[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Milano Bicocca\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":674},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,52,81,105,135,163,195,217,236,259,288,313,336,364,390,416,440,467,492,515,537,563,589,615,647],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100563058","optimizing-prevention-of-hospital-acquired-disability-through-multidomain-interventions-100563058",false,"NCT06611228","Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions","Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project","OPTIMAge-IT","Inclusion Criteria:\n\n* Age \\>70 years;\n* Mild to moderate frailty, defined by a panel of tools agreed upon by the group of researchers involved in the study (Primary Care Frailty Index \\[PC-FI\\] between 0.07 and 0.21, Clinical Frailty Scale \\[CFS\\] 4-6);\n* Ability to walk with or without assistance\n* Ability to communicate and cooperate with the research team;\n* Ability to sign informed consent.\n\nExclusion Criteria:\n\n* Expected hospital stay duration \\<3 days;\n* Estimated prognosis quoad vitam \\<12 months;\n* Persistent clinical instability, indicated by a NEWS2 score \\>5 (assessed within 48 hours of admission) and\u002For the presence of delirium (4AT \\>4);\n* History of schizophrenia, major depression, bipolar disorder, or psychosis;\n* Severe sensory deficits (visual and auditory);\n* Presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG);\n* Severe cardiac conduction disorder (e.g., third-degree atrioventricular block), uncontrolled arrhythmia, new Q wave in the past six months, or ST segment depression (\\>3 mm) on the electrocardiogram;\n* Terminal stage oncological or organic disease (e.g., Child-Pugh C cirrhosis, stage V renal disease, GOLD stage D chronic obstructive pulmonary disease, end-stage heart failure);\n* Residence in a nursing home before hospital admission;\n* Presence of dissected aortic aneurysm, severe aortic stenosis, acute endocarditis\u002Fpericarditis, acute thromboembolism, uncontrolled hypertension (\\>180\u002F100 mmHg) or postural hypotension, uncontrolled hypoglycemia, recent fracture within the last month, or any other medical condition that hinders the execution of physical activity according to clinical judgment;\n* Any condition that prevents safe participation in the intervention and\u002For cooperation with the study;\n* Concurrent participation in other clinical studies;\n* Clinical conditions or situations significantly different from the condition under study, which in the investigator's opinion could interfere with the study or prevent optimal participation;\n* Participants refusal to participate in the study.","ALL","70 Years",{"count":21,"type":22},288,"ESTIMATED","INTERVENTIONAL",[25],"NA","The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Additionally, the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge.\n\nParticipants will:\n\n* Receive an MDI during their hospital stay and continue with remote at-home support for 3 months, or receive usual care.\n* Attend outpatient clinics for follow-up assessment at 3 and 6 months.",[28,29],"Frailty Syndrome","Aging",[31,28,32,33,34,35,36,37,38],"Hospital Acquired Disability","Comprehensive Geriatric Assessment","Prevention","Integrated Multidomain Interventions","Telemedicine","Telemonitoring","Outcomes","Hospital","RECRUITING","2026-05-22",{"date":42,"type":43},"2026-05-28","ACTUAL",{"date":45,"type":43},"2024-12-01",{"date":47,"type":22},"2027-01-01",{"name":49,"class":50},"University of Milano Bicocca","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100538978","phase-2-head-down-tilt-15-to-increase-collateral-flow-in-acute-ischemic-stroke-100538978","NCT06297863","Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke","Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke: a Multicenter, Randomised, Proof of Concept, Phase 2a\u002Fb Trial in Patients Treated With Mechanical Thrombectomy","DOWN-SUITE","Inclusion Criteria:\n\n* Acute ischemic stroke due to left or right MCA occlusion of the M1 segment (excluding occlusion of the internal carotid artery terminus + M1)\n* Decision to treat with mechanical thrombectomy (with or without intravenous thrombolysis)\n* Informed consent obtained from patient or patient's next of kin, or emergency consent procedure\n\nExclusion Criteria:\n\n* Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive.\n* Vomiting upon stroke onset.\n* History of glaucoma.\n* History or imaging findings of intracranial hypertension of any aetiology\n* Major breath disorders, defined as follows:\n\n  * oxygen saturation ≤92% in room air at admission\n  * severe chronic obstructive pulmonary disease (COPD) treated with long-term oxygen therapy.\n  * severe heart failure with NYHA class 3 or 4 (breathlessness during ordinary physical activity or at rest).\n* Severe obesity, defined as body mass index (BMI) \\> 35.\n* Patients participating in another interventional trial that would interfere with this study.\n* Female patients who are pregnant","18 Years",{"count":62,"type":22},118,[64],"PHASE2","The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.\n\nThis study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).\n\nThe investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°).",[67],"Acute Ischemic Stroke",[69,70,71],"Collaterals","Cerebral hemodynamics","Head down positioning","2026-04-29",{"date":74,"type":43},"2026-05-06",{"date":76,"type":43},"2025-03-01",{"date":78,"type":22},"2026-12-31",{"name":49,"class":50},6,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":80},"100517625","fdg-pet-in-the-diagnosis-of-autoimmune-encephalitis-100517625","NCT06019975","FDG-PET in the Diagnosis of Autoimmune Encephalitis","PEA","Inclusion Criteria:\n\n* Diagnosis of autoimmune encephalitis according to clinical criteria\n* Brain magnetic resonance imaging performed between clinical presentation and treatment\n* Cerebrospinal fluid analysis performed between clinical presentation and treatment\n* Brain FDG-PET performed between clinical presentation and treatment\n* Autoantibodies testing performed between clinical presentation and treatment\n\nExclusion Criteria:\n\n* Refusal to give consent for the study",{"count":89,"type":22},90,"OBSERVATIONAL","The goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question it aims to answer is:\n\n•is there a specific pattern of brain metabolism in patients with autoimmune encephalitis Participants data and images will be retrospectively collected from hospital records, and FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls will be selected from validated public databases.",[93],"Autoimmune Encephalitis",[93,95,96],"FDG-PET","SPM","2026-03-23",{"date":99,"type":43},"2026-03-24",{"date":101,"type":43},"2023-03-01",{"date":103,"type":22},"2027-04-30",{"name":49,"class":50},{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100628092","lombard-cohort-of-brain-health-services-100628092","NCT07457138","Lombard Cohort of Brain Health Services","LoBHeS","Inclusion Criteria:\n\n* Adults (≥18 years)\n* Diagnosis of SCD, FCD, or \"well worried\" individuals without objective cognitive impairment\n* Evaluation at one of the Lombardy BHS\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of mild cognitive impairment or dementia at baseline visit\n* Enrollment in another interventional study with an expected effect on cognition\n* Pregnancy or breastfeeding",{"count":113,"type":22},1000,"The goal of this multicenter prospective observational cohort study is to better understand the clinical, neuropsychological, and biological characteristics of individuals attending Brain Health Services (BHS) in the Lombardy region. The study focuses on adults with subjective cognitive decline (SCD), functional cognitive disorder (FCD), or \"well worried\" individuals without objective cognitive impairment.\n\nThe main questions it aims to answer are:\n\n* What clinical, cognitive, and biological differences exist between individuals who are positive versus negative for Alzheimer's disease (AD) plasma biomarkers (p-tau217) at baseline?\n* What factors predict positivity to AD biomarkers at baseline?\n* How does communication of biomarker results (risk disclosure) affect psychological well-being shortly after receiving results?\n* What factors predict longitudinal changes in AD biomarkers over 5 years?\n* Do baseline biomarkers predict the development of mild cognitive impairment (MCI) or dementia during follow-up?\n\nParticipants will:\n\n* Undergo standard clinical evaluation at their local BHS\n* Provide blood samples for plasma biomarker analysis (e.g., p-tau217, GFAP, NfL, ApoE)\n* Undergo neuropsychological testing and cognitive screening\n* Complete questionnaires assessing psychological impact and risk perception (before and after biomarker disclosure)\n* Undergo additional center-specific procedures when clinically indicated (e.g., MRI, lumbar puncture, polysomnography)\n* Be followed annually for 5 years\n\nThe study plans to enroll approximately 1000 participants across multiple BHS in Lombardy and will follow them for a total duration of 7 years. The results will help clarify the role of biomarkers in early cognitive complaints and support the development of preventive strategies within BHS.",[116,117,118,119],"Subjective Cognitive Decline (SCD)","Functional Cognitive Disorder","Alzheimer's Disease","Brain Health",[121,122,118,117,123,124,125],"Brain Health Services","Subjective Cognitive Decline","pTau-217","GFAP","NfL","2026-03-13",{"date":128,"type":43},"2026-03-17",{"date":130,"type":43},"2026-02-01",{"date":132,"type":22},"2033-02-01",{"name":49,"class":50},5,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":143,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":162,"locationsCount":51},"100625548","non-invasive-vibratory-stimulation-of-the-knee-muscles-for-the-improvement-of-the-somatosensory-input-and-motor-performance-100625548","NCT07424066","Non-invasive Vibratory Stimulation of the Knee Muscles for the Improvement of the Somatosensory Input and Motor Performance","Stimolazione Vibratoria Non-invasiva Per il Miglioramento Del Ritorno Sensoriale e Della Performance Motoria in Atleti Con Lesione al Legamento Crociato Anteriore","VIBMOT","Inclusion Criteria:\n\n* Age equal to or greater than 18 years.\n\nExclusion Criteria:\n\n* Neurological disorders.\n* Musculoskeletal injuries, including previous ones, that may compromise the execution of required movements.\n* Cardiorespiratory disorders.",true,{"count":145,"type":22},35,[25],"The goal of this interventional cross-sectional study is to evaluate motor responses to non-invasive vibratory stimulation applied to the hamstring muscle tendons in healthy individuals. Knee flexion and extension efforts, in both isometric and concentric contractions, will be tested.\n\nThe investigators hypothesize that vibratory stimulation causes an increase in activity in the flexor muscles (hamstrings) and a decrease in the extensor muscles (quadriceps) of the knee in all motor tasks. It follows that during knee flexion (both concentric and isometric), vibratory stimulation should cause an increase in the distance between the angular trajectories of the knee obtained with and without vibratory stimulation (with a positive sign). The increased activity of the hamstring muscles would, in fact, contribute to increasing the velocity of the flexor movement. Conversely, during extensor movements (both concentric and isometric), vibratory stimulation should reduce the instantaneous velocity of the movement, therefore causing an increase in distance (with a negative sign) between the trajectories obtained with and without stimulation.\n\nParticipants will be tested using an isokinetic dynamometer and they will be asked to perform the following motor tasks in a random order: concentric knee flexion, concentric knee extension, isometric knee flexion, and isometric knee extension. The dominant limb will be tested, only. The assessment will be performed one time.",[149],"Vibration",[151,152,153,154,155],"vibratory stimulation","muscle spindle","muscle contraction","spinal reflex","somatosensory system","2026-02-13",{"date":158,"type":43},"2026-02-20",{"date":160,"type":43},"2025-05-20",{"date":78,"type":22},{"name":49,"class":50},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":171,"minAge":60,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":51},"100624282","ablative-radiotherapy-for-unfavorable-prostate-tumors-20-100624282","NCT07407608","ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0","Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer","ABRUPT 2","Inclusion Criteria:\n\n* Histologically proven prostate adenocarcinoma;\n* Intermediate and High risk disease, as per the NCCN definition;\n* a PI-RADS 3-5 dominant intraprostatic lesion on multiparametric MRI (mpMRI);\n* N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) PSMA PET-CT;\n* World Health Organization performance status 0-1;\n* Life expectancy of \\> 5 years, in the opinion of the investigator;\n* IPSS score must be ≤ 15 (alpha blockers allowed);\n* Prostate gland volume ≤100 g as estimated by computed tomography (CT), ultrasound, or MRI.\n\nExclusion Criteria:\n\n* ≥T3b disease according to the 8th AJCC classification;\n* PSA\\>20 ng\u002Fml;\n* Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) or transurethral resection;\n* Previous radiotherapy to the pelvis;\n* Presence of a periurethral dominant lesion;\n* Previous invasive malignancy unless disease free for a minimum of 5 years;\n* Active Crohn's Disease or Ulcerative Colitis;\n* Presence of hip prostheses.","MALE","90 Years",{"count":174,"type":22},58,"Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.",[177,178,179],"Prostate Cancer","Prostate Cancer (Adenocarcinoma)","Prostate Cancer Non-Metastatic",[181,182,183,184,185,186],"Unfavorable Prostate Tumors","Stereotactic Body Radiotherapy (SBRT)","Volumetric Modulated Arc Therapy (VMAT)","Prostate Imaging Reporting and Data System (PI-RADS)","Toxicity","Quality of Life","2026-02-09",{"date":189,"type":43},"2026-02-12",{"date":191,"type":43},"2026-01-28",{"date":193,"type":22},"2034-07-31",{"name":49,"class":50},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":171,"minAge":60,"maxAge":172,"enrollmentInfo":202,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":51},"100588435","salvage-ultrahypofractionated-postoperative-external-radiotherapy-for-biochemical-recurrence-100588435","NCT06941363","Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence","SUPERB","Inclusion Criteria:\n\n* Subjects of male sex ≥ 18 years of age.\n* Subjects have freely signed the pertinent informed consent before the beginning of the study\n\n  * Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)\n  * Detectable post-prostatectomy PSA of ≥ 0.1 - \\\u003C 2.0 ng\u002FmL either (1) persistently detectable post-operatively or (2) developing biochemical recurrence after prostatectomy (initially undetectable)\n  * No evidence of N1 and\u002For M1 disease assessed by PSMA PET-CT within 90 days prior to registration\n  * Negative Magnetic Resonance Imaging (MRI) of the pelvis in case of equivocal evidence of local relapse on PSMA PET-CT\n  * Androgen deprivation therapy (ADT) allowed as per physician's discretion\n  * ECOG performance status of 0-1\n  * Ability to complete the questionnaires\n\nExclusion Criteria:\n\n* N1 and or M1 patients\n* Macroscopic local relapse at pelvic MRI.\n* Prior radiation of any kind to the prostate gland or pelvis\n* Prior brachytherapy\n* History of inflammatory colitis or other active severe comorbidities\n* Patients who are on immunosuppressant medication",{"count":203,"type":22},50,"Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility",[206],"Prostate Cancer (Post Prostatectomy)",[208],"biochemical recurrence; salvage RT; toxicity profile; oncological outcomes; linac-based SBRT","2026-01-29",{"date":211,"type":43},"2026-02-02",{"date":213,"type":43},"2025-05-02",{"date":215,"type":22},"2033-05",{"name":49,"class":50},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":51},"100605670","quality-of-life-and-care-organization-of-patients-with-chronic-myeloid-leukemia-in-the-lombardy-hematology-network-100605670","NCT07165535","Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network","Inclusion Criteria:\n\n* Subjects aged 18 years or older.\n* Subjects diagnosed with Chronic Myeloid Leukemia.\n* Subjects diagnosed with CML under care at the hematology outpatient clinics of the 21 REL centers.\n* Subjects followed at the reference hematology center for a minimum of 6 months.\n* Freely given informed consent obtained before the start of the study.\n\nExclusion Criteria:\n\n* Subjects who have not given consent to participate in the study.\n* Subjects who do not meet the inclusion criteria.",{"count":224,"type":22},2000,"The primary objective of the study is to assess the impact of the organizational model of the hematology center on the quality of life of patients with CML estimated through standardized tools (EORTC QLQ-30, CML24) and through the patient's opinion regarding aspects of the quality of care.",[227],"Chronic Myeloid Leukemia (CML)","2025-09-08",{"date":230,"type":43},"2025-09-10",{"date":232,"type":43},"2025-04-17",{"date":234,"type":22},"2026-05-17",{"name":49,"class":50},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":258,"locationsCount":51},"100397798","intracranial-pressure-time-dose-impeto-100397798","NCT04459806","Intracranial PrEssure Time dOse (ImPETO)","Evaluation of Intracranial Pressure Time Dose by the New Integra CereLink ICP Monitor","ImPETO","Inclusion Criteria:\n\n* Aged within 18 and 80 years;\n* Diagnosed of an acute brain injury (ABI) for hemorrhagic stroke (including intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury;\n* ICP monitoring started for clinical indication and accordingly to local policies\n* ICP device connected to the Integra CereLink ICP monitor.\n\nExclusion Criteria:\n\n* ICP monitoring not inserted\n* No availability of the Integra CereLink ICP monitor.","80 Years",{"count":246,"type":22},250,"The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting.\n\nTherefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.",[249,250,251,252],"Intracranial Hypertension","Traumatic Brain Injury","Subarachnoid Hemorrhage","Intracranial Hemorrhages",{"date":254,"type":43},"2025-09-15",{"date":256,"type":43},"2023-11-13",{"date":78,"type":22},{"name":49,"class":50},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":267,"minAge":60,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":51},"100584307","rebozo-and-maternal-procedures-to-reduce-persistent-occiput-posterior-position-of-the-fetal-head-100584307","NCT06887634","Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head","Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -","ReMaP-POPP","Inclusion Criteria:\n\n* woman in labor between 3 and 8 cm of cervical dilation\n* woman with a singleton term fetus (≥37 0\u002F7 weeks of gestation) in an Occiput Posterior Persistent Position clinically diagnosed and confirmed by transabdominal sonography\n\nExclusion Criteria:\n\n* Women with growth restricted fetuses according to the Delphi's consensus\n* Fetuses with congenital anomalies or infections or with chromosomal abnormalities\n* Intrauterine fetal demise\n* Fetal and\u002For maternal conditions requiring urgent or emergent delivery or impeding the use of FLI and SLR and\u002For the Rebozo technique (non-reassuring fetal heart rate, abnormal vaginal bleeding, immobilizing epidural analgesia, polyhydramnios, extrapelvic fetal head, body mass index ≥35 Kg\u002Fm2, hypertensive disorders of pregnancy with inadequate control of blood pressure, maternal heart disease in class III to V according to the modified World Health Organization, glaucoma or ocular surgery, esophageal reflux disease, hypermobile sacro-ileac joint, and severe symphysis dysfunction)","FEMALE",{"count":269,"type":22},578,[25],"The goal of this clinical trial is to assess whether a combination of forward-leaning inversion and side-lying release procedures and Rebozo technique in a pre-specified sequence during the first stage of labor among women with a posterior fetus would favor anterior rotation. The main questions it aims to answer is:\n\n• What is the probability of persistent occiput posterior position of the fetal head three hours and thirty minutes after randomization, diagnosed by sonography? Researchers will compare the intervention group, which received a sequence of forward-leaning inversion (FLI), side-lying release procedures (SLR), and the Rebozo technique (lasting 90-105 minutes), to the control group, which received standard care (free maternal postures), to assess whether the specific combination of interventions in the experimental group reduces the probability of the fetal head remaining in the occiput posterior position.\n\nParticipants in the intervention group will undergo a combination of forward-leaning inversion, side-lying release procedures, and the Rebozo technique, administered in a pre-determined sequence. In contrast, participants in the control group will receive standard care (free maternal postures).",[273],"Persistent Occiput Posterior Position During Labor",[275,276,277,278],"Occiput posterior position","Persistent Occiput Posterior Position","Rebozo technic","Maternal postures","NOT_YET_RECRUITING","2025-08-29",{"date":282,"type":43},"2025-09-05",{"date":284,"type":22},"2025-09",{"date":286,"type":22},"2027-07",{"name":49,"class":50},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":143,"sex":18,"minAge":295,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":51},"100535199","italian-study-with-tailored-multidomain-interventions-to-prevent-functional-and-cognitive-decline-in-community-dwelling-older-adults-100535199","NCT06248723","ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults","IN TeMPO","Inclusion Criteria:\n\n* Aged 60 or older\n* Mild\u002Fmoderate vulnerability (Primary Care Frailty Index score between 0.07 and 0.21)\n* Cardiovascular risk factors, Ageing and Incidence of Dementia (CAIDE) \\> 6\n* Clinical Dementia Rating (CDR) ≤ 0.5\n* Presence of increased risk of developing dementia by family history (≥ 1 family member with dementia) and\u002For at least one modifiable risk factor, with Lifestyle Index ≥2. Lifestyle index evaluation: each \"Yes\" answer to the following questions = 1 point.\n\n  1. Physical activity less than 2.5 hours per week (defined as physical activity intense enough to lead to sweating and breathlessness)\\*\n  2. Diet: less than 5 servings of fruits and vegetables per day\\*\n  3. Diet: less than 2 servings of fish per week\\*\n  4. Hypertension: diagnosed by a physician or on medication, or Systolic Blood Pressure (SBP)\\>140 mmHg, or Diastolic Blood Pressure (DBP)\\>90 mmHg)\n  5. Diabetes: type 1 or type 2 diagnosed by a physician, or on medication, or HbA1C ≥7 % in the previous 6 months\n  6. Sleep disturbances, depressive symptoms, or mental\u002Fphysical stress symptoms, for at least 1 month, judged by the physician to be disabling in daily life\n  7. BMI ≥ 25 kg\u002Fm\\^2\\*\n  8. Alcohol: \\> 21 alcohol units\u002Fweek\\*. \\*Based on international and WHO guidelines.\n* Informed consent freely given and acquired before the start of the study\n\nExclusion Criteria:\n\n* Diagnosis of dementia or suspected dementia following the screening visit\n* CDR \\> 0.5\n* Residents in residential facilities for the elderly\n* Inability to consent to informed consent and\u002For actively participate in study interventions, according to clinical judgment\n* Any condition that prevents safe involvement in the intervention and\u002For cooperation in the study. For example, a significant neurological or psychiatric condition, including but not limited to brain tumors (benign or malignant), major psychiatric disorders (e.g. current major depressive disorder, schizophrenia, schizoaffective disorder or bipolar disorder), recent brain hemorrhage (parenchymal or subdural), history of concussive head trauma with persistent or significant neurological outcomes, known morpho-structural abnormalities in the brain, active alcohol\u002Fdrug abuse, active uncontrolled disease of any major organ system; history within the last six months of any acute disease of a major organ system requiring emergency care or hospitalization, including revascularization procedures; severe renal or hepatic insufficiency; unstable or poorly controlled diabetes mellitus, hypertension, or heart failure; malignant neoplasms within the past 3 years (except basal cell carcinoma or squamous cell carcinoma in situ of the skin or localized prostate adenocarcinoma in male participants); any clinically relevant abnormality in blood parameters; severe loss of vision, smar or communication ability, such as to prevent cooperation.\n* Enrollment in other trials\n* High performance on screening memory tests: RAVL-T immediate score \\>48 (score ranges 0-75), RAVL-T delayed \\>10 (score ranges 0-15)\n* Planned transfers from the municipality of residence during the duration of the study for a duration longer than 2 weeks.","60 Years",{"count":297,"type":22},1340,[25],"The goal of this interventional non-pharmacological study is to investigate the effects of a multi-domain intervention ( \"active intervention\"), compared to that followed by normal clinical practice (\"self-guided intervention\"), in older adults. The primary objective is whether these interventions can prevent functional and cognitive decline in at-risk subjects.\n\nThe multi-domain interventions will include physical exercise, a Mediterranean diet-based nutritional plan, cognitive training, regular medical check-ups, oral hygiene treatments and counseling, monitoring and counseling on visual and auditory abilities, counseling on sleep hygiene and treatment, control of cardiovascular, metabolic, and infectious risk factors, adjustment of drug therapy, suggestions for improving social interactions.",[301],"Age-related Cognitive Decline",[303,304,29],"Cognitive decline","Dementia","2025-07-24",{"date":307,"type":43},"2025-07-29",{"date":309,"type":43},"2024-07-16",{"date":311,"type":22},"2026-03",{"name":49,"class":50},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":326,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":51},"100510673","phase-2-phase-2-open-label-single-arm-study-on-the-use-of-metformin-as-adjunctive-therapy-in-high-grade-glioma-100510673","NCT05929495","Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma","Inclusion Criteria:\n\n* Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;\n* hypomethylation or hypermethylation of MGMT assessed post-surgery;\n* adult patients (≥18 years), both sexes;\n* Patients undergoing Stupp protocol including patients aged \\> 70 years performing the hypofractionated protocol and three weeks of chemotherapy;\n* Karnofsky Performance Status (KPS)\\> 60 assessed post-surgery;\n* life expectancy at least 6 months defined by size and location of lesion tumor;\n* freely given written informed consent prior to any activity related to the study. Patients must be able to communicate with the investigator and comply with the study procedures;\n* Women of childbearing age must test negative for pregnancy at enrollment and, if they have sexual intercourse, they must agree to use specific contraceptive methods. Female subjects of childbearing age, i.e., fertile, after menarche and until post-menopause unless they are permanently infertile, who are sexually active, must apply a highly effective method of birth control with a low failure rate (i.e., less than 1 percent per year), such as combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral intravaginal, or transdermal), progestin-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone delivery system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence, throughout the treatment period and for four weeks after the last dose of the study treatment. Hormonal methods other than levonorgestrel-containing devices or medroxyprogesterone injections should be supplemented with the use of a male condom. Women of nonfertile age may be included if surgically sterile or postmenopausal for at least 2 years. The investigator is responsible for determining whether the patient has adopted an appropriate method of contraception for participation in the study.\n* Male subjects with female partners of childbearing age must use condoms during treatment and until the end of relevant systemic exposure.\n\nExclusion Criteria:\n\n* Multicenter GBMs;\n* Patients diagnosed with diabetes or diabetes-related conditions;\n* other active malignancies;\n* hypersensitivity, intolerance to metformin or excipients;\n* Impaired renal function with creatinine clearance \\\u003C 60 mL\u002Fmin assessed at recruitment, liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin, and other contraindications to metformin use;\n* taking metformin, insulin or other biguanides, regardless of the reason;\n* pregnancy or lactation;\n* patient has serious pre-existing medical conditions that, in the opinion of the investigator, would preclude participation in this study.",{"count":7,"type":22},[64],"About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies.\n\nThis is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months.\n\nThe clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.",[323,324,325],"Glioblastoma, IDH-wildtype","Metformin","Malignancies",[324,327,328],"Gliomas","GBM",{"date":330,"type":43},"2025-07-25",{"date":332,"type":43},"2024-02-12",{"date":334,"type":22},"2026-01-01",{"name":49,"class":50},{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":344,"maxAge":19,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":353,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":51},"100506576","phase-2-vancomycin-in-primary-sclerosing-cholangitis-in-italy-100506576","NCT05876182","Vancomycin in Primary Sclerosing Cholangitis in Italy","A Prospective, Randomized, Placebo-controlled Clinical Trial of Oral Vancomycin in Adults and Young Adults (15-17 Years Old) Affected by Primary Sclerosing Cholangitis With or Without Inflammatory Bowel Disease","VanC-IT","Inclusion Criteria:\n\n1. Willing and able to give informed consent prior to any study specific procedure being performed;\n2. Male and non-pregnant, non-lactating female subjects, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of informed consent;\n3. Diagnosis of large-duct PSC based on cholangiogram (at MRCP, ERCP, PTC) according to the most recent published guidelines (EASL);\n4. Baseline ALP ≥1.5 times upper limit normal at screening;\n5. Absence of biliary obstruction and\u002For malignancy within 6-12 months of entry into the study;\n6. If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period;\n7. Patients who received antibiotics or probiotics may participate if they had a washout period of at least 3-month prior to study entry;\n8. If a patient has been on obeticholic acid or other experimental therapies (e.g. cilofexor and norUDCA) for PSC, they must complete a 3-month washout period before study entry;\n9. PSC with or without IBD. IBD diagnosis should be documented and with a minimum disease duration of 6 months, as determined by endoscopic and histopathology assessment. IBD should be in clinical remission or mildly active according to CDAI and partial Mayo score for CD and UC, respectively (i.e. patients with CDAI score \\\u003C 220 and pMayo score \\\u003C5). Patients without documented IBD need a colonoscopy with segmental biopsies within 12 months prior to baseline visit;\n10. Female subjects of childbearing potential must test negative for pregnancy at screening, baseline and follow-up visits and if engage in sexual intercourse must agree to use specific methods of contraception.\n11. Male subjects with female partners of childbearing potential must use condoms during treatment and until the end of relevant systemic exposure.\n\nExclusion Criteria:\n\n1. Receiving an antibiotic or probiotic within 3 months prior to the study;\n2. Expected to receive antibiotics within the weeks leading up to enrollment (such as patients with recurrent cholangitis, ongoing infectious illnesses, etc.);\n3. Allergy to vancomycin or teicoplanin;\n4. Biliary intervention within 3 months prior to study enrollment or planned;\n5. Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week);\n6. Pregnancy and lactation;\n7. Advanced renal disease (GFR\\\u003C 70);\n8. Active hepatitis B and\u002For C infection;\n9. Other chronic or cholestatic liver diseases such as PBC, autoimmune hepatitis, nonalcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, hemochromatosis, α-1 antitrypsin deficiency, IgG4-related sclerosing cholangitis, and liver cancer;\n10. History of CCA;\n11. Advanced liver disease (history of variceal bleeding, ascites, hepatic encephalopathy, and\u002For bilirubine \\>4 mg\u002FdL);\n12. On active transplantation list;\n13. IBD with uncontrolled moderate to severe activity;\n14. Active treatment or within the previous four weeks (washout period) with any immunosuppressive medication for controlling IBD (i.e. azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous four weeks\n15. Active treatment with rifampicin or within the previous three months (washout period);\n16. Dose change within last 3 months prior to baseline of concomitant treatment with vitamin D or fibrates;\n17. Treatment with any experimental drug within the previous three months;\n18. Any known relevant infectious disease (e.g. active tuberculosis, AIDS defining disease);\n19. History or active hearing problems;\n20. Any active malignant disease;\n21. Well found doubt about patient's cooperation, e.g. addiction to alcohol or drugs;\n22. Imprisoned person, person admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent.","15 Years",{"count":346,"type":22},84,[64],"Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications.\n\nThis is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg\u002Fday) in subject between 15 - 70 years old with PSC.",[350,351,352],"Primary Sclerosing Cholangitis","Liver and Intrahepatic Bile Duct Disorder","IBD",[354,355,356,357],"liver","oral vancomycin","primary sclerosing cholangitis","Inflammatory bowel disease",{"date":330,"type":43},{"date":360,"type":43},"2023-06-15",{"date":362,"type":22},"2026-06",{"name":49,"class":50},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},"100497390","dual-anti-glutamate-therapy-in-super-refractory-status-epilepticus-after-cardiac-arrest-100497390","NCT05756621","Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest","SUPER-refractory Status Epilepticus After Cardiac Arrest: a Multicenter, Retrospective, Cohort Study of Dual Anti-glutamate Therapy With Ketamine and Perampanel","SUPER-CAT","Inclusion Criteria:\n\n* age ≥ 18 years\n* patients in coma after cardio-circulatory arrest (CCA) admitted to the Intensive Care Unit and treated with target temperature management (TTM) for the first 24 hours\n* initiation of continuous electroencephalographic (cEEG) monitoring within 24-36 hours of CCA\n* diagnosis of super-refractory status epilepticus, relapsed after the first cycle of anesthetics (lasting \\> 24 hours) and antiepileptic therapy, defined according to the international Salzburg criteria9\n* presence of pupillary reflex present bilaterally\n* presence of N20 cortical response present bilaterally\n\nExclusion Criteria:\n\n* EEG with periodic pattern (generalized periodic discharges; GPDs)\n* status epilepticus resolved after the first cycle of anesthetics + antiepileptics\n* pregnant women",{"count":373,"type":22},80,"Status epilepticus (SE) is found in 20-30% of patients in coma after cardiac arrest, is often refractory to medical therapy and is considered a negative prognostic factor. Intensity and duration of treatment of refractory and super-refractory post-anoxic SE pose the ethical dilemma between futility of treatments and, conversely, their premature suspension. A recent study by the Epilepsy Center of the San Gerardo Hospital has shown that patients with super-refractory post-anoxic SE and favorable prognostic indicators can achieve a good functional outcome in more than 40% of cases, if treated with intensive and protracted therapy.\n\nHowever, there is profound uncertainty about the best combination of antiseizure medications and anesthetics to use in this condition. A combined anti-glutamatergic therapy with ketamine (anti-NMDA receptor) and perampanel (anti-AMPA receptor), aimed at counteracting the excitotoxicity linked to global cerebral ischemia, could be particularly effective in the treatment of super-refractory SE with post-anoxic etiology. Preliminary results in the first 26 patients treated in the Coordinating Center of the project indicate that this therapy appears safe and highly effective (80% SE resolution, 40% good neurological outcome).\n\nThe aim of the SUPER-CAT study is to investigate the efficacy and safety of combined therapy with ketamine and perampanel (dual anti-glutamatergic therapy) in patients with post-anoxic super-refractory status epilepticus, compared to other therapies, using a multi-centre, retrospective, cohort study design.",[376,377],"Status Epilepticus","Cardiac Arrest",[379,380,381,382],"super-refractory","prognostic indicators","perampanel","ketamine",{"date":307,"type":43},{"date":385,"type":43},"2022-01-15",{"date":387,"type":22},"2025-09-30",{"name":49,"class":50},10,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":18,"minAge":398,"maxAge":60,"enrollmentInfo":399,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":415},"100483844","epos-discoid-meniscus-dime-project-100483844","NCT05580315","EPOS Discoid Meniscus (DiMe) Project","EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol","DiMe","Inclusion Criteria:\n\n* symptomatic DM confirmed by a senior orthopedic surgeon based on physical examination and MRI\n* age less than eighteen years\n* informed consent freely granted and acquired before the start of the study from legal representative\n\nExclusion Criteria:\n\n* concomitant or previous knee surgeries\n* concomitant ligament knee injury that requires a surgical treatment\n* concomitant fractures\n* inflammatory or arthritic diseases.","1 Year",{"count":400,"type":22},500,"The aims of this Discoid Meniscus (DiMe) project are to analyze DM tears characteristics in the pediatric European population to describe current treatment options in symptomatic DM, and to evaluate clinical outcomes. To reach these objectives, a prospective database including symptomatic DM and variables associated with DM characteristics, type of tears, treatment, imaging, and clinical follow-up will be implemented. Data collection platform will provide future studies to understand the best treatment option for skeletally immature patient with symptomatic DM according to their history and lesion characteristics.",[403],"Discoid Meniscus of Knee",[405,406,407,408],"discoid meniscus","knee","pediatric","sport medicine",{"date":330,"type":43},{"date":411,"type":43},"2022-09-08",{"date":413,"type":22},"2042-09-01",{"name":49,"class":50},12,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":424,"targetDuration":426,"studyType":90,"phases":4,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100450923","national-database-on-primary-biliary-cholangitis-100450923","NCT05151809","National Database on Primary Biliary Cholangitis","Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage","PBC322","Inclusion Criteria:\n\nAll PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:\n\n* elevated alkaline phosphatase and \u002For GGT;\n* positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);\n* characteristic histological features of florid bile ducts lesions and granulomatous lesion.\n\nExclusion Criteria:\n\nThe patient has explicitly declared his\u002Fher unwillingness to participate to the study",{"count":425,"type":22},6000,"10 Years","Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.",[429],"Primary Biliary Cholangitis",[429,431,432],"Disease phenotypes","National Database",{"date":330,"type":43},{"date":435,"type":43},"2019-09-19",{"date":437,"type":22},"2029-01-24",{"name":49,"class":50},55,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":447,"maxAge":4,"enrollmentInfo":448,"targetDuration":450,"studyType":90,"phases":4,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100450803","prospective-observational-study-based-on-a-cohort-of-geriatric-patients-with-hip-fracture-treated-in-the-centers-belonging-to-the-giog-group-100450803","NCT05150249","Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group","GIOG","Inclusion Criteria:\n\n* Fracture of the femur, regardless of the cause\n* Age ≥ 65 years\n* Willingness to participate in the study by the patient or a relative \u002F caregiver, if the patient is unable to understand and is not \"competent\" at the time of the evaluation.\n* Able to speak the Italian language\n\nExclusion Criteria:\n\n* none","65 Years",{"count":449,"type":22},7000,"5 Years","The study aims to collect the clinical activity and management data of the Orthogeriatrics and Orthopedics Units participating in the study on a continuous and long-term basis. By collecting clinical data and comparing the performance of the various centers, the study aims to guide the participating centers towards the principles of good clinical practice in orthogeriatrics.",[453,454,32],"Hip Fractures","Older Patients",[456,457,458,459],"GIOG ( Italian Society of Anesthesiology);","geriatric","orthogeriatric","co-management",{"date":330,"type":43},{"date":462,"type":43},"2019-07-15",{"date":464,"type":22},"2025-12-31",{"name":49,"class":50},11,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":51},"100438254","chemotherapy-induced-peripheral-neurotoxicity-cipn-why-should-we-care-100438254","NCT04986891","Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care","Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care (CIPN COST) - Pilot Study","CIPN COST","Inclusion Criteria:\n\n1. Cancer patients with this characteristics:\n\n   1. at least 75 consecutive subjects sent for a neurological evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);\n   2. at least 75 consecutive subjects sent for a neurological evaluation due to stable CIPN condition (CIPN defined as TNSc \\> or = 1) after chemotherapy completion (at least 2 months off treatment).\n2. Male and female subjects who are 18 years of age or older.\n3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.\n4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.\n5. Subjects must have a Karnofsky performance score greater than or equal to 70.\n\nExclusion Criteria:\n\n1. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.\n2. Severe depression that in the opinion of the Investigator would complicate the assessments.\n3. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g., metronidazole, isoniazid, amiodarone, antiretroviral medications).\n4. Subjects who suffer from another medical condition that can cause neuropathy (e.g., diabetes)\n5. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.",{"count":476,"type":22},150,"This is a pilot, observational, cross-sectional, study on socio-economic burden related to chemotherapy-induced peripheral neurotoxicity (CIPN). Investigators will collect CIPN healthcare related costs on a detailed clinical patient-level. As a sub-study, data obtained in this cross-sectional study, will be compared with administrative larger datasets on patients affected by cancer. The aim is to run a test for potential proxy variables which are available in larger administrative datasets, even if not directly measuring CIPN, to learn more about the impact of CIPN.",[479],"CIPN",[481,482,483,484,479,485],"chemotherapy","neuropathy","socio-economic indicators","neurotoxicity","quality of life",{"date":307,"type":43},{"date":488,"type":43},"2021-07-31",{"date":490,"type":22},"2025-12",{"name":49,"class":50},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":514},"100411141","international-cipn-assessment-and-validation-study-100411141","NCT04633655","International CIPN Assessment and Validation Study","International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study","ICAVS","Inclusion Criteria\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:\n\n1. Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).\n2. Male and female subjects who are 18 years of age or older.\n3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.\n4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.\n5. Subjects must have a Karnofsky performance score greater than or equal to 70. Exclusion Criteria\n\nSubjects presenting with any of the following will not be included in the study:\n\n1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.\n2. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.\n3. Severe depression that in the opinion of the Investigator would complicate the assessments.\n4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.\n5. Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).\n6. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g. metronidazole, isoniazid, amiodarone, antiretroviral medications).\n7. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.\n8. Previous neurotoxic chemotherapy.",{"count":113,"type":22},"This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.",[503,186],"Chemotherapy-induced Peripheral Neuropathy",[505,506,507,508],"clinimetrics","biomarker","PRO","outcome measures",{"date":330,"type":43},{"date":511,"type":43},"2020-06-08",{"date":464,"type":22},{"name":49,"class":50},30,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":51},"100395124","the-natural-history-of-hospitalized-covid-19-patients-100395124","NCT04424992","The Natural History of Hospitalized COVID-19 Patients","Observational Cohort Study on the Natural History of Hospitalized SARS-COV-2 Patients: the STORM Trial","STORM","Inclusion Criteria:\n\n1. Clinical and \u002F or radiological diagnosis of lung infection with COVID-19;\n2. Positive test for SARS-CoV-2 infection.\n\nExclusion Criteria:\n\n1\\. Age less than 18 years",{"count":524,"type":22},1433,"This is an observational study. The aim is to describe the natural history and clinical evolution over time of hospitalized patients affected by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of the disease and improve therapeutic procedures.",[527],"Sars-CoV2",[529,530,531],"Coronavirus","sars-covid-2","coronavirus infection",{"date":330,"type":43},{"date":534,"type":43},"2020-02-28",{"date":464,"type":22},{"name":49,"class":50},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":562},"100596203","self-care-behaviors-of-type-2-diabetes-mellitus-patients-100596203","NCT07042399","Self-care Behaviors of Type 2 Diabetes Mellitus Patients","Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes;\n* Age over 18 years old;\n* Adequate comprehension of the Italian language;\n* Signed and dated informed consent.\n\nExclusion Criteria:\n\n* Presence of documented psychiatric or neurodegenerative disease;\n* Pregnancy;\n* Any condition that, by the investigators' judgment, may limit adherence to study procedures",{"count":545,"type":22},300,"The goal of this observational study is to explore the experience of the chronic disease, with a particular focus on self-care, in adults with type 2 diabetes mellitus. The main questions it aims to answer are:\n\n* what is the association between self-care and glycated hemoglobin over time?\n* what are participants' clinical and sociodemographic characteristics influencing self-care behaviors? Participants' socio-demographic and clinical data will be collected by medical records and, at the beginning or at the end of the clinical standard outpatient visit, they will be asked to complete study questionnaires.\n\nThe results of this study could be helpful in providing quality assistance, improving resource consumption, and reducing the onset of complications.",[548],"Type 2 Diabetes",[550,551,552,553],"Self-care","Chronic diseases","Type 2 diabetes","Self-management","2025-06-19",{"date":556,"type":43},"2025-06-29",{"date":558,"type":43},"2024-03-01",{"date":560,"type":22},"2027-05-31",{"name":49,"class":50},2,{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":588,"locationsCount":51},"100553673","multi-domain-improvements-in-high-technology-rehabilitation-programs-for-post-stroke-patients-100553673","NCT06489145","Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients","Users' Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients: a Multi-method, Multi-informant, Patient-centred Approach","ITER","Study 1 (ID: 0025654\u002F24)\n\nPatients\n\nInclusion Criteria:\n\n* Acute stroke event occurring within a maximum of 12 months prior to treatment;\n* Age over 18 years;\n* Acceptable hyposthenia evaluated with the Motricity Index (scores less than the maximum)\n* Spasticity, if present, compatible with limb function (MAS score \\\u003C 2)\n* Mental health condition allowing for a full understanding of the study objectives and completion of self-report measures\n\nExclusion Criteria:\n\n* Severe clinical condition (e.g., cognitive impairment - MMSE score \\\u003C 24), presence of sever apraxia, complete upper limbs hemiplegia, severe upper limb sensory disorders, joint fractures and dislocations);\n* clinical non-eligibility to the use of exoskeleton devices as per technical specifications of the devices\n* Inability or difficulty in completing self-report measures in Italian and\u002For secondary illiteracy;\n* Presence of psychiatric pathology in medical history or recent psychiatric pathology that could affect reliability of data collected;\n* Refusal or withdrawal of informed consent at any stage of the study.\n\nCaregivers\n\nInclusion Criteria:\n\n* Any informal caregiver (e.g., family member, friend) who continuously assists the enrolled patient for at least half a day;\n\nExclusion Criteria:\n\n* Inability or difficulty in understanding Italian language and\u002For illiteracy;\n* Refusal or withdrawal of informed consent at any stage of the study\n\nTherapists\n\nInclusion Criteria:\n\n* Physiotherapists who assist enrolled patients throughout the entire intervention period\n\nExclusion Criteria:\n\n* Physiotherapists who partially assist enrolled patients throughout the entire intervention period\n\nStudy 2 (ID: RM-2024-803)\n\nTherapists\n\nInclusion Criteria:\n\n* Physiotherapists who have sufficient professional experience in use of rehabilitation technology in post-stroke rehabilitation programs;\n\nExclusion Criteria:\n\n* Refusal or withdrawal of informed consent at any stage of the study",{"count":373,"type":22},[25],"Through a multi-method, multi-informant, and patient-centred approach, the study aims to investigate the experience of use and the effectiveness of rehabilitation technology (robotics and virtual reality - VR) in post-stroke patients and their caregivers and therapists",[575],"Stroke",[577,578,579,186,580,581],"Stroke Rehabilitation","Technology","Cognition","Well-Being","Experience of Use","2024-12-04",{"date":584,"type":43},"2024-12-09",{"date":586,"type":43},"2024-06-24",{"date":387,"type":22},{"name":49,"class":50},{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":143,"sex":18,"minAge":60,"maxAge":19,"enrollmentInfo":595,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":601,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":51},"100486962","efficacy-of-a-tailored-communication-intervention-aimed-at-increasing-the-number-of-daily-steps-100486962","NCT05620888","Efficacy of a Tailored Communication Intervention Aimed At Increasing the Number of Daily Steps","Inclusion Criteria:\n\n* Participants from the general population, in good health and sedentary\n* A level of education sufficient to understand the procedures of the study and to use a smartphone\n* Having a smartphone\n\nExclusion Criteria:\n\n* The participant always (or almost always) takes at least 7,000 steps a day\n* The participant achieves an IPAQ score equal to or greater than 3000 MET-min \u002F week\n* The participant has symptoms or pathologies that could represent a contraindication to the physical activity proposed by the study. In particular\n* Cardiovascular diseases for which physical activity is allowed only under medical supervision\n* Chest pain during daily activities\n* Drug treatment for cardiovascular diseases\n* Severe arterial hypertension not pharmacologically controlled\n* Episodes of loss of consciousness within the past 12 months\n* Osteoarticular disorders that could be aggravated by a change in the level of physical activity\n* Fractures of the lower limbs, vertebrae, or pelvis in the past six months\n* Walking difficulty\n* Respiratory insufficiency",{"count":596,"type":22},255,[25],"This study aims to evaluate the efficacy of a physical activity promotion intervention focused on walking behavior. The intervention is delivered via mobile application in a sample drawn from the healthy adult population.",[600],"Physical Inactivity",[602,603,604,605,606,607,608],"Physical Activity","Tailored communication","Behavior Change","Self Efficacy","Health Action Process Approach","Persuasive Communication","Walking",{"date":584,"type":43},{"date":611,"type":43},"2022-10-03",{"date":613,"type":22},"2025-06",{"name":49,"class":50},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":18,"minAge":447,"maxAge":4,"enrollmentInfo":623,"targetDuration":625,"studyType":90,"phases":4,"briefSummary":626,"conditions":627,"keywords":634,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":644,"leadSponsor":646,"locationsCount":51},"100567586","exploring-the-correlations-of-lung-ultrasound-with-delirium-and-outcomes-in-acute-geriatrics-world-a-multicenter-prospective-observational-study-from-the-greta-group-of-the-italian-society-of-gerontology-and-geriatrics-100567586","NCT06670118","Exploring the Correlations of Lung Ultrasound with Delirium and Outcomes in Acute GEriatrics World: a Multicenter, Prospective, Observational Study from the GRETA Group of the Italian Society of Gerontology and Geriatrics","EXPLORING the CORRELATION of the LUNG ULTRASOUND with DELIRIUM and OUTCOMES in ACUTE GERIATRICS WORLD (ECO-AGE): a MULTICENTER, PROSPECTIVE, OBSERVATIONAL STUDY from the GRETA GROUP (GRUPPO DI RICERCA in ECOGRAFIA TORACICA NELL' ANZIANO) of the ITALIAN SOCIETY of GERONTOLOGY and GERIATRICS (SIGG)","ECO-AGE","Inclusion Criteria:\n\n* Patients aged 65 years or older, admitted directly from the Emergency Room or Emergency Medical Services with acute respiratory symptoms or signs.\n\nPresence of acute respiratory symptoms, including:\n\n* Dyspnea or cough.\n* Oxygen saturation less than 94% or respiratory rate ≥ 22 breaths per minute, or PaO2\u002FFiO2 \\\u003C 300.\n* Clinical suspicion of acute respiratory illness (e.g., pneumonia, acute congestive heart failure, pulmonary edema, COPD, pleural effusion, pneumothorax).\n* Lung ultrasound (LUS) performed within 48 hours of admission for clinical reasons.\n* Signed informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Presence of delirium upon admission.\n* Refusal to sign the informed consent form or consent to data collection.\n* Terminal illness with an estimated survival prognosis of no more than 3 months.\n* Previous open thoracic or cardiothoracic surgery compromising the quality of LUS images.\n* Lack of cooperation during the LUS examination.\n* Any condition determined by the investigators that could introduce bias into the study or compromise the quality of the LUS examination.",{"count":624,"type":22},480,"3 Months","The purpose of this observational study is to investigate the prognostic relevance of lung ultrasound (LUS) performed on older patients (aged 65 and above) admitted to the hospital with acute respiratory symptoms. The primary objective is to determine if LUS-detected pulmonary abnormalities upon hospital admission are associated with the development of delirium during hospitalization. Secondary objectives include assessing the association between LUS patterns and clinical outcomes such as oxygen supplementation duration, non-invasive ventilation use, mortality, and length of hospital stay. This study involves no interventions and will monitor patients using LUS as part of their regular clinical care in multiple centers.",[628,629,630,631,632,633],"Acute Respiratory Failure","Delirium in Old Age","Pneumonia","Acute Heart Failure (AHF)","Chronic Obstructive Pulmonary Disease (COPD)","Ultrasound Exams",[635,636,637,638,639],"Lung Ultrasound Abnormalities in Older Adults","Lung ultrasound","delirium","respiratory failure","geriatrics","2024-10-31",{"date":642,"type":43},"2024-11-01",{"date":45,"type":22},{"date":645,"type":22},"2026-12-01",{"name":49,"class":50},{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":143,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":656,"conditions":657,"keywords":659,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":80},"100554182","preventing-premature-family-maladjustment-an-e-health-interdisciplinary-research-100554182","NCT06495762","Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research","e-ParWelB","Inclusion Criteria:\n\n* Parents of children born before 36+6 of gestational age (GA).\n* The parents must be at least 18 years old\n* Children must have been hospitalized in intensive or sub-intensive care for at least ten days.\n* Parents must be able to speak fluent Italian or English.\n\nExclusion Criteria:\n\n\\- Children must not have other genetic pathologies or other pathologies not linked to the preterm birth.",{"count":655,"type":22},350,"The consequences of preterm birth extend beyond the clinical conditions of the newborn, profoundly impacting the functioning and well-being of families. Although various research examines changes in parents' well-being and perception of self-efficacy during the stay in NICU, there is a lack of research analyzing what happens in the delicate transition phase at home after the baby's discharge. Recently, scholars have advocated for the use of web-based and app-based support programs both to monitor and prevent preterm family maladjustment and to assist parents struggling with the transition home. The main aim of this interdisciplinary research project is to develop a socio-psychological model focused on assessing the well-being of parents of premature infants during and after their stay in a NICU. Specifically, the study aims to (1) monitor the mental health of parents of premature infants, both at the time of the child's discharge from the NICU and in the first six months after discharge to prevent family maladjustment, (2) deepen our understanding of the role of digital tools in monitoring and supporting the well-being of parents of premature infants, and (3) study the potential impact of the relationship with healthcare professionals on the overall well-being of parents. The project combines mixed methods of social research and psychological support with an e-health approach. The well-being of parents of premature infants will be assessed using validated scales administered through a questionnaire to parents of preterm infants within six NICUs at the time of the child's discharge. Subsequently, a follow-up assessment of parental well-being will be implemented through the administration of the validated scales in a web app. Additionally, an ethnographic phase will be conducted in the NICUs, involving observation of the interaction between healthcare professionals and parents, as well as narrative interviews with healthcare staff. It is expected to shed light on the determinants of well-being among parents of premature infants, in relation to varying levels of prematurity severity, socio-demographic characteristics such as gender, age, and socioeconomic status, and parental involvement in NICU care practices. With the follow-up phase via web app, the project also aims to prevent family maladjustment by providing psychological support and utilizing an e-health tool.",[658],"Psychological Distress",[660,661,662,663,664,665],"Preterm birth","Parental well-being","Sociology of Health","Digital-Based Monitoring","Mixed-method Research","e-Health","2024-07-10",{"date":668,"type":43},"2024-07-11",{"date":670,"type":22},"2024-09-02",{"date":672,"type":22},"2025-10-01",{"name":49,"class":50},""]