[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS San Raffaele Roma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":595},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,53,81,111,142,170,190,215,239,267,295,326,353,379,405,429,456,478,503,525,549,568],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100643139","aide-decision-support-for-anastomosis-or-colostomy-in-emergency-surgery-for-complicated-acute-diverticulitis-100643139",false,"NCT07651072","AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis","AIDE: a Multicenter Observational Study to Support the Decision Between Anastomosis and Colostomy in Emergency Surgery for Complicated Acute Diverticulitis","AIDE\u002FOBS\u002F2025","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of acute complicated diverticulitis requiring non-elective operative management\n* Emergency or urgent surgery for complicated diverticulitis, including surgery after failure of non-operative management\n* Minimally invasive approach: laparoscopic\u002Frobotic surgery\n* Patients undergoing sigmoid resection with primary anastomosis, Hartmann's procedure, or other operative strategy according to local practice\n* Availability of clinical and operative data\n* Local ethical approval, authorization, or waiver according to national and institutional regulations\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Elective surgery for diverticular disease\n* Uncomplicated diverticulitis managed non-operatively\n* Surgery performed for conditions not related to diverticulitis\n* Surgical procedures performed via primary open approach (i.e., no attempt at minimally invasive surgery), unless converted intraoperatively.\n* Lack of required consent or authorization for data use, when required by local regulations","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","The AIDE\u002FOBS study is a multicenter, observational, non-interventional study designed to collect standardized clinical, radiological, intraoperative visual, and surgical reasoning data from adult patients undergoing non-elective surgery for complicated acute diverticulitis.\n\nThe study focuses on patients requiring urgent or emergency operative management, including cases following failure of non-operative management. The main intraoperative decision of interest is the choice between sigmoid resection with primary anastomosis, with or without diverting stoma, and Hartmann's procedure.\n\nThe current phase aims to build a structured multimodal dataset and to validate and refine a preliminary expert-informed decision-support tool. The study does not modify standard clinical practice, surgical indication, operative strategy, or postoperative management. All treatment decisions remain at the discretion of the treating surgical team according to local practice.",[25,26,27,28],"Complicated Diverticulitis","Acute Diverticulitis","Peritonitis","Perforated Diverticulitis",[30,31,32,33,34,35,36,37,38,39],"Perforated diverticulitis","Emergency surgery","Non-elective surgery","Primary anastomosis","Hartmann's procedure","Intraoperative decision-making","Artificial intelligence","Computer vision","Surgical video analysis","Multimodal dataset","NOT_YET_RECRUITING","2026-06-10",{"date":43,"type":44},"2026-06-16","ACTUAL",{"date":46,"type":21},"2026-05-31",{"date":48,"type":21},"2028-04-30",{"name":50,"class":51},"IRCCS San Raffaele Roma","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":63,"studyType":22,"phases":4,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100600915","i-need-new-migraine-drugs-database-100600915","NCT07103694","i-NEED: NEw migrainE Drugs Database","Italian Real-life Multicenter Observational Study on Efficacy, Tolerability, and Safety of Innovative Drugs (Monoclonal Antibodies, Gepants, Ditans, Sumatriptan-naproxen) for Preventive or Acute Migraine Treatment.","i-NEED","Inclusion Criteria:\n\n* Age more or equal 18 years;\n* Males and females;\n* Willingness to sign the informed consent;\n* Episodic migraine for the use of drug indicated for migraine attack\n* High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;\n* Chronic migraine, according to the ICHD-III criteria;\n\nExclusion Criteria:\n\n* Other headaches different than migraine;\n* Known intolerance to the eccipients;\n* Vascular disease or Raynaud.",{"count":62,"type":21},2641,"3 Years","Approved by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) starting in 2018, anti-CGRP monoclonal antibodies (anti-CGRP mAbs) represent the first true revolution in the preventive treatment of migraine due to their selectivity and specificity. To date, four anti-CGRP mAbs have been developed for the preventive treatment of migraine: eptinezumab, erenumab, fremanezumab, and galcanezumab.Anti-CGRP mAbs constitute not only the first specific and selective treatment for the prevention of migraine but also the most extensively studied pharmacological category in this field, considering the vast and complex populations examined. The clinical effects of the various mAbs are substantially comparable and are characterized by several fundamental aspects:\n\n* High efficacy in both episodic and chronic migraine, with the presence of super-responders who experience a reduction in the average monthly number of migraine days of \\>75% (or even 100%) compared to before treatment.\n* Efficacy that is independent of the clinical form of migraine - with or without aura - and regardless of whether there is analgesic overuse.\n* Efficacy maintained even in the presence of depressive or anxious comorbidities.\n* Rapid onset of action (even more pronounced with eptinezumab), with the therapeutic effect appearing within the first week in most cases.\n* Excellent tolerability with an absence of class-specific adverse events.\n* Outstanding treatment adherence and a very low rate of treatment discontinuation in the long term. It should also be noted that the development of anti-drug antibodies or neutralizing antibodies to anti-CGRP mAbs is rare and does not significantly impact the efficacy or tolerability of treatment. Future clinical practice will need to clarify several additional aspects, such as: 1) whether treatment with anti-CGRP mAbs can modify the course of migraine; 2) the appropriate approach regarding any traditional preventive treatment (whether to continue or discontinue it); 3) the definition of the characteristics of non-responders; 4) the definition of patients with a delayed response to treatment.\n\nGepants are oral antagonists of the CGRP receptor. Among the four gepants synthesized so far (atogepant, rimegepant, ubrogepant, zavegepant), atogepant and rimegepant are currently available in Italy. Atogepant has proven to be an effective and well-tolerated option for the prevention of episodic and chronic migraines. Rimegepant is effective for both acute treatment and prevention of migraines, with a favorable safety profile and flexible oral administration. Lasmiditan is the first ditan effective for migraine attack and it represents a new therapeutic option for patients with contraindications to triptans, due to the presence of vascular risk factors, or for patients who experience undesirable side effects with these, thus increasing the therapeutic possibilities for the symptomatic treatment of migraine. The combination of sumatriptan 85 mg and naproxen sodium 500 mg is indicated for the acute treatment of migraine attacks in adult patients for whom sumatriptan monotherapy is insufficient.",[66,67,68],"Episodic Migraine","Chronic Migraine","Medication Overuse Headache",[70],"migraine, anti-CGRP monoclonal antobodies, gepants, ditans, sumatriptan and naproxen combination","RECRUITING","2026-06-09",{"date":74,"type":44},"2026-06-11",{"date":76,"type":44},"2022-03-24",{"date":78,"type":21},"2026-12-31",{"name":50,"class":51},2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":80},"100642840","evaluation-of-a-soft-elbow-exoskeleton-and-a-haptic-armband-in-post-stroke-and-parkinsons-disease-patients-100642840","NCT07637123","Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients","Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband: Feasibility, Usability, and Clinical Impact in Post-stroke and Parkinson's Disease Patients (EMBA-IP)","EMBA-IP","Inclusion Criteria:\n\n* Age 18 years or older.\n* Able to understand the study procedures and follow study instructions.\n* Signed informed consent obtained before participation.\n* Adequate cognitive function, defined as Mini-Mental State Examination score ≥24 or equivalent clinical assessment.\n* Upper-limb functional limitation compatible with participation in the study.\n* QuickDASH score between 20 and 70.\n* Arm and forearm dimensions compatible with safe and appropriate fitting of the wearable device.\n\nAdditional inclusion criteria for stroke participants\n\n* Clinically confirmed diagnosis of ischemic or hemorrhagic stroke, documented by computed tomography or magnetic resonance imaging.\n* Upper-limb motor impairment involving the proximal upper limb, including shoulder and\u002For elbow functional limitation.\n* Modified Ashworth Scale score \\\u003C3 in the affected upper limb.\n* Residual upper-limb motor function compatible with the assigned device-assisted experimental tasks.\n* Fugl-Meyer Assessment Upper Extremity score ≥15.\n\nAdditional inclusion criteria for Parkinson's disease participants\n\n* Clinically confirmed diagnosis of idiopathic Parkinson's disease.\n* Modified Hoehn and Yahr stage II or III.\n* Upper-limb motor impairment such as bradykinesia, rigidity, tremor, or reduced dexterity.\n* Unified Parkinson's Disease Rating Scale Part III upper-limb motor items compatible with mild-to-moderate impairment.\n* Assessment performed in the \"on\" medication state, within two hours after levodopa intake.\n\nExclusion Criteria:\n\n* Severe cognitive impairment, defined as Mini-Mental State Examination score \\\u003C24, or any condition preventing comprehension of study procedures or instructions.\n* Unstable medical condition that could increase risk during participation, including uncontrolled cardiovascular disease, severe respiratory failure, active systemic infection, or recent major surgery.\n* Dermatological disease, open wounds, skin lesions, or skin hypersensitivity in the areas where the wearable devices would be applied.\n* Contraindications to use of the study devices, including implanted pacemaker, relevant metallic implants near the application area, or known allergy to device materials.\n* Severe spasticity of the affected upper limb that would prevent safe device use, defined as Modified Ashworth Scale score ≥3.\n* Severe upper-limb pain that could be worsened by active or passive movement.\n* Participation in another interventional clinical study involving upper-limb rehabilitation or motor rehabilitation within 30 days before enrollment.\n* Use of investigational drugs or investigational treatments within 30 days before study participation.\n* Confirmed or suspected pregnancy.\n* Any condition that, in the investigator's judgment, could interfere with study procedures, affect participant safety, or expose the participant to undue risk.\n* Refusal or inability to provide signed informed consent.",{"count":90,"type":21},45,"INTERVENTIONAL",[93],"NA","This pilot feasibility study will evaluate a wearable soft elbow exosuit and a haptic forearm bracelet for upper-limb neurorehabilitation in people with stroke and Parkinson's disease. The soft elbow exosuit is designed to assist elbow flexion and extension during functional motor tasks while preserving comfort and natural movement, with the possibility of deploying vibrotactile stimuli. The haptic bracelet provides tactile and vibrotactile feedback to support sensorimotor engagement, movement guidance, and proprioceptive awareness.\n\nThe study will assess the feasibility, usability, comfort, acceptability, safety, and preliminary clinical impact of these devices in a real neurorehabilitation setting. Participants with stroke will be tested using either the soft elbow exosuit or the haptic bracelet, depending on their stage of recovery and residual upper-limb motor function. Participants with Parkinson's disease will be tested with the soft elbow exosuit combined with integrated haptic feedback, with specific interest in motor performance and tremor modulation.\n\nParticipants will undergo baseline clinical and functional assessment, followed by supervised experimental sessions involving upper-limb functional tasks such as reaching, grasping, releasing, pick-and-place exercises, elbow flexion-extension, forearm pronation-supination, and fine or gross motor activities. Sessions may be performed with and without device assistance. Non-invasive sensors, including inertial measurement units and electromyography, will be used to collect movement and muscle activity data. User experience will be assessed using standardized questionnaires addressing usability, satisfaction, perceived benefit, comfort, and musculoskeletal discomfort.\n\nThe study is intended to generate preliminary evidence on the safe and acceptable use of wearable soft robotic and haptic technologies in neurological rehabilitation and to inform the design of future larger clinical trials.",[96,97],"Stroke","Parkinson Disease",[99,100,101,102,103],"Soft Robotics","Haptic device","Feasibility","Acceptance of Technology","Pilot Study","2026-06-05",{"date":72,"type":44},{"date":107,"type":21},"2026-06",{"date":109,"type":21},"2026-12",{"name":50,"class":51},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":91,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100580606","robotic-rehabilitation-of-the-upper-limb-in-subacute-stroke-100580606","NCT06839482","Robotic Rehabilitation of the Upper Limb in Subacute Stroke","Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial","GLORIA","Inclusion Criteria:\n\n* Both sexes\n* Age 18-90 years\n* Paresis of the upper limb following a recent cerebrovascular event (subacute ischemic or hemorrhagic stroke)\n* Moderate to mild muscle weakness in the thumb opponens, common finger flexors, and wrist flexors, assessed with complete joint movement in absence of gravity, Medical Research Council Scale (MRC) ≥ 2\n* Time from acute event \\\u003C90 days\n* Ability to understand and sign the study informed consent\n* Ability to perform study procedures.\n\nExclusion Criteria:\n\n* Presence of other overlapping neurological disorders\n* Presence of osteoarticular or neuromuscular disorders affecting upper limb mobility\n* Severe psychiatric disorders\n* Severe cognitive (MMSE ≤ 17) and\u002For language impairment compromising exercise comprehension\n* Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period\n* Open wounds, infections, or unprotected skin lesions on the upper limb\n* Severe spasticity of the upper limb (biceps and wrist and finger flexors) (MAS \\> 3)\n* Inability to adhere to the exercise program due to low compliance\n* Participants who have not signed the informed consent for the study","85 Years",{"count":121,"type":21},130,[93],"This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component).\n\nParticipants will be randomly assigned to one of two groups:\n\n* Experimental Group (EG): Robotic-assisted upper limb rehabilitation combined with conventional therapy.\n* Control Group (CG): Conventional therapy alone including upper limb rehabilitation.\n\nClinical assessments will be conducted at baseline (T1), post-treatment (T2), and at a 3-month follow-up (T3) using remotely administered scales.\n\nSecondary objectives include evaluating improvements in muscle strength, range of motion, eye-hand coordination, manual dexterity, and functional independence. The study will also assess prognostic factors influencing response to robotic therapy, patient satisfaction, and potential adverse events.",[96],[96,126,127,128,129,130,131,132],"Upper Limb","Hand","Rehabilitation","Robotic- Assisted Therapy","Subacute phase","Activities of Daily Living (ADL)","Quality of Life","2026-04-20",{"date":135,"type":44},"2026-04-23",{"date":137,"type":44},"2025-02-06",{"date":139,"type":21},"2028-01-31",{"name":50,"class":51},21,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":17,"minAge":151,"maxAge":18,"enrollmentInfo":152,"targetDuration":4,"studyType":91,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":169,"locationsCount":52},"100632875","monitoring-daily-mobility-in-children-with-autism-100632875","NCT07519369","Monitoring Daily Mobility in Children With Autism","Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism","SIMBA","Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria\n* Age between 2 and 18 years\n* Ability to walk independently\n* Willingness to wear a wearable device (wrist sensor) continuously for 7 days and pedobarographic insoles for reproducible gait monitoring\n* Willingness to undergo one night of home polysomnography with video-EEG\u002Fpolygraphy during the wearable monitoring period\n* Informed consent signed by both parents\u002Flegal guardian; assent from the minor when applicable\n\nExclusion Criteria:\n\n* Skin contraindications to the wristband\u002Ffixation systems (known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use)\n* Severe motor impairments\n* Recent orthopedic surgery (\\\u003C6 months)\n* Use of orthoses or assistive devices during walking\n* Severe behavioral disorder making device use impracticable despite acclimatization strategies",true,"2 Years",{"count":153,"type":21},80,[93],"Children with autism spectrum disorder (ASD) often show motor abnormalities and sleep disturbances that affect behavior, learning, and family quality of life. Emerging technologies such as wearable devices and markerless systems provide accessible tools for gait and sleep assessment, with actigraphy recommended for long-term monitoring in natural settings. Evidence also suggests links between sleep problems and sensory processing differences. This project, aims to integrate these approaches in a clinical-translational framework.",[157],"Autism Spectrum Disorder (ASD",[159,160,161,162],"Autism Spectrum Disorder","ASD","sleep","movement disorders","2026-04-02",{"date":165,"type":44},"2026-04-09",{"date":167,"type":44},"2026-02-18",{"date":107,"type":21},{"name":50,"class":51},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":52},"100579437","evaluation-of-electroencephalographic-biomarkers-in-physiological-aging-100579437","NCT06824285","Evaluation of Electroencephalographic Biomarkers in Physiological Aging","Investigating Brain Connectivity and Complexity as Biomarkers of Healthy Aging and Brain Rejuvenation by Stem Cell-derived Exosomes","AGE-MARK","Inclusion Criteria:\n\n* healthy subjects\n* \\> 18 years old\n\nExclusion Criteria:\n\n* neurological disorders\n* head injuries,\n* substance abuse,\n* psychiatric conditions\n* any medications affecting the cardiovascular or central nervous systems",{"count":179,"type":21},96,"Aging is the inevitable biological process that results in a progressive structural and functional decline from the cellular level to whole body function. It is associated with functional changes in the resting brain activity, brain morphology, plasticity, complexity and function. Moreover, aging is the main risk factor for neurodegenerative disease.\n\nUnderstanding the molecular mechanisms underlying the age-related neurophysiological changes and identifying novel biomarkers of healthy brain ageing is thus instrumental for the development of efficient interventions against age-related motor\u002Fcognitive impairments. Within this context, there is now a significant literature establishing the enhanced efficacy of secreted exosomes over the stem cells from which they are derived when used as a possible treatment for neurodegenerative disorders. Exosomes are a subgroup of extracellular vesicles which regulate intercellular communication and, unlike stem cells, easily cross into the brain and can be administered in non-syngeneic species without immune rejection.\n\nStudies on brain ageing in humans has major limitation in the lack of accessibility of the central nervous system. EEG has allowed the non-invasive assessment of functional changes in the aging brain. In fact, this technique can provide a direct assessment of neural activity and information flow with a higher temporal resolution that is particularly important for investigating the dynamics of brain changes underlying cognitive processing and age-related changes, providing novel biomarkers of brain aging that could be used to unveil differences between healthy and unhealthy processes particularly in the pre-symptomatic and pre-clinical stage. To reach this aim, it is necessary to demonstrate, in experimental models, the relationship between age-dependent changes in brain activity and cellular\u002Fmolecular processes occurring in aged brain.\n\nOur project will pursue this overall goal by:\n\n1\\) identifying neurophysiological biomarkers of brain aging in human subjects based on functional network and complexity analyses; 2) characterizing age-dependent changes in brain connectivity and complexity in mice and correlating them to changes in motor and cognitive performances and to molecular alterations occurring in both the brain and blood; 3) evaluating changes of the identified electrophysiological and molecular biomarkers in mice treated with stem cell derived exosomes for the rejuvenation of the aged brain.\n\n4\\) designing Artificial Intelligence (AI) predictor of brain age trajectories on individual basis to evaluate individual neural reserve and resilience.\n\nThis study will identify novel electrophysiological biomarkers of healthy brain ageing and will advance knowledge on cellular\u002Fmolecular signature of brain aging that could targeted for the preservation of brain health.",[182],"Aging",{"date":184,"type":44},"2026-04-03",{"date":186,"type":44},"2023-10-20",{"date":188,"type":21},"2026-10-19",{"name":50,"class":51},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":151,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":91,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":52},"100626133","feeding-disorders-in-children-100626133","NCT07431671","Feeding Disorders in Children","Feeding Disorders in Pediatric Age: Effects of an Interdisciplinary Intervention","FEEDING","Inclusion Criteria:\n\n* Age between 2 and 7 years.\n* Diagnosis of a neurodevelopmental disorder according to DSM-5 criteria.\n* Presence of a feeding disorder.\n\nExclusion Criteria:\n\n* Presence of respiratory, cardiovascular, gastrointestinal, or neurological conditions preventing oral feeding.\n* Insufficient caregiver proficiency in the Italian language, such as to compromise completion of the questionnaires.\n* Children who are undergoing a different feeding intervention at the time of screening.","7 Years",{"count":200,"type":21},24,[93],"Pediatric Feeding Disorders (PFDs) are conditions characterized by persistent difficulties in food intake, commonly manifesting as food selectivity, food refusal, and dysfunctional mealtime behaviors. Their prevalence in the general pediatric population ranges from 3% to 10%, with substantially higher rates reported among children with neurodevelopmental disorders. The impact of PFDs extends beyond growth and nutritional status, affecting cognitive and emotional development as well as the well-being of the entire family system. Although several treatment models have been proposed, scientific evidence supporting outpatient interventions remains limited and Italy-specific studies are lacking. Moreover, despite the availability of standardized assessment tools, feeding-related outcomes are not yet systematically addressed within outpatient clinical practice for children with neurodevelopmental disorders.\n\nThe present study aims to evaluate whether an interdisciplinary intervention protocol involving a psychologist, a speech and language therapist (SLP), and a Neuro and Psychomotor Therapist of Developmental Age (TNPEE) can improve food variety and reduce dysfunctional mealtime behaviors in this population. The study is designed as a pilot randomized controlled trial developed across five sequential phases: participant enrollment and screening using the Montreal Children's Hospital Feeding Scale (MCH-FS); baseline standardized assessment (T0) using the Pediatric Eating Assessment Tool (PediEAT) and the Short Sensory Profile (SSP); random allocation of participants to an experimental group or a control group; delivery of the interdisciplinary intervention exclusively to the experimental group; and a final standardized assessment conducted six weeks later (T1) to evaluate changes over time and between groups.\n\nThis pilot study primarily aims to assess feasibility and to estimate the variability of outcome measures; therefore, no formal sample size or power calculation was performed. The planned enrollment of 12 participants per group was determined based on feasibility considerations and in line with CONSORT recommendations for pilot trials. The proposed protocol seeks to address current gaps in the literature by systematically targeting feeding-related outcomes through an explicitly interdisciplinary approach that integrates psychological, speech and language, and neuropsychomotor perspectives in the management of PFD.",[204,205,206],"Neurodevelopmental Disorder (Diagnosis)","Feeding Disorder","ARFID","2026-02-25",{"date":209,"type":44},"2026-02-27",{"date":211,"type":44},"2026-01-01",{"date":213,"type":21},"2026-02-28",{"name":50,"class":51},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":225,"studyType":22,"phases":4,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":52},"100605507","italian-migraine-registry-i-graine-new-100605507","NCT07163416","(Italian Migraine Registry, I-GRAINE-NEW)","Project for the Construction of the Italian Migraine Registry I-GRAINE-New","I-GRAINE-NEW","Inclusion Criteria:\n\n* Adult Patients(Age ≥ 18 years) of both sexes\n* Diagnosis confirmed of episodic migraine ( \\\u003C15 days\u002Fmonth ) with or without aura or chronic migraine (\\>15days\u002Fmonth) ,with or without headeche due to overuse of analgesics;\n* Provision of signed and dated the Informed Consent Form before the inclusion in the study\n\nExclusion Criteria:\n\n* Patients affected by other forms of primary or secondary headaches or in whom the diagnosis is not certain",{"count":224,"type":21},2030,"5 Years","Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic \"evolutionary\" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments. When patients are admitted to the center is therefore the time when their history in terms of disease evolution and healthcare costs is most effectively collected, but also when it is assumed that the treatment strategy offered to the patient will have a greater impact.\n\nFor this reason, it was decided to conduct a large-scale retrospective and prospective observational study in order to draw a detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.\n\nDesign A multicenter, observational, retrospective and prospective cohort study, aimed at obtaining a more detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.6,000 of the incident patients (defined as those who had their first visit during the 6 months preceding enrollment in the registry), will be invited to take part in a follow-up and expanded data collection study.\n\nPatients will be consecutively enrolled by specialists at each individual site.. Eligible patients who agree to take part in the study by signing an informed consent form will be assessed clinically and through a direct interview with a structured questionnaire organized in several ad hoc sections.\n\nObjectives: The aim of the study is:\n\nanalyze episodic and chronic migraine in Italy from an epidemiological point of view, especially in terms of prevalence of the two forms of migraine and their endophenotypes in different population subgroups; 2. characterize the demographic distribution and clinical characteristics of patients (including the definition of endophenotypes); 3. measure the influence of the disease on the patient's daily activity, in terms of disability (assessed using the validated MIDAS and HIT-6 scales); 4. study the clinical and care pathway (patient journey) and identify the preferred care pathways based on the characteristics of the patients and the migraine subtype; 5. evaluate the prescribed pharmacological treatments, medical visits and diagnostic procedures performed (ascertaining the degree of adherence to current guidelines); 6. analyze the use of health resources by migraine patients, with particular attention to their impact on the SNS.\n\nVisits and Treatments:\n\nBaseline Visit: Patients enrolled in the study will undergo a thorough clinical and neurological examination.\n\nFollow-up Visits: Clinical data will continue to be collected over time, at each scheduled clinic visit based on the needs of clinical practice.\n\nStudy Population: Adult patients of both sexes with episodic or chronic migraine who have recently attended a specialized migraine center in the I-GRAINE-NEW registry.\n\nEstimated Study Duration: The duration of each patient's participation in the study is 24 months from the date of the initial visit to the participating migraine site",[228],"Migraine Disorders",[230],"Migraine,Register,Italy","2025-09-01",{"date":233,"type":44},"2025-09-09",{"date":235,"type":44},"2021-04-19",{"date":237,"type":21},"2026-03-05",{"name":50,"class":51},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":17,"minAge":247,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":91,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":264,"leadSponsor":266,"locationsCount":4},"100600408","parkinsons-research-in-metagenomic-early-stage-biomarkers-100600408","NCT07097103","Parkinson's Research In Metagenomic Early Stage Biomarkers","A 2x2 Factorial Randomized Controlled Non-pharmacological Interventional Multicenter Pilot Study on the Influence of the Mediterranean Diet and Physical Exercise on the Microbiome of Patients With Parkinson's Disease","PRIME_2025","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria;\n* aged 35-80 years;\n* Hoehn \\& Yahr stage \\> 1 and \\\u003C 3 in the clinical \"ON\" state;\n* MoCA score ≥17.54;\n* MMSE ≥24;\n* Stable dopaminergic midication regimen for ≥ 4 weeks;\n* Ability to interact with the research team and provide informed consent in Italian;\n* Suitable to physical exercise;\n* Able to walk unassisted (no walking aids);\n* Willingness and ability to comply with all study procedures;\n* Willingness to maintain usual diet during a ≥ 4-week pre-baseline period;\n* Willingness to switch to a Mediterranean-style diet during the intervention;\n* Ability to provide stool samples at each collection timepoint;\n* Willing to avoid strenuous exercise and alcohol for 24 hours prior to each visits.\n\nExclusion Criteria:\n\n* Pre-existing psychiatric disorders;\n* Atypical or secondary Parkinsonism;\n* Presence of pacemakers or other subcutaneous electronic devices;\n* Any other neurological or neurodegenerative disorders;\n* Moderate to severe cognitive decline;\n* Beck Depression Inventory-II (BDI-II)\\] score ≥28;\n* Dementia diagnosis;\n* Thyroid dysfunctions;\n* Type1 Diabetes Mellitus;\n* Type 2 diabetes mellitus with HbA₁c ≥ 8% or on insulin therapy;\n* Acute diseases;\n* Active Neoplasia;\n* IBD or IBS;\n* Celiac disease;\n* History of major gastrointestinal surgery or acute GI conditions (e.g., gastroenteritis) within the past 3-6 months;\n* Chronic corticosteroid therapy;\n* Use of proton pump inhibitors within the past 30 days;\n* Acute, antibiotic-resistant infections;\n* Antibiotic intake within the past 30 days;\n* Prebiotic\u002Fprobiotic supplement use in the past 30 days;\n* Prolonged intake of anxiolytic drugs, antidepressants, antipsychotics, cognitive stimulants, and analogs in the past 3 months;\n* Underweight (BMI \\\u003C18.5);\n* History of deep brain stimulation (DBS) surgery;\n* Pregnancy or lactation;\n* Regular use of enemas or suppositories to alleviate constipation;\n* Use of experimental products in the 3 months prior to the screening visit\n* Patients who, for medical reasons, are required to follow special dietary regimens that could interfere with the adoption or effectiveness of the Mediterranean model;\n* Vegan\u002FVegetarian diet or any other dietary behaviour that excludes one or more of the typical food groups of the Mediterranean model.","35 Years","80 Years",{"count":153,"type":21},[93],"This 2x2 factorial, randomized, controlled pilot study aims to identify a specific microbiota pattern, which could constitute a biomarker of Parkinson's disease, and to evaluate whether specific pathotypes can be associated with different stages of the disease; furthermore, the investigators are committed to evaluating how and to what extent the changes induced by a personalized nutritional intervention combined with physical exercise affect the symptoms and quality of life of patients.",[253],"Parkinson's Disease (PD)",[255,256,257,258,259],"Physical activity","Mediterranean Diet","Pilot study","Microbiome","Parkinson's disease","2025-07-30",{"date":262,"type":44},"2025-07-31",{"date":231,"type":21},{"date":265,"type":21},"2029-07-31",{"name":50,"class":51},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":275,"enrollmentInfo":276,"targetDuration":63,"studyType":22,"phases":4,"briefSummary":278,"conditions":279,"keywords":280,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":294,"locationsCount":52},"100483062","eptinezumab-in-real-world-evidence-multicenter-real-life-cohort-study-in-migraine-100483062","NCT05570149","EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.","EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)","EMBRACE","KEY INCLUSION CRITERIA\n\n1. Age between 18 and 75 years;\n2. Males and females;\n3. Willingness to sign the informed consent;\n4. High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;\n5. Chronic migraine, according to the ICHD-III criteria;\n\nKEY EXCLUSION CRITERIA\n\n1. Other headaches different than migraine;\n2. Known intolerance to eptinezumab or eccipients;\n3. Current treatment with other mAbs;\n4. Vascular disease or Raynaud.","75 Years",{"count":277,"type":21},500,"The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.",[228],[281,282,283,284,285,286,287],"Eptinezumab,","Calcitonin gene-related peptide,","Effectiveness,","Real-life,","Migraine,","Safety","Treatment","2025-04-29",{"date":290,"type":44},"2025-05-01",{"date":292,"type":44},"2023-01-01",{"date":78,"type":21},{"name":50,"class":51},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":303,"targetDuration":4,"studyType":91,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":80},"100585914","balance-rehabilitation-based-on-serious-games-100585914","NCT06908564","Balance Rehabilitation Based on Serious Games","Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study","BERTHA","Inclusion Criteria:\n\n* Age over 18 years;\n* First elective hip arthroplasty;\n* Cognitive ability to understand and perform the exercises outlined in the protocol;\n* Ability to sign the informed consent.\n\nExclusion Criteria:\n\n* Unable to adhere to the exercise program due to poor compliance;\n* Previous contralateral hip arthroplasty;\n* Surgical wound complications;\n* Severe cognitive, linguistic, or visual impairments (inability to understand and follow the study procedures);\n* Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons;\n* Diagnosis of epilepsy;\n* Presence of implanted cardiac pacemakers;\n* Lack of signed informed consent for the study.",{"count":304,"type":21},20,[93],"The effects of new technologies, particularly exergames, on the rehabilitation process of patients with hip arthroplasty have not yet been verified. For this reason, the aim of this study is to evaluate the effectiveness, in terms of balance recovery, of a balance rehabilitation program based on serious games in individuals with hip arthroplasty compared to conventional treatment.",[308],"Hip Replacement, Total",[310,311,312,128,313,314,315,316,317],"Hip Arthroplasty Replacement","Lower Limb","Balance","Robotic-Assisted Therapy","Range Of Motion","Pain","Activity of Daily Living","Hip Replacement Total","2025-04-07",{"date":320,"type":44},"2025-04-09",{"date":322,"type":44},"2023-06-23",{"date":324,"type":21},"2026-03-23",{"name":50,"class":51},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":334,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":91,"phases":336,"briefSummary":337,"conditions":338,"keywords":342,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":52},"100585929","risk-of-falling-and-cardiac-rehabilitation-100585929","NCT06908759","Risk of Falling and Cardiac Rehabilitation","Risk of Falling Assessment in a Population of Patients With Cardiovascular Diseases Undergoing Cardiac Rehabilitation","CARDIO-BALANCE","Inclusion Criteria:\n\n\\- Age \\> 65 years\n\nRecent acute cardiac event, including:\n\n1. Cardiac surgery (CABG, aortic and\u002For mitral valve replacement, mitral valvuloplasty, or combined CABG + valve surgery)\n2. Recent myocardial infarction treated with percutaneous revascularization\n3. Episode of acute heart failure\n\nExclusion Criteria:\n\nPersistent clinical instability, defined as:\n\n* Marked hypotension (BP ≤ 95\u002F60 mmHg) or hypertension (BP ≥ 160\u002F100 mmHg)\n* Bradycardia (HR \\\u003C 50 bpm) or tachycardia (HR \\> 115 bpm)\n* Resting dyspnea\n* Signs and symptoms of infection","65 Years",{"count":20,"type":21},[93],"Background and Rationale Cardiac rehabilitation (CR) is a key intervention for patients with chronic heart disease or recent acute cardiovascular events. In elderly and frail patients, CR aims not only to improve functional capacity but also to maintain or recover independence in daily activities. Hospitalization following an acute event often leads to bed rest, which-even after just 2-3 days-can cause hypokinetic syndrome, characterized by loss of muscle tone, orthostatic hypotension, decreased mobility, and psychological decline, including depression. Moreover, immobility increases thrombotic risk and vascular complications.\n\nTo mitigate these effects, CR is initiated promptly after clinical stabilization and includes three phases:\n\n1. Phase I - In-hospital rehabilitation\n2. Phase II - Early outpatient rehabilitation\n3. Phase III - Long-term maintenance Elderly patients are particularly vulnerable to falls due to the combined effects of reduced muscle strength, orthostatic hypotension, cognitive decline, and pre-existing sarcopenia-often exacerbated by acute events and immobility. Approximately 60% of cardiac patients hospitalized for acute events present with moderate-to-high fall risk. Fall risk in this population is multifactorial, involving cardiovascular issues (e.g., arrhythmias, orthostatic hypotension), medication effects, and non-cardiac factors such as vision loss, balance impairment, neuromuscular conditions, and cognitive deficits.",[339,340,341],"Risk of Falling","Elderly (People Aged 65 or More)","Cardiovascular Diseases",[343,344],"risk of fall","cardiac rehabilitation","2025-04-02",{"date":347,"type":44},"2025-04-03",{"date":349,"type":44},"2024-05-31",{"date":351,"type":21},"2025-06-30",{"name":50,"class":51},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":361,"maxAge":248,"enrollmentInfo":362,"targetDuration":4,"studyType":91,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":80},"100585769","upper-limb-rehabilitation-in-people-with-parkinsons-disease-100585769","NCT06906679","Upper Limb Rehabilitation in People With Parkinson's Disease:","Effectiveness of a Robotic End-effector Device for Upper Limb Rehabilitation in People With Parkinson's Disease: a Multicenter Randomized Controlled Pilot Study","MOTORPARK","Inclusion Criteria:\n\n* Age between 30 and 80 years;\n* Diagnosis of Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria;\n* Hoehn \\& Yahr scale score between 2 and 3 in the \"ON\" phase;\n* Montreal Cognitive Assessment (MoCA) screening test with a score ≥ 17.54;\n* Stable pharmacological therapy for at least 4 weeks and throughout the treatment;\n* Ability to understand and sign the informed consent for the study;\n* Signed informed consent for the study;\n* Ability to comply with the study procedures.\n\nExclusion Criteria:\n\n* Unable to adhere to the exercise program due to poor compliance;\n* Neurological disorders overlapping with Parkinson's disease, psychiatric complications, or personality disorders;\n* Presence of osteoarticular and neuromuscular diseases that may impair upper limb mobility;\n* Participants who have not signed the informed consent for the study.","30 Years",{"count":363,"type":21},40,[93],"This study evaluates the effectiveness of upper limb rehabilitation using an end-effector robotic device with exercises designed to improve movements, strength, and coordination of the shoulder, elbow, and wrist in patients with Parkinson's disease who have mild to moderate disability, compared to conventional rehabilitation treatment. The study protocol will involve individuals diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank criteria, who will be randomly assigned to one of the following groups:\n\nA - Experimental Group (EG) - robotic treatment for upper limb rehabilitation. B - Control Group (CG) - conventional treatment for upper limb rehabilitation.\n\nSecondary objectives include:\n\n\\- Evaluating the effectiveness of an end-effector robotic system in terms of improving upper limb coordination and functionality through the ARAT test and the UPDRS.\n\nIdentifying subgroups of participants who may benefit more from robotic therapy based on PD disease stage (Hoehn \\& Yahr), age, and upper limb impairment.\n\nAnalyzing the effects of robotic rehabilitation on quality of life.\n\nAssessing participants' compliance and satisfaction levels with the robotic system in terms of improving participation in upper limb rehabilitation.",[97],[368,369,128,370,131,371],"Parkinson disease","Upper limb","Robotic-assisted therapy","Quality of life",{"date":373,"type":44},"2025-04-04",{"date":375,"type":44},"2023-12-20",{"date":377,"type":21},"2026-12-20",{"name":50,"class":51},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":91,"phases":389,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":403,"locationsCount":404},"100585762","bilateral-robot-assisted-upper-extremity-rehabilitation-on-motor-recovery-in-people-with-subacute-stroke-100585762","NCT06906588","Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke","Effects of Bilateral Upper Limb Robot-assisted Rehabilitation on Motor Recovery in Patients With Subacute Stroke: an Italian Multicenter Randomized Controlled Trial","BILAX","Inclusion Criteria:\n\n* Both sexes;\n* Age \\>18 years;\n* Unilateral hemipyramidal syndrome as demonstrated by a brain CT or MRI;\n* Distance from acute event \\\u003C 6 months;\n* Modified Ashworth Scale (MAS) of shoulder, elbow, and wrist \\\u003C3;\n* Ability to understand and sign the informed consent for the study;\n* Ability to perform the study procedures.\n\nExclusion Criteria:\n\n* Unstable general clinical conditions;\n* Bilateral pyramidal hemisyndrome severe visual impairment;\n* Recent injection of Botulinum Toxin to the affected upper limb or planned for the duration of the study;\n* Interruption of treatment for 1 week or 5 consecutive sessions;\n* Inability to adhere to the exercise program due to poor compliance;\n* Presence of neurological pathologies superimposed on the stroke event, psychiatric complications or personality disorders;\n* Presence of osteoarticular and neuromuscular pathologies that may compromise the motor skills of the upper limb;\n* Participants who have not signed the informed consent to the study.",{"count":388,"type":21},70,[93],"The goal of this clinical trial is to study the clinical effects of a robotic rehabilitation treatment through a bilateral exoskeleton (Bilateral Robot-Assisted Therapy-BRAT) during standard rehabilitation, on motor recovery, compared to conventional arm re-education in people suffering from stroke in the subacute phase. The main question it aims to answer is what the effectiveness of Bilateral Robot-Assisted Therapy (BRAT) is in rehabilitating the upper limb in individuals with subacute stroke compared to conventional rehabilitation treatment in terms of motor function improvement as measured by the Fugl-Meyer Assessment - Upper Limb (FMA-UL), motor domain. Researchers will compare two groups (Experimental Group - EG and Control Group - CG) to see if the BRAT is more effective than conventional rehabilitation treatment in terms of motor recovery. Participants will be randomly assigned to one of the two treatment groups (EG or CG) and will be clinically and instrumentally evaluated at baseline (T0) and at the end of treatment (T1). EG, in addition to the standard rehabilitation treatment, will perform a 45-minute session of BRAT per day through the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system. The CG, in addition to the standard routine rehabilitation treatment, will follow a conventional rehabilitation of the upper limbs without the use of technological devices. Finally, a telephone follow-up is scheduled three months after the end of the treatment.",[96,392],"Sabacute Stroke",[394,395,396,397,398],"Upper limb rehabilitation","Bilateral Robot-Assisted Therapy-BRAT","stroke","subacute","Robotic rehabilitation",{"date":373,"type":44},{"date":401,"type":44},"2024-05-19",{"date":78,"type":21},{"name":50,"class":51},3,{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":52},"100586454","drug-management-in-heart-failure-100586454","NCT06915584","Drug Management in Heart Failure","DRUM-HF","Inclusion Criteria:\n\n* Both gender\n* Age \\>18 years\n* Signed informed consent for the study\n* Known diagnosis of heart failure \\> 6 months\n* Recent or ongoing hospitalization for heart failure exacerbation\n\nExclusion Criteria:\n\n* Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons\n* Concurrent diagnosis of neoplasia\n* Advanced COPD (FEV1 \\\u003C50%)\n* Advanced valvular heart disease (severe mitral-aortic stenosis-insufficiency requiring cardiac surgery)",{"count":413,"type":21},450,"Aim of the proposal is to create an interactive AI-based multicentre prospective database to provide information on how to improve the QoC for pts with HF.This will provide detailed information on pts characteristics,treatment practices, adherence to prescribed guideline-based optimal drug therapy,and outcomes.The database stems from a registry started two years ago,conceived to provide a contemporary snapshot on the adherence to the latest European GGLL for the therapeutic management of pts with HF.The database will be integrated with a specifically designed algorithm that provides an accurate feedback on whether patients are properly treated according to the ESC most recent recommendations.The expected outcomes are:-define non-adherence level to GGLL-based recommendations for treatment of HF;-provide information on initiation, adherence and persistence over time of the recommended treatment;-reduce medical inertia;produce practical implications to reduce morbidity and mortality",[416],"Heart Failure",[416,418,419,420],"Descriptive appropriateness","Registry","Digital therapy","2025-03-31",{"date":423,"type":44},"2025-04-08",{"date":425,"type":44},"2024-11-30",{"date":427,"type":21},"2025-08-31",{"name":50,"class":51},{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":17,"minAge":361,"maxAge":248,"enrollmentInfo":437,"targetDuration":4,"studyType":91,"phases":438,"briefSummary":439,"conditions":440,"keywords":442,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":80},"100498717","telerehabilitation-in-people-with-parkinsons-disease-100498717","NCT05773885","Telerehabilitation in People With Parkinson's Disease","Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease","TEMPO","Inclusion Criteria:\n\n* age between 30 and 80 years;\n* diagnosis of Parkinson's Disease according to the \"Movement Disorders Society's diagnostic criteria\";\n* Hoehn \\& Yahr (H\\&Y) score between 2 and 3 (ON-state);\n* absence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 ≤ 2;\n* absence of cognitive impairment measured by the MoCA total score ≥ 18;\n* stabilized drug treatment;\n* have access to the Internet for TR;\n* have a caregiver available during rehabilitation sessions in TR;\n* have sufficient cognitive and linguistic level to understand and comply with study procedures;\n* sign informed consent.\n\nExclusion Criteria:\n\n* having any cognitive problems or low compliance that prevent using the TR system;\n* other neurological pathologies, psychiatric complications or personality disorders;\n* musculoskeletal diseases that impair movement;\n* presence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 \\> 2;\n* presence of cognitive impairment measured by the MoCA total score \\\u003C 18;\n* severe cognitive or linguistic deficits (inability to understand and comply with study procedures);\n* presence of blurred or low vision problems;\n* hearing and speech impairment affecting participation in the system;\n* absence of signature of the informed consent.",{"count":363,"type":21},[93],"Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's Disease (PD). Therefore, further studies on the efficacy of TR in the management of motor and non-motor symptoms of PD are needed.\n\nThe study TEMPO aims at assessing the efficacy (in terms of autonomy in carrying out the activities of daily life) of a home TR program based on serious games in people with PD compared to conventional day-hospital treatment.",[441],"Parkinson's Disease",[443,444,445,371,446,447],"Parkinson","Telerehabilitation","Activities of daily living","Belance","Compliance","2025-03-28",{"date":450,"type":44},"2025-03-30",{"date":452,"type":44},"2022-09-01",{"date":454,"type":21},"2026-03-31",{"name":50,"class":51},{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":334,"enrollmentInfo":463,"targetDuration":465,"studyType":22,"phases":4,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":477,"locationsCount":4},"100582872","use-of-the-combination-of-sumatriptan-and-naproxen-in-the-acute-treatment-of-migraine-real-world-evidence-study-100582872","NCT06868953","Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study","SMART","Inclusion Criteria:\n\n1. Migraineurs (age ≥18 years, \\\u003C65 years) with at least 4 migraine days per month according to ICHD-3 criteria who have been prescribed the combination of sumatriptan 85 mg and naproxen 500 mg;\n2. Signed informed consent as required;\n3. Agreement to comply with all study procedures, including follow-up visits;\n4. Use of a contraceptive method by all participants throughout the study duration.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years or \\>65 years\n2. Pregnancy or breastfeeding\n3. Poor knowledge of the Italian language\n4. Comorbidities with other neurological, cardiovascular, hepatic, respiratory, hematological, or autoimmune diseases, or clinically significant laboratory abnormalities\n5. Inability to distinguish migraine attacks from tension-type headaches\n6. Migraine characterized by mild attacks or attacks that resolve spontaneously within 2 hours\n7. Hemiplegic or basilar migraine\n8. Headache with the use of acute medication on more than 10 days per month in each of the 3 months prior to screening\n9. Unwillingness to participate in the study -",{"count":464,"type":21},300,"6 Months","This is a multicenter, observational, prospective, real-life study that will be conducted at Headache Centers, aimed at confirming the efficacy and safety of the combination of sumatriptan 85 mg with naproxen 500 mg. The combination of sumatriptan 85 mg and naproxen sodium 500 mg is indicated for the acute treatment of migraine attacks, with or without aura, in adult patients for whom sumatriptan monotherapy is insufficient. In two randomized studies, the sumatriptan\u002Fnaproxen sodium combination demonstrated significantly greater efficacy (65% of participants-n=1461-reported pain freedom at 2 hours) compared to sumatriptan alone (55%), naproxen sodium alone (44%), or placebo (28%) when used as a late therapy for a single migraine episode in adults. Similar results were observed in a second study (n=1495), with 57% of participants achieving pain freedom within 2 hours after taking the sumatriptan\u002Fnaproxen sodium combination, outperforming both sumatriptan monotherapy (50%) and naproxen sodium monotherapy (43%), as well as placebo (29%). This superiority was further assessed through sustained pain freedom over 24 hours, with an efficacy of 23-25% in participants treated with the sumatriptan\u002Fnaproxen combination compared to placebo (7-8%; p\\\u003C0.001 for both studies) and its individual components (sumatriptan monotherapy: 14%-16%; p=0.009 and p\\\u003C0.001, naproxen sodium monotherapy: 10%).\n\nIn four additional randomized studies, the combination was also found to be effective in menstrual migraine and dysmenorrhea, as well as in cases of poor response or intolerance to triptan therapy. In clinical trials, sumatriptan\u002Fnaproxen sodium was generally well tolerated, with an overall safety profile similar to that of sumatriptan. The most common adverse events were consistent with those expected for sumatriptan and naproxen sodium.",[468],"Migraine",[470],"migraine attack","2025-03-07",{"date":473,"type":44},"2025-03-11",{"date":475,"type":21},"2025-04-10",{"date":78,"type":21},{"name":50,"class":51},{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":80},"100581827","biomarkers-for-monitoring-dementia-progression-100581827","NCT06855368","Biomarkers for Monitoring Dementia Progression","Brain Connectivity and Complexity Parameters to Monitor Disease Progression in Dementia Patients and Antiinflammatory Nanotherapeutics in a Preclinical Model of Alzheimer's Disease","ADvance","Inclusion Criteria:\n\n* mild AD and patients with mild cognitive impairment (MCI).\n\nExclusion Criteria:\n\n* major psychosis, genetic, metabolic and other neurological disorders, acute or chronic non-compensated medical illness\n* any medical or drug-related condition affecting cognitive or mood status\n* history or current alcohol\u002Fillicit drug abuse.",{"count":464,"type":21},"The variable course of Alzheimer's disease (AD) and the paucity of adequate cures urges to implement new strategies for its early detection and clinical intervention. Studying the etiopathogenesis and pathophysiological mechanisms of AD is a necessary prerequisite for the development of new biomarkers and innovative therapies. Contrarily to anatomical structures, cortical connectivity networks are already deteriorated in early AD and could be a reliable marker of early cognitive decline. Our aim is to characterize the neurophysiological parameters in mild AD, in patients with mild cognitive impairment and in matched healthy subjects to identify discriminating criteria. Concurrently, the study of AD onset and progression in a mouse model, will allow evaluating the causal effect of inflammation on disease progression and to develop a new class of biomimetic anti-inflammatory nanoparticles formulated to have the intrinsic ability to induce brain's activated microglia to an M2 phenotype.",[489],"Alzheimer Disease",[491,492,493,494],"EEG","functional connectivity","neuroinflammation","nanoparticles","2025-02-28",{"date":497,"type":44},"2025-03-03",{"date":499,"type":44},"2023-05-18",{"date":501,"type":21},"2025-12-31",{"name":50,"class":51},{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":91,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":52},"100579590","cervical-tsdcs-on-stroke-patients-100579590","NCT06826274","Cervical TsDCS on Stroke Patients","Clinical and Neurophysiological Evaluation of the Effects of Cervical TsDCS on Stroke Patients with Distal Upper Limb Strength Deficit","AMPLI-MOV","Group Stroke:\n\nInclusion criteria:\n\n1. age over 18 years;\n2. first ischemic\u002Fhemorrhagic stroke (within 30 days of onset);\n3. mild-to-moderate stroke (NIHSS scale score\\\u003C16).\n4. residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;\n5. ability to give informed consent and understand instructions.\n\nExclusion criteria:\n\n1. severe spasticity (Ashworth Scale score \\> 2);\n2. severe aphasia;\n3. severe neglect;\n4. history of disabling neurological disease;\n5. history of epilepsy;\n6. significant comorbidities;\n7. contraindications to tsDCS.\n\nHealthy Group:\n\nInclusion criteria:\n\n1. age over 18 years;\n2. equalized in age with the patient group.\n\nExclusion criteria:\n\n1. history of stroke progress;\n2. history of severe neurological disease.",{"count":363,"type":21},[93],"The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm\u002Fhand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.",[515,516],"Functional Recovery","Motor Rehabilitation","2025-02-12",{"date":519,"type":44},"2025-02-13",{"date":521,"type":21},"2025-03",{"date":523,"type":21},"2026-03",{"name":50,"class":51},{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":17,"minAge":533,"maxAge":534,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":537,"conditions":538,"keywords":541,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":548,"locationsCount":52},"100579300","prevalence-of-sarcopenic-obesity-in-copd-100579300","NCT06822504","Prevalence of Sarcopenic Obesity in COPD","ESPEN-EASO Sarcopenic Obesity (OS) Diagnostic Criteria Application in a COPD Cohort and OS Correlation to Diaphragmatic Thickness and Mobility for Determination of Tailored Pulmonary Rehabilitation Program: an Observational Study","OS-BPCO","Inclusion Criteria:\n\n* Patients aged \\> 40 years of either sex;\n* BMI \\>18.5\n* COPD diagnosis according to the GOLD \\[2021 Global initiative for chronic obstructive lung disease\\] classification in the stable stage;\n* Signing of informed consent after receiving all information about the study.\n\nExclusion Criteria:\n\n* COPD not stabilized at the time of enrollment;\n* BMI \\\u003C 18.5\n* presence of tracheostomy\n* uncontrolled hypertension (systolic blood pressure \\> 160 mmHg, diastolic \\> 100 mmHg);\n* hypotension (systolic blood pressure \\\u003C100 mm Hg);\n* Significant comorbidities that limit exercise tolerance;\n* intercurrent infectious diseases, including HIV diagnosis;\n* Patients diagnosed with malignancy in progress or in remission for less than 5 years;\n* patients diagnosed with severe neurological, rheumatologic, or musculoskeletal diseases;\n* patients with a history of thoracic surgery;\n* presence of severe aortic stenosis, uncontrolled atrial\u002Fventricular arrhythmia, recent cardiac ischemic event;\n* cognitive impairment conditions that prevent full understanding of the study protocol (mental retardation, dementia, etc.) and\u002For adequate test performance compliance;\n* failure to sign informed consent;\n* any other serious medical condition that may interfere with data interpretation and safety or that may make the respiratory rehabilitation course difficult, limited, or uncomfortable.","40 Years","100 Years",{"count":536,"type":21},236,"The goal of this observational study is to the purpose is to apply of ESPEN\u002FEASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients.\n\nIn addition, this study want to evaluate the impact of sarcopenic obesity on the respiratory function of COPD patients and the degree of severity of respiratory disease, assessed by spirometric examination; diaphragm thickness and excursion, by ultrasonographic study; performance, assessed by six-minute walk test (6-MWT); quality of life and degree of dyspnea (mMRC, Barthel dyspnea, S. George Respiratory Questionnaire); compliance and outcomes at the end of the respiratory rehabilitation course. Comparison with normal-weight patients with and without sarcopenia will help to better understand the clinical impact of sarcopenic obesity in this category of patients.",[539,540],"Sarcopenic Obesity","COPD",[542,540,543],"sarcopenic obesity","diaphragmatic ultrasound",{"date":517,"type":44},{"date":546,"type":44},"2024-06-01",{"date":351,"type":21},{"name":50,"class":51},{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":52},"100578025","correlation-between-clinical-neurological-biomarkers-and-rehabilitation-outcome-100578025","NCT06805929","Correlation Between Clinical Neurological Biomarkers and Rehabilitation Outcome","Correlation Study Between Clinical, Neurophysiological, and Neuroradiological Biomarkers and Rehabilitation Outcomes to Predict Functional Recovery After Stroke and Personalize Treatment.","PREVICTUS","Inclusion Criteria:\n\n* First stroke in the middle cerebral artery territory.\n* Ischemic or hemorrhagic stroke (7-30 days post-acute event).\n* Upper limb plegia or paresis.\n* Both genders, aged \\>18 years.\n* Ability to provide informed consent by the patient or caregiver\u002Fresponsible relative.\n\nExclusion Criteria:\n\n* Previous stroke.\n* Stroke in territories other than the middle cerebral artery.\n* Inability to provide informed consent.\n* Contraindications to TMS or MRI.\n* History of cancer in the past two years.\n* Presence of other neurological conditions interfering with biomarkers",{"count":464,"type":21},"Our study purpose is to evaluate the predictive power of various clinical, neurophysiological, and neuroimaging biomarkers-acquired and analyzed using advanced and integrated techniques-on motor functional recovery and disability post-stroke. The goal is to construct an integrated individual biomarker algorithm with a high predictive value for outcomes.",[96],"2025-02-04",{"date":562,"type":44},"2025-02-07",{"date":564,"type":44},"2020-06-15",{"date":566,"type":21},"2028-06-30",{"name":50,"class":51},{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":579,"conditions":580,"keywords":583,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":52},"100565094","persistent-pain-in-pharmacologically-or-surgical-treated-osteoarthritis-role-of-mu-limpho-marker-100565094","NCT06637709","Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho Marker","Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: the Role of the Mu-Lympho Marker As a Candidate Innovative Diagnostic Tool","MLM","Inclusion Criteria:\n\n* primary osteoarthritis with disabling pain, age older than 18 years at the time of surgery, capability tocommunicate with healthcare professionals and give valid informed consent, and a willingness to participate in a 24-month follow-up.\n\nExclusion Criteria:\n\n* (1) patients who underwent: surgical knee joint procedures; intra-articular knee injection in the last 3 months; (2) patients with: severe psychiatric disorder \\[excluding mild depression\\] or mental\u002Fcognitive impairment; a history \\[in the last 3 months\\] of fracture or trauma; (3) patients with a history in the last 6 months or currently suffering from: immunodeficiency diseases; connective tissue disease; infections; (4) pregnancy (5) patients ongoing opioids.","99 Years",{"count":578,"type":21},192,"The goal of this prospective observational study is to analyze the percentage of expression of B and NK cells expressing Mu opioid receptor on their surface, named Mu-Lympho-Marker (MLM), to measure pain progression in Osteoarthritis patients and its association with specific rehabilitation programs. In particular, we want to analyze the role of MLM as diagnostic biomarker of pain chronicization.\n\nThe main aims are:\n\n* to explore the relationship between Mu+ B and NK cells percentage and pain progression in OA patients, also investigating whether this characteristic is associated to particular outcome of pharmacological and\u002For surgery interventions and rehabilitation\n* to characterize Mu+ B and NK cells in terms of maturation states, activation\u002Finhibition and functional properties, as well as their ability to respond to Mu stimulation, in order to understand whether these cells can have a role in the pathogenesis of OA associated CP\n* to investigate the potential confounding effect of other biological and psychological elements in the relationship between the MLM and OA pain progression\n\nResearchers will compare two study groups:\n\n1. Experimental group: subjects suffering from symptomatic knee OA. 1S)surgical subgroup: OA patients from the experimental group requiring primary TKA due to the failure of conservative treatment, thus undergoing surgical intervention;\n2. Control group: subjects without any chronic pain, undergoing occupational health surveillance matched by age, sex and psychological profile with the experimental group patients Participants will be asked to do blood sample collections at specific time points to evaluate MLM stability over time and its modulation according to pharmacological\u002Fsurgical and rehabilitation interventions. Subjects in the control group will undergo 2 blood sample collections. Pain assessment will be performed at all scheduled time points to correlate pain severity with Mu expression in B and NK cells.",[581,582],"Chronic Pain","Osteo Arthritis Knee",[584,585,586],"pain biomarkers","Mu opioid receptor","tailored therapy","2024-10-09",{"date":589,"type":44},"2024-10-15",{"date":591,"type":44},"2023-11-07",{"date":593,"type":21},"2026-04-28",{"name":50,"class":51},""]