[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Sao Paulo General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":712},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,47,81,111,141,169,196,224,249,278,306,342,363,392,416,440,466,495,525,553,579,606,631,657,688],{"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},"100652699","study-evaluating-the-effects-of-red-grape-juice-consumption-on-metabolism-in-men-with-coronary-artery-disease-100652699",false,"NCT07777341","Study Evaluating the Effects of Red Grape Juice Consumption on Metabolism in Men With Coronary Artery Disease","Effects of Red Grape Juice on the Plasma Metabolome in Chronic Coronary Artery Disease.","GRAPEOMICS","Inclusion Criteria:\n\nIndividuals aged 46 to 69 years with established chronic coronary artery disease diagnosed more than 30 days after acute myocardial infarction, angiographic evidence of ≥50% stenosis in one or more epicardial coronary arteries, previous percutaneous coronary intervention, or previous coronary artery bypass graft surgery, with a body mass index (BMI) \\\u003C30 kg\u002Fm² and without symptoms of angina or dyspnea.\n\nExclusion Criteria:\n\nExclusion criteria include the use of antibiotics within the eight weeks preceding study enrollment; heart failure (New York Heart Association functional class ≥II); renal insufficiency (creatinine clearance \\\u003C30 mL\u002Fmin calculated using the Cockcroft-Gault equation); and hepatic insufficiency (defined by thrombocytopenia, reduced serum albumin, and prolonged prothrombin time). Individuals with cancer, inflammatory bowel disease, obstructive biliary disease, or a history of digestive surgery, including cholecystectomy, gastrectomy, or colectomy, will also be excluded. Patients with diabetes mellitus, those receiving antidiabetic medications, or those with hypertriglyceridemia will be excluded because of the high sugar content of red grape juice (400 mL contains approximately 280 kcal and 60 g of carbohydrates). The use of illicit drugs and habitual consumption of wine or other alcoholic beverages are also exclusion criteria. In addition, individuals with unstable angina, moderate valvular heart disease, Chagas disease, permanent pacemaker implantation, chronic obstructive pulmonary disease (COPD), aortic aneurysm, or aortic ectasia measuring less than 40 mm will be excluded.","MALE","49 Years","69 Years",{"count":22,"type":23},50,"ESTIMATED","INTERVENTIONAL",[26],"NA","Previous studies suggest that both RW and red grape juice (RGJ) have beneficial properties upon risk factors and cardiovascular events. However, the effects of grape polyphenols on metabolomics in men are still poorly understood. Recent advances in mass spectroscopy allowed substantial advances in the analysis of molecular signatures of several diseases.\n\nTherefore, the objective of this study is to evaluate the impact of RGJ on plasma metabolomics in patients with chronic coronary disease (CAD). This is a crossover, prospective, randomized and controlled study, with two 3-week interventions: 1. daily consumption of RGJ (400 mL) and 2. total abstention from foods rich in polyphenols. Plasma metabolomics will be performed by gas chromatography (GC)\u002Fmass spectroscopy (MS) by (Prof. Labate, Department of Plant Genetics, ESALQ). The sample will consist of 50 patients with chronic CAD. aged between 46 and 69 years. The inclusion and exclusion criteria were defined to achieve homogeneity of the group and avoid interference. The central hypothesis of this study is that RGJ will exert effects upon pathways involved in lipids, carbohidrates and energy production, contributing to the understanding of the mechanisms of action of polyphenols on cardiovascular health, without the risks associated with alcohol.",[29],"Coronary Arterial Disease (CAD)",[31,32,33],"Coronary Artery Disease (CAD)","Red Grape Juice","Metabolomics","RECRUITING","2026-08-17",{"date":37,"type":38},"2026-08-20","ACTUAL",{"date":40,"type":38},"2026-07-10",{"date":42,"type":23},"2028-08-10",{"name":44,"class":45},"University of Sao Paulo General Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":46},"100649121","incidence-of-tuberculosis-in-patients-with-autoimmune-rheumatic-diseases-100649121","NCT07731672","Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases","Prospective Randomized Controlled Study to Evaluate the Effectiveness of Annual Tuberculosis Re-Screening in Patients With Autoimmune Rheumatic Diseases Receiving Biologic and\u002For Immunosuppressive Therapy","TB-RESCREEN","Inclusion Criteria:\n\n* Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria\n* negative baseline screening for tuberculosis infection.\n\nExclusion Criteria:\n\n* History of tuberculosis infection or disease\n* Radiographic evidence suggestive of prior TB\n* Previous treatment for TBD or TBI\n* Positive baseline TB screening;\n* Follow-up shorter than 12 months","ALL",{"count":57,"type":23},1660,[26],"This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving biologic and\u002For immunosuppressive therapy.\n\nPatients with negative baseline TBI screening will be randomized to undergo annual re-screening using interferon-gamma release assay (IGRA) or to a control group without routine re-screening.\n\nPatients with newly detected TBI will receive preventive treatment. The primary objective is to assess whether annual re-screening combined with TBI treatment reduces the incidence of active tuberculosis. Secondary objectives include determining TBI conversion rates and identifying risk factors for infection.",[61,62],"Autoimmune Rheumatic Diseases","Prevention",[64,65,66,61,67,68,69,70,62,71],"Tuberculosis","Tuberculosis disease","Tuberculosis infection","Biologic Therapy","Screening","IGRA","Rheumatology","Prospective Study","NOT_YET_RECRUITING","2026-08-14",{"date":75,"type":38},"2026-08-18",{"date":77,"type":23},"2026-08-01",{"date":79,"type":23},"2031-07-30",{"name":44,"class":45},{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":24,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":46},"100488389","foot-care-and-exercises-implementation-for-people-with-diabetes-in-primary-care-100488389","NCT05639478","FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care","Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life","FOCAIN","Inclusion Criteria:\n\n* Adults of both sexes;\n* Diabetes mellitus type 1 or 2;\n* Residence within the catchment area of the Family Health Units.\n* Availability to participate in the intervention at the established group time.\n\nNon-inclusion Criteria:\n\n* Clinical diagnosis of dementia;\n* Inability to provide reliable and consistent information;\n* Perform physiotherapy intervention throughout the intervention period;\n* Active foot ulcer or major vascular complications.","18 Years",{"count":91,"type":23},356,[26],"The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira\u002FSP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.",[95],"Diabetes; Neuropathy, Polyneuropathy (Manifestation)",[97,98,99,100,101,102],"exercise therapy","diabetic foot","preventive care","foot-related exercises","musculoskeletal functions","primary health care","2026-08-10",{"date":105,"type":38},"2026-08-12",{"date":107,"type":38},"2023-03-01",{"date":109,"type":23},"2026-12-31",{"name":44,"class":45},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":55,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":24,"phases":122,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":4},"100650083","funcional-recovery-after-minithoracotomy-or-sternotomy-for-cabg-in-frail-patients-100650083","NCT07742475","Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients","Functional Recovery After Coronary Artery Bypass Graft Surgery in Frail Patients: Randomized Clinical Trial Between Minithoracotomy Versus Sternotomy.","MINIFRAGILE","Inclusion Criteria:\n\n* Age 60 years or older.\n* Diagnosis of coronary artery disease with an established indication for coronary artery bypass grafting.\n* Coronary anatomy considered suitable for complete surgical revascularization through a left anterolateral minithoracotomy, including suitable distal coronary targets with a luminal diameter of at least 1.5 mm.;\n\n  \\> Alternatively, coronary anatomy suitable for a planned hybrid revascularization strategy, with coronary territories not treated surgically considered amenable to percutaneous coronary intervention.\n* Presence of pre-frailty or frailty, defined by at least 2 of the following Fried frailty criteria:\n\n  * Unintentional weight loss of at least 4.5 kg or at least 5% of body weight during the previous year.\n  * Self-reported exhaustion or fatigue.\n  * Reduced handgrip strength.\n  * Slow walking speed.\n  * Low level of physical activity.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Requirement for emergency cardiac surgery.\n* Planned concomitant cardiac surgical procedure in addition to coronary artery bypass grafting.\n* Clinically significant peripheral vascular disease involving the femoral vessels that prevents safe peripheral cannulation for cardiopulmonary bypass, when peripheral cannulation may be required.\n* Contraindication to left minithoracotomy, including pleural adhesions, pleural thickening, or other thoracic conditions that prevent safe access to the mediastinum through the intercostal space.\n* Severe chronic obstructive pulmonary disease or another pulmonary condition that prevents safe single-lung ventilation or temporary compression of the left lung.","60 Years",{"count":121,"type":23},194,[26],"Frailty is a major predictor of adverse outcomes following coronary artery bypass grafting (CABG), being associated with increased postoperative complications, prolonged hospitalization, delayed functional recovery, and reduced quality of life. Although minimally invasive coronary surgery (MICS) through left minithoracotomy has been associated with reduced surgical trauma and faster recovery in selected patients, its benefits have not been evaluated in a randomized trial specifically involving frail patients.\n\nThe MINI FRAGILE trial is a prospective, multicenter, randomized, open-label clinical trial designed to compare minimally invasive CABG performed through left anterior minithoracotomy with conventional median sternotomy in patients aged 60 years or older with pre-frailty or frailty undergoing surgical coronary revascularization. Eligible participants will be randomized in a 1:1 ratio to either surgical approach.\n\nThe primary objective is to determine whether minimally invasive CABG improves functional recovery, assessed by the change in the physical component of the SF-36 Health Survey 30 days after surgery. Secondary outcomes include major adverse cardiovascular events, mortality, intensive care unit and hospital length of stay, duration of mechanical ventilation, return to usual activities, surgical site infection, perioperative complications, postoperative pain, readmission, and adherence to enhanced recovery measures. The results of this trial are expected to provide high-quality evidence regarding the optimal surgical approach for frail patients requiring coronary artery bypass grafting.",[125,126,127],"Frailty","Coronary Artery Disease","Coronary Artery Bypass Graft (CABG)",[129,130,131,125,132],"Coronary Artery Bypass Grafting","Minimally Invasive Coronary Surgery","Minithoracotomy","Functional Recovery","2026-08-03",{"date":135,"type":38},"2026-08-05",{"date":137,"type":23},"2026-09",{"date":139,"type":23},"2027-08",{"name":44,"class":45},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":55,"minAge":149,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":24,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":46},"100619189","phase-4-prevention-of-recurrence-of-herpes-simplex-in-autoimmune-rheumatic-diseases-100619189","NCT07341386","Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases","Prevention of Recurrence of Herpes Simplex in Patients With Autoimmune Rheumatic Diseases","PRoHerpARD","Inclusion Criteria\n\n* Eligible participants must be \\>12 years old\n* Any sex\n* Have a confirmed diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted classification criteria, including: rheumatoid arthritis (ACR\u002FEULAR 2010), juvenile idiopathic arthritis (ILAR), axial spondyloarthritis (ASAS 2009), psoriatic arthritis (CASPAR 2012), systemic lupus erythematosus (SLICC 2012), systemic sclerosis (ACR 2013), dermatomyositis\u002Fpolymyositis (Bohan \\& Peter), systemic vasculitis (Takayasu arteritis, granulomatosis with polyangiitis, polyarteritis nodosa), primary Sjögren's syndrome (ACR\u002FEULAR 2016), mixed connective tissue disease (Alarcón-Segovia or Kasukawa criteria), chronic recurrent multifocal osteomyelitis (Jansson et al., 2007), sarcoidosis (ATS\u002FERS\u002FWASOG 2020 statement) and behçet's syndrome (International Study Group, 1990).\n* Present serologic evidence of prior HSV infection (complement fixation titer ≥ 1:8)\n* A clinical history of recurrent oral or genital herpes simplex virus infection, defined as at least four episodes in the past 12 months.\n\nExclusion Criteria\n\n-Participants will be excluded if they have a known hypersensitivity to acyclovir or any component of the study medication.","12 Years",{"count":151,"type":23},62,[153],"PHASE4","The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate the effectiveness and safety of oral suppressive therapy with acyclovir in preventing herpes simplex virus (HSV) reactivation in patients with autoimmune rheumatic diseases (ARDs) who have a history of recurrent HS episodes.\n\nThe main questions this study aims to answer are:\n\nDoes continuous oral acyclovir reduce the frequency of HSV reactivation in ARD patients compared to placebo? What is the safety profile of prolonged acyclovir use in this population? What are the main risk factors (clinical and treatment-related) associated with HSV reactivation in immunosuppressed patients.\n\nParticipants will:\n\nBe randomly assigned (1:1) to receive oral acyclovir (400 mg BID) or placebo for 12 months; Be followed for a total of 24 months, with regular clinical evaluations (every 3 months) and laboratory monitoring (every 3 months); Be assessed for HSV recurrence based on clinical symptoms, detection of HSV DNA by polymerase chain reaction (PCR) in mucocutaneous swabs in doubtful cases, and standardized reporting forms; Undergo disease activity assessments and adverse event monitoring at regular intervals.\n\nThe study includes adult and pediatric patients with confirmed diagnoses of one of the following ARDs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), dermatomyositis\u002Fpolymyositis (DM\u002FPM), systemic sclerosis (SSc), systemic vasculitis, primary Sjögren's syndrome, Mixed connective tissue disease (MCTD), Chronic recurrent multifocal osteomyelitis (CRMO), Sarcoidosis and Behçet's Syndrome. All participants must have a documented history of recurrent HSV (oral and\u002For genital) before inclusion.",[61,156,62],"Recurrent Herpes Simplex",[158,159,61,70,160,161,162],"Herpes Simplex Virus","Acyclovir","Pediatric Rheumatology","Antiviral Suppressive Therapy","Infectious Disease Prevention",{"date":135,"type":38},{"date":165,"type":38},"2026-06-25",{"date":167,"type":23},"2028-04-01",{"name":44,"class":45},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":179,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":195,"locationsCount":4},"100614129","phase-4-antibiotic-prophylaxis-after-simple-tooth-extraction-in-immunosuppressed-patients-with-autoimmune-rheumatic-diseases-100614129","NCT07275580","Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases","Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases","PRO-EXOD","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis of an ARD: SLE, RA, JIA, AS, PsA, IIM, systemic vasculitis, primary Sjögren's syndrome, or SSc\n* Use of prednisone and\u002For at least one synthetic immunosuppressant (methotrexate, azathioprine, mycophenolate mofetil, leflunomide, cyclophosphamide, cyclosporine, or tacrolimus), immunobiological agent or immunomodulator (chloroquine, sulfasalazine), with no plans to switch medications.\n* Indication for simple tooth extraction with chronic odontogenic focus\n* Provided informed consent\n\nExclusion Criteria:\n\n* Individuals who do not agree to participate in the study will be excluded.\n* Patients requiring extractions that are more complex from a technical standpoint, such as impacted third molars.\n* Patients with local or systemic conditions requiring more extensive antibiotic coverage, such as cases with clinical signs of acute infections, patients on anticoagulant therapy, patients with heart disease, patients who have undergone radiation therapy, or patients currently being treated for neoplasms;\n* Patients allergic to amoxicillin.\n* Patients currently receiving any antibiotic prophylaxis or treatment;\n* Patients who have undergone corticosteroid pulse therapy within the last month;\n* Patients taking drugs with antiresorptive effects on bone, such as oral or injectable bisphosphonates and denosumab.",{"count":178,"type":23},352,[153],"This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether single-dose amoxicillin prophylaxis administered prior to simple tooth extraction reduces postoperative infection rates inpatients with autoimmune rheumatic diseases (ARDs).\n\nAlthough antibiotic prophylaxis is not recommended for healthy individuals undergoing simple extractions, immunosuppressed ARD patients frequently receive antibiotics despite limited evidence supporting this practice.\n\nSecondary objectives include assessing infection severity, postoperative complications, and the impact of ARD diagnosis and immunosuppressive treatment on infection risk.",[61,182,183,184],"Tooth Extraction","Infection Prevention","Antibiotic Prophylaxis",[61,182,183,186,187,188,189],"Amoxicillin","Antibiotic Stewardship","hydroxychroloquine","immunosupressive therapy",{"date":191,"type":38},"2026-08-06",{"date":37,"type":23},{"date":194,"type":23},"2029-12-30",{"name":44,"class":45},{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":24,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":46},"100647917","phase-4-randomized-study-of-triple-therapy-vs-sildenafil-dose-optimization-in-pulmonary-arterial-hypertension-100647917","NCT07713914","Randomized Study of Triple Therapy vs Sildenafil Dose Optimization in Pulmonary Arterial Hypertension","A Prospective, Randomized, Open-Label Study Comparing Triple Therapy Versus Sildenafil Dose Optimization in Patients With Pulmonary Arterial Hypertension Using COMPERA 2.0 Risk Stratification as the Primary Outcome","ASCEND-PAH","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of pulmonary arterial hypertension (PAH, Group 1) confirmed according to accepted clinical and hemodynamic criteria\n* Stable treatment with an endothelin receptor antagonist in combination with sildenafil prior to randomization\n* Classified as intermediate-low, intermediate-high, or high risk according to the COMPERA 2.0 four-stratum model\n* Clinical indication for therapeutic escalation\n* Availability for follow-up assessment between 3 and 6 months after randomization\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Participation in another interventional clinical trial that mandates treatment modification\n* Known contraindication to prostacyclin pathway agents (including iloprost or selexipag)\n* Known contraindication to sildenafil dose escalation\n* Pregnancy or breastfeeding\n* Women of childbearing potential not using effective contraception\n* Any clinical condition that, in the investigator's judgment, would interfere with study participation or outcome assessment",{"count":205,"type":23},196,[153],"Pulmonary arterial hypertension (PAH) is a rare and progressive disease characterized by increased pressure in the pulmonary arteries, leading to right heart failure and premature death. Although combination therapy has improved outcomes, many patients remain at intermediate or high clinical risk despite treatment.\n\nWhen patients do not reach low-risk status, treatment escalation is recommended. However, different escalation strategies are used in clinical practice, including increasing the dose of existing medications or adding a third drug that targets a different biological pathway. There is limited prospective randomized evidence directly comparing these approaches.\n\nThe ASCEND-PAH study is a prospective, randomized, open-label clinical trial designed to compare two therapeutic escalation strategies in adults with PAH who remain at intermediate or high risk despite dual therapy with an endothelin receptor antagonist and sildenafil. Participants will be randomized to either: (1) escalation to triple therapy with the addition of a prostacyclin pathway agent, or (2) optimization of dual therapy by increasing the dose of sildenafil.\n\nThe primary objective is to compare the proportion of patients who improve their risk category according to the COMPERA 2.0 four-stratum risk model within 3 to 6 months after randomization. Secondary outcomes include changes in functional status, exercise capacity, biomarkers, clinical worsening, safety, and treatment persistence",[209],"Pulmonary Arterial Hypertension (PAH)",[211,212,213,214,215],"Pulmonary Arterial Hypertension","Therapeutic Escalation","Triple Therapy","Sildenafil Dose Optimization","Randomized Clinical Trial","2026-07-28",{"date":218,"type":38},"2026-07-30",{"date":220,"type":23},"2026-07-22",{"date":222,"type":23},"2028-12-31",{"name":44,"class":45},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":24,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":46},"100649509","tris-contingency-management-app-for-alcohol-use-disorder-100649509","NCT07735585","TRIS: Contingency Management App for Alcohol Use Disorder","Remote Treatment With Incentives for Sobriety (TRIS): A Randomized Controlled Trial of a Contingency Management App for Alcohol Use Disorder","Inclusion Criteria:\n\n* Able to read and speak Portuguese.\n* Provide signed informed consent.\n* Age 18 to 70 years.\n* Alcohol consumption within the past month.\n* Current diagnosis of Alcohol Use Disorder (AUD).\n* Seeking treatment for AUD at AME Vila Maria or Instituto Perdizes.\n* Breath alcohol concentration (BrAC) of 0.00 at the time of consent.\n* Own and be able to operate a smartphone with an active mobile service plan.\n* Smartphone compatible with the Bluetooth frequency required for the BACtrack breathalyzer.\n\nExclusion Criteria:\n\n* Crack cocaine use within the past 90 days.\n* Any seizure episode within the past 12 months.\n* Diagnosis of a psychotic disorder (DSM-5).\n* Suicide attempt within the past two years.\n* Any medical or psychiatric condition that may compromise safe participation, as determined by the study medical director.","70 Years",{"count":233,"type":23},130,[26],"Alcohol Use Disorder (AUD) is a major public health concern associated with substantial morbidity, mortality, and impaired social and occupational functioning. Contingency Management (CM) is an evidence-based behavioral intervention that provides incentives contingent on abstinence and has demonstrated effectiveness in the treatment of substance use disorders. This study will evaluate the efficacy of Tratamento Remoto com Incentivos à Sobriedade (TRIS), a Brazilian mobile health application that integrates a smartphone app with a Bluetooth-enabled breathalyzer (BACtrack) to deliver remote CM for AUD. Participants will be randomized to receive either standard outpatient treatment plus TRIS-based CM or standard outpatient treatment with remote alcohol monitoring only. The primary objective is to determine whether TRIS-based CM increases biochemically verified alcohol abstinence compared with standard outpatient treatment alone.",[237],"Alcohol Use Disorder (AUD)",[239,240,241],"Alcohol Use Disorder","Contingency Management","Sobriety","2026-07-27",{"date":218,"type":38},{"date":245,"type":38},"2026-02-19",{"date":247,"type":23},"2027-12",{"name":44,"class":45},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":260,"conditions":261,"keywords":266,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100576555","impact-of-a-technology-platform-based-on-enhanced-recovery-aftereras-surgery-on-length-of-stay-after-coronary-artery-bypass-grafting-timely-project-100576555","NCT06786819","Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project","Estudo Randomizado de Cluster Escalonado Para Avaliar o Impacto de Uma Plataforma tecnológica Baseada no ERAS (Enhanced Recovery After Surgery) no Tempo de permanência após Cirurgia de revascularização miocárdica: Projeto Tempos Certos - REPLICCAR III","REPLICCARIII","Inclusion Criteria:\n\n* Adults over 18 years old\n* Indication for primary isolated CABG (elective or urgent status)\n* Own a personal cell phone\n* Have internet access\n* Knowledgeable in using the device\n* Full understanding and agreement regarding the informed consent form (ICF)\n\nExclusion Criteria:\n\n* Indication for associated surgery\n* Glycosylated hemoglobin level greater than 8%\n* Creatinine clearance less than 30 mL\u002Fmin\n* Pre-operative atrial fibrillation or use of pre-operative anticoagulation\n* Hemoglobin less than 12 g\u002FdL\n* Users of illicit drugs\n* STS score greater than 4%\n* Physical or mental disabilities that prevent adherence to the protocol\n* Refusal by the patient or family member",{"count":258,"type":23},480,[26],"Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.",[262,263,264,265],"ERAS","Cardiac Surgery","Cardiac Surgery-CABG","Digital Health",[263,267,268,262,265],"CABG","ERASCS","2026-07-21",{"date":271,"type":38},"2026-07-23",{"date":273,"type":38},"2025-03-10",{"date":275,"type":23},"2026-09-01",{"name":44,"class":45},2,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":24,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":46},"100611554","phase-4-influence-of-methotrexate-discontinuation-on-immunogenicity-after-pcv-20-vaccine-in-patients-ards-100611554","NCT07242092","Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs","Effect of Methotrexate Discontinuation on Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Patients With Autoimmune Rheumatic Diseases","MTX-PCV20-ARD","Inclusion Criteria:\n\n* Adults (\\>=18 years ) with confirmed ARD diagnosis (e.g., RA, PsA, axial SpA, primary Sjögren's, SLE, IIM, SSc, MCTD).\n* Stable MTX dose ≥12 weeks.\n* Prednisone ≤5 mg\u002Fday.\n* Low disease activity\u002Fremission according to specific disease activity criteria.\n* Eligible for PCV20 vaccination (no prior PCV20).\n\nExclusion Criteria:\n\n* Anaphylaxis to vaccine components.\n* Acute febrile illness.\n* Guillain-Barré, decompensated CHF (NYHA III-IV), demyelinating disease.\n* Live virus vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before.\n* Blood products in last 6 months.\n* Severe infection in last month (including pneumococcal).\n* Hospitalization at enrollment.\n* Refusal to participate or inability to complete study procedures.","100 Years",{"count":288,"type":23},192,[153],"This clinical trial aims to evaluate the effect of temporary methotrexate (MTX) discontinuation on the humoral immunogenicity of the 20-valent pneumococcal conjugate vaccine (PCV20) in adult patients with autoimmune rheumatic diseases (ARDs).\n\nKey questions:\n\n* Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity?\n* What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity?\n* What is the risk of disease flaring with MTX withdrawal?",[61],[293,294,295,296,297,70],"Pneumococcal Vaccine","Methotrexate","PCV20","Immunogenicity","Vaccination","2026-07-17",{"date":300,"type":38},"2026-07-20",{"date":302,"type":38},"2026-06-22",{"date":304,"type":23},"2028-12-30",{"name":44,"class":45},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":314,"sex":55,"minAge":149,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":24,"phases":318,"briefSummary":319,"conditions":320,"keywords":333,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":341,"locationsCount":277},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701","NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment",true,"59 Years",{"count":317,"type":23},477,[153],"The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[321,322,323,324,325,326,327,328,329,330,331,332],"Rheumatoid Arthritis (RA)","Juvenile Idiopathic Arthritis (JIA)","Systemic Lupus Erythematosus (SLE)","Juvenile Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathies (IIMs)","Axial Spondyloarthritis","Psoriatic Arthritis (PsA)","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[334,335,61,70,160,162,336],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Vaccine",{"date":300,"type":38},{"date":339,"type":38},"2026-03-16",{"date":304,"type":23},{"name":44,"class":45},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":55,"minAge":4,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":352,"phases":4,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":361,"leadSponsor":362,"locationsCount":4},"100646138","temozolomide-in-aggressive-pituitary-neuroendocrine-tumors-a-latin-american-multicenter-retrospective-cohort-tmz-latam-100646138","NCT07695844","Temozolomide in Aggressive Pituitary Neuroendocrine Tumors: A Latin American Multicenter Retrospective Cohort (TMZ-LATAM)","TEMPLA: TEMozolomide in Pituitary Tumors - Latin America - A Multicenter Retrospective Cohort of Temozolomide Therapy in Aggressive Pituitary Neuroendocrine Tumors and Pituitary Carcinomas","TEMPLA","Inclusion Criteria:\n\nHistologically confirmed pituitary neuroendocrine tumor (PitNET) meeting criteria for aggressive behavior (Knosp grade ≥3, radiological tumor growth \\>20% within 6 months, and\u002For progression despite optimized standard therapy including surgery and\u002For radiotherapy), OR histologically or clinically confirmed pituitary carcinoma (defined by the presence of craniospinal or systemic metastasis) Treatment with temozolomide, at any dose or duration, administered for the above indication Availability of pre-treatment and post-treatment imaging sufficient to assess radiological response Temozolomide treatment initiated within the defined study period\n\nExclusion Criteria:\n\nInsufficient clinical or imaging data to assess the primary outcome measure Temozolomide administered for an indication other than aggressive PitNET or pituitary carcinoma Loss to follow-up before any post-treatment imaging assessment",{"count":351,"type":23},80,"OBSERVATIONAL","Temozolomide is the main chemotherapy drug used for aggressive pituitary tumors and pituitary carcinomas that do not respond to standard treatments like surgery or radiation. Most of what is known about how well this treatment works comes from small studies in Europe and the United States, with very little data from Latin America. Building on a previous multicenter study conducted in Brazil, this study (TEMPLA) expands data collection to additional centers across Latin America to better understand how patients in this region respond to temozolomide, how long the treatment controls the tumor, and whether certain tumor characteristics (such as MGMT status) can help predict which patients are more likely to benefit.",[355],"Pituitary Neoplasms",[357],"Temozolomide; Aggressive Pituitary Tumor; Pituitary Carcinoma; PitNET; MGMT; Latin America; Retrospective Cohort; Multicenter Study","2026-07-04",{"date":40,"type":38},{"date":77,"type":23},{"date":222,"type":23},{"name":44,"class":45},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":352,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":46},"100593954","the-impact-of-era-switching-on-risk-stratification-in-pulmonary-arterial-hypertension-100593954","NCT07013149","The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension","ACTION - The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension","ACTION","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of pulmonary arterial hypertension (PAH) by right heart catheterization\n* Documented therapeutic switch from ambrisentan (10 mg once daily) to bosentan (125 mg twice daily) within the previous 6 months for the switch group\n* Treatment with ambrisentan for at least 6 months without switching to bosentan for the maintenance group\n\nExclusion Criteria:\n\n* History of severe hepatic impairment\n* Incomplete clinical or laboratory records that prevent risk score calculation\n* Inability to attend clinical follow-up between 3 and 6 months after medication switch",{"count":372,"type":23},183,"Pulmonary arterial hypertension (PAH) is a rare, progressive, and potentially life-threatening disease characterized by pulmonary vascular remodeling, increased pulmonary vascular resistance, and right ventricular dysfunction. The endothelin pathway plays a central role in its pathophysiology and is targeted by endothelin receptor antagonists (ERAs), including ambrisentan and bosentan.\n\nAmbrisentan is a selective ETA receptor antagonist, whereas bosentan blocks both ETA and ETB receptors. Although transitions between ERAs occur in clinical practice, evidence regarding the clinical impact of switching from ambrisentan to bosentan remains limited.\n\nACTION is a retrospective, observational, single-center cohort study evaluating adult patients with pulmonary arterial hypertension (World Health Organization Group 1) and\u002For chronic thromboembolic pulmonary hypertension (World Health Organization Group 4) confirmed by right heart catheterization. Patients who switched from ambrisentan to bosentan because of a national ambrisentan shortage will be compared with clinically similar patients who remained on ambrisentan.\n\nClinical, functional, and laboratory data recorded at baseline and at 3 to 6 months of follow-up will be assessed. The primary outcome is the proportion of patients with worsening risk stratification after switching from ambrisentan to bosentan compared with patients who continued ambrisentan. Risk will be evaluated using the COMPERA 2.0 and REVEAL Lite 2 assessment tools.\n\nSecondary outcomes include changes in World Health Organization\u002FNew York Heart Association functional class, 6-minute walk distance, BNP levels, individual risk-assessment components, hepatic enzymes, hemoglobin levels, and clinically relevant events such as hospitalization, emergency department visits, initiation of supplemental oxygen, and right heart failure decompensation.",[211,209,375],"Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)",[211,377,378,379,380,381,382,383],"PAH","Endothelin Receptor Antagonists","ERA","Ambrisentan","Bosentan","Drug Switching","Risk Stratification","2026-07-01",{"date":386,"type":38},"2026-07-06",{"date":388,"type":38},"2025-08-20",{"date":390,"type":23},"2026-12-01",{"name":44,"class":45},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":231,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":400,"briefSummary":401,"conditions":402,"keywords":405,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":46},"100548836","effect-of-resistance-training-in-patients-on-the-waiting-list-for-heart-transplant-100548836","NCT06426173","Effect of Resistance Training in Patients on the Waiting List for Heart Transplant","Effect of Resistance Training on Functional Capacity, Quality of Life and Cardiac Biomarkers in Patients on the Waiting List for Heart Transplant: a Randomized and Controlled Clinical Trial","Inclusion Criteria:\n\n* patients included in heart transplant list ≤1 month\n* hemodynamically stable in the last 48 hours defined as mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg and - Heart rate (HR) ≥ 60 bpm and ≤ 120 mmHg.\n* dobutamine dose ≤ 10 mcg\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* heart failure of arrhythmogenic and\u002For restrictive etiology\n* presence of uncontrolled acute arrhythmias\n* cognitive, orthopedic, or neuromotor changes that prevent functional tests from being carried out",{"count":22,"type":23},[26],"The present longitudinal, randomized, and blinded clinical trial aims to:\n\n* Evaluate the effects of resistance training on the functional capacity, quality of life, and cardiac biomarkers of hospitalized patients with heart failure (HF) on the waiting list for heart transplantation (HTx).\n* Evaluate the associations between Fried's frailty classification and functional capacity responses to resistance training.\n\nThe protocol will have a total duration of 12 weeks.",[403,404],"Heart Failure","Heart Transplant",[406,407,408],"heart failure","resistance training","cardiac rehabilitation","2026-06-18",{"date":302,"type":38},{"date":412,"type":38},"2024-06-18",{"date":414,"type":23},"2027-06-30",{"name":44,"class":45},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":24,"phases":425,"briefSummary":426,"conditions":427,"keywords":430,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":437,"leadSponsor":439,"locationsCount":46},"100540400","isolated-resistance-training-and-neuromuscular-electrical-stimulation-in-patients-with-femoral-intra-aortic-balloon-pump-100540400","NCT06316349","Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.","Isolated Resistance Training Program Versus Combined With Neuromuscular Electrical Stimulation for Femoral Quadriceps in Patients With Femoral Intra Aortic Balloon Pump: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Intra-aortic balloon pump (IABP) for more than 48 hours\n* Dobutamine ≤ 20 mcg\u002Fkg\u002Fmin\n* Norepinephrine ≤ 0.2 mcg\u002Fkg\u002Fmin (35)\n* Absence of device failures or bleeding in the last 24 hours\n* Mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg\n* Heart rate (HR) ≥ 60 bpm and ≤ 120 bpm\n* Absence of neurological event with previous cognitive or motor deficit\n* Presence of untreated deep venous thrombosis\n* Absence of previous autoimmune diseases\n* Absence of previous rheumatic diseases\n\nProtocol Discontinuation Criteria:\n\n* Need for norepinephrine \\> 0.2 mcg\u002Fkg\u002Fmin\n* Acute arrhythmia of any etiology with hemodynamic instability\n* Hemodynamic instability: MAP \\\u003C 60 mmHg or \\>120 mmHg or HR \\\u003C 60 bpm or \\> 120 bpm\n* Occurrence of neurological event with cognitive or motor deficit\n\nExclusion Criteria:\n\n* Need for invasive mechanical ventilatory support\n* If the patient or responsible family member fails to sign or withdraws the informed consent",{"count":424,"type":23},60,[26],"The objective of this randomized clinical trial is to compare the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation in patients undergoing heart failure . The main questions it aims to answer are:\n\n* Assessing the ultrasonographic parameters: echo intensity (echogenicity), cross-sectional area, thickness, and pennation angle of the rectus femoris muscle in both lower limbs.\n* Evaluating the strength of the femoral quadriceps muscle\n* Evaluating the changes in the chronaxie of the rectus femoris muscle in both lower limbs.\n\nThe protocol will have a total duration of 32 days, with an initial intervention period of 18 days, followed by a 14-day follow-up period.",[403,428,429],"Physical Therapy","Neuromuscular Electrical Stimulation",[403,431,432,429,433],"Intra-Aortic Ballom Pump","Acquired Muscle Weakness","Muscular echo intensity",{"date":435,"type":38},"2026-06-23",{"date":412,"type":38},{"date":438,"type":23},"2027-05-30",{"name":44,"class":45},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":352,"phases":4,"briefSummary":448,"conditions":449,"keywords":453,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":46},"100538135","frailty-physical-capacity-and-lung-function-in-postoperative-pulmonary-endarterectomy-patients-100538135","NCT06286891","Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients","Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Both genders\n* Elective pulmonary endarterectomy surgery\n* Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.\n\nExclusion Criteria:\n\n* Reoperation for any reason\n* Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.",{"count":22,"type":23},"The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).",[450,451,452],"Chronic Thromboembolic Pulmonary Hypertension","Physical Disability","Fragility",[454,455,456,457,458,459],"Pulmonary Endarterectomy Surgery","Six-minute walk test","Short Physical Performance Battery","One-minute sit-to-stand test","Muscular strength","Spirometry",{"date":302,"type":38},{"date":462,"type":38},"2024-02-29",{"date":464,"type":23},"2026-11-30",{"name":44,"class":45},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":24,"phases":475,"briefSummary":477,"conditions":478,"keywords":482,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":46},"100642041","phase-2-sbrt-lattice-pathy-100642041","NCT07645261","SBRT-LATTICE-PATHY","Impact of Partial Stereotactic Body Radiotherapy in Hypoxic Segments of Large-volume Unresectable Tumors (SBRT-LATTICE-PATHY) - a Prospective Phase II Study.","Inclusion Criteria:\n\n* age =or\\> 18 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2; benign and malignant tumors for which the use of radiotherapy is well established in the literature;\n* tumors =or\\> 340 cm³ or with a largest diameter =or\\> 7 cm;\n* no indication for any other type of treatment due to lack of proven clinical benefit (surgery, chemotherapy, standard radiotherapy, immunotherapy, targeted therapy, etc.);\n* Palliative Prognostic Index (PPI) =or\\\u003C 2;\n* metastatic disease in the central nervous system (CNS), if present, controlled (up to 3 metastases, each up to 1 cm);\n* up to 5 extracranial distant metastases (nodal or extranodal) =or\\\u003C 5 cm; signed Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* cases in which tumor volume and\u002For the patient's clinical condition make adequate immobilization\u002Fsimulation impossible;\n* previous local radiotherapy;\n* pregnant patients;\n* autoimmune diseases;\n* genetic instability syndromes;\n* ongoing systemic therapy;\n* renal insufficiency that prevents the use of iodinated contrast.",{"count":474,"type":23},20,[476],"PHASE2","To assess the importance of using SBRT-LATTICE-PATHY for the radiotherapy treatment of large tumors that would be considered intractable by currently used standard techniques. In this present study, the investigators will have the possibility of combining SBRT and LATTICE techniques, incorporating the concept of hypoxic tissue irradiation, which are potential modulators of abscopal and bystander effects, performing partial punctual treatment in the vertex region, without the need for irradiation of the entire tissue volume, further improving safety in relation to possible toxicities.",[479,480,481],"Cancer (Advanced Stage)","Cancer (Solid Tumors)","Tumor",[483,484,485,486],"SBRT","LATTICE","partial irradiation","large volume tumors","2026-06-08",{"date":489,"type":38},"2026-06-12",{"date":491,"type":38},"2026-04-28",{"date":493,"type":23},"2027-12-31",{"name":44,"class":45},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":24,"phases":504,"briefSummary":505,"conditions":506,"keywords":510,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":4},"100643358","effect-of-discarding-initial-reperfusion-blood-on-hemodynamics-liver-function-and-30-day-outcomes-in-liver-transplantation-100643358","NCT07631689","Effect of Discarding Initial Reperfusion Blood on Hemodynamics, Liver Function, and 30-Day Outcomes in Liver Transplantation","Assessment of the Impact of Discarding the Initial Reperfusion Blood on Early Liver Function, Cardiovascular and Metabolic Changes and on 30-Day Liver and Renal Outcomes. A Prospective Randomized Trial in Liver Transplantation","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Candidates for liver transplantation at Hospital das Clínicas, University of São Paulo Medical School (HCFMUSP)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Previous liver surgery\n* Fulminant hepatitis\n* Specific liver diseases associated with severe electrolyte disturbances\n* End-stage renal disease requiring dialysis\n* Combined organ transplantation\n* Living donor liver transplantation\n* Liver retransplantation\n* Highly sensitized patients with limited availability of blood products\n* Hematologic diseases\n* Portal vein thrombosis involving more than 50% of the lumen\n* Portopulmonary hypertension (mean pulmonary artery pressure \\> 20 mmHg), diagnosed preoperatively or intraoperatively",{"count":503,"type":23},132,[26],"Hepatic reperfusion during liver transplantation remains a critical phase associated with significant hemodynamic and systemic disturbances, despite advances in surgical and anesthetic management. This phase is characterized by the release of acidotic, hypothermic, and hyperkalemic blood containing metabolic byproducts and inflammatory mediators resulting from ischemia-reperfusion injury.\n\nClinically, reperfusion is associated with hemodynamic instability, including reductions in cardiac output and arterial pressure, as well as cardiac dysfunction and arrhythmias, often requiring pharmacologic support. These alterations may affect not only immediate intraoperative stability but also short- and long-term outcomes for both the patient and the graft.\n\nThe abrupt restoration of blood flow to the transplanted liver leads to the systemic release of accumulated metabolites, reactive oxygen species, and inflammatory mediators, contributing to a systemic inflammatory response that may impact distant organs, including the kidneys and heart.\n\nSeveral revascularization strategies have been investigated to mitigate reperfusion-related injury: initial reperfusion via the portal vein, initial reperfusion through the hepatic artery, and simultaneous reperfusion through the portal vein and hepatic artery.\n\nA less frequently used and insufficiently studied strategy, not routinely or systematically implemented, involves diverting the initial reperfusion blood from the graft to the surgical field, followed by the restoration of hepatic blood outflow to the systemic circulation.\n\nThis study hypothesizes that discarding the initial reperfusion blood via the infrahepatic vena cava will attenuate early hemodynamic, metabolic, and inflammatory changes and reduce postoperative complications compared to conventional reperfusion techniques.",[507,508,509],"Liver Transplantation","Ischaemia Reperfusion Injury","Perioperative Complications",[511,512,513,514,515,516,517],"liver transplantation","ischemia-reperfusion injury","liver graft function","anesthesia","inflamatory response","perioperative complications","hemodynamics","2026-06-03",{"date":487,"type":38},{"date":521,"type":23},"2026-07",{"date":523,"type":23},"2028-02",{"name":44,"class":45},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":24,"phases":535,"briefSummary":536,"conditions":537,"keywords":540,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":46},"100638137","hypothermic-machine-perfusion-for-liver-graft-preservation-100638137","NCT07595627","Hypothermic Machine Perfusion for Liver Graft Preservation","Prospective and Randomized Clinical Study of the Effect of Hypothermic Machine Perfusion on Liver Graft Preservation","HOPE-Liver","Donor-related inclusion criteria:\n\n* Liver donors with confirmed diagnosis of brain death.\n* Extended criteria donors (ECD).\n* Age ≥18 years.\n* Family consent for organ donation obtained.\n* Negative serology for HTLV, HIV, Chagas disease, and hepatitis B and C.\n\nRecipient-related inclusion criteria:\n\n* Adult patients (≥18 years) undergoing liver transplantation.\n* Diagnosis of end-stage liver disease or indication for liver transplantation.\n* Candidates for primary liver transplantation.\n* Ability to understand and provide written informed consen\n\nDonor-related exclusion criteria:\n\n* Presence of moderate or severe hepatic steatosis.\n* Pediatric donors.\n* Donors classified as ideal, defined by the simultaneous presence of all of the following criteria: Age \\\u003C35 years, Body mass index (BMI) \\\u003C28 kg\u002Fm², No history of cardiopulmonary resuscitation, Norepinephrine requirement \\\u003C0.5 µg\u002Fkg\u002Fmin, Liver enzymes (AST or ALT) ≥2 times the upper limit of normal, Intensive care unit stay ≤7 days\n\nRecipient-related exclusion criteria:\n\n* Complex portal vein thrombosis (grade III or IV).\n* Combined or dual organ transplantation.\n* Retransplantation.\n* Acute liver failure.\n* MELD score \\>30.\n* History of multiple prior liver or biliary surgeries.",{"count":534,"type":23},40,[26],"The goal of this clinical trial is to evaluate whether hypothermic machine perfusion improves liver graft preservation and post-transplant outcomes compared to conventional static cold storage in adult patients undergoing liver transplantation. This study focuses on liver grafts from deceased donors, including those with extended criteria, which are more susceptible to ischemia-reperfusion injury and early graft dysfunction.\n\nThe main questions it aims to answer are:\n\nDoes hypothermic machine perfusion reduce ischemia-reperfusion injury and improve early graft function after liver transplantation? Does this preservation strategy improve clinical outcomes, including graft survival, complication rates, and post-transplant recovery, compared to static cold storage?\n\nResearchers will compare hypothermic machine perfusion (ex situ, oxygenated perfusion at low temperature) to standard static cold storage to assess differences in graft preservation quality and post-transplant outcomes.\n\nParticipants will:\n\nReceive a liver graft preserved either by hypothermic machine perfusion or static cold storage, according to a 1:1 randomization protocol Undergo standard liver transplantation procedures Be followed after transplantation with clinical, laboratory, imaging, and biomarker assessments at predefined time points (7 days, 30 days, 6 months, and 1 year)\n\nAdditional evaluations will include biochemical markers of liver function, inflammatory and immunological mediators, mitochondrial function assessment, and histological analysis to better characterize graft injury and recovery.",[538,539],"Liver Transplant","Liver Failure",[541,507,542,543,544],"Hypothermic Machine Perfusion","Ischemia-Reperfusion Injury","Ex Vivo Liver Perfusion","Extended Criteria Donors","2026-05-14",{"date":547,"type":38},"2026-05-19",{"date":549,"type":23},"2026-05-07",{"date":551,"type":23},"2028-05-07",{"name":44,"class":45},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":24,"phases":561,"briefSummary":562,"conditions":563,"keywords":566,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":46},"100637098","assessment-of-pulmonary-perfusion-and-hemodynamic-measurements-by-electrical-impedance-tomography-in-patients-undergoing-pulmonary-thromboendarterectomy-100637098","NCT07577700","Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.","Inclusion Criteria:\n\n\\- Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) followed at the Pulmonology Service of InCor-HCFMUSP and scheduled for pulmonary thromboendarterectomy at InCor-FMUSP.\n\nExclusion Criteria:\n\n* Age under 18 years\n* Pregnancy\n* Structural heart disease (atrial septal defect, ventricular septal defect, or valvular heart disease)\n* Cardiac arrhythmias\n* Use of a cardiac pacemaker or other implantable electronic device\n* Skin lesions on the thoracic region at the site of EIT electrode belt placement\n* Absence of central venous access on the day of the preoperative protocol evaluation\n* Difficulty understanding the procedures to be performed\n* Refusal to participate in the study (non-signing of the Informed Consent Form)\n* Refusal by the attending medical team",{"count":560,"type":23},36,[26],"Chronic thromboembolic pulmonary hypertension (CTEPH) is a condition in which old blood clots block the blood vessels in the lungs, making it harder for the heart to pump blood through the lungs. Surgery called pulmonary thromboendarterectomy can remove these clots and improve blood flow, but doctors need reliable ways to evaluate lung blood flow before and after surgery.\n\nThis study will evaluate a bedside imaging method called electrical impedance tomography (EIT), which can measure how blood flows through different regions of the lungs without radiation or invasive procedures. Patients undergoing surgery for CTEPH will be monitored with EIT before and after surgery, and the results will be compared with standard lung perfusion imaging.\n\nThe goal of this study is to determine whether EIT can provide useful information about lung blood flow and changes after surgery, and whether it could serve as a complementary bedside tool to help monitor patients with CTEPH.",[564,565],"Pulmonary Thromboendarterectomy","Pulmonary Embolism and Thrombosis",[567,568,569,570],"Pulmonary Perfusion","Electrical Impedance Tomography (EIT)","Cardiac Output","Resistência Vascular Pulmonar","2026-05-04",{"date":573,"type":38},"2026-05-11",{"date":575,"type":38},"2025-02-25",{"date":577,"type":23},"2026-12",{"name":44,"class":45},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":586,"minAge":4,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":24,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":46},"100630575","screening-for-dysglycemia-during-postpartum-period-in-women-with-gdm-100630575","NCT07489456","Screening for Dysglycemia During Postpartum Period in Women With GDM","Strategies for Improving the Detection of Dysglycemia in the Postpartum Period in Women With Gestational Diabetes: Electronic Reminders and New Diagnostic Criteria","Inclusion Criteria:\n\n* Diagnosis of gestational diabetes mellitus, according to diagnostic criteria proposed by the IADPSG, namely:\n* initial fasting blood glucose ≥ 92mg\u002FdL OR\n* 75g oral glucose tolerance test with fasting ≥ 92mg\u002FdL or after 1h ≥ 180mg\u002FdL or after 2h ≥ 153mg\u002FdL Delivery performed at HC-FMUSP Scheduling of the 75g oral glucose tolerance test between 6 and 12 weeks after delivery Agreement with the informed consent form\n\nExclusion Criteria:\n\nWithdrawal of consent Failure to complete the TOTG exam due to vomiting (exclusion from analysis 2 only)","FEMALE",{"count":588,"type":23},182,[26],"Gestational diabetes mellitus (GDM) is one of the most common clinical conditions in pregnancy, with an increasing incidence due to the rise in overweight women and the postponement of motherhood. It is associated with perinatal complications and an increased risk of developing prediabetes and type 2 diabetes after delivery. Therefore, it is recommended that a 75g oral glucose tolerance test (OGTT-75g) be performed between 6 and 12 weeks postpartum. Despite its relevance, the rate of adherence to the test is low. Recent studies also indicate that measuring blood glucose one hour after the overload may be more sensitive than the traditional two-hour measurement in the early detection of dysglycemia. This study aims to evaluate strategies for qualifying the screening of metabolic changes in the postpartum period among women with GDM. The objectives are: (1) to analyze the impact of sending reminders via WhatsApp on the attendance rate for the 75g OGTT; and (2) to compare the frequency of prediabetes and diabetes diagnoses using two different diagnostic strategies applied to the same test-the traditional (fasting and 2-hour blood glucose) and the alternative (fasting and 1-hour blood glucose).",[592],"Gestational Diabetes Mellitus (GDM)",[594,595,596,597,598],"dysglycemia","gestational diabetes","prediabetes","diabetes","postpartum OGTT","2026-04-27",{"date":571,"type":38},{"date":602,"type":38},"2026-03-24",{"date":604,"type":23},"2026-11",{"name":44,"class":45},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":314,"sex":55,"minAge":614,"maxAge":615,"enrollmentInfo":616,"targetDuration":4,"studyType":24,"phases":618,"briefSummary":619,"conditions":620,"keywords":622,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":628,"leadSponsor":630,"locationsCount":277},"100612378","phase-4-immunogenicity-and-safety-of-menb-vaccine-in-pediatric-patients-with-autoimmune-rheumatic-diseases-100612378","NCT07252804","Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases","Short- and Long-Term Immunogenicity and Safety of Meningococcal Group B Vaccine in Children and Adolescents With Autoimmune Rheumatic Diseases","MENB-PARD","Inclusion Criteria:\n\n* Participants must be between 2 and 25 years of age with no prior history of MenB-4C vaccination.\n* Patients classified with autoimmune rheumatic diseases will be invited to participate.\n\nPatients with JIA must meet the classification criteria of the International League of Associations for Rheumatology; patients with JSLE, the American College of Rheumatology criteria; and those with JDM, the Bohan \\& Peter criteria.\n\nExclusion Criteria:\n\n* History of any reaction or hypersensitivity to any vaccine component;\n* Acute infectious disease and\u002For fever at the time of vaccination;\n* Pregnancy or breastfeeding;\n* History of Guillain-Barré syndrome;\n* Participants who fail to attend evaluation visits and laboratory sample collection; hospitalization at study inclusion;\n* Transfusion of blood products within 6 months prior to the study;\n* Application of any vaccine within one month prior to each dose.","2 Years","25 Years",{"count":617,"type":23},263,[153],"The goal of this clinical trial is to evaluate the humoral immunogenicity of the meningococcal B vaccine (MenB-4C) in pediatric patients with autoimmune rheumatic diseases (ARDs), compared to age- and sex-matched non-immunosuppressed controls.\n\nThe main questions it aims to answer are:\n\n* To assess the influence of treatment on the response to the MenB-4C vaccine in patients with ARDs;\n* To evaluate the impact of the MenB-4C vaccine on disease activity in patients with ARDs;\n* To evaluate the safety of the MenB-4C vaccine in pediatric patients with ARDs and controls.\n* To evaluate the association between physical activity levels and immunogenicity after vaccination.\n\nParticipants will:\n\nReceive the MenB-4C vaccine (Bexsero©), administered intramuscularly in the deltoid muscle, in a 2-dose schedule (0.5 mL each), 1 month apart.\n\nAll participants will have blood samples collected immediately before vaccination at the baseline visit (D0), then receive the first vaccine dose on the same day (D0). The second dose will be administered 4 weeks after the first dose (D28). Blood samples will be collected on D0, D28, and D56. A final sample will be collected one year after the last dose (D208) to evaluate the persistence of immune response.\n\nAt study entry and one month after each dose, patients will also be assessed for clinical and laboratory disease activity using disease-specific indices and scores.\n\n* Juvenile Systemic lupus erythematosus (JSLE): Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) (CBC, anti-dsDNA, complement, urinalysis, protein\u002Fcreatinine ratio)\n* Juvenile Idiopatic Arthritis (JIA): Juvenile Arthritis Disease Activity Score (JADAS) (ESR, CRP)\n* Juvenile dermatomyositis (JDM): Manual Muscle Testing (MMT) e Childhood Myositis Assessment Scale (CMAS): (CPK, transaminases, LDH)\n\nResearcher will also perform analysis in:\n\nHumoral immunogenicity will be assessed using serum bactericidal activity (SBA) assay with exogenous complement (baby rabbit, Pel Freez) against four test strains: H44\u002F76 (fHBP), 5\u002F99 (NadA), NZ98\u002F254 (PorA), and M10713 (NHBA), from blood samples collected at D0, D28, D56, and D208. SBA assays will be conducted at the Immunology Center of the Adolfo Lutz Institute, São Paulo. Exogenous complement will be added to serially diluted serum samples, followed by the addition of a bacterial suspension. The humoral response rate induced by the vaccine, or seroconversion, will be defined by the bactericidal titer (the dilution that results in 50% bacterial killing within 60 minutes compared to the control), with titers ≥ 1:4 considered bactericidal. The geometric mean titers will be calculated using the exponential of the mean of the log-transformed concentrations.\n\nImmunosuppressive treatments (NSAIDs, prednisone\u002Fprednisolone, intra-articular steroids, hydroxychloroquine, methotrexate, azathioprine, leflunomide, cyclosporine, tacrolimus, mycophenolate mofetil, and biologics \\[anti-TNF, tocilizumab, abatacept, belimumab, rituximab\\]) will be recorded sistematicaly.\n\nPhysical activity levels will be assessed using validated, age-appropriate methods.",[621],"Autoimmune Rheumatologic Disease",[623,61,70,160,162],"Meningococcal B vaccine","2026-04-14",{"date":626,"type":38},"2026-04-20",{"date":245,"type":38},{"date":629,"type":23},"2027-12-30",{"name":44,"class":45},{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":314,"sex":55,"minAge":89,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":24,"phases":640,"briefSummary":641,"conditions":642,"keywords":645,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":46},"100508962","effects-of-focal-extracorporeal-shock-wave-therapy-in-the-treatment-of-temporomandibular-disorders-of-muscular-origin-100508962","NCT05907239","Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin","Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin: a Randomized, Double-blind, Controlled Clinical Trial","Inclusion Criteria:\n\n* Pain in the temporomandibular region;\n* Myofascial pain diagnosed with or without limitation of mouth opening based on the Diagnostic Criteria for TMD (DC\u002FTMD);\n* Myofascial pain associated or not with joint abnormalities;\n* Presence of moderate to severe pain: Visual Analogue Scale (VAS) \\>4;\n* Duration of TMD pain (temporomandibular musculoskeletal) ≥3 months;\n* Written granting of the informed consent form to participate in the study\n\nExclusion Criteria:\n\n* Abnormality in blood clotting (coagulopathy) or using some type of anticoagulant;\n* Primary malignant disease (tumors) in the treatment area;\n* Acute infection of soft tissue or bone;\n* Systemic infections;\n* Epilepsy;\n* Infiltration of corticosteroids at the application site in the last 6 weeks;\n* Patient at high risk of some type of anesthesia or analgesia when it eventually has to be used;\n* Polyarthritis;\n* Polytrauma Local joint infections;\n* Previous temporomandibular surgical treatments that compromise mastication;\n* Treatment by physiotherapy, acupuncture before 3 months of performing the procedures\n* Depression or other mental disorders;\n* Clinical diagnosis of associated fibromyalgia;\n* Associated systemic inflammatory rheumatic diseases;\n* Widespread pain or pain elsewhere that predominates and overlaps with TMD muscle pain;\n* Inability to understand the treatment protocol.",{"count":639,"type":23},100,[26],"The objective of the study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in improving pain in patients with TMD pain after 5 weeks of treatment, 1 month and 3 months after the end of treatment. As secondary objectives, we plan to evaluate the effectiveness of focal shockwave therapy in relation to:\n\n1. Range of motion (ROM) of the temporomandibular joint using goniometry after 5 weeks of treatment;\n2. Degree of inflammation, using ultrasound evaluation in the temporomandibular joint relating to the degree of pain after focal shockwave therapy for 5 weeks;\n3. Jaw movement (MM), joint noise (RA), joint pressure (PA) and disability index (DI) will be measured at each treatment session and after 5 weeks of treatment, 1 month and 3 months after the end of treatment in the affected joints;\n4. Quality of life will be assessed using the \"Short Form Health 36\" questionnaire (SF-36) during the 5 weeks of treatment, 1 month and 3 months after the end of treatment;\n5. Pain control medication will also be considered and compared before and after the proposed treatment for 5 weeks.\n\nSafety will be assessed throughout the study by monitoring the incidence of study-related adverse events. All patients will be contacted periodically and encouraged to report any side effects.",[643,644],"Temporomandibular Joint Disorders","Extracorporeal Shockwave Therapy",[643,644,646,647,648],"Temporomandibular Joint Dysfunction Syndrome","High-Energy Shock Waves","Pain Management","2026-03-20",{"date":651,"type":38},"2026-03-25",{"date":653,"type":38},"2023-04-20",{"date":655,"type":23},"2029-06-25",{"name":44,"class":45},{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":314,"sex":55,"minAge":665,"maxAge":666,"enrollmentInfo":667,"targetDuration":4,"studyType":24,"phases":669,"briefSummary":670,"conditions":671,"keywords":676,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":687,"locationsCount":46},"100619946","pediatric-airway-noninferiority-trial-of-devices-for-intubation-assessment-100619946","NCT07351227","Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment","Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and Besdata Videolaryngoscopes in the Orotracheal Intubation of Children: A Non-Inferiority Randomized Clinical Trial","PANDA","Inclusion Criteria:\n\n* The study will include children aged between 6 months and 3 years who are scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança - ICr) of the Hospital das Clínicas Complex, University of São Paulo Medical School (HC-FMUSP), provided that informed consent is obtained from their parents or legal guardians.\n\nExclusion Criteria:\n\n* Patients under one year of age will be excluded if informed consent is not obtained from their legal guardians, if they are classified as ASA physical status IV or higher, present with hemodynamic instability, or have craniofacial abnormalities or oral deformities suggestive of a potentially difficult airway.","6 Months","3 Years",{"count":668,"type":23},226,[26],"The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device.\n\nThe main questions this study aims to answer are:\n\nIs the BESDATA BD-DF videolaryngoscope as effective as the McGRATH™ MAC videolaryngoscope for successful placement of a breathing tube on the first attempt in infants?\n\nAre there differences between the two devices in terms of procedure time, number of attempts, airway-related complications, and overall costs?\n\nResearchers will compare infants who are intubated using the BESDATA BD-DF videolaryngoscope with infants who are intubated using the McGRATH™ MAC videolaryngoscope to see whether the two devices perform similarly and whether one is more cost-effective than the other.\n\nParticipants will:\n\nBe randomly assigned to have a breathing tube placed using one of the two videolaryngoscopes;\n\nReceive standard general anesthesia for an elective surgical procedure;\n\nHave information collected during and after the procedure to assess safety, effectiveness, and costs.",[672,673,674,675],"Intubation, Intratracheal","Airway Management","Video Laryngoscope","Cost Effectiveness",[677,678,679,680,681],"Videolaryngoscope","Pediatric orotracheal intubation","Cost effectiveness","McGrath MAC","BESDATA","2026-03-18",{"date":649,"type":38},{"date":685,"type":38},"2026-03-01",{"date":493,"type":23},{"name":44,"class":45},{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":694,"eligibilityCriteria":695,"healthyVolunteers":12,"sex":55,"minAge":89,"maxAge":696,"enrollmentInfo":697,"targetDuration":4,"studyType":24,"phases":698,"briefSummary":700,"conditions":701,"keywords":703,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":705,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":4},"100630167","phase-1-motor-and-non-motor-effects-of-low-intensity-focused-ultrasound-lifu-as-a-neuromodulation-tool-in-essential-tremor-100630167","NCT07484152","Motor and Non-Motor Effects of Low-Intensity Focused Ultrasound (LIFU) as a Neuromodulation Tool in Essential Tremor","Motor and Non-Motor Effects of Low-Intensity Focused Ultrasound (LIFU) as a Neuromodulation Tool in Movement Disorders: A Randomized, Double-Blind, Sham-Controlled, Crossover Clinical Trial in Essential Tremor","LIFU-ET","Inclusion Criteria:\n\n1. Diagnosis of essencial Tremor.\n2. Presence of clinically relevant tremor despite optimized pharmacological treatment.3. Age 18-80 years.4. Ability and willingness to provide written informed consent.5. Availability to attend all scheduled study visits at HC-FMUSP.6. Availability of a brain MRI suitable for neuronavigation planning\n\nExclusion Criteria:\n\n\\- 1. Dementia syndrome or severe cognitive impairment precluding informed consent or reliable clinical assessment.\n\n2\\. Uncontrolled psychiatric disorders.3. Alcohol or illicit substance dependence.4. Use of stimulants or medications that lower seizure threshold.5. History of epileptic seizures within the last 6 months.6. Hospitalization or surgery within the last 6 months.7. Presence of implanted metallic or electronic devices in the cranium or spine that are contraindicated for focused ultrasound procedures (e.g., deep brain stimulator, cochlear implant, cardiac pacemaker, metal plates or wires).8. History of brain surgery or traumatic brain injury.9. Skull defects, craniotomy, or significant calvarial irregularities that preclude safe ultrasound delivery.10. Pregnancy or breastfeeding.11. Social impossibility of follow-up attendance.","80 Years",{"count":474,"type":23},[699,476],"PHASE1","This study investigates the motor and non-motor effects of Low-Intensity Focused Ultrasound (LIFU) as a non-invasive neuromodulation technique in patients with essential tremor (ET) and refractory tremor. LIFU is a non-thermal, non-ablative form of transcranial focused ultrasound that modulates neural activity through mechanical mechanisms, including direct effects on neuronal membranes, alterations in membrane excitability, and modulation of synaptic transmission. Unlike high-intensity focused ultrasound (HIFU), which produces tissue ablation, LIFU induces reversible effects with a favorable safety profile, making it a promising candidate for non-invasive neuromodulation in movement disorders.\n\nIn this randomized, double-blind, sham-controlled, crossover trial, 20 patients with ET and refractory tremor will receive active LIFU targeting the ventral intermediate nucleus (VIM) of the thalamus and sham stimulation in separate sessions, separated by a washout period of at least 12 weeks. Clinical assessments using standardized and validated neurological scales will be performed before and after each session to evaluate changes in motor symptoms, tremor severity, quality of life, and non-motor features.\n\nThe primary outcome is the change in the Fahn-Tolosa-Marín Tremor Rating Scale (FTMTRS) and the Essential Tremor Rating Assessment Scale (TETRAS©). Secondary outcomes include the Patient Global Impression of Change (PGIC) and monitoring of adverse events.\n\nThis study is being conducted at the Movement Disorders Center of Hospital das Clínicas, University of São Paulo (HC-FMUSP), São Paulo, Brazil, and has been approved by the institutional ethics committee (CAPPesq; approval number 7.406.027).",[702],"Essential Tremor (ET)",[704],"essential tremor",{"date":706,"type":38},"2026-03-19",{"date":708,"type":23},"2026-03-17",{"date":710,"type":23},"2028-12-10",{"name":44,"class":45},""]