[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Pavia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":645},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,46,81,115,148,179,207,228,261,291,318,347,376,406,428,451,480,507,535,565,584,609],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644086","comparison-of-digital-analysis-and-artificial-intelligence-for-cephalometric-tracing-100644086",false,"NCT07664488","Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing","Cephalometric Tracing: A Comparison Between Digital Analysis and Artificial Intelligence","Inclusion Criteria:\n\n* Availability of digital lateral cephalometric radiographs of adequate diagnostic quality\n* Radiographs acquired with patients in centric occlusion and proper head positioning using a cephalostat\n* Patients of any age and sex\n* Absence of congenital or acquired craniofacial anomalies\n* No previous orthodontic treatment\n* No previous orthognathic surgical treatment\n* Absence of agenesis of incisors or first molars\n* Absence of supernumerary teeth overlapping the region of interest\n\nExclusion Criteria:\n\n* Radiographs presenting artifacts or inadequate visualization of anatomical structures\n* History of significant craniofacial trauma\n* Radiographs acquired without a cephalostat\n* Presence of severe skeletal asymmetries\n* Incomplete clinical or radiographic records\n* Radiographs unsuitable for manual or AI-based cephalometric landmark identification","ALL",{"count":18,"type":19},100,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the accuracy and reliability of artificial intelligence (AI)-based cephalometric analysis compared with digital manual tracing. A total of 100 standardized lateral cephalometric radiographs will be analyzed using Delta-Dent software with manual landmark identification and three fully automated AI-based systems (WebCeph, QuantX, and Smartee). Sagittal, vertical, dental, and soft tissue cephalometric parameters will be compared among the different methods. Statistical analysis will assess inter-method agreement and the clinical relevance of any observed discrepancies. The study seeks to determine whether AI-based systems provide measurements comparable to conventional digital tracing and whether they can be considered reliable adjunctive tools in orthodontic diagnosis and treatment planning.",[23,24,25,26],"Cephalometric Analysis","Cephalometry","Artificial Intelligence (AI)","Artificial Intelligence (AI) in Diagnosis",[28,29,30,31,32],"artificial intelligence","cephalometric analysis","lateral cephalogram","landmark identification","automated cephalometric tracing","RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2026-06-01",{"date":41,"type":19},"2026-09-30",{"name":43,"class":44},"University of Pavia","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100643698","auto-calibrating-system-for-upper-limb-disability-assessment-neurological-and-occupational-rehabilitation-100643698","NCT07636538","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)","ASULDAR","Inclusion Criteria:\n\n* Adult patients aged between 18 and 80 years.\n* Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).\n* Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.\n* Ability to understand and follow the study protocol instructions.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.\n* Individuals unable to provide informed consent.\n* Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.\n* Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).\n* Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.\n* Unstable health conditions that could make device use unsafe or inappropriate, including unstable medical conditions or severe visual impairments.","18 Years","80 Years",{"count":57,"type":19},30,"INTERVENTIONAL",[60],"NA","This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI).\n\nThe system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data.\n\nThe main questions the study aims to answer are:\n\nIs the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales?\n\nResearchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes.\n\nThirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff.\n\nParticipants will undergo:\n\nBaseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.",[63,64,65,66],"Stroke","Amyotrophic Lateral Sclerosis","PARKINSON DISEASE (Disorder)","Mild Cognitive Impairment (MCI)",[68,69,70,71],"Collaborative Robot","Robotic rehabilitation","Neurological disorders","Graphical User Interface","NOT_YET_RECRUITING","2026-06-03",{"date":75,"type":37},"2026-06-09",{"date":77,"type":19},"2026-06",{"date":79,"type":19},"2026-10",{"name":43,"class":44},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":58,"phases":92,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100629446","understanding-alpha-synuclein-spread-in-parkinsons-disease-through-blood-biomarkers-and-neuroimaging-100629446","NCT07474779","Understanding Alpha-Synuclein Spread in Parkinson's Disease Through Blood Biomarkers and Neuroimaging","From Genes to Virtual Brain: Defining the Pathogenic Mechanisms Promoting Alfa-synuclein Seeding and Spreading in Parkinson's Disease.","SYNchronPD","Inclusion criteria for Parkinson's disease cohorts (GBA-PD and nonGBA-PD):\n\n* Diagnosis of PD according to MDS-PD criteria and, for the GBA-PD group, presence of heterozygous GBA mutations (with a balanced distribution of severe, risk, mild, and complex variants);\n* Disease duration between 3 and 7 years;\n* Disease stage according to Hoehn \\& Yahr ≤ 3;\n* Absence of mutations in other known genes associated with PD susceptibility;\n* Age \\> 18 Years;\n* Ability to understand and voluntarily sign informed consent and to comply with study procedures.\n\nExclusion criteria for Parkinson's disease cohorts:\n\n* Diagnosis of atypical and\u002For secondary parkinsonism;\n* Diagnosis of dementia according to DSM-5 criteria;\n* Presence of other neurological disorders and\u002For essential tremor;\n* Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment.\n\nInclusion criteria for unaffected subjects (GBA-nonPD and nonGBA-nonPD):\n\n* Age \\> 18 Years;\n* Ability to understand and voluntarily sign informed consent and to comply with study procedures;\n* No diagnosis of PD or other neurological disorders;\n* Presence of a heterozygous GBA mutation for the GBA-nonPD group and absence of such mutation for control subjects (nonGBA-nonPD);\n* Absence of mutations in other known genes associated with PD susceptibility.\n\nExclusion criteria for unaffected subjects (GBA-nonPD and nonGBA-nonPD):\n\n* Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment;\n* Diagnosis of atypical and\u002For secondary parkinsonism;\n* Diagnosis of dementia according to DSM-5 criteria.\n\nInclusion criteria for subjects with idiopathic REM Sleep Behavior Disorder (GBA-iRBD and nonGBA-iRBD):\n\n* Diagnosis of idiopathic REM Sleep Behavior Disorder according to ICSD-3;\n* Age \\> 18 Years;\n* Ability to understand and voluntarily sign informed consent and to comply with study procedures;\n* No diagnosis of PD or other neurological disorders;\n* Presence of a heterozygous GBA mutation for the GBA-iRBD group and absence of such mutation for the nonGBA-iRBD group;\n* Absence of mutations in other known genes associated with PD susceptibility.\n\nExclusion criteria for subjects with idiopathic REM Sleep Behavior Disorder (GBA-iRBD and nonGBA-iRBD):\n\n* Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment;\n* Diagnosis of atypical and\u002For secondary parkinsonism;\n* Diagnosis of dementia according to DSM-5 criteria.",true,{"count":91,"type":19},160,[60],"The project aims to investigate how abnormal accumulation of alpha synuclein and its interaction with tau influence brain function across the Parkinson's disease (PD) spectrum, with particular focus on individuals carrying GBA1 mutations. This interventional, monocentric, cross sectional study includes patients with PD, individuals with idiopathic REM sleep behavior disorder, and participants without PD.\n\nAll enrolled subjects will undergo clinical and neuropsychological assessments, blood based biomarker analyses related to neurodegeneration, synaptic and mitochondrial function, and multimodal brain MRI to evaluate brain structure, white matter integrity, and functional connectivity.\n\nThe study aims to:\n\n* characterize the relationship between alpha synuclein\u002Ftau pathology and synaptic mitochondrial dysfunction;\n* identify biomarker and connectivity signatures across disease stages and genetic backgrounds;\n* integrate preclinical, clinical, biological, and imaging data to support the development of mechanistic models of alpha synuclein propagation.\n\nIn parallel, preclinical studies in GBA PD mouse models and wild type mice will be used to investigate how changes in PD-related pathology (alpha-synuclein and tau) relates to behavior, brain imaging alterations and mitochondrial, axonal and synaptic damage. Animal model will also aid the validation of a new PET tracer that targets alpha synuclein (i.e., \\[¹⁸F\\]Syntacasyn).\n\nTogether, human and preclinical studies are designed to provide a translational framework integrating molecular changes with brain network alterations and clinical heterogeneity in PD.",[95,96,97],"Parkinson's Disease (PD)","GBA1 Parkinson Disease","REM Sleep Behavior Disorder (iRBD)",[99,100,101,102,103,104,105],"GBA1 carriers","Brain Connectivity","Virtual Brain","Extracellular vesicles","Mitochondrial Dysfunction","Mice Models","Translational Science","2026-04-27",{"date":108,"type":37},"2026-05-01",{"date":110,"type":19},"2026-05-11",{"date":112,"type":19},"2029-02",{"name":43,"class":44},2,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":58,"phases":125,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":45},"100598256","hydroxyapatite-based-home-treatment-for-dentin-sensitivity-in-celiac-patients-100598256","NCT07069127","Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients","Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial","CELIADENT","Inclusion Criteria:\n\n* Adults (≥18 years of age) with a confirmed diagnosis of celiac disease.\n* Presence of enamel defects (hypomineralization or demineralization).\n* Presence of active carious lesions.\n* Self-reported dentin hypersensitivity.\n* Willingness to comply with the study protocol and follow-up schedule.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Age below 18 years.\n* Absence of confirmed celiac disease.\n* Poor compliance or low motivation to participate in a 6-month study.\n* Ongoing treatment with products affecting enamel mineralization.\n* Pregnancy or breastfeeding.\n* Participation in another clinical trial within the previous 30 days.",{"count":124,"type":19},40,[60],"This single-center, randomized controlled clinical trial aims to evaluate the effectiveness of a home-based treatment using hydroxyapatite-based oral care products in adult patients with celiac disease who exhibit enamel demineralization and dentin hypersensitivity. Forty patients will be enrolled and randomly allocated into two parallel groups. The control group will perform home oral hygiene using only a hydroxyapatite-based toothpaste (Biorepair® Total Protection) twice daily. The trial group will follow the same regimen with the toothpaste, but will also apply a hydroxyapatite mousse (Biorepair® Plus Intensive Enamel Repair) once every evening before bedtime throughout the study period.\n\nThe primary objective is to assess the reduction in dentin hypersensitivity using the Schiff Air Index. Secondary outcomes include changes in plaque accumulation (Plaque Index), gingival bleeding (Bleeding on Probing), pain perception (Visual Analogue Scale), and caries experience (DMFT and DMFS indices). Enamel demineralization will be analyzed through near-infrared transillumination (DIAGNOcam), laser fluorescence (DIAGNOdent), and digital image analysis (ImageJ software).\n\nAll clinical parameters will be evaluated at baseline and after 1 week, 1 month, 3 months, and 6 months. The study seeks to determine whether the addition of a remineralizing mousse to daily oral care provides superior benefits in reducing sensitivity and improving enamel integrity in patients with celiac disease.",[128,129,130],"Celiac Disease","Dentin Hypersensitivity","Tooth Demineralization",[128,129,132,133,134,135,136,137,138,139],"Enamel Demineralization","Hydroxyapatite","Remineralizing Agents","Biorepair","Toothpaste","Oral Mousse","Dental Sensitivity","Randomized Controlled Trial","2026-04-22",{"date":142,"type":37},"2026-04-23",{"date":144,"type":37},"2025-07-30",{"date":146,"type":19},"2026-09-10",{"name":43,"class":44},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":89,"sex":16,"minAge":54,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":58,"phases":158,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":45},"100634694","amino-acids-and-exercise-in-fshd-100634694","NCT07543016","Amino Acids and Exercise in FSHD","Amino Acid Supplementation and Physical Exercise in Facioscapulohumeral Muscular Dystrophy: Effects on Body Composition and Physical Efficiency in a Model of Muscular Disease","Inclusion Criteria:\n\n1. Subjects of both sexes with a diagnosis of FSHD, confirmed by genetic testing.\n2. Age between 18 and 50 years.\n3. Belonging to clinical category A among the four defined in the Comprehensive Clinical Evaluation Form. These patients present the most characteristic signs of the disease: muscle weakness of the facial and scapular girdle.\n4. Clinical score ranging from 2 to 5.\n5. Preserved ability to walk at the time of enrollment.\n6. Absence of central or peripheral nervous system involvement based on neurological history and physical examination.\n7. Absence of scoliosis, limb contractures, and tendon retractions.\n\nExclusion Criteria:\n\n1. Use of beta-blocker medications;\n2. Psychological or psychiatric disorders;\n3. Musculoskeletal injuries that impair the ability to perform physical exercise;\n4. Recent medication adjustment, use of drugs that may affect fatigue, or use of fatigue-stimulating agents (e.g., Modafinil, amantadine);\n5. Ongoing participation in another clinical investigation involving a medical device or drug, or participation in such a study completed less than 30 days prior;\n6. Pregnant or breastfeeding women;\n7. Patients unable to understand the purpose and conditions of the study and unable to provide informed consent;\n8. Presence of additional diseases that may interfere with measurements;\n9. Patients deprived of liberty or under legal guardianship.\n\nHealthy participants will be age- and sex-matched adults without neuromuscular disease:\n\n1. no chronic disease;\n2. no neuromuscular disorders;\n3. Same age range.","50 Years",{"count":157,"type":19},48,[60],"This study evaluates whether amino acid supplementation, combined with a structured diet and exercise program, improves body composition (increased muscle mass and reduced fat mass) and physical performance in individuals with facioscapulohumeral muscular dystrophy (FSHD). The study also compares responses to the intervention between individuals with FSHD and healthy individuals matched for age and sex.",[161,162],"FSH Muscular Dystrophy","Muscular Dystrophy",[164,165,166,167,168,169,170],"amino acids supplementation","muscular dystrophy","amino acids","exercise","facioscapulohumeral muscular dystrophy","exercise training","nutritional supplementation","2026-04-17",{"date":173,"type":37},"2026-04-21",{"date":175,"type":37},"2026-04-08",{"date":177,"type":19},"2029-04",{"name":43,"class":44},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":89,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":187,"targetDuration":4,"studyType":58,"phases":189,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100634406","device-for-driving-simulation-for-the-rehabilitation-of-balance-and-proprioception-100634406","NCT07539272","Device for Driving Simulation for the Rehabilitation of Balance and Proprioception","A Multicenter Interventional Study on the Use of a Driving Simulator to Assess the Safety and Usability of the System and Its Impact on Motor and Cognitive Performance in the Rehabilitation of Patients With Neurological Disorders","DRIVESIM","Inclusion Criteria:\n\n* Patients: adults aged 18 to 80 years.\n* Patients: confirmed diagnosis of one of the following chronic neurological conditions: stroke, Parkinson's disease, amyotrophic lateral sclerosis (ALS), or mild cognitive impairment (MCI).\n* Patients: able to understand and follow study procedures and provide informed consent.\n* Healthy volunteers: adults aged 18 to 65 years.\n* Healthy volunteers: able to understand and follow study procedures and provide informed consent.\n* Healthy volunteers: rehabilitation staff members from the participating centers.\n\nExclusion Criteria:\n\n* Patients: severe psychiatric disorders or cognitive disorders that impair the ability to complete cognitive tests and self-report questionnaires.\n* Patients: unable to provide informed consent.\n* Patients: moderate to severe cognitive impairment, defined as an ECAS score below 81.92 in participants with ALS or a Raven's Matrices score below 18.36 in participants with mild cognitive impairment.\n* Patients: neurological or physical conditions that significantly limit lower-limb use and prevent standing on the platform, including lower-limb muscle strength of 3 or less on the Medical Research Council (MRC) scale.\n* Patients: body weight greater than 100 kg.\n* Patients: current or recent participation, within the last 3 months, in other rehabilitation programs or interventions that could affect study results.\n* Patients: alcohol or substance dependence that could compromise safety during training sessions.\n* Patients: unstable health conditions that could make use of the DRIVESIM and\u002For head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.\n* Healthy volunteers: health conditions that could make use of the DRIVESIM and\u002For head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.\n* Healthy volunteers: any motor disability.",{"count":188,"type":19},60,[60],"The DriveSim clinical trial investigates a dynamic driving simulator designed to train and assess functional motor and cognitive skills in individuals with neurological disorders. The study addresses a critical need in current rehabilitation practice, where maintaining patient engagement and providing ecologically valid training environments are essential yet challenging. Neurological conditions such as stroke, Parkinson's disease, amyotrophic lateral sclerosis and mild cognitive impairment often result in deficits in balance, proprioception, coordination, attention and motor planning, all of which critically affect daily functioning and driving ability. The novelty of this study lies in the integration of a three-degree-of-freedom motion platform with active steering, customizable haptic and inertial feedback, and adaptive task modules in a virtual urban scenario. This enables controlled, multisensory rehabilitation sessions that combine motor, vestibular and cognitive stimuli in a single system. The primary objective of the trial is to evaluate the safety, usability and feasibility of the DriveSim platform in both healthy individuals and patients with neurological impairment. Secondary objectives include assessing its impact on postural control, trunk and head stability, upper and lower limb motor performance, cognitive functions, perceived stress and fatigue, and quality of life. The study also aims to support the development of adaptive software capable of automatically adjusting task difficulty based on patient performance. By integrating functional tasks such as slalom, speed control, line keeping and reaction tests with customizable sensory feedback, this research has the potential to enhance the ecological validity of rehabilitation and to provide individualized motor-cognitive training. The expected outcome is a more engaging, adaptable and measurable rehabilitation pathway that may improve functional independence and support safer driving-related abilities in neurological populations.",[192,193],"Neurological Disorders","Health Adult Subjects",[195,196,197,198],"neurological rehabilitation","driving simulator","dynamic platform","motor-cognitive training","2026-04-13",{"date":201,"type":37},"2026-04-20",{"date":203,"type":19},"2026-04",{"date":205,"type":19},"2026-11",{"name":43,"class":44},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":89,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":214,"targetDuration":4,"studyType":58,"phases":215,"briefSummary":216,"conditions":217,"keywords":218,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":226,"leadSponsor":227,"locationsCount":4},"100631611","a-multicenter-interventional-study-on-the-use-of-a-3-degree-of-freedom-3dof-platform-to-evaluate-the-safety-and-usability-of-the-system-and-its-impact-on-balance-proprioception-and-neurological-deficits-in-the-rehabilitation-of-patients-with-neurological-disorders-100631611","NCT07502937","A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders.","3DOF","Inclusion Criteria:\n\n* Patients: adults aged 18 to 80 years.\n* Patients: confirmed diagnosis of one of the following chronic neurological conditions: stroke, Parkinson's disease, amyotrophic lateral sclerosis (ALS), or mild cognitive impairment (MCI).\n* Patients: able to understand and follow study procedures and provide informed consent.\n* Healthy volunteers: adults aged 18 to 65 years.\n* Healthy volunteers: able to understand and follow study procedures and provide informed consent.\n* Healthy volunteers: rehabilitation staff members from the participating centers.\n\nExclusion Criteria:\n\n* Patients: severe psychiatric disorders or cognitive disorders that impair the ability to complete cognitive tests and self-report questionnaires.\n* Patients: unable to provide informed consent.\n* Patients: moderate to severe cognitive impairment, defined as an ECAS score below 81.92 in participants with ALS or a Raven's Matrices score below 18.36 in participants with mild cognitive impairment.\n* Patients: neurological or physical conditions that significantly limit lower-limb use and prevent standing on the platform, including lower-limb muscle strength of 3 or less on the Medical Research Council (MRC) scale.\n* Patients: body weight greater than 100 kg.\n* Patients: current or recent participation, within the last 3 months, in other rehabilitation programs or interventions that could affect study results.\n* Patients: alcohol or substance dependence that could compromise safety during training sessions.\n* Patients: unstable health conditions that could make use of the 3DoF Platform and\u002For head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.\n* Healthy volunteers: health conditions that could make use of the 3DoF Platform and\u002For head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.\n* Healthy volunteers: any motor disability.",{"count":188,"type":19},[60],"This multicenter interventional study aims to evaluate a three-degrees-of-freedom dynamic platform (3DoF Platform) designed to support rehabilitation of balance, proprioception, and motor and cognitive functions in patients with neurological disorders. The device integrates a mobile platform capable of roll, pitch, and vertical translation movements, a markerless motion-capture system, and an interactive environment delivered through a monitor or virtual reality headset. Compared with conventional rehabilitation systems, it offers an additional vertical degree of freedom and increased proprioceptive stimulation, with the ability to customize exercises according to individual patient capabilities. The clinical conditions under investigation include Parkinson's disease, post-stroke motor impairment, amyotrophic lateral sclerosis, and mild cognitive impairment, all of which are associated with deficits in balance and proprioception. The novelty of this study lies in the combined use of the 3DoF platform, the markerless acquisition system, and exergames integrated with a mathematical model that adapts the platform's dynamic response in real time. The primary objective is to assess the usability, feasibility, and safety of the device. Secondary objectives include evaluating the impact of the intervention on balance, motor performance, cognitive functions, stress, fatigue, and quality of life, as well as comparing conventional rehabilitation with and without the addition of the device. The study involves 45 patients and 15 healthy volunteers and is structured into an initial phase of testing on healthy subjects and a subsequent randomized two-arm treatment phase for patients.",[192,193],[219,220,221,195],"3DoF Platform","proprioception","exergame","2026-03-31",{"date":224,"type":37},"2026-04-06",{"date":203,"type":19},{"date":205,"type":19},{"name":43,"class":44},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":58,"phases":238,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":45},"100630735","ozone-therapy-with-biomimetic-oral-care-for-cancer-related-oral-mucositis-100630735","NCT07491536","Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis","Combined Gas Ozone Therapy and Biomimetic Oral Care in the Management of Radio- and Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Clinical Trial","OZOMUC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of radio- and\u002For chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale\n* Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers\n* Clinically stable general health condition (ASA physical status I-III)\n* Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Oral mucositis grade 4 according to the WHO Oral Toxicity Scale\n* Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis)\n* Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease)\n* Ongoing head and neck radiotherapy with cumulative dose \\>70 Gy or completion within 7 days prior to enrollment\n* Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents\n* Systemic or topical therapies known to interfere with salivary function or mucosal healing (e.g., anticholinergics, tricyclic antidepressants, diuretics)\n* Known allergy or hypersensitivity to components of the oral care products or materials used during ozone therapy\n* Severe or uncontrolled systemic diseases (including hepatic, renal, respiratory, or cardiac insufficiency)\n* Severe immunosuppression or neutropenia (neutrophils \\\u003C1,000\u002Fmm³)\n* Pregnancy or breastfeeding\n* Alcohol or substance abuse, or any condition that may compromise adherence to the protocol\n* Inability to attend scheduled follow-up visits through Day 30",{"count":237,"type":19},50,[60],"Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment.\n\nThis randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone.\n\nEligible participants will be randomly assigned to one of two parallel groups. The control group will receive gas ozone therapy administered in an outpatient setting according to a standardized protocol. The experimental group will receive the same ozone therapy combined with a defined home oral care regimen. Each participant will be followed for 30 days.\n\nThe primary outcome is the change in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale. Secondary outcomes include oral pain intensity, salivary flow rates, perceived dry mouth, taste alterations, swallowing function, oral pH, overall oral health-related quality of life, and treatment tolerability.\n\nThe findings of this study are expected to clarify the role of ozone-based supportive care strategies in the management of cancer therapy-related oral mucositis and to contribute to the development of standardized non-pharmacological treatment protocols.",[241,242,243],"Oral Mucositis","Chemotherapy-induced Oral Mucositis","Head and Neck Neoplasms",[245,246,247,248,249,250,251,252,139],"Ozone Therapy","Cancer Treatment-Induced Oral Mucositis","Supportive Oncology","Non-Pharmacological Treatment","Head and Neck Cancer","Oral Toxicity","Salivary Function","Xerostomia","2026-03-19",{"date":255,"type":37},"2026-03-24",{"date":257,"type":19},"2026-03-01",{"date":259,"type":19},"2026-12-15",{"name":43,"class":44},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":58,"phases":271,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":288,"leadSponsor":290,"locationsCount":45},"100598259","para-probiotic-oral-care-in-periodontal-patients-with-type-2-diabetes-100598259","NCT07069166","Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes","Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial","PPDM2","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Diagnosis of periodontitis (Stage II or III; Grade B or C)\n* Presence of at least one periodontal pocket per side of the mouth, with a maximum of 20 teeth presenting pathological probing depths\n* Presence of both single- and multi-rooted teeth\n* Type 2 diabetes mellitus diagnosed at least one year prior to enrollment\n* Good general health status and ability to comply with study protocol\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Presence of cardiac pacemakers\n* History of neurological disorders\n* History of psychiatric disorders\n* Current pregnancy or breastfeeding\n* Steroid-induced diabetes mellitus\n* Inability or unwillingness to attend follow-up visits or adhere to home oral care instructions","70 Years",{"count":124,"type":19},[60],"This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM).\n\nA total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule.\n\nClinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2.\n\nThe primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction.\n\nThis study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.",[274,275],"Periodontitis","Type 2 Diabetes Mellitus (T2DM)",[277,274,278,135,279,280,281,282,283],"Para-probiotics","Type 2 Diabetes Mellitus","Oral microbiota","Glycated hemoglobin (HbA1c)","Chlorhexidine","Non-surgical periodontal therapy","Randomized controlled trial","2026-02-19",{"date":286,"type":37},"2026-02-20",{"date":144,"type":37},{"date":289,"type":19},"2026-06-10",{"name":43,"class":44},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":269,"enrollmentInfo":299,"targetDuration":4,"studyType":58,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":45},"100603717","trehalose-vs-glycine-air-polishing-in-peri-implant-mucositis-treatment-100603717","NCT07140146","Trehalose vs Glycine Air-Polishing in Peri-Implant Mucositis Treatment","Comparison of Trehalose and Glycine Air-Polishing Powders in the Supportive Treatment of Peri-Implant Mucositis and Their Effect on Implant Surface Integrity: A Randomized Controlled Clinical Trial","TREAL-G","Inclusion Criteria:\n\n* Adults aged between 18 and 70 years\n* Presence of peri-implant mucositis, defined as bleeding on probing (BoP) around implants without radiographic evidence of bone loss beyond initial remodeling\n* Visible biofilm on implant surfaces\n* Ability to understand and sign informed consent\n* Good oral hygiene and patient compliance\n* Availability for all follow-up visits (1, 3, and 6 months)\n\nExclusion Criteria:\n\n* Presence of systemic conditions that may affect healing (e.g., uncontrolled diabetes, immunosuppression)\n* Current smokers or former smokers who quit less than 6 months ago\n* Pregnant or breastfeeding women\n* Use of antibiotics or anti-inflammatory drugs in the 3 months prior to baseline\n* Presence of peri-implantitis (i.e., bleeding on probing with concomitant radiographic bone loss)\n* History of head and neck radiotherapy\n* Presence of pacemakers or cardiac stimulators\n* Neurological or psychological disorders affecting study compliance",{"count":124,"type":19},[60],"This randomized controlled clinical trial investigates the effectiveness of trehalose powder compared to glycine powder when used in air-polishing during supportive therapy for peri-implant mucositis, a reversible inflammatory condition affecting the soft tissues around dental implants.\n\nA total of 40 adult patients with peri-implant mucositis will be enrolled and randomly assigned to receive non-surgical periodontal therapy combined with air-polishing using either trehalose powder (test group) or glycine powder (control group). Clinical parameters will be evaluated at baseline, 1 month, 3 months, and 6 months. These include Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), and Bleeding Score (BS), in order to assess plaque accumulation, inflammation, and bleeding.\n\nThe primary objective is to compare the reduction in plaque levels between the two groups over the study period. Secondary outcomes include evaluation of changes in gingival inflammation and probing depths, as well as assessment of implant surface integrity through in vitro scanning electron microscopy (SEM) after treatment.\n\nThe aim of the study is to determine whether trehalose powder offers improved clinical outcomes and greater implant surface preservation compared to glycine powder in the non-surgical management of peri-implant mucositis.",[303],"Peri-implant Mucositis",[305,306,307,308,309,310,311,139,312],"Peri-Implant Mucositis","Trehalose Powder","Glycine Powder","Air Polishing","Dental Implants","Implant Surface Integrity","Biofilm Removal","Scanning Electron Microscopy (SEM)",{"date":286,"type":37},{"date":315,"type":37},"2025-08-30",{"date":289,"type":19},{"name":43,"class":44},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":326,"maxAge":54,"enrollmentInfo":327,"targetDuration":4,"studyType":58,"phases":328,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":45},"100598263","hydroxyapatite-toothpastes-and-enamel-remineralization-100598263","NCT07069218","Hydroxyapatite Toothpastes and Enamel Remineralization:","Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: A Randomized Controlled Trial","HEREMI","Inclusion Criteria:\n\n* Subjects aged between 6 and 18 years\n* Ability to understand and follow instructions in Italian or English\n* Signed written informed consent provided by the parent\u002Flegal guardian and assent from the minor\n* Good cooperation and adherence to clinical instructions\n* Fully erupted permanent first molars and upper central incisors in good general condition\n* DIAGNOdent Pen baseline values in the C1 (0-12) or C2 (13-24) range\n\nExclusion Criteria:\n\n* DIAGNOdent Pen values greater than 25\n* Ongoing systemic antibiotic therapy\n* Presence of sealants or composite restorations on first permanent molars or upper central incisors\n* Severe enamel alterations such as molar-incisor hypomineralization (MIH), fluorosis, or extensive white\u002Fbrown spot lesions\n* Poor motivation or limited compliance with study procedures","6 Years",{"count":124,"type":19},[60],"This randomized controlled clinical trial aims to evaluate the efficacy of two commercially available toothpastes containing hydroxyapatite in the remineralization of early enamel lesions. The study compares Biorepair® Total Protection Plus, which contains biomimetic microRepair particles, with Bioniq® Repair, a conventional hydroxyapatite-based toothpaste.\n\nForty participants will be randomly assigned to either the trial group (Biorepair®) or the control group (Bioniq®), and both groups will receive quarterly professional dental cleanings and use the assigned toothpaste twice daily for 6 months.\n\nThe primary outcome is the change in enamel demineralization, assessed by DIAGNOdent Pen scores, in permanent molar fissures and upper central incisors. Secondary outcomes include enamel integrity assessed by DIAGNOcam imaging and ICDAS scores, as well as changes in dental sensitivity (Schiff Air Index), erosive wear (BEWE Index), plaque accumulation (Plaque Index), gingival inflammation (Bleeding Index), and extrinsic stains (Modified Lobene Stain Index). Patient satisfaction will also be evaluated at the end of the study using a self-administered questionnaire.\n\nThis study will help determine whether biomimetic hydroxyapatite offers superior benefits in maintaining enamel health compared to conventional formulations, supporting evidence-based preventive strategies in dental care.",[331,332],"Enamel Hypomineralization","Tooth Erosion",[334,335,336,337,332,338,339,340,139,341],"Hydroxyapatite Toothpaste","Enamel Remineralization","DIAGNOcam","DIAGNOdent","Dentin Sensitivity","Dental Plaque","Oral Health","Preventive Dentistry",{"date":286,"type":37},{"date":344,"type":37},"2025-07-25",{"date":289,"type":19},{"name":43,"class":44},{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":355,"minAge":54,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":58,"phases":358,"briefSummary":359,"conditions":360,"keywords":365,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":374,"leadSponsor":375,"locationsCount":45},"100598257","lactoferrin-based-oral-care-for-periodontal-health-in-pregnancy-100598257","NCT07069140","Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy","Effectiveness of an Oral Care Protocol Based on Lactoferrin Toothpaste and Mouthwash in Pregnant Women for the Prevention of Periodontal Disease: A Randomized Controlled Clinical Trial","LBC-PREG","Inclusion Criteria:\n\n* Pregnant women aged between 18 and 45 years\n* Gestational age between 14 and 28 weeks at the time of enrollment (second trimester)\n* Diagnosis of periodontitis according to the 2017 World Workshop classification (Stages I-III, Grades A-B)\n* Presence of at least 20 natural teeth\n* Willingness to comply with study procedures and attend follow-up visits\n* Signed informed consent\n\nExclusion Criteria:\n\n* History of systemic diseases that could affect periodontal status (e.g., diabetes mellitus, immunosuppression)\n* Antibiotic or anti-inflammatory therapy within 3 months prior to enrollment Current use of probiotics, antioxidant supplements, or medicated mouthwashes\n* Periodontal treatment within 6 months before enrollment\n* High-risk pregnancy or pregnancy complications (e.g., preeclampsia, gestational diabetes)\n* Smoking or tobacco use\n* Known allergy to any of the investigational product components\n* Participation in another clinical trial within the previous 3 months","FEMALE","45 Years",{"count":124,"type":19},[60],"This randomized controlled clinical trial aims to evaluate the effectiveness of a lactoferrin-based oral hygiene protocol in improving periodontal health during pregnancy. Forty pregnant women between the fourth and eighth month of gestation will be enrolled and randomly assigned to one of two groups. The trial group will undergo professional dental cleaning every three months and will perform home oral hygiene using both a lactoferrin-based toothpaste and a lactoferrin-based mouthwash (Emoform Glic) twice daily. The control group will follow the same schedule of professional dental cleanings but will use only the lactoferrin-based toothpaste (Emoform Glic) at home. The primary objective is to assess the reduction in dental plaque, measured by the Plaque Index (PI). Secondary outcomes include improvements in gingival inflammation, probing pocket depth, clinical attachment level, and other periodontal indices. Participants will be followed for six months, with evaluations conducted at baseline, 1, 3, and 6 months.",[361,362,363,364],"Pregnancy","Periodontal Disease","Gingivitis","Oral Microbiota",[366,361,362,364,339,363,367,136,368,369,370,139,371],"Lactoferrin","Non-surgical Periodontal Therapy","Mouthwash","LBC Complex","Maternal Oral Health","Oral Hygiene in Pregnancy",{"date":286,"type":37},{"date":144,"type":37},{"date":289,"type":19},{"name":43,"class":44},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":355,"minAge":54,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":58,"phases":385,"briefSummary":386,"conditions":387,"keywords":391,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":405,"locationsCount":45},"100595200","effectiveness-of-coenzyme-q10-and-probiotics-in-periodontal-therapy-during-pregnancy-100595200","NCT07029360","Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy","Adjunctive Use of Coenzyme Q10 and Probiotics to Improve Periodontal Health in Pregnant Women: A Randomized Controlled Trial","PREG-Q10","Inclusion Criteria:\n\n* Pregnant women between the 4th and 8th month of gestation\n* Age ≥ 18 years\n* Able to understand and communicate in Italian and\u002For English\n* Willing to provide written informed consent\n* Good compliance and willingness to follow study instructions\n\nExclusion Criteria:\n\n* Presence of cardiac pacemakers\n* Diagnosed psychological, neurological, or psychiatric disorders\n* Ongoing oncological therapy\n* Use of bisphosphonates within the last 12 months\n* Poor motivation or low compliance\n* Substance abuse (drugs or alcohol) or lifestyle incompatible with study requirements",{"count":124,"type":19},[60],"This randomized controlled clinical trial aims to evaluate the effectiveness of adjunctive coenzyme Q10 and probiotic supplementation (Limosilactobacillus reuteri Prodentis®) in improving periodontal health in pregnant women undergoing non-surgical periodontal therapy. Forty participants will be randomly assigned to two groups: the test group will receive professional oral hygiene every three months along with a coenzyme Q10-based toothpaste and daily probiotic supplementation; the control group will follow the same protocol without probiotics. The primary outcome is the reduction of the Plaque Index (PI), while secondary outcomes include Bleeding on Probing (BoP), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), gingival inflammation (MGI, PMGI), plaque distribution (PCR%, API), and gingival recession (R). The study duration is 6 months. The goal is to assess whether this combined therapy can promote a balanced oral microbiota and enhance periodontal health during pregnancy.",[361,362,363,339,388,389,390],"Probiotics","Coenzyme Q10","Microbiota",[392,393,389,339,394,363,395,390,396,364,397,398,399,361,400,388,139],"Bleeding on Probing","Clinical Attachment Loss","Gingival Inflammation","Limosilactobacillus reuteri","Non-Surgical Periodontal Treatment","Periodontal Therapy","Plaque Control","Plaque Index","Pregnant Women",{"date":286,"type":37},{"date":403,"type":37},"2025-07-01",{"date":289,"type":19},{"name":43,"class":44},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":89,"sex":16,"minAge":414,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":58,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":425,"leadSponsor":427,"locationsCount":4},"100625322","the-pause-learn-and-activate-yourself-play-100625322","NCT07421128","The Pause, Learn, and Activate Yourself (PLAY)","Active Breaks in School: The Pause, Learn, and Activate Yourself (PLAY) Cluster-Randomized Controlled Trial","PLAY","Inclusion Criteria:\n\n* Regular participation in school activities and physical education classes.\n* Ability to understand and follow the instructions related to the study protocol.\n* Enrollment in the study through verbal assent from the child and written informed consent from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Any medical contraindication to participation in physical activity.\n* Musculoskeletal injuries occurring within the three months prior to baseline assessment.\n* Physical or cognitive limitations that prevent participation in the planned activities.","5 Years","12 Years",{"count":417,"type":19},810,[60],"Many children spend a large part of the school day sitting, which can limit their opportunities to be physically active. Regular physical activity is important for children's physical health, mental well-being, and positive attitudes toward movement. Schools represent an ideal setting to promote healthy behaviors, as they reach nearly all children on a daily basis.\n\nThis study aims to evaluate the effects of short, classroom-based Active Breaks on children attending primary school. Active Breaks are brief periods of physical activity integrated into regular classroom lessons. These activities are designed to be fun, safe, and easy to perform in the classroom, without reducing academic teaching time.\n\nThe main goal of the study is to assess whether participating in Active Breaks improves children's enjoyment of physical activity. Enjoyment is an important factor because children who find physical activity enjoyable are more likely to stay active over time. The study also examines whether Active Breaks influence physical activity levels, basic motor skills, physical fitness perception, attention and executive functions, vitality, and quality of life.\n\nThe intervention lasts 12 weeks and is carried out during the normal school timetable. In the intervention group, children perform one Active Break during each school hour. Each break lasts approximately 5 minutes and includes playful aerobic and strength-based movements that require little or no equipment. The activities are guided by classroom teachers, who receive specific training and materials before the start of the study. A comparison group continues with the usual classroom routine without Active Breaks.\n\nParticipation in the study is voluntary. Parents or legal guardians provide written informed consent, and children provide verbal assent. All activities are appropriate for primary school children and are conducted in a safe and supervised environment. Children may withdraw from the study at any time without any consequences.\n\nThe results of this study may help schools and policymakers understand whether simple, low-cost strategies such as Active Breaks can promote healthier and more active school days for children.",[421],"Children","2026-02-16",{"date":284,"type":37},{"date":422,"type":19},{"date":426,"type":19},"2026-09-15",{"name":43,"class":44},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":16,"minAge":415,"maxAge":269,"enrollmentInfo":435,"targetDuration":4,"studyType":58,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":114},"100589146","associations-between-dental-anomalies-and-ocular-cutaneous-and-skin-appendages-features-100589146","NCT06950619","Associations Between Dental Anomalies and Ocular, Cutaneous and Skin Appendages Features","A Clinical Investigation Into the Co-occurrence of Dental Anomalies With Ocular and Cutaneous Features","Inclusion Criteria:\n\n* Supernumerary teeth\n* oligodontia\n* screw driver sharped incisors\n* Hutchinson's teeth\n* mulberry molars\n* tooth agenesis\n* congenital cataract, keratitis, keratoconus, corneal dystrophies, ectopia lentis, glaucoma, retinitis pigmentosa, coloboma and aniridia in probands or relatives\n* skin appendages anomalies in probands or relatives\n\nExclusion Criteria:\n\n* Previous orthodontic, restorative, endodontic, prosthetic and surgical treatment that could alter tooth morphology and position",{"count":436,"type":19},5,[60],"Considering recent literature, it is possible to hypothesise a link between dental anomalies and ocular and\u002For cutaneous findings, given the existence of shared genetic and developmental mechanisms between these two anatomical areas. Both the eye and teeth develop from ectodermal and mesenchymal tissues, involving common molecular signalling pathways such as Wnt, BMP and PAX. Genetic variants affecting these pathways can therefore determine combined phenotypes, such as congenital cataracts associated with dental agenesis or enamel malformations. Some rare genetic syndromes, such as Nance-Horan syndrome and oculofacio-cardio-dental (OFCD) syndrome, support the hypothesis of a systemic correlation between odontogenesis and ocular development. In a previous study on congenital cataracts, nearly 10% of probands with variants in the BCOR, CWC27, IFIH1, NHS, and PAX6 genes had various dental abnormalities. Therefore, exploring the possible connection between eye and dental diseases may not only facilitate early and multidisciplinary diagnosis, but also open up new perspectives in genetic research and the development of personalised therapeutic approaches, for which whole genome sequencing (WGS) appears to be the first choice for investigating non-syndromic forms. Therefore, the current clinical study aims to identify variants in genes common to eye diseases and dental anomalies (agenesis, supernumerary teeth, Hutchinson's teeth, mulberry molars) in orthodontic patients over the age of 12 with dental anomalies who are about to begin orthodontic treatment or who are attending routine check-ups at the Orthodontics and Paediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic and Paediatrics Sciences at the University of Pavia who have a family history of ocular and cutaneous manifestations or presenting at the same time dental, ocular and\u002For cutaneous anomalies. Patients who are eligible will be invited to participate in the study. After signing the informed consent form, the Case Report Form will be completed to collect the data of interest for the study; previous medical reports will be asked to patients or parents\u002Flegal guardians in case of minors to ascertain ocular and cutaneous pathologies; a buccal swab will be taken to collect a DNA sample that will be analysed with Next Generation Sequencing. In addition, cephalometric evaluations will be performed if lateral teleradiographs will be available, if already performed in accordance with Good Clinical Practice for the purposes of orthodontic assessment of patients.",[440,441,442],"Congenital Cataract","Tooth Abnormalities","Ocular Pathologies","2025-11-14",{"date":445,"type":37},"2025-11-19",{"date":447,"type":19},"2026-02",{"date":449,"type":19},"2027-04",{"name":43,"class":44},{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":269,"enrollmentInfo":459,"targetDuration":4,"studyType":58,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":477,"leadSponsor":479,"locationsCount":45},"100599760","natural-bioactive-gel-for-peri-implantitis-100599760","NCT07088679","Natural Bioactive Gel for Peri-Implantitis","Efficacy of a Natural Bioactive Gel as an Adjunct to Standard Therapy in the Treatment of Peri-Implantitis: A Randomized Controlled Split-Mouth Clinical Trial","PERISTER","Inclusion Criteria:\n\n* Patients aged between 18 and 70 years\n* Presence of peri-implantitis involving at least two dental implants located in different quadrants\n* Presence of bleeding and\u002For suppuration on probing\n* Increased probing depth (PD) and radiographic bone loss compared to previous examinations\n* In the absence of previous clinical data: PD ≥ 6 mm and bone loss ≥ 3 mm apically from the coronal portion of the intraosseous implant area (radiographically assessed)\n* Willingness and ability to comply with study protocol and follow-up visits\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Patients with cardiac pacemakers or other implanted electronic devices\n* Neurological or psychiatric disorders that may interfere with study participation\n* Systemic diseases, metabolic disorders, or autoimmune conditions\n* Pregnancy or lactation Current participation in other clinical trials",{"count":460,"type":19},20,[60],"This study is a randomized controlled clinical trial using a split-mouth design to evaluate the effectiveness of a natural bioactive gel (Sterify Gel®) as an adjunct to standard non-surgical therapy for peri-implantitis. Peri-implantitis is an inflammatory disease that affects the tissues around dental implants and can lead to bone loss and implant failure. The goal of the study is to determine whether the application of Sterify Gel®, which contains polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, can improve clinical outcomes when used in addition to conventional mechanical debridement and air-polishing.\n\nThe trial will include 20 patients, each with at least two implants in different quadrants affected by peri-implantitis. One implant will be treated with standard therapy plus the gel (test site), while the other will receive standard therapy alone (control site). Clinical outcomes will be measured over a 9-month period, including plaque levels, bleeding on probing, probing depth, suppuration, and bone loss. The results will help assess whether this gel enhances the effectiveness of routine non-surgical peri-implantitis treatment.",[464,309,367],"Peri-implantitis",[464,466,467,468,469,470,471,472,283],"Dental implants","Bioactive gel","Sterify Gel","Non-surgical therapy","Split-mouth design","Oral biofilm","Mechanical debridement","2025-08-17",{"date":475,"type":37},"2025-08-22",{"date":144,"type":37},{"date":478,"type":19},"2026-05-30",{"name":43,"class":44},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":89,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":58,"phases":489,"briefSummary":490,"conditions":491,"keywords":494,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100587093","potassium-nitrate-gel-and-diode-laser-in-the-treatment-of-dentinal-hypersensitivity-100587093","NCT06923904","Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity","PotassiumNitra","The inclusion criteria will be as follows: (a) a good standard of home oral hygiene and (b) at least two teeth affected by DH.\n\nThe exclusion criteria will be: (a) individuals taking pain relievers; (b) individuals undergoing orthodontic treatment; (c) non-vital teeth; (d) teeth with restorative materials; and (e) pregnant or breastfeeding women",{"count":488,"type":19},12,[60],"Our aim will be to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. Dental hypersensitivity (DH) will be assessed pre- (T0) and post-treatment (T1) and at 1 month (T2), 3 months (T3), and 6 months (T4).",[492,493],"Dentistry","Desensitization",[495,496,497,498],"desensitizing treatment","diode laser","oral hygiene","dental sensitivity","2025-04-04",{"date":501,"type":37},"2025-04-11",{"date":503,"type":19},"2025-04-15",{"date":505,"type":19},"2025-10-30",{"name":43,"class":44},{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":89,"sex":16,"minAge":514,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":58,"phases":516,"briefSummary":517,"conditions":518,"keywords":521,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":45},"100583144","meditation-and-psychophysical-well-being-in-elderly-100583144","NCT06872502","Meditation and Psychophysical Well-Being in Elderly","Mindfulness-based Intervention for Psychophysical Well-Being in the Italian Elderly","Inclusion Criteria:\n\n* Understanding of the Italian language\n* Age ≥ 65 years\n* No cognitive impairment, as measured by the Addenbrooke's Cognitive Examination (ACE-R)\n\nExclusion Criteria:\n\n* Presence of severe mental disorders and\u002For significant medical conditions\n* Substance dependence","65 Years",{"count":188,"type":19},[60],"The goal of this experimental study is to assess whether a mindfulness-based meditation intervention can reduce loneliness and improve psychophysical well-being in older adults (aged 65 and above).\n\nThe main questions it aims to answer are:\n\n* Does the intervention reduce the perception of loneliness in older adults? (primary outcome)\n* Does it improve various aspects of psychological well-being, including social isolation, depression, life satisfaction, mindfulness, emotional regulation, self-acceptance, and sleep quality? (secondary outcomes) Researchers will compare the intervention group with a passive control group (waiting-list control) to determine whether the mindfulness-based intervention leads to significant improvements in the measured outcomes.\n\nParticipants will:\n\nComplete baseline assessments, including neuropsychological tests and validated questionnaires, before the intervention.\n\nUndergo a 12-session mindfulness-based intervention over 6 weeks, consisting of guided breathing, focused attention, physical relaxation, and emotional awareness exercises.\n\nComplete post-intervention assessments to measure changes in their psychological and physiological well-being.",[519,520],"Loneliness","Psychophysical Well-being",[522,523,524,525,526],"mindfulness","elderly","loneliness","social isolation","wellbeing","2025-03-13",{"date":529,"type":37},"2025-03-19",{"date":531,"type":37},"2025-02-15",{"date":533,"type":19},"2025-11-01",{"name":43,"class":44},{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":89,"sex":16,"minAge":54,"maxAge":514,"enrollmentInfo":543,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":545,"conditions":546,"keywords":551,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":45},"100583854","lifestyle-and-nutrition-evaluation-in-physically-active-people-and-athletes-100583854","NCT06881745","Lifestyle and Nutrition Evaluation in Physically Active People and Athletes","NUTRI_ACTIVE Study: Lifestyle and Nutrition Evaluation in Physically Active People and Athletes","NUTRI_ACTIVE","Inclusion Criteria:\n\n* Age: ≥ 18 years old and ≤ 65 years old\n* Regular physical activity (at least 150 minutes of moderate-intensity aerobic physical activity; or at least 75 of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week)\n* All genders\n\nExclusion Criteria:\n\n* Sedentary population: \\\u003C 150 minutes of moderate-intensity aerobic physical activity or \\\u003C 75 minutes of vigorous-intensity aerobic physical activity throughout the week\n* Age: \\\u003C 18 years old and \\> 65 years old\n* Presence of diseases (i.e. diabetes, hypertension, dyslipidemia, metabolic syndrome, neurological diseases,…) and\u002For injuries",{"count":544,"type":19},181,"The goal of this observational study is to explore the dietary intake, nutrition knowledge and body composition in Italian athletes and physically active adults. This is a nonprofit study aimed at improving clinical practice. The main questions it aims to answer are:\n\n* Assessment of level of adherence to Mediterranean Diet using MEDI-LITE questionnaire\n* Assessment of nutrition knowledge\n* Current dietary intake and eating habits evaluation and comparison to the recommendations, according to sport practised\n* Eating behaviour assessment\n\nParticipants will undergo the following assessments: anthropometric and body composition assessments, Resting Metabolic Rate measurement, Dietary intake assessment, Nutrition knowledge, Lifestyle and behaviour, Physical activity assessment.",[547,548,549,550],"Dietary Habits","Nutritional Status","Body Composition","Athlete",[552,553,554,555,556],"Mediterranean Diet","Physical Activity","Athletes","Nutritional status","Nutrition knowledge","2025-03-11",{"date":559,"type":37},"2025-03-18",{"date":561,"type":37},"2024-07-05",{"date":563,"type":19},"2026-02-28",{"name":43,"class":44},{"id":566,"slug":567,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":11,"sex":16,"minAge":326,"maxAge":572,"enrollmentInfo":573,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":583,"locationsCount":45},"100553383","electromiographic-evaluation-and-skeletal-parameters-of-patients-requiring-orthodontic-treatment-100553383","NCT06485375","Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment","Electromiographic Evaluation and Skeletal Parameters of Patients Requiring Orthodontic Treatment: a Prospective Cross-sectional Study","Inclusion Criteria:\n\n* Patients needing an orthopaedic and\u002For orthodontic treatment\n* Deciduous, mixed, or permanent dentition\n\nExclusion Criteria:\n\n* Systemic diseases or congenital anomalies affecting craniofacial growth or development\n* Signs or symptoms of temporomandibular disorder (TMD)\n* Dental Pain\n* Past maxillofacial surgery","25 Years",{"count":237,"type":19},"The relationship between form and function within the craniofacial complex has been investigated by several Authors. However, there is still controversy regarding the different electromyographic activation patterns of the elevator muscles of the jaw. One particularly contentious area of enquiry is whether it is facial morphology that determines the strength of muscle activation, or whether a strong musculature can influence skeletal growth processes.\n\nIn light of the aforementioned considerations, the objective of the current clinical observational study was to investigate the potential correlation between the electromyographic activity of selected masticatory muscles (masseter, anterior temporalis and suprahyoid) and the craniofacial morphology of subjects under examination, with a particular focus on elucidating the mechanical advantage derived from different sagittal relationships between the maxillae. The electromyographic evaluation is carried out before the beginning of the orthodontic treatment (T0).",[576],"Skeletal Malocclusion","2024-06-28",{"date":579,"type":37},"2024-07-03",{"date":579,"type":19},{"date":582,"type":19},"2024-09-25",{"name":43,"class":44},{"id":585,"slug":586,"hasResults":11,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":89,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":58,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":608,"locationsCount":114},"100552580","adapting-food-culture-to-the-mediterranean-pattern-for-international-students-in-italy-100552580","NCT06474936","Adapting Food Culture to the Mediterranean Pattern for International Students in Italy","Nutritional Health Assistance for Adapting Food Culture to the Mediterranean Pattern for International Students at the University of Pavia (MeditEat)","MeditEat","Inclusion Criteria:\n\n* ≥ 18 years old\n* Able to understand English or Italian\n* Nationality diverse than Italian\n* Absence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.\n\nExclusion Criteria:\n\n* ≤18 years old;\n* Italian nationality;\n* Presence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.",{"count":593,"type":19},23,[60],"The goal of this clinical trial is to describe the adherence to the Mediterranean diet, the nutritional status, the level of physical activity, and possible eating disorders in international students attending the University of Pavia before and after a food education intervention. The main questions it aims to answer are:\n\nDoes the intervention of food education change the nutritional status of the international students of the University of Pavia? Does the intervention of food education change the level of physical activity of international students of the University of Pavia? Does the intervention of food education change the possible risk of eating disorders related to the possible change of diet from the country of origin of international students? Researchers will compare the measurements done at the first meeting to the measurements made at the last meeting (6 months) to see if the food educational intervention helped the students.\n\nParticipants will:\n\n* have the body composition analysed by anthropometric measurements (weight, height, electric bio impedance)\n* Receive personalized guidance and support from our team of experts for 6 months.\n\nVisit the clinic 3 times (beginning, 3 months, and by the end of 6 months) for check-ups and tests, and participate in online meetings the other 3 months (second, fourth, and fifth).\n\nAnswer online questionnaires and perform a 3-day food diary (beginning, 3 months, and by the end of 6 months).",[597,598,599,600,601],"Physical Inactivity","Eating Disorders","Eating Habit","Diet, Healthy","Diet Habit","2024-06-19",{"date":604,"type":37},"2024-06-26",{"date":606,"type":37},"2024-05-01",{"date":533,"type":19},{"name":43,"class":44},{"id":610,"slug":611,"hasResults":11,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":89,"sex":16,"minAge":617,"maxAge":618,"enrollmentInfo":619,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":621,"conditions":622,"keywords":626,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":4},"100436241","limit-early-adiposity-rebound-in-children-100436241","NCT04960670","LIMIT Early Adiposity Rebound in Children","LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children","LIMIT","* Inclusion criteria: i) Infants of both sexes born to vaginal\u002Fcaesarean delivery; ii) Gestational age: 37-42 weeks; iii) Italian-speaking parent; iv) 7 Ability of the parent\u002Fguardian to give informed consent; v) Ability of the mother to answer questionnaires.\n* Exclusion Criteria: i) Infants with genetic\u002Fcongenital diseases; ii) Infants selected for another clinical study; iii) Infants hospitalized immediately after birth; iv) Presence of gestational diabetes; v) Presence of hyperthyroidism during pregnancy; vi) Parents refusing to sign the informed consent.","1 Day","48 Months",{"count":620,"type":19},150,"Childhood obesity is a strong predictor of adult obesity with health and economic consequences for the individual and society. Adiposity rebound (AR) is a rise in the Body Mass Index occurring between 3-7 years. Early adiposity rebound (EAR) occurs at a median age of 2 years and is a risk factor for later obesity. Events happening in \"the first 1,000 days\" play a role in obesity development. One of the key elements in this crucial time window is the gut microbiome, a highly dynamic organ that is sensitive to environmental exposure being linked to obesity development. Prenatal (dietary\u002Flifestyle maternal factors and environmental exposure) and postnatal determinants (the type of feeding, sleep patterns, speed of growth) and environmental obesogenic pollutants may influence the infant microbial colonization, thus increasing the risk of EAR onset.\n\nLIMIT will holistically identify the longitudinal interplay between the intestinal microbiome and infant\u002Fmaternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with AR vs EAR, driving new mechanistic insights to create an EAR predictive model.\n\nThe study will evaluate a group of 150 mother-infant pairs, during the first four years of life at different follow-up.",[623,624,625],"Childhood Obesity","Life Style","Intestinal Microbiome",[627,628,629,630,631,632,633,634,635,636],"childhood obesity","maternal lifestyle","gut microbiome","adiposity rebound","fetal programming","first thousand days","pregnancy","breastfeeding","children nutrition","endocrine disruptors chemicals","2021-07-01",{"date":639,"type":37},"2021-07-14",{"date":641,"type":19},"2021-12-01",{"date":643,"type":19},"2026-12-31",{"name":43,"class":44},""]