[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Magna Graecia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":121},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,71,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100606292","consensus-statements-on-deep-brain-stimulation-in-patients-with-parkinsons-disease-100606292",false,"NCT07173660","Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease","Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease - A Delphi Study","DBS_Consensus","Panelist selection\n\nHealthcare professionals will be recruited as panelists based on the following predefined criteria:\n\nInclusion criteria:\n\n* At least 5 years of clinical experience in the care of patients with Parkinson's disease, including involvement in deep brain stimulation (DBS) implantation (in both teaching and non-teaching settings).\n* Prior participation in guideline development or authorship of at least one peer-reviewed publication on neuromodulation in Parkinson's disease.\n\nExclusion criteria:\n\n\\- None.\n\nRecruitment strategy:\n\n\\- Purposive sampling will be applied to identify Italian panelists, primarily through a review of recent publications in the field of DBS for Parkinson's disease. Panelist selection will adhere to the predefined criteria, with deliberate efforts to ensure gender balance and broad geographical representation across Italy.",true,"ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","OBSERVATIONAL","Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), showing superior outcomes over best medical treatment in randomized clinical trials. By delivering adjustable electrical stimulation to key basal ganglia targets, DBS improves tremor, rigidity, bradykinesia, and motor fluctuations, while also reducing dopaminergic medication requirements. Its success, however, depends not only on precise surgical targeting but also on careful patient selection, multidisciplinary planning, and structured long-term follow-up.\n\nIn Italy, PD affects nearly 176,000 individuals, of whom an estimated 2-4.5% are potential candidates for DBS. A national survey conducted by the Italian Neurosurgery Society (SINch) revealed marked heterogeneity in surgical approaches, target selection, and team composition across DBS centers-reflecting similar international variability. Yet, clear national indications and guidelines have not been established. To address this gap, we conducted an expert consensus using the Delphi methodology.",[26,27],"Deep Brain Stimulation","Parkinson Disease",[29,30],"Expert Consensus","Neurosurgery","NOT_YET_RECRUITING","2025-09-17",{"date":34,"type":35},"2025-09-23","ACTUAL",{"date":37,"type":22},"2025-09-15",{"date":39,"type":22},"2026-04-01",{"name":41,"class":42},"University Magna Graecia","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100579912","measurement-of-the-optic-nerve-diameter-in-different-healthcare-operators-100579912","NCT06830460","Measurement of the Optic Nerve Diameter in Different Healthcare Operators","Efficacy of a Theoretical-practical Course for the Ultrasound Measurement of the Optic Nerve Diameter in Different Healthcare Operators","Inclusion Criteria:\n\n* medical student, or nurse student, or residents in anesthesia or nurse with at least 3 years of Intensive care unit experience\n\nExclusion Criteria:\n\n* previous skills on ONSD measurements",{"count":51,"type":22},40,"INTERVENTIONAL",[54],"NA","The study evaluates the effectiveness of a theoretical-practical training course for the ultrasound measurement of the optic nerve sheath diameter (ONSD), a non-invasive method used to estimate intracranial pressure (ICP). The optic nerve sheath is continuous with the subarachnoid space, which contains cerebrospinal fluid (CSF). An increase in ICP leads to an increase in CSF within the sheath, enlarging its diameter. ONSD measurement is typically performed by placing an ultrasound probe on the closed eyelid, allowing visualization of the optic nerve behind the eyeball.\n\nWhile the correlation between ONSD enlargement and elevated ICP is well-documented, there is variability in diagnostic cut-off values due to differences in measurement techniques, equipment, and operator experience. Previous studies have shown that even novice operators can achieve clinically acceptable accuracy after brief training.\n\nThis study aims to assess whether medical students, nursing students, anesthesiology and intensive care residents, and intensive care nurses can learn to perform reliable ONSD measurements after a short training session.\n\nMethodology:\n\nThe study will involve 40 participants unfamiliar with ONSD measurement: 10 medical students, 10 nursing students, 10 anesthesiology and intensive care residents, and 10 experienced intensive care nurses. The training will consist of a four-hour session, including a 30-minute lecture on ocular anatomy and ultrasound techniques, a real-time demonstration, and supervised hands-on practice with at least 20 measurements.\n\nParticipants must pass a multiple-choice test with at least 70% correct answers to proceed to practical verification, where they will measure ONSD in five healthy volunteers. These measurements will be compared with those taken by an expert tutor.\n\nMeasurement Technique:\n\nThe ultrasound technique follows expert consensus guidelines, using a linear probe with a minimum frequency of 7.5 MHz. Volunteers will be positioned semi-seated at a 45° head elevation with closed eyelids. The ONSD measurement will be taken 3 mm behind the retina on the right eye. Care will be taken to avoid pressure on the eyeball, and safety parameters will be monitored to ensure compliance with FDA guidelines.\n\nThe study aims to demonstrate that various healthcare professionals can achieve accurate and reliable ONSD measurements with proper training, enhancing the utility of this technique in diverse clinical settings.",[57,58],"Healthy Volunteer","Healthy Volunteer Study",[60,61],"optic nerve sheath diameter","theoretical-practical course","2025-02-11",{"date":64,"type":35},"2025-02-17",{"date":66,"type":22},"2025-03-01",{"date":68,"type":22},"2025-03-31",{"name":41,"class":42},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":70},"100491656","practice-of-oxygenation-and-respiratory-support-during-fiberoptic-bronchoscopy-100491656","NCT05681962","Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy","Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY","Inclusion Criteria:\n\n* Need for any procedure with flexible FOB\n* Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)\n\nExclusion Criteria:\n\n* None",{"count":79,"type":22},10000,"The current practice of oxygenation and\u002For ventilation supports in patients undergoing Fiberoptic Bronchoscopy is very heterogeneous among studies published in the literature; in addition, clear outcomes advantages of one strategy over another currently lack.\n\nThe goal of this observational study is to describe the current practice of oxygenation and\u002For ventilation supports in patients undergoing Fiberoptic Bronchoscopy (FOB), stratified by baseline respiratory condition, co-morbidities, type of procedure and hospital settings.\n\nInvestigators will enroll all adult patients undergoing any fiberoptic bronchoscopy in any clinical settings (from outpatients to critically ill patients). No specific exclusion criteria are indicated for enrollment in this study.\n\nInvestigators will record the following data:\n\n* Patient's baseline data.\n* Type of FOB procedure: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS). The type and size of bronchoscope (with or without an internal\u002Fexternal camera) and the time of the procedure will be also recorded.\n* Type of supportive strategy: no support, Standard Oxygen Therapy, High Flow Nasal Cannula, Continuous Positive Airway Pressure and or non invasive ventilation trough mask or helmet, invasive mechanical ventilation.\n* Sedation\n* Intra-procedural vital parameters\n* Occurrence of adverse events: desaturation (i.e. SpO2\\\u003C 90% for at least 10 seconds), severe desaturation (i.e. SpO2\\\u003C 80%), need for procedure interruption, hypotensive (systolic blood pressure \\\u003C90 mmHg) or hypertensive (systolic blood pressure \\>140 mmHg) events, new onset of cardiac arrhythmias (specify the rhythm) or myocardial ischemia or electrocardiographic ST-alterations, neurological events (i.e. severe sensorium depression, psychomotor agitation).\n* Post-procedural vital parameters (15 minutes after the procedure).\n* Clinical outcomes: need for support escalation, need for admission to ward (for outpatient) or ICU (for outpatients and ward-admitted patient).",[82,83,84,85,86],"Acute Respiratory Failure","Pneumonia","Lung Cancer","Fibrosis Lung","Interstitial Lung Disease",[88],"Bronchoscopy","RECRUITING","2024-12-24",{"date":92,"type":35},"2024-12-30",{"date":94,"type":35},"2023-02-15",{"date":96,"type":22},"2026-01-31",{"name":41,"class":42},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":52,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100469859","phase-4-four-six-trial-for-the-treatment-of-enterococcal-endocarditis-100469859","NCT05398289","FOUR-SIX TRIAL for the Treatment of Enterococcal Endocarditis","Four-week Duration Versus 6-week Duration of Therapy for the Treatment of Enterococcal Endocarditis","FOURSIX","Inclusion Criteria:\n\n* documented infective endocarditis due to enterococcal strains, according to the modified Duke criteria.\n\nExclusion Criteria:\n\n* patients candidate for chronic suppressive antibiotic treatment",{"count":107,"type":22},130,[109],"PHASE4","Duration of therapy in severe infections has a high impact in term of compliance, adverse events, and costs but also in term of antibiotic pressure on selection of multidrug-resistant pathogens. In this context, many advancements have been obtained for an early diagnosis of IE with a strict selection of criteria for surgery. Moreover, the use in antibiotic regimen of new drugs with peculiar PK\u002FPD characteristics, as a quick bactericidal action, also for IE was not accompanied to a revaluation of duration of antibiotic treatment. On this basis, US and European guidelines recommend a 6-week duration of antibiotic treatment for IE due to enterococcal species.\n\nAIM 1: To evaluate a 4-week duration of antibiotic therapy versus a 6-week duration according to international guidelines.\n\nAIM 2: Second aim is to evaluate the PK\u002FPD of antimicrobials in relation to the probability of target attainment (PTA) of optimal exposure against enterococci.\n\nAIM 3: Finally, we will analyze the bactericidal activities of antibiotic combinations used in patients with IE and the survival of the subgroup of patients who underwent surgery.\n\nOpen-label, multicenter, randomized, non-inferiority trial to be conducted in a 3-year period. The institutional review board at each site will approve the protocol, and all patients or their authorized representatives will provide written informed consent. Eligible patients will be 18 years of age or older with a documented IE due to enterococcal strains, according to the modified Duke criteria.\n\n63 patients in each of the two arms. The study will be conducted at Italian sites. Data on demographic characteristics, comorbidities, antibiotic and concomitant therapies will be collected. Baseline treatments will be defined according to the patients' pharmacological history. IE will be defined according to modified Duke criteria. Antibiotic treatment, indications and timing of surgery will be based on the 2015 American Heart Association and European Society of Cardiology guidelines.\n\nBlood samples for determining antibiotic concentrations of ampicillin, gentamicin, vancomycin, daptomycin and linezolid will be collected at predetermined times in order to allow estimation of PK\u002FPD.\n\nRandomization:\n\n1. 4-week duration of antibiotic therapy\n2. standard 6-week duration of antibiotic therapy The intention-to-treat population (ITT) will include all randomized patients. The modified intention-to-treat population (mITT) will include all randomized patients receiving at least one dose of study medication. The clinically evaluable (CE) population will include ITT patients demonstrating sufficient adherence to study protocol.\n\nPrimary endpoint: non-inferiority of a 4-week course in terms of outcome at 60 days.\n\nSecondary endpoints: microbiological eradication, pharmacological concentrations of antibiotic regimens, patients undergoing surgery, duration of therapy according with resistance profile of enterococcal species.",[112],"Enterococcal Endocarditis","2023-05-09",{"date":115,"type":35},"2023-05-10",{"date":117,"type":22},"2024-01-01",{"date":119,"type":22},"2026-09-01",{"name":41,"class":42},""]