[{"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:":703},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,47,74,98,127,158,186,212,239,268,298,335,361,386,417,440,468,499,525,549,575,598,627,648,679],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100548836","effect-of-resistance-training-in-patients-on-the-waiting-list-for-heart-transplant-100548836",false,"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","ALL","18 Years","70 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29],"Heart Failure","Heart Transplant",[31,32,33],"heart failure","resistance training","cardiac rehabilitation","RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2024-06-18",{"date":42,"type":22},"2027-06-30",{"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":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"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":21,"type":22},"OBSERVATIONAL","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).",[58,59,60],"Chronic Thromboembolic Pulmonary Hypertension","Physical Disability","Fragility",[62,63,64,65,66,67],"Pulmonary Endarterectomy Surgery","Six-minute walk test","Short Physical Performance Battery","One-minute sit-to-stand test","Muscular strength","Spirometry",{"date":37,"type":38},{"date":70,"type":38},"2024-02-29",{"date":72,"type":22},"2026-11-30",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"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":82,"type":22},60,[25],"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.",[28,86,87],"Physical Therapy","Neuromuscular Electrical Stimulation",[28,89,90,87,91],"Intra-Aortic Ballom Pump","Acquired Muscle Weakness","Muscular echo intensity",{"date":93,"type":38},"2026-06-23",{"date":40,"type":38},{"date":96,"type":22},"2027-05-30",{"name":44,"class":45},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"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":106,"type":22},20,[108],"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.",[111,112,113],"Cancer (Advanced Stage)","Cancer (Solid Tumors)","Tumor",[115,116,117,118],"SBRT","LATTICE","partial irradiation","large volume tumors","2026-06-08",{"date":121,"type":38},"2026-06-12",{"date":123,"type":38},"2026-04-28",{"date":125,"type":22},"2027-12-31",{"name":44,"class":45},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"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":135,"type":22},132,[25],"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.",[139,140,141],"Liver Transplantation","Ischaemia Reperfusion Injury","Perioperative Complications",[143,144,145,146,147,148,149],"liver transplantation","ischemia-reperfusion injury","liver graft function","anesthesia","inflamatory response","perioperative complications","hemodynamics","NOT_YET_RECRUITING","2026-06-03",{"date":119,"type":38},{"date":154,"type":22},"2026-07",{"date":156,"type":22},"2028-02",{"name":44,"class":45},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"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":167,"type":22},40,[25],"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.",[171,172],"Liver Transplant","Liver Failure",[174,139,175,176,177],"Hypothermic Machine Perfusion","Ischemia-Reperfusion Injury","Ex Vivo Liver Perfusion","Extended Criteria Donors","2026-05-14",{"date":180,"type":38},"2026-05-19",{"date":182,"type":22},"2026-05-07",{"date":184,"type":22},"2028-05-07",{"name":44,"class":45},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"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":193,"type":22},36,[25],"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.",[197,198],"Pulmonary Thromboendarterectomy","Pulmonary Embolism and Thrombosis",[200,201,202,203],"Pulmonary Perfusion","Electrical Impedance Tomography (EIT)","Cardiac Output","Resistência Vascular Pulmonar","2026-05-04",{"date":206,"type":38},"2026-05-11",{"date":208,"type":38},"2025-02-25",{"date":210,"type":22},"2026-12",{"name":44,"class":45},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":219,"minAge":4,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"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":221,"type":22},182,[25],"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).",[225],"Gestational Diabetes Mellitus (GDM)",[227,228,229,230,231],"dysglycemia","gestational diabetes","prediabetes","diabetes","postpartum OGTT","2026-04-27",{"date":204,"type":38},{"date":235,"type":38},"2026-03-24",{"date":237,"type":22},"2026-11",{"name":44,"class":45},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":251,"conditions":252,"keywords":257,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"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* Under immunosuppressive or biologic therapy ≥3 months\n* Indication for simple extraction of tooth 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 who require more technically complex extractions, such as impacted or impacted third molars.\n* Patients with local and systemic changes that require more extensive antibiotic coverage, such as cases with clinical signs of acute infections, anticoagulated patients, heart patients, patients who have undergone radiotherapy or are undergoing treatment for neoplasms.\n* Patients allergic to amoxicillin.",{"count":248,"type":22},352,[250],"PHASE4","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 in immunosuppressed patients 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.",[253,254,255,256],"Autoimmune Rheumatic Diseases","Tooth Extraction","Infection Prevention","Antibiotic Prophylaxis",[253,254,255,258,259],"Amoxicillin","Antibiotic Stewardship","2026-04-14",{"date":262,"type":38},"2026-04-15",{"date":264,"type":22},"2026-06-01",{"date":266,"type":22},"2029-12-30",{"name":44,"class":45},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":276,"sex":17,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"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.",true,"2 Years","25 Years",{"count":280,"type":22},263,[250],"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.",[284],"Autoimmune Rheumatologic Disease",[286,253,287,288,289],"Meningococcal B vaccine","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention",{"date":291,"type":38},"2026-04-20",{"date":293,"type":38},"2026-02-19",{"date":295,"type":22},"2027-12-30",{"name":44,"class":45},2,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":276,"sex":17,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":325,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":297},"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","12 Years","59 Years",{"count":309,"type":22},477,[250],"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.",[313,314,315,316,317,318,319,320,321,322,323,324],"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",[326,327,253,287,288,289,328],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Vaccine",{"date":262,"type":38},{"date":331,"type":22},"2026-03-16",{"date":333,"type":22},"2028-12-30",{"name":44,"class":45},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":276,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":349,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"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":343,"type":22},100,[25],"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.",[347,348],"Temporomandibular Joint Disorders","Extracorporeal Shockwave Therapy",[347,348,350,351,352],"Temporomandibular Joint Dysfunction Syndrome","High-Energy Shock Waves","Pain Management","2026-03-20",{"date":355,"type":38},"2026-03-25",{"date":357,"type":38},"2023-04-20",{"date":359,"type":22},"2029-06-25",{"name":44,"class":45},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":385,"locationsCount":4},"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":371,"type":22},192,[250],"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?",[253],[376,377,378,379,380,287],"Pneumococcal Vaccine","Methotrexate","PCV20","Immunogenicity","Vaccination","2026-03-19",{"date":235,"type":38},{"date":355,"type":22},{"date":333,"type":22},{"name":44,"class":45},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":276,"sex":17,"minAge":394,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":405,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":416,"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":397,"type":22},226,[25],"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.",[401,402,403,404],"Intubation, Intratracheal","Airway Management","Video Laryngoscope","Cost Effectiveness",[406,407,408,409,410],"Videolaryngoscope","Pediatric orotracheal intubation","Cost effectiveness","McGrath MAC","BESDATA","2026-03-18",{"date":353,"type":38},{"date":414,"type":38},"2026-03-01",{"date":125,"type":22},{"name":44,"class":45},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":429,"conditions":430,"keywords":432,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"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":106,"type":22},[428,108],"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).",[431],"Essential Tremor (ET)",[433],"essential tremor",{"date":381,"type":38},{"date":436,"type":22},"2026-03-17",{"date":438,"type":22},"2028-12-10",{"name":44,"class":45},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":219,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":467},"100628561","phase-3-safety-and-potency-of-a-high-cabergoline-dosage-in-microprolactinomas-100628561","NCT07463235","Safety and Potency of a High Cabergoline Dosage in Microprolactinomas","SPARAGMOS","Inclusion Criteria:\n\n* 1\\. Willing and able to provide written informed consent prior to any study-related procedures\n* 2\\. Adults \\>18 years old\n* 3\\. Pre-menopausal women\n* 4\\. Presence of signs and symptoms matching prolactinoma\n* 5\\. Hyperprolactinemia, defined as a prolactin (PRL) level ≥2 times the local laboratory maximum level of normality, present at the time of enrolment\n* 6\\. Presence of an identifiable pituitary mass on MRI with a maximum diameter of less than 1cm, independently of Knosp\u002Finvasiveness of the cavernous sinus\n* 7\\. Treatment naïve\n* 8\\. Females who engage in heterosexual intercourse must agree to use either a highly effective or a clinically acceptable method of contraception from the beginning of screening to the last study visit, which will include:\n* Hysterectomy or bilateral salpingectomy\n* Bilateral tubal occlusion or ligation\n* Vasectomized partner\n* Intrauterine device (copper or hormonal)\n* Progestogen-only contraception (oral, injectable or implantable)\n* Male or female condom with or without spermicide\n* Sexual abstinence (only when it is the usual and preferred lifestyle of the subject)\n\nExclusion Criteria:\n\n* 1\\. History of primary hyperparathyroidism\n* 2\\. Use of combined hormonal contraceptive within the past 4 weeks\n* 3\\. Pregnancy or current pregnancy desire\n* 4\\. Prolactinoma associated with a known genetic syndrome\n* 5\\. Familial history of pituitary adenoma\n* 6\\. Renal failure (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin \u002F1.73m2)\n* 7\\. IGF-1 level above the age-adjusted normal range of the local laboratory (IGF 1 \\>1x ULNR)\n* 8\\. Idiopathic hyperprolactinemia (normal MRI) or presence of macroprolactinemia\n* 9\\. Concomitant mental condition rendering her unable to understand the nature, scope, and possible consequences of the study, and\u002For decompensated psychiatric disease (i.e. gambling or severe obsessive-compulsive disorder), as judged by the Investigator\n* 10\\. Chronic use of drugs related to hyperprolactinemia (such as metoclopramide, methyldopa, ranitidine, and opioid-related analgesics)\n* 11\\. Resistant prolactinoma, defined as non-normalization of PRL levels with 2mg\u002Fw of CAB\n* 12\\. Patients in the high dosage group who did not use 3.5mg\u002Fw of CAB for an entire 6 months (due to intolerance or non-compliance) or failed to achieve the target dose for any other reason\n* 13\\. Active malignant disease within the last 5 years, except basal and squamous cell carcinoma of the skin with complete local excision\n* 14\\. Any decompensated chronic condition (i.e. heart failure NYHA 3-4, diabetes with HbA1c \\>8.5%, hypothyroidism with TSH \\>10 mIU\u002FL) that, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes\n* 15\\. Male sex\n* 16\\. Cushing stigmas (moon face, muscle weakness, red striation) or suspicious\n* 17\\. Prior radiotherapy of the pituitary gland area for any reason\n* 18\\. Additional pituitary tumor-directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy\n* 19\\. Hepatopathy with AST\u002FTGO or ALT\u002FTGP \\>3x the upper limit of normality",{"count":448,"type":22},70,[450],"PHASE3","This will be a multicenter, prospective, randomized, open-label trial with women harboring microprolactinomas and treatment naïve. The sample will be added consecutively and randomized into 2 unblinded groups: the high dosage group will receive a high cabergoline (CAB) dose for a period of \\~6 months vs the standard dosage group, which will use the lowest needed dose of CAB to achieve normoprolactinemia for 2 years. The primary outcome will be remission rate.",[453,454],"Prolactinoma","Prolactin Excess",[456,457,458],"cabergoline","prolactinoma","remission","2026-03-10",{"date":461,"type":38},"2026-03-13",{"date":463,"type":38},"2026-03-04",{"date":465,"type":22},"2029-12-20",{"name":44,"class":45},16,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":484,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":46},"100602229","validation-of-a-patient-knowledge-questionnaire-for-pulmonary-hypertension-100602229","NCT07120789","Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension","Content, Semantic, and Psychometric Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension","SAVOIR","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Confirmed diagnosis of Group 1 Pulmonary Arterial Hypertension (PAH)\n* Ability to read and understand the questionnaire language\n* Provided informed consent to participate in the study\n* For expert judges (content validation phase): professionals with recognized expertise in pulmonary hypertension, with academic or clinical experience in the field\n\nExclusion Criteria:\n\n* Cognitive, visual, or auditory impairments that hinder questionnaire comprehension\n* Refusal to participate or withdrawal of informed consent\n* Inability to complete the questionnaire due to clinical instability",{"count":477,"type":22},215,[25],"This methodological study aims to develop and validate a questionnaire named for the Assessment of Patient Knowledge in Pulmonary Arterial Hypertension. The study will be conducted in four phases: (1) questionnaire development based on guidelines and literature; (2) content validation by expert judges; (3) semantic validation with patients; and (4) psychometric testing in a sample of up to 200 patients with confirmed pulmonary arterial hypertension (PAH).\n\nIn addition to validation, the study will collect clinical and functional data from medical records, including risk stratification using the COMPERA 2.0 method The final instrument is expected to support patient education strategies and contribute to improved clinical management of PAH.",[481,482,483],"Pulmonary Arterial Hypertension (PAH)","Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)","Pulmonary Hypertension",[483,485,486,487,488,489,490,491,492],"Patient Knowledge","Questionnaire Validation","Content Validity","Semantic Analysis","Psychometric Validation","Health Education","Patient Education","Chronic Disease","2026-03-07",{"date":459,"type":38},{"date":496,"type":38},"2025-09-01",{"date":210,"type":22},{"name":44,"class":45},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":46},"100614526","phase-4-recombinant-herpes-zoster-vaccine-in-patients-with-autoimmune-rheumatic-diseases-under-immunomodulators-100614526","NCT07280741","Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators","Efficacy, Immunogenicity, and Safety of the Recombinant Herpes Zoster Vaccine (RZV) in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators","IMUNO-RZV","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosis of an autoimmune rheumatic disease (such as rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, psoriatic arthritis, systemic sclerosis, Sjögren syndrome, idiopathic inflammatory myopathies, or primary systemic vasculitis) according to validated classification criteria.\n* Clinical stability at the time of enrollment, defined as no change in disease-modifying therapy or corticosteroid dose in the preceding four weeks and no evidence of infection or disease flare.\n* Current use of hydroxychloroquine or sulfasalazine in monotherapy for at least three months prior to inclusion.\n* Can be under prednisone use of 5mg\u002Fweek.\n* Ability and willingness to comply with study procedures and follow-up visits.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Previous vaccination with recombinant zoster vaccine (RZV).\n* History of herpes zoster or varicella infection within 12 months before enrollment.\n* Concomitant use of systemic immunosuppressive therapy including but not limited to methotrexate, mycophenolate mofetil, azathioprine, cyclophosphamide, biologics, or JAK inhibitors.\n* Use of glucocorticoids \\>5mg\u002Fweek.\n* Acute febrile illness or active infection at the time of vaccination.\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to any component of the recombinant zoster vaccine.\n* History of Guillain-Barré syndrome.\n* Any condition that, in the investigators' judgment, could interfere with study participation or interpretation of results.",{"count":508,"type":22},200,[250],"This interventional phase IV clinical trial will evaluate the efficacy, immunogenicity and safety of the adjuvanted recombinant herpes zoster vaccine (RZV) in adults with autoimmune rheumatic diseases (ARDs) receiving immunomodulatory monotherapy. Humoral immune response will be quantified by anti-glycoprotein E (anti-gE) antibody titers. Patients will receive two doses of RZV. Outcomes include seroconversion and geometric mean titers six weeks after completion of the vaccination schedule, persistence of antibody titers at one year, and incidence of confirmed herpes zoster during follow-up.",[253],[379,513,328,514,515,516],"Hepers Zoster","Safety","Immunomodulators","Inflammation","2026-03-06",{"date":519,"type":38},"2026-03-11",{"date":521,"type":38},"2025-12-02",{"date":523,"type":22},"2028-07-30",{"name":44,"class":45},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":537,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":46},"100628140","airdrop-can-we-improve-adherence-to-inhaled-treatment-for-pulmonary-arterial-hypertension-100628140","NCT07457762","AIRDROP: Can we Improve Adherence to Inhaled Treatment for Pulmonary Arterial Hypertension?","AIRDROP","Inclusion Criteria:\n\n* \"Adult patients aged ≥ 18 years, treated at the referral center for PH management at the Heart Institute of the University of São Paulo Medical School, with an invasive confirmed diagnosis of PAH (mean pulmonary arterial pressure \\[mPAP\\] greater than 20 mmHg at rest, pulmonary vascular resistance \\[PVR\\] equal to or greater than 2 Wood units, and pulmonary capillary wedge pressure \\[PCWP\\] equal to or less than 15 mmHg), and who have been using Iloprost.\n\nExclusion Criteria:\n\n* Patients who are unable to perform the 6-minute walk test (6MWT) or who have experienced gastrointestinal bleeding within the 12 weeks prior to the start of the study will be excluded.",{"count":533,"type":22},72,[25],"Pulmonary Arterial Hypertension is a rare and progressive condition that compromises pulmonary circulation and can lead to right ventricular failure. Despite recent advances in diagnosis and treatment, the median survival of patients is only 2.8 years. The treatment for this disease is based on drugs that act on three main pathways: prostacyclin, endothelin, and nitric oxide. Iloprost, a prostacyclin analogue available in an inhaled form, is an important and well-established treatment. However, its mandatory frequent administration, the need for a specific inhalation technique, and its adverse event profile make its use complex. Although pharmacotherapeutic and inhalation technique follow-up by a qualified professional is widely studied in diseases like asthma and COPD, its application in Pulmonary Arterial Hypertension still lacks evidence. Thus, this study aims to evaluate how a pharmacist's intervention can improve treatment adherence, mitigate side effects and difficulties associated with inhalation, in addition to optimizing clinical and hemodynamic outcomes in patients with Pulmonary Arterial Hypertension using iloprost.",[481],[538,539,540],"PAH","adherence","iloprost","2026-03-03",{"date":543,"type":38},"2026-03-09",{"date":545,"type":38},"2025-05-01",{"date":547,"type":22},"2026-12-28",{"name":44,"class":45},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":306,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":564,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":4},"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.",{"count":558,"type":22},62,[250],"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.",[253,562,563],"Recurrent Herpes Simplex","Prevention",[565,566,253,287,288,567,289],"Herpes Simplex Virus","Acyclovir","Antiviral Suppressive Therapy",{"date":569,"type":38},"2026-03-05",{"date":571,"type":22},"2026-04-01",{"date":573,"type":22},"2028-04-01",{"name":44,"class":45},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":276,"sex":17,"minAge":277,"maxAge":278,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":588,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":46},"100612377","phase-4-safety-and-immunogenicity-of-pcv20-in-pediatric-patients-with-autoimmune-rheumatic-diseases-100612377","NCT07252791","Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases","PCV20-PARD","Inclusion Criteria:\n\n* Age 2-25 years\n* Diagnosis of JIA, jSLE, or JDM by validated classification criteria\n* Clinically stable\n* Informed consent\u002Fassent\n\nExclusion Criteria:\n\n* Acute infection or fever at vaccination\n* Severe allergic reaction to vaccine components\n* Recent blood transfusion (\\\u003C6 months)\n* Other vaccine within 4 weeks prior at the time of inclusion\n* Pregnancy or breastfeeding\n* Prior PCV20",{"count":584,"type":22},114,[250],"This clinical trial evaluates the immunogenicity (humoral and cellular) and safety of the 20-valent pneumococcal conjugate vaccine (PCV20) in children, adolescents, and young adults aged 2-25 years with autoimmune rheumatic diseases (ARDs). All participants will receive PCV20 according to prior vaccine history. Antibody titers, opsonophagocytic activity, cellular immune responses, and adverse events will be measured up to 6 months post-vaccination. Effects of immunosuppressive therapy and physical activity levels related vaccine response will also be assessed.",[284],[589,378,590,288,379,591],"Pneumococcal Conjugate Vaccine","Autoimmune Diseases","Vaccine Safety","2026-03-02",{"date":463,"type":38},{"date":595,"type":38},"2026-01-16",{"date":295,"type":22},{"name":44,"class":45},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":219,"minAge":606,"maxAge":607,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":610,"conditions":611,"keywords":615,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":46},"100604727","phase-4-treatment-of-vaginal-dryness-in-sjgrens-disease-with-co2-laser-versus-topical-promestriene-100604727","NCT07153276","TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE","TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY","VaLS","Inclusion Criteria:\n\n* Diagnosis of SjD according to the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria (2016).\n* Controlled systemic disease activity \\[EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)\\] \\\u003C 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg\u002Fday.\n* Present complaints of vaginal dryness upon study entry.\n* Agreeing to participate in the protocol according to the informed consent form signed before study inclusion.\n\nExclusion Criteria:\n\n* History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure.\n* Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease.\n* Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.","30 Years","65 Years",{"count":82,"type":22},[250],"Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency\u002Fincontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.",[612,613,614],"Sjogren Syndrome","Sjogren Disease","Primary Sjogren Syndrome",[616,617,618,619,620],"Sjogren syndrome","vaginal dryness","vaginitis sicca","vaginal fractional CO2 laser","promestriene",{"date":541,"type":38},{"date":623,"type":38},"2026-02-27",{"date":625,"type":22},"2030-01-30",{"name":44,"class":45},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":637,"conditions":638,"keywords":640,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":647,"locationsCount":46},"100627775","electrical-impedance-tomography-for-assessment-of-pulmonary-hypertension-100627775","NCT07453017","Electrical Impedance Tomography for Assessment of Pulmonary Hypertension","Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization","Inclusion Criteria:\n\n* Patients with a diagnosis or clinical suspicion of pulmonary arterial hypertension (PAH) and with a medical indication for right heart catheterization.\n* Patients evaluated at the Pulmonology Service of InCor-HCFMUSP.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Structural heart disease, such as atrial septal defect, ventricular septal defect, or valvular disease.\n* Cardiac arrhythmias.\n* Presence of a cardiac pacemaker or other implantable electronic device.\n* Skin lesions at the thoracic region that would prevent placement of the EIT electrode belt.\n* WHO functional class IV of new york heart association (NYAH)..\n* Inability to perform a voluntary respiratory pause (apnea) of at least 30 seconds or inability to understand and follow instructions required.\n* Decline to participate in the study by not signing the informed consent form or refusal by the attending medical team.",{"count":635,"type":22},120,[25],"Pulmonary hypertension is a serious and progressive disease that is difficult to treat and diagnose, mainly because its symptoms are nonspecific and often delay recognition. Early diagnosis is a major challenge. Although several tests may suggest the disease, the definitive diagnosis still requires right heart catheterization, an invasive procedure that directly measures pulmonary hemodynamics such as pulmonary artery pressure, cardiac output, and vascular resistance.\n\nElectrical impedance tomography (EIT) is a non-invasive, radiation-free bedside monitoring method that can evaluate ventilation and pulmonary perfusion. The number of studies investigating perfusion with EIT has been increasing, since the possibility of having a safe, radiation-free, and repeatable method available at the bedside is of great clinical interest in different fields of medicine.\n\nOur hypothesis is that EIT provides information that correlates with the findings of right heart catheterization in patients with suspected pulmonary arterial hypertension (PAH). EIT may serve as a useful screening tool prior to catheterization and may also help in risk stratification of patients with pulmonary hypertension",[483,639],"Pulmonary Thromboembolisms",[641,201,642,202],"Right Heart Catheterization","Pulmonary Vascular Resistance",{"date":569,"type":38},{"date":645,"type":38},"2024-04-26",{"date":210,"type":22},{"name":44,"class":45},{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":658,"conditions":659,"keywords":664,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":46},"100625387","prospective-registry-of-vertigo-due-to-vertebrobasilar-transient-attacks-100625387","NCT07421973","Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks.","The UTRAVERA: a Multicenter Prospective Observational Investigation on Vertigo and Dizziness Due to Vertebrobasilar Transient Neurological Attacks - Diagnoses, Clinical Features, Treatment Responses, and Prognostic Factors.","UTRAVERA","Inclusion Criteria:\n\n* Episodic acute vertigo, dizziness or unsteadiness transient or in evolution, therefore, lasting \\\u003C24 h\n* Such an episode may be isolated or associated with one or more of the following:\n\n  1. focal central neurological symptoms or severe postural instability;\n  2. new-onset, moderate-to-severe craniocervical pain; or\n  3. symptoms that are not better accounted for by another disease or disorder.\n\nExclusion Criteria:\n\n* Patients who present with findings of acute hemorrhage or ischemia on the cranial magnetic resonance imaging (MRI), including diffusion-weighted MRI (DWI-MRI) at recruitment;\n* Patients who also fulfill the diagnostic criteria for other neurotological diseases that may present acute or recurrent transient dizziness\u002FVertigo (Unilateral Vestibulopathy; benign paroxysmal positional vertigo; Meniére's disease; Vestibular Migraine; Vestibular Paroxysmia; Persistente Postural-Perceptual Dizziness; and Postural Hypotension;\n* Patients whose symptoms last more than 24 hours or who have evidence of sequelae during follow-up;\n* Patients with contraindications to any of the therapeutic options proposed by this study method;\n* Patients who have other symptoms during the follow-up that suggest another etiology of dizziness or vertigo;\n* Patients who do not complete the entire evaluation;\n* Patients who refuse to sign the informed consent form.",{"count":657,"type":22},400,"Vertigo and dizziness are common neurological complaints in the emergency department and may represent a wide spectrum of etiologies, including vertebrobasilar transient neurological attacks (VB-TNAs). Distinguishing VB-TNAs, particularly vertebrobasilar transient ischemic attacks (VB-TIAs), from migraine-like and other non-vascular conditions is often challenging at first presentation due to the absence of specific biomarkers and overlapping clinical features. The UTRAVERA study is a multicenter, prospective, observational investigation designed to characterize the clinical features of patients presenting with acute transient vertigo or dizziness suspected to be VB-TNAs. The study will also evaluate diagnostic evolution over time, treatment responses, and prognostic factors associated with clinical outcomes.",[660,661,662,663],"Vertigo","Dizziness","TIA (Transient Ischemic Attack)","Transient Neurologic Symptoms",[665,666,667,668,669,670,671],"vertigo and dizziness","Vertebrobasilar Transient Neurological Attack","TIA","Vestibular Symptom","Diagnostic Accuracy","Prognostic Factors","Emergency Department","2026-02-24",{"date":623,"type":38},{"date":675,"type":22},"2026-05-01",{"date":677,"type":22},"2028-10",{"name":44,"class":45},{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":684,"acronym":4,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":607,"enrollmentInfo":686,"targetDuration":4,"studyType":23,"phases":687,"briefSummary":688,"conditions":689,"keywords":692,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":696,"lastUpdatePostDateStruct":697,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":46},"100617034","phase-4-efficacy-of-clonidine-in-reducing-craving-in-inpatients-with-cocaine-and-crack-use-disorder-100617034","NCT07313371","Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder","Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Patients hospitalized in the adult Alcohol and Drugs ward of the Perdizes Institute (IPer) at the Hospital das Clínicas, University of São Paulo Medical School\n* DSM-5 criteria for cocaine and\u002For crack use disorder\n* Voluntarily seeking treatment\n* Must be able to swallow pills\n\nExclusion Criteria:\n\n* Inability to read and\u002For understand the study questionnaires\n* benzodiazepine use disorder\n* opioid use disorder\n* alcohol use disorder",{"count":193,"type":22},[250],"This is a single-center, randomized intervention study in a volunteer population of patients with cocaine\u002Fcrack use disorder to evaluate the pharmacological treatment of cocaine\u002Fcrack craving, comparing the drug clonidine with the active placebo clonazepam.",[690,691],"Cocaine Use Disorder","Crack Abuse or Dependence",[693,694,695],"crack","cocaine","craving","2026-02-20",{"date":672,"type":38},{"date":699,"type":38},"2026-01-28",{"date":701,"type":22},"2027-07",{"name":44,"class":45},""]