[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"D'Or Institute for Research and Education\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":174},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,70,98,125,148],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100598639","phase-2-til-driven-de-escalated-chemotherapy-in-stage-i-ii-tnbc-100598639",false,"NCT07074106","TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC","DespaTIL Study: A Phase II Trial of De-escalated Neoadjuvant Chemotherapy for Early-Stage Triple-Negative Breast Cancer Guided by Tumor-Infiltrating Lymphocytes (TILs) and Radiologic Response","DespaTIL","Inclusion Criteria:\n\n* Histologically confirmed primary invasive breast carcinoma.\n* One of the following conditions:\n* Clinical stage T1c N0 M0 with any level of TILs; or\n* Clinical stage T2 N0 M0 with TILs ≥ 50%.\n* Estrogen receptor (ER) and progesterone receptor (PR) expression \\\u003C 10%.\n* HER2-negative or non-amplified, according to current ASCO-CAP criteria.\n* No evidence of distant metastasis based on imaging performed prior to study entry (chest\u002Fabdomen\u002Fpelvis CT scan or FDG PET-CT).\n* Age ≥ 18 years.\n* ECOG performance status of 0 to 2.\n* Adequate organ function\n\nExclusion Criteria:\n\n* The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), active ischemic heart disease, or chronic liver or kidney disease.\n* Pregnant or breastfeeding participants.\n* History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment.\n\nPatients with stage I triple-negative breast cancer (regardless of TIL levels) and those with stage II disease and high TILs (50% or more) will receive a combination of two chemotherapy drugs (carboplatin and a taxane) for four cycles.\n\nIf imaging shows the tumor has completely disappeared after this treatment, the patient will go straight to surgery. If the tumor is still visible, the treatment will be strengthened with additional chemotherapy drugs (anthracycline and cyclophosphamide), with or without a medicine called pembrolizumab, which helps the immune system fight cancer.\n\nThe main goal of the study is to see how many patients have a complete disappearance of the cancer after treatment. Other goals include understanding how imaging results relate to what is found during surgery and tracking how long patients live without the cancer coming back.",[27],"Breast Cancer",[29,30,31,32],"TILs","Breast cancer","radiological response","Descalonation of neoadjuvant treatment","RECRUITING","2026-03-26",{"date":36,"type":37},"2026-04-01","ACTUAL",{"date":39,"type":37},"2025-10-31",{"date":41,"type":21},"2028-07-01",{"name":43,"class":44},"D'Or Institute for Research and Education","OTHER",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100621555","phase-3-creatine-and-cognitive-health-in-patients-with-early-stage-breast-cancer-during-and-after-chemotherapy-treatment-100621555","NCT07372144","Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemotherapy Treatment","Phase III, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of Creatine Supplementation in Attenuating Chemotherapy-related Cognitive Decline in Patients With Early-stage Breast Cancer Undergoing Chemotherapy.","IARA","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed invasive breast cancer (stages I-III).\n* Indication for neoadjuvant or adjuvant chemotherapy containing an anthracycline or a taxane.\n* Targeted therapies and hormone therapy are permitted according to clinical indication.\n* Ability to provide informed consent and comply with study procedures.\n* ECOG performance status 0-2.\n* Ability to maintain adequate hydration.\n\nExclusion Criteria:\n\n* Prior neurologic conditions that may impair cognitive assessment, including previous stroke, dementia, traumatic brain injury with neurologic sequelae, or other neurologic disorders affecting cognition.\n* Uncorrected sensory impairments that preclude cognitive assessment and\u002For completion of study instruments.\n* History of uncontrolled psychiatric disorders that may interfere with cognitive evaluation.\n* Creatinine clearance \\\u003C60 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n* Known liver disease.\n* Pregnancy.\n* Heart failure.\n* Presence of ascites.\n* Inflammatory bowel disease.\n* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs).\n* Lactation.\n* Chronic use of immunosuppressive agents, including doses greater than 10 mg\u002Fday or equivalent.\n* Prior chronic creatine supplementation within the last 3 months.\n* Known allergy to any component of the supplement or placebo.",{"count":55,"type":21},227,[57],"PHASE3","The goal of this clinical trial is to evaluate whether oral creatine supplementation can prevent chemotherapy-related cognitive impairment in patients with early-stage breast cancer undergoing neoadjuvant or adjuvant chemotherapy. The main questions it aims to answer are:\n\n* Does creatine supplementation reduce the occurrence and severity of chemotherapy-related cognitive impairment, as measured by patient-reported cognitive function?\n* Does creatine supplementation preserve objective cognitive performance compared with placebo during and after chemotherapy?\n\nResearchers will compare creatine supplementation (5 g\u002Fday) with placebo to assess differences in cognitive outcomes, safety, and exploratory biological markers.\n\nParticipants will:\n\n* Receive oral creatine or placebo starting 7 days before chemotherapy and continuing until 12 months after chemotherapy completion\n* Complete patient-reported cognitive assessments and objective neuropsychological tests at predefined time points\n* Undergo clinical follow-up for safety and oncologic outcomes\n* Provide blood samples for biomarker analyses and stool samples for gut microbiota assessment\n* Undergo brain magnetic resonance imaging at selected study visits",[27],"NOT_YET_RECRUITING","2026-01-20",{"date":63,"type":37},"2026-01-28",{"date":65,"type":21},"2026-08-01",{"date":67,"type":21},"2028-06-01",{"name":43,"class":44},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":45},"100595414","phase-1-dose-optimization-and-efficacy-assessment-of-a-fluoropyrimidine-antidote-100595414","NCT07032142","Dose Optimization and Efficacy Assessment of a Fluoropyrimidine Antidote","A Phase I\u002FII Trial to Evaluation of the Dose and Efficacy of an Antidote to Fluoropyrimidines","ARCTURUS","Inclusion Criteria:\n\nPresence of at least one severe toxicity or intoxication resulting from fluoropyrimidine use, defined as: receiving an overdose of medication (total dose and\u002For infusion rate higher than recommended in the package insert) and\u002For Grade 3 or 4 serious adverse events after fluoropyrimidine exposure, according to CTCAE v5.0, which may include (but are not limited to): nausea, vomiting, diarrhea, anemia, neutropenia, febrile neutropenia, thrombocytopenia, and mucositis;\n\nLack of access to uridine triacetate (UT) in the standard of care;\n\nDiagnosis of an invasive solid tumor under systemic treatment with a fluoropyrimidine (5-fluorouracil or capecitabine);\n\nOrgan function considered adequate by the investigator prior to the current fluoropyrimidine intoxication episode;\n\nAbility to take oral medication;\n\nFor men and women of reproductive potential, agreement to practice abstinence or use highly effective contraceptive methods during study participation and for at least 6 months after the last dose of IP;\n\nMen must agree not to donate sperm for at least 6 months after the last dose of IP;\n\nBody surface area between 1.4 and 2.4 m², calculated using the Du Bois method;\n\nAST\u002FALT within normal limits for participants without liver metastases;\n\nAST\u002FALT up to 3x the upper limit of normal in participants with liver metastases;\n\nTotal and fractionated bilirubin up to 2x the upper limit of normal;\n\nAgreement to abstain from alcohol consumption during the treatment period;\n\nAs a specific inclusion criterion for participants in Phase 1 of the study: a medical indication, according to routine care, for hospitalization of at least 48 hours for the clinical management of fluoropyrimidine-related toxicity.\n\nExclusion Criteria:\n\nPregnant or breastfeeding women;\n\nKnown history of allergic reaction to the molecules of the copound and\u002For to other molecules in the same class;\n\nLife expectancy of less than 30 days prior to hospital admission, based on underlying cancer and existing comorbidities;\n\nEstimated creatinine clearance \\\u003C70 mL\u002Fmin;\n\nLiver cirrhosis;\n\nKnown liver or kidney disease;\n\nIndividuals with acquired immunodeficiency may be included only if they have no active opportunistic infections and following careful clinical assessment by the investigator, taking into account concurrent medications;\n\nFamily history or known deficiency of the enzyme responsible for metabolizing the molecules of the copound and\u002For to other molecules in the same class;\n\nUncontrolled infection;\n\nHemodynamically unstable patients;\n\nPatients under orotracheal intubation;\n\nPatients unable to take oral medication;\n\nProlonged QT interval;\n\nCNS metastases considered uncontrolled by the investigator;\n\nHistory of malabsorptive or inflammatory gastrointestinal disease;\n\nUse within the last 30 days of lactulose, protease inhibitors, amiodarone, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, or rifapentine;\n\nUse within the last 5 days of dietary supplements containing the molecules of the copound;\n\nUse within the last 30 days of drugs classified as anticonvulsants;\n\nPersonal history of seizures;\n\nComorbidities deemed limiting by the investigator;\n\nHistory of renal or liver transplant;\n\nPresence of intestinal obstruction.",{"count":79,"type":21},66,[81,24],"PHASE1","Fluoropyrimidines (FLU) are drugs widely used in chemotherapy for various tumors, such as breast, colon, rectal, and gastric cancers. FLU is a drug that inhibits thymine synthesis and, consequently, DNA synthesis, leading to tumor cell death. However, up to 30% of patients treated with FLU experience severe toxicities, depending on the dose and regimen received. The most common symptoms include mucositis, vomiting, nausea, diarrhea, and neutropenia.\n\nThe enzyme dihydropyrimidine dehydrogenase (DPD) plays a key role in FLU metabolism. Patients with mutations in the DPYD gene (which encodes DPD) are at high risk of experiencing severe toxicities from FLU. Uridine triacetate (UT) is a drug that can be used as an antidote for 5-FU in patients who develop severe toxicities. However, despite its efficacy, it is expensive and not commercially available in Brazil.\n\nCurrently, the Brazilian population has no access to an antidote for the treatment of FLU-related toxicities. This Phase I\u002FII study will evaluate the dose, safety, and efficacy of compound the association of two molecules as an antidote for grade 3 or higher toxicities resulting from the use of FLU.",[84,85],"Cancer","Toxicity Due to Chemotherapy",[87,88,89],"cancer","fluoropyrimidines","Toxicities from Fluoropyrimidines","2025-06-13",{"date":92,"type":37},"2025-06-22",{"date":94,"type":21},"2025-07",{"date":96,"type":21},"2028-07",{"name":43,"class":44},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100571844","comprehensive-demographics-and-clinical-profile-of-nsclc-patients-100571844","NCT06725537","Comprehensive Demographics and Clinical Profile of NSCLC Patients","Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Treatment Patterns With PD-L1 Stratification","CA209-1529","Inclusion Criteria:\n\n* Over 18 years old;\n* Histological diagnosis of advanced non-small cell cancer;\n* Clinical and demographic data available in medical records;\n\nExclusion Criteria:\n\n* Patients with localized disease that can be treated locally;\n* Non-epithelial histology;\n* small cell carcinoma\n* neuroendocrine tumor",{"count":107,"type":21},500,"OBSERVATIONAL","Advances in the treatment of non-small cell lung cancer in the last decade have been significant. Currently, there are several first-line therapeutic options. The molecular biology of the disease, biomarkers and the patient's clinical characteristics can assist in decision making. The study in question aims to retrospectively evaluate the patterns of choice in the first line treatment of metastatic non-small cell lung cancer without driver mutations, from 2019 to 2022 in 7 centers in Brazil.",[111],"Lung Cancer Non Small Cell",[113,114,115,116],"neoplasia","lung","metastasis","first line treatment","2025-01-13",{"date":119,"type":37},"2025-01-15",{"date":121,"type":21},"2025-01-20",{"date":123,"type":21},"2025-08-01",{"name":43,"class":44},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":132,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100566581","music-for-surgical-intensive-care-music-100566581","NCT06657040","Music for Surgical Intensive Care (MUSIC)","(MUSIC)","Inclusion Criteria:\n\n* Elective surgery admitted to the ICU in the immediate period after the surgical procedure; · Age equal to or greater than 65 years\n\nExclusion Criteria:\n\n* · Moderate to severe dementia, defined by 2 to 3 points in the clinical dementia rating (CDR)66;\n\n  * Impossibility of verbal communication (eg: aphasia);\n  * Lack of understanding of the Portuguese language;\n  * Inability to listen to music due to hearing impairment or intolerance to the use of headphones;\n  * Mechanical ventilation for more than 12 hours;\n  * Richmond Agitation Sedation Scale (RASS) less than or equal to 324;\n  * Neurosurgical and craniofacial procedures;\n  * Refusal or failure to sign the free and informed consent form (TCLE).","65 Years",{"count":134,"type":21},360,[136],"NA","Intensive care units (ICUs) are environments specialized in the care of critically ill patients. Despite significant advances, ICUs are often seen as a dehumanized environment. Among the various stressors in ICUs, anxiety, pain, psychomotor agitation and mental confusion, need for mechanical restraint, lack of privacy, noise, restricted visiting time with family members and excessive lighting stand out. The tripod composed of pain, anxiety and delirium (often associated with the presence of psychomotor agitation, mental confusion and altered level of consciousness) has a high incidence and morbidity. A set of prevention, intensity reduction and treatment measures has been proposed for these conditions, with a growing number of scientific evidence supporting their routine use.\n\nElderly patients tend to be particularly susceptible to the stressors described above. This aspect represents an additional source of concern for ICUs, since the elderly today represent the majority of patients admitted to ICUs. Hospitalization in ICUs after surgical procedures is often an unknown moment for the individual and, consequently, associated with the development of numerous unpleasant sensations, directly interfering with the patient's recovery.\n\nMusic as a therapy tool in medical practice has been used since 1890. After a little more than two decades, in 1914 it was applied in a surgical procedure by physician Evan Kane as a way of \"calming patients and diverting attention from fear\". associated with combined therapy with local anesthesia. In this context, being a low-cost tool, with minimal adverse effects and high acceptability, the use of music has proven to be a great ally in the arsenal of non-pharmacological therapies for the prevention of delirium, anxiety and pain.\n\nWe intend, through a randomized multicenter clinical trial, to investigate whether the use of music as therapy is capable of reducing the incidence of anxiety, pain and delirium in elderly patients undergoing surgical procedures and hospitalized during the postoperative period in intensive care units.",[139],"DELIRIUM","2024-10-22",{"date":142,"type":37},"2024-10-24",{"date":144,"type":21},"2024-11-01",{"date":146,"type":21},"2025-01",{"name":43,"class":44},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":173,"locationsCount":69},"100539560","encouraging-positive-parenting-habits-100539560","NCT06305429","Encouraging Positive Parenting Habits","Encouraging Positive Parenting Habits Through Digital Media: Feasibility Study","HABITE","Inclusion Criteria:\n\n* Parents of children aged from 4 to 10 years old\n* Parents experiencing behavior difficulties with daily transition routines (parent-report).\n\nExclusion Criteria:\n\n* Parents that do not have the children living with them at least 5 days per week every week;\n\n  * While participating parents are informed that the program was developed for children demonstrating symptoms of ADHD, the low symptom number will not be used as an exclusion criteria.","4 Years","10 Years",{"count":159,"type":21},200,[136],"This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study.",[163],"ADHD",[163,165,166],"Parent Training","Treatment Access","2024-10-10",{"date":169,"type":37},"2024-10-15",{"date":171,"type":37},"2024-06-01",{"date":94,"type":21},{"name":43,"class":44},""]