscious Processing in Decision-making","Behavioral Evidence on the Modulators of Unconscious Processing in Decision-making","Inclusion Criteria:\n\n* Healthy participants, as determined by screening assessments and principal investigator judgment\n* The participant must be able to comply with study requirements as judged by the principal investigator\n\nExclusion Criteria:\n\n* Any history of alcohol and\u002For drug abuse, addiction or suspicion of regular consumption of drugs of abuse\n* Use of any psychoactive medication, or medications known to have effect on central nervous system","60 Years",{"count":159,"type":22},200,"This behavioral study on healthy participants aims to provide a baseline reference for assessing alterations of decision-making performance in pathological conditions. To this purpose, this single center non-interventional behavioral study will assess the extent to which decision-making performance is affected by distinct experimental manipulations, as well as by ageing effects, in 200 healthy individuals. The main questions it aims to answer are:\n\n* to what extent is decision-making performance stable, within individuals, regardless of non-economic manipulations concerning stimuli perceptual features as well as type of processing and motor response required to participants?\n* are these manipulations additionally influenced by participants' age?\n\nHealthy participants will be recruited for distinct behavioral studies assessing the effects of the aforementioned manipulations of distinct metrics of decision-making performance, such as loss aversion, risk aversion, and delay discounting.",[162],"Healthy Volunteers",[164,165,166],"decision-making","unconscious processing","subliminal processing","2026-05-04",{"date":169,"type":35},"2026-05-08",{"date":171,"type":35},"2021-05-24",{"date":173,"type":22},"2027-10-31",{"name":41,"class":42},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":157,"enrollmentInfo":182,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":195,"locationsCount":43},"100498792","neural-bases-of-social-cognitive-processing-in-healthy-individuals-100498792","NCT05774860","Neural Bases of Social Cognitive Processing in Healthy Individuals","A Non-interventional Functional Magnetic Resonance Imaging (fMRI) and ElectroEncephalography (EEG) Study on the Neural Bases of Social Cognitive Processing in Healthy Individuals","Inclusion Criteria:\n\n* Healthy participants, as determined by screening assessments and principal investigator judgment\n* The participant must be able to comply with study requirements as judged by the principal investigator\n\nExclusion Criteria:\n\n* Any history of alcohol and\u002For drug abuse, addiction or suspicion of regular consumption of drugs of abuse\n* Use of any psychoactive medication, or medications known to have effect on central nervous system (CNS) or blood flow\n* Any contraindications for magnetic resonance imaging (MRI) scans or any brain\u002Fhead abnormalities restricting MRI eligibility",{"count":159,"type":22},"The goal of this single center non-interventional fMRI and EEG study is to assess the neural bases of social cognitive processing in healthy individuals, and whether\u002Fhow their responsiveness is modulated by ageing. The main questions it aims to answer are:\n\n* are there specific brain regions where individual differences in social cognitive performance reflect well-established metrics of social cogntion such as empathy and mentalizing?\n* is there a relationship, at the behavioral and neural levels, between ageing-related changes in social cognitive performance and empathy\u002Fmentalizing?\n\nHealthy participants will be recruited for:\n\n* a behavioral assessment including multiple tests of social cognition focused on empathy and mentalizing;\n* for half participants: a fMRI session to collect data concerning a) brain activity associated with action observation and social cognitive processing, b) brain structural morphometriy (grey-matter volume\u002Fdensity), and c) brain structural connectivity (diffusion weighted imaging)\n* for half participants: a EEG session to collect data concerning brain responsiveness to social cognitive processing with higher temporal resolution than that afforded by fMRI.\n\nResults will provide an useful baseline for investigating alterations of social cognitive processing, and of their neural bases, in pathological conditions.",[162],[186,187,188,189,190],"social cognitive processing","empathy","mentalizing","fMRI","ageing",{"date":169,"type":35},{"date":193,"type":35},"2018-07-14",{"date":173,"type":22},{"name":41,"class":42},{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":157,"enrollmentInfo":202,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":43},"100498790","neural-bases-of-decision-making-in-healthy-individuals-100498790","NCT05774834","Neural Bases of Decision-making in Healthy Individuals","A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study on the Neural Bases of Decision-making in Healthy Individuals",{"count":203,"type":22},150,"The goal of this single center non-interventional fMRI study is to assess the neural bases of decision-making and executive functioning in healthy individuals,and whether\u002Fhow their responsiveness is modulated by ageing. The main questions it aims to answer are:\n\n1. are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making?\n2. Is there a relationship, at the behavioral and neural levels, between ageing-related changes in executive functioning and decision-making?\n\nHealthy participants will be recruited for\n\n1. a behavioral assessment including multiple tests of decision-making and executive functioning\u002Finhibitory control;\n2. a fMRI session to collect data concerning a) brain activity associated with decision-making and executive functioning, b) brain structural morphometriy (grey-matter volume\u002Fdensity), and c) brain structural connectivity (diffusion weighted imaging).\n\nResults will provide an useful baseline for investigating alterations of decision-making and executive functioning, and of their neural bases, in pathological conditions.",[162],[164,207,189,190],"executive functioning",{"date":169,"type":35},{"date":210,"type":35},"2018-11-10",{"date":173,"type":22},{"name":41,"class":42},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":43},"100633034","awareness-of-risk-factors-and-perception-of-cardiovascular-risk-in-secondary-prevention-among-women-and-men-100633034","NCT07521436","Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention Among Women and Men","Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention: A Comparison Between Women and Men","CORPS-CV","Inclusion criteria:\n\n* Male or female participants aged ≥ 18 years at the time of signing informed consent.\n* Individuals with atherosclerotic cardiovascular disease (ASCVD), defined as at least one of the following:\n* Ischemic heart disease (e.g., documented myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or ≥50% coronary stenosis in at least two coronary territories);\n* Cerebrovascular disease (e.g., documented ischemic stroke; transient ischemic attack, primary intracerebral hemorrhage, and subarachnoid hemorrhage are not qualifying conditions; carotid stenting or endarterectomy);\n* Peripheral arterial disease (e.g., peripheral arterial intervention, stent placement, surgical revascularization, lower limb amputation due to obstructive disease, or intermittent claudication with ABI \\\u003C0.90 in the past 12 months);\n* Atherosclerotic aortic disease (e.g., abdominal or descending thoracic aortic aneurysm).\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Inability or difficulty in completing the questionnaires in Italian and\u002For functional illiteracy.\n* History of or current severe psychiatric disorder that could compromise the reliability of questionnaire responses.\n* Refusal or withdrawal of informed consent.",{"count":159,"type":22},"The present research project aims to assess, through a survey, awareness of general and sex\u002Fgender-specific cardiovascular risk factors, as well as the perception of the risk of developing further cardiovascular diseases, among patients in secondary prevention.",[224],"Cardiovascular Disease","2026-04-28",{"date":227,"type":35},"2026-04-29",{"date":229,"type":35},"2026-04-10",{"date":231,"type":22},"2027-01-10",{"name":41,"class":42},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":43},"100396480","role-of-asthma-school-in-disease-management-100396480","NCT04442646","Role of \"Asthma School\" in Disease Management","Inclusion Criteria:\n\n* Asthma diagnosis according to GINA \u002F ATS guidelines.\n* Age ≥18 years\n\nExclusion Criteria:\n\n•cognitive impairment","85 Years",{"count":241,"type":22},92,[25],"According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and\u002For cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (\\~ 10% of total prevalence of asthma and at high risk of exacerbations and\u002For hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy.The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals",[245],"Asthma","2026-04-23",{"date":248,"type":35},"2026-04-24",{"date":250,"type":35},"2019-04-01",{"date":252,"type":22},"2026-12-15",{"name":41,"class":42},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":86,"minAge":51,"maxAge":239,"enrollmentInfo":262,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":43},"100601533","intraoperative-margin-assessment-in-breast-cancer-with-hsi-raman-100601533","NCT07111728","Intraoperative Margin Assessment in Breast Cancer With HSI-Raman","Multimodal Hyperspectral Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins","Spectra-BREAST","Inclusion Criteria:\n\nHistologically confirmed diagnosis of ductal carcinoma in situ (B5a) or invasive breast carcinoma (B5b) on pre-operative core needle biopsy\n\nScheduled to undergo breast-conserving surgery (lumpectomy)\n\nAble and willing to provide written informed consent\n\nExclusion Criteria:\n\nPre-operative histologic or cytologic diagnosis of a benign breast lesion (B2\u002FC2)\n\nInitial diagnosis of advanced (stage III\u002FIV) or metastatic breast carcinoma, or indication for neoadjuvant chemotherapy\n\nNeurocognitive disorders that would impair comprehension of the study procedures or consent process\n\nConcurrent pregnancy or breastfeeding",{"count":263,"type":22},104,"Breast-conserving surgery (lumpectomy) aims to remove cancer while preserving healthy tissue, but up to 20% of patients require a second operation because cancer cells remain at the edge (margin) of the removed tissue. The Spectra-BREAST study evaluates a new optical device that combines hyperspectral imaging (HIS) and Raman spectroscopy (RS) with artificial-intelligence analysis to quickly assess the entire surface of excised breast specimens during surgery. By flagging areas at risk of positive margins in real time, the device may help surgeons remove any remaining cancer in a single procedure.\n\nIn this prospective, single-arm diagnostic study, surgeons will use the Spectra-BREAST system on freshly resected breast tissue from up to 99 women undergoing lumpectomy for invasive carcinoma or ductal carcinoma in situ. First, the device's cancer-detection algorithms will be trained on 74 specimens with known pathology. Then, in a separate group of patients, the fully integrated device will be tested on all six faces of each lumpectomy specimen and its predictions will be compared against the gold-standard histopathology margin assessment. Key measures include the sensitivity and specificity of the device's margin predictions, the time needed to generate results, and the device's usability in a clinical setting.",[93],[267,93,268,269,270,271],"Breast-conserving surgery","Surgical margin assessment","Hyperspectral imaging","Raman spectroscopy","Optical spectroscopy","2026-04-22",{"date":246,"type":35},{"date":275,"type":35},"2025-10-06",{"date":277,"type":22},"2028-12",{"name":41,"class":42},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":85,"sex":18,"minAge":287,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":123},"100629733","cognitive-evaluation-of-patients-with-eating-disorders-100629733","NCT07478510","Cognitive Evaluation of Patients With Eating Disorders","Neuro-cognitive Profiles of Patients With Nutritional and Eating Disorders","DNA_ARFID","Inclusion Criteria:\n\n* Diagnosis of a Feeding and Eating Disorder (ARFID, anorexia nervosa, or bulimia nervosa);\n* Patients of both sexes;\n* Age between 14 and 65 years;\n* Confirmed diagnosis of a Feeding and Eating Disorder;\n* Body Mass Index (BMI) \\\u003C 25;\n* Signed informed consent form for participation in the study.\n\nExclusion Criteria:\n\n* Diagnosis of Bipolar Disorder according to DSM-5-TR criteria;\n* Diagnosis of a Schizophrenia Spectrum Disorder according to DSM-5-TR criteria;\n* Intellectual disability according to DSM-5-TR criteria;\n* Presence of brain tumors;\n* History of seizure events;\n* Presence of other moderate to severe neurological disorders;\n* Lack of the patient's consent to voluntary participation in the study;\n* Lack of parental or legal guardian consent for participation of a minor in the study.","14 Years","65 Years",{"count":290,"type":22},84,"The goal of this cross - sectional observational study is to improve understanding of the psychological and cognitive characteristics of Feeding and Eating Disorders (FEDs), a group of conditions that represent a growing public health concern due to their significant impact on physical health, emotional well-being, and everyday functioning. Within this broader diagnostic category, particular attention is given to Avoidant\u002FRestrictive Food Intake Disorder (ARFID), a diagnosis introduced in the DSM-5 and still relatively underexplored compared to other feeding and eating disorders.\n\nDespite its clinical relevance, ARFID remains less well understood in terms of its underlying cognitive and psychological mechanisms. Individuals with ARFID often experience severe food avoidance or restriction that is not driven by weight or shape concerns, but rather by sensory sensitivities, fear of negative consequences of eating, or a lack of interest in food. For this reason, investigating ARFID can offer important insights into the diversity of mechanisms involved in feeding and eating disorders as a whole.\n\nThe study has two main objectives. The first objective is to examine the cognitive profile of individuals with ARFID, with a specific focus on autistic traits and cognitive flexibility, as previous research suggests potential overlaps between ARFID and neurodevelopmental conditions such as Autism Spectrum Disorders. Cognitive flexibility refers to the ability to adapt thoughts and behaviors in response to changing situations, and reduced flexibility may contribute to rigid eating patterns and food avoidance.\n\nThe second objective is to explore the role of body representation (how individuals perceive and mentally represent their own body) and inhibitory control (the ability to regulate or suppress automatic responses) in shaping the cognitive and behavioral features of ARFID and other feeding and eating disorders. These processes may help distinguish ARFID from other diagnoses and clarify shared and disorder-specific mechanisms across the FED spectrum.\n\nThe study involves adult participants of all genders, including individuals diagnosed with ARFID, anorexia nervosa, and bulimia nervosa, as well as healthy control participants without a history of feeding or eating disorders. This design allows meaningful comparisons between different diagnostic groups and with the general population.\n\nThe main questions the study aims to answer are:\n\nDo individuals with ARFID show a distinct cognitive profile, particularly in terms of autistic traits and cognitive flexibility, compared to individuals with other feeding and eating disorders and healthy controls?\n\nHow do body representation and inhibitory control contribute to differences in eating-related behaviors across feeding and eating disorders?\n\nAre there differences in brain activity associated with implicit, automatic attitudes toward food in individuals with feeding and eating disorders compared to healthy individuals?\n\nWhere comparison groups are included, researchers will compare participants with ARFID, anorexia nervosa, bulimia nervosa, and healthy controls to examine differences in cognitive functioning, psychological characteristics, and neural responses related to food processing.\n\nParticipants will be asked to take part in a series of non-invasive and well-established research activities, designed to be accessible and safe. These include:\n\nCompleting self-report questionnaires assessing autistic traits, body image perception, and general psychological well-being;\n\nPerforming computer-based tasks that assess cognitive flexibility and decision-making;\n\nCompleting behavioral tasks designed to measure inhibitory control and automatic associations with food-related stimuli;",[293,294,295,296,297,298],"ARFID","Anorexia Nervosa","Bulimia Nervosa","Cognitive Flexibility","Implicit Association Test","Executive Functions","2026-04-15",{"date":301,"type":35},"2026-04-16",{"date":303,"type":35},"2024-11-26",{"date":305,"type":22},"2028-03-31",{"name":41,"class":42},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":43},"100510365","phase-2-pembrolizumab-in-locally-advanced-sinonasal-carcinoma-100510365","NCT05925491","Pembrolizumab in Locally Advanced Sinonasal Carcinoma","Neoadjuvant Pembrolizumab Plus Chemotherapy in Locally Advanced Sinonasal Carcinoma","NeoPeSino","Inclusion Criteria:\n\n1. Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies.\n2. Have locally advanced disease defined as stage III of IV a-b according to American Joint Committee on Cancer (AJCC) cancer staging system VIII edition.\n3. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.\n4. Be ≥ 18 years of age on day of signing informed consent.\n5. Have measurable disease based on RECIST 1.1 as determined by the site.\n6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n7. Demonstrate adequate organ function.\n8. A male participant must agree to use contraception during the treatment period and for at least 180 days after last dose, corresponding to time needed to eliminate any study treatments plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity. He must refrain from donating sperm during this period, too.\n9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   o Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees use contraception during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatments plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.\n10. Have provided tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).\n2. 2\\. Have metastatic disease defined as stage IV c according to AJCC cancer staging system VIII edition.\n3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n5. Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.\n6. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.\n7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n8. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n9. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ (eg, breast carcinoma or cervical cancer in situ that have undergone potentially curative therapy are not excluded\n10. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n11. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n12. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n13. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n14. Has an active infection requiring systemic therapy.\n15. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n16. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA qualitative is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n17. Has a known history of active TB (Bacillus Tuberculosis).\n18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n21. Has had an allogenic tissue\u002Fsolid organ transplant",{"count":316,"type":22},28,[318],"PHASE2","This study will test the Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced sinonasal undifferentiated carcinoma (SNUC).\n\nActivity of neoadjuvant chemotherapy in locally advanced SNUC has been already demonstrated; the primary hypothesis is that the addition of pembrolizumab as neoadjuvant and adjuvant agent might confirm the results obtained with a combined treatment strategy including chemotherapy, decreasing the burden of treatment-related side effects.",[321],"Sinonasal Undifferentiated Carcinoma",[321,323,324,325,326,327,328],"SNUC","neoadjuvant immunotherapy","neoadjuvant treatment","locally advanced","pembrolizumab","neoadjuvant",{"date":301,"type":35},{"date":331,"type":35},"2024-12-24",{"date":333,"type":22},"2027-12",{"name":41,"class":42},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":43},"100504737","phase-2-pembrolizumab-in-high-risk-thyroid-cancer-100504737","NCT05852223","Pembrolizumab in High-risk Thyroid Cancer","Neoadjuvant Pembrolizumab in High-risk Thyroid Cancers","NePenThe","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of differentiated thyroid carcinoma candidate to surgery not previously treated will be enrolled in this study.\n2. Patients with a risk \\> 20% for persistent\u002Frecurrent disease: primary tumor \\> 4 cm; multifocal papillary microcarcinoma with extra tumor extension (ETE) and known BRAF V600E mutation; clinical N1; gross ETE (macroscopic invasion of perithyroidal soft tissues); extranodal extension; expected incomplete tumour resection.\n3. Poorly differentiated carcinoma; Hurtle cell carcinoma.\n4. Patients with distant metastasis at diagnosis.\n5. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n6. Have measurable disease based on RECIST 1.1.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation\u002Frandomization.\n8. Have adequate organ function as defined in the following table (Table 2) Specimens must be collected within 10 days prior to the start of study treatment.\n9. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months (e.g. 5 terminal half-lives for pembrolizumab) after the last dose of study treatment and refrain from donating sperm during this period.\n10. female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP).\n    2. a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 months after the last dose of study treatment\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.\n4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ (eg, breast carcinoma or cervical cancer in situ that have undergone potentially curative therapy are not excluded).\n9. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n13. Has an active infection requiring systemic therapy.\n14. History of Human Immunodeficiency Virus (HIV) infection.\n15. History of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a known history of active TB (Bacillus Tuberculosis).\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n20. Has had an allogenic tissue\u002Fsolid organ transplant",{"count":7,"type":22},[318],"This window of opportunity trial is studying a checkpoint inhibitor agent to treat differentiated thyroid cancer in a neoadjuvant setting. A checkpoint inhibitor is a compound aimed at restoring tumor immunosurveillance. The name of this agent is pembrolizumab.",[347],"Differentiated Thyroid Cancer",[349,325,327],"differentiated thyroid carcinoma",{"date":351,"type":35},"2026-04-20",{"date":353,"type":35},"2024-12-20",{"date":355,"type":22},"2026-11",{"name":41,"class":42},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100496728","definition-of-autonomic-nervous-system-involvement-in-patients-with-multiple-sclerosis-100496728","NCT05748015","Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis","Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* diagnosis of relapsing-remitting and primary progressive multiple sclerosis.\n\nExclusion Criteria:\n\n* other forms of multiple sclerosis,\n* known other neurological disorders\n* assumption of potentially neurotoxic substances or drugs.",{"count":365,"type":22},60,[25],"The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis.\n\nThe main questions it aims to answer are:\n\n* Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ?\n* Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ?\n* How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ?\n* Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ?\n\nParticipants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy.\n\nResearchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.",[30],[370,371,372,373],"autonomic nervous system","sensory nervous system","rehabilitation","skin biopsy","2026-04-14",{"date":376,"type":35},"2026-04-17",{"date":378,"type":35},"2021-03-04",{"date":380,"type":22},"2027-05-30",{"name":41,"class":42},2,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":85,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":23,"phases":391,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":382},"100496722","longitudinal-assessment-of-autonomic-and-sensory-nervous-system-in-als-100496722","NCT05747937","Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS","Inclusion Criteria:\n\n* ALS patients will be recruited within 18 months from the motor symptoms onset\n\nExclusion Criteria:\n\n* glucose intolerance or conditions potentially affecting the peripheral nervous system",{"count":390,"type":22},100,[25],"The goal of this interventional non-pharmacological study is to evaluate, using a multimodal approach, the progression of autonomic and sensory involvement in in amyotrophic lateral sclerosis (ALS) patients enrolled within 18 months from motor onset and its relationship with the progression of overall clinical disability.\n\nThe main questions it aims to answer are:\n\n* Is autonomic dysfunction at diagnosis associated with disease progression and survival in patients with Amyotrophic Lateral Sclerosis ?\n* Can we identify in the skin biomarkers to be used as reliable measures of disease progression and to apply in future clinical trials for patient stratification and to assess response to drug treatment ? Participants at time 0 will receive a full clinical and instrumental examination and a blood sample testing to check inclusion and exclusion criteria, genetic screening for the most common genes associated with ALS (SOD1, FUS, TARDBP and c9orf72), questionnaires about clinical characteristics, quality of life, pain and a multidomain battery of neuropsychological tests, multimodal assessment of the autonomic nervous system including skin biopsy for morphological study. At follow-up we'll perform clinical scales and skin biopsy.\n\nResearchers will compare results from ALS patients with data obtained from a population of age and sex matched healthy subjects.",[394],"Amyotrophic Lateral Sclerosis",[396,373,397,398],"Autonomic nervous system","biomarkers","cutaneous sensory an autonomic innervation",{"date":376,"type":35},{"date":401,"type":35},"2021-05-15",{"date":403,"type":22},"2026-12-30",{"name":41,"class":42},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":424,"locationsCount":425},"100496729","pain-and-autonomic-symptoms-in-parkinsons-disease-and-atypical-parkinsonisms-100496729","NCT05748028","Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms","Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms: Identification of Predictive Patterns of Rehabilitation Outcome and Evaluation of the Impact on Quality of Life","Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's Disease or Multiple System Atrophy according to current international criteria (Gilman S et al, 2008; Postuma RB et al. 2015).\n* Mini-Mental State Examination score at least 10\n\nExclusion Criteria:\n\n* vascular or pharmacological parkinsonism\n* diabetes mellitus\n* hepatic or renal dysmetabolism,\n* hypothyroidism or hyperthyroidism\n* assumption of potentially neurotoxic drugs",{"count":413,"type":22},280,"The goal of this observational study is to learn about the impact of the different types of pain and of the domains involved in the autonomic disorders of inpatients and outpatients diagnosed with Parkinson disease (PD) and multiple system atrophy (MSA) admitted to Istituti Clinici Scientifici Maugeri Centers.\n\nThe main aims are:\n\nEvaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms (MSA) Evaluate the effect of rehabilitation on pain and autonomic symptoms Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms (MSA) Assess the impact of pain and autonomic symptoms on quality of life. Participants will perform neurological examination, rehabilitation program and clinical scales.\n\nResearchers will compare the two groups of patients (PD and MSA) and the effect of the rehabilitation on pain, autonomic symptoms and quality of life.",[28,416],"Multiple System Atrophy",[418,419,372],"pain","autonomic symptoms",{"date":376,"type":35},{"date":422,"type":35},"2019-06-15",{"date":403,"type":22},{"name":41,"class":42},9,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"100586853","prismatic-adaptation-in-cognitive-rehabilitation-100586853","NCT06920784","Prismatic Adaptation in Cognitive Rehabilitation","Prismatic Adaptation for Cognitive Rehabiliation in Traumatic Brain Injury Patients","PACoR-TBI","Inclusion Criteria:\n\n* Age \\>18 years\n* Traumatic brain injury (TBI)\n* Rancho Level of Cognitive Functioning (LCF) for TBI patients \\> 4\n* Admission within 90 days from the onset\n\nExclusion Criteria:\n\n* Unilateral Spatial Neglect\n* Aphasia\n* Severe vigilance deficits\n* Severe verbal comprehension deficits\n* Motor deficits of both hands\n* Previous neurological stroke\n* Previous neurological disease\n* Previous psychiatric disease\n* Use of alcohol or drugs\n* Severe visual deficits\n* Premorbid dementia",{"count":435,"type":22},50,[25],"The study aims to evaluate the effects of prismatic adaptation and then of a novel rehabilitation protocol that combines PA and Serious Games on cognitive and behavioural deficits in patients with traumatic brain injury , compared to a rehabilitation training without prismatic adaptation.\n\nMoreover, this study aims to assess the impact of this rehabilitation protocol on functional cognitive outcomes.\n\nHypothesis Hypothesis 1 (H1): It is postulated that the utilization of Prismatic Adaptation Treatment (PAT) has a positive impact on the enhancement of cognitive outcome among patients suffering from TBI\n\nHypothesis 2 (H2): It is hypothesized that there will be discernible alterations in resting-state Electroencephalography (EEG) patterns between the initial assessment point (T0) and the subsequent measurement during the course of treatment (T1) in individuals diagnosed with TBI\n\nAssessment times of outcome measures will be conducted before the experimental treatment (T0) and after the 10 rehabilitation sessions (T1).\n\nPatients will be randomized into two groups:\n\n1. Experimental group: Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session.\n2. Control group: patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.\n\nBoth groups will receive also the standard cognitive rehabilitation for the detected deficits, using paper and pen materials.\n\nEach rehabiliation session will last aproximately 1 hour for 5 days a week for 2 weeks.",[439],"Traumatic Brain Injury",[439,441,442,443],"prismatic adaptation","cognitive rehabilitation","serious games","2026-03-24",{"date":446,"type":35},"2026-03-25",{"date":448,"type":35},"2024-11-07",{"date":450,"type":22},"2026-12-31",{"name":41,"class":42},5,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":85,"sex":18,"minAge":157,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},"100629680","a-muscle-brain-interplay-study-in-neurological-disorders-100629680","NCT07477821","A Muscle-brain Interplay Study in Neurological Disorders","A Translational Approach to Characterize the Muscle-brain Interplay in Neurological Non-communicable Diseases. The M-Brain Project","M-Brain","Inclusion Criteria:\n\nfor Good aging group:\n\n* Subjects aged 60 years or older\n* Frailty Index below the pathological cut-off (\\>0.25)\n* Absence of general cognitive impairment (MMSE \\> 24 points)\n* Absence of a diagnosis of sarcopenia\n\nfor Bad aging group:\n\n* Patients aged over 60 years\n* Exclusive presence of one of the following diagnoses:\n\n  1. Definite, probable, or probable laboratory-supported Amyotrophic Lateral Sclerosis (ALS), either sporadic or familial, according to the revised El Escorial Criteria for ALS diagnosis.\n  2. Parkinson's disease (PD) according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., Mov Disord., 2015 Oct; 30(12): 1591-1601).\n  3. Alzheimer's disease (AD), possible or probable, according to international diagnostic guidelines.\n  4. Diagnosis of severe acquired brain injury according to the Italian Guidelines for the Care of Patients in Vegetative State and Minimally Conscious State 2011 (approved by the Unified Conference on May 5, 2011 - Ministry of Health, Italy), with the presence of Sarcopenia.\n  5. Presence of Mild Cognitive Impairment (MCI), subjective memory complaint, or deficit in a single cognitive domain, according to international criteria and in absence of established neurological diseases and sarcopenia.\n  6. Presence of Sarcopenia as defined by the EWGSOP2 Sarcopenia Consensus, in the absence of cognitive deficits and established neurological diseases.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Presence of severe and\u002For acute comorbidities (e.g., uncontrolled diabetes, heart failure, or a diagnosis of oncological disease), as determined by the research team.\n* Evidence of other previous neurological or psychiatric disorders involving the cognitive domain.\n* Uncontrolled or complicated systemic diseases or history of traumatic brain injury.\n* For subjects with Alzheimer's disease (AD), Parkinson's disease (PD), and Amyotrophic Lateral Sclerosis (ALS), individuals with a history of epilepsy will also be excluded.",{"count":203,"type":22},"Despite the improvements in life expectancy, neurodegenerative diseases (NDGs) have become the most dreaded disorders of older people. Aged brains show characteristic changes that are linked to neurodegeneration raising the question of whether these hallmarks represent the harbingers of NDGs. Lifestyle factors including, in particular physical exercise, have given particular attention to factors associated to movement issue as ones of the major factors in modulating the risk of developing NDGs, emphasizing the interest in the muscle-brain axis. Indeed, one of the crucial systems severely affected in several neuromuscular diseases is the loss of effective connection between muscle and nerve, and the neuromuscular junction (NMJ) represents the critical region at the level of which the two entities communicate.\n\nEven if controversy exists on whether pathological events beginning at the NMJ precede or follow loss of motor units, some recent data highlight as NGDs (e.g. Amyotrophic Lateral Sclerosis, Alzheimer's Disease, and Parkinson's Disease) and Aging share some common pathologic features such as the loss of fast-twich fiber, a decreased number of synaptic vesicles and sarcopenia giving evidence supports the notion that NMJ dismantlement can occur independently from motor neuron degeneration and may represent an early pathogenic signature of muscle-nerve communication defects.\n\nThe M-Brain project is an observational, analytical case-control study that will apply a new approach to interpret data underling the NMJ dismantlement in NDGs patients by comparing their clinical and biological information with data obtained from people who have had a so called \"good aging\" and those who have had a \"bad aging\".\n\nThe study will collect data useful to identify potential predisposing or risk factors for the subsequent development of a NDGs or able to predict the phenotype traiectories of selected pathologies with differerent movement levels. The combination of a muscular and neurological phenotyping and a biological characterization combining biomarkers, miRNA and extracellular vesicle (EV) assessments will allow to better identify the determinants of muscle-brain cross-talk that can then be used as potential indicators for the definition of critical morphological and functional components involved in aging and some NGDs. The project then will aim to identify phenotyope trajectories of patients giving particular attention to the brain-muscle axis and movement issues in order to provide information useful for future clinical strategies able to minimaze risk\u002Fpredisponent Factors.",[464,465],"Neurological Disorders","Health Adult Subjects",[467,468,469,470],"muscle","brain","aging","Neuromuscolar","2026-03-12",{"date":473,"type":35},"2026-03-17",{"date":475,"type":35},"2025-07-24",{"date":477,"type":22},"2027-02-28",{"name":41,"class":42},4,{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":489,"conditions":490,"keywords":494,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":505,"locationsCount":43},"100627403","real-life-ecological-momentary-assessment-of-lived-burden-in-hereditary-angioedema-100627403","NCT07448181","Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema","REAL-HAE","Inclusion Criteria:\n\n* Confirmed diagnosis of Type 1 or Type 2 hereditary angioedema;\n* Age ≥ 18 years;\n* Ability to understand instructions and provide informed consent;\n* Ownership and proficiency in using a personal smartphone compatible with the m-Path application (Android or iOS);\n* Willingness to participate in the study for the entire duration of the observation period (8 weeks).\n\nExclusion Criteria:\n\n* Diagnosis of acquired angioedema or other forms of angioedema unrelated to C1-inhibitor deficiency;\n* Severe cognitive or psychiatric disorders that compromise the ability to complete the questionnaires independently;\n* Age \\\u003C 18 years;",{"count":488,"type":22},30,"The aim of this study is to conduct an in-depth analysis of the Burden of Disease (BoD) perceived by patients with Hereditary Angioedema (HAE), through daily prospective observations based on Ecological Momentary Assessment (EMA) via digital surveys and standardised questionnaires.\n\nParticipants will answer online survey questions about their perceived burden of disease for 8 consecutive weeks. The main hypothesis is that daily prospective observation (EMA) will reveal a higher and more fluctuating burden of disease compared to traditional retrospective scales, providing a more accurate representation of the impact of HAE on patients' daily lives.",[491,492,493],"Hereditary Angioedema With C1 Esterase Inhibitor Deficiency","Hereditary Angioedema - Type 1","Hereditary Angioedema - Type 2",[495,496,497,498],"Hereditary Angioedema","Burden of disease","Ecological Momentary Assessment","Quality of Life","2026-03-03",{"date":501,"type":35},"2026-03-04",{"date":503,"type":35},"2026-02-23",{"date":477,"type":22},{"name":41,"class":42},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":19,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":522,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":531,"locationsCount":532},"100579279","high-tech-rehabilitation-pathway-for-acute-adult-neuromuscular-diseases---fit4medrob-acute-mnd-project-100579279","NCT06822231","High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project","Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases (Fit4MedRob-Acute MND Project)","Fit4MR-AcMND","Inclusion Criteria:\n\n* Adults with ages ranging from 18 to 80 years.\n* Patients with a confirmed diagnosis of acute\u002Fsubacute neuromuscular diseases (e.g. GBS, CIM, CIP)\n* Time of onset ranging from 15 to 30 days\n* Patients with lower limb strength (Medical Research Council or MRC) \\>=2 in at least two of the flexor and extensor muscles of the following joints: hip, knee and ankle\n* Possibility of obtaining informed consent\n\nExclusion Criteria:\n\n* Patients with unstable medical conditions (e.g. severe cardiovascular diseases, such as \"New York Heart Association\" - NYHA=4, respiratory distress not compensated by ventilation) that could interfere, in the clinician's judgment, with their ability to safely participate in the study or to perform the assessments related to the protocol.\n* Patients currently participating in other clinical trials that could interfere with this study.\n* Pregnant or breastfeeding women.",{"count":515,"type":22},124,[25],"The goal of this study is determine if a high-tech rehabilitation circuit is more effective than usual rehabilitation methods in improving functional outcome, particularly balance control, for patients with acute neuromuscolar diseases. The main question it aims to answer is:\n\nAre high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, more effective than traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with acute neuromuscular diseases (NMDs)? Researchers will compare a robotic treatment group, that consists in an high-tech rehabilitation, with a control group, that will receive the traditional rehabilitative treatment.",[519,520,521],"Critical Illness Myopathy","Guillain Barré Syndrome","Critical Illness Polyneuromyopathy (CIPNM)",[523,524,525],"high-tech rehabilitation","acute neuromuscular diseases","robotic platform","2026-03-02",{"date":499,"type":35},{"date":529,"type":35},"2025-05-28",{"date":355,"type":22},{"name":41,"class":42},8,{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":543,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":479},"100626223","personalized-high-definition-tdcs-protocols-for-chronic-pain-treatment-100626223","NCT07432841","Personalized High-Definition tDCS Protocols for Chronic Pain Treatment","Innovative Neuromodulation Treatments for Chronic Pain: Assessing and Predicting the Effects of Personalized High-Definition Protocols for Transcranial Direct Current Stimulation (HD-tDCS)","Inclusion Criteria:\n\n* Diagnosis of chronic pain lasting for at least six months\n* Pain scores equal to or greater than 4 on Numerical Rating Scale (NRS) 0-10 on most days for the last 3 months\n* Pain unresponsive to conservative treatment such as pharmacological therapy and physiotherapy, and unresponsive to minimally invasive treatments such as peripheral nerve blocks or neuromodulation or steroid epidural injections, when appropriate\n* Age between 18 and 75\n* Stable pain levels and willingness not to modify any ongoing pain management therapies during the study period (1 week)\n\nExclusion Criteria:\n\n* History of seizure disorders\n* Active malignancy\n* Implanted medical devices and\u002For metallic implants in the head or neck region\n* Cranial abnormalities\n* Severe cognitive impairment (Montreal Cognitive Assessment (MoCA)\\\u003C15.5)\n* Neurological or psychiatric conditions, or significant comorbidities, that may interfere with tDCS\n* Pregnancy\n* Incompatibility with MRI and\u002For TMS","75 Years",{"count":542,"type":22},144,[25],"This study aims to examine the use of neurostimulation as a potential adjuvant treatment for chronic pain. Among neurostimulation techniques, transcranial direct current stimulation (tDCS) represents a promising, yet not fully exploited, option. Recent methodological advances allow for increased intensity and focality of its effects through personalized high-definition tDCS protocols (HD-tDCS), enabling targeted stimulation of specific brain regions involved in pain and analgesia processing, such as the dorsal anterior cingulate cortex (dACC).\n\nBased on this evidence, the specific objective of the study is to investigate the effect of an innovative HD-tDCS protocol (personalized using structural and functional magnetic resonance imaging (fMRI)), with stimulation applied to the dACC. The experimental design involves randomly assigning 144 patients with chronic pain to three groups, who will undergo an intensive treatment (five sessions in the same week) with cathodal, anodal, or sham (placebo) HD-tDCS.\n\nPatient recruitment and treatment will be equally distributed between sites located in Lombardy (IRCCS Maugeri-Pavia; University of Milano-Bicocca; n=72) and Palermo (IRCCS ISMETT-Palermo; University of Palermo; n=72).\n\nThe effects of neurostimulation will be: a) evaluated using self-reported measures of physical and social functioning (Brief Pain Inventory, BPI; primary outcome) before and after treatment, and at follow-up assessments at 3 weeks and 3 months; b) interpreted in relation to underlying neurophysiological changes, as revealed by the high spatial and temporal resolution provided, respectively, by fMR) and by transcranial magnetic stimulation-evoked potentials combined with electroencephalographic recording (TMS-EEG) before and after treatment (secondary outcome).",[546],"Chronic Pain",[548,549,550,551,552,553,554,555,556,557,558,559,560],"Chronic pain","High-Definition transcranial Direct Current Stimulation","HD-tDCS","Magnetic Resonance Imaging","MRI","functional MRI","structural MRI","Transcranial Magnetic Stimulation","Electroencephalography","EEG","TMS-EEG","Randomized Controlled Trial","RCT","2026-02-24",{"date":563,"type":35},"2026-02-25",{"date":565,"type":35},"2025-04-03",{"date":567,"type":22},"2027-05-31",{"name":41,"class":42},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":85,"sex":18,"minAge":576,"maxAge":19,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":43},"100579353","the-impact-of-self-processing-on-mental-time-travel-100579353","NCT06823193","The Impact of Self-processing on Mental Time Travel","How Self-processing Affects Mental Time Travel: a Neuropsychological Study","Inclusion Criteria:\n\n* the absence of general cognitive impairment, assessed by neuropsychological testing\n* the presence of a focal brain lesion will be adopted as an inclusion criterion for patients.\n\nExclusion Criteria:\n\n* psychiatric disorders\n* multiple brain lesions","40 Years",{"count":578,"type":22},66,[25],"Mental time travel (MTT) refers to the ability to project oneself backward into the past or forward into the future to envision past and future events. This study examines the role of the ventromedial prefrontal cortex (vmPFC) in orienting toward past and future events during MTT.",[582],"Brain Injuries, Focal",[584,585,586],"Mental Time Travel","Projection","Self\u002Fother distinction","2026-02-20",{"date":503,"type":35},{"date":590,"type":35},"2024-12-01",{"date":592,"type":22},"2026-09-30",{"name":41,"class":42},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":43},"100552343","clinical-and-psychological-adjustment-of-patients-with-lla-a-multidisciplinary-rehabilitative-intervention-project-100552343","NCT06471855","Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project","Clinical and Psychological Adjustment of Patients With Lower Limb Amputation: a Multidisciplinary Rehabilitative Intervention Project (AMP_ADinRehab Study)","AMPADinRehab","Inclusion Criteria:\n\n* Risk of amputation or Lower limb amputation or prothesis use for vascular disease and diabetes type 2\n\nExclusion Criteria:\n\n* more than 80 years older\n* severe clinical condition (ie, chronic heart failure \\[New York Heart Association Classification-IV - NYHA-IV\\], ischemic heart disease \\[Canadian Cardiovascular Society Classification-IV - CCS-IV\\], neoplastic disease, acute respiratory disease);\n* non-Italian education\n* severe visual-perceptive deficits\n* severe cognitive impairment (MMSE ≤ 26 Foderaro et al, 2022);\n* severe mental health condition or psychiatric disorder compromising participation in the study;\n* absence or withdrawal of the informed consent to participate.",{"count":603,"type":22},70,[25],"Most of the limb amputation related to vascular disease is often secondary to a diagnosis of type 2 diabetes mellitus. The amputation involves significant motor, psychological, and social challenges for patients, with a major effect on their psycho-physical health. The psychological processes that characterize this clinical population are still poorly investigated. Adopting a biopsychosocial approach, the present randomized prospective quali-quantitative study protocol aims to evaluate the behavioural and psychological adaptation at various stages of the disease: risk of amputation, lower limb amputation, and prosthesis use. In the last phase, patients with prosthesis will receive traditional rehabilitation treatment and technology-based rehabilitation (experimental) or not (active comparator) with randomized controlled enrolment. The evaluation will be based on a semi-structured interview, specific to the disease stage and constructed using the Three Factor Model, and rating scales. Patient's medical history, functional status (ie, motor functionality, autonomy in BIM and FIM, risk of falls, subjective perceived pain), and psychological aspects (ie, emotional impact, HRQoL, anxiety and depression symptoms, personality traits, acceptance, adherence, body image, the experience of the prosthesis and technology-based rehabilitation, expectations for the future) will be investigated. The audio-recorded and transcribed interviews will be analyzed using the Interpretive Description approach.",[607,608],"Lower Limb Amputation","Prosthesis User",[610,611,612,613,614,615,616],"Amputee","Multidisciplinary rehabilitation","HRQoL","Psychological adaptation","Usability","HT\u002Frobotic rehabilitation","Psychoeducation",{"date":503,"type":35},{"date":619,"type":35},"2023-06-01",{"date":621,"type":22},"2027-06",{"name":41,"class":42},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":18,"minAge":576,"maxAge":239,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":76},"100494638","rehabilitation-training-with-music-support--exercise-tolerance-in-copd-and-crf-patients-100494638","NCT05720780","Rehabilitation Training With Music-support & Exercise Tolerance in COPD and CRF Patients.","Can Rehabilitation Training With Music-support Increase Exercise Tolerance in Individuals With COPD and CRF Compared to Rehabilitation Training Alone? A Randomized Control Trial.","Inclusion Criteria:\n\n* Diagnosis of COPD (Forced expiratory volume in 1 second \u002F post-bronchodilator forced vital capacity \\\u003C 0.7) without functional reversibility\n* Chronic respiratory failure with stable hypoxia (PaO2 \\\u003C 60 mmHg in room air)\n* Long Term Oxygen Therapy (LTOT) for at least 3 months\n* Clinical stability: pH range 7.38-7.42, with no recent exacerbations in the last 7 days and no changes in drug therapy in the previous 7 days\n\nExclusion Criteria:\n\n* Non-invasive ventilation at home\n* Cognitive impairment (Mini-Mental State Examination Score \\\u003C 22)\n* Asthma or evidence of bronchodilator response\n* Pulmonary fibrosis\n* Obstructive sleep apnea syndrome\n* Lung cancer\n* Active microbial infections\n* Neuromuscular, orthopedic, and\u002For medical conditions that preclude testing\n* Pulmonary rehabilitation program in the previous 6 months",{"count":631,"type":22},156,[25],"Therapeutic-rehabilitative interventions supported by music can be considered important resources in many clinical contexts. Some studies report the improvement of psychological (i.e. anxiety) and physiological parameters such for example, dyspnea, blood pressure, quality of life, sleep disturbances, etc. through voice, singing, exercise with wind instruments, and sometimes listening to music. Among the various instruments proposed to support the physical training of COPD patients, music was also tested and, in particular, music as a distracting auditory stimulus (DAS) has been used to increase exercise and physical activity adherence and to reduce the perception of dyspnea in COPD subjects.\n\nThis randomized controlled trial will compare -in patients with COPD and CRF- the effects of the addiction of music to the training on exercise capacity (possible improvement of endurance and reduction of fatigue and dyspnea) with respect to the usual rehabilitation modality (no music).",[112],[636,112,637,638,372],"distracting auditory stimulus (DAS)","CRF","music therapy",{"date":503,"type":35},{"date":641,"type":35},"2023-01-26",{"date":643,"type":22},"2027-04-30",{"name":41,"class":42},""]