[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pontificia Universidad Catolica de Chile\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":703},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,47,72,99,126,150,179,206,237,263,292,318,345,374,402,426,452,482,519,547,573,600,624,651,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100500012","development-of-a-pharmacodynamic-model-for-propofol-in-older-adults-100500012",false,"NCT05790720","Development of a Pharmacodynamic Model for Propofol in Older Adults","Development of a Pharmacodynamic Model for Propofol in Older Adults (Development phaRmacodynamic mOdel Propofol oLdEr adulTs: DROPLET)","DROPLET","Inclusion Criteria:\n\n* Patients undergoing non-cardiac elective surgery requiring general anesthesia\n* American Society of Anesthesiologists Physical Status I to III\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery\n* Neurosurgical patients\n* History of alcohol abuse or recreational drug use\n* Known allergie to Propofol\n* Body mass index ≥ 35 Kg m-2\n* Unstable heart failure","ALL","65 Years","99 Years",{"count":22,"type":23},36,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this pharmacodynamic study is to develop a model for Propofol administration for older adults (\\>65 years). The main objective is to create a model based on a new pharmacodynamic parameter, derived from frontal electroencephalogram (EEG), to admininster Propofol in older adults. With this new model, the investigators aim to:\n\n* Evaluate the relationship between the plasmatic concentration, described by the Eleveld pharmacokinetic model, versus the effect of the drug represented with a new parameter derived from the intraoperative frontal EEG.\n* To validate the predictive ability of Eleveld's pharmacokinetic-pharmacodynamic model, based on the bispectral index (BIS), compared to the new model based on a parameter derived from intraoperative frontal EEG.\n\nParticipants will be asked to answer preoperative questionnaires, receive a Propofol intravenous infusion concomitantly with continuous BIS and EEG monitoring, and to be evaluated for clinical sings of loss and return of consciousness.",[29],"Aged",[31,32,33],"Propofol","TCI","TIVA","RECRUITING","2026-06-23",{"date":37,"type":38},"2026-06-26","ACTUAL",{"date":40,"type":38},"2024-06-01",{"date":42,"type":23},"2026-08-01",{"name":44,"class":45},"Pontificia Universidad Catolica de Chile","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100642248","simulation-based-training-for-ultrasound-guided-popliteal-sciatic-nerve-block-100642248","NCT07659145","Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block","Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block Performance: a Randomized Non-inferiority Study Comparing Direct Synchronous Feedback With Remote Asynchronous Feedback","Inclusion Criteria:\n\n* Medicine students\n\nExclusion Criteria:\n\n* No exclusion Criteria",{"count":5,"type":23},[26],"The goal of this study is to evaluate whether remote asynchronous feedback is non-inferior to direct synchronous feedback during simulation-based training for ultrasound-guided popliteal sciatic nerve block performance. The main questions it aims to answer are:\n\nDoes asynchronous feedback achieve technical skill acquisition outcomes comparable to direct synchronous feedback? Can asynchronous feedback optimize teaching resources without compromising training quality?\n\nResearchers will compare two feedback modalities within a simulation-based training program for deliberate practice of ultrasound-guided popliteal sciatic nerve block techniques.\n\nParticipants will:\n\nReceive training with either direct synchronous feedback or remote asynchronous feedback Perform simulation-based deliberate practice sessions Be assessed using validated instruments for technical skill performance",[58],"Feedback",[60,61,62,63],"Procedural skills","Distance-based simulation","simulation-based training","feedback","2026-06-16",{"date":66,"type":38},"2026-06-22",{"date":68,"type":38},"2026-05-28",{"date":70,"type":23},"2027-03-27",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":18,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100641490","clinical-characteristics-of-prilocaine-for-spinal-anesthesia-in-ambulatory-surgery-clinical-profile-and-efficacy-100641490","NCT07661628","Clinical Characteristics of Prilocaine for Spinal Anesthesia in Ambulatory Surgery: Clinical Profile and Efficacy","Prilocaine","Inclusion Criteria:\n\n* outpatient knee arthroscopic surgery\n\nExclusion Criteria:\n\n* pediatric patients\n* hospitalized patients",true,"18 Years","75 Years",{"count":83,"type":23},50,"1 Day","OBSERVATIONAL","Introduction:\n\nHyperbaric prilocaine is widely used internationally for outpatient orthopedic and perineal surgery because of its favorable recovery profile compared with other intermediate-acting local anesthetics, such as bupivacaine, and its lower incidence of transient neurologic symptoms compared with lidocaine. Recently approved for intrathecal use in Chile, prilocaine offers advantages including shorter onset time, faster motor recovery, and earlier return of bladder function.\n\nObjective:\n\nTo describe the clinical use of intrathecal prilocaine in outpatient knee arthroscopy, including the characteristics of sensory and motor block, incidence of anesthesia-related complications, and hospital readmissions. The study hypothesizes that prilocaine enables rapid postoperative recovery, early ambulation, and a low incidence of complications such as urinary retention, nausea and vomiting, and hypotension.\n\nMethods:\n\nFollowing institutional ethics committee approval and written informed consent, a prospective descriptive study will be conducted in 50 ASA physical status I-II patients undergoing ambulatory knee arthroscopy. Spinal anesthesia will be performed using 40 mg of 2% prilocaine under standard monitoring, with supplemental oxygen and midazolam sedation. Surgical type and duration will be recorded. Outcomes will include sensory and motor block duration, time to ambulation, time to first voiding, time to discharge, and the occurrence of complications such as urinary retention, nausea and vomiting, and hypotension during recovery. As this is a convenience sample, no formal sample size calculation has been performed. Data will be analyzed descriptively and reported as means and standard deviations, without inferential statistical testing.",[88],"Healthy",[90,91],"prilocaine","spinal anesthesia","NOT_YET_RECRUITING",{"date":66,"type":38},{"date":95,"type":23},"2026-07-01",{"date":97,"type":23},"2027-03-31",{"name":44,"class":45},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":79,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":107,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":46},"100643262","my-wellness-begins-with-the-steps-100643262","NCT07639814","My Wellness Begins With the Steps!","My Wellness Begins With the Steps! \u002F Mi Bienestar se Inicia en Los Peldaños! (Mi BIP!) N-of-1 Pilot Trial","Mi BIP!","Inclusion Criteria:\n\n* All subway users\n\nExclusion Criteria:\n\n* None",{"count":108,"type":23},2000,"This study evaluates the effect of street signs inviting to use the conventional stairs instead of escalators at a subway station without and with active pop music.",[111],"Physical Activity",[113,114,115,116,117],"Subway","Phsysical activity","Chile","Street signs","Music","2026-06-06",{"date":120,"type":38},"2026-06-10",{"date":122,"type":23},"2026-06-01",{"date":124,"type":23},"2026-08-30",{"name":44,"class":45},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":46},"100618386","incidence-and-risk-factors-of-postoperative-chronic-pain-in-patients-who-have-undergone-hallux-valgus-surgery-100618386","NCT07330947","Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery","Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery in the UC-Christus Clinical Hospital","Inclusion Criteria:\n\n* Patients who underwent Hallux Valgus surgery at various centers within the UC Christus network from January 2021 to April 2024.\n\nExclusion Criteria:\n\n* Patients who had difficulty responding to follow-up from the UC Christus health network Pain Unit and\u002For who do not answer the telephone call",{"count":134,"type":23},350,"The goal of this observational study is to learn about the incidence and risk factors of postoperative chronic pain in adult patients who have undergone Hallux Valgus surgery (between january 2021 and december 2024). This will be assesed through scales and medical records information.\n\nThe main questions to be answered are:\n\n* How many patients who have undergone Hallux Valgus surgery are experiencing postoperative chronic pain.\n* What factors are there present in those who do experience chronic pain after surgery.\n\nAfter accepting the informed consent, participants will be asked to answer a Brief Pain Inventory Scale and a Risk Factor Questionnaire for Postoperative Chronic Pain.",[137,138],"Postoperative Chronic Pain","Hallux Valgus Surgery",[140,141,142,143],"Hallux Valgus surgery","postoperative chronic pain","risk factors","brief pain inventory","2026-05-26",{"date":68,"type":38},{"date":122,"type":23},{"date":148,"type":23},"2026-12-30",{"name":44,"class":45},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100639213","elucidating-the-neural-correlates-of-anesthesia-induced-unconsciousness-in-neonates-100639213","NCT07601854","Elucidating the Neural Correlates of Anesthesia-induced Unconsciousness in Neonates","NeoNCC","Inclusion Criteria:\n\n* Full term neonates (37 - 42 weeks of gestational age)\n* Require general anesthesia\u002Fdeep sedation during their first 28 days of life because they require a surgery or a specific procedure (cardiac or non-cardiac)\n* Scheduled for propofol induction\n\nExclusion Criteria:\n\n* Neurological surgeries\n* Perinatal asphyxia\n* Evidence of neurological injury or pathology\n* Suspected brain malformations\n* Patients with metabolic or hemodynamic instability at the time of the surgery or procedure.","28 Days",{"count":159,"type":23},64,"This study will try to elucidate the neural responses of neonatal patients to surgery-level propofol infusions during induction and maintenance of anesthesia. The main objective is to elucidate the EEG patterns of neural activity that can reliably reflect the level of hypnotic depth in full term neonates undergoing propofol anesthesia based on the classification of EEG into states and the characterization of discrete neonatal EEG events.",[162,163,164],"Anesthesia Brain Monitor","Anesthesia","Neonatal Surgery",[166,167,168,169,170],"neonatal anesthesia","propofol","brain monitoring","neonatal brain monitoring","neonatal brain states","2026-05-18",{"date":173,"type":38},"2026-05-22",{"date":175,"type":23},"2026-05-15",{"date":177,"type":23},"2029-05-15",{"name":44,"class":45},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":24,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100581770","effect-of-continuous-prolonged-prone-position-versus-intermittent-daily-prone-position-in-ards-100581770","NCT06854627","Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS","Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial","ePRONE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Endotracheal intubation and mechanical ventilation for less than 72 hours\n* Moderate-severe ARDS defined as:\n\n  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms\n  2. Bilateral infiltrates not fully explained by effusions, lobar\u002Flung collapse, or nodules\n  3. Respiratory failure not fully explained by cardiac failure or fluid overload\n  4. PaO2\u002FFiO2 \\\u003C 150 mmHg in supine position\n* Prone positioning has been indicated by the attending physician, OR has already been initiated within the last 16 hours\n\nExclusion Criteria:\n\n* Contraindications for prone positioning such as intracranial pressure \\> 20 mmHg, massive hemoptysis, recent tracheal surgery or sternotomy or abdominal surgery with an open wound, recent facial trauma or facial surgery, unstable spine, femur, or pelvic fractures, or a single anterior chest tube with air leaks\n* Patient on extracorporeal membrane oxygenation (ECMO) before randomization\n* Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation (NIV)\n* Known pregnancy\n* Anticipating withdrawal of life support or shift to palliative care",{"count":188,"type":23},780,[26],"Prone position (placing the patient on his abdomen) has been shown to be an effective intervention to decrease mortality in adults connected to mechanical ventilation for moderate to severe Acute Respiratory Distress Syndrome (ARDS). Patients may require one or more sessions of prone position. However, the optimal duration of prone sessions is unknown. The goal of this clinical trial is to learn if applying prone position in prolonged sessions (\\> 48 hours - prolonged prone position) is more effective than applying it in daily sessions (16 to 24 hours - intermittent prone position). The trial will also learn about the safety of prolonged prone position compared to intermittent prone position. The main questions it aims to answer are:\n\n* Does prolonged prone position increase survival compared to intermittent prone position in participants with moderate to severe ARDS ?\n* How does prolonged prone position compare to intermittent prone position in terms of medical problems associated to prone position ?\n\nResearchers will compare prolonged versus intermittent prone position to see which approach is better to treat moderate to severe ARDS.\n\nParticipants will:\n\n* Receive prone position either in prolonged (\\> 48 hours) or daily (16 to 24 hours) sessions during the first 7 days\n* Be followed for up to 90 days to assess their clinical evolution",[192],"Acute Respiratory Distress Syndrome",[194,195,196,197],"ACUTE RESPIRATORY DISTRESS SYNDROME","RESPIRATORY FAILURE","PRONE POSITION","MECHANICAL VENTILATION","2026-05-14",{"date":171,"type":38},{"date":201,"type":38},"2025-04-07",{"date":203,"type":23},"2028-01",{"name":44,"class":45},38,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":79,"sex":214,"minAge":215,"maxAge":19,"enrollmentInfo":216,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":218,"conditions":219,"keywords":223,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100639641","priority-study-in-cervical-cancer-100639641","NCT07593066","PRIORITY Study in Cervical Cancer","The PRIORITY Study in Cervical Cancer: A Prospective Multicenter Observational Evaluation of an Integrated Molecular and Digital Model for Diagnostic Prioritization","PRIORITY","Inclusion Criteria:\n\n* Women aged 30 to 65 years\n* Eligible for cervical cancer screening according to national guidelines\n* Able and willing to provide informed consent\n* Able to perform self-sampling or attend clinical evaluation if required\n\nExclusion Criteria:\n\n* Previous diagnosis of cervical cancer\n* History of total hysterectomy (removal of the cervix)\n* Current pregnancy if it precludes study procedures according to clinical judgment\n* Any medical or social condition that, in the opinion of the investigators, would interfere with participation or follow-up","FEMALE","30 Years",{"count":217,"type":23},700,"The PRIORITY study is a prospective, multicenter observational study designed to evaluate an integrated diagnostic model combining extended molecular self-sampling and digital colposcopy supported by telemedicine for the prioritization of women at risk of cervical cancer.\n\nThe study aims to assess the diagnostic performance, concordance, and clinical utility of this integrated approach in real-world settings, as well as its impact on diagnostic timeliness and patient navigation across different levels of care.\n\nParticipants will undergo standard-of-care evaluation, and data will be collected on molecular test results, colposcopic findings, diagnostic outcomes, and time intervals within the care pathway. No interventions are assigned as part of the study protocol.\n\nThe findings are expected to inform scalable strategies to improve early detection and optimize diagnostic pathways for cervical cancer, particularly in settings with structural and geographic barriers to timely care.",[220,221,222],"Cervical Cancer","Cervical Intraepithelial Neoplasia","HPV Infection",[224,225,226,227,228],"HPV self-sampling","Digital colposcopy","Telemedicine","Diagnostic prioritization","Cervical cancer screening","2026-05-11",{"date":171,"type":38},{"date":232,"type":23},"2026-06-30",{"date":234,"type":23},"2026-12-31",{"name":44,"class":45},8,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":19,"enrollmentInfo":245,"targetDuration":4,"studyType":24,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100622194","modular-intervention-for-depression-study-100622194","NCT07380451","Modular Intervention for Depression Study","Modular Optimization of Psychotherapy for Individuals With Depression Complicated by Personality Dysfunction and Complex Trauma: A Pilot Study in the Chilean Public Health System","MIND","Inclusion Criteria:\n\n* Current diagnosis of major depressive disorder, defined as:\n\n  * Positive diagnosis on the MINI diagnostic interview, and\n  * PHQ-9 score greater than 10\n* Evidence of personality dysfunction, defined as a score above the cutoff on the Level of Personality Functioning Scale-Brief Form (LPFS-BF 2.0).\n* History of moderate to severe early life adversity, defined as elevated scores on at least one scale of the Childhood Trauma Questionnaire (CTQ), and\u002For clinically significant alterations in self-organization.\n* Presence of at least one elevated domain of alteration of self-organization, including emotion regulation difficulties, interpersonal sensitivity, and\u002For interpersonal functioning problems, as assessed by standardized self-report measures (DERS, A-RSQ, OQ-45-IR).\n* Receiving care at a participating public community mental health center in Chile.\n* Ownership of a smartphone (Android or iOS) with internet access and an active data plan.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI.\n* Any severe psychiatric disorder other than major depressive disorder that is the primary clinical diagnosis, including:\n\n  * Schizophrenia or other psychotic disorders\n  * Bipolar I disorder\n* Severe substance use disorder, active within the past 6 months.\n* Diagnosis of post-traumatic stress disorder (PTSD) meeting full diagnostic criteria, as assessed by standardized instruments (ITEM and ITQ).\n* Meeting diagnostic criteria for:\n\n  * Antisocial personality disorder (two or more criteria), or\n  * Borderline personality disorder with more than three diagnostic criteria\n* Severe medical, cognitive, or psychosocial condition that would interfere with participation in weekly psychotherapy.\n* Concurrent participation in another active psychotherapy or initiation\u002Fchange of psychotropic medication during the study period, except for:\n\n  * Stable antidepressant treatment\n  * Medications prescribed for sleep\n  * Benzodiazepines used only on an as-needed (PRN) basis.\n* Inability to comply with study procedures or assessments.",{"count":246,"type":23},150,[26],"The goal of this psychotherapy clinical trial is to evaluate whether a algorithm-based personalized modular psychotherapy is more effective than usual individual psychotherapy in treating major depressive disorder complicated by personality dysfunction and\u002For complex trauma in adults aged 18 to 65 receiving care in the Chilean public mental health system.\n\nThe main questions it aims to answer are:\n\n* Does algorithm-based modular psychotherapy lead to greater clinically significant reduction and remission of depressive symptoms compared to usual psychotherapy?\n* Does algorithm-based modular psychotherapy lead to greater improvement in emotional regulation, interpersonal functioning, and self-related functioning, including changes observed in daily life?\n\nResearchers will compare algorithm-based modular psychotherapy to usual individual psychotherapy provided in public community mental health centers to see if the modular, personalized approach results in better clinical outcomes, stronger therapeutic alliance, and higher treatment satisfaction.\n\nParticipants will:\n\n* Be randomly assigned to receive either algorithm-based modular psychotherapy or usual individual psychotherapy\n* Attend weekly individual psychotherapy sessions\n* Complete structured diagnostic interviews and self-report questionnaires before, during, and after treatment\n* Provide brief daily reports on mood, emotions, and interpersonal experiences using a smartphone before and after treatment",[250],"Major Depression",[252,253,254],"Complicated Depression","Early Life Adversity","Personality Dysfunction",{"date":256,"type":38},"2026-05-12",{"date":258,"type":23},"2026-05-01",{"date":260,"type":23},"2028-02-28",{"name":44,"class":45},5,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":270,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":24,"phases":273,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100623399","phase-1-assessing-the-efficacy-of-a-high-dose-lidocaine-tetracaine-cream-for-the-treatment-of-peripheral-neuropathic-pain-100623399","NCT07396129","Assessing the Efficacy of a High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain","Assessing the Efficacy of High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain: A Crossover Study in Elderly Patients Refractory to Pharmacological Treatments","Inclusion Criteria:\n\n* Age 60 years or older.\n* Clinical diagnosis of peripheral neuropathic pain that has lasted for at least 6 months.\n* Baseline Visual Analog Scale (VAS) pain score of 6 or higher.\n* Ability to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Known hypersensitivity (allergy) to lidocaine, tetracaine, or any excipients (inactive ingredients) in the preparation\n* Dermatological lesions (skin damage or sores) in the intended application area.\n* Concomitant use of other topical therapies (creams, gels, patches) in the affected area.\n* Severe cognitive impairment or unstable medical comorbidity.","60 Years",{"count":272,"type":23},30,[274,275],"PHASE1","PHASE2","The goal of this clinical trial is to learn if the topical anesthetic cream works to treat neuropathic chronic pain in older adults who have not found sufficient relief undergoing other pain treatments and\u002For medications. The safety of this drug has already been tested in other studies. The main questions it aims to answer are:\n\n* Does the anesthetic cream lower the pain of participants?\n* Can the participants return to daily activities that they have quit due to chronic pain?\n* What medical problems do participants have when using this cream?\n\nResearchers will compare the anesthetic cream to a placebo (a look-alike substance that contains no drug) to see if it works to treat neuropathic chronic pain.\n\nParticipants will:\n\n* Use the anesthetic cream or a placebo every day for 14 days\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of their symptoms and the number of times they use the anesthetic cream.\n\nThis study is divided into two phases, separated by 30 days.\n\n* Phase 1: Application of the active cream (Lidocaine 23% \u002F Tetracaine 7%) twice daily: once in the morning upon waking and once at night before bed.\n* Phase 2: Application of the placebo cream under the exact same conditions.\n\nThe order of administration (active\u002Fplacebo) will be randomly assigned.\n\nProcedure: Participants will sign the informed consent form. A baseline evaluation will be conducted, assessing VAS (Visual Analog Scale) score, functionality, and quality of life.\n\nThe use of other medications will be recorded. The creams will be applied at home with weekly telephone follow-up and daily patient self-reporting. Evaluations will be conducted on day 14 of each phase. Follow-up controls will occur one and two months after the treatment is suspended. Adherence and adverse effects will also be logged.",[278],"Neuropathic Chronic Pain",[280,281,282,283,284],"neuropathic chronic pain","lidocaine","tetracaine","anesthetic cream","crossover study","2026-05-05",{"date":287,"type":38},"2026-05-07",{"date":175,"type":23},{"date":290,"type":23},"2026-12-23",{"name":44,"class":45},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":79,"sex":18,"minAge":80,"maxAge":81,"enrollmentInfo":299,"targetDuration":4,"studyType":24,"phases":301,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":46},"100632187","artificial-intelligence-vs-automated-messaging-for-continuous-regional-analgesia-follow-up-100632187","NCT07510425","Artificial Intelligence vs. Automated Messaging for Continuous Regional Analgesia Follow-up","Postoperative Follow-up Via Artificial Intelligence-Based Application Versus Automated Messaging Application in Patients Receiving Continuous Regional Analgesia: A Comparative Study","Inclusion Criteria:\n\n* Patients aged between 18 and 75 years.\n* Physical status classification ASA I or II.\n* Scheduled for ambulatory surgical programs at UC Christus Health Network centers (Hospital Clínico, Clínica San Carlos de Apoquindo, or Centro Médico Santa Lucía).\n* Patients receiving postoperative pain management via continuous peripheral nerve block (CPNB) with a perineural catheter and disposable infusion pump.\n* Ownership and documented proficiency in operating a smartphone to access the mobile application.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Inability to understand or follow the digital monitoring protocol.\n* Patients not meeting the age or ASA physical status requirements.",{"count":300,"type":23},166,[26],"Effective postoperative analgesia is critical for patient recovery, satisfaction, and the reduction of hospital stay duration. Continuous peripheral nerve blocks (CPNB) via catheter placement represent a cornerstone in achieving these objectives. Traditionally, follow-up for these patients has relied on standardized telephone protocols conducted by trained personnel. Original previous research in 2024 demonstrated that an automated text-messaging platform was feasible and maintained high patient satisfaction, it resulted in a significantly higher rate of unscheduled patient-initiated inquiries (28.3% vs. 6.4%) compared to traditional phone calls, likely due to a lack of adaptive response capabilities.\n\nObjective: This study aims to evaluate an enhanced technological iteration of our follow-up platform. By integrating an Artificial Intelligence (AI) interface trained on specialized clinical protocols, the new system is designed to provide automated, personalized and adaptive recommendations to patients.\n\nMethods and Intervention: The study will compare the effectiveness of this AI-driven platform against the previous version of the non-adaptive automated messaging system. The primary outcome is to compare the number of patient-initiated inquiries (re-consultations). Secondary outcomes include patient satisfaction, adherence to the follow-up protocol, and response rates from postoperative days one through three.\n\nImpact: The investigators hypothesize that the integration of AI will optimize human resources and improve patient autonomy without compromising safety or satisfaction, ultimately providing a scalable model for postoperative regional analgesia monitoring.",[163,304,305,306],"Anesthesia , Analgesia","Regional Anesthesia","Regional Anesthesia Success",[163,305,308,309,310],"Continuous Nerve Block","Ambulatory","Outpatient follow-up","2026-04-01",{"date":313,"type":38},"2026-04-03",{"date":311,"type":23},{"date":316,"type":23},"2027-07-01",{"name":44,"class":45},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":79,"sex":18,"minAge":80,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":24,"phases":327,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":46},"100631295","impact-of-immersive-virtual-reality-ivr-on-respiratory-effort-a-pilot-study-in-healthy-adults-100631295","NCT07498816","Impact of Immersive Virtual Reality (IVR) on Respiratory Effort: A Pilot Study in Healthy Adults","Inclusion Criteria:\n\n* Healthy adults aged 18-40 years\n* Ability to perform cycle ergometer exercise testing\n* No known history of cardiovascular, pulmonary, neurological, or metabolic disease\n\nExclusion Criteria:\n\n* Current respiratory symptoms or acute illness\n* Known cardiovascular, pulmonary, neurological, or metabolic disease\n* Use of medications that may affect respiratory or cardiovascular responses to exercise\n* Contraindications to exercise testing according to standard clinical guidelines\n* Pregnancy\n* Inability to tolerate placement of an esophageal balloon catheter\n* Susceptibility to motion sickness or discomfort with immersive virtual reality devices","40 Years",{"count":326,"type":23},10,[26],"This pilot randomized crossover study will evaluate the acute effects of immersive virtual reality (IVR) on respiratory effort during submaximal exercise in healthy adults. Dyspnea and increased respiratory effort are influenced not only by mechanical and metabolic factors, but also by emotional and central neural inputs. IVR has shown potential to reduce anxiety, promote relaxation, and modulate physiological responses, but its direct effect on respiratory effort has not been adequately studied.\n\nHealthy adults will complete two experimental exercise sessions: one session with IVR and one session without IVR, in randomized order. In both conditions, participants will perform a 6-minute constant-load cycling test at a submaximal workload individualized from a prior incremental exercise test. Respiratory effort will be assessed continuously using esophageal pressure monitoring. Additional measurements will include ventilatory variables, perceived dyspnea, acute state anxiety, heart rate, oxygen saturation, and heart rate variability.\n\nThe primary aim is to determine whether IVR reduces respiratory effort compared with the control condition. This pilot study is intended to provide physiological evidence on the potential role of IVR as a non-pharmacological strategy to modulate respiratory effort and dyspnea, and to inform future research in clinical populations.",[330,331,332],"Virtual Reality","Respiratory Effort","Exercise",[334,335,336],"immersive virtual reality","breathing effort","inspiratory effort","2026-03-23",{"date":339,"type":38},"2026-03-27",{"date":341,"type":38},"2025-10-01",{"date":343,"type":23},"2026-12-15",{"name":44,"class":45},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":353,"targetDuration":354,"studyType":85,"phases":4,"briefSummary":355,"conditions":356,"keywords":361,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100612394","ai-assisted-analgesia-copilot-system-100612394","NCT07253012","AI-Assisted Analgesia Copilot System","AI-assisted Analgesia Copilot System for Proper Management of Nociception","SEASCAPE","Inclusion Criteria:\n\n* Patients scheduled for elective surgery with general anesthesia.\n* Surgeries scheduled to last at least two hours.\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery.\n* Pregnant women.\n* Presence of a mental or intellectual disability before the hospitalization.\n* Drug dependence.\n* Surgeries scheduled for more than 4 hours.\n* Intraoperative complications requiring changes in routine behavior.",{"count":246,"type":23},"5 Weeks","The primary objective of the SEASCAPE project is to design, develop, and to apply a clinical implementation tool of a machine learning (ML) and artificial intelligence (AI)-based co-pilot system for the real-time monitoring and control of nociception during general anesthesia (GA).\n\nThe ultimate clinical purpose is to optimize individualized pain management by achieving precise titration of intravenous opioids (specifically remifentanil), thereby minimizing the incidence of over- and under-dosing. This optimization is projected to enhance patient outcomes, reduce opioid-related complications, and improve overall cost-effectiveness of anesthetic procedures.\n\nThe main scientific question guiding this work is: Can a novel algorithm be generated and validated to provide superior analytical precision for analgesic management by reliably differentiating genuine nociceptive responses from confounding physiological variables-such as inadequate neuromuscular blockade or changes in depth of anesthesia-thereby significantly improving the clinical decision-making framework for intraoperative nociception control? This project addresses the recognized challenge in anesthesiology: defining an objective measure to quantify nociception and antinociception during GA.\n\nStudy Population: Patients scheduled for elective surgical procedures requiring general anesthesia (GA).\n\nExisting Intervention: The standard anesthetic regimen includes continuous intravenous infusion of the remifentanil for intraoperative analgesia, typically governed by a Target Controlled Infusion (TCI) system utilizing a pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) model (Eleveld TCI model).\n\nProject Focus: The research seeks to improve the accuracy and efficacy of this existing analgesic strategy by integrating a multivariate patient data stream with the newly developed SEASCAPE co-pilot AI. This aims to refine the remifentanil dose predictions beyond the current TCI model's capabilities, personalized system.",[357,358,359,360],"Nociception","Artificial Intelligence (AI)","Target Controlled Infusion (TCI)","Remifentanil Consumption",[357,362,363,364],"Target Controlled Infusion","Remifentanil","Artificial Intelligence","2026-03-06",{"date":367,"type":38},"2026-03-09",{"date":369,"type":38},"2026-01-29",{"date":371,"type":23},"2027-10-27",{"name":44,"class":45},2,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":24,"phases":384,"briefSummary":385,"conditions":386,"keywords":390,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":46},"100626608","impact-of-peep-on-respiratory-effort-during-assisted-ventilation-100626608","NCT07437846","Impact of PEEP on Respiratory Effort During Assisted Ventilation","Impact of Positive End-Expiratory Pressure on the Modulation of Respiratory Effort During Assisted Ventilation: A Physiological Randomized Crossover Study","PEEP-EFFORT","Inclusion criteria:\n\n* Age ≥18 years.\n* ICU patients receiving invasive mechanical ventilation (endotracheal tube or tracheostomy).\n* Ventilated in an assisted mode with spontaneous breathing\n* Clinically stable to undergo protocolized PEEP changes.\n* Sedation level compatible with spontaneous breathing and ventilator triggering\n* Informed consent from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Contraindication to esophageal balloon placement (if applicable).\n* Significant hemodynamic instability or unstable vasopressor requirements.\n* Unstable arrhythmia or active myocardial ischemia.\n* Undrained pneumothorax or major air leak.\n* Controlled ventilation without effective spontaneous effort (apnea, neuromuscular blockade, deep sedation).\n* Pregnancy\n* Acute or chronic neurological conditions that may impair respiratory drive or interfere with the regulation of spontaneous breathing.",{"count":383,"type":23},12,[26],"Assisted mechanical ventilation is widely used to preserve diaphragmatic activity and improve lung aeration in patients with acute respiratory failure. However, during assisted ventilation, excessive inspiratory effort may develop and contribute to lung injury, diaphragmatic overload, and patient self-inflicted lung injury.\n\nOptimizing ventilator settings to modulate respiratory effort therefore represents a major physiological and clinical challenge.\n\nPositive end-expiratory pressure (PEEP) is a key determinant of lung recruitment and respiratory system mechanics and may influence inspiratory effort by modifying lung volume, compliance, and respiratory drive. Despite its widespread use, PEEP titration in clinical practice is still mainly guided by oxygenation parameters, while its direct effects on inspiratory effort during assisted mechanical ventilation remain insufficiently characterized.\n\nThis physiological randomized crossover study aims to evaluate the effect of four predefined levels of positive end-expiratory pressure (0, 5, 10, and 15 cmH₂O) on the respiratory system and inspiratory effort in adult patients receiving assisted mechanical ventilation. Patients will be exposed to each PEEP level in randomized order, with stabilization and washout periods between conditions, while ventilatory support settings other than PEEP are kept constant.",[387,388,389],"Mechanical Ventilation","Respiratory Failure","Effort",[391,392,393],"Assisted mechanical ventilation","Inspiratory Effort","Breathing effort","2026-02-23",{"date":396,"type":38},"2026-02-27",{"date":398,"type":38},"2025-01-01",{"date":400,"type":23},"2026-07",{"name":44,"class":45},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":79,"sex":18,"minAge":4,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":24,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":373},"100623397","efficacy-of-pimun-by-reducing-intermittent-hypoxia-events-100623397","NCT07396103","Efficacy of PIMUN by Reducing Intermittent Hypoxia Events","Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept","Inclusion Criteria:\n\n* Preterm infants with a gestational age at birth \\\u003C34 weeks\n* Age \\\u003C30 days at the time of enrollment\n* Documented diagnosis of apnea of prematurity (AOP)\n\nExclusion Criteria:\n\n* Currently receiving mechanical ventilation (MV)\n* Presence of major congenital malformations\n* Clinically unstable or critically ill at the time of screening\n* Active sepsis or undergoing treatment for sepsis\n* Intraventricular hemorrhage (IVH) Grade \\> II\n* Receiving sedatives or anticonvulsant medications","30 Days",{"count":411,"type":23},20,[26],"The goal of this clinical trial is to learn if the use of PIMUN(medical device) works to reduce the intermittent hypoxemia of 24-34 weeks of birth gestational age babies. . It will also learn about the safety of the use of PIMUN. The main questions it aims to answer are:\n\nDoes PIMUN lower the time of oxygen saturation under 90%? What medical problems do participants have using PIMUN? Researchers will compare the use of PIMUN during 48 hours to 48 hours of usual treatments (not using PIMUN).\n\nParticipants will:\n\nUse\u002F or not use of PIMUN for a 48 hours period- randomly assigned. Regional brain oxygenation by near infrared spectroscopy (NIRS) monitoring at the first day of each 48 hours period. 4-6 hours of polysomnography at the second day of each intervention. Plasma and urine stress oxygen metabolites at the end of each 48-hours intervention.",[415,416,417],"Preterm","Apnea of Prematurity","Hypoxemia","2026-02-03",{"date":420,"type":38},"2026-02-09",{"date":422,"type":38},"2024-09-01",{"date":424,"type":23},"2026-05-31",{"name":44,"class":45},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":24,"phases":435,"briefSummary":436,"conditions":437,"keywords":442,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":4},"100617890","effect-of-dexamethasone-on-plasma-levels-of-bupivacaine-and-dexamethasone-after-a-single-injection-interscalene-nerve-block-100617890","NCT07324499","Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone After a Single-injection Interscalene Nerve Block.","Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone Following a Single-injection Interscalene Nerve Block: A Randomized Controlled Study","Inclusion Criteria:\n\n\\- ASA I-II patients, with a body mass index (BMI) between 20 and 34 kg\u002Fm2 scheduled for shoulder surgery requiring single-needle interscalene block\n\nExclusion Criteria:\n\n\\- Chronic opioid use, liver failure, kidney failure, allergy to protocol drugs","90 Years",{"count":5,"type":23},[26],"Recent studies have highlighted the comparative advantages of perineural dexamethasone, particularly regarding its safety profile and its ability to prolong analgesia in various peripheral nerve blocks. A recent systematic review demonstrated that perineural administration of dexamethasone significantly extends the duration of analgesia compared to intravenous administration.\n\nThe mechanism of action of perineural dexamethasone remains unclear. Moreover, there is a lack of research comparing the systemic absorption of local anesthetics administered perineurally with or without dexamethasone, and the systemic absorption and bioavailability of dexamethasone when used as a perineural adjuvant have not been studied.\n\nObjective: This study aims to compare plasma concentrations of bupivacaine following a single-shot interscalene block with dexamethasone administered either perineurally or intravenously.\n\nMethodology: A prospective, randomized, double-blind trial will be conducted involving 40 patients undergoing shoulder surgery requiring a single-shot interscalene block. Each patient will receive 20 mL of 0.25% bupivacaine combined with 8 mg of dexamethasone administered either perineurally or intravenously. Venous blood samples (5 mL) will be collected at 5, 10, 20, 40, 80, 120, and 240 minutes post-block, and one sample at discharge, to measure plasma concentrations of both enantiomers of bupivacaine (D(+)-bupivacaine and L(-)-bupivacaine) and dexamethasone.\n\nOutcomes: The study will compare plasma levels of bupivacaine between groups, characterize the pharmacokinetics of bupivacaine and dexamethasone, and assess block duration and opioid consumption.",[438,439,440,441],"Pain","Interscalene Blocks","Dexamethasone","Bupivacaine",[440,441,438,443],"Interscalene blocks","2025-12-30",{"date":446,"type":38},"2026-01-07",{"date":448,"type":23},"2026-03-01",{"date":450,"type":23},"2027-12-01",{"name":44,"class":45},{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":79,"sex":18,"minAge":460,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":24,"phases":463,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":373},"100618573","retention-of-vernix-caseosa-in-newborns-for-primary-prevention-of-atopic-dermatitis-100618573","NCT07333378","Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis","Post-partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome.","PROTEGO","Inclusion Criteria:\n\n* pregnant mother aged 18 and older, who is able to provide informed consent for participation\n* delivery of a healthy, singleton newborn (vaginal or cesarean) at one of the study sites.\n* parents are able and willing to comply with the study schedule and procedures\n\nExclusion Criteria:\n\n* birthweight \\\u003C2000 g\n* prematurity younger than 34 weeks of gestation\n* multiple gestation \u002F multiple births\n* maternal HIV-positivity\n* clinical and\u002For laboratory diagnosis of chorioamnionitis.\n* need for neonatal hospitalization or presence of an acute illness (e.g., neonatal respiratory distress syndrome) within the first 24 hours of life.\n* severe and generalized congenital skin disorder (e.g., congenital ichthyosis).","0 Days",{"count":462,"type":23},1383,[26],"Atopic dermatitis (AD), also known as eczema, is a common chronic inflammatory skin disease that usually begins in infancy and causes significant itching, discomfort, and sleep disturbance. It affects up to one in five children worldwide and represents a growing public-health problem. Research has shown that genetic and environmental factors contribute to its development, especially those related to skin-barrier integrity and the skin microbiome during early life. Preventing AD before it starts-known as primary prevention-has become an important goal.\n\nVernix caseosa is a naturally occurring, white, creamy substance that covers the skin of newborns at birth. It forms during the last trimester of pregnancy and plays a key role in protecting and hydrating the baby's skin before and after birth. Vernix contains water, lipids, and proteins with antimicrobial and anti-inflammatory properties. Despite these potential benefits, in many hospitals vernix is routinely removed soon after delivery as part of standard newborn cleaning or bathing practices. However, there is little scientific evidence to support early removal, and some studies suggest that keeping vernix on the skin for longer may help the newborn's skin barrier function and reduce colonization by harmful bacteria.\n\nThe PROTEGO Study (Post-Partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome) is a randomized controlled clinical trial designed to test whether delaying the removal of vernix caseosa after birth can help prevent atopic dermatitis and improve skin health during the first year of life.\n\nA total of 1,383 mother-infant pairs will be enrolled from three maternity hospitals in Santiago, Chile. Participants will be randomly assigned to one of two groups:\n\n1. Retention group: Vernix caseosa will be left on the skin and allowed to dry naturally; the baby's first bath will be delayed according to the study protocol.\n2. Removal group: Vernix will be removed following current hospital practice using gentle cleaning with water and oil or petroleum jelly shortly after birth.\n\nAll infants will be followed for 12 months with regular clinical assessments, standardized skin evaluations, and collection of biological samples. The main outcome will be the cumulative incidence of atopic dermatitis, diagnosed using modified UK Working Party criteria and\u002For Hanifin \\& Rajka criteria at 12 months of age. Secondary outcomes include skin-barrier measurements (transepidermal water loss, skin pH, and natural moisturizing factor), the composition of the skin microbiome, and early signs of allergic or infectious diseases.\n\nThis study will provide high-quality evidence on whether preserving vernix caseosa after birth is a simple, safe, cost-effective and natural strategy to strengthen the newborn's skin barrier and reduce the risk of eczema and related conditions. The results could help improve newborn-care practices and promote skin health in early life worldwide.",[466],"Atopic Dermatitis",[468,469,470,471,472,473,474],"vernix caseosa","primary prevention","newborn","eczema","atopic dermatitis","skin infections","Staphylococcus aureus",{"date":476,"type":38},"2026-01-12",{"date":478,"type":23},"2026-01-02",{"date":480,"type":23},"2028-03-31",{"name":44,"class":45},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":490,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":24,"phases":494,"briefSummary":495,"conditions":496,"keywords":503,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":518},"100599617","window-prophylaxis-for-pediatric-tuberculosis-prevention-trial-100599617","NCT07086820","Window Prophylaxis for Pediatric Tuberculosis Prevention Trial","Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial","TB-WIN","Inclusion Criteria:\n\n* Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis\n* Age ≥5 to \\\u003C18 years old\n\nExclusion Criteria:\n\n* Suspected active tuberculosis in initial assessment (clinical or radiological)\n* Current pregnancy or breastfeeding\n* Immunocompromised\n* Allergy or contraindication to isoniazid or rifapentine\n* Chronic liver disease or alcohol use disorder\n* History of previous treatment for active or latent tuberculosis infection\n* Previous tuberculin skin test\n* Household contacts of a tuberculosis index patient with a known or suspected drug-resistant M. tuberculosis strain\n* Household contacts or a tuberculosis index patient currently living away from home for more than four weeks\n* Household contacts of a tuberculosis index patient who have already received more than 15 daily doses of antituberculous treatment","5 Years","17 Years",{"count":493,"type":23},647,[26],"The goal of this cluster-randomized controlled trial is to evaluate the effectiveness of tuberculosis preventive treatment (TPT) administered during the \"window period\" to prevent new Mycobacterium tuberculosis infections in children and adolescents.\n\nThe main question it aims to answer is:\n\nCan immediate TPT reduce the incidence of IGRA conversions in children and adolescents who are household contacts of a newly diagnosed pulmonary tuberculosis patient?\n\nResearchers will compare the incidence of new tuberculosis infections-measured by IGRA conversion at 12 weeks-between participants who receive immediate TPT while still uninfected (baseline IGRA-negative) and those who receive standard care, in which TPT is not offered to IGRA-negative contacts.\n\nParticipants will be:\n\n1. Tested for M. tuberculosis infection using the Interferon-Gamma Release Assay (IGRA), specifically the QuantiFERON-TB Gold Plus, at enrollment and after 12 weeks of follow-up.\n2. Take weekly isoniazid and rifapentine for 12 weeks if:\n\n   1. They are assigned to the intervention arm (regardless of baseline IGRA result), or\n   2. They are in the control arm and test IGRA-positive at baseline.\n\nAdditionally, participants from the control arm who experience an IGRA conversion at 12 weeks (following the primary outcome assessment) will also receive TPT, as per standard of care.",[497,498,499,500,501,502],"Tuberculosis Infection","Household Contacts","Children","Adolescent","Tuberculosis Infection, Latent","Tuberculosis",[504,505,506,507,499,500,508,502,509],"Household contacts","Prophylaxis","Tuberculosis infection","Mycobacterium tuberculosis","Randomized clinical trial","Cluster-randomized trial","2025-12-20",{"date":512,"type":38},"2025-12-29",{"date":514,"type":38},"2025-10-27",{"date":516,"type":23},"2028-11",{"name":44,"class":45},13,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":79,"sex":18,"minAge":80,"maxAge":81,"enrollmentInfo":527,"targetDuration":4,"studyType":24,"phases":529,"briefSummary":530,"conditions":531,"keywords":534,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":4},"100615344","effectiveness-of-retrolaminar-block-in-lumbar-spine-fusion-with-multimodal-analgesia-100615344","NCT07291388","Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia","Effectiveness of Retrolaminar Block in Reducing Postoperative Opioid Consumption in Patients Undergoing Lumbar Spine Fusion With Multimodal Analgesia","RBLUF","Inclusion Criteria:\n\n* Adults aged 18-75 years, scheduled for lumbar spine fusion surgery by a trauma team\n* American Society of Anesthesiologists (ASA) Classification I-III\n* Willing and able to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* History of chronic use of strong or weak opioids for more than 3 months.\n* Diagnosis of chronic pain and treatment by a pain management team.\n* ASA score greater than or equal to 4.\n* Patients with prior lumbar spine surgery. Spinal instrumentation at the surgical site.\n* Estimated creatinine clearance less than 60 ml\u002Fmin.\n* Coagulation disorder or abnormal coagulation tests.\n* Infection at the surgical site.\n* Weight less than 50 kg.\n* Altered mental status that prevents reliable evaluation.\n* Allergy to local anesthetics or analgesic drugs used in the study.\n* Patients with contraindications to peripheral nerve blocks.\n* Lumbar spine fixation due to oncologic disease or acute trauma.\n* Use of intraoperative neuromonitoring and TIVA.",{"count":528,"type":23},44,[26],"This randomized, blinded, controlled clinical trial aims to evaluate the effectiveness of ultrasound-guided retrolaminar block in reducing postoperative opioid consumption in patients undergoing lumbar spine fusion surgery under multimodal analgesia.\n\nThe participants will:\n\n* Be randomly assigned in a 1:1 ratio to receive either a retrolaminar block with 0.25% bupivacaine plus epinephrine or a sham block (normal saline) prior to surgical incision.\n* Receive standardized multimodal analgesia.\n* Have follow-up by the Acute Pain Unit during the first 3 days, to assess opioid consumption (morphine) in 24 hours, pain intensity measured by Numeric Rating Scale, quality of recovery assessed by the QoR-15 questionnaire, intraoperative blood loss, and postoperative complications.",[532,163,533],"Acute Pain","Lumbar Spine Disease",[535,536,537,538],"acute pain","retrolaminar block","regional anesthesia","lumbar arthrodesis","2025-12-05",{"date":541,"type":38},"2025-12-18",{"date":543,"type":23},"2025-12",{"date":545,"type":23},"2027-03",{"name":44,"class":45},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":554,"maxAge":270,"enrollmentInfo":555,"targetDuration":4,"studyType":24,"phases":557,"briefSummary":558,"conditions":559,"keywords":562,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":46},"100615047","metabolic-effects-of-linoleic-acid-rich-oil-compared-to-a-blend-oil-in-adults-with-insulin-resistance-100615047","NCT07287514","Metabolic Effects of Linoleic Acid-Rich Oil Compared to a Blend Oil in Adults With Insulin Resistance","Role of Linoleic Acid in Cardiometabolic Health Beyond Its Lipid-lowering Effects, and Its Dietary and Pathophysiological Implications","Inclusion Criteria:\n\n* Men and women aged 20 to 60 years.\n* Insulin resistance (HOMA-IR \\> 2.6).\n* At least one cardiometabolic risk factor: abdominal obesity (waist circumference \\> 90 cm in men or \\> 80 cm in women); low HDL-cholesterol (\\\u003C 40 mg\u002FdL in men or \\\u003C 50 mg\u002FdL in women); elevated LDL-cholesterol (\\> 70 \u002F 100 \u002F 130 mg\u002FdL, according to estimated cardiovascular risk); or elevated blood pressure (≥ 130\u002F85 mmHg).\n\nExclusion Criteria:\n\n* Diabetes diagnosis.\n* Severe psychiatric illness.\n* Malabsorption disorders or previous bariatric surgery.\n* Pregnancy or lactation.\n* Previous clinical cardiovascular disease.\n* Regular use of medications that could influence study outcomes, including:\n\nlipid-lowering agents insulin sensitizers antihypertensive drugs anticoagulants antiretroviral therapy thyroid hormones oral corticosteroids immunosuppressants polyunsaturated fatty acid (PUFA) supplements.\n\n* Fasting serum triglycerides ≥ 500 mg\u002FdL or LDL-cholesterol ≥ 190 mg\u002FdL.\n* Body mass index (BMI) ≥ 35 kg\u002Fm².\n* Very high blood pressure.\n* Any additional condition that may limit adherence to the study.","20 Years",{"count":556,"type":23},120,[26],"Linoleic acid (LA), the predominant omega-6 polyunsaturated fatty acid in human diets, has been associated with improved lipid metabolism and insulin sensitivity compared with saturated fats. However, its role in metabolic health remains debated due to the limited number of well-controlled intervention studies.\n\nThis randomized controlled trial aims to evaluate the metabolic effects of an LA-rich oil compared with a blended oil in adults with insulin resistance. Participants will be randomly assigned to receive either a daily supplement of LA-rich oil or a control blend oil for 8 weeks, while maintaining their usual diet and lifestyle. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include changes in fasting glucose, insulin, lipid profile, inflammatory and oxidative stress markers, and body composition.\n\nThe study is designed as a single-blind, parallel-group intervention conducted at the Pontifical Catholic University of Chile. The results are expected to clarify the effects of increased dietary linoleic acid intake on insulin sensitivity and metabolic risk factors, contributing to the ongoing debate about the role of omega-6 fatty acids in cardiometabolic health.",[560,561],"Insulin Resistance","Metabolic Disease",[563,560,564],"linoleic acid","omega-6 fatty acid","2025-12-03",{"date":567,"type":38},"2025-12-17",{"date":569,"type":38},"2025-05-13",{"date":571,"type":23},"2026-12",{"name":44,"class":45},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":79,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":24,"phases":581,"briefSummary":582,"conditions":583,"keywords":586,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":46},"100605064","phase-2-efficacy-of-a-photosynthetic-dermal-matrix-for-the-treatment-of-full-thickness-skin-wounds-100605064","NCT07157657","Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds","Evaluation of the Efficacy of a Dermal Regeneration Matrix With Photosynthetic Microalgae for the Treatment of Patients With Full-Thickness Skin Wounds: Phase 2 Study","Inclusion Criteria:\n\nPatients covered by social insurance law or under the \"Complementary Service Sales\" (VSC) program, aged 18 years or older.\n\n* Presence of full-thickness skin wounds.\n* Wounds with homogeneous granulation tissue.\n* Wound size between 25 cm² and 200 cm².\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* History of a psychiatric disorder that may impair decision-making or adherence to treatment.\n* Presence of an acute medical condition unrelated to the wound at the time of enrollment.\n* Wound with exposed bone, tendon, or major blood vessels.\n* Psychosocial conditions that may hinder adherence to the study protocol.",{"count":411,"type":23},[275],"The goal of this clinical trial is to evaluate whether the incorporation of photosynthetic microalgae into scaffolds for dermal regeneration improves healing outcomes in adult patients with acute and cronic full-thickness skin wounds.\n\nThe primary objectives are to determine whether the use of photosynthetic scaffolds enhances wound granulation and reduces infection rates compared to standard dermal regeneration scaffolds. Additionally, the quality of the regenerated skin will be assessed and compared between treatment types.\n\nParticipants will:\n\n* Receive treatment with either standard dermal regeneration scaffolds or identical scaffolds containing photosynthetic microalgae. These treatments will be applied either to randomly assigned areas of the same wound or to different wounds on the same patient.\n* Undergo regular follow-up assessments to monitor wound healing progress, infection rates, graft integration, and the qualiy of the regenerated skin.\n* Complete self-assessment questionnaires regarding their experience and perceived outcomes.",[584,585],"Cronic Full-thinkness Skin Wound","Acute Full-thickness Skin Wound",[587,588,589,590,591],"Full-thickness skin wounds","Scaffolds for dermal regeneration","Matrix for dermal regeneration","Photosynthetic biomaterials","Oxygen producing biomaterials","2025-09-04",{"date":594,"type":38},"2025-09-05",{"date":596,"type":38},"2025-06-24",{"date":598,"type":23},"2028-05",{"name":44,"class":45},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":214,"minAge":80,"maxAge":4,"enrollmentInfo":606,"targetDuration":607,"studyType":85,"phases":4,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":373},"100603070","intraoperative-detection-of-breast-cancer-by-electrosurgical-gas-analysis-and-artificial-intelligence-100603070","NCT07131735","Intraoperative Detection of Breast Cancer by Electrosurgical Gas Analysis and Artificial Intelligence","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of malignant breast cancer\n* Scheduled for BCS at the Hospital UC\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patients with known hypersensitivity or allergy to any component of the BCGC device\n* Participation in another interventional clinical trial within 30 days prior to enrolment",{"count":272,"type":23},"3 Years","The aim of this clinical trial is to assess the feasibility of training a device capable of distinguishing various gases emitted by tissues cauterized by an electrosurgical unit during a breast cancer resection surgery. The patients to be enrolled will be women over 18 years old diagnosed with breast cancer who are indicated for conservative breast cancer resection surgery as treatment.\n\nThe main questions to be answered are:\n\nThe specificity and sensitivity of the device in detecting margins compromised with tumor cells in resection surgeries.\n\nEvaluate the applicability of the device in breast cancer surgeries for real-time detection of margins.\n\nEvaluate the differences in the pattern of gases emitted in tumor cells vs normal cells.\n\nBy consenting, the study patients will allow the investigative team to access the clinical record, results of images, post-surgical biopsies, recording of the surgery while preserving the patient's anonymity, and the installation of the gas detection device. This device does not alter the flow of the surgery and does not add additional risk to it.",[610],"Breast Cancer",[610,612,613,614,615],"odors and cancer","breast surgery","intraoperative margin assistant","artificial intelligence","2025-08-12",{"date":618,"type":38},"2025-08-20",{"date":620,"type":38},"2023-12-18",{"date":622,"type":23},"2025-09-18",{"name":44,"class":45},{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":630,"targetDuration":631,"studyType":85,"phases":4,"briefSummary":632,"conditions":633,"keywords":639,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":650,"locationsCount":373},"100582028","patients-database-prepare-for-your-surgery-program-100582028","NCT06857981","Patient's Database: Prepare for Your Surgery Program","Inclusion Criteria:\n\n* Patients referred to the Prepare for Your Surgery program\n* Patients characterized as frail according to the Clinical Frailty Scale (score ≥ 4), FRAIL scale or FRIED frailty phenotype or the clinical judgment of the referring surgeon, with at least 4 weeks to receive surgery\n* Elective surgery to be performed at Hospital Clinico Red de Salud UC-Christus\n\nExclusion Criteria:\n\n* Patients who will not undergo elective surgery at Hospital Clínico Red de Salud UC-Christus.\n* Patients who require emergency surgery\n* Patients who for various reasons cannot comply with the interventions proposed for this preparation.",{"count":556,"type":23},"3 Months","Frailty is a multidimensional syndrome that predominantly affects older people and people with long-term treatments such as cancer and chronic pain. This results in an increased risk of disability, reduced resistance and greater vulnerability to stressors.\n\nThese factors culminate in worse postoperative outcomes, including higher rates of complications and mortality. With the current demographic shift towards an aging population in Latin America and Chile, the prevalence of frailty among surgical patients is increasing.\n\nDespite the clear association between frailty and adverse postoperative effects, in Chile there are few centers that routinely perform objective preoperative frailty assessment before to surgery. This is due to logistical challenges, the need for specialized training, and assessment tools. As a result, frailty remains an underestimated syndrome in the perioperative setting.\n\nVarious interventions have been proposed to improve the care of fragile surgical patients. Prehabilitation, a multidisciplinary program designed to prepare patients for surgery and improve their resilience to surgical stress, has emerged as a promising intervention. Recent studies indicate that prehabilitation may lead to shorter hospital length of stay (LOS) and fewer complications.\n\nRecognizing the vital role that frailty plays in surgical outcomes and the paucity of research on prehabilitation, a prehabilitation or timely presurgical conditioning program (Prepare for Your Surgery Program) has been implemented at our center. This proposal seeks to optimize the patient before a surgical intervention in order to reduce frailty and complications, thus improving recovery and medium-term results.\n\nThe program consists of interventions 4 to 6 weeks before surgery focused on: nursing assessment, screening and follow-up, geriatric and\u002For internal medicine assessment and intervention, physiotherapy assessment and intervention, nutrition assessment and intervention, psychological assessment and intervention, and preoperative anesthesiology intervention.\n\nFor this purpose, it has been proposed to create a prospective database of patients from the Prepare for Your Surgery Program, who undergo elective surgery at Hospital Clinico Red Salud UC-Christus.",[634,635,636,637,638],"Frailty in Adult Surgery","Frail Elderly Syndrome","Database","Perioperative Care","Prehabilitation",[636,640,641,642,643,638],"Perioperative care","Prospective Studies","Frailty","Follow-Up Studies","2025-06-05",{"date":646,"type":38},"2025-06-10",{"date":648,"type":38},"2025-05-21",{"date":232,"type":23},{"name":44,"class":45},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":24,"phases":661,"briefSummary":662,"conditions":663,"keywords":666,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":676,"locationsCount":46},"100515611","non-pharmacological-prevention-of-pod-in-frailty-elderly-undergoing-elective-surgery-applied-by-nursing-teams-100515611","NCT05993754","Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams","Impact of Non-pharmacological Measures Applied by the Nursing Team in Reducing the Incidence of Postoperative Delirium During the Postoperative and 24hr After Surgery in Frail Elderly Undergoing Elective Non-cardiac Surgeries.","NPPOD","Inclusion Criteria:\n\n* Patients older than 65 years\n* Elective non-cardiac surgery\n* General anesthesia with Bilateral BIS electroencephalographic monitoring or SedLine\n* ASA I, II or III.\n\nExclusion Criteria:\n\n* Neurosurgical patients\n* History of alcohol and\u002For drug abuse\n* History of recreational psychoactive drug use\n* Allergy to anesthetic drugs.",{"count":660,"type":23},400,[26],"The increase in the population over 60 years of age who could receive surgery due to changes in life expectancy and advances in surgical and anesthetic techniques.\n\nLikewise, elderly people (EP) may have a higher risk of postoperative morbidity and mortality compared to young people, with frailty being one of the risk factors that increases adverse outcomes in this period and increases the probability of developing syndromes such as postoperative delirium (POD).\n\nAssessment of frailty in EP prior to surgery is not routine, so it is unknown how many frail and\u002For pre-frail EP undergo surgery in health care systems. There is an association between being frail and developing greater delirium and\u002For postoperative cognitive deficit, which in summary translates into an increase in perioperative morbidity and mortality.\n\nFor the prevention of POD, there are pharmacological and non-pharmacological measures that seek to promote orientation with respect to their environment and make it as familiar as possible, stimulate early aspects of memory and thinking skills, as well as promote sleep using environmental hygiene measures.\n\nIn Chile, protocols of non-pharmacological measures have been proposed by occupational therapy teams, which have had positive results in reducing POD in frail elderly patients. These measures are temporal-spatial reorientation, physical mobilization, correction of sensory deficits, environmental management, sleep protocol, and reduction of anticholinergic drugs with statistically significant results in the reduction of POD.\n\nIn accordance with the above, the objective of this study is to evaluate the impact of non-pharmacological measures applied by the nursing team in reducing the incidence of POD during the post-surgical period in fragile and pre-fragile EP undergoing elective non-cardiac surgeries.\n\nIt is expected that in the end, frail and pre-frail EP who receive non-pharmacological interventions by the nursing team will present a lower incidence of POD at 24 hours compared to those who receive traditional care.",[635,664,665,642],"Primary Prevention","Postoperative Delirium",[667,668,669,642,670,671],"Delirium","Non-pharmacological","Elderly","Nursing","Postoperative",{"date":646,"type":38},{"date":674,"type":38},"2024-04-01",{"date":234,"type":23},{"name":44,"class":45},{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":683,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":685,"targetDuration":687,"studyType":85,"phases":4,"briefSummary":688,"conditions":689,"keywords":691,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":696,"lastUpdatePostDateStruct":697,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":702,"locationsCount":373},"100567413","multiparameter-monitoring-system-for-sedation-inthe-icu-100567413","NCT06667869","multipaRameter mOnitoring systeM for sedAtion iNThe ICu","Sistema de monitorización multiparámetros Para sedación de Pacientes críticos en UCI (ROMANTIC: multipaRameter mOnitoring systeM for sedAtion iNThe ICu)","ROMANTIC","Inclusion Criteria:\n\n* Patients admitted to adult critical care units\n* Individuals over 18 years old\n* Requiring sedation for more than 24 hours\n* Patients needing mechanical ventilation for more than 24 hours\n\nExclusion Criteria:\n\n* Patients with neurological pathology as the cause of mechanical ventilation (including recovered cardiocirculatory arrest, fulminant liver failure, and neurocritical conditions, except subdural hematomas or subarachnoid hemorrhages).\n* Pregnancy\n* Presence of psychiatric or intellectual disability prior to hospitalization\n* Drug dependency\n* History of chronic liver damage with hepatic encephalopathy\n* Second period of mechanical ventilation during hospitalization\n* Early limitation of therapeutic effort\n* Patients under 18 years old",{"count":686,"type":23},80,"2 Weeks","The administration of sedation in Intensive Care Units (ICU) is a vital and complex task, essential for the well-being of critically ill patients. Proper dosing is crucial, as both under-dosing and overdosing have adverse consequences for patients, including risks such as accidental extubation, ventilator disconnections, delirium, prolonged ventilation, ICU stays, and even increased mortality.\n\nMonitoring sedation levels is essential to maintain a balance in sedative administration. Clinical scales (RASS\u002FSAS) are currently used as the reference method, but they have limitations. These scales may be inadequate when the patient is unresponsive or when neuromuscular blockers are used. An alternative is electroencephalography (EEG)-based monitors, though they also have limitations in accurately representing the level of hypnosis.\n\nThe proposal is to develop an advanced multiparameter system called ROMANTIC, which utilizes machine learning algorithms to monitor sedation status continuously. The aim is for this system to surpass current techniques and provide a more accurate determination of sedation levels. ROMANTIC would incorporate a variety of variables, demographic, pharmacological, hemodynamic, respiratory, and EEG data, to predict sedation status in three categories: under-dosing, appropriate dosing, and overdosing.\n\nWith ROMANTIC, clinical staff (users) are expected to be able to determine sedation levels more quickly and accurately, reducing patients' wake-up times and possibly decreasing the incidence of delirium. In the long term, this could result in fewer ICU bed days, less time on mechanical ventilation, cost savings, and reduced complications.\n\nAt the end of the project, the goal is to have a prototype model or software that allows non-specialized staff (users) to quickly determine sedation levels in the ICU. This machine learning-based model targets hospitals with ICUs and mechanical ventilation to offer more efficient and cost-effective clinical care. ROMANTIC seeks to innovate in sedation monitoring, providing a more advanced and precise tool for the care of critically ill patients (beneficiaries) in the ICU.",[690],"Sedation Complication",[692,693,667,694,695],"Intensive Care Unit","Machine Learning","Mechanical ventilation","Monitoring","2025-06-04",{"date":698,"type":38},"2025-06-08",{"date":700,"type":38},"2025-02-14",{"date":343,"type":23},{"name":44,"class":45},""]