[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Pisa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":449},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,46,75,98,125,146,178,204,225,258,282,304,324,350,379,406,428],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636988","alter-ego-as-an-assistive-robotic-device-100636988",false,"NCT07572838","Alter-Ego as an Assistive Robotic Device.","Alter-Ego as an Assistive Robotic Device for Hospital and Domestic Applications.","Alter-Ego","* Inclusion Criteria\n\n  * Healthcare Professionals\n\n    1. Age within the legal working age range for professional employment.\n    2. Experience in the management and treatment of patients affected by motor neuron disease.\n    3. Expected employment at ICS Maugeri IRCCS, Milan Camaldoli, for the entire duration of the study.\n    4. Ability to understand and provide informed consent.\n  * Patients\n\n    1. Diagnosis of possible, probable, or definite Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria.\n    2. Adults aged between 18 and 80 years.\n    3. Ability to understand and provide informed consent.\n    4. Absence of psychiatric disorders or psychological conditions that, in the physician's judgment, could cause stress during interaction with the robot.\n\n       \\---\n* Exclusion Criteria\n\n  * Healthcare Professionals\n\n    1\\. Health conditions that, in the clinician's judgment, could make the use of the Alter-Ego system via a head-mounted display unsafe or inappropriate.\n  * Patients\n\n    1. Individuals with severe psychiatric disorders or cognitive impairments that compromise the ability to complete assessment scales (based on medical history data).\n    2. Individuals with moderate to severe cognitive impairment, defined as a score below 81.92 on the ECAS questionnaire (routinely administered during the first days of hospitalization).\n    3. Individuals in isolation due to infectious causes.","ALL","18 Years","80 Years",{"count":21,"type":22},52,"ESTIMATED","OBSERVATIONAL","The ALTER-EGO study is a monocentric, observational clinical investigation designed to evaluate the safety, usability, and feasibility of the humanoid robotic platform Alter-Ego as an assistive device in hospital and simulated home-care settings. The system is intended to support healthcare and rehabilitation professionals in the management of patients with Amyotrophic Lateral Sclerosis (ALS). Alter-Ego is an anthropomorphic, wheeled, self-balancing social robot equipped with compliant robotic arms and SoftHand synergistic grippers. It operates in teleoperated, semi-autonomous, or fully autonomous modes and integrates advanced navigation, mapping, object manipulation, and natural language processing capabilities. The robot is not classified as a medical device under EU Regulation 2017\u002F745, as it does not perform diagnostic or therapeutic functions, but provides logistical, communicative, and organizational support.\n\nThe study is conducted at ICS Maugeri IRCCS (Milan Camaldoli). Participants include healthcare professionals (physicians, nurses, physiotherapists, occupational therapists, speech therapists, and healthcare assistants) and up to 40 hospitalized ALS patients. Patients are not direct operators of the robot but provide experiential feedback.\n\nA total of 40 experiments are organized into four clusters:\n\nCluster 1 - Telemedicine (Teleoperated or Semi-Autonomous Mode)\n\nWithin a simulated home-care environment, Alter-Ego supports remote clinical and rehabilitation activities through four specific tasks:\n\nSimulated Remote Medical Visit (First Home Transition):\n\nA physician conducts a tele-visit via the robot, asking health-related questions, performing visual neurological assessments using cameras and microphones, requesting specific motor tasks, and reviewing vital parameters from home monitoring devices. This task addresses the need for expert supervision during early discharge phases.\n\nAssistive Device Training:\n\nA physiotherapist and nurse remotely verify and guide the correct use of assistive devices such as non-invasive ventilation systems, PEG, or patient lifters, providing practical instructions to patients and caregivers.\n\nHome Environment Assessment:\n\nAn occupational therapist uses the robot in semi-autonomous mode to map the domestic environment and, in tele-guided mode, visually inspect spaces to identify architectural barriers and optimize assistive device placement.\n\nTelerehabilitation:\n\nPhysiotherapists and speech therapists use the robot's audio-video interface and display to conduct remote rehabilitation sessions and functional evaluations, providing visual and verbal feedback.\n\nCluster 2 - Delivery Services (Autonomous Mode) The robot autonomously transports small items within the hospital ward, including medical records, blood collection kits, rehabilitation tools, and small food or beverage packages.\n\nCluster 3 - Guidance and Welcome Assistance (Autonomous Mode) Alter-Ego presents ward service information to newly admitted patients and provides personalized daily reminders regarding scheduled rehabilitation activities.\n\nCluster 4 - Monitoring (Autonomous Mode) The robot administers the Visual Analog Scale (VAS) for pain assessment and includes an exploratory function for detecting vocal distress keywords (e.g., \"pain,\" \"help,\" \"thirst\") using AI-based speech recognition, alerting staff when necessary.\n\nPrimary endpoints include usability and feasibility (System Usability Scale - SUS; Questionnaire for User Interaction Satisfaction - QUIS; NASA Raw Task Load Index - NASA-RTLX) and safety assessment through systematic recording of adverse events.\n\nSecondary outcomes include healthcare professionals' satisfaction with autonomous robot performance, patient satisfaction (Likert scales), and psychosocial impact on professionals (selected PIADS items).\n\nThe ALTER-EGO study aims to determine whether an anthropomorphic robotic platform can safely and effectively support multidisciplinary ALS care, improve workflow efficiency, and enhance patient-centered assistance in both hospital and transitional home-care settings.",[26,27],"Amyotrophic Lateral Sclerosis","Health Adult Subjects",[29,30,31,32],"Humanoid robotic platform","Assistive Device","Telemedicine","Healthcare","NOT_YET_RECRUITING","2026-04-30",{"date":36,"type":37},"2026-05-07","ACTUAL",{"date":39,"type":22},"2026-05",{"date":41,"type":22},"2026-11",{"name":43,"class":44},"University of Pisa","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100631960","performance-of-the-treatment-of-periodontitis-according-to-the-bioperio-protocol-100631960","NCT07507474","Performance of the Treatment of Periodontitis According to the Bioperio® Protocol","Performance of the Treatment of Periodontitis According to the Bioperio® Protocol: a Prospective Cohort Study","BIOPERIO","Inclusion Criteria:\n\n* Confirmed diagnosis of periodontitis (proximal attachment loss in ≥2 non-adjacent teeth)\n* No previous treatment for periodontitis\n* Systemically healthy or with well-controlled chronic medical conditions\n* Willingness to participate in the study and comply with the follow-up schedule\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Patients previously treated for periodontitis\n* Poorly controlled systemic conditions\n* Refusal to participate\n* Patients who did not complete the proposed treatment plan",{"count":55,"type":22},5000,"This multicenter, prospective, single-arm observational study evaluated the clinical performance of the Bioperio® protocol, a standardized, patient-centered framework for managing periodontitis. The protocol combined professional supra-gingival scaling, oral hygiene instruction and motivation, full-mouth subgingival instrumentation, and-in Stage III\u002FIV cases-adjunctive enamel matrix derivative application in deep pockets.",[58],"Periodontitis",[60,61,62,63,64,65],"Enamel matrix proteins","dental scaling","root planing","oral hygiene","non-surgical periodontal therapy","periodontitis","RECRUITING","2026-04-27",{"date":69,"type":37},"2026-05-01",{"date":71,"type":37},"2023-12-05",{"date":73,"type":22},"2030-12-05",{"name":43,"class":44},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100612922","efficacy-of-a-bilateral-robotic-treatment-in-chronic-patients-100612922","NCT07259876","Efficacy of a Bilateral Robotic Treatment in Chronic Patients","Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for the Upper Limbs in Patients With Chronic Stroke Outcomes","BUILT","Inclusion Criteria:\n\n* Subjects aged between 18 and 80 years, of either sex\n* Subjects able to understand and provide, or have provided on their behalf, informed consent\n* History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (\\> 6 months)\n* Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements)\n\nExclusion Criteria:\n\n* Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education \\\u003C 24\u002F30)\n* Subjects with severe visual deficits\n* Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale \\> 3)\n* Inability or unwillingness to provide informed consent\n* Left-handed subjects",{"count":84,"type":22},60,"INTERVENTIONAL",[87],"NA","The goal of this clinical trial is to evaluate how manual dominance influences the effectiveness of bilateral robotic treatment in right-handed patients with chronic stroke.\n\nResearchers will compare the outcome of a bilateral robotic treatment for the upper limbs in left vs right hemisphere lesions following stroke.\n\nParticipants will:\n\n* perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions\n* be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements",[90],"Stroke",{"date":92,"type":37},"2026-04-28",{"date":94,"type":22},"2026-07",{"date":96,"type":22},"2026-12",{"name":43,"class":44},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100632992","oral-biopsy-bleeding-in-patients-on-direct-oral-anticoagulants-doacs-100632992","NCT07520890","Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)","Bleeding Outcomes Following Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants","DOACS_BX","Inclusion Criteria:\n\n* capacity to understand and sign informed consent;\n* documented indication for oral soft tissue biopsy\n\nExclusion Criteria:\n\n* inability to provide consent;\n* congenital or acquired coagulopathy (including haemophilia, von Willebrand disease, thrombocytopenia, or hepatic cirrhosis);\n* active antiplatelet therapy other than low-dose aspirin",true,{"count":108,"type":22},100,"Direct oral anticoagulants (DOACs) are increasingly used, but evidence on bleeding risk during oral soft tissue biopsy is limited. This prospective case-control study compared intraoperative, perioperative, and postoperative bleeding in 50 patients on uninterrupted DOAC therapy versus 50 anticoagulant-naive controls undergoing standardized oral soft tissue biopsy with suturing. All bleeding events were managed with local haemostatic measures. The study aims to determine whether DOAC continuation is safe for this procedure.",[111,112],"Direct Oral Anticoagulants (DOACs)","Oral Surgical Procedures",[114,115,116],"direct oral anticoagulants","post-operative bleeding","oral surgery","2026-04-02",{"date":119,"type":37},"2026-04-09",{"date":121,"type":37},"2026-04-01",{"date":123,"type":22},"2026-12-31",{"name":43,"class":44},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100553033","application-of-ultra-high-frequency-ultrasonography-uhfus-to-the-study-of-gingival-tissues-100553033","NCT06480825","Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues","Ulta-High Frequency Ultrasound Assessment of Normal Versus Gingivitis Affected Gingival Tissues","Inclusion Criteria:\n\n* males or females of age \\> 18 years\n* presence of at least 20 teeth\n* full-mouth plaque score (FMPS) \\>50%\n* FMBS \\>30%\n* ability and willingness to give informed consent\n\nExclusion Criteria:\n\n* pregnancy or breastfeeding\n* pharmacological treatment with antinflammatory drugs, statins, or either local or systemic antibiotics (within the previous 30 days)\n* smoking habit\n* dental or periodontal condition requiring immediate treatment\n* refusal to be enrolled in the study","70 Years",{"count":134,"type":22},40,"Gingival inflammation triggered by the accumulation of bacterial is the primary risk factor for the development of periodontitis. Clinically, localized signs of inflammation limited to the gingiva, presence of significant bacterial plaque load, and stable attachment levels on the periodontium can be observed in course of gingivitis. The aim of the present study is to compare clinical aspects of gingival tissue in healthy patients versus patients with gingivitis to assess the ultrastructural variations present in course of inflammation.\n\nPatients with gingivitis and healthy controls will be enrolled. All patients will undergo ultra-high frequency ultrasonographic scans (70 MHz) of gingival tissue on three areas per dental arch (anterior, middle right, middle left). Gingival thickness, echogenicity, and vascularization assessed through resisitive index will be evaluated.",[137,58],"Gingivitis","2026-03-31",{"date":121,"type":37},{"date":141,"type":37},"2024-04-02",{"date":143,"type":22},"2028-07",{"name":43,"class":44},2,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":85,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100627099","team-based-learning-integrated-into-clinical-simulation-in-nursing-students-100627099","NCT07444229","Team-Based Learning Integrated Into Clinical Simulation in Nursing Students","Effectiveness of Team-Based Learning Integrated Into Clinical Simulation in Nursing Education: A Randomized Controlled Trial (TBLab)","TBLab","Inclusion Criteria:\n\n* Enrollment in the third year of the Bachelor of Nursing program at the University of Pisa.\n* Participation in scheduled clinical simulation activities as part of the undergraduate nursing curriculum.\n* Provision of written informed consent to participate in the study\n\nExclusion Criteria:\n\n* None",{"count":155,"type":22},150,[87],"This study aims to evaluate whether integrating Team-Based Learning (TBL) into clinical simulation improves learning outcomes in undergraduate nursing students compared with traditional simulation alone.\n\nTeam-Based Learning (TBL) is an educational approach that actively involves students in small groups through individual preparation, teamwork, and application of knowledge to real-world problems. Clinical simulation is already widely used in nursing education to help students practice technical and non-technical skills in a safe environment. Combining these two approaches may enhance learning, but evidence is still limited.\n\nIn this randomized controlled trial, third-year nursing students enrolled in the Bachelor of Nursing program at the University of Pisa will be randomly assigned to one of two groups. One group will receive a Team-Based Learning session before participating in a clinical simulation, while the control group will take part in standard simulation activities without TBL.\n\nThe study will assess students' knowledge, technical skills, and teamwork competencies immediately after the educational activities and again at three and six months to evaluate retention of learning outcomes. Participation is voluntary and does not involve additional risks beyond standard educational activities.",[159],"Nursing Education",[161,162,163,164,165,166,167,168,169],"Nursing education","Team-Based Learning","Clinical simulation","Undergraduate nursing students","Educational intervention","Randomized controlled trial","Simulation-based education","Active learning","Teamwork skills","2026-03-14",{"date":172,"type":37},"2026-03-17",{"date":174,"type":22},"2026-03-01",{"date":176,"type":22},"2026-06-30",{"name":43,"class":44},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":85,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":45},"100541982","ultra-high-frequency-intraoral-ultrasonography-of-the-tongue-houston-100541982","NCT06336941","\"Ultra-High Frequency intraOral UltraSonography of the TONgue\" (HOUSTON)","Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions","HOUSTON","Inclusion Criteria:\n\n* Clinical diagnosis of oral squamous cell carcinoma\n* Eligibility for surgical treatment\n* Acceptance to be included in the study\n\nExclusion Criteria:\n\n* Oral lesions other than oral squamous cell carcinoma\n* Pregnant or breastfeeding patients\n* Uncontrolled chronic diseases and\u002For conditions hindering the participation in the study\n* Denial of inclusion in the study",{"count":187,"type":22},400,[87],"Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.\n\nIn the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions.",[191],"Oral Squamous Cell Carcinoma",[193,194,195],"oral neoplasm","ultrasonography","depth of invasion","2026-02-24",{"date":198,"type":37},"2026-02-25",{"date":200,"type":37},"2018-06-07",{"date":202,"type":22},"2030-12-31",{"name":43,"class":44},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":212,"targetDuration":4,"studyType":85,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":224,"locationsCount":45},"100625131","evaluation-of-a-multimodal-tactile-feedback-system-for-upper-limb-loss-users-embodiment-and-performance-100625131","NCT07418645","Evaluation of a Multimodal Tactile Feedback System for Upper Limb-loss Users: Embodiment and Performance","ENG: Evaluation of the Effectiveness of a Feedback Device Fully Integrated Within a Prosthesis for Users With Upper Limb Amputation. IT: Valutazione Dell'Efficacia di un Dispositivo di Feedback Completamente Integrato All'Interno di Una Protesi, Per Utenti Che Presentano Amputazione Dell'Arto Superiore.","THE_FBHAND","Inclusion Criteria:\n\n* Presence of a stump at the transradial level\n* Active lifestyle (i.e., K-level K4, according to Medicare functional level classification)\n* Ability to understand and provide Informed Consent to participate in the study - Ability to participate in experimental acquisitions\n\nExclusion Criteria:\n\n* Bilateral transradial amputation\n* Learning disabilities\n* Inability to understand the informed consent form\n* History or evidence of any medical, neurological or psychiatric conditions, which may affect brain function, metabolism, balance or motion, perception, representing, thus, a contraindication to the study (also stump pain or tenderness), other than the medical conditions or pathologies that have caused the upper-limb amputation\n* Hypertension, cardiovascular disease, and other endocrine diseases, neuromuscular diseases, malignancies\n* Vision and\u002For hearing problems severe enough to interfere with experimental procedures\n* Carrier of infectious diseases\n* Alcoholism or other substance abuse",{"count":213,"type":22},9,[87],"The aim of this study is to evaluate the effect of integrating tactile feedback systems into a robotic upper-limb prosthesis. These systems deliver pressure stimuli (through small silicone chambers that inflate), vibration stimuli (through small circular actuators), or a combination of both to the arm, in order to improve the feeling of owning and controlling the artificial hand. In this way, when the robotic hand touches, grasps, and holds an object, the user receives sensory feedback that may make prosthesis use more natural, intuitive, and functional in everyday life. This is expected to improve the sense of bodily integration of the prosthesis, particularly by enhancing the perception of owning the bionic limb and the feeling of control over it, thereby improving the ability to perform daily activities with the prosthesis.\n\nIn addition, the study aims to investigate whether the simultaneous delivery of multiple stimuli may confuse or discomfort the user or they are well integrated by the sensitive system improving the experience of tactile sensation.\n\nThis is a pilot, open-label study, meaning that both the researchers and the participants will be aware of the different phases of the study. The study population will include individuals with unilateral transradial upper-limb loss, either acquired or congenital. The planned sample size is 9 participants who meet the inclusion and exclusion criteria and who provide written informed consent to take part in the study.\n\nThe study consists of two phases. Phase 1: Rubber Hand Illusion experiment During this phase, the feedback devices called WISH (pressure sensation provided by the inflation of silicone chambers), VIBES (vibration sensation), and PUSE (both devices applied and activated together to provide both sensations, either synchronously or with minimal delay) will be placed on the residual limb and secured with elastic Velcro straps. A robotic hand, controlled by the participant through electromyographic sensors, will be positioned on a table in front of the participant. The participant will see the robotic hand move while receiving sensory feedback synchronized with its movements. Different stimulation conditions (pressure only, vibration only, and combined feedback) will be tested. At the end of each condition, a questionnaire will be administered to assess the perception of ownership and agency.\n\nPhase 2: Upper-limb prosthesis use In the second phase, the actuators will be integrated into the socket of a SoftHand robotic prosthesis, a myoelectric upper-limb prosthesis. Participants will be asked to wear the prosthesis and perform tasks under each of the feedback conditions tested in Phase 1. After a free-use familiarization period of approximately 10 minutes, participants will be asked to perform tasks involving object and surface recognition, as well as activities of daily living, which will be timed. The results of the different conditions will be compared to identify the feedback configuration associated with the best performance, defined as fewer errors and shorter execution time. At the end of each condition, a questionnaire will be administered to assess ease of use and tolerability of the prosthesis.",[217],"Amputees","2026-02-13",{"date":220,"type":37},"2026-02-18",{"date":222,"type":37},"2026-01-09",{"date":96,"type":22},{"name":43,"class":44},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":233,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":236,"conditions":237,"keywords":244,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":45},"100612893","predictors-of-emergency-department-use-in-frail-patients-100612893","NCT07259499","Predictors of Emergency Department Use in Frail Patients","Towards an Integrated Care System for the Assistance of Patients With Chronic Diseases, Multimorbidity, Frailty, and Polypharmacy","THE-Spoke 10","Inclusion Criteria:\n\n* fluency in Italian language,\n* age higher than 64 years,\n* loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires,\n* having performed routinary blood exams in the 6 months prior to recruitment\n* having performed head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment.\n\nExclusion Criteria:\n\n* withdrawal of the informed consent","65 Years",{"count":235,"type":22},110,"When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. While cognitive impairment is a known clinical risk factor, biomarkers of most prevalent dementias have been scarcely investigated as possible ED use predictors. Within this context, this prospective study aims at exploring whether plasma phospho-tau181 and cerebrovascular burden can predict ED use at 6 months in elderly non-autonomous patients, irrespective of frailty.",[238,239,240,241,242,243],"Alzheimer s Disease","Vascular Dementia","Frailty","Elderly","Emergency Department Visits","Autonomy",[245,246,247,240,248,241,249],"phosphorylated tau 181","dementia","Emergency Department","Autonomies","cerebrovascular","2025-11-20",{"date":252,"type":37},"2025-12-02",{"date":254,"type":37},"2023-11-19",{"date":256,"type":22},"2025-12-31",{"name":43,"class":44},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":45},"100609528","real-world-evidence-of-anifrolumab-in-systemic-lupus-erythematosus-investigator-initiated-observational-multicenter-study-evaluating-effectiveness-and-safety-of-anifrolumab-in-active-sle-patients-100609528","NCT07215754","Real World Evidence of Anifrolumab in Systemic Lupus Erythematosus: Investigator Initiated, Observational, Multicenter Study Evaluating Effectiveness and Safety of Anifrolumab in Active SLE Patients","Real World Evidence of Anifrolumab in Systemic Lupus Erythematosus: a Multicenter Spontaneous Observational Study Aimed at Evaluating the Efficacy and Safety of Anifrolumab in a Cohort of Patients With Active Systemic Lupus Erythematosus","REVEAL","Inclusion Criteria:\n\n* Patients diagnosed with SLE according to classification criteria valid at diagnosis time (1997, 2012, 2019)\n* Written informed consent\n* Active disease for which the patient is a candidate for Anifrolumab treatment (including compassionate use)\n* Active disease for which the patient has started Anifrolumab treatment\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Absence of patient consent",{"count":267,"type":22},300,"BACKGROUND AND RATIONALE. The role of type I interferons (IFN) in innate and adaptive immunity has been extensively studied, establishing a key role for type I IFNs in immune homeostasis. With growing evidence that type I IFNs play an important role in autoimmune diseases, inhibition of type I IFN biological activity with Anifrolumab represents a significant therapeutic option in SLE. Phase II and III clinical trials have demonstrated the efficacy and safety of the drug in patients with moderate-to-severe active disease.\n\nOBJECTIVES. The primary objective of the study is to evaluate the clinical efficacy and incidence of adverse events associated with Anifrolumab therapy in a multicenter cohort of patients with SLE. Secondary objectives of the study are: - to evaluate the efficacy of therapy on different types of clinical manifestations; - to assess the impact of therapy on quality of life and other patient-reported outcome measures (PROMs); - to evaluate the steroid-sparing potential of therapy; - to assess the speed of therapeutic action on different clinical manifestations; - to identify predictive variables of clinical response to therapy; - to evaluate drug retention rate; - to assess the efficacy of therapy in reducing organ damage accumulation.\n\nPRIMARY AND SECONDARY ENDPOINTS. Primary efficacy endpoints: - Percentage of patients in remission (DORIS criteria) at 6, 12, 24, 36, 48, and 60 months; - Percentage of patients in low disease activity state (LLDAS) at 6, 12, 24, 36, 48, and 60 months. Secondary efficacy endpoints: - Incidence of disease flares according to the modified SFI; - Percentage of patients with organ damage accumulation (SLICC\u002FDI \\> 0) compared to baseline at 12, 24, 36, 48, and 60 months; - Longitudinal changes in disease activity indices SLEDAI-2K and SLE-DAS; - Percentage of patients on steroid therapy ≤5 mg prednisone equivalent and percentage of patients who discontinued steroids at 6, 12, 24, 36, 48, and 60 months; - Longitudinal changes in PROMs (quality of life, fatigue, pain, PGA); - Longitudinal changes in Physician's Global Assessment and Patient's Global Assessment; - Longitudinal changes in CLASI score (in patients with cutaneous manifestations); - Longitudinal changes in joint count (in patients with articular manifestations); - Evaluation of predictive variables of response to therapy; - Evaluation of \"time to response\". Primary safety endpoints: - Incidence of adverse events (serious and non-serious). Secondary safety endpoints: - Incidence of serious adverse events; - Incidence of hospitalizations due to adverse events; - Incidence of infections (particularly Herpes Zoster and its outcomes); - Incidence of cardiovascular events; - Incidence of neoplasms or precancerous lesions.\n\nELIGIBILITY. Inclusion criteria: - Patients diagnosed with SLE according to classification criteria valid at diagnosis time (1997, 2012, 2019); - Written informed consent; - Active disease for which the patient is a candidate for Anifrolumab treatment (including compassionate use); - Active disease for which the patient has started Anifrolumab treatment. Exclusion criteria: - Age \\\u003C18 years; - Absence of patient consent. Withdrawal criteria: - Patient withdrawal of consent.\n\nSTUDY TIMELINES. Duration per patient: 60 months. Enrollment period: 3 years. Total study duration: 5 years.\n\nSAMPLE SIZE CALCULATION. Due to the study design and novelty of the topic, a formal sample size calculation is not feasible. However, based on disease frequency, estimated flare rates over one year, and the number of centers involved, at least 150 patients are expected to be enrolled. The study population will be analyzed by intention-to-treat (ITT), including all enrolled patients. For the primary safety and efficacy endpoints, the percentage of patients in remission and low disease activity, as well as event incidence, will be calculated over 60 months. An interim analysis is planned when the first 50 patients complete the 24-week evaluation. Adverse event incidence will be summarized overall, by severity (SAE, any AE), time of onset (early, late), and relationship to the study treatment. Disease flare incidence will be summarized overall and by severity. Time-to-event for disease occurrence will be evaluated using Kaplan-Meier method. Analyses will be performed using STATA software, with statistical significance set at p\\\u003C0.05.",[270],"Systemic Lupus Erythematosus",[270,272,273],"Anifrolumab","Real World Evidence","2025-10-02",{"date":276,"type":37},"2025-10-10",{"date":278,"type":37},"2023-05-25",{"date":280,"type":22},"2031-05",{"name":43,"class":44},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":290,"targetDuration":292,"studyType":23,"phases":4,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":45},"100596160","remodeling-in-st-elevation-myocarrdial-infarction-a-comparison-of-left-ventricular-functions-in-long-term-follow-up-among-stemi-patients-100596160","NCT07041840","ReModeling in ST-elevation myocARrdial Infarction: a Comparison of Left VEntricuLar Functions in Long-term Follow-up Among STEMI Patients","ReModeling in ST-elevation myocARrdial Infarction: a Comparison of Left VEntricuLar Functions in Long-term Follow-up Among STEMI Patients: The MARVEL Study","MARVEL","Inclusion Criteria:\n\n* STEMI\n\nExclusion Criteria:\n\n* Contraindication to CMR imaging",{"count":291,"type":22},80,"36 Months","Patients diagnosed with STEMI who underwent pPCI were included in this study. The investigators collected comprehensive data on each patient's status, including laboratory findings such as NT-proBNP, troponin levels, and inflammatory profile assessed by leukocyte count, C-reactive protein, interleukin-1, and interleukin-6. Additionally, electrocardiographic and echocardiographic features, details of the coronary intervention procedure, hospital stay duration, complications, and medical treatments were recorded.\n\nComprehensive transthoracic echocardiograms (TTE) were performed at admission and before discharge. Myocardial tissue characterization was conducted by cardiac magnetic resonance (CMR) imaging before discharge, assessing intramyocardial hemorrhage (IMH), microvascular obstruction (MVO), infarct size (IS), area at risk (AAR), salvaged myocardium, and salvage index.\n\nAt the six-month follow-up, laboratory tests, CMR imaging, and TTE were repeated, along with a thorough clinical evaluation. LVR was defined by one of the following criteria: a 20% increase in end-diastolic volume by TTE or 12% by CMR, a 15% increase in end-systolic volume, a sphericity index greater than 42% (CMR only), the emergence of new concentric hypertrophy, or a reduction greater than 10% in left ventricular ejection fraction (LVEF).",[295],"STEMI","2025-07-13",{"date":298,"type":37},"2025-07-17",{"date":300,"type":37},"2024-01-01",{"date":302,"type":22},"2027-01-01",{"name":43,"class":44},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":264,"eligibilityCriteria":309,"healthyVolunteers":106,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":310,"targetDuration":312,"studyType":23,"phases":4,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":323,"locationsCount":45},"100597181","retinal-octa-for-microvascular-dysfunction-evaluation-and-outcome-prediction-in-minoca-patients-100597181","NCT07055152","Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients","Inclusion Criteria:\n\n* Age: Patients aged \\> 18.\n\nDiagnosis:\n\nMINOCA Group: Patients diagnosed with Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA) confirmed by coronary angiography.\n\nACS Group: Patients with Acute Coronary Syndrome (ACS) with significant coronary artery stenosis which are matched with MINOCA patients for gender, age, LVEF at admission and chronic kidney disease stage.\n\nHealthy Controls: Age and gender-matched healthy individuals with no history of cardiovascular disease.\n\nConsent: Written informed consent obtained from all participants. Feasibility: Ability to undergo OCTA and other required imaging procedures.\n\nExclusion Criteria:\n\n* Ocular Conditions: Any significant ocular disease (e.g., glaucoma, diabetic retinopathy, macular degeneration) that could interfere with OCTA imaging quality.\n\nSevere Comorbidities: Presence of severe systemic diseases, such as advanced renal failure, active cancer, or severe liver disease, which might impact study participation.\n\nCoronary Artery Disease or Myocarditis: For the MINOCA group, patients with coronary artery stenosis \\> 50% or functionally significant (FFR \\\u003C0.8) or patients with Myocarditis detected through CMR will be excluded Pregnancy: Pregnant or breastfeeding women. Inability to Comply: Patients unable or unwilling to comply with study procedures, including follow-up visits.",{"count":311,"type":22},90,"24 Months","The aim of this study is to evaluate microvascular dysfunction through OCTA in MINOCA patients. In order to better understand the condition, OCTA will also be performed in two matched patient groups: healthy controls and ACS patients. The study will compare the retinal microvascular parameters across these groups to determine differences in microvascular function in MINOCA patients. Additionally, in the MINOCA subgroup, the study will further evaluate the differences in microvascular dysfunction within specific subsets of patients (e.g., Takotsubo, vasospastic angina, microvascular angina, patients with evidence of plaque erosion) to understand the variability and potential mechanisms underlying each subgroup of MINOCA.",[315,295,316],"MINOCA","Normal","2025-07-03",{"date":319,"type":37},"2025-07-08",{"date":321,"type":37},"2025-01-01",{"date":302,"type":22},{"name":43,"class":44},{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":348,"locationsCount":349},"100525248","ponatinib-in-chronic-myeloid-leukemia-patients-in-chronic-phase-100525248","NCT06119269","Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase","Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol","PHOENICS","Patients will be enrolled according the following inclusion criteria:\n\n* Subjects ≥18 years old affected by CML\n* Patients being treated with ponatinib at a dose of 45, 30 or 15 mg\u002Fday for more than 14 days\n* Patients who have provided informed consent to the study\n\nExclusion criteria:\n\n* Subjects \\\u003C18 years old\n* Patients who did not provide an informed consent to the study\n\nThe co-administration of drugs other than ponatinib will not be considered an exclusion criterium, but all of the drugs will be registered (together with daily doses and duration of treatment) as possible factors of ponatinib PK variability.",{"count":108,"type":22},"The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy\u002Ftolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP).\n\nIn particular, the aims of the study will be:\n\n* primary aim: to investigate the relationships (if any) between plasma concentrations and activity\u002Ftoxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers;\n* secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy).\n\nThe study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.",[335],"Chronic Myeloid Leukemia, Chronic Phase",[337,338,339,340,341],"Chronic myeloid leukemia, chronic phase","Ponatinib","Therapeutic drug monitoring","Efficacy","Tolerability","2025-06-02",{"date":344,"type":37},"2025-06-05",{"date":346,"type":37},"2023-08-02",{"date":256,"type":22},{"name":43,"class":44},5,{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":17,"minAge":357,"maxAge":18,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":360,"conditions":361,"keywords":367,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":45},"100454517","pharmacokinetics-of-intravenous-acyclovir-in-oncologic-paediatric-patients-100454517","NCT05198570","Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients","Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy","Inclusion Criteria:\n\n* Patients with Hematological malignancies\n* HSCT recipients who require ACV prophylaxis or treatment for HSV-VZV infection or\n* Children undergoing high-intensity antineoplastic chemotherapy who need ACV treatment.\n* Intravenous or oral ACV dosing\n* Active\u002Favailable a therapeutic drug monitoring (TDM) protocol for ACV\n* Informed consent signed by patient's parents\n\nExclusion Criteria:\n\n* lack of signed informed consent\n* lack of TDM for ACV\n* unavailable patient's demographic characteristics","6 Months",{"count":359,"type":22},200,"* Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality.\n* Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals.\n* Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection.\n* Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection.\n* Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children.\n* Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.",[362,363,364,365,366],"Herpesviridae Infections","Herpes Simplex 1","Varicella Zoster Virus Infection","Transplantation Infection","Oncology",[368,369,370,371,372],"Hematopoietic stem cell transplantation","Herpes virus infections","Aciclovir","Children","Pharmacokinetics",{"date":374,"type":37},"2025-06-04",{"date":376,"type":37},"2021-09-15",{"date":138,"type":22},{"name":43,"class":44},{"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":85,"phases":389,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":45},"100542120","ultra-high-frequency-ultrasonography-in-sjgrens-syndrome-100542120","NCT06338735","Ultra-High Frequency Ultrasonography in Sjögren's Syndrome","Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome","UltraSjögren","Inclusion Criteria:\n\n* adults ≥ 18 years of age\n* clinical suspect of Sjogren\\'s syndrome\n* acceptance to undergo complete Sjogren\\'s Syndrome diagnostic work-up\n* acceptance to be included in the study.\n\nExclusion Criteria:\n\n* pregnancy or breastfeeding\n* any acute or chronic condition that would limit the ability of the patient to participate in the study\n* refusal to give informed consent",{"count":388,"type":22},800,[87],"Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR\u002FEULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands.",[392],"Sjogren's Syndrome",[394,395,396,397],"ultra-high frequency ultrasonography","diagnostic imaging","Sjogren's syndrome","salivary glands","2024-06-24",{"date":400,"type":37},"2024-06-26",{"date":402,"type":37},"2016-01-11",{"date":404,"type":22},"2030-12",{"name":43,"class":44},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":85,"phases":417,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":426,"leadSponsor":427,"locationsCount":45},"100443070","phase-3-a-randomized-clinical-trial-to-evaluate-the-effects-of-atorvastatin-on-graves-orbitopathy-go-the-stago-2-study-100443070","NCT05049603","A Randomized Clinical Trial to Evaluate the Effects of Atorvastatin on Graves' Orbitopathy (GO): the STAGO-2 Study","Phase III, Double-blinded, Multicenter, Randomized Clinical Trial to Evaluate the Effects of Atorvastatin on Moderate-to-severe and Active Graves' Orbitopathy (GO) Treated With Intravenous Glucocorticoids: the STAGO-2 Study","STAGO-2","Inclusion Criteria\n\n1. Patients willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form\n2. A diagnosis of Graves' disease based on the presence of hyperthyroidism associated with detectable anti-thyrotropic hormone (TSH) receptor autoantibodies (TRAb). Patients must be euthyroid under control on stable medical regimen and every effort will be made to maintain the euthyroid status for the entire duration of the clinical trial\n3. A moderate-to-severe GO, defined as the presence of at least one of the following criteria: an exophthalmos ≥2 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm, lasting since no longer than 9 months\n4. Active GO: CAS (4) ≥ 3 out of 5 points in the most affected eye\n5. Male and female patients of age: 18-75 years\n6. AST, ALT and CPK levels ≤ 3 times the upper value of normal range\n7. Women of childbearing potential (WOCBP, namely not in menopause or in menopause since less than two years; in all other instances women will be considered as non-WOCBP) and men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (as indicated in Appendix) for at least 6 and 7,5 months, respectively, after the last dose of the investigational drug (see also 2014\\_09\\_HMA\\_CTFG\\_Contraception.pdf, namely the \"2014 CTFG Reccommendtions related to contraception and pregnancy testing in clinical trials\").\n8. Compliant patient, regular follow-up possible\n\nExclusion Criteria\n\n1. Optic neuropathy\n2. Corticosteroids or immunosuppressive treatment for GO in the last 3 months. Use of selenium in the last 3 months or during the clinical trial\n3. Previous surgical or radiant (orbital irradiation) treatment for GO\n4. Radioiodine treatment for hyperthyroidism over the last 3 months, as it can affect GO (4)\n5. Statin treatment in the last 3 months\n6. Contraindications to GC: hypersensitivity to the active substance or to any of the excipients; uncontrolled hypertension, uncontrolled diabetes; history of peptic ulcer; urinary infections, glaucoma, systemic fungal infections, systemic infections unless appropriate therapy is employed, idiopathic thrombocytopenic purpura, cerebral edema associated with malaria. Use of medications interfering with GC or increasing the risk of GC-related adverse events (see prohibited therapies)\n7. Pregnant or lactating females as determined by positive serum or urine HCG test at baseline\n8. Acute or chronic liver disease\n9. All factors that could increase the risk of rhabdomyolysis, in particular medications that could increase this risk (see prohibited therapies)\n10. Contraindications to statins, namely: hypersensitivity to atorvastatin or other statins, or hypersensitivity or intolerance to the medication excipients such as lactose; current or past liver diseases; alterations of liver tests.\n11. Medications interfering\u002Finteracting with statins (see prohibited therapies)\n12. Relevant Malignancy\n13. Recent (≤1 year) history of alcoholism or drug abuse\n14. Mental illness that prevent patients from comprehensive, written informed consent","75 Years",{"count":416,"type":22},102,[418],"PHASE3","Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease (GD). Based on its clinical signs and symptoms, GO is graded as mild, moderate-to-severe, or severe, and active or inactive, the latter feature being established on a 5\u002F7-scale score named Clinical Activity Score (CAS).\n\nThe European Group on Graves Orbitopathy (EUGOGO) has recently formulated and published up-to-date guidelines for the management of GO, according to which high dose intravenous (iv) glucocorticoids (GC) (ivGC) is the first line treatment for moderate-to-severe and active GO. A protective effect of atorvastatin on the development of GO in patients with GD has been reported, based on which we recently conducted a phase II, randomized, open label clinical trial and found that atorvastatin improves the response of GO to ivGCs in hypercholesterolemic patients. The effect was unrelated to cholesterol levels, suggesting that it may be the consequence of a direct action of atorvastatin. To investigate this issue further and to introduce atorvastatin in the clinical practice, we designed the present Phase III, double-blinded, multicenter, randomized, adaptive, superiority, no profit, clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy, regardless of cholesterol levels.",[421],"Graves' Orbitopathy","2023-03-14",{"date":424,"type":37},"2023-03-15",{"date":300,"type":22},{"date":123,"type":22},{"name":43,"class":44},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":17,"minAge":436,"maxAge":414,"enrollmentInfo":437,"targetDuration":4,"studyType":85,"phases":439,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100293313","phase-4-a-trial-to-evaluate-the-efficacy-of-orbital-radiotherapy-in-graves-orbitopathy-100293313","NCT03098225","A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy","A Phase IV, Randomized, Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves' Orbitopathy","ORGO","Inclusion Criteria:\n\n1. A diagnosis of Graves' disease based on the presence of hyperthyroidism (either untreated or treated with antithyroid drugs) associated with detectable anti-TSH receptor autoantibodies\n2. No major treatments for hyperthyroidism (thyroidectomy or radioiodine) in the last 3 months\n3. Euthyroidism on anti-thyroid medications or L'thyroxine (LT4) since at least 2 months\n4. GO symptoms lasting since no more than one year\n5. Active GO: CAS ≥ 3 out of 7 (worst eye)\n6. Moderate or moderately severe GO: at least one of the following signs (worst eye):\n\n   * Exophthalmos ≥ 22 mm\n   * Eye muscle involvement with mono-ocular ductions in any direction of gaze of less than 30° or evident dismotility\n   * Diplopia according to Gorman score of grades a-c\n7. No corticosteroids or immunosuppressive treatment for GO in the last 3 months\n8. No contraindication to OR: diabetes, hypertension, retinopathy of any type, glaucoma\n9. Male and female patients of age: 35-75 years\n10. Effective method of contraception during the whole trial and at least six weeks after last intake of trial drugs (only female of reproducing age)\n11. No mental illness that prevent patients from comprehensive, written informed consent\n12. Compliant patient, regular follow-up possible\n\nExclusion Criteria:\n\n1. Absence of Graves' hyperthyroidism (present or past)\n2. Thyroidectomy or radioiodine in the last 3 months\n3. Uncontrolled hyperthyroidism or hypothyroidism\n4. GO symptoms lasting since more than one year\n5. CAS \\\u003C3 (worst eye)\n6. Optic neuropathy\n7. Contraindications to OR (diabetes, retinopathy of any kind)\n8. Pregnancy, breast-feeding women\n9. No informed consent\n10. Acute or chronic liver disease\n11. Relevant Malignancy\n12. Chronic renal failure or other diseases of any relevance to prevent steroid treatment 13) Corticosteroids or other immunosuppressive agents within last 3 months\n13. Recent (≤1 year) history of alcoholism or drug abuse\n14. Previous orbital disease other than GO, eye injuries or surgery","35 Years",{"count":438,"type":22},120,[440],"PHASE4","Graves' orbitopathy (GO) is a disfiguring and disabling disease that profoundly impairs the quality of life of affected patients. High dose intravenous (iv) glucocorticoids (GC) (ivGC) is a well established, widely used treatment for active GO. The use of systemic glucocorticoids takes advantage from their immune suppressive and antiinflammatory actions, resulting in an overall beneficial effect ranging from \\~35 to \\~60% of patients in various studies. The intravenous route of administration has been shown to be superior to the oral route, both in terms of GO outcome and side effect profile. The combination of ivGC and orbital radiotherapy (OR) is used routinely in patients with moderate-severe, active GO, as a second-line treatment, as also recommended in the recent Guidelines published by the European Thyroid Association\u002FEuropean Group on Graves' Orbitopathy. Thus, the majority of studies have shown that OR increases the response rate to GC. Those studies were performed using oral GC, whereas it is not known whether OR potentiate also the effects of ivGC.\n\nThe present study is aimed at determining whether OR potentiate the effects of ivGC in the treatment of moderately severe and active GO, in terms of GO outcome and quality of life. A possible extension of the study can be foreseen, aimed at investigating the very long time GO outcome.",[443],"Thyroid Associated Ophthalmopathy",{"date":424,"type":37},{"date":300,"type":22},{"date":447,"type":22},"2027-03-31",{"name":43,"class":44},""]