[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital Sirio-Libanes\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":271},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,73,98,128,157,186,210,240],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053729","administration-of-a-thirst-relieve-kit-versus-placebo-in-patients-after-hospital-based-bowel-preparation-for-colonoscopy-and-assessment-of-thirst-intensity-100053729",false,"NCT07699809","Administration of a 'Thirst Relieve Kit' Versus Placebo in Patients After Hospital-based Bowel Preparation for Colonoscopy and Assessment of Thirst Intensity","Inclusion Criteria:\n\n* both sexes\n* aged 18 years or older, with clear awareness and good cooperation\n* who underwent colonoscopy with hospital bowel preparation\n\nExclusion Criteria:\n\n* any risk of oral fluid aspiration\n* swallowing disorders\n* post-operative advanced head and neck surgeries\n* advanced head and neck neoplasia, active oral diseases (oral mucosal lesions, stomatitis, among others)\n* history of gastric surgeries (gastrectomized, upper gastrointestinal tract surgeries for obesity)\n* use of GLP-1 analog medications and derivatives in the last 10 days according to hospital protocol (e.g., semaglutide, liraglutide, dulaglutide, tirzepatide...)\n* history of dementia.",true,"ALL","18 Years",{"count":19,"type":20},158,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this study is to evaluate whether a \"thirst kit\" (lemon popsicle) is effective in reducing thirst intensity in patients undergoing hospital bowel preparation for colonoscopy. The study also aims to assess the impact of the thirst kit on associated symptoms and patient satisfaction. The main questions it aims to answer are:\n\n* Does the thirst kit reduce the intensity of thirst after bowel preparation for colonoscopy?\n* Does the thirst kit reduce symptoms such as dry mouth and dry throat?\n* How satisfied are patients when using the thirst kit compared to a placebo?\n\nResearchers will compare the thirst kit to a placebo to determine its effectiveness in managing thirst during the pre-colonoscopy period.\n\nParticipants will:\n\n* Be randomly assigned to receive either the thirst kit (lemon popsicle) or a placebo\n* Use the assigned intervention during the hospital preparation period for colonoscopy\n* Rate thirst intensity, associated symptoms, and satisfaction using numerical scales",[26,27,28],"Thirst","Bowel Preparation for Colonoscopy","Colonoscopy","RECRUITING","2026-07-07",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-12-08",{"date":37,"type":20},"2026-09-01",{"name":39,"class":40},"Hospital Sirio-Libanes","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":41},"100644635","enhancing-patient-experience-in-geriatric-oncology-100644635","NCT07671586","Enhancing Patient Experience in Geriatric Oncology","Enhancing the Experience of Older Adults With Cancer Through a Comfort Menu and Cart for: Protocol of a Quasi-experimental, Before-and-after Study in a Tertiary Oncology Center","Inclusion Criteria:\n\n* Age 60 years or older.\n* Receiving care at the Oncology Center in the context of active cancer treatment: intravenous chemotherapy, supportive therapy, or clinical evaluation.\n* Capacity to provide informed consent and respond to the interview, or presence of a legal representative or companion able to do so.\n\nExclusion criteria.\n\n* Refusal to participate in the study or to use the comfort menu and cart items.\n* Decreased level of consciousness or acute clinical instability (hemodynamic instability, acute respiratory failure).\n* Absence of a companion able to consent and provide information when the patient presents cognitive impairment.\n* Inability to be contacted by telephone for the follow-up interview.","60 Years",{"count":51,"type":20},264,[23],"Approximately 60% of new cancer diagnoses and 70% of cancer-related deaths occur in adults aged 65 years and older, a population frequently affected by multimorbidity, frailty, sensory impairment, and treatment-related symptom burden. Outpatient oncology centers, although designed for efficient antineoplastic therapy delivery, are rarely adapted to the specific needs of older adults, and pragmatic, low-cost interventions to enhance patient experience and the clinical care journey remain scarce. The \"comfort menu and cart,\" a non-pharmacological strategy initially developed for the emergency department, has shown promising effects on patient and staff experience, but has not been evaluated in the geriatric oncology setting.\n\nMethods: This protocol describes a quasi-experimental, before-and-after, single-center study evaluating the implementation of a comfort menu and cart at the Oncology Center of Hospital Sírio-Libanês, a tertiary philanthropic hospital in São Paulo, Brazil. Patients aged 65 years and older receiving intravenous chemotherapy, supportive therapy, or evaluation of intercurrent symptoms during oncological treatment will be recruited over 12 months: six months pre-intervention and six months post-intervention, with 132 participants per phase and a total sample of 264 participants. All participants will undergo a comprehensive geriatric assessment, including G8, Charlson Comorbidity Index, Clinical Frailty Scale, Geriatric Depression Scale - 15-item version, Katz Index of Independence in Activities of Daily Living, Barthel Index of Activities of Daily Living, Lawton-Brody Instrumental Activities of Daily Living Scale, 10-point Cognitive Screener, and EuroQol 5-Dimension questionnaire. This assessment will be complemented by oncology-specific patient-reported outcomes, including the Edmonton Symptom Assessment System, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information 25, and a structured adherence questionnaire. Caregiver anxiety, depression, and burden will be assessed using the Hospital Anxiety and Depression Scale and the Zarit Burden Interview short version. The primary outcome will be patient experience, measured using Likert-scale instruments adapted from previously published comfort care and emergency department experience instruments. Secondary outcomes include staff experience, length of stay, satisfaction indicators, oncological treatment adherence, symptom control, patient understanding of disease-related information, functionality, need for re-evaluation, hospital admissions, and caregiver outcomes at 30 days.\n\nExpected Results: The study is expected to demonstrate that a low-cost, non-pharmacological intervention can enhance the experience of older adults with cancer and multidisciplinary teams, with favorable effects on symptom control, information comprehension, treatment adherence, and 30-day clinical outcomes.",[55,56],"Confort","Older Adults With Cancer",[58,59,60,61,62,63],"Older adults with cancer","Patient experience","Comprehensive Geriatric assessment","Non Pharmacological Intervention","Caregiver Burden","Geriatric Oncology","NOT_YET_RECRUITING","2026-06-23",{"date":67,"type":33},"2026-06-26",{"date":69,"type":20},"2026-08-20",{"date":71,"type":20},"2027-10-20",{"name":39,"class":40},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":41},"100568449","enhancing-the-emergency-department-experience-for-older-adults-study-protocol-for-the-implementation-of-a-comfort-menu-and-cart-100568449","NCT06681376","Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart","Inclusion Criteria:\n\n* ED attendance at Hospital Sírio-Libanês (HSL), São Paulo, Brazil.\n* Age ≥ 65 years.\n* Capacity to consent and respond to the interview or the presence of a companion capable of doing so.\n\nExclusion Criteria:\n\n* Decline to participate in the study or use the comfort menu and cart.\n* Absence of a companion able to consent to study participation and provide necessary information for patients with altered mental status or cognitive impairment.\n* Decreased level of consciousness.\n* Hemodynamic instability.\n* Acute respiratory failure.\n* Inability to be contacted by phone for the follow-up interview.",{"count":51,"type":20},[23],"Introduction: The aging of the population is a global phenomenon, with projections indicating a significant increase in the proportion of individuals aged 60 years and older by 2050. This demographic shift requires adapting emergency department (ED) services to meet the specific demands of older patients, who often present with multiple comorbidities and face challenges such as sensory and cognitive difficulties. EDs, traditionally designed for acute illness and injury management, may not be adequately equipped to meet the unique needs of this vulnerable population. This can result in suboptimal patient experiences, prolonged ED stays, increased hospitalizations, and poorer outcomes.\n\nMethods: This study protocol outlines a before-and-after study to evaluate the impact of implementing a comfort menu and cart on the experience and outcomes of older patients treated in the ED. The study will be conducted in the ED of Hospital Sírio-Libanês (HSL), a tertiary private hospital in São Paulo, Brazil. Patients aged 60 and older who presented to the ED will be eligible for inclusion. Participants will be recruited in two phases: pre-intervention and post-implementation of the comfort menu and cart. Data will be collected through patient and staff interviews, chart reviews, and a 30-day follow-up interview. Patient experience, staff experience, length of hospital stays, hospital costs, ED readmissions, falls, delirium incidence, quality of life, functional status, cognitive performance, and mortality will be assessed.\n\nEthics and dissemination: Ethical approval for this study has been granted by the Institutional Review Board of HSL. All participants, or their legal representatives for those with cognitive impairment, will provide written informed consent before any study procedures are initiated. The consent process has been designed keeping the study hypothesis blind by not revealing the outcomes that will be measured after the comfort cart intervention. The results will be shared with the academic community through peer-reviewed publications and presentations at relevant conferences to inform future clinical practice and research.\n\nExpected Results: A positive impact of implementing the comfort menu and cart in the ED is expected on patient-centered outcomes. Improvements in the experience of older patients and medical and multidisciplinary staff are anticipated, and improvements in other exploratory outcomes, such as length of hospital stay, hospital costs, readmissions, falls, delirium incidence, quality of life, functionality, and cognitive performance, will be explored.",[83,84],"Emergency Department Patient","Comfort",[86,87,88,89],"comfort cart","patient experience","older adult","emergency department","2026-06-08",{"date":92,"type":33},"2026-06-10",{"date":94,"type":20},"2026-08-01",{"date":96,"type":20},"2027-03-10",{"name":39,"class":40},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":5},"100600127","quality-improvement-intervention-for-a-safe-antimicrobial-use-reduction-in-critically-ill-patients-100600127","NCT07093450","Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients","Estudo de Implementação de Melhoria de Qualidade Para Redução do Uso de Antimicrobianos em Unidades de Terapia Intensiva","SAFE-REDUCE","Intensive care units inclusion Criteria:\n\n* ICU leadership acceptance to participant in the quality improvement intervention;\n* Hospital infection control leadership acceptance to participant in the quality improvement intervention;\n* ICU participation in the IMPACTO-MR platform with high quality data;\n* ICU potential for quality improvement based on a subjective assessment of the ICU and hospital infection leaderships\n\nIntensive care units exclusion Criteria:\n\n\\- Absence of local IRB approval\n\nParticipants inclusion Criteria:\n\n* All patients admitted to the intensive care unit\n\nParticipants exclusion Criteria:\n\n* Patients younger than 18 years-old will be excluded from individual-level analysis",{"count":107,"type":20},9000,[23],"The goal of this clinical trial is to learn if an educational intervention with audit and feedback on physicians and health care professionals who participate in antimicrobial treatment decisions can reduce the use of antimicrobials in adult patients admitted to a sample of Brazilian intensive care units (ICUs). The educational intervention is based on a literature review of current recommendations for a more rational use of antimicrobials and microbiological tests in daily ICU practice.\n\nThe main questions it aims to answer are:\n\n* Does the educational intervention reduce the antimicrobial consumption in the intensive care units?\n* Does this educational intervention aiming to reduce antimicrobial utilization in accordance with the latest guidelines have any safety signals regarding ICU mortality rates or ICU length-of-stay?\n\nResearchers will compare (1) ICUs sequentially randomized to this quality improvement educational intervention aimed at improving antimicrobial utilization to (2) the same ICUs at months where the educational intervention has not been delivered yet.\n\nEach participant ICU will transition to the quality improvement intervention approximately each month, starting at July, 2025. This quality improvement intervention is based on current recommendations for antimicrobial stewardship from regulatory agencies and medical societies, including cognitive aids for physicians to improve decision-making regarding the commencement of antimicrobials, their duration and antimicrobial time-outs. The investigators hypothesize that intensivists (ICU doctors) need to embrace antimicrobial stewardship as a core competence of their daily activities.",[111,112,113],"Infection","Antimicrobial Stewardship","Critically Ill Intensive Care Unit Patients",[115,116,111,117,118,119],"Antimicrobial stewardship","Intensive care unit","Stepped-wedge cluster trials","Hybrid effectiveness-implementation trials","Diagnostic stewardship","2025-11-25",{"date":122,"type":33},"2025-12-03",{"date":124,"type":33},"2025-06-01",{"date":126,"type":20},"2026-07",{"name":39,"class":40},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":41},"100599795","virtual-reality-in-intensive-care-unit-patient-satisfaction-clinical-and-functional-outcomes-feasibility-100599795","NCT07089134","Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility","Efficacy of Immersive Virtual Reality Rehabilitation on Patient Satisfaction and Experience, Functional and Clinical Outcomes, and Its Feasibility in Intensive Care Unit Treatment: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged ≥18 years\n* Glasgow Coma Scale (GCS) score ≥14\n* Richmond Agitation-Sedation Scale (RASS) score between -1 and +1\n* Negative for delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)\n* Estimated ICU stay of ≥72 hours\n* Able to communicate in Portuguese\n* Understand and follow verbal instructions\n* Have no psychotic disorders, visual impairment or hearing loss.\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Signs of respiratory distress\n* Contact isolation for infectious diseases\n* Conditions that limit head and neck movement",{"count":136,"type":20},90,[23],"Background: Virtual reality is recognized as a progressive technology with the potential to enhance the rehabilitation process. Immersive virtual reality-based treatments can improve motor outcomes in physical rehabilitation, reduce stress caused by the intensive care unit environment and maximize patients' recovery processes.\n\nObjective: To analyze the efficacy of rehabilitation using immersive virtual reality on patient satisfaction and experience, functional and clinical outcomes and the feasibility of its application during the hospitalization period in an intensive care unit (ICU).\n\nMethods: This is a randomized controlled clinical trial involving ICU patients aged 18 years or older, with an estimated ICU stay of ≥ 72 hours, the ability to understand and follow verbal instructions and no diagnosis of psychotic disorders, visual impairment, or hearing loss. Patients will be divided into two groups: one undergoing traditional physiotherapy rehabilitation - control group (CG), and the other receiving physiotherapy using immersive virtual reality (IVR group). The following evaluations will be conducted: mobility condition, physical and psychological discomfort, estimated physical activity level, occurrence of delirium, cognitive decline screening, functionality classification, motivation level, patient experience, sense of immersion in the virtual reality environment, patient satisfaction during the rehabilitation process, occurrence of adverse events, and protocol feasibility. Data will be presented in graphs and tables. Results will be considered statistically significant at a 5% significance level (p ≤ 0.05), and all analyses will be performed using SPSS Statistics version 22.\n\nExpected results: The investigators expect to find evidence that rehabilitation using immersive virtual reality can promote and enable a more pleasant and less traumatic experience during the patient's hospitalization, with greater satisfaction and adherence to the proposed rehabilitation, in addition to being an effective tool to optimize patients' functional and clinical outcomes.",[140,141,142],"Hospitalized Patients","ICU Hospitalization","Intensive Care Unit-acquired Weakness",[144,145,146,147,148,87],"virtual reality","rehabilitation","intensive care","stress","satisfaction","2025-09-08",{"date":151,"type":33},"2025-09-12",{"date":153,"type":20},"2025-12-15",{"date":155,"type":20},"2026-08-31",{"name":39,"class":40},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100459703","ventilator-associated-tracheobronchitis-initiative-to-conduct-antibiotic-evaluation-100459703","NCT05266066","Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation","Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis","VATICAN","Inclusion Criteria:\n\n* Admission to one of the participating ICUs\n* Invasive Mechanical ventilation ≥ 48 hours\n* Available chest imaging of screening day\n* Clinical diagnosis of VAT, defined by the presence of:\n\n  1. Temperature \\>38.0°C or \\\u003C36°C OR leukocytes \\>12000\u002FmL or \\\u003C4000\u002FmL or presence \\>10% of immature forms, AND\n  2. Onset of purulent tracheal secretion, or change in characteristics of the secretion, or increase in the amount of respiratory secretion, or increased need for aspiration\n* Culture of tracheal secretion from the day of screening under analysis or collected for analysis\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening\n* Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose \\> 0.1mcg\u002Fkg\u002Fmin of noradrenaline or equivalent in the past 6 hours\n* Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days\n* Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more\n* Presence of pulmonary radiological image suggestive of new infectious infiltrate\n* Previous lung disease that makes radiological interpretation for the diagnosis of VAP difficult\n* Previous diagnosis of ventilator associates pneumonia (VAP) during hospitalization\n* Neutropenic patients (neutrophils \\\u003C1000\u002FmL)\n* Known severe immunosuppression\n* Tracheostomized patients at the time of screening\n* Inclusion in the study in the past 30 days\n* Expected limitation of care or early withdrawal of supportive therapies (\\\u003C 7 days)\n* Patients with a survival expectancy of less than 48 hours\n* Refusal of consent to participate in the study",{"count":166,"type":20},590,[23],"The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.",[170,171],"Ventilator Associated Tracheobronchitis","Tracheobronchitis",[173,174,175,176],"Antibiotics","Ventilator associated Tracheobronchitis","Mechanical ventilation","Critically ill","2025-06-16",{"date":179,"type":33},"2025-06-19",{"date":181,"type":33},"2022-07-11",{"date":183,"type":20},"2026-12-01",{"name":39,"class":40},16,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":41},"100542189","effects-of-transcutaneous-electrical-phrenic-nerve-stimulation-and-transcutaneous-electrical-diaphragmatic-stimulation-100542189","NCT06339632","Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation","Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation: a Randomized Controlled Crossover Trial","Inclusion Criteria:\n\n* Age between 18 and 60 years;\n* Normal pulmonary function test, without alterations, assessed through spirometry;\n* Body Mass Index (BMI) between 18.5 and 24.9 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Smokers or former smokers;\n* Individuals with previously known cardiopulmonary diseases (restrictive lung diseases, chronic obstructive pulmonary disease - COPD, asthma, cystic fibrosis, among other pathologies);\n* Presence of implanted electrical devices (pacemaker, implantable cardioverter-defibrillator, among others);\n* Individuals who have contraindications to undergo evaluation and\u002For application of transcutaneous electrical stimulation of the diaphragm muscle, such as: altered sensitivity, wounds at the site of application, deformities, among other conditions.",{"count":194,"type":20},12,[23],"Transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) are modalities that use surface electrodes placed on the patients' skin to generate action potentials and contractions of the muscle fibers of the diaphragm. The primary objective will be to evaluate the efficacy of TEPNS and TEDS in healthy adult individuals. Secondary objectives will be to assess the feasibility, safety, and level of discomfort reported by the individual resulting from the application of TEPNS and TEDS.",[198],"Diaphragm",[198,200,201],"Transcutaneous electrical nerve stimulation","Ultrasound","2025-04-22",{"date":204,"type":33},"2025-04-24",{"date":206,"type":33},"2024-04-01",{"date":208,"type":20},"2026-03-01",{"name":39,"class":40},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100547044","phase-4-vitamin-k-antagonist-factor-xa-inhibitor-or-no-anticoagulation-in-atrial-fibrillation-and-dialytic-end-stage-renal-disease-visionaire-100547044","NCT06402851","Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)","A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction","VISIONAIRE","Inclusion Criteria:\n\n* Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent);\n* CHA2DS2-Vasc ≥ 2 points (≥ 3 if female);\n* Chronic kidney disease with estimated glomerular filtration rate (eGFR) ≤ 15 ml\u002Fmin\u002F1.73 m2 by the CKD-EPI equation (confirmed by two lab results at least 3 months apart) or on chronic renal replacement therapy (Of note: number of patients included in no renal replacement therapy stratum will be capped at around 30% from the total study population).\n\nExclusion Criteria:\n\n* Active bleeding or severe bleeding \\\u003C 1 month;\n* Prior kidney transplantation;\n* Refusal de provide consent\n* Severe chronic liver disease (Child C);\n* Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism);\n* Prior intracranial hemorrhage;\n* Bleeding disorder (other than uremia);\n* Platelet count \\\u003C 50,000 \u002F mm3 ;\n* Pregnancy or breastfeeding;\n* Mechanical valvar prosthesis;\n* Moderate to severe mitral stenosis;\n* Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker;\n* Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.",{"count":219,"type":20},1500,[221],"PHASE4","VISIONAIRE (Vitamin K AntagonISt, Factor Xa Inhibitor Or Nothing In Atrial Fibrillation And DIalytic End-stage Renal DiseasE) trial will be a prospective randomized open-label with blinded endpoint adjudication trial including 1500 patients with atrial fibrillation or atrial flutter and advanced chronic kidney disease",[224,225],"Atrium; Fibrillation","Chronic Kidney Diseases",[227,228,229,230],"atrial fibrillation","atrial flutter","oral anticoagulation","dialysis","2025-02-19",{"date":233,"type":33},"2025-02-21",{"date":235,"type":33},"2024-12-18",{"date":237,"type":20},"2026-12",{"name":39,"class":40},6,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":251,"briefSummary":253,"conditions":254,"keywords":258,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},"100435054","phase-3-biperiden-trial-for-epilepsy-prevention-100435054","NCT04945213","Biperiden Trial for Epilepsy Prevention","Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury","BIPERIDEN","Inclusion Criteria:\n\n* Given informed consent\n* 18 - 75 years of age\n* GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene with previous GCS between 6 and 15.\n* Moderate or severe acute traumatic brain injury\n* All genders\n* Brain CT scan with signs of of acute intraparenchymal hemorrhage and\u002For contusion\n* Able to receive the first dose of treatment or placebo within 18 hours of brain injury,\n\nExclusion Criteria:\n\n* Previous use of biperiden\n* History of epilepsy (confirmed by patient chart)\n* History of seizures or use of antiepileptic medication\n* Pregnancy\n* Participation in another clinical trial at the time of randomization\n* History of neoplasia, neurodegenerative diseases; history of stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or any other cardiac arrhythmia, or glaucoma megacolon or mechanical obstruction\n* Homeless patient","75 Years",{"count":250,"type":20},312,[252],"PHASE3","One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE. In previous studies with animals models of epilepsy, the biperiden decreased the incidence and intensity of spontaneous epileptic seizures besides delaying their appearance. The aim of this study is the evaluation of biperiden as antiepileptogenic drug to prevent PTE and also the determination of side effects, evaluating its cost-effectiveness in patients with moderate and severe TBI.",[255,256,257],"Brain Injury Traumatic Moderate","Brain Injury Traumatic Severe","Post Traumatic Epilepsy",[259,260,261],"Brain Injury","Epilepsy","Biperiden","2024-03-25",{"date":264,"type":33},"2024-03-26",{"date":266,"type":33},"2023-01-10",{"date":268,"type":20},"2026-12-20",{"name":39,"class":40},10,""]