[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital de Clinicas de Porto Alegre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":685},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,48,76,109,138,168,193,212,243,268,301,327,353,379,400,428,457,483,505,527,560,582,609,640,660],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100644227","psychosocial-support-program-for-public-school-teachers-100644227",false,"NCT07666542","Psychosocial Support Program for Public School Teachers","Evaluation of the Effectiveness and Feasibility of Different Formats of a School-Based Psychosocial Support Program for Public School Teachers: A Randomized Clinical Trial","PSP","Inclusion Criteria:\n\nSchool-level inclusion criteria:\n\n* Public schools from the state education system of Rio Grande do Sul, Brazil, serving students in \"Ensino Fundamental\" and \"Ensino Médio\" (equivalent to grades 1-12), and belonging to \"Polo 1\" or \"Polo 2\", administrative groupings defined by the Rio Grande do Sul State Department of Education that includes the following Regional Education Coordinators (Coordenadorias Regionais de Educação \\[CREs\\]): 1st, 2nd, 11th, 12th, 27th, and 28th CREs (Polo 1) and the 4th, 7th, 15th, 16th, 23rd, 25th, 39th CREs (Polo 2);\n* Schools with 10 or more teachers on staff;\n\nParticipant-level inclusion criteria (staff level)\n\nParticipating teachers must meet all of the following criteria:\n\n* School staff currently working in participating public schools;\n* Able and willing to participate in all stages of the intervention and scheduled assessments;\n* Provide informed consent prior to participation\n\nExclusion Criteria:\n\nSchool-level exclusion criteria:\n\n* Schools with fewer than 10 teachers on staff;\n* Youth and Adult Education Centers (Núcleos de Educação de Jovens e Adultos \\[EJA\\]);\n* Schools that began operating as full-time schools in 2026;\n* Schools not belonging to Polo 1 or 2 of the state education system of Rio Grande do Sul;\n* Schools that do not serve students in grades 1-12\n\nParticipant-level exclusion criteria\n\n* Not currently working in a participating public school;\n* Unable to participate in the training in the planned date for the specific school the teacher works at;\n* Decline or are unable to provide informed consent","ALL",{"count":20,"type":21},2970,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if different formats of a school-based psychosocial support training program can improve teachers' ability to recognize and respond to students' mental health needs. The study will include teachers working in public schools in Brazil.\n\nThe main questions it aims to answer are:\n\n1. Do teachers who receive the training improve their knowledge on how to better to identify and support students with mental health difficulties?\n2. Do different formats of training (synchronous online or self-paced) and the presence of supervision lead to different levels of improvement in this knowledge, in attitudes related to mental health, and helping behaviors?\n\nResearchers will compare three versions of the program (synchronous online with supervision sessions, synchronous online without supervision sessions, and asynchronous format) to see which approach is more effective, acceptable, and feasible.\n\nParticipants will:\n\n1. Take part in a training program delivered online or through self-paced materials;\n2. In some groups, attend additional supervision sessions to discuss real-life cases;\n3. Receive brief follow-up materials through mobile messages after the training\n4. Complete online questionnaires at multiple time points (before the training, during the program, after completion, and at follow-up).\n\nThe study will measure changes in teachers' knowledge, attitudes, and behaviors related to supporting students' mental health, as well as satisfaction with the program and its feasibility for large-scale implementation.",[27,28],"Mental Health Literacy","School Mental Health Training of Teachers",[30,31,32,33,34,35],"School Mental Health","Psychosocial Support","Cluster Randomized Controlled Trial","Teacher Professional Development","Mental Health Promotion","Education Policy","NOT_YET_RECRUITING","2026-08-17",{"date":39,"type":40},"2026-08-19","ACTUAL",{"date":42,"type":21},"2026-09",{"date":44,"type":21},"2026-12",{"name":46,"class":47},"Hospital de Clinicas de Porto Alegre","OTHER",{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100651685","comparison-of-paravertebral-versus-epidural-block-for-post-thoracotomy-pain-control-100651685","NCT07763249","Comparison of Paravertebral Versus Epidural Block for Post-thoracotomy Pain Control","Comparison Between Paravertebral Block and Epidural Block for the Management of Postoperative Pain in Patients Undergoing Thoracotomy and One-Lung Ventilation: A Prospective Non-inferiority Study.","Inclusion Criteria:\n\n* Patients aged 18 years or older;\n* Elective thoracic surgeries requiring open thoracotomy;\n* American Society of Anesthesiologists (ASA) physical status I to III.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* Urgent or emergency surgeries;\n* Contraindications to epidural catheter insertion or neuraxial anesthesia;\n* Infection at the proposed block site;\n* Patient refusal to undergo the study blocks;\n* Video-assisted thoracic surgeries;\n* Anticipated need for invasive mechanical ventilation in the postoperative period;\n* Chronic opioid use (daily use for more than 3 months of ≥10 mg oral morphine equivalent);\n* Severe vertebral deformities or previous thoracic spine surgery that prevent safe performance of the blocks;\n* Known allergy to local anesthetics, opioids, or study medications;\n* Body mass index \\> 35 kg\u002Fm²;\n* Advanced liver or kidney failure (Child-Pugh C or estimated glomerular filtration rate \\\u003C 50 mL\u002Fmin\u002F1.73 m²);\n* Severe cognitive impairment that prevents understanding of instructions or pain assessment.","18 Years",{"count":57,"type":21},80,[24],"This is a randomized, assessor-blinded, non-inferiority clinical trial comparing continuous thoracic paravertebral block (BPV) versus continuous thoracic epidural block (BPD) for postoperative pain control in adult patients undergoing elective open thoracotomy with one-lung ventilation. The primary outcome is the mean pain intensity at rest assessed by the Numeric Verbal Scale (NVS 0-10) during the first 48 hours after surgery. A total of 80 participants will be randomized 1:1 at Hospital de Clínicas de Porto Alegre, Brazil. The study aims to determine whether BPV provides non-inferior analgesia compared to BPD, with a potential advantage of less hemodynamic interference and better postoperative mobilization.",[61],"Postoperative Pain",[61,63,64,65,66],"Thoracotomy","Acute Pain","Thoracic Surgery","Regional Anesthesia","2026-08-10",{"date":69,"type":40},"2026-08-13",{"date":71,"type":21},"2026-09-01",{"date":73,"type":21},"2028-07-31",{"name":46,"class":47},1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":75},"100613253","tracheal-cuff-pressure-and-postoperative-complications-a-prospective-observational-study-100613253","NCT07264179","Tracheal Cuff Pressure and Postoperative Complications","Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.","TCP-POC","Inclusion Criteria:\n\n* Age greater than 18 years.\n* Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.\n\nExclusion Criteria:\n\n* Age less than 18 years.\n* Refusal to participate in the study.\n* Surgeries performed on an urgent or emergency basis.\n* Surgeries in pregnant women.\n* Cardiac surgeries.\n* Surgeries requiring single-lung ventilation.\n* Head and neck surgeries.\n* Surgeries on the cervical segment of the dorsal spine.\n* Surgeries requiring lateral or prone positioning.\n* Anticipated difficult airway (unanticipated difficult airways will be included).\n* Insufficient fasting time.\n* Surgeries in patients admitted to intensive care units.\n* Patients presenting the same symptoms included in the outcomes to be measured (pre-existing hoarseness, pain, cough, hemoptysis).\n* Tracheostomized patients or those with previous tracheobronchial segment lesions.",{"count":85,"type":21},362,"30 Days","OBSERVATIONAL","This prospective observational study aims to identify risk factors for tracheal mucosal injuries caused by orotracheal tube use during the intraoperative period in patients undergoing elective surgeries at the Hospital de Clínicas de Porto Alegre. The study will recruit patients sequentially for elective procedures requiring general anesthesia and orotracheal intubation. Primary outcomes include symptoms such as hoarseness, pharyngolaryngeal pain, cough, and hemoptysis, assessed up to 30 days post-surgery. A risk score for tracheal injuries will be derived.",[90,91],"Tracheal Intubation","Postoperative Complications (Cardiopulmonary)",[93,94,95,96,97,98,99],"Tracheal cuff pressure","Tracheal mucosal lesions","Cough","Orotracheal tube","Postoperative hoarseness","Pharyngolaryngeal pain","Hemoptysis","RECRUITING","2026-08-08",{"date":103,"type":40},"2026-08-11",{"date":105,"type":40},"2026-01-05",{"date":107,"type":21},"2029-04-30",{"name":46,"class":47},{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":18,"minAge":4,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":75},"100651181","effects-of-tummy-time-associated-with-therapeutic-positioning-in-premature-newborns-with-cranial-asymmetry-100651181","NCT07758426","Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry","Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry: A Randomized Clinical Trial","plagiocephaly","Inclusion criteria\n\n* Newborns with suspected cranial asymmetry.\n* Newborns of both sexes.\n* Gestational age of less than 37 weeks.\n* Admission to the HCPA Neonatal ICU or Neonatal Intermediate Care Unit.\n* Breathing without invasive ventilatory support and clinically stable, or breathing room air.\n* No expected hospital discharge within the next 15 days.\n\nExclusion criteria\n\n* Patients with congenital cranial malformations (e.g., hydrocephalus).\n* Patients with chronic diseases that could compromise the assessment of cranial asymmetry.\n* Patients with clinical conditions that prevent or compromise the performance of the procedures proposed in the study.\n* Patients with prolonged hospital stays requiring transfer to the Pediatric Intensive Care Unit (PICU) or the Pediatric Inpatient Unit (PIU).",true,"37 Weeks",{"count":120,"type":21},300,[24],"Deformational plagiocephaly is an alteration in the shape of a baby's head caused by pressure exerted on the skull. This condition can begin during gestation and worsen after birth, especially when the baby spends a lot of time lying on their back. Premature babies are at higher risk of developing this alteration, especially those who are hospitalized for long periods in intensive care units and use respiratory support devices. This study aims to evaluate the effects of a physiotherapy protocol in premature newborns with cranial asymmetry. To this end, the babies will be divided into two groups: one will receive daily positioning exercises and tummy time, while the other will continue to receive the unit's usual physiotherapy care.",[124,125],"Premature Newborns","Cranial Asymmetry",[127,128,129,130],"Brachycephaly","Non-synostotic deformational plagiocephaly","Prematurity","Positional Plagiocephaly","2026-08-06",{"date":103,"type":40},{"date":134,"type":21},"2026-08",{"date":136,"type":21},"2030-01-30",{"name":46,"class":47},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":117,"sex":18,"minAge":55,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":75},"100650832","phase-1-frequency-dependent-effects-of-transcranial-photobiomodulation-with-same-peak-irradiance-on-cortical-excitability-and-fine-motor-performance-100650832","NCT07752602","Frequency-Dependent Effects of Transcranial Photobiomodulation With Same Peak Irradiance on Cortical Excitability and Fine Motor Performance","Frequency-Dependent Effects of Transcranial Photobiomodulation With Same Peak Irradiance on Cortical Excitability and Fine Motor Performance: A Randomized, Double-Blind, Sham-Controlled, Within-Subject Crossover Trial","Inclusion Criteria:\n\n* Voluntary Participation: Participants who are clear of their cognitive faculties, capable of understanding all experimental procedures, and who provide written informed consent prior to enrollment.\n* Neurologically and Psychiatrically Healthy Status: Individuals with no current or prior history of neurological, neurodevelopmental, or psychiatric conditions;\n* Age Range: Young adult volunteers aged between 18 and 35 years.\n\nExclusion Criteria:\n\n* Use of any continuous psychotropic medication within the past 12 months.\n* Any current psychiatric diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n* Diagnosis of any neurological disorder capable of altering cortical excitability (e.g., seizures\u002Fepilepsy, cerebrovascular accidents\u002Fstroke, brain tumors).\n* Any clinical, psychological, or social condition that, in the investigator's opinion, places the participant at an increased risk, compromises participant safety, or precludes full compliance and successful completion of the study protocol.\n* Presence of any intracranial devices or implants, including cochlear implants and aneurysm clips.\n* Severe or uncompensated systemic medical illness that could interfere with study participation or confound physiological outcomes.\n* Participation in any other interventional neuromodulation study within the preceding 6 months.","35 Years",{"count":147,"type":21},20,[149],"PHASE1","This study investigates the frequency-dependent neuromodulatory effects of transcranial photobiomodulation (tPBM) over the primary motor cortex (M1) on cortical excitability and fine motor performance in healthy young adults. Using a randomized, double-blind, sham-controlled, 5-arm crossover design, 20 healthy participants will undergo five experimental conditions separated by a mandatory 7-day washout period: Continuous Wave (CW), 10 Hz pulsed tPBM, 40 Hz pulsed tPBM, 100 Hz pulsed tPBM, and a Sham control. To isolate pulse frequency while holding peak intensity constant, all active interventions will utilize an identical peak irradiance, with pulsed modes operating at a 50% duty cycle (delivering 50% of the cumulative energy dose relative to CW). Primary outcomes include corticospinal excitability measured via single- and paired-pulse Transcranial Magnetic Stimulation (TMS), alongside fine motor speed and dexterity assessed via a computerized finger-tapping task.",[152,153,154],"Healthy Volunteers (HV)","Transcranial Photobiomodulation","Cortical Excitability",[156,157,158,159],"Finger Tapping Test","Healthy volunteers","Cortical excitability","Transcranial photobiomodulation","2026-08-03",{"date":162,"type":40},"2026-08-07",{"date":164,"type":21},"2027-01-01",{"date":166,"type":21},"2027-12-01",{"name":46,"class":47},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":184,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":75},"100650790","diaphragmatic-ultrasonography-in-difficult-weaning-100650790","NCT07751237","Diaphragmatic Ultrasonography in Difficult Weaning","The Role of Diaphragmatic Ultrasonography in Difficult Weaning From Mechanical Ventilation: A Randomized Clinical Trial","DUS-WEAN","Inclusion Criteria:\n\n* Adults patients receiving invasive mechanical ventilation who are classified as having difficult weaning, defined as failure of the first spontaneous breathing trial.\n* Richmond Agitation-Sedation Scale (RASS) score between -2 and +1.\n* Clinical stability, defined as:\n* No vasopressor support or only low-dose, stable vasopressor therapy.\n* Absence of significant cardiac arrhythmias or ongoing myocardial ischemia.\n* Adequate oxygenation (SpO₂ \\>90% or PaO₂ \\>60 mmHg).\n* Respiratory rate \\\u003C35 breaths\u002Fmin.\n\nExclusion Criteria:\n\n* Inability to obtain informed consent.\n* Pre-existing neuromuscular disease.\n* Pregnancy.\n* Inability to perform the ultrasound examination because of chest drains, surgical wounds, or skin lesions at the assessment sites.",{"count":177,"type":21},220,[24],"Weaning from mechanical ventilation (MV) is a gradual process that includes several steps until the complete withdrawal of ventilatory support. Difficult weaning is defined as weaning completed only after the first attempt to withdraw the patient from ventilatory support, that is, a patient who failed the first spontaneous breathing trial (SBT). The use of ultrasound (US) to assess diaphragmatic and extradiaphragmatic muscles, such as the parasternal muscles, has been employed to determine diaphragmatic dysfunction and ventilatory effort, contributing to the decision-making process regarding weaning. Among the tools used for bedside monitoring and evaluation of patients are ventilatory variables that indicate an adequate level of ventilatory assistance in spontaneous modes through ventilatory drive, such as P0.1 (occlusion pressure in the first 100 ms) and assessment of ventilatory effort-inspiratory muscle pressure (Pmus)-which have also contributed to the downscaling of ventilatory support. However, there is still no consensus in the literature regarding predicted values or the effective role of these tools as predictors of weaning during the spontaneous breathing trial (SBT). The available studies investigating the relationship between diaphragmatic US, through measurements of diaphragmatic excursion and thickening fraction, and weaning failure from mechanical ventilation are mostly observational, which limits the strength of the current evidence. Therefore, it is essential to conduct randomized clinical trials, which are still unprecedented on this topic, to more robustly assess the efficacy of this technique as a decision-support tool during the weaning process, thereby contributing to more precise clinical practice. OBJECTIVES: The primary objective of this study is to evaluate the effect of diaphragmatic US use on ventilator-free days in patients with difficult weaning. The secondary objective is to analyze the relationship between the ventilatory variables P0.1 and Pmus, diaphragmatic US, and parasternal muscle recruitment during the SBT. METHODS: This is a randomized clinical trial, following CONSORT recommendations, which will be prospectively registered on the ClinicalTrials platform. Patients will be included after failing the first SBT. Subsequently, they will be randomized into two groups: In the shared US group, the results of diaphragmatic assessment via US will be shared with the attending team for decision-making regarding extubation. In the second group, the non-shared US group, the attending team will not have access to the diaphragmatic assessment for decision-making. EXPECTED RESULTS: It is expected that the shared US group of patients will have a shorter duration of MV and a lower number of extubation failures.",[181,182,183],"Weaning Mechanical Ventilation","ICU Ill Patients","Diaphragm Dysfunction",[185,186,187],"ultrasound Diaphragm","complicated weaning","Critical Illness",{"date":162,"type":40},{"date":134,"type":21},{"date":191,"type":21},"2029-09",{"name":46,"class":47},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":117,"sex":18,"minAge":55,"maxAge":145,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":75},"100647277","phase-1-frequency-dependent-effects-of-transcranial-photobiomodulation-on-cortical-excitability-100647277","NCT07707284","Frequency-Dependent Effects of Transcranial Photobiomodulation on Cortical Excitability","Frequency-Dependent Effects of Transcranial Photobiomodulation on Cortical Excitability and Fine Motor Performance: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial",{"count":147,"type":21},[149],"This study aims to investigate the frequency-dependent effects of near-infrared (NIR) transcranial photobiomodulation (tPBM) on human cortical excitability and fine motor performance. A cohort of 20 healthy adult volunteers (aged 18-35 years) will participate in a randomized, double-blind, sham-controlled, single-center study utilizing a within-subject, five-arm crossover design. Each participant will undergo five distinct experimental conditions separated by a strict washout period: active Continuous Wave (CW) tPBM, active pulsed tPBM at three neural oscillation frequencies (10 Hz, 40 Hz, and 100 Hz), and an inactive Sham comparator. All interventions will be delivered using a clinical-grade near-infrared device.\n\nTo isolate the specific effects of pulse frequency from overall energy delivery, the total energy dose (cumulative Joules) and total exposure time will be held perfectly constant across all active arms. The pulsed conditions will keeps the average irradiance and cumulative fluence identical to the continuous wave mode. Cortical excitability will be assessed via single- and paired-pulse Transcranial Magnetic Stimulation (TMS) protocols over the primary motor cortex (M1). Fine motor performance will be quantified using a smartphone-based Finger Tapping Test (FTT). Safety and systemic parameters will be tracked using the Systematic Assessment for Treatment Emergent Events - Systematic Inquiry (SAFTEE-SI) and vital signs. The central hypothesis is that distinct modulation frequencies will differentially influence corticospinal excitability and motor execution, independent of the total energy delivered.",[152,153,154],[159,158,157,156],"2026-07-27",{"date":206,"type":40},"2026-07-28",{"date":208,"type":21},"2027-05",{"date":210,"type":21},"2028-07",{"name":46,"class":47},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":219,"minAge":55,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":75},"100649279","pelvic-floor-physical-therapy-and-exercise-for-women-with-endometriosis-and-chronic-pelvic-pain-100649279","NCT07733583","Pelvic Floor Physical Therapy and Exercise for Women With Endometriosis and Chronic Pelvic Pain","Pelvic Floor Physical Therapy and Physical Exercise Versus Placebo for the Treatment of Endometriosis With Chronic Pelvic Pain: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Female, aged 18 to 45 years.\n* Diagnosis of endometriosis confirmed by surgery and\u002For imaging examinations.\n* Chronic pelvic pain for at least 6 months.\n* Visual Analog Scale (VAS) score ≥4 for chronic pelvic pain.\n* Willingness and ability to provide written informed consent and comply with all study procedures.\n\nExclusion Criteria:\n\n* Current pregnancy or planned pregnancy during the study period.\n* Pelvic surgery within the previous 3 months.\n* Neuromodulation treatment within the previous 3 months.\n* Medical or musculoskeletal conditions that contraindicate participation in pelvic floor physical therapy or the exercise program.","FEMALE","45 Years",{"count":222,"type":21},64,[24],"Endometriosis is a chronic gynecological condition that can cause persistent pelvic pain, painful menstruation, painful sexual intercourse, and reduced quality of life. This study will evaluate whether specialized pelvic floor physical therapy combined with a structured physical exercise program is more effective than a placebo intervention combined with the same exercise program in reducing chronic pelvic pain in women with endometriosis. Participants will be randomly assigned to one of the two groups and followed for 12 weeks.",[226,227],"Endometriosis","Chronic Pelvic Pain",[229,227,226,230,231,232,233,234],"Pelvic Floor Physical Therapy","Randomized Controlled Trial","Physical Exercise","Quality of Life","Dyspareunia","Dysmenorrhea","2026-07-23",{"date":237,"type":40},"2026-07-29",{"date":239,"type":40},"2026-03-05",{"date":241,"type":21},"2027-09-30",{"name":46,"class":47},{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":265,"leadSponsor":267,"locationsCount":75},"100649114","high-protein-diet-and-hmb-supplementation-in-patients-with-heart-failure-100649114","NCT07731048","High-Protein Diet and HMB Supplementation in Patients With Heart Failure","Effect of a High-Protein Diet and β-Hydroxy-β-Methylbutyrate Supplementation in Comparison to a Normo-protein Diet on Muscle Mass, Strength, and Physical Function in Patients With Heart Failure: Protocol of a Three-Arm, Parallel-Group, Superiority Randomized Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 years or older;\n* Male or female;\n* Diagnosis of chronic heart failure for at least 3 months, established according to the Brazilian Guidelines for Chronic and Acute Heart Failure and confirmed by medical records.\n\nExclusion Criteria:\n\n* Chronic kidney disease stage 3b or higher;\n* Listed for heart transplantation;\n* Hospitalization for decompensated heart failure within the previous 3 months;\n* Active cancer treatment or cancer treatment within the previous 5 years;\n* History of alcohol or illicit drug abuse within the previous 12 months;\n* Chronic use of anti-inflammatory drugs, anticonvulsants, corticosteroids, or immunosuppressive agents;\n* Pregnancy or breastfeeding;\n* Wheelchair use preventing anthropometric assessment;\n* Current use of protein supplements;\n* Participation in another randomized clinical trial with interventions that may interfere with the primary outcome.",{"count":251,"type":21},84,[24],"The goal of this clinical trial is to evaluate the effects of a high-protein diet with or without HMB supplementation compared with a normoprotein diet on clinical, nutritional, and functional outcomes in patients with heart failure. The main questions it aims to answer are:\n\n1. Does a normocaloric high-protein diet improve muscle mass, muscle strength, and physical function compared with a normocaloric normoprotein diet after 8 weeks?\n2. Does adding 3 g\u002Fday of β-hydroxy-β-methylbutyrate (HMB) to a normocaloric high-protein diet provide additional benefits for muscle mass, muscle strength, and physical function compared with a normocaloric high-protein diet alone?\n3. Do these nutritional interventions improve renal function, inflammatory and clinical biomarkers, functional status, and quality of life after 8 weeks?\n\nResearchers will compare three groups (normocaloric normoprotein diet, normocaloric high-protein diet, and normocaloric high-protein diet plus HMB supplementation) to determine the effects of these interventions on clinical, nutritional, and functional outcomes.\n\nParticipants will:\n\n* Be randomly assigned to one of the three study groups\n* Receive individualized dietary counseling according to their assigned intervention\n* Receive one study sachet daily containing either an HMB-enriched nutritional supplement (providing 3 g\u002Fday of HMB) or a matched placebo, according to the assigned study group\n* Undergo assessments of muscle mass, muscle strength, physical function, renal function, inflammatory and clinical biomarkers, and quality of life at baseline, 4 weeks, and 8 weeks",[255],"Heart Failure",[257,258,259,260,261,262],"High-Protein Diet","β-Hydroxy-β-Methylbutyrate","Muscle Mass","Muscle Strength","Physical Function","Dietary Intervention",{"date":206,"type":40},{"date":71,"type":21},{"date":266,"type":21},"2027-11-30",{"name":46,"class":47},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":75},"100609382","nutritional-intervention-for-constipation-symptoms-in-patients-with-parkinsons-disease-100609382","NCT07213856","Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease","Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial","NUTRI-GUT-PD","Inclusion Criteria:\n\n* Adults with a previous diagnosis of Parkinson's disease\n* On a stable dose of levodopa for at least 3 months\n* Diagnosis of Functional Constipation by the Rome IV protocol\n\nExclusion Criteria:\n\n* Diagnosis of atypical or secondary parkinsonism\n* Hoehn and Yahr stage greater than 2\n* Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures\n* Previous diagnosis of dementia\n* Presence of comorbidities such as active cancer, chronic obstructive pulmonary disease (COPD), heart failure, and\u002For chronic kidney disease\n* History of gastrointestinal cancers, inflammatory bowel diseases, or surgeries involving the gastrointestinal tract\n* Constipation secondary to clinical conditions such as hypothyroidism or diabetes mellitus\n* Use of opioids\n* Use of probiotics or antibiotics in the past 8 weeks\n* Continuous use of laxatives in the past 8 weeks\n* Presence of severe dysphagia according to the Functional Oral Intake Scale (FOIS)\n* Individuals receiving enteral or parenteral nutrition\n* Individuals under nutritional follow-up in the past 3 months",{"count":277,"type":21},54,[24],"The goal of this clinical trial is to evaluate whether a dietitian-guided nutritional intervention can improve constipation symptoms in people with Parkinson's disease (PD). The main questions it aims to answer are:\n\n* Can a dietitian-guided nutritional intervention increase the number of weekly bowel movements in individuals with PD and functional constipation?\n* Can this intervention positively influence gut microbiota composition, dietary intake, and nutritional status?\n\nResearchers will compare the intervention group to a control group that will receive general dietary guidance only after the study period, to see if the intervention leads to improvements in bowel function and related health outcomes.\n\nParticipants will:\n\n* Follow a diet plan developed by a dietitian, based on dietary reference intakes and tailored to the needs of individuals with PD and constipation\n* Participate in follow-up sessions with the dietitian for 3 months\n* Complete assessments at baseline, midpoint, and end of the intervention to evaluate bowel function, constipation symptoms, gut microbiota, nutritional status, and diet quality",[281,282],"Parkinsons Disease (PD)","Constipation - Functional",[284,285,286,287,288,289,290,291,292],"Microbiota","Diet","Diet, Protein-Restricted","Diet Therapy","Diet, Healthy","Nutrition Therapy","Constipation","Non-Motor Symptoms","Nutritionists","2026-06-15",{"date":295,"type":40},"2026-06-16",{"date":297,"type":40},"2026-04-02",{"date":299,"type":21},"2029-08",{"name":46,"class":47},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":311,"conditions":312,"keywords":316,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":324,"leadSponsor":326,"locationsCount":75},"100635870","suprapapillary-metal-stent-vs-routine-transpapillary-drainage-in-malignant-hilar-biliary-obstruction-smart-b-trial-100635870","NCT07558304","Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)","Randomized Clinical Trial of Suprapapillary Drainage With Metal Stent vs. Routine Internal-External Transpapillary Drainage in Patients With Malignant Hilar Biliary Obstruction","SMART-B","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.\n3. Total bilirubin \\> 3 mg\u002FdL.\n4. Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.\n5. Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria:\n\n5.1 Estimated future liver remnant \\\u003C40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.\n\n5.2 Prolonged jaundice with total bilirubin \\>10 mg\u002FdL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin \\\u003C3 g\u002FdL, presumably attributable to cholestasis.\n\n5.4 Indication for neoadjuvant chemotherapy.\n\nExclusion Criteria:\n\n1. Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage.\n2. Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP).\n3. Acute cholangitis, clinically defined as fever (axillary temperature \\>38°C) and leukocytosis (white blood cell count \\>10,000\u002Fmm³).\n4. Uncorrectable coagulopathy.\n5. Iodinated contrast allergy not amenable to desensitization.",{"count":251,"type":21},[24],"Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow.\n\nThere are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection.\n\nCurrently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking.\n\nThe purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.",[313,314,315],"Cholangiocarcinoma","Bile Duct Neoplasms","Malignant Biliary Obstruction",[313,317,318,319,320,315],"Percutaneous biliary drainage","Self-expanding metal stent","Suprapapillary drainage","Malignant hilar biliary obstruction","2026-06-12",{"date":295,"type":40},{"date":293,"type":21},{"date":325,"type":21},"2028-12-31",{"name":46,"class":47},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":334,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100637494","social-deprivation-and-postoperative-mortality-100637494","NCT07621211","Social Deprivation and Postoperative Mortality","Assessment of the Impact of Socioeconomic Factors on Perioperative Outcomes","Inclusion Criteria:\n\n* Patients aged 16 years or older.\n* Patients who underwent an elective or urgent surgical procedure in an operating room at a participating hospital.\n* Surgical procedure performed between January 1, 2024, and December 31, 2024.\n\nExclusion Criteria:\n\n* Patients who underwent ophthalmologic surgery, diagnostic procedures only and procedures performed under local anesthesia only.\n* Patients who underwent liver, lung or heart transplantation.\n* Patients diagnosed with brain death who were organ donor candidates.","16 Years",{"count":336,"type":21},45000,"Socioeconomic factors are associated with differences in health outcomes, but their impact on surgical patients is still not well understood, especially in low- and middle-income countries. Social deprivation may affect perioperative outcomes through differences in access to healthcare, burden of comorbidities, timing of care, and hospital resources. However, few studies have evaluated this association in large and diverse surgical populations, and data from Brazil are limited.\n\nThis retrospective multicenter cohort study will evaluate the association between socioeconomic deprivation and perioperative outcomes among patients undergoing surgery in Brazil. The study will include patients aged 16 years or older who underwent elective or urgent surgical procedures in participating public and private hospitals between January 1 and December 31, 2024. Patients undergoing ophthalmologic procedures, diagnostic procedures, procedures performed under local anesthesia only, selected transplant procedures, and organ donors after brain death will be excluded.\n\nSocioeconomic deprivation will be assessed using georeferenced area-level indices derived from each patient's residential address, including the Brazilian Deprivation Index, the Social Vulnerability Index, and the Municipal Human Development Index. The researchers will grou patients according to deprivation levels, and analyze the association between deprivation and postoperative outcomes.\n\nThe primary outcome will be 30-day in-hospital postoperative mortality. The study will also evaluate demographic, clinical, surgical, and hospital-level factors associated with mortality, including age, sex, ethnicity, American Society of Anesthesiologists physical status classification, surgical urgency, surgical magnitude, surgical specialty, and type of healthcare system. Multivariable logistic regression models will be used to assess whether socioeconomic deprivation is independently associated with postoperative mortality after adjustment for relevant clinical and surgical factors.\n\nThe results of this study may improve the understanding of how socioeconomic deprivation influences perioperative risk in Brazil. The findings may help identify vulnerable surgical patients, support risk prediction models that include social determinants of health, and inform strategies to reduce inequities in perioperative care.",[339],"Social Deprivation",[341,342,343],"surgical procedures","social deprivation","risk factors","2026-05-27",{"date":346,"type":40},"2026-06-02",{"date":348,"type":21},"2026-05-15",{"date":350,"type":21},"2028-12",{"name":46,"class":47},7,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":18,"minAge":360,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":369,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":75},"100552157","the-impact-of-geriatric-assessment-on-the-treatment-plan-of-elderly-patients-with-t2dm-100552157","NCT06469437","The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM","The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With Type 2 Diabetes Mellitus: a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Age 60 years or older\n* Diagnostic of type 2 diabetes mellitus according to American Diabetes Association criteria\n* Patients under follow-up in a specialized endocrinology outpatient clinic\n* Patients who have a glycated hemoglobin measurement of up to three months\n\nExclusion Criteria:\n\n* Lack of consent for research participation from the patient or the physician\n* Patients classified as Clinical Frailty Scale 9.","60 Years",{"count":177,"type":21},[24],"Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals.\n\nMethods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews.\n\nDiscussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.",[365,366,367,368],"Type2diabetes","Frail Elderly Syndrome","Frailty","Geriatric Assessment",[370,367,371,372],"Type 2 diabetes","Geriatric assessement","Glycated hemoglobin",{"date":374,"type":40},"2026-05-29",{"date":376,"type":40},"2024-07-05",{"date":325,"type":21},{"name":46,"class":47},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":117,"sex":18,"minAge":55,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":75},"100596944","phase-2-triple-blind-randomized-clinical-trial-of-tocilizumab-vs-placebo-potential-use-of-an-il-6-antagonist-as-an-adjuvant-to-standard-treatment-for-treatment-resistant-major-depression-in-the-brazilian-public-health-system-sus-100596944","NCT07052058","Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to Standard Treatment for Treatment-Resistant Major Depression in the Brazilian Public Health System (SUS)","Inclusion Criteria:\n\nAge ≥ 18 years Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling Willing to abstain from strenuous exercise for 72 hours prior to assessment Meet DSM-5\u002FMINI criteria for a diagnosis of depression resistant to at least two adequate courses of treatment at the time of eligibility assessment Baseline HDRS score of 19 or higher at Serum\u002Fplasma CRP level ≥3 mg\u002FL\n\nExclusion Criteria:\n\nDiagnosis of bipolar disorder or personality disorder History of substance use disorder in the past six months. Presence of active\u002Frecent infection (including TB, Hepatitis B, Hepatitis C, or HIV) or autoimmune disease Pregnancy or breastfeeding History of significant cardiovascular disease, recent cancer, or hematological disorders BMI \\>40 kg\u002Fm² or weight \\>100 kg Hypersensitivity to tocilizumab or any of its excipients. CRP ≥20 mg\u002FL Active liver disease or transaminase elevation \\>1.5× the upper limit of normal\n\nInclusion criteria to the 10 healthy controls recruited for comparison of inflammatory biomarkers:\n\nAge ≥ 18 No current or lifetime psychiatric diagnosis, as measured by the SRQ-20 Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling","65 Years",{"count":387,"type":21},32,[389],"PHASE2","Clinical trial aimed at evaluating whether a single infusion of tocilizumab, a medication that blocks the action of an inflammatory molecule called interleukin-6 (IL-6), can reduce symptoms of treatment-resistant major depression compared to placebo in non-hospitalized patients.",[392],"Treatment-Resistant Major Depressive Disorder","2026-05-13",{"date":348,"type":40},{"date":396,"type":21},"2026-07-01",{"date":398,"type":21},"2028-07-01",{"name":46,"class":47},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":4},"100637241","impact-of-biofire-filmarray-pneumonia-panel-vs-routine-diagnostics-on-antimicrobial-outcomes-door-mat-100637241","NCT07585604","Impact of BioFire FilmArray Pneumonia Panel vs Routine Diagnostics on Antimicrobial Outcomes (DOOR-MAT)","A Randomized Multicenter Clinical Trial Comparing BIOFIRE® FILMARRAY® Pneumonia (PN) Panels Versus Routine Diagnostic Methods in Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR MAT) in Hospitalized Patients With Lower Respiratory Tract Infections.","Inclusion Criteria:\n\n* Age ≥18 years.\n* Clinical diagnosis of hospital-acquired pneumonia or clinically relevant tracheobronchitis requiring antimicrobial treatment, with or without mechanical ventilation.\n* No respiratory cultures collected in the last 72 hours (except for the culture that will potentially be evaluated in the study-trigger for inclusion).\n* Agreement from the patient or legal representative to sign the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Inadequate respiratory samples according to laboratory cutoffs for squamous epithelial cells and polymorphonuclear leukocytes (sputum or endotracheal aspirate).\n* Incarcerated populations.\n* Pregnant women.",{"count":408,"type":21},150,[24],"Multidrug-resistant bacterial infections are a growing global health concern. Hospital-acquired pneumonia is one of the most common infections occurring during hospitalization and can be associated with high mortality, reaching up to 50% in severe cases. One of the main reasons for poor outcomes is the delay in starting the most appropriate antibiotic treatment.\n\nStandard laboratory methods used to identify the bacteria and determine which antibiotics are effective usually take between 48 and 96 hours to provide results. During this time, patients often receive broad-spectrum antibiotics, which may not be optimal and can contribute to antimicrobial resistance.\n\nRapid diagnostic tests, such as the BIOFIRE® FILMARRAY® Pneumonia Panel, can detect multiple bacteria and important resistance markers directly from respiratory samples in about one hour. These tests are already approved for use in Brazil and are easy to perform. Previous studies in patients with community-acquired pneumonia have shown that these rapid tests can help doctors choose more appropriate antibiotics earlier and may improve patient outcomes.\n\nHowever, their benefit has not been well studied in patients with hospital-acquired pneumonia, especially in settings where multidrug-resistant bacteria are common. In these situations, early and appropriate adjustment of antibiotic therapy is particularly important for improving outcomes and ensuring the responsible use of advanced antibiotics.\n\nThis study aims to compare the use of rapid diagnostic panels with standard laboratory methods in hospitalized patients with suspected pneumonia. The main focus is to evaluate how quickly and how appropriately antibiotic treatment can be adjusted after sample collection, using a structured scoring system, the Desirability of Outcome Ranking for the Management of Antimicrobial Therapy(DOOR-MAT), as well as to assess clinical outcomes.\n\nThe results of this study may help determine whether rapid diagnostic testing improves patient care in real-world hospital settings. The findings could support decision-making within the Brazilian Unified Health System (SUS) regarding the adoption of this technology, and may also contribute to future analyses of its cost-effectiveness.",[412],"Pneumonia - Bacterial",[414,415,416,417,418,419],"BIOFIRE® FILMARRAY®","Hospital-acquired pneumonia","Ventilator-associated pneumonia","DOOR-MAT","Antimicrobial resistance","Cost-effectiveness","2026-05-08",{"date":422,"type":40},"2026-05-14",{"date":424,"type":21},"2026-05-02",{"date":426,"type":21},"2027-06-02",{"name":46,"class":47},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":436,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":4},"100636629","ultrasound-guided-long-vs-short-peripheral-iv-catheters-in-neonates-with-congenital-syphilis-receiving-antibiotics-100636629","NCT07568171","Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Receiving Antibiotics","Ultrasound-Guided Long Peripheral Intravenous Catheters Versus Conventional Short Peripheral Catheters for Reducing Post-Insertion Failure in Neonates With Congenital Syphilis Receiving Antibiotic Therapy: A Randomized Clinical Trial","ULTRA-ACCESS","Inclusion Criteria:\n\n* Newborns admitted to the Neonatal Intermediate Care Unit;\n* Diagnosis of congenital syphilis;\n* Indication for intravenous penicillin therapy for an estimated duration of 10 days;\n* Enrollment on the first day of treatment.\n\nExclusion Criteria:\n\n* Newborns who have received any type of peripheral venous catheter prior to study enrollment;\n* Clinical instability at the time of vascular access indication and\u002For requirement for admission to a Neonatal Intensive Care Unit;\n* Requirement for concomitant administration of another antimicrobial agent in addition to crystalline penicillin;\n* Need for catheter insertion outside the operating hours of the Vascular Access Program (7:00 AM to 7:00 PM, Monday to Friday).","1 Day","28 Days",{"count":439,"type":21},104,[24],"Congenital syphilis in newborns requires intravenous antibiotic therapy, making reliable peripheral venous access essential. However, high rates of catheter failure and repeated punctures remain a significant clinical challenge. This randomized, controlled, parallel clinical trial aims to compare ultrasound-guided long peripheral intravenous catheters inserted by a specialized vascular access team with conventional short peripheral catheters inserted by neonatal nurses. A total of 104 newborns with congenital syphilis receiving intravenous penicillin will be randomly assigned to either group. The primary outcome is functional dwell time. Secondary outcomes include catheter failure, number of insertion attempts, first-attempt success, complications, and total number of devices required. The study hypothesizes that ultrasound-guided long peripheral catheters will improve vascular access outcomes, reduce complications, and minimize the need for repeated punctures.",[443,444,445,446,447,448,449],"Infant, Newborn","Syphilis, Congenital","Catheterization, Peripheral","Ultrasonography","Advanced Practice Nursing","Patient Safety","Neonatal Nursing","2026-05-06",{"date":452,"type":40},"2026-05-11",{"date":454,"type":21},"2026-05",{"date":350,"type":21},{"name":46,"class":47},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":18,"minAge":360,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":470,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":75},"100634924","navigation-for-elderly-people-with-multiple-morbidity-after-hospital-discharge-100634924","NCT07546006","Navigation for Elderly People With Multiple Morbidity After Hospital Discharge.","NAVIM","Inclusion Criteria:\n\n* Elderly individuals aged 60 or older;\n* With confirmed multimorbidity documented in their medical records;\n* Hospitalized in the SUS (Unified Health System) clinical units (5th North, 6th North, and 7th North), regardless of specialty;\n* Who will be discharged home;\n* Have telephone access and have a primary caregiver responsible for assisting with communication, in cases where the elderly person is unable to respond for themselves.\n\nExclusion Criteria:\n\n* Elderly people hospitalized in restricted access clinical units (6th south), and those with private insurance or paying out-of-pocket (4th south);\n* Those transferred to another hospital service or to other institutions;\n* Patients who are already receiving or will receive navigation care or other safe discharge follow-up care;\n* Patients in palliative care.",{"count":465,"type":21},148,[24],"This research aims to create and test a tracking (navigation) model to assist in providing care guidance to elderly people (60 years or older) who have two or more chronic diseases at the same time (multimorbidity) immediately after being discharged from the hospital.",[469],"Multimorbidity",[471,472,469,473,474],"Aged","Patient Navigation.","Comprehensive Health Care","Geriatric Nursing","2026-04-15",{"date":477,"type":40},"2026-04-22",{"date":479,"type":21},"2026-06-01",{"date":481,"type":21},"2028-03-30",{"name":46,"class":47},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":22,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":75},"100552971","ipt-based-group-intervention-by-non-specialist-for-improvement-of-depressive-symptoms-in-community-young-adults-in-brazil-100552971","NCT06480019","IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil","IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Young adults (between 18 and 24 years old)\n* Young adults who work, live or study in Porto Alegre\n* PHQ ≥ 5 - without suicide ideation\n\nExclusion Criteria:\n\n* Maniac or hypomanic episode\n* Psychotic Syndrome\n* Substance Abuse\n* Suicide Risk or Ideation","24 Years",{"count":492,"type":21},50,[24],"Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Interpersonal psychotherapy (IPT) is a first-line treatment and can also be used for the prevention of depression.\n\nThis randomized controlled clinical trial is planned to have 50 participants randomized between an interventional and a control group (waiting list). Our study covers young adults (18 to 24 years old) with depression. Participants will be invited by social media to undergo treatment in an IPT group. The intervention group will be separated into groups with up to 10 participants, with a weekly meeting for eight weeks. The intervention will focus on interpersonal relationships within the model of IPT and will be held by a university student and a doctor trained in IPT.",[496,497],"Depression","Interpersonal Relations","2026-04-08",{"date":500,"type":40},"2026-04-13",{"date":502,"type":40},"2024-03-01",{"date":325,"type":21},{"name":46,"class":47},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":75},"100630582","phase-2-medication-withdrawal-in-stable-hf-with-improved-lvef-100630582","NCT07489547","Medication Withdrawal in Stable HF With Improved LVEF","Simplification of Treatment by Withdrawal of Medications in Stable Heart Failure With Improved Left Ventricular Ejection Fraction","SIMPLIFY-HF","Inclusion Criteria:\n\n* Diagnosis of heart failure (HF) and use of MRAs and an ACE inhibitor\u002FARB\u002FARNI for at least 12 months\n* Left ventricular ejection fraction (LVEF) ≥40%, improved from a prior value ≤35%, with a sustained absolute increase \\>10%\n* Left ventricular end-diastolic diameter within normal limits according to predefined criteria (≤59 mm for men and ≤53 mm for women)\n* NYHA functional class I or II\n* BNP levels \\\u003C100 pg\u002FmL, or NT-proBNP levels within age-adjusted thresholds: ≥450 pg\u002FmL for individuals \\\u003C50 years, ≥900 pg\u002FmL for those 50-75 years, and ≥1800 pg\u002FmL for individuals \\>75 years\n* In cases of atrial fibrillation, NT-proBNP thresholds should be doubled\n* Clinical stability defined as no hospitalizations or need for increased diuretic therapy due to congestion within the previous 12 months\n* Optimized heart failure medications with no modifications for at least 3 months\n* Maximum allowed dose of furosemide of 80 mg\u002Fday\n* Acceptable etiologies: HF following cardiac resynchronization therapy (CRT); non-ischemic HF after myocarditis; non-ischemic HF due to tachycardiomyopathy; non-ischemic HF due to alcoholic cardiomyopathy; non-ischemic HF due to cardiotoxicity; non-ischemic HF due to peripartum cardiomyopathy; non-ischemic HF after correction or intervention for valvular disease; ischemic HF after revascularization\n\nExclusion Criteria:\n\n* Acute coronary syndrome within the past 12 months\n* Arrhythmia requiring therapy within the past 12 months\n* Syncope or appropriate device therapy (if ICD present) within the past 12 months\n* Uncorrected moderate to severe valvular disease\n* Severe unrevascularized coronary artery disease, defined as \\>50% stenosis of the left main coronary artery (LMCA) or \\>70% stenosis of the left anterior descending artery (LAD), circumflex artery (LCx), or right coronary artery (RCA)",{"count":514,"type":21},90,[389,516],"PHASE3","The goal of this clinical trial is to evaluate the safety and feasibility of withdrawing mineralocorticoid antagonists (MRA) in patients with stable heart failure with improved left ventricular ejection fraction (HFimpEF). The main questions it aims to answer are:\n\nDoes withdrawal of MRAs lead to a reduction in left ventricular ejection fraction greater than 10%, resulting in a final LVEF below 40%? Does withdrawal of MRAs cause a relative increase in NT-proBNP levels greater than 50% above age-adjusted thresholds? Researchers will compare MRAs withdrawal (placebo) with continuation of therapy to determine whether medication withdrawal can be performed safely without worsening heart failure status.\n\nParticipants will:\n\nAttend scheduled clinical visits over a 24-week follow-up period; Undergo echocardiographic evaluation of left ventricular ejection fraction before study visits; Provide blood samples for NT-proBNP measurement at each visit; Provide one blood sample for genetic analysis of polymorphisms related to the renin-angiotensin-aldosterone system; Receive either continued MRA therapy or placebo as part of a double-blind randomized design; Be monitored for clinical stability, symptoms of heart failure, and potential adverse events during follow-up.",[255],"2026-03-25",{"date":521,"type":40},"2026-03-30",{"date":523,"type":40},"2025-03-01",{"date":525,"type":21},"2026-12-31",{"name":46,"class":47},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":546,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":559,"locationsCount":75},"100629059","phase-2-pocus-intervention-for-tailoring-diuretic-strategy-in-acute-decompensated-heart-failure-100629059","NCT07469722","POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure","Point-of-care Ultrasound Intervention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure","POINTER-HF","Inclusion Criteria:\n\n* Men or women aged 18 years or older.\n* Diagnosis of acute decompensated heart failure (ADHF) with left ventricular ejection fraction \\\u003C50%, presenting with symptoms (dyspnea, orthopnea, fatigue) and\u002For signs (pulmonary crackles, peripheral edema, jugular venous distension, hepatomegaly, hepatojugular reflux) of decompensated heart failure.\n* Brain natriuretic peptide (BNP) ≥ 300 pg\u002FmL.\n* Signs of systemic and\u002For pulmonary congestion on POCUS, defined as DUCS ≥ 3 points.\n* Time from hospital admission ≤ 48 hours.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients under evaluation for heart transplantation or with prior heart transplantation.\n* Acute coronary syndrome as the primary cause of hospitalization.\n* Evidence of uncontrolled infection.\n* Cardiac surgery or percutaneous coronary or structural cardiac intervention within the previous 30 days.\n* Signs of hypoperfusion, defined as any of the following: mean arterial pressure \\\u003C 60 mmHg, capillary refill time \\> 4 seconds, arterial lactate \\> 2 mmol\u002FL or venous lactate \\> 2.5 mmol\u002FL.\n* Acute pulmonary embolism (segmental or more proximal) as the primary cause of hospitalization.\n* Acute stroke.\n* Chronic kidney disease stage 5 (estimated glomerular filtration rate \\\u003C 15 ml\u002Fmin\u002Fm²) or requirement for renal replacement therapy.\n* Liver cirrhosis with portal hypertension.\n* Known pulmonary disease with extensive parenchymal involvement, including interstitial lung disease, pulmonary metastases, prior pneumonectomy, lobectomy, or pleurodesis.\n* Severe hypokalemia (serum potassium \\\u003C 2.5 mmol\u002FL).\n* Pregnancy or breastfeeding.\n* Refusal to participate in the clinical trial.",{"count":536,"type":21},128,[389,516],"Acute decompensated heart failure (ADHF) is a frequent cause of hospitalization and is associated with high morbidity and mortality. Congestion is the primary pathophysiological mechanism leading to clinical deterioration and hospitalization in ADHF. Diuretics remain the cornerstone of treatment for most ADHF phenotypes; however, evidence regarding optimal strategies to guide diuretic therapy during the decongestion process is limited. Recently, point-of-care ultrasound (POCUS) has emerged as a promising tool to support clinical assessment in ADHF, improving diagnostic accuracy, prognostication, and pre-discharge evaluation. Nevertheless, the role of POCUS in guiding therapeutic management in ADHF remains uncertain. To specifically assess congestion in patients with ADHF, a pragmatic POCUS-based score, the Dynamic Ultrasound Congestion Score (DUCS), was developed. DUCS integrates lung ultrasound and Venous Excess Ultrasound (VExUS) to dynamically evaluate congestion severity, treatment response, and therapeutic goals during ADHF management. Observational data suggest that DUCS is associated with in-hospital outcomes and short-term prognosis, and correlates with markers of decongestion such as urinary output and weight loss. This study is a randomized, single-center, single-blind clinical trial designed to evaluate whether a DUCS-guided POCUS strategy improves clinical and decongestion outcomes compared with standard of care. Eligible patients hospitalized due to ADHF will be randomized within 48 hours of admission to one of two groups: (1) diuretic treatment guided by institutional standard-of-care combined with information from the EVEREST congestion score assessment and guideline-based treatment recommendations; or (2) diuretic treatment guided by serial DUCS-based POCUS assessments used to inform diuretic adjustment recommendations. Participants in both groups will undergo evaluations at baseline (day 1), day 2, day 3 and day 5, including clinical data collection, physical examination using the EVEREST congestion score, and standardized DUCS-based POCUS assessments. Outcomes to be assessed include in-hospital mortality, length of hospital stay, decongestion parameters, and changes in biomarkers.",[540,541,542,543,544,545],"Acute Heart Failure (AHF)","Congestive Heart Failure Acute","Diuretic Effect","Lung Ultrasonography Score","Ultrasonography, Doppler","Point-of-care Ultrasound (POCUS)",[547,548,549,550,551,552],"Acute Heart Failure","Congestive Heart Failure","Point-of-Care Ultrasound","Lung Ultrasound","Venous Excess Ultrasound","Diuretic","2026-03-16",{"date":555,"type":40},"2026-03-18",{"date":557,"type":21},"2026-03-23",{"date":398,"type":21},{"name":46,"class":47},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":75},"100594413","efficacy-of-artificial-intelligence-for-gatekeeping-in-referrals-to-specialized-care-100594413","NCT07019116","Efficacy of Artificial Intelligence for Gatekeeping in Referrals to Specialized Care","Efficacy of an Artificial Intelligence Algorithm for Gatekeeping in Referrals From Primary Care to Specialized Care: a Randomized Controlled Trial","Inclusion Criteria:\n\n* All referrals from a given specialty (waitlist) will be eligible.\n* Specialties will be selected following Rio Grande do Sul Health Department priorities.\n\nExclusion Criteria:\n\n* Referrals that the AI algorithm can not evaluate. These include referrals with attachments (further information in image or PDF files) and referrals with previous rounds of discussion.\n* Referrals in which the algorithm has low confidence in the decision (i.e., informed data lead to a decision with a probability below 80%) will not be included in the study.",{"count":568,"type":21},934,[24],"In Rio Grande do Sul, Brazil, the demand for specialty care referrals has increased sharply with the adoption of the electronic regulatory system, especially in rural areas. In 2023 alone, over 79,000 referrals were submitted monthly, totaling 1.7 million annual gatekeeping decisions. Due to workforce limitations, nearly 70% of referrals are authorized automatically, often without clinical validation. This leads to delays for high-risk patients, unnecessary specialist visits, and a growing backlog, currently over 172,000 pending referrals. To address this, an AI algorithm was developed to triage referrals based on urgency and appropriateness.\n\nThe investigators propose a prospective controlled study with randomized implementation of the AI tool across selected specialty queues in the electronic referral system. The population will consist of referrals from specialties waitlists from municipalities in Rio Grande do Sul. Specialties to be included will be selected by the State Health Department prospectively according to gatekeeping needs. The intervention will be an AI-based triage algorithm. The control will be a standard gatekeeping process. The primary outcome is the proportion of referrals with a final decision (authorized or redirected to primary care) within six months; secondary outcomes include time to decision and appointment, system-level performance metrics. Referrals will be randomly assigned to algorithmic or human gatekeeping with a 1:1 ratio. The algorithm classifies referrals into two groups: not authorized (pending more data or teleconsultation), authorized. Authorization cases are further divided into routine and high-risk referrals to help the manage demand. Each AI prediction provides a probability from 0 to 1 of authorization (or deferring). The implementation threshold is set at 0.8; cases below this level will be classified as low confidence for decision and will not be included. According to the State Health Department's decisions, several referral lines are expected to be selected for the intervention. A sample size 934 (467 per arm) for each included specialty was calculated to detect a 1.2 relative risk for the primary outcome with 90% power and 5% significance.",[572,573],"Primary Care","Primary Care Patients With Chronic Conditions","2026-02-19",{"date":576,"type":40},"2026-02-20",{"date":578,"type":40},"2025-11-15",{"date":580,"type":21},"2029-12",{"name":46,"class":47},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":385,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":597,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":75},"100493515","effect-of-partial-dietary-replacement-from-animal-to-plant-based-protein-for-type-2-diabetes-management-100493515","NCT05706155","Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management","Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adults (≥18 and ≤65 years old)\n* Diagnosis of Type 2 Diabetes;\n* Glycated hemoglobin from 7% to 11%;\n* Overweight or obesity (BMI ≥25 kg\u002Fm² and \\\u003C40 kg\u002Fm²);\n* Use of any hypoglycemic and insulin;\n* Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening;\n* Not having undergone dietary intervention in the last 6 months;\n* Have the ability to understand and be able to adhere to intervention proposals;\n* Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol;\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus;\n* Retinopathy with vision deficit that limits the activities proposed in the interventions;\n* Chronic kidney disease with estimated glomerular filtration \\\u003C 30 mL\u002Fmin per 1.73m²;\n* Liver failure, chronic viral hepatitis;\n* Grade III or IV heart failure\n* Active or progressive neurodegenerative disease;\n* Prior stroke that has caused sequelae;\n* Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss;\n* Chronic treatment with oral or parenteral corticosteroids (\\>7 days consecutive treatment) within 4 weeks prior to screening;\n* Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening;\n* Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening;\n* History of active substance abuse (including alcohol) within the last year;\n* Thyroid Stimulating Hormone (TSH) outside the normal range;\n* Fasting triglycerides ≥ 600 mg\u002FdL;\n* Tumor diagnosed and\u002For treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years;\n* Severe psychiatric illness;\n* Predisposition or diagnosis of eating disorders;\n* Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding;\n* Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and\u002For weight loss in the last 3 months;\n* Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma;\n* Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study;\n* Night workers who work after 10pm;\n* Being on a vegetarian, vegan or flexitarian diet at the time of recruitment;\n* Having undergone bariatric surgery;\n* Carriers of the human immunodeficiency virus (HIV);\n* Any other medical condition\u002Fdisorder that the investigators consider that are likely to: interfere with the patient's ability to complete the entire study period or participate in study activities;\n* Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.",{"count":590,"type":21},146,[24],"The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. The plant-based diet will be compared to a standard healthy diet according to guidelines for people with diabetes. Participants will follow a plant-based or a standard healthy diet for 24 weeks and will maintain their habitual levels of physical activity.",[594,595,596],"Type 2 Diabetes","Overweight","Obesity",[598,596,599,600],"Diabetes Mellitus","Plant-based Diet","Insulin Resistance","2026-01-26",{"date":603,"type":40},"2026-01-29",{"date":605,"type":40},"2022-11-01",{"date":607,"type":21},"2027-12-30",{"name":46,"class":47},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":219,"minAge":55,"maxAge":617,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":628,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":639,"locationsCount":75},"100608575","home-based-transcranial-direct-current-stimulation-tdcs-compared-to-duloxetine-non-inferiority-clinical-trial-fibrostim-100608575","NCT07203339","Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)","Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine in the Treatment of Fibromyalgia: a Randomized Non-inferiority Clinical Trial (FIBROSTIM)","FIBROSTIM","Eligibility Criteria\n\nInclusion Criteria:\n\n* Woman aged between 18 and 75 years\n* Right-handed\n* Literate in reading and writing\n* Clinical diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) 2010-2016 criteria\n* Numeric Pain Scale (NPS) score ≥ 4 on most days in the past 30 days\n* Agree no changes in medication dosage during the treatment period (except for analgesics)\n* Able to swallow tablets\n* Able to understand instructions for using tDCS at home\n\nExclusion Criteria:\n\n* Living more than 250 km from Porto Alegre\n* Pregnancy\n* Decompensated systemic diseases\n* Chronic inflammatory rheumatologic diseases\n* Untreated hypothyroidism\n* Active cancer under treatment\n* Alcohol or drug abuse in the past 6 months\n* Decompensated psychiatric disorders with suicide risk and a defined plan\n* Use of duloxetine at a dose \\> 60 mg\u002Fday\n* Metal implants in the brain\n* Implanted brain medical devices\n* Cardiac pacemaker\n* Cochlear implant\n* Neurological disorders\n* History of traumatic brain injury or neurosurgery","75 Years",{"count":619,"type":21},610,[24],"Fibromyalgia is characterized by widespread pain, fatigue, non-restorative sleep, and psychocognitive alterations, compromising quality of life and leading to absenteeism and early retirement. Up to 70% of patients discontinue treatment with antidepressants and anticonvulsants due to adverse effects or low efficacy, and more than 30% resort to opioid use. Given the treatment challenges and the scarcity of safe alternatives, there is growing interest in interventions such as transcranial direct current stimulation (tDCS), which has shown efficacy in improving symptoms and functionality, with low cost and few side effects. In this context, we designed a randomized, double-blind, double-dummy clinical trial to compare the non-inferiority of 28 home-based anodal tDCS (2 mA) applied over the primary motor cortex (M1) versus duloxetine 60 mg. Both treatments will be combined with physical exercise and pain education. Outcomes will be assessed through multidimensional measures of pain, functionality, global impression of improvement, and the function of the descending pain inhibitory system. Secondary outcomes include quality of life, depressive symptoms, psychophysical pain measures, and treatment adherence. An additional analysis will compare the results of sham tDCS and duloxetine placebo within the non-inferiority model. Predictors of treatment response will also be explored, including symptom severity and oscillatory patterns of cortical electrical activity, rest-activity rhythm, and autonomic function assessed by R-R interval. Furthermore, serum levels of S100-B protein, brain-derived neurotrophic factor (BDNF), and genetic variants related to neuroplasticity in the BDNF Val66Met, Catechol-O-Methyltransferase (COMT) (rs4680) (G\\>A), OPRM1, and PER2 genes will be analyzed. Inflammatory markers (TNF-α, IL-1, IL-2, IL-6, IL-10, C-reactive protein) and serum endorphins will also be assessed. A total of 610 women with fibromyalgia (aged 18 to 75 years) will be randomized into three groups (2:2:1): duloxetine + sham tDCS (n=244); active tDCS + placebo (n=244); and sham tDCS + placebo (n=122). Participants will be assessed during treatment and at 3, 6, and 12 months after completing the intervention protocol. An interim analysis will be conducted when \\~50% of participants (n ≈ 305) complete the 3-month follow-up by an independent, blinded Data Monitoring Committee (DMC). (i) The trial may be stopped if the conditional probability of demonstrating non-inferiority is \\\u003C10%, based on frequentist or Bayesian methods. (i) The trial will be stopped if serious adverse events (SAEs) in the active tDCS group increase by ≥30% compared to duloxetine (p \\\u003C 0.01, adjusted). (ii) Early stopping for efficacy will be considered if active tDCS demonstrates clear non-inferiority or superiority over duloxetine on the primary outcome. Superiority requires: (iii) a clinically relevant difference exceeding the non-inferiority margin (≥10% pain reduction); (ii) statistical significance (p \\\u003C 0.005, O'Brien-Fleming adjusted); and (iii) a ≥2-point (20%) improvement on the BPI, confirmed in the ITT analysis. This study aims to generate evidence to support the decision-making process of the National Committee for Health Technology Incorporation (CONITEC) regarding the availability of tDCS in the Brazilian Unified Health System (SUS). In addition, identifying predictors of response to tDCS and duloxetine, through the integration of genetic, neurophysiological, inflammatory, and psychosocial markers using machine learning algorithms, will allow for identifying factors that can personalize fibromyalgia treatment. This approach enhances clinical efficacy, reduces costs associated with ineffective interventions, and supports more accurate therapeutic decisions, expanding access to safe, effective, and sustainable care within the public healthcare system",[623,624,625,626,627],"Fibromyalgia (FM)","tDCS","Duloxetine","BDNF","EEG",[629,630,625,631,632],"Fibromyalgia","Transcranial Direct Current Stimulation","Biomarkers","Precision Medicine","2025-12-31",{"date":635,"type":40},"2026-01-06",{"date":637,"type":40},"2025-09-30",{"date":350,"type":21},{"name":46,"class":47},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":219,"minAge":55,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":22,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":659,"locationsCount":75},"100535006","from-prevention-to-treatment-how-biological-rhythms-can-maintain-perinatal-mental-health-100535006","NCT06246214","From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health","Innovations in Biological Rhythms in the Context of Mental Health: Effectiveness of New Technologies and Exposure to Different Lighting Patterns in Women During the Postpartum Period","Inclusion Criteria:\n\n* 4-6 weeks postpartum;\n* Postnatal depression confirmed through Edinburgh Postnatal Depression Scale (EPDS) \\&amp;gt; 10;\n* Mini-International Neuropsychiatric Interview (M.I.N.I.) positive for current depressive episode.\n\nExclusion Criteria:\n\n* Active suicidal ideation;\n* Psychotic symptoms;\n* Unstable general medical conditions that interfere with the acquisition of actigraphy;\n* Newborn with severe health conditions (hospitalization, care in the neonatal ICU).",{"count":408,"type":21},[24],"Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo\u002Ftreatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health\u002Fdisease process.",[651,652],"Depression, Postpartum","Anxiety State","2025-11-25",{"date":655,"type":40},"2025-12-03",{"date":657,"type":40},"2024-01-04",{"date":208,"type":21},{"name":46,"class":47},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":670,"briefSummary":671,"conditions":672,"keywords":674,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":684,"locationsCount":75},"100611153","artificial-intelligence-for-diagnosing-diabetic-retinopathy-in-primary-care-100611153","NCT07236879","Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care","Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes","AID-DR","Inclusion Criteria:\n\n* Adults (\\> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.\n\nExclusion Criteria:\n\n* Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).\n* Life expectancy less than 6 months",{"count":669,"type":21},922,[24],"This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.",[673],"Diabetic Retinopathy",[675,676,677],"screening","diabetic retinopathy","artificial intelligence","2025-11-17",{"date":680,"type":40},"2025-11-19",{"date":682,"type":40},"2024-08-08",{"date":44,"type":21},{"name":46,"class":47},""]