[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Sao Paulo\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":743},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,44,78,121,148,177,203,225,250,281,326,356,381,436,459,485,512,536,559,585,609,634,661,689,720],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100602205","phase-4-esketamine-versus-crisis-response-planning-versus-optimized-treatment-as-usual-for-suicide-prevention-a-pragmatic-controlled-trial-in-two-brazilian-cities-100602205",false,"NCT07120477","Esketamine Versus Crisis Response Planning Versus Optimized Treatment as Usual for Suicide Prevention: A Pragmatic Controlled Trial in Two Brazilian Cities","SAVE","Inclusion Criteria:\n\n1. Age 14 years or older\n2. Presentation to a public emergency service (ED\u002FUEU) within the study municipality\n3. Recent suicide attempt within the past 30 days (actual, interrupted, or aborted attempt)\n4. Current severe suicidal ideation, defined as endorsement of items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) screening version, indicating active suicidal ideation with specific plan and\u002For method, or active suicidal ideation with intent to act\n5. Residency in the catchment area of the study municipality (Indaiatuba, São Paulo, Brazil), enabling completion of follow-up assessments\n6. Ability to provide written informed consent (for participants aged 18 years or older) or written assent with written informed consent from a parent or legal guardian (for participants aged 14-17 years)\n7. No clinical decision for involuntary or voluntary hospitalization in a psychiatric inpatient unit following the index emergency department evaluation\n\nExclusion Criteria:\n\n1. Contraindications to esketamine, including: aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or known hypersensitivity to esketamine or ketamine\n2. Current pregnancy or breastfeeding (confirmed by rapid pregnancy test in the emergency setting for female participants of childbearing potential)\n3. Medical instability requiring intensive care unit (ICU) admission without feasible study follow-up\n4. Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder), current acute psychosis, or current acute manic episode precluding informed participation\n5. Severe substance use disorder compromising capacity for treatment adherence, as assessed by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)\n6. Inability to maintain contact for follow-up assessments, including participants whose residential address is located outside the study municipality","ALL","14 Years",{"count":20,"type":21},468,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Suicide is one of the leading causes of early death worldwide. In Brazil, suicide rates have been rising steadily over the past two decades, and most suicides occur in low- and middle-income countries where access to specialized care is limited. There is an urgent need for fast-acting, practical interventions that can be delivered in public emergency settings. Two promising approaches have emerged: esketamine, a medication that can rapidly reduce suicidal thoughts within hours, and Crisis Response Planning (CRP), a brief session in which a trained clinician works with the person to create a personalized written plan for managing future suicidal crises.\n\nThe goal of this clinical trial is to learn if esketamine or Crisis Response Planning (CRP), each added to enhanced treatment as usual (eTAU), can prevent future suicide-related events compared to eTAU alone in adolescents and adults aged 14 years or older who recently attempted suicide or have severe suicidal thoughts. The main questions it aims to answer are:\n\nDoes a single esketamine infusion plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Does a single session of Crisis Response Planning plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Which approach leads to faster or more lasting improvements in suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life? Are these interventions feasible, acceptable, and cost-effective within a public health system?\n\nResearchers will compare three groups to see which approach works best to prevent suicide attempts, suicide-related hospitalizations, and suicide deaths over one year.\n\nA total of 468 participants will be randomly assigned in equal numbers (156 per group) to one of three groups:\n\nEsketamine group: receive a single intravenous esketamine infusion (0.50 mg\u002Fkg given over 40 minutes) in a monitored medical setting with continuous heart rate, blood pressure, and oxygen monitoring, plus eTAU. A physician will be present throughout. Participants will be observed for up to 24 hours before discharge.\n\nCrisis Response Planning group: complete one 20-to-45-minute session with a trained clinician to build a personal crisis plan that includes warning signs, coping strategies, reasons for living, support contacts, and emergency resources. Participants will leave with a written and digital copy of their plan, plus eTAU.\n\nEnhanced treatment as usual (eTAU) group: receive standard emergency care, safety counseling about access to lethal means, connection to the local mental health network (including Psychosocial Care Centers and primary care), and a scheduled psychiatric follow-up appointment within 7 days.\n\nParticipants will:\n\nComplete health questionnaires about suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life at 11 time points over one year (at enrollment, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year) Provide a blood sample at the start of the study for exploratory analyses of biological markers that may be related to treatment response Use a smartphone app to report their mood, thoughts, and emotions four times a day for four weeks after enrollment Be monitored for safety and adverse events throughout the entire study period\n\nThe study takes place in the public emergency network of Indaiatuba, São Paulo, Brazil (population approximately 256,000), and is designed to reflect real-world clinical conditions. Participants who experience a new suicide-related event during the study will be offered an open-label rescue treatment combining esketamine and Crisis Response Planning, and will continue to be followed for the remainder of the year. The study also includes an evaluation of how well these interventions can be adopted and sustained within Brazil's public mental health system, including assessments of acceptability, feasibility, and cost-effectiveness.",[27,28,29],"Suicide Prevention","Ketamine","Crisis Response Plan",[27,28,29],"RECRUITING","2026-06-28",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2026-06-01",{"date":39,"type":21},"2029-12",{"name":41,"class":42},"University of Sao Paulo","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":43},"100625972","transcranial-alternating-current-stimulation-for-generalized-anxiety-disorder-and-insomnia-an-open-label-pilot-study-100625972","NCT07429578","Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study","Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial","NewWaves","Inclusion Criteria:\n\nAge between 18 and 65 years; Diagnosis of Generalized Anxiety Disorder (GAD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria; Diagnosis of chronic primary insomnia; Hamilton Anxiety Rating Scale (HAM-A) score ≥15 at screening, indicating at least moderate anxiety severity; Score \\>5 on the Pittsburgh Sleep Quality Index (PSQI); Stable use of antidepressants (SSRI or SNRI) is allowed; Limited use of benzodiazepines (maximum of 10 mg\u002Fday diazepam equivalent).\n\nExclusion Criteria:\n\nHistory of mania, hypomania, or bipolar disorder; Contraindications to the use of transcranial stimulation; Active suicidal ideation or suicide attempt in the last 4 weeks; Refractoriness to 3 or more antidepressant treatments; Pregnancy; Other psychiatric diagnoses (e.g., schizophrenia, substance dependence, major depressive disorder); Severe medical or neurological conditions; Anxiety or insomnia secondary to other medical or psychiatric conditions (e.g., hypothyroidism, anemia).","18 Years","65 Years",{"count":55,"type":21},30,[57],"NA","This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.",[60,61],"Generalized Anxiety Disorder (GAD)","Chronic Insomnia",[63,64,65,66,67,68,69],"tACS","Neuromodulation","Non-invasive brain stimulation","Sleep disorders","Anxiety treatment","Transcranial alternating current stimulation","Generalized Anxiety Disorder","2026-06-19",{"date":72,"type":35},"2026-06-23",{"date":74,"type":35},"2025-06-01",{"date":76,"type":21},"2026-07-31",{"name":41,"class":42},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100641214","phase-1-cd19-directed-car-t-cell-therapy-in-refractory-systemic-lupus-erythematosus-100641214","NCT07659704","CD19-Directed CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus","CD19-targeted Lymphocyte Engineering Validation for the trEatment of Refractory Systemic Lupus Erythematosus","CLEVER-SLE","Inclusion Criteria:\n\n* Adults aged 18 to 50 years, inclusive.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 ACR\u002FEULAR classification criteria.\n* Active disease at screening, defined as SLEDAI-2K ≥4 and Physician Global Assessment (PGA) ≥0.5.\n* Inadequate response, intolerance, or contraindication to corticosteroids and at least two of the following therapies: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, belimumab, rituximab, or tacrolimus.\n* Adequate organ function, including:\n\n  * Hepatic function: AST and ALT ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN (participants with documented Gilbert syndrome are eligible).\n  * Hematologic function: neutrophils ≥1,000\u002Fmm³; hemoglobin ≥8 g\u002FdL without transfusion within 14 days; lymphocytes ≥500\u002Fmm³; platelets ≥20,000\u002Fmm³ without transfusion within 14 days.\n  * Renal function: estimated creatinine clearance ≥30 mL\u002Fmin (CKD-EPI).\n  * Cardiac function: left ventricular ejection fraction ≥40%.\n  * Pulmonary function: oxygen saturation ≥92% on room air.\n* Women of childbearing potential must agree to use highly effective contraception during study participation and for 12 months after CAR-T cell infusion.\n* Male participants must agree to use barrier contraception during study participation and for 12 months after CAR-T cell infusion.\n* Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe pulmonary hypertension (estimated pulmonary artery systolic pressure \\>50 mmHg).\n* Requirement for systemic anticoagulation at screening.\n* Clinically significant cardiovascular disease, including NYHA Class III\u002FIV heart failure, myocardial infarction, unstable arrhythmias, or unstable angina within the previous 6 months.\n* Active neurological disease (stroke, epilepsy, or neurodegenerative disorders) within the previous 12 months.\n* History of malignancy within 2 years prior to screening, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or stage I uterine cancer.\n* Previous or suspected hemophagocytic lymphohistiocytosis\u002Fmacrophage activation syndrome.\n* Active or uncontrolled bacterial, viral, fungal, or other infection.\n* Active hepatitis B infection or detectable HBV DNA.\n* Active hepatitis C infection or detectable HCV RNA.\n* Human immunodeficiency virus (HIV) infection.\n* Pregnancy, breastfeeding, or plans to become pregnant during the study or within 12 months after CAR-T cell infusion.\n* Major surgery within 4 weeks prior to screening.\n* Administration of a live attenuated vaccine within 4 weeks prior to screening.\n* Prior allogeneic or autologous hematopoietic stem cell transplantation or prior solid organ transplantation.\n* Inability or unwillingness to comply with study procedures and follow-up requirements.\n* Any medical condition that, in the investigator's judgment, could compromise participant safety or interfere with study assessments.","50 Years",{"count":88,"type":21},16,[90,91],"PHASE1","PHASE2","Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues and organs. The disease can affect the skin, joints, kidneys, blood cells, brain, and other organs, leading to significant health problems and reduced quality of life. Although several treatments are available, some patients continue to have active disease despite receiving standard therapies.\n\nRecent research has shown that B cells, a type of immune cell, play a central role in the development and persistence of SLE. CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy is an innovative treatment that uses a patient's own immune cells, genetically modified to recognize and eliminate B cells. This approach has already shown remarkable success in certain blood cancers and has recently produced encouraging results in patients with severe autoimmune diseases, including SLE.\n\nThe CLEVER-SLE study is a Phase I\u002FII clinical trial designed to evaluate the safety and potential effectiveness of CD19-directed CAR-T cell therapy produced at Ribeirao Preto Blood Bank in patients with SLE who have not responded adequately to conventional treatments. Participants will undergo the collection of their own immune cells, which will be modified in a specialized laboratory to produce CAR-T cells. After receiving preparatory chemotherapy, participants will receive a single intravenous infusion of these CAR-T cells.\n\nThe main goal of this study is to evaluate the safety of this treatment. Researchers will also assess its effects on disease activity, symptoms, organ involvement, medication requirements, immune system markers, and the duration of clinical responses. The study aims to determine whether CD19-directed CAR-T cell therapy can provide a new treatment option for patients with refractory SLE and contribute to the development of CAR-T therapies for autoimmune diseases.",[94],"Lupus Erythematosus, Systemic",[96,97,98,99,100,101,102,103,104,105,106,107,108,109,110],"Systemic Lupus Erythematosus","SLE","Refractory Systemic Lupus Erythematosus","Lupus Nephritis","CAR-T Cell Therapy","CD19-Directed CAR-T Cells","CD19","Chimeric Antigen Receptor T Cells","B Cell Depletion","B Lymphocytes","Autoimmune Diseases","Cellular Therapy","Advanced Therapy Medicinal Products","Immune Reconstitution","Autologous CAR-T Cells","NOT_YET_RECRUITING","2026-06-15",{"date":114,"type":35},"2026-06-22",{"date":116,"type":21},"2026-10-01",{"date":118,"type":21},"2028-10-01",{"name":41,"class":42},2,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":43},"100642546","phase-2-telerehabilitation-and-biomarkers-of-recovery-after-stroke-in-brazil-100642546","NCT07646522","Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil","Telerehabilitation and Biomarkers of Functional Recovery After Stroke in Brazil: TR-BR-1 Clinical Trial","TR-BR-1","Inclusion Criteria:\n\n1. Age 18-80 years at the time of randomization.\n2. The index stroke was radiologically verified, due to ischemia, and had time of onset 120±30 days prior to randomization.\n3. The stroke caused upper extremity deficits as defined by Action Research.\n4. Arm Test score 18-44 (out of 57) at Baseline Visit.\n5. Box \\& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.\n6. Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit.\n7. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent).\n\nExclusion Criteria:\n\n1. A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures.\n2. Unable or unwilling to perform study procedures\u002Ftherapy, or expectation of noncompliance with study procedures\u002Ftherapy, or expectation that subject cannot participate in all study visits.\n3. A diagnosis (apart from the index stroke) that substantially affects paretic arm function.\n4. Severe depression, defined as Geriatric Depression Scale Score \\>10\u002F15 at Baseline Visit.\n5. Significant cognitive impairment, defined as Montreal Cognitive Assessment \\[a lower score can be permitted at the discretion of the PI\\].\n6. Deficits in communication that interfere with reasonable study participation.\n7. Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis.\n8. Modified Rankin Scale score \\>2 prior to the index stroke.\n9. A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke.\n10. Lacking visual acuity, with or without corrective lens, of 20\u002F50 or better in at least one eye.\n11. Life expectancy \\\u003C 9 months\n12. Pregnancy; women of child-bearing potential must have a negative pregnancy test.\n13. Botulinum toxin to the paretic arm: received in the prior 3 months or expected by the 1-Month Visit.\n14. Concurrent enrollment in another therapy-based investigational study where the duration of the investigational therapy's activity is likely to occur during the subject's participation in the study.\n15. Subject lacks sufficient Portuguese to comply with study procedures and TR instructions.\n16. Contraindication to MRI.\n17. Contraindication to TMS.\n18. Box and Block Test score of ≥30 blocks with the unaffected arm within 60 seconds at Baseline Visit;\n19. Spatial neglect interfering with reasonable participation in the study;\n20. On isolation precautions, e.g., due to active COVID-19.\n21. Expectation that participant will not have a single domicile address during the 6 weeks of therapy.\n22. Distance from the participant's home to the study site greater than 120 km \\[this can be waived at the discretion of the PI\\].\n\n22\\. Availability of a 2 m² space for a table and chair setup.","80 Years",{"count":131,"type":21},20,[91],"The purpose of this research study is to provide preliminary evidence of whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone in Brazil. Evaluate the safety and feasibility of telerehabilitation in the Brazilian context. Explore the clinical, neuroimaging, neurophysiological, and economic factors that influence telerehabilitation efficacy in functional recovery following stroke.",[135],"Stroke",[137,138,139],"stroke","telerehabilitation","functional recovery","2026-06-13",{"date":142,"type":35},"2026-06-16",{"date":144,"type":35},"2026-06-12",{"date":146,"type":21},"2028-02-29",{"name":41,"class":42},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":155,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":43},"100628550","creatine-supplementation-and-resistance-training-to-improve-sarcopenia-parameters-in-patients-with-prostate-cancer-after-androgen-deprivation-therapy-100628550","NCT07463092","Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy","The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy","Inclusion Criteria:\n\n* Men aged ≥ 40 years;\n* Patients with histologically or cytologically confirmed localized prostate cancer;\n* Patients who have undergone surgical castration or pharmacological castration with gonadotropin-releasing hormone (GnRH\u002FLHRH) agonists or antagonists for at least six months prior to the start of the intervention;\n* Patients receiving continuous or intermittent androgen deprivation therapy;\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Not engaged in resistance training in the three months prior to the intervention;\n* Not using creatine supplementation in the three months prior to the intervention;\n* Willing to participate in a 12-week intervention consisting of resistance training performed three times per week and daily supplementation with creatine monohydrate or maltodextrin.\n\nExclusion Criteria:\n\n* Patients with insulin-dependent diabetes mellitus;\n* Patients with dialysis-dependent renal failure;\n* Patients with severe chronic liver disease;\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m²;\n* Any hormonal treatment outside that established by the medical team;\n* Patients planning to undergo chemotherapy within the next six months.","MALE","40 Years",{"count":158,"type":21},34,[57],"This randomized, double-blind, placebo-controlled clinical trial will investigate the effects of creatine supplementation combined with a 12-week supervised resistance training program on muscle mass, muscle strength, physical performance (e.g., parameters of sarcopenia), and muscle density in men with prostate cancer undergoing androgen deprivation therapy (ADT). ADT often causes loss of lean mass, reduced muscle strength, functional impairment, and increased fat mass. Eligible male patients will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) in a double-blind manner, in addition to participating in the resistance exercise program. Assessments will be performed at baseline and after the 12-week intervention period and will include:\n\n* Muscle density and architecture assessed by ultrasound\n* Body composition (lean mass and fat mass)\n* Muscle strength\n* Physical performance (functional performance tests)\n* Inflammatory biomarkers\n* Vascular function parameters\n\nThe primary goal is to assess whether creatine supplementation combined with resistance training can safely improve muscle quality and quantity, strength, and physical function in these patients. If effective and safe, the intervention could help reduce muscle loss and improve quality of life in men undergoing ADT.",[162,163],"Prostate Cancer","Sarcopenia",[162,165,166,167,168,163],"Androgen Deprivation Therapy","Creatine","Resistance Training","Muscle Density","2026-06-10",{"date":171,"type":35},"2026-06-11",{"date":173,"type":35},"2026-05-01",{"date":175,"type":21},"2029-01",{"name":41,"class":42},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":202,"locationsCount":43},"100640776","volume-stable-collagen-matrix-versus-subepithelial-connective-tissue-graft-for-multiple-gingival-recessions-100640776","NCT07613775","Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions","Volume-Stable Xenogeneic Collagen Matrix Versus Subepithelial Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: A 12-Month Randomized Controlled Clinical Trial","VCMX-SCTG","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Presence of at least two Cairo RT1 gingival recessions in anterior teeth and\u002For premolars.\n* Gingival recession depth greater than or equal to 2 mm.\n* Presence of at least 2 mm of keratinized gingiva apical to the gingival recession.\n* Indication for root coverage treatment due to esthetic concern and\u002For dentin hypersensitivity.\n* Sites with non-carious cervical lesions may be included if they are previously restored and, after restoration, present residual gingival recession greater than or equal to 2 mm.\n* Good plaque control, defined as full-mouth plaque score and full-mouth marginal gingival bleeding score below 20%.\n\nExclusion Criteria:\n\n* Current smokers or individuals who stopped smoking less than 12 months before enrollment.\n* Decompensated systemic diseases.\n* Pregnancy or lactation.\n* Active periodontal disease.\n* Untreated root caries.\n* Previous mucogingival surgery in the study area.",{"count":186,"type":21},40,[57],"Gingival recession is a clinical condition in which the gingival margin is displaced apically, exposing the root surface. This condition may be associated with esthetic concerns, dentin hypersensitivity, and difficulties in oral hygiene. Subepithelial connective tissue grafting is considered a standard surgical approach for root coverage, but it requires harvesting tissue from the palate, which may increase postoperative discomfort. Volume-stable xenogeneic collagen matrices have been proposed as an alternative biomaterial to reduce the need for a palatal donor site.\n\nThis randomized controlled clinical trial will compare a volume-stable xenogeneic collagen matrix with an autogenous subepithelial connective tissue graft for the treatment of multiple gingival recessions. Participants will be allocated to one of two treatment groups. The test group will receive root coverage surgery using a volume-stable collagen matrix, while the control group will receive root coverage surgery using a subepithelial connective tissue graft. Clinical, patient-reported, esthetic, and digital outcomes will be assessed at baseline and during follow-up visits up to 12 months.\n\nThe primary outcome will be the change in gingival recession depth from baseline to 12 months. Secondary outcomes will include keratinized tissue width, gingival thickness, percentage of root coverage, complete root coverage, dentin hypersensitivity, patient-reported satisfaction, early wound healing, and digital volumetric changes assessed by intraoral scanning.",[190],"Gingival Recession",[192,193,194,195],"Multiple Gingival Recessions","Volume-Stable Collagen Matrix","Subepithelial Connective Tissue Graft","Coronally Advanced Flap","2026-05-30",{"date":198,"type":35},"2026-06-02",{"date":116,"type":21},{"date":201,"type":21},"2027-12-01",{"name":41,"class":42},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":211,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":43},"100637864","development-of-a-sanitizing-tablet-for-removable-partial-dentures-100637864","NCT07608211","Development of a Sanitizing Tablet for Removable Partial Dentures","Development of a Denture Cleanser Tablet: Evaluation of Antibiofilm Activity and Effects on the Constituent Surfaces of Removable Partial Dentures.","DSRPD","Inclusion Criteria:\n\n* Participants aged 18 years or older.\n* Users of maxillary and\u002For mandibular removable partial dentures (RPD) made of acrylic resin.\n* Good systemic and oral health status, with enough healthy remaining teeth to support the RPD.\n* Agreement to follow the requested oral hygiene and denture cleaning protocols.\n* Ability to understand and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Use of systemic antibiotics, antifungals, or anti-inflammatory drugs within the last 3 months.\n* History of allergic reactions to N-acetylcysteine (NAC), Melaleuca alternifolia (tea tree) oil, or components of the commercial positive control (NitrAdine).\n* Severe periodontal disease or extensive untreated caries in the remaining teeth.\n* Severe systemic diseases, immunodeficiency, or conditions that compromise manual dexterity to perform denture brushing.\n* Pregnant or lactating women.",true,{"count":213,"type":21},15,[57],"The goal of this clinical trial is to learn if a new experimental effervescent tablet works to clean removable partial dentures. It will test if the tablet lowers bacteria and fungi on denture surfaces. The main questions it aims to answer are: Does the experimental tablet lower the number of microbes on different denture materials? How happy are participants with the taste, odor, and cleanliness of the tablet? Researchers will compare the experimental tablet to a known commercial cleanser and to a neutral water solution to see which one works best. Total participation will last 70 days. First, researchers will place small material discs on the side of the participant's current denture to collect natural plaque. Participants will wear their dentures 24 hours a day and brush them with soap and water after meals. Participants will then cycle through three separate 14-day testing phases. In each phase, participants will soak their dentures daily for 15 minutes in one of the assigned solutions. Participants will also have a 7-day break between each phase where they return to their basic regular cleaning routine. At the end of each testing phase, researchers will remove the small discs to count the microbes in a laboratory. Participants will also answer a short survey about their satisfaction with each product.",[217],"Denture Stomatitis","2026-05-27",{"date":37,"type":35},{"date":221,"type":21},"2026-06-08",{"date":223,"type":21},"2027-12-30",{"name":41,"class":42},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100640986","phase-4-vitamin-b-complex-for-inferior-alveolar-nerve-paresthesia-recovery-100640986","NCT07592897","Vitamin B Complex for Inferior Alveolar Nerve Paresthesia Recovery","Efficacy of Vitamin B Complex in the Recovery of Inferior Alveolar Nerve Paresthesia: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Clinical diagnosis of mandibular neurossensorial disturbances.\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n\\- Any known allergy to complex B supplementation or its components.","70 Years",{"count":234,"type":21},50,[24],"Why is this study being done? Paresthesia is a change in sensation that can cause numbness, tingling, or loss of feeling in a part of the body. This condition can occur after dental procedures such as wisdom tooth (third molar) extraction, dental implant placement, or jaw surgery. When this happens, the inferior alveolar nerve - which is responsible for sensation in the lower lip, chin, and gum area on the side of the jaw - may be injured. This can affect a person's quality of life, making everyday activities like eating, drinking, speaking, and even smiling feel different or uncomfortable.\n\nWhat is being studied? This study is testing whether taking B vitamins (vitamin B complex) can help the inferior alveolar nerve recover faster and more completely compared to a placebo (an inactive pill that looks the same but contains no active medicine). B vitamins - especially B1 (thiamine), B6 (pyridoxine), and B12 (cyanocobalamin) - are known to play important roles in nerve health, including helping repair damaged nerves and maintaining the protective covering around nerves called myelin.\n\nWho can participate? Adults between 18 and 70 years old who have numbness or altered sensation in the lower lip, chin, or gum area caused by damage to the inferior alveolar nerve following a dental procedure (specifically wisdom tooth extraction), and whose symptoms began between 7 and 30 days ago.\n\nWhat will happen in the study?\n\nParticipants will be randomly assigned (like flipping a coin) to one of two groups:\n\nVitamin B complex group: Takes one capsule daily containing B vitamins\n\nPlacebo group: Takes one identical-looking capsule daily with no active ingredients\n\nNeither the participants nor the doctors performing the sensory tests will know which group they are in. This is called a \"blinded\" study and helps ensure the results are reliable.\n\nParticipants will attend 6 scheduled visits over 8 weeks:\n\nT0 (baseline): Initial sensory testing, questionnaires, and receiving the study medication\n\nT1 (1 week): Follow-up sensory testing\n\nT2 (2 weeks): Follow-up sensory testing\n\nT3 (4 weeks): Follow-up sensory testing\n\nT4 (6 weeks): Follow-up sensory testing\n\nT5 (8 weeks): Final sensory testing and end of study participation\n\nAt each visit, researchers will perform simple, non-invasive tests to measure sensation in the affected area, including:\n\nLight touch tests with soft nylon filaments (monofilaments)\n\nTwo-point discrimination (testing the ability to feel one or two points touching the skin)\n\nPinprick sensation (testing sharp touch)\n\nTemperature sensation (warm and cold)\n\nVisual Analog Scale (VAS) where participants rate their sensation on a scale\n\nWhat are the possible benefits? Participants who receive the vitamin B complex may experience faster or more complete recovery of sensation in their lower lip, chin, or gum area. Even those in the placebo group may experience some improvement due to the body's natural healing process. All participants will receive close monitoring of their nerve function over 8 weeks.\n\nWhat are the possible risks? The risks are considered low. B vitamins are generally safe at the doses used in this study. Some people may experience mild side effects such as nausea or stomach discomfort. Rarely, allergic reactions may occur. The sensory tests may cause mild, temporary discomfort but no pain. If any side effects occur, the study medication will be stopped and appropriate care will be provided.\n\nIs participation voluntary? Yes. Participants can withdraw from the study at any time without any impact on their regular dental or medical care.\n\nWhere will the study take place? The study will be conducted at the Faculdade de Odontologia da Universidade de São Paulo (FOUSP) and the Fundação para o Desenvolvimento da Odontologia (FUNDECTO).",[238],"Paresthesia and Hypoesthesia",[240,241,242],"paresthesia","third molar","surgery, oral","2026-05-18",{"date":245,"type":35},"2026-05-20",{"date":169,"type":21},{"date":248,"type":21},"2028-06-10",{"name":41,"class":42},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":211,"sex":17,"minAge":257,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":268,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":280,"locationsCount":43},"100595983","harm-reduction-intervention-for-anabolic-androgenic-steroids-users-a-randomized-controlled-trial-100595983","NCT07039539","Harm Reduction Intervention for Anabolic-androgenic Steroids Users: a Randomized Controlled Trial","SOS-RCT-HR","Inclusion Criteria:\n\n* Anyone over 15 years of age;\n* Planning to use\u002Fincrease the dose of AAS for aesthetic and\u002For physical performance purposes;\n* Plan to use\u002Fincrease the dose of AAS during eight to twelve weeks.\n\nExclusion Criteria:\n\n* Medical prescription for AAS use;\n* Use for sexual reassignment.","15 Years",{"count":259,"type":21},32,[57],"This clinical trial aims to investigate the short and long-term efficacy of a harm reduction intervention in reducing the use of non-clinical anabolic-androgenic steroids (AAS) in abusive users of AAS. As secondary objectives, the study will investigate the intervention's effect on health parameters (i.e., blood), quality of life, sleep quality, body image, eating behavior, depression, anxiety, fatigue, aggressiveness, cardiovascular parameters, muscle strength, body composition and muscle cross-sectional area outcomes.",[263,264,265,266,267],"Drug Abuse","Harm Reduction","Minimization, Harm","Anabolic Steroids Adverse Events","Brief Intervention",[269,270,271,272,273,274,267],"human enhancement drug","performance and image enhancement drug","anabolic androgenic steroids","drug consumption","doping","harm reduction","2026-05-12",{"date":243,"type":35},{"date":278,"type":21},"2026-07-01",{"date":223,"type":21},{"name":41,"class":42},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":289,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":295,"conditions":296,"keywords":307,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":323,"leadSponsor":325,"locationsCount":4},"100634665","early-phase-1-chloramphenicol-tetracycline-zinc-oxide-and-eugenol-paste-ctz-paste-for-emergency-dental-treatment-in-public-health-settings-a-randomized-trial-100634665","NCT07542639","Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial","Clinical and Radiographic Efficacy of Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) in the Context of Emergency Dental Treatments in Brazilian Public Health: Randomized Clinical Trial","CTZ- emergency","Inclusion Criteria:\n\n* Pediatric patients presenting with:\n* Irreversible pulpitis in primary molars;\n* Pulp necrosis, with or without abscess, in primary molars.\n* Primary molars with sufficient remaining tooth structure to allow endodontic treatment.\n* Primary teeth in which the permanent successor tooth germ presents developmental stages compatible with Nolla stages 1 to 7, defined as:\n\nStage 1: Presence of bony crypt with no evidence of calcification; Stage 2: Initial calcification, with appearance of radiopaque points in the crown region; Stage 3: Approximately one-third of crown formation; Stage 4: Approximately two-thirds of crown formation; Stage 5: Crown almost complete, without full calcification; Stage 6: Crown completely formed, without initiation of root formation; Stage 7: Initial root formation.\n\n* Clinical and radiographic conditions indicating feasibility of tooth maintenance through endodontic treatment, including:\n* Permanent successor in developmental stages prior to Nolla Stage 8;\n* Preservation of the bony crypt.\n\nExclusion Criteria:\n\n* Pediatric patients presenting with:\n* Reversible pulpitis;\n* Indication for endodontic treatment in permanent teeth.\n* History of allergy or hypersensitivity to any components of the obturation materials (e.g., CTZ paste or zinc oxide-eugenol).\n* Clinical conditions that prevent adequate management in an outpatient setting.\n* Primary teeth in which the permanent successor:\n* Is in advanced developmental stages (Nolla Stage 8 or higher), and\u002For\n* Presents disruption of the bony crypt, contraindicating endodontic treatment.\n* Teeth presenting internal root resorption that compromises the feasibility of endodontic treatment.","2 Years","11 Years",{"count":292,"type":21},110,[294],"EARLY_PHASE1","The treatment of pulpal diseases in primary teeth represents a significant challenge in public health, particularly in emergency dental care settings, where factors such as limited clinical time, low child cooperation, and structural constraints directly impact treatment effectiveness. In these contexts, conventional pulpectomy using zinc oxide-eugenol (ZOE), although effective, may present operational limitations that restrict its large-scale applicability in public health systems.\n\nIn this scenario, non-instrumental endodontic treatment (NIET), based on the concept of Lesion Sterilization and Tissue Repair (LSTR), has emerged as a simplified alternative. Among the available options, CTZ paste shows potential for single-visit application, reducing clinical time and technical complexity.\n\nThis study aims to evaluate the clinical and radiographic non-inferiority of CTZ paste compared to conventional pulpectomy with ZOE in primary molars with pulp necrosis, with or without abscess or fistula, treated in emergency dental care settings.\n\nThis is a randomized, pragmatic, controlled, non-inferiority clinical trial conducted at a single center, with clinical and radiographic follow-up at 3, 6, and 12 months. Participants will be allocated into two groups: (1) NIET with CTZ paste and (2) conventional pulpectomy with ZOE.\n\nPrimary outcomes include pain resolution and absence of clinical signs of infection. Secondary outcomes include radiographic success, clinical time, child behavior (Frankl Scale), need for retreatment, and oral health-related quality of life.\n\nThe findings are expected to provide robust evidence regarding the effectiveness of CTZ paste under real-world clinical conditions, contributing to the development of more accessible and effective protocols within public health systems, with the potential to expand access to conservative treatment and reduce early tooth extractions in pediatric dentistry.",[297,298,299,300,301,302,303,304,305,306],"Pulp Disease, Dental","Pulp Necrosis","Pulp Therapy in Primary Molars","Primary Teeth","Pulpectomy","Endodontics","Dental Care for Children","Treatment Outcome","Quality of Life","Health Services Accessibility",[308,309,310,311,312,313,314,315,316,317,318,319],"pulpectomy","pulpotomy","CTZ paste","NIET","Non-instrumental endodontic treatment","LSTR","Lesion sterilization and tissue repair","Endodontic infection","dental abscess","Fistula","Emergency dental treatment","Public health dentistry","2026-05-07",{"date":275,"type":35},{"date":221,"type":21},{"date":324,"type":21},"2028-02-28",{"name":41,"class":42},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":4},"100639344","phase-3-brief-cognitive-behavioral-therapy-for-suicide-prevention-in-a-brazilian-sample-a-study-protocol-of-a-randomized-clinical-trial-100639344","NCT07574658","Brief Cognitive Behavioral Therapy for Suicide Prevention in a Brazilian Sample: a Study Protocol of a Randomized Clinical Trial","Study participants meet inclusion criteria if they are (1) Between the ages of 18-65; (2) Treatment-seeking status in outpatient mental health and\u002F or inpatient psychiatry discharge; (3) Report current (within the past week) suicide ideation (e.g., score greater than 2 on the Scale for Suicide Ideation) and\u002For a suicide attempt within the past month (e.g., as assessed by the Beck Scale for Suicide Ideation (BSI); (4) Able to understand and speak Portuguese; (5) Able to complete the informed consent process.","60 Years",{"count":334,"type":21},150,[336],"PHASE3","The vast majority of suicides occur in low-and middle-income countries (LMICs), and evidence on effective psychotherapeutic interventions to prevent suicide that are culturally adapted to these contexts is limited. This scenario implies an urgent need for evidence-based suicide prevention strategies in Brazil. This research aims to evaluate the effectiveness of brief cognitive-behavioral therapy in preventing suicide in an outpatient setting of a Brazilian university. A randomized, controlled clinical trial with two arms, whose participants are adults who have attempted suicide or have had suicidal ideation with intent to die, will be designed. Inclusion criteria will be suicidal ideation with intent to die in the last week and\u002For suicide attempt in the last month. Patients will be randomly assigned to receive either a weekly 12-session supportive therapy or brief cognitive-behavioral therapy. The duration of treatment will be approximately 3 months. Both groups will have weekly individual therapy. Follow-up contact will be made 1 month and 6 months after treatment. If necessary, patients are entitled to two booster sessions during the follow-up period. The outcomes to be assessed, a priori, are suicide attempts, self-harm without suicidal intent and suicidal ideation, assessed by the Beck Scale for Suicide Ideation (BSI). Linear mixed models will be used to assess the outcomes of continuous variables, logistic regression models for categorical outcomes and survival analysis for the analysis of suicide attempts.",[339,340],"Suicide Ideation","Suicide Attempts",[342,343,344,345,346,347],"Suicide","Suicide prevention","Brief Cognitive Behavioral Therapy (BCBT)","Randomized clinical trial","Evidence-based psychotherapy","Low- and middle-income countries (LMICs)","2026-05-04",{"date":350,"type":35},"2026-05-08",{"date":352,"type":21},"2026-05-10",{"date":354,"type":21},"2028-07-10",{"name":41,"class":42},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":363,"maxAge":232,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":43},"100316407","early-immunosuppressive-therapy-on-the-course-of-vogt-koyanagi-harada-disease-100316407","NCT03399175","Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease","Influência de imunomodulação Precoce Influence of Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease: a Prospective Study","Inclusion criteria:\n\n\\- acute Vogt-Koyanagi-Harada disease\n\nExclusion criteria:\n\n* non collaborative patient\n* minimum one-year follow-up","10 Years",{"count":186,"type":21},[57],"This prospective study will include patients with Vogt-Koyanagi-Harada disease from disease onset, treated with early systemic high-dose corticosteroid and immunosuppressive therapy. Clinical and subclinical signs of disease activity added with electroretinogram exams, through predefined intervals, will be evaluated through a minimum 12-month follow-up.",[368],"Vogt Koyanagi Harada Disease",[370,371,372,373,374],"Vogt-Koyanagi-Harada disease","Immunosuppressive therapy","Indocyanine green angiography","Enhanced depth imaging optical coherence tomography","Electroretinogram",{"date":320,"type":35},{"date":377,"type":35},"2015-03-23",{"date":379,"type":21},"2028-12",{"name":41,"class":42},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":388,"minAge":52,"maxAge":389,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":407,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":43},"100571149","aerobic-exercise-and-its-impact-on-sensory-musculoskeletal-and-psychosocial-aspects-in-migraine-100571149","NCT06716489","Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine","Influence of Aerobic Exercise on Sensory Perception, Musculoskeletal and Psychosocial Alterations in Patients With Migraine","Inclusion Criteria:\n\n* Women aged between 18 and 48 years.\n* Diagnosed with migraine by an experienced neurologist specialized in headaches, following the criteria of the International Classification of Headache Disorders (ICHD).\n* Frequency of headache between 3 and 8 days per month, to ensure adherence to the treatment.\n\nExclusion Criteria:\n\n* Presence of any other type of concurrent headache.\n* Medical conditions affecting sensitivity and autonomic modulation, such as peripheral neuropathies, autonomic disorders, severe neurological diseases, and others.\n* Conditions that prevent physical activity, such as severe musculoskeletal injuries, cardiovascular diseases, or related conditions.\n* Premature ovarian failure.\n* Regular physical exercise in the past year.\n* Body Mass Index (BMI) above 30.0.\n* Smokers or individuals using drugs that interfere with sensitivity and cardiac modulation (e.g., beta-blockers).\n* Abuse of abortive medications.","FEMALE","48 Years",{"count":391,"type":21},100,[57],"Migraine is a neurological disorder associated with high levels of disability and changes in sensory processing, musculoskeletal function, and psychosocial factors. Aerobic exercise is a low-cost, non-pharmacological strategy that has shown potential benefits for migraine management, but its effects on sensory perception and musculoskeletal function are not yet fully understood.\n\nThis randomized controlled trial will investigate the effects of a supervised aerobic exercise program combined with pain neuroscience education compared with an active control condition in women aged 18 to 48 years diagnosed with migraine. Participants will be randomly allocated to either an intervention group, which will perform supervised aerobic exercise three times per week for 16 weeks and receive one session of pain neuroscience education, or a control group, which will receive recommendations for unsupervised physical activity at home.\n\nOutcomes related to migraine-related disability, self-reported symptoms, sensory sensitivity, and musculoskeletal function will be assessed at baseline and after the intervention period. Questionnaires will also be collected at a 6-month follow-up. The results of this study may contribute to the development of accessible and low-risk non-pharmacological treatment strategies for people with migraine.",[395,396,397,398,399,400,401,402,403,404,405,406,305],"Migraine","Migraine Disease","Migraine Disorder","Migraine Disorders, Brain","Headache","Headache (Migraine)","Headache Disorders","Headache Disorders, Primary","Aerobic Exercise","Pain Management","Sensory Disorders","Psychosocial Factors",[408,409,410,411,412,413,414,415,416,417,418,406,419,420,421,422,423,424,425,426,427],"migraine","aerobic exercise","sensory perception","exercise","headache","disability","musculoeskeletal alterations","quality of life","neck pain","cervical pain","Sensory Thresholds","Physical Fitness","Exercise Intervention","Central Sensitization","Physical Therapy","Migraine Management","Non-pharmacological Treatment","Clinical Trial","Headache Relief","sensitization","2026-04-27",{"date":430,"type":35},"2026-04-28",{"date":432,"type":35},"2026-03-03",{"date":434,"type":21},"2028-11-30",{"name":41,"class":42},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":232,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":450,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":43},"100521754","effects-of-adjunct-antimicrobial-photodynamic-therapy-in-periodontal-treatment-of-patients-with-obesity-100521754","NCT06073704","Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity","Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients With Obesity","Inclusion Criteria:\n\n* Obesity (grade II and III classified according to Body Mass Index)\n* Periodontitis stage II to IV\n* Presence of at least 20 teeth excluding 3rd molars.\n\nExclusion Criteria:\n\n* Smokers\n* Alcohol or drugs consumption\n* Kidney disorders\n* Pregnancy or lactation\n* Use of antibiotics at the last 30 days\n* Use of drugs that alter periodontal structures as phenytoin or ciclosporin\n* Periodontal treatment at the last 6 months",{"count":444,"type":21},24,[57],"The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.",[448,449],"Periodontitis","Obesity",[451,452],"periodontitis","obesity",{"date":348,"type":35},{"date":455,"type":35},"2023-10-09",{"date":457,"type":21},"2026-12-30",{"name":41,"class":42},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":4},"100635086","effects-of-intensive-glycemic-control-in-the-postoperative-period-of-neurosurgical-patients-on-the-incidence-of-surgical-site-infection-100635086","NCT07548112","Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection","Brain Sugar","Inclusion Criteria\n\n* Adults aged ≥18 years\n* Patients undergoing elective cranial neurosurgical procedures classified as clean surgeries\n\nExclusion Criteria:\n\n* Patients who underwent any surgical or neurosurgical procedure within 30 days prior to enrollment\n* Presence of active infection at any site\n* Patients undergoing emergency or urgent neurosurgical procedures\n* Patients with trauma and exposed brain tissue\n* Diagnosis of diabetic ketoacidosis\n* Blood glucose levels \\>600 mg\u002FdL",{"count":467,"type":21},572,[57],"Surgical site infections (SSIs) are frequent complications in neurosurgical patients, often worsened by perioperative hyperglycemia. This randomized, controlled trial will compare intensive glycemic control (continuous insulin infusion, 140-180 mg\u002FdL) with standard care (subcutaneous insulin, 81-180 mg\u002FdL) in 544 patients. The primary outcome is SSI occurrence within 90 days post-surgery. Results aim to guide optimal glycemic management for SSI prevention in neurosurgery.",[471],"Surgical Site Infection (SSI)",[473,474,475,476],"Nursing","Surgical Site Infection","Neurosurgery","Glycemic Control","2026-04-20",{"date":479,"type":35},"2026-04-23",{"date":481,"type":21},"2026-04-05",{"date":483,"type":21},"2027-10",{"name":41,"class":42},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":388,"minAge":52,"maxAge":156,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":500,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":509,"leadSponsor":511,"locationsCount":120},"100545889","acute-beetroot-juice-supplementation-in-pre-eclampsia-pregnancies-100545889","NCT06387784","Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies","Acute Effect of Beetroot Juice Supplementation in Pregnant Women With Pre-eclampsia: a Single-Blind Randomized Placebo-Controlled Trial","BEET_PE","1. Pre-eclampsia pregnat women\n\n   Inclusion Criteria:\n   * Pregnant women at or beyond the 20th week of gestation.\n   * Hospitalized at Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto.\n   * Diagnosed with early-onset pre-eclampsia confirmed by a medical professional.\n   * Capacity to provide written informed consent for study participation.\n\n   Exclusion Criteria:\n   * Multiple pregnancies.\n   * Uncontrolled arterial hypertension (Systolic Blood Pressure \\> 160 mmHg or Diastolic Blood Pressure \\> 100 mmHg).\n   * Pregnant women with a body mass index \\> 40 kg\u002Fm²\n   * Severe gestational complications.\n   * History of food allergy with hypersensitivity to beetroot.\n   * Smokers.\n   * Chronic alcohol consumption.\n   * Medications such as non-steroidal anti-inflammatory drugs, nasal decongestants, users of proton pump inhibitors and H2 receptor antagonists or any other medication that interferes with stomach pH.\n   * Diagnosis of renal or hepatic disease affecting nitrate metabolism.\n   * Cardiac conditions such as moderate to severe congestive heart failure and coronary artery disease.\n   * Pre-existing type 1 or type 2 diabetes.\n2. Healthy Pregnant Women\n\nInclusion Criteria:\n\n* Healthy pregnant women at or beyond the 20th week of gestation.\n* Absence of pre-eclampsia diagnosis or other obstetric complications.\n* Willingness and ability to remain admitted at the Clinical Research Unit for the - period required by the study.\n* Capacity to provide written informed consent for study participation.\n\nExclusion Criteria:\n\n\\- The same exclusion criteria from Pre-eclampsia group apply.",{"count":494,"type":21},60,[57],"Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia and healthy pregnant. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. We want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, we seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia.",[498,499],"Pre-Eclampsia","Pregnacy",[501,502,503,504],"Pre-eclampsia","Pregnancy","Beetroot Juice","Nitric Oxide","2026-04-15",{"date":507,"type":35},"2026-04-21",{"date":243,"type":21},{"date":510,"type":21},"2028-07",{"name":41,"class":42},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":388,"minAge":52,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":523,"conditions":524,"keywords":527,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":43},"100524211","inorganic-nitrate-supplementation-in-chronic-hypertensive-pregnancies-100524211","NCT06105775","Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies","Inorganic Nitrate Supplementation for Blood Pressure Control in Chronic Hypertensive Pregnancies From the 2nd Trimester (NIT_CH): a Triple-Blind Randomized Placebo-Controlled Trial","NIT_CH","Inclusion Criteria:\n\n* Pregnant women diagnosed with chronic hypertension (systolic blood pressure above 140 mmHg and\u002For diastolic blood pressure above 90 mmHg before pregnancy or before 20 weeks of gestation) as defined by the Brazilian Network for Studies on Hypertension in Pregnancy (RBEHG, Brazilian acronym) Protocol and Chronic Hypertension\u002FPreeclampsia by the Brazilian Federation of Gynecology and Obstetrics Associations (FEBRASGO, Brazilian acronym) Protocol.\n* Patients on monotherapy with methyldopa as treatment at the time of inclusion.\n* Women with less than 16 weeks of gestation confirmed by first-trimester ultrasonography confirming gestational age.\n\nExclusion Criteria:\n\n* Multiple pregnancies, age below 18 years old, inability to provide informed consent, or history of low adherence to medication therapy.\n* Patients with uncontrolled chronic hypertension, with blood pressure values above 160x110mmHg.\n* History of food allergies, especially hypersensitivity to beetroot.\n* Users of illicit drugs, smokers, or alcohol abusers.\n* Diagnosis of coronary artery disease, congestive heart failure (moderate to severe), moderate to severe liver failure, chronic renal insufficiency (with plasma creatinine clearance less than 30 ml\u002Fmin\u002F1.73 m² of body surface), pre-existing type 1 diabetes, and type 2 diabetes.\n* Pregnant women who frequently used non-steroidal anti-inflammatory drugs, nasal decongestants, and anorectics before getting pregnant; users of proton pump inhibitors and H2 receptor antagonists or any other medication that interferes with stomach pH, starting 2 weeks before the beginning and continuing throughout the remainder of the study.",{"count":521,"type":21},144,[57],"High blood pressure during pregnancy poses significant risks to both the mother and baby. A combination of factors, including advancing maternal age, rising obesity rates, and metabolic health issues, have amplified the prevalence of this condition. While conventional medicines are available, safety during pregnancy remains a concern. Recent studies suggest that inorganic nitrate might be a safer alternative. The power of nitrate lies in its ability to stimulate the body's production of a compound that aids in dilating and relaxing blood vessels. Preliminary studies conducted on mice and a select group of pregnant women have yielded encouraging results. Early tests indicated that after consuming inorganic nitrate, there was a reduction in blood pressure and an improvement in the health of the mother's uterine artery-a vital vessel responsible for nourishing the fetus. Our study aims to investigate the effects of inorganic nitrate supplementation on pregnant women from the start of their pregnancy and continuing it throughout their term. If our findings are positive, it could revolutionize how we approach blood pressure management during pregnancy, paving the way for healthier futures for both mothers and babies.",[525,526,502],"Hypertension in Pregnancy","Hypertension",[528,525,504,529],"Endothelial Dysfunction","inorganic nitrate",{"date":477,"type":35},{"date":532,"type":35},"2025-03-06",{"date":534,"type":21},"2027-07",{"name":41,"class":42},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":548,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":43},"100633130","polynucleotide--hyaluronic-acid-gel-with-xenogeneic-graft-for-intrabony-periodontal-defects-100633130","NCT07522684","Polynucleotide + Hyaluronic Acid Gel With Xenogeneic Graft for Intrabony Periodontal Defects","Effects of the Combination of a Polynucleotide and Hyaluronic Acid-Based Gel With Xenogeneic Bone Graft in the Treatment of Intrabony Defects in Patients With Periodontitis: a Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n* ≥ 18 years of age;\n* diagnosis of periodontitis stage III or IV, grade B or C (Chapple et al., 2018; Papapanou et al., 2018);\n* full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) of ≤ 20%;\n* presence of a 2- or 3-wall intrabony defect with a depth ≥ 3 mm and probing depth and clinical attachment level ≥ 5 mm in the interproximal region of a single- or multi-rooted tooth;\n* pulp vitality or satisfactory endodontic treatment in the tooth to be treated;\n* at least 1 mm of keratinized tissue on the buccal surface of the tooth to be treated.\n\nExclusion Criteria:\n\n* presence of furcation involvement associated with the intrabony defect;\n* presence of systemic conditions that may affect the progression of periodontitis or the response to its treatment;\n* long-term use of anti-inflammatory or immunosuppressive medications;\n* use of antimicrobials within the last 6 months;\n* continuous use of mouthwashes containing antimicrobial agents within the last 6 months;\n* need for prophylactic antibiotic therapy for routine dental procedures;\n* current or past tobacco use within the last 5 years;\n* pregnancy;\n* breastfeeding.",{"count":544,"type":21},66,[57],"Over the last 30 years, the prevalence of periodontitis (PE) has increased substantially, including among younger populations, highlighting the need to improve the management of this condition as a chronic disease and to develop techniques that favor its control and stability in the short and long term. After non-surgical periodontal therapy (NSPT), the first phase of PE treatment, residual periodontal pockets may persist, often associated with intraosseous defects, which compromise the tooth's prognosis and are associated with disease progression and increased treatment complexity. Surgical treatment of intrabony defects often results in the formation of long junctional epithelium, weakly attached to the root surface, since true regeneration of periodontal tissues is an unpredictable event and depends on complex biological processes. In recent decades, various biomaterials have been proposed as aids to open-flap debridement (OFD) in the surgical treatment of intrabony defects, with the aim of promoting periodontal regeneration, enhancing clinical results and favoring treatment prognosis. Recently, the combination of polynucleotides (PN) and hyaluronic acid (HA) has emerged as a promising auxiliary strategy to promote periodontal regeneration, due to its biological potential in stimulating cell growth and increasing cell viability. The aim of this controlled, randomized, parallel-group clinical study is to compare OFD alone with its association with xenogenous bone graft or xenogenous bone graft plus gel containing PN\u002FHA in the surgical treatment of intrabony defects in patients with PE (stages III or IV, grades B or C). The patients will be randomly divided into three experimental groups (n=22): control (C), xenogeneic bone graft (XENO) and xenogeneic bone graft plus gel containing PN\u002FHA (R-XENO). The patients will receive NSPT, and after eight weeks will undergo surgical procedures to treat the intrabony defects (baseline). Clinical, radiographic, tomographic and immunological periodontal parameters will be assessed at baseline and after 12 months. The wound healing index will be recorded 1, 2 and 6 weeks after the surgical procedure. Patient-centered outcomes will be assessed by means of a visual analog scale (VAS), applied two weeks after the surgical procedure, and oral health-related quality of life (OHRQoL) questionnaires, applied at the beginning of the study and after 6 and 12 months. At the start of the study and after 6 and 12 months, anthropometric data will be collected, blood pressure (BP) will be measured and questionnaires will be applied to survey socio-demographic and nutritional parameters. The data obtained will be statistically analyzed (p\\\u003C0.05).",[448],[425,448,549,550,551],"Wound Healing","Polynucleotides","Hyaluronic Acid","2026-04-14",{"date":477,"type":35},{"date":555,"type":35},"2026-02-25",{"date":557,"type":21},"2028-05",{"name":41,"class":42},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":155,"minAge":52,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":573,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":4},"100631445","phase-2-clinical-evaluation-of-subcutaneous-testosterone-implants-in-men-with-symptomatic-hypogonadism-100631445","NCT07500766","Clinical Evaluation of Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism","Inclusion Criteria:\n\n* Absence of desire for future fertility.\n* Two fasting total testosterone measurements ≤ 350 ng\u002FdL obtained between 6:00 and 10:00 a.m.\n* A positive ADAM questionnaire result (Participants with a prior diagnosis of testosterone deficiency established at this institution who are currently receiving testosterone replacement therapy and wish to participate in the study will be eligible for inclusion after completion of an appropriate washout period of the testosterone formulation in use.)\n\nExclusion Criteria:\n\n* Inability to complete or respond to study questionnaires.\n* Body mass index (BMI) \\> 35 kg\u002Fm².\n* Untreated depression, defined as a Beck Depression Inventory score \\> 20.\n* Personal history of cancer.\n* Suspicious findings on digital rectal examination or breast examination.\n* Prostate-specific antigen (PSA) \\> 4 ng\u002FmL.\n* History of thrombosis.\n* Known thrombophilia.\n* Erythrocytosis.\n* Polycythemia.\n* Elevated liver enzymes (AST or ALT \\> 1.5 times the upper limit of normal).\n* Untreated chronic disease.\n* Heart failure classified as New York Heart Association (NYHA) class III or IV.\n* History of cardiovascular disease within the previous 6 months.\n* Substance use disorder or alcohol dependence.\n* Use of antiandrogen medications (flutamide, bicalutamide, enzalutamide, apalutamide, spironolactone, cyproterone acetate, abiraterone, ketoconazole, dutasteride, finasteride).\n* Use of estrogenic medications (estradiol, conjugated estrogens, progestogens).\n* Use of anabolic androgenic steroids without medical indication.\n* Untreated hypothyroidism.\n* Known allergy or hypersensitivity to testosterone or any component of the implant (testosterone, stearic acid).",{"count":55,"type":21},[91],"Introduction:\n\nMale hypogonadism is a clinical syndrome associated with significant consequences for health and quality of life. In Brazil, approved testosterone replacement therapy options are limited to injectable formulations and transdermal gels, which are often associated with suboptimal adherence. Subcutaneous testosterone implants, already used in the United States and recommended by international guidelines, represent a promising alternative but are not yet available in Brazil.\n\nObjective:\n\nTo evaluate the efficacy, safety, pharmacokinetics, and quality-of-life impact of 200 mg testosterone implants manufactured in Brazil for the treatment of men with symptomatic hypogonadism.\n\nMethods:\n\nThis is a prospective interventional study conducted at the Division of Urology of the Hospital das Clínicas, University of São Paulo School of Medicine (FMUSP). Thirty cisgender hypogonadal men meeting strict inclusion and exclusion criteria will be enrolled. Participants will receive subcutaneous testosterone implants totaling 800 mg and will be followed for six months. Serial blood sampling will be performed to assess hormonal levels (total and free testosterone, LH, FSH, and PSA) and metabolic parameters (lipid profile, body mass index, and waist circumference). Validated questionnaires, including the IIEF-15, ADAM, and WHOQOL-BREF, will be used to evaluate sexual function, hypogonadal symptoms, quality of life, and patient satisfaction.\n\nOutcomes:\n\nThe primary outcome is the ability of the implants to achieve and maintain therapeutic serum testosterone levels (450-800 ng\u002FdL). Secondary outcomes include pharmacokinetic profile (Cmax, half-life, and mean duration), metabolic effects, changes in quality of life, and treatment adherence.\n\nClinical Significance:\n\nThis study advances the understanding of a testosterone replacement modality that may offer greater convenience for selected patients and for which data on nationally manufactured products are currently lacking. Over a six-month period, the study will investigate laboratory behavior, clinical impact, and patient satisfaction.\n\nRelevance and Impact:\n\nThis is the first study of its kind conducted in Brazil, combining methodological rigor with a robust design to evaluate the safety and efficacy of domestically manufactured testosterone implants. The methodology incorporates detailed ethical and scientific criteria, ensuring high-quality data. The results may support regulatory and clinical decision-making, benefiting patients and potentially contributing to the Brazilian Unified Health System (SUS).",[569,570,571,572],"Male Hypogonadism","Testosterone Deficiency","Testosterone Replacement Therapy","Testosterone",[574,575,576],"testosterone pharmacokinetics","testosterone pharmacodynamics","testosterone pellets","2026-03-24",{"date":579,"type":35},"2026-03-30",{"date":581,"type":21},"2026-03",{"date":583,"type":21},"2027-04",{"name":41,"class":42},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":232,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":598,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":43},"100628609","effects-of-periodontal-treatment-associated-with-antimicrobial-photodynamic-therapy-on-halitosis-in-patients-with-diabetes-mellitus-100628609","NCT07463859","Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus","Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients diagnosed with type 2 diabetes mellitus according to the 2019 WHO criteria\n* Stage 3 or 4 periodontitis\n* No periodontal treatment in the previous 12 months\n* a minimum of 20 remaining teeth.\n\nExclusion Criteria:\n\n* Smokers\n* Alcohol-dependent individuals\n* Pregnant or lactating women\n* Patients with renal disorders\n* Patients using medications that affect the periodontium",{"count":259,"type":21},[57],"The goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. The main question it aims to answer is: aPDT treatment is more effective in treating halitosis? aPDT treatment is more effective in periodontitis? Researchers will compare aPDT treatment to conventional treatment (scaling and root planning and tongue scraper) to see if aPDT has additional effects in reducing halitosis and improving periodontal health.\n\n* Participants will be asked to visit the clinic once a week for exam and treatment during 1 month.\n* After active treatment they will be asked to come to maintenance and control visits once a month until 6 months.",[596,597,448],"Type 2 Diabetes","Halitosis",[597,451,599,600],"lasers","Photodynamic Therapy","2026-03-11",{"date":603,"type":35},"2026-03-16",{"date":605,"type":21},"2026-04-02",{"date":607,"type":21},"2027-02-28",{"name":41,"class":42},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":624,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":43},"100629303","empagliflozin-adjunctive-therapy-in-bipolar-depression-100629303","NCT07472920","Empagliflozin Adjunctive Therapy in Bipolar Depression","Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)","EMPA-BD","Inclusion Criteria:\n\n1. Adults aged 18 to 65 years.\n2. Diagnosis of Bipolar Disorder type I or II according to DSM-5 criteria, confirmed by the MINI International Neuropsychiatric Interview.\n3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 15 at screening.\n4. Currently receiving stable pharmacological treatment for bipolar disorder, with no medication changes (addition or withdrawal) in the past 4 weeks.\n5. Ability to provide informed consent.\n6. Insulin resistance, defined as HOMA-IR ≥ 1.8.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to empagliflozin or any SGLT2 inhibitor.\n2. Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening.\n3. Known pancreatic disease (pancreatitis or pancreatic surgery).\n4. Chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n5. Recurrent genital fungal infections.\n6. Pregnant or breastfeeding.\n7. Alcohol abuse or dependence within the past 12 months.\n8. YMRS score ≥ 12 (presence of manic or hypomanic symptoms).",{"count":131,"type":21},[57],"Bipolar disorder is a long-term mental health condition that causes mood changes, with depressive episodes being the most frequent and disabling. Many people do not fully recover with current treatments, showing the need for new therapeutic options.\n\nRecent research shows that insulin resistance (IR), a condition in which the body does not respond well to insulin, is common in people with bipolar disorder. It is linked to more severe mood symptoms, poorer treatment response, and higher risk of heart disease. IR may raise inflammation and affect how the brain uses energy, which can influence mood regulation.\n\nEmpagliflozin is a medicine approved for type 2 diabetes. In addition to its metabolic and heart benefits, studies suggest that it may also protect the brain and reduce inflammation, possibly helping to improve mood.\n\nThis open-label, proof-of-concept clinical trial will test how well empagliflozin works and how safe it is as an add-on treatment for people with bipolar depression and insulin resistance. A total of 20 adults with bipolar disorder type I or II, currently in a depressive episode, will take part in the study over a 12-week period.\n\nThe main goal is to see whether empagliflozin can lower depressive symptoms, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Other measures include changes in insulin resistance and incidence of adverse events.\n\nThe study aims to explore whether improving insulin resistance can help both mood and metabolic health in people with bipolar disorder, guiding future clinical research.",[621,622,623],"Bipolar Disorder","Bipolar Depression","Insulin Resistance",[621,622,623,625,626,627],"Empagliflozin","SGLT2 Inhibitors","Metabolic Psychiatry",{"date":603,"type":35},{"date":630,"type":21},"2026-03-09",{"date":632,"type":21},"2026-12",{"name":41,"class":42},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":363,"maxAge":18,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":642,"briefSummary":643,"conditions":644,"keywords":649,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":659,"leadSponsor":660,"locationsCount":43},"100628778","lifestyle-intervention-for-obesity-and-eating-disorder-prevention-in-transgender-adolescents-100628778","NCT07466069","Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents","Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 10-14 years\n* Self-identified as transgender or gender-diverse\n\nExclusion Criteria:\n\n* Current diagnosis of eating disorder requiring specialized treatment\n* Severe psychiatric instability\n* Cognitive impairment limiting participation",{"count":444,"type":21},[57],"Transgender and gender-diverse adolescents are at increased risk for obesity, disordered eating behaviors, body dissatisfaction, and reduced quality of life due to minority stress and structural inequities. However, no structured lifestyle interventions specifically tailored to this population have been developed.\n\nThis randomized controlled trial aims to evaluate the effectiveness of a 6-month interdisciplinary lifestyle intervention designed to prevent obesity and eating disorders in transgender and gender-diverse adolescents aged 10-14 years. Participants will be randomized (1:1) to either an intervention group receiving monthly group sessions (for adolescents and caregivers separately) and weekly supportive messages, or a control group receiving standard outpatient care and general health recommendations.\n\nThe primary outcome is quality of life measured by the WHOQOL-BREF. Secondary outcomes include eating disorder symptoms, body image, diet quality, physical activity levels, sedentary behavior, body composition, and anthropometric measures.",[645,646,647,648],"Obesity & Overweight","Eating Disorders","Body Image Disturbance","Gender Diverse Populations",[650,651,652,653,654,449],"Transgender","Adolescent","Gender-diverse","Lifestyle","Eating disorders","2026-03-06",{"date":657,"type":35},"2026-03-12",{"date":581,"type":21},{"date":632,"type":21},{"name":41,"class":42},{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":332,"enrollmentInfo":669,"targetDuration":4,"studyType":22,"phases":671,"briefSummary":672,"conditions":673,"keywords":675,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":43},"100553629","program-to-enhance-cardiovascular-risk-trough-an-intervention-of-nutrition-in-bipolar-disorder-100553629","NCT06488573","PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder","The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder","PROTECTION-BD","Inclusion Criteria:\n\n* Clinical diagnosis of Bipolar disorder types I and II diagnosis\n* Adults of both genders, from 18 to 60 years old\n* In typical pharmacotherapy for BD, for at least one month\n* Agreement to participate in the study with signature of the consent form\n\nExclusion Criteria:\n\n* Patients with \"very good or excellent\" diet quality assessed by the diet quality scale (ESQUADA): \\>275 out of a score of 375\n* Patients in a state of hypomania or mania: score \\>8 (Young Mania Rating Scale - YMRS)\n* Patients with severe depression \\>21 Montgomery-Åsberg Depression Rating Scale\n* Patients at low cardiovascular risk (\\\u003C7 points for men or \\\u003C9 points for women on the Framingham Global Risk Score)\n* Low weight or eutrophic body mass index: \\\u003C25kg\u002Fm² as in similar studies\n* Pregnant or breastfeeding women\n* Patients diagnosed with anorexia and bulimia nervosa\n* Patientes diagnosed with Irritable Bowl Syndrome or other diagnosed conditions that affect the gastrointestinal function",{"count":670,"type":21},88,[57],"Individuals with Bipolar Disorder (BD) have twice the risk of being affected by metabolic comorbidities and a 1.8-fold increased risk of mortality from cardiovascular diseases when compared to the general population. These factors are fundamental in the 14-year reduction in the life expectancy of people with TB reported in recent meta-analyses. This occurs mainly due to the increased inflammation associated with the disease, the adverse effects of pharmacological treatments and unhealthy lifestyle habits that are more common in people diagnosed with BD. Nutrition has been studied as an adjunctive treatment in other psychiatric disorders, but there is a lack of studies about the role of nutrition in TB. Considering that diet can impact metabolic health, this randomized controlled study aims to evaluate the effect of a nutritional intervention on cardiovascular risk in patients with TB. The intervention is based on the dietary pattern recommended in the Dietary Guidelines for the Brazilian Population and will be applied by a registered dietitian. According to the literature, the sample size will be 72 individuals with TB (36 in the control group with usual treatment + 36 in the intervention group added to the usual treatment). The intervention will be carried out in 7 individual sessions and 8 group sessions with specific themes. The primary aim of this protocol will be an intervention to contribute to cardiovascular health - verified by serum markers, anthropometric measurements and the Framingham Cardiovascular Risk Score (algorithm used to estimate an individual's 10-year cardiovascular risk). The secondary stages will be the adherence of the intervention and the impact on the quality of life of the participants. The possible positive results of this nutritional intervention can open new clinical perspectives. Meaning that might show that better food choices can protect the cardiovascular health of individuals with TB, leading to a reduction in morbidity and mortality associated with the disease.",[622,674],"Bipolar Disorder (BD)",[676,677,678,679,680],"nutrition intervention","nutritional psychiatry","bipolar disorder","dietary intervention","brazilian dietary guideline","2026-02-26",{"date":683,"type":35},"2026-03-02",{"date":685,"type":21},"2026-04",{"date":687,"type":21},"2027-12",{"name":41,"class":42},{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":695,"eligibilityCriteria":696,"healthyVolunteers":12,"sex":17,"minAge":697,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":22,"phases":699,"briefSummary":700,"conditions":701,"keywords":706,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":712,"lastUpdatePostDateStruct":713,"startDateStruct":715,"completionDateStruct":717,"leadSponsor":719,"locationsCount":43},"100626130","intraoperative-cryoanalgesia-versus-thoracic-epidural-block-in-mirpe-minimally-invasive-repair-of-pectus-excavatum-100626130","NCT07431632","Intraoperative Cryoanalgesia Versus Thoracic Epidural Block in MIRPE (Minimally Invasive Repair of Pectus Excavatum)","Comparative Study of the Efficacy of Intraoperative Intercostal Cryoanalgesia and Thoracic Epidural Block in the Postoperative Period of Minimally Invasive Pectus Excavatum Repair (MIRPE): a Prospective, Randomized Clinical Trial","FROZEN MIRPE","Inclusion Criteria:\n\n1. Having pectus excavatum;\n2. Having signed the Informed Consent Form for the study.\n\nExclusion Criteria:\n\n1. Age \\\u003C 13 years at the time of the procedure;\n2. Chronic use of analgesics preoperatively;\n3. Pectus carinatum, Poland syndrome, or other chest wall anomalies;\n4. Previous pectus excavatum repair by any technique;\n5. Previous thoracic surgery;\n6. Congenital heart disease;\n7. Hemorrhagic dyscrasia;\n8. Major anesthetic risk factors or history of previous problems with anesthesia;\n9. Pregnancy.","13 Years",{"count":186,"type":21},[57],"The main objective of this study is to compare epidural blockade with cryoanalgesia of the intercostal nerves as an analgesic method in the postoperative period of minimally invasive repair of pectus excavatum (MIRPE).",[702,703,704,705],"Funnel Chest","Pectus Excavatum","Postoperative Pain After Video Assisted Thoracic Surgery","Postoperative Pain",[707,708,709,710,711],"cryoanalgesia","pectus excavatum","funnel chest","postoperative pain","MIRPE","2026-02-18",{"date":714,"type":35},"2026-02-24",{"date":716,"type":35},"2024-11-28",{"date":718,"type":21},"2028-01",{"name":41,"class":42},{"id":721,"slug":722,"hasResults":12,"nctId":723,"briefTitle":724,"officialTitle":725,"acronym":4,"eligibilityCriteria":726,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":727,"targetDuration":4,"studyType":22,"phases":728,"briefSummary":729,"conditions":730,"keywords":732,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":712,"lastUpdatePostDateStruct":736,"startDateStruct":738,"completionDateStruct":740,"leadSponsor":742,"locationsCount":43},"100624630","phase-3-evaluation-of-the-efficacy-safety-and-tolerability-of-lacosamide-in-major-depressive-episodes-of-bipolar-disorder-types-i-and-ii-100624630","NCT07412132","Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.","Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial.","Inclusion Criteria:\n\n1. Diagnosis of bipolar disorder (type I or II) confirmed by structured clinical interview;\n2. acute major depressive episode of moderate or severe intensity;\n3. no response to at least two adequate pharmacological interventions to treat the current episode.\n\nExclusion Criteria:\n\n1. Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other psychiatric disorders (personality disorders, anxiety disorders, substance use disorders, eating disorders, and attention deficit disorder) will be permitted provided the primary diagnosis is bipolar disorder;\n2. acute suicidal ideation (defined by HAMD-17 item 3 ≥ 3 points or by clinical assessment);\n3. current depressive episode with psychotic features (by clinical assessment);\n4. suspected or confirmed pregnancy;\n5. severe or unstable clinical illnesses;\n6. previous history of non-response to an adequate course of at least 8 sessions of electroconvulsive therapy;\n7. previous history of non-response to an adequate course of ketamine treatment.",{"count":186,"type":21},[336],"Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving depressive and manic symptoms in individuals with bipolar disorder (BD). The primary objective of this study is to evaluate the efficacy of combining lacosamide as an augmentation treatment to first- or second-line medication treatments in moderate to severe major depressive episodes of treatment-resistant BD I and II (failure of at least two adequate treatments during the current episode). The main hypothesis of the study is that lacosamide produces a greater reduction in depression scores compared to a placebo treatment and that both groups will exhibit similar rates of side effects and adverse events. We will conduct a double-blind, randomized, parallel-group pilot study, comparing the enhancement of the treatment that patients had been using with lacosamide and placebo, over a duration of 12 weeks. Forty subjects aged between 18 and 65 years with a diagnosis of BD (I or II) in a moderate or severe major depressive episode, despite the use of first- or second-line treatments, will be selected. The primary outcome will be the assessment of lacosamide efficacy through the difference in scores on the Hamilton Depression Rating Scale (HAMD-17) from the initial visit to the end of week 12 of intervention between the lacosamide and placebo groups.",[731],"Bipolar Affective Disorder",[733,734,678,735],"lacosamide","randomized clinical trial","bipolar depression",{"date":737,"type":35},"2026-02-20",{"date":739,"type":35},"2026-01-09",{"date":741,"type":21},"2027-01",{"name":41,"class":42},""]