[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Honduras\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":738},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,76,100,139,170,199,227,256,285,311,338,366,393,415,443,469,493,516,541,567,607,633,657,680,705],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":28,"conditions":29,"keywords":31,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100627068","phase-1-calm-af-ai-counteracting-age-related-loss-of-muscle-with-aav-follistatin-combined-with-angiogenesis-inducing-vegf-plasmid-gene-therapy-100627068",false,"NCT07443826","CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy","CALM-AF-AI","Inclusion Criteria:\n\n* Voluntary written informed consent obtained prior to any study-related procedures\n* Ability to read, understand, and sign the Informed Consent Form and reliably complete required study documents\n* Willingness to undergo medical intervention, including genetic therapy, and to comply with the visit schedule and all study procedures\n* Commitment to maintain a stable medication and supplement regimen throughout the study, with no initiation of new medications, supplements, or performance-enhancing substances unless approved by the Investigator\n* Men and women aged 35-75 years\n* Body mass index (BMI) between 18.0 and 35.0 kg\u002Fm² at screening\n* Active Prospera ZEDE eResidency or Physical Residency\n* Stable comorbid conditions for at least 3 months prior to screening\n* Postmenopausal status (women)\n* Willingness to use reliable contraception for 6 months following therapy\n* Low or undetectable antibody titers to AAV9 (≤1:100 by ELISA)\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or intent to become pregnant; premenopausal status (unless ≥12 months amenorrhea or FSH ≥30 IU\u002FL)\n* Subjects who have a history of alcohol or drug abuse within 1 year of study entry\n* Initiation of prohibited medications, supplements, or interventions during the study period that may confound efficacy or safety assessments\n* Active malignancy or ANY history of cancer\n* Strong family history of cancer in first-degree relatives (≥2 relatives with cancer diagnosed \\\u003C60 years) OR known hereditary cancer syndrome (BRCA1\u002F2, Lynch syndrome, Li-Fraumeni, FAP, HNPCC) without genetic counseling and enhanced surveillance clearance\n* Clinically significant cardiovascular disease, including:\n* Any history of stroke, transient ischemic attack (TIA), myocardial infarction (MI), or unstable angina (regardless of time since event)\n* Diagnosed coronary artery disease (CAD) documented by coronary angiography or stress testing\n* Significant atherosclerotic disease at any location (stenosis ≥50% in carotid, femoral, or other major arteries)\n* Prior coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\])\n* Prior valvular repair or replacement\n* History or current diagnosis of heart failure\n* Uncontrolled hypertension (SBP \\>140 mmHg or DBP \\>85 mmHg despite treatment)\n* Left ventricular ejection fraction (LVEF) \\\u003C50%, QTc ≥480 ms, or severe valvular heart disease\n* Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator\n* Presence of pacemaker or persistent left bundle branch block (LBBB)\n* Known diagnosed cardiomyopathy of any etiology\n* Significant left ventricular hypertrophy, defined as maximal left ventricular wall thickness ≥15 mm in any segment at end-diastole (by echocardiography or cardiac MRI)\n* Known or suspected hypercoagulable state\u002Fthrombophilia, including any of the following:\n* Any history of venous thromboembolism (DVT, PE, or thrombosis at any site), particularly if:\n* Unprovoked, or\n* Associated with only minor provoking factors (e.g., minor surgery, combined oral contraceptives, short-term immobilization)\n* Recurrent thrombotic events, including recurrent superficial venous thrombosis\n* Thrombosis at unusual sites, including but not limited to:\n* Mesenteric, portal, or splenic vein thrombosis\n* Cerebral venous sinus thrombosis\n* Hepatic vein thrombosis (Budd-Chiari syndrome)\n* Renal vein thrombosis\n* Retinal vein thrombosis\n* Superior vena cava thrombosis not related to central venous catheterization\n* Strong family history of venous or arterial thrombosis at a young age in first-degree relatives\n* History of recurrent pregnancy loss or severe obstetric complications suggestive of a hypercoagulable state\n* High-degree myopia (≥ -6.0 diopters) or pathological myopia without ophthalmologic clearance\n* Any history of retinal detachment, vitreous hemorrhage, or retinal vascular disease (diabetic retinopathy, retinal vein occlusion, age-related macular degeneration with neovascularization)\n* Use of systemic anti-VEGF therapy (e.g., bevacizumab)\n* Current use of prohibited medications or supplements (see Section 4.3)\n* Fasting plasma glucose ≥7.0 mmol\u002FL (≥126 mg\u002FdL) at screening\n* HbA1c ≥6.5% (≥48 mmol\u002Fmol) at screening\n* Current diabetes mellitus (any type)\n* History of peptic ulcer disease within 12 months\n* Known osteoporosis (DXA T-score ≤ -2.5 at the hip or spine)\n* Severe pulmonary disease, including COPD or restrictive lung disease (FVC \\\u003C49% predicted)\n* Advanced renal disease (CKD stage 3-5, eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²) or dialysis dependence\n* Chronic liver disease or hepatic impairment:\n* Any history of cirrhosis, chronic viral hepatitis (HBV, HCV), autoimmune hepatitis, or cholestatic liver disease\n* Active hepatitis or evidence of hepatic decompensation\n* ALT or AST \\>1.5× upper limit of normal (ULN)\n* Total bilirubin \\>1.5× ULN (unless due to Gilbert's syndrome)\n* Non-alcoholic steatohepatitis (NASH) and clinically significant liver fibrosis\n* Active cholecystitis, symptomatic gallbladder disease (e.g., biliary colic), or any other clinically significant hepatobiliary abnormality\n* Neurodegenerative, neuromuscular, psychiatric, or movement disorders associated with functional or cognitive impairment (e.g., dementia, Parkinson's disease)\n* History of drug-induced myopathy or rhabdomyolysis\n* Elevated creatine kinase (CK) at screening CK \\>1.0× ULN confirmed on two separate occasions at least 48 hours apart\n* Exception: Transient CK elevation within 72 hours of strenuous exercise, intramuscular injections, or trauma is permitted if CK normalizes (≤1.0× ULN) on repeat testing before baseline visit\n* Systemic connective tissue diseases (CTDs), including:\n* Systemic lupus erythematosus (SLE), SLE overlap syndromes, or drug-induced SLE\n* Mixed connective tissue disease (MCTD)\n* Systemic sclerosis (SSc, scleroderma): diffuse, limited, or sine scleroderma\n* Inflammatory myopathies: polymyositis (PM), dermatomyositis (DM), inclusion body myositis (IBM), immune-mediated necrotizing myopathy (IMNM), or overlap myositis\n* Primary Sjögren's syndrome requiring systemic immunosuppression (corticosteroids \\>10 mg\u002Fday prednisone equivalent, DMARDs, or biologics)\n* Rheumatoid arthritis with extra-articular manifestations or requiring biologic DMARDs\n* Undifferentiated connective tissue disease (UCTD) meeting ≥2 CTD classification criteria\n* Current or recent (within 3 months) use of immunosuppressive agents, including corticosteroids, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, IVIG, or rituximab\n* Acute bacterial, fungal, or viral infection, fever, or receipt of live vaccines within 30 days prior to screening\n* Infectious disease exclusions, including:\n* Active hepatitis B infection or reactivation risk (HBsAg positive, HBV DNA detectable, or isolated anti-HBc without anti-HBs)\n* Hepatitis C infection (detectable HCV RNA or treatment within 6 months)\n* HIV infection\n* Active or latent tuberculosis (positive QuantiFERON-TB Gold Plus ≥0.35 IU\u002FmL)\n* Acute herpesvirus infection, defined as\n* Active HSV-1 or HSV-2 lesions (vesicles, ulcers, crusts) on clinical examination at screening\n* CMV or EBV IgM positive\n* Increased bleeding risk, including platelet count \\\u003C100 ×10⁹\u002FL, active anticoagulation (unless washout possible), or known coagulation disorders\n* Severe physical functional limitation (CFS\\>6)\n* Prior exposure to any AAV gene therapy product (any AAV serotype)\n* Prior exposure to any investigational drug within 90 days\n* Participation in another clinical trial within 90 days\n* Known hypersensitivity to investigational product components or immunosuppressive agents (e.g., prednisone, rapamycin)\n* Life expectancy \\\u003C6 months\n* Any condition that, in the Investigator's judgment, may pose undue risk, interfere with study outcomes, or impair study participation",true,"ALL","35 Years","75 Years",{"count":22,"type":23},12,"ESTIMATED","INTERVENTIONAL",[26,27],"PHASE1","PHASE2","This Phase 1\u002F2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding plasmid. Secondary objectives include the assessment of preliminary signals of biological and functional activity, including changes in skeletal muscle mass and performance.",[30],"Age-related Muscle Decline",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62],"Sarcopenia","Muscle Atrophy","Skeletal Muscle","Muscle Weakness","Muscle Strength","Aging","Frailty","Follistatin","Myostatin","Viral Vectors","Adeno-Associated Viruses","Activins","Vascular Endothelial Growth Factor A","Angiogenesis Inducing Agents","Plasmids","Intramuscular Injections","Immunosuppression","Prednisolone","Sirolimus","Safety","Dual-Energy X-Ray Absorptiometry","Physical Endurance","Quality of Life","Adults","Middle Aged","Gene Therapy","Grip strength","Rapamycin","6MWT","VO2max","1RM","RECRUITING","2026-07-10",{"date":66,"type":67},"2026-07-13","ACTUAL",{"date":69,"type":67},"2026-06-01",{"date":71,"type":23},"2028-06-30",{"name":73,"class":74},"Unlimited Biotechnology LLC","INDUSTRY",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":4,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":22},"100475978","an-observational-pregnancy-safety-study-in-women-who-were-exposed-to-the-drug-nifurtimox-during-pregnancy-to-learn-about-the-risk-of-pregnancy-complications-and-about-the-mothers-and-babys-health-100475978","NCT05477953","An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health","Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant","Inclusion Criteria:\n\n* Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period \u002F time of conception to pregnancy outcome).\n* Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None","FEMALE",{"count":85,"type":23},50,"OBSERVATIONAL","This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.\n\nChagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems.\n\nNifurtimox has been used for more than 50 years to treat Chagas disease in children and adults.\n\nIt is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans.\n\nIn this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information:\n\n* Birth defects (abnormal and problematic structures or functions, a child is born with)\n* Pregnancy outcomes (like live birth, preterm birth, still birth\u002Fdeath of the unborn baby, miscarriage, or abortion)\n* Certain health problems of the child up to 12 months of age\n* Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population.\n\nThe study will run for approximately 10 years.",[89],"Chagas Disease","NOT_YET_RECRUITING","2026-07-02",{"date":93,"type":67},"2026-07-06",{"date":95,"type":23},"2026-12-31",{"date":97,"type":23},"2032-01-31",{"name":99,"class":74},"Bayer",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":24,"phases":112,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":75},"100641330","phase-3-combination-therapies-for-trichuris-trichiura-infection-in-schoolchildren-in-honduras-100641330","NCT07661316","Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras","Randomized, Open-Label, Assessor-Blinded Clinical Trial of Combination Therapies Versus Standard Treatment for Trichuris Trichiura Infection in Schoolchildren in La Moskitia, Honduras","AIM-T","Inclusion Criteria:\n\n* Trichuris trichiura infection documented by quantitative real-time PCR (qPCR) performed within 30 days prior to randomization.\n* Age 6 to 15 years inclusive.\n* Written informed consent provided by a parent or legal guardian. Assent provided by children aged 9 years or older, according to local ethical requirements.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to albendazole or ivermectin.\n* Receipt of an anthelmintic treatment (albendazole, mebendazole, or ivermectin) within 3 months prior to enrollment.\n* Participation in another clinical trial within 3 months prior to enrollment.\n* Severe comorbidity at the investigator's discretion (e.g., diarrhea, tuberculosis, or malaria).\n* Body weight \\\u003C15 kg.\n* Positive pregnancy test or refusal to undergo pregnancy testing in post-menarcheal girls and female adolescents of childbearing potential.","6 Years","15 Years",{"count":111,"type":23},368,[113],"PHASE3","The goal of this Phase III clinical trial is to evaluate the efficacy, safety, and acceptability of different treatment regimens for Trichuris trichiura infection in schoolchildren aged 6 to 15 years living in La Moskitia, Honduras, an area with a high burden of soil-transmitted helminth infections.\n\nThe main questions it aims to answer are:\n\n* Are combination treatments of albendazole and ivermectin more effective than albendazole alone for treating Trichuris trichiura infection?\n* Does a fixed-dose combination (FDC) of albendazole and ivermectin achieve cure rates comparable to co-administration of the two drugs?\n* How effective are the different treatment regimens against other soil-transmitted helminths, including Strongyloides stercoralis?\n* What adverse events occur following treatment with the different regimens?\n* How acceptable are the different treatment regimens to children and their caregivers?\n\nResearchers will compare four treatment groups: placebo, albendazole alone, albendazole plus ivermectin, and a fixed-dose combination of albendazole plus ivermectin.\n\nParticipants will:\n\n* Be randomly assigned to one of the four treatment groups.\n* Receive a single dose of the assigned treatment.\n* Provide stool samples before treatment and approximately 21 days after treatment.\n* Undergo laboratory testing using quantitative real-time PCR (qPCR) to detect and quantify helminth infections.\n* Be monitored for adverse events after treatment.\n* Complete acceptability assessments together with their caregivers.\n\nThe study will provide evidence on the efficacy, safety, and acceptability of a fixed-dose combination of albendazole and ivermectin and its potential use as a simplified treatment strategy for the control of soil-transmitted helminth infections in endemic settings.",[116,117,118,119,120],"Trichuriasis","Strongyloidiasis","Ascariasis","Hookworm Infection","Soil-Transmitted Helminthiasis",[122,123,124,125,126,127,128],"HONDURAS","TRICHURIS TRICHIURA","IVERMECTIN","MOSKITIA","SCHOOL AGE CHILDREN","SOIL TRANSMITTED HELMINTHIASIS","ALBENDAZOLE AND IVERMECTIN FIXED DOSE COMBINATION","2026-06-18",{"date":131,"type":67},"2026-06-23",{"date":133,"type":23},"2026-11-01",{"date":135,"type":23},"2027-05-31",{"name":137,"class":138},"Mundo Sano Foundation","OTHER",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":17,"sex":18,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":24,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100624870","phase-3-skyvaricella-nbp608-vaccine-with-lower-potencies-in-healthy-children-aged-12-months-to-12-years-100624870","NCT07415252","SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years","A Phase III, Randomized, Double-blinded, Active-controlled, Multinational, Multicenter Study to Assess the Safety and Immunogenicity of a Two-dose Regimen of SKYVaricella® (NBP608) in Children Aged 12 Months to 12 Years","Inclusion Criteria:\n\nAge\n\n1. Participant must be ≥12 months to ≤12 years of age, at the time of informed consent.\n\n   Type of Participant and Disease Characteristics\n2. Participant is healthy or medically stable, as determined by the investigator through medical history, physical examination, and overall clinical assessment.\n\n   \\* Medically stable condition is defined as no significant change in therapy and no hospitalization for worsening disease within 8 weeks prior to the first study vaccination\n3. Participant's parents\u002FLARs are able and willing to comply with all study procedures and attend all scheduled visits.\n\n   Sex and Contraceptive\u002FBarrier Requirements\n4. Female participants of childbearing potential (i.e., post-menarcheal females) must agree to maintain complete sexual abstinence from heterosexual intercourse, from at least 4 weeks prior to the first study vaccination and through 12 weeks following the second study vaccination (Visit 5).\n5. Female participants of a childbearing potential must have a negative urine pregnancy test at screening; pregnancy testing is not required for those not of childbearing potential.\n\n   Informed Consent\u002FAssent\n6. Participant's parents\u002FLARs are capable of providing signed informed consent, including agreement to comply with the requirements and restrictions specified in this protocol and in the informed consent form (ICF), before initiation of any study-specific procedures. Where applicable, the participant must also be able to provide written assent in accordance with local regulations and IRB\u002FIEC requirements.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \\>38°C), or acute illness within 24 hours prior to any study vaccination (Participant may be enrolled 24 hours after resolution of these symptoms).\n2. History of suspected or laboratory-confirmed VZV infection\n3. Close contact or household exposure to an individual with suspected or laboratory-confirmed VZV infection within 4 weeks prior to the first study vaccination.\n4. Household member(s) considered at high risk of severe VZV infection, including:\n\n   * Immunocompromised individuals\n   * Pregnant women or newborn infants whose mothers lack history of varicella infection or varicella vaccination\n   * Newborn infants born at \\\u003C 28 weeks gestational age.\n5. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.\n6. History of bleeding disorder or thrombocytopenia contraindicating subcutaneous vaccination, based on the investigator's judgment.\n7. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis) to any vaccines or to any components of the study intervention, including gelatin or neomycin.\n8. History of Guillain-Barre syndrome following receipt of any prior vaccines.\n9. Active untreated tuberculosis infection.\n10. Significant unstable chronic or acute illness that, in the investigator's judgment, could pose a risk to the participant's safety, interfere with protocol-specified procedures, or complicate the interpretation of study results.\n11. Any other medical conditions that, in the opinion of the investigator, might interfere with the evaluation of study objectives (e.g., major congenital anomalies, neurological disorders, history of seizure disorders)\n\n    Prior\u002FConcomitant therapy\n12. Prior receipt of any varicella-containing vaccine.\n13. Receipt of any vaccine within 4 weeks prior to the first study vaccination, except influenza vaccine, which may be received ≥ 2 weeks prior, and pneumococcal conjugate vaccine (PCV), for which the last dose of the primary series must have been administered ≥ 8 weeks prior to the first study vaccination.\n14. Receipt of any live-attenuated vaccine within 4 weeks prior to the first study vaccination, or planned receipt of any live-attenuated vaccine through 4 weeks following each study vaccination, if not administered on the same day as the study vaccine.\n15. Receipt of antiviral medications within 4 weeks prior to the first study vaccination, or planned use of antiviral medications at any time during the study through 6 weeks following the second vaccination.\n16. Receipt of salicylates within 2 weeks prior to the first study vaccination, or planned use of salicylates at any time during the study through 6 weeks following the second vaccination.\n17. Receipt of immunoglobulins (except for BeyfortusTM \\[nirsevimab\\]) or any blood products within 24 weeks prior to the first study vaccination, or planned receipt at any time during the study period.\n18. Receipt or planned chronic use (defined as \\> 2 consecutive weeks) of systemic immunosuppressive therapy or immune-modifying medications, including anti-cancer chemotherapy, radiation therapy; or systemic corticosteroids (equivalent to ≥ 1 mg\u002Fkg\u002Fday of prednisone or 20 mg\u002Fday for individuals weighing \\>10 kg) within 24 weeks prior to the first study vaccination throughout the end of the study period (Use of inhaled, topical, or intranasal glucocorticoids is permitted).\n\n    Prior\u002FConcurrent Clinical Study Experience\n19. Participation in another clinical study involving study intervention within 4 weeks (6 months in Korea in accordance with local regulations) prior to the first study vaccination, or concurrent \u002F planned participation in another clinical study involving study intervention during this study.\n\n    Other Exclusions\n20. Investigators, study staff directly involved in conducting the study or supervised by the investigator, and their respective family members.","12 Months","12 Years",{"count":149,"type":23},780,[113],"The goal of this study is to evaluate the safety and immunogenicity of an investigational varicella vaccine in children. Researchers will compare the investigational vaccine, NBP608, with licensed varicella vaccines. The study includes children aged 12 months to 12 years.\n\nApproximately 780 participants will take part in this study. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Some participants will receive two doses, while others will receive one dose, according to the assigned study group.\n\nParticipants will:\n\nReceive two subcutaneous injections of a study vaccine, administered approximately three months apart (if applicable).\n\nVisit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.",[153],"Varicella (Chickenpox)",[155,156,157,158,159],"SKYVaricella","NBP608","Varicella vaccine","Chickenpox vaccine","Pediatric vaccination","2026-06-11",{"date":162,"type":67},"2026-06-15",{"date":164,"type":23},"2026-06-05",{"date":166,"type":23},"2028-01-02",{"name":168,"class":74},"SK Bioscience Co., Ltd.",15,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":83,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":24,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":75},"100642539","phase-2-furosemide-vs-placebo-in-severe-preeclampsia-postpartum-100642539","NCT07648251","Furosemide vs Placebo in Severe Preeclampsia Postpartum","Furosemide Oral Versus Placebo for Reduction of Hospital Length of Stay in Postpartum Women With Severe Preeclampsia: A Double-Blind, Randomized Controlled Trial","FUROPE","Inclusion Criteria:\n\n* Signed informed consent (assent for minors 14-17 years with parental\u002Fguardian consent)\n* Confirmed severe preeclampsia (BP ≥160\u002F110 mmHg, or lower BP with thrombocytopenia, hepatic dysfunction, renal insufficiency, pulmonary edema, or cerebral\u002Fvisual symptoms)\n* Postpartum (12-24 hours after delivery, vaginal or cesarean)\n* Hemodynamically stable (no vasopressors for ≥6 hours)\n* Preserved diuresis (\\>30 mL\u002Fhour for ≥6 hours)\n* Serum creatinine \\\u003C0.8 mg\u002FdL\n\nExclusion Criteria:\n\n* Current or chronic diuretic use (before or during pregnancy)\n* Known allergy to sulfonamides or furosemide\n* Active febrile illness\n* Known chronic kidney disease (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m²)\n* Participation in another interventional trial\n* Pregnancy (current - not applicable postpartum, but excludes undiagnosed concurrent pregnancy)","14 Years","49 Years",{"count":181,"type":23},186,[27],"This randomized, double-blind, placebo-controlled trial evaluates whether oral furosemide 40 mg, initiated 12 hours postpartum, reduces hospital length of stay compared to placebo (folic acid 5 mg) in postpartum women with severe preeclampsia. Secondary outcomes include need for rescue antihypertensive medications, weight reduction, and metabolic safety (hypokalemia, renal function). A total of 186 participants (93 per arm) will be enrolled across two hospitals in Honduras.",[185],"Severe Preeclampsia",[187,188,189,190,191],"Preeclampsia","Furosemide","Postpartum","Hypertension","Length of Stay","2026-06-09",{"date":162,"type":67},{"date":162,"type":23},{"date":196,"type":23},"2027-01-15",{"name":198,"class":138},"Universidad Nacional Autonoma de Honduras",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":207,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":24,"phases":210,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100593653","a-study-evaluating-the-safety-and-efficacy-of-miniject-s-in-subjects-with-open-angle-glaucoma-100593653","NCT07009236","A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma","A Multi-center, Prospective, Cohort Expansion Clinical Study Evaluating the Safety, Usability, Implantation Accuracy and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma (STAR VII Study)","STAR VII","Inclusion criteria\n\n1. Males or females, 20 years of age or older\n2. Diagnosis of open angle glaucoma (OAG) in the study eye\n3. Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction (with IOL implantation) with MINIject implantation, a grade 2 angle is acceptable prior to cataract surgery so long is the angle becomes grade 3 or greater prior to MINIject implantation).\n4. Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy \u002F intolerance to a medication or inability to consistently access medication. Examples include but are not limited to prostaglandins, beta blockers, carbonic anhydrase inhibitors or alpha-2-agonists\n5. Minimal visual acuity in the study eye must be 35 letters EDTRS (20\u002F200) or better and 50 letters ETDRS (20\u002F100) or better in the fellow eye\n6. Maximal C\u002FD ratio must be 0.9 in the study eye\n7. Subjects must be willing and able to follow study instructions and to return for scheduled study-related examinations\n8. Subjects must provide written informed consent prior to any study procedures\n9. Part 2 Only: Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation\n10. Part 2 Only: The following intraoperative criteria following the IOL implantation need to be met in order for investigator to proceed with the investigational device placement:\n\n    1. Capsulorhexis is intact and centered\n    2. Posterior capsular bag is intact\n    3. The IOL is well-centered in the capsular bag\n    4. There is no evidence of zonular dehiscence\u002Frupture\n    5. The Anterior Chamber (AC) angle was able to be clearly visualized using direct gonioscopy.\n\nExclusion criteria\n\nSubjects are not eligible for inclusion in this clinical investigation if one or more of the following criteria are met:\n\n1. Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to Shaffer Angle Grading System in the study eye except for the situation described in inclusion criterion #3.\n2. Any eye surgery that was performed \\\u003C 90 days before Screening\u002FBaseline visit in the study eye\n3. Diagnosis of diabetes mellitus with HbA1C \\>7%\n4. Known or suspected allergy or hypersensitivity to medical silicone\n5. Allergy to fluorescein\n6. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant\n7. Central endothelial cell density (ECD) at Screening visit with a mean value \\\u003C1900 cells\u002Fmm2 or coefficient of variation (CV) of endothelium \\>0.45 A variance of 5% less than this cell count is permitted if in the clinical judgement of the Investigator the potential benefit\u002Frisk to subject participation is favorable and the central corneal endothelial morphology is characterized as normal by the usual criteria of hexagonality, polymorphism, and polymegathism\n8. Anticipated need for ocular surgery or retinal laser procedure in the study eye\n9. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye,\n10. Pre-existing ocular or systemic pathology that, in the opinion of the investigator (reason to be specified on the case report form), is likely to cause post-operative complications following implantation\n11. Central corneal thickness greater than 600 microns\n12. Clinically significant degenerative visual disorders that, in the opinion of the investigator, can impact study examinations (e.g. exudative macular degeneration or other retinal disorders)\n13. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye\n14. Evidence of crystalline lens subluxation or luxation in the study eye\n15. Inability to perform Visual Field (VF) testing in either eye\n16. Evidence of vitreous loss in the anterior chamber in the study eye\n17. Clinically significant intra-ocular inflammation or infection\n18. Presence of silicone oil in the study eye\n19. Participation in any study involving a drug or device within the past 3 months and planned participation to any other study during the present study. There is no exclusion period after completion of the present trial\n20. Only for women of childbearing potential: positive pregnancy test at Screening\u002FBaseline visit. Pregnant or lactating women\n21. Subject is under tutorship or trusteeship\n22. Subject has a condition such that his \u002F her ability to provide personal informed consent is compromised\n23. Diagnosis of cataract in the study eye that is not age-related e.g., traumatic, inflammatory or resulting from diabetes in the study eye\n24. Unable to discontinue anticoagulant\u002Fantiplatelet therapy (i.e. acetylsalicylic acid, coumadin, heparin, apixaban, etc.) for the surgical procedure. The amount of washout and when to restart therapy after surgery is at the Principal Investigator's discretion and may be based on literature references (see Annexes) or in consultation with the subject's primary care team.","20 Years",{"count":209,"type":23},60,[211],"NA","This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).",[214],"Glaucoma",[216],"MINIject","2026-06-08",{"date":219,"type":67},"2026-06-10",{"date":221,"type":67},"2025-09-29",{"date":223,"type":23},"2028-07",{"name":225,"class":74},"iSTAR Medical",5,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":17,"sex":18,"minAge":146,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":24,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":255},"100578041","phase-3-a-study-on-the-immune-response-and-safety-of-the-second-dose-of-an-investigational-chickenpox-vaccine-when-given-to-healthy-children-3-months-after-a-first-dose-at-12-to-15-months-of-age-100578041","NCT06806137","A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age","A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age","Inclusion Criteria:\n\n* Participant's parent(s)\u002FLegally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol\n* Written or witnessed\u002Fthumb printed informed consent obtained from the participant's parent(s)\u002FLAR(s) prior to performance of any study-specific procedure.\n* Healthy participants as established by medical history and clinical examination before entering into the study.\n* A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1 year birthday until the day before 16 months of age) at the time of the administration of the first study interventions.\n* Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.\n\nExclusion Criteria:\n\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Hypersensitivity to latex.\n* Major congenital defects, as assessed by the investigator.\n* Recurrent history of uncontrolled neurological disorders or seizures.\n* History of varicella disease.\n* Active untreated tuberculosis.\n* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n* Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or their planned use during the study period.\n* Planned administration of a vaccine in the period starting 30 days before the first dose and ending 43 days after the second dose of study interventions administration (Visit 3), with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.\n* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and\u002For planned use of long-acting immune-modifying treatments at any time up to the end of the study.\n\n  * Up to 90 days prior to the study intervention administration:\n\n    i) For corticosteroids, this will mean prednisone equivalent \\>=0.5 mg\u002Fkg\u002Fday with maximum of 20 mg\u002Fday for pediatric participants. Inhaled and topical steroids are allowed.\n\nii) Administration of immunoglobulins and\u002For any blood products or plasma derivatives.\n\n* Up to 180 days prior to study interventions administration: long acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccinese.g., nirsevimab), antitumoral medication.\n* Previous vaccination against measles, mumps, and rubella.\n* Previous vaccination against hepatitis A virus.\n* Previous vaccination against varicella virus.\n* Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.\n* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug\u002Finvasive medical device).\n* Child in care.\n* Any study personnel's immediate dependents, family, or household members.\n* Participants with the following high-risk individuals in their household:\n\n  i) Immunocompromised individuals. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (\\\u003C) 28 weeks of gestation.","15 Months",{"count":236,"type":23},600,[113],"The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.",[240],"Chickenpox",[242,243,244,245],"Chicken pox","Investigational varicella vaccine (VNS) Varicella","Varivax (VV)","Healthy Children","2026-05-27",{"date":248,"type":67},"2026-05-29",{"date":250,"type":67},"2025-05-15",{"date":252,"type":23},"2027-05-03",{"name":254,"class":74},"GlaxoSmithKline",6,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":17,"sex":18,"minAge":263,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":24,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100619751","phase-3-lot-to-lot-consistency-study-of-a-21-valent-pneumococcal-conjugate-vaccine-in-healthy-infants-from-2-months-of-age-100619751","NCT07348692","Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age","A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers","Inclusion Criteria:\n\n* Aged 42 to 89 days on the day of inclusion\n* Participants who are healthy as determined by medical evaluation including medical history and physical examination\n* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable\n\nExclusion Criteria:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy\n* History of microbiologically confirmed Streptococcus pneumoniae infection or disease\n* Any contraindication to the routine pediatric vaccine being administered in the study\n* History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy\n* Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3\n* Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) \u002F legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* Moderate or severe acute illness\u002Finfection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \\[≥ 100.4°F\\]) on the day of study intervention administration.\n* Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period\n* Previous vaccination against Streptococcus pneumoniae\n* Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus\n* Receipt of more than 1 dose of hepatitis B vaccine\n* Receipt of immune globulins, blood or blood-derived products since birth\n* Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure\n\nNote: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","42 Days","89 Days",{"count":266,"type":23},2195,[113],"This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called \"antibodies\" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).\n\nThe study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.\n\nThere will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days",[270,271],"Pneumococcal Immunization","Healthy Volunteers",[273,274],"Pneumococcal Infection","21 Valent Pneumococcal Vaccine","2026-05-21",{"date":277,"type":67},"2026-05-22",{"date":279,"type":67},"2026-01-20",{"date":281,"type":23},"2028-05-29",{"name":283,"class":74},"Sanofi",19,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":17,"sex":18,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":24,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":310},"100600873","phase-3-a-phase-iii-control-study-of-the-safety-and-immunogenicity-of-vyf-in-pediatric-population-100600873","NCT07103148","A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population","A Parallel Group, Phase III Randomized, Modified Double-blind, Active Controlled Study to Investigate the Immunogenicity and Safety of vYF Compared to Licensed YF Vaccines in Pediatric Population Aged 9 Months to 5 Years of Age","Inclusion Criteria:\n\n* Aged 9 months to 5 years on the day of inclusion\\*\n\n  \\* \"9 months to 5 years\" means from the day of the 9th month after birth to the day before the 6th year birthday\n* Aged 11 to 15 months\\* on the day of inclusion for participants enrolled in the MMR co-administration group\n\n  \\* \"11 to 15 months\" means from the day of the 11th month after birth to the day before the 16th month birthday\n* Participants who are healthy as determined by medical evaluation including medical history and physical examination\n* For infants\\*, born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: \"Medically stable\" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention\n\n  \\* Infants aged 9 months to 11 months up to the day before the 12th month birthday\n* Participant and parent\u002FLAR are able to attend all scheduled visits and to comply with all study procedures\n* ICF has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations)\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy irradiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* Known history of FV infection\n* Known systemic hypersensitivity to any of the study intervention components, eggs or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances\n* Moderate or severe acute illness\u002Finfection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \\[≥ 100.4°F\\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.\n* Chronic illness\\* that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion , including malignancy, such as leukemia, or lymphoma\n\n  \\*Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection\n* History of central nervous system disorder or disease, including seizures and febrile seizures\n* Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration. Vaccine to be administered as part of the National Immunization Schedule will be postponed after the D29 visit\n* Previous vaccination against a FV disease at any time including YF with an investigational or marketed vaccine\n* Receipt of immune globulins, blood or blood-derived products in the past 6 months\n* Administration of any anti-viral within 2 months preceding the study intervention administration and up to the 6 weeks following the study intervention administration\n* For participants enrolled in the MMR co-administration group: previous vaccination against measles, measles\u002Fmumps\u002Frubella\n* For participants enrolled in the MMR co-administration group: history of measles, mumps, rubella confirmed either clinically, serologically, or microbiologically\n* Known history or laboratory evidence of HIV infection\n* Known history of hepatitis B or hepatitis C seropositivity\n* Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia)\n* Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the first year of the 3-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 6 months of follow-up is permitted, assuming it does not exclude participation in this study.\n* In an emergency setting, or hospitalized involuntary\n* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study","9 Months","5 Years",{"count":295,"type":23},2440,[113],"The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and when they are co-administered with Measles Mumps Rubella (MMR) vaccines in infants aged 11-15 months.\n\nNumber of Participants:\n\nA total of 2440 participants is planned to be enrolled in VYF04 study.\n\nStudy Arms and Duration:\n\nEligible participants will be randomized in 2 independent groups (9-24 months, 2-5 years) to receive 1 dose of either vYF or Stamaril or YF-VAX in a 2:1:1 ratio within each age group. An additional group with participants of 11-15 months of age will also receive at the same vaccination visit vYF and a single dose of MMR vaccine.\n\nFor the 2nd step (YF booster vaccine administration in a subset), at the Year (Y) 3 visit, a subset of 120 participants of the 9-24 months of age group who did receive a YF vaccine on Day(D) 01 will be invited to join a booster dose assessment (booster dose administered after the Y3 visit blood sample has been taken). Participants aged 11 to 15 months at the time of the concomitant administration of vYF and MMR will not be eligible for receiving a booster dose.\n\nThe duration of each participation will be approximately 3 years for all participants (including participants co-administered on D01 with vYF and MMR), and 6 more months post-booster dose administration for the participants enrolled in the booster subset.",[299],"Yellow Fever Immunization",[301],"Yellow fever","2026-05-05",{"date":304,"type":67},"2026-05-06",{"date":306,"type":67},"2025-07-11",{"date":308,"type":23},"2030-03-04",{"name":283,"class":74},13,{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":17,"sex":18,"minAge":318,"maxAge":20,"enrollmentInfo":319,"targetDuration":4,"studyType":24,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":75},"100634802","phase-1-aklmrna-mediated-protein-replacement-therapy-100634802","NCT07544420","aKLmRNA-mediated Protein Replacement Therapy","A Randomized, Double-Blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (Protein Expression) of Multiple Administrations of Alpha Klotho mRNA (aKLmRNA), aKL003","Subjects will only be included in the trial if they meet all following criteria:\n\n1. Written informed consent (ICF) signed and dated by the patient\n2. Ability and willingness to co-operate with the investigator and to comply with the requirements of the entire study.\n3. Healthy subjects, 25 50 to 75 90 years of age\n4. Sexually active females of childbearing potential and male partners of sexually active females of childbearing potential must use medically accepted form of contraception or be surgically sterile (hysterectomy or bilateral oophorectomy).\n5. Women of childbearing potential and men with female partners of childbearing potential must use an effective method of birth control during the course of the trial and for at least 90 days after the last dose in a manner such that risk of failure is minimized. Male participants should refrain from donating sperm during the intervention period and for at least 90 days after the last dose of study intervention (see additional considerations in section 5.3)\n6. Females of childbearing potential must have a negative pregnancy test at the time of enrollment (serum hCG test)\n\nExclusion Criteria:\n\nSubjects will be excluded from the trial if they present one or more of the following conditions:\n\n1. Known of suspected allergy to IMP or related procedure\n2. Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the Investigator\n3. Contraindications for the use of emergency treatments\n4. Clinically relevant findings at screening, e.g., active diseases of any kind particularly infections\n5. History of chronic alcohol or drug abuse\u002F dependence within the past 5 yearsUse of any prescription or over-the-counter medication within 7 days prior to first dosing or planned use during the study period, with the exception of medications considered medically necessary and administered at a stable dose and regimen. Stable medication is defined as medication for which no initiation, discontinuation, or dose adjustment has occurred for at least 3 monthsprior to first dosing and for which no change is anticipated during the study period. Occasional use of paracetamol (acetaminophen) and\u002For ibuprofen is permitted at the discretion of the investigator.\n6. Employee at the study site, spouse\u002Fpartner or relative of any study staff (e.g., investigator, sub investigators, or study nurse) or employee of the Sponsor\n7. Known or suspected pregnancy, planned pregnancy of lactation\n8. Clinically significant unstable psychiatric illness in the past 6 months\n9. Presence of autoimmune disease, autoinflammatory syndrome, or immunological deficiency syndrome (including human immunodeficiency virus (HIV) infection)\n10. Relevant cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the Investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry\n11. Presence of end stage kidney failure (on dialysis)\n12. Current or anticipated use of immunosuppressive drugs such as, but not limited to, azathioprine, cyclosporine, methotrexate, tacrolimus, or mycophenylate within 2 months or any myelosuppressive or cytotoxic chemotherapies within the 12 months prior to the screening visit. Use of systemic corticosteroids equivalent to ≥20mg\u002Fweek prednisone within the past 4 weeks before screening and during the course of the study (intranasal or inhaled steroids for allergies\u002Fasthma is allowed)\n13. History within the last 2 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment; or has a life expectancy of \\\u003C2 years.\n14. Patients with long covid-19 showing long-term neurological sequelae within the past 12 months at the time of screening\n15. Has had a history within the last 5 years of a serious infectious disease affecting the brain, liver, lung and\u002For kidneys.\n16. Refractory epilepsy (has had seizures within the past 2 years)\n17. Hypothyroidism or vitamin B12 deficiency (patients with corrected hypothyroidism or vitamin B12 deficiency are eligible for the study provided that treatment has been stable for 3 months before study entry)\n18. Patient has hemochromatosis\n19. Pre-existing PEG antibodies of significant levels","50 Years",{"count":320,"type":23},21,[26],"This is a Phase 1b randomized, double-blind, placebo-controlled study to assess the safety and tolerability of a proprietary aKLmRNA formulated in lipid nanoparticles. Approximately 21 subjects will be enrolled.\n\nEach subject will receive a total of two injections during the study. The cohort will consist of approximately 21 subjects, with each receiving 0.5 mg aKLmRNA (AKL003) or placebo. Subjects will be randomized in a 2:1 ratio (active treatment:placebo). The placebo will be saline, matching the active treatment in both appearance and volume.",[37],[325,326,327,328],"Longevity","Healthy Aging","Klotho","mRNA","2026-04-15",{"date":331,"type":67},"2026-04-22",{"date":333,"type":23},"2026-05-15",{"date":335,"type":23},"2026-11-30",{"name":337,"class":74},"Klothea Bio Inc",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":17,"sex":83,"minAge":346,"maxAge":179,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":75},"100625093","effect-of-maternal-chocolate-consumption-on-fetal-non-stress-test-nst-reactivity-100625093","NCT07418151","Effect of Maternal Chocolate Consumption on Fetal Non-Stress Test (NST) Reactivity.","Effect of Maternal Consumption of Dark Chocolate on the Reactivity of the Fetal Non-Stress Test (NST): A Single-Blind, Randomized Clinical Trial.","CHOCO-NST","Inclusion Criteria:\n\n* Singleton pregnancy between 36+0 and 41+6 weeks of gestation.\n* Baseline Non-Stress Test (NST) classified as non-reactive after a standard 20-minute recording (absence of ≥2 accelerations of ≥15 beats per minute lasting ≥15 seconds).\n* Intact amniotic membranes and not in active labor (cervical dilation \\\u003C4 cm, with absent or irregular contractions).\n* Ability to provide written, informed consent.\n* Literacy: Ability to read and write (to ensure comprehension of the consent form and study materials).\n* Access to a telephone or electronic device for the 24-hour safety follow-up contact.\n\nExclusion Criteria:\n\n1. Pregnancy-related exclusions:\n\n   * Multiple gestation (twins, triplets, etc.).\n   * Known major fetal malformation.\n   * Diagnosis of severe fetal growth restriction with abnormal umbilical artery Doppler.\n   * Premature rupture of membranes.\n   * Active vaginal bleeding or placenta previa with hemorrhage.\n   * Suspected or confirmed chorioamnionitis.\n2. Maternal medical exclusions:\n\n   * Severe preeclampsia, eclampsia, or HELLP syndrome.\n   * Uncontrolled severe hypertension.\n   * Pregestational diabetes or gestational diabetes requiring insulin or other antihyperglycemic medication.\n   * Capillary blood glucose level \\>140 mg\u002FdL at the time of screening.\n   * Maternal fever ≥38°C or maternal tachycardia \\>120 beats per minute.\n3. Interference with test interpretation:\n\n   * Use of sympathomimetic drugs within 12 hours prior to the study intervention.\n   * Maternal cardiac arrhythmias.\n4. Contraindications to the intervention:\n\n   * Known allergy to cocoa or chocolate.\n   * Severe caffeine intolerance.\n   * Phenylketonuria.\n   * Gastrointestinal conditions that would prevent oral intake (e.g., intractable vomiting, ileus, obstruction).","18 Years",{"count":348,"type":23},190,[211],"This is a single-blind, randomized, parallel-group, superiority clinical trial. The study aims to determine whether a single intake of 30g of dark chocolate (≥80% cocoa) by pregnant women with a non-reactive fetal non-stress test (NST) increases the conversion rate to a reactive NST within 20 minutes, compared to observation with a sugar-free white chocolate placebo. A total of 190 singleton pregnant women at 36-41 weeks gestation with a non-reactive NST will be recruited at the Hospital General San Felipe, Tegucigalpa, Honduras. Participants will be randomly assigned to either the intervention group (dark chocolate) or the control group (placebo). The primary outcome is the proportion of NSTs that become reactive. Secondary outcomes include changes in specific cardiotocographic parameters, total monitoring time, need for additional tests, and maternal satisfaction.",[352],"Fetal Distress",[354,355,356,357],"Chocolate","Theobromine","Non-Stress Test","Cardiotocography","2026-02-27",{"date":360,"type":67},"2026-03-03",{"date":362,"type":23},"2026-02-15",{"date":364,"type":23},"2026-09-30",{"name":198,"class":138},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":17,"sex":83,"minAge":109,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":24,"phases":377,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":391,"locationsCount":392},"100626779","phase-4-analgesic-efficacy-and-obstetric-effects-of-tramadol-paracetamol-and-placebo-in-active-labor-100626779","NCT07440069","Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor","Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor: A Randomized Double-Blind Controlled Trial","TRAMPA","Inclusion Criteria:\n\n* Nulliparous pregnant women\n* Age between 15 and 45 years\n* Singleton pregnancy, term (37-41 weeks gestation)\n* Cephalic presentation\n* Active labor defined as cervical dilation ≥4 cm with regular contractions\n* Signed informed consent\n\nExclusion Criteria:\n\n* Multiple gestation or high-risk pregnancy (preeclampsia, gestational diabetes, etc.)\n* Known allergy or contraindication to tramadol or paracetamol\n* Recent use (less than 6 hours) of any analgesic medication\n* Previous cesarean section or other uterine surgery\n* Active infection or fever at admission\n* Inability to provide informed consent due to mental or communication conditions\n* Non-cephalic presentation\n* Rupture of membranes \\>18 hours without labor\n* Participation in another clinical trial within the last 3 months","45 Years",{"count":376,"type":23},300,[378],"PHASE4","This randomized, double-blind, placebo-controlled trial aims to compare the analgesic efficacy and obstetric effects of tramadol (100 mg IV) versus paracetamol (1 g IV) versus placebo (saline solution) in nulliparous women during active labor. The primary outcome is duration of active labor (minutes). Secondary outcomes include duration of expulsive phase, type of delivery, need for oxytocin augmentation, maternal adverse events (nausea, vomiting, somnolence, hypotension), and neonatal outcomes (Apgar scores at 1 and 5 minutes, NICU admission). The study hypothesizes that tramadol significantly reduces active labor duration compared to paracetamol and placebo, without compromising maternal or neonatal safety. A total of 300 nulliparous women (100 per group) will be enrolled at Hospital Escuela, Tegucigalpa, Honduras.",[381],"Labor Pain",[383,384,385,381,386],"Tramadol","Paracetamol","Acetaminophen","Labor Duration","2026-02-24",{"date":358,"type":67},{"date":362,"type":23},{"date":364,"type":23},{"name":198,"class":138},2,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":400,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":24,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"100492777","clinical-trial-to-evaluate-the-safety-and-effectiveness-of-a-canaloplasty-device-in-subjects-with-open-angle-glaucoma-100492777","NCT05696561","Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma","A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery","Inclusion Criteria:\n\n1. Subjects qualifying for cataract surgery\n2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.\n\nExclusion Criteria:\n\n1\\. Patients who cannot be washed-out of IOP-lowering medications.","22 Years",{"count":402,"type":23},70,[211],"Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma",[406],"OAG - Open-Angle Glaucoma",{"date":358,"type":67},{"date":409,"type":67},"2025-09-09",{"date":411,"type":23},"2027-10",{"name":413,"class":74},"New World Medical, Inc.",3,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":17,"sex":83,"minAge":346,"maxAge":179,"enrollmentInfo":423,"targetDuration":4,"studyType":24,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":442,"locationsCount":75},"100625875","use-of-lubricant-gel-to-shorten-the-second-stage-of-labor-during-vaginal-delivery-100625875","NCT07428317","Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery","Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial","OBY-GEL","Inclusion Criteria:\n\n* Signed informed consent form\n* Willingness to comply with study procedures\n* Age between 18 and 40 years\n* Term pregnancy (37-41.6 weeks) with active labor\n* Diagnosis of spontaneous labor and planned vaginal delivery\n* Fetus in cephalic presentation\n* Agreement to comply with lifestyle restrictions during the study\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Previous cesarean section\n* High-risk pregnancy (preeclampsia, uncontrolled gestational diabetes, etc.)\n* Presence of fever or active infection\n* Contraindication for vaginal delivery\n* Refusal to sign informed consent\n* Premature rupture of membranes \\>18 hours without labor\n* Known allergy to lubricant gel components\n* Participation in another clinical trial in the last 3 months",{"count":424,"type":23},160,[211],"This experimental study aims to evaluate whether the application of obstetric lubricant gel during vaginal delivery can significantly reduce the duration of the second stage of labor, preserve perineal integrity, and decrease the need for episiotomies. The study hypothesis is that lubricant gel facilitates fetal passage through the birth canal by reducing friction, shortening the expulsion phase and reducing maternal-neonatal complications. Two groups will be included: with and without gel application. Follow-up will span from admission of the pregnant woman until immediate postpartum discharge.",[428],"Prolonged Second Stage of Labor",[430,431,432,433,434,435,386,436],"Lubricant Gel","Second Stage of Labor","Perineal Integrity","Episiotomy","Vaginal Delivery","Obstetric Gel","Birth Canal Lubrication","2026-02-16",{"date":439,"type":67},"2026-02-23",{"date":437,"type":67},{"date":364,"type":23},{"name":198,"class":138},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":17,"sex":18,"minAge":450,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":24,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":392},"100609607","phase-1-safety-and-efficacy-of-injectable-klotho-plasmid-gene-therapy-in-humans-100609607","NCT07216781","Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans","Evaluating the Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans: An Interventional, Non-Placebo-Controlled Pilot Phase Study","Inclusion Criteria:\n\n* Participant is open to morphological change\n* If female, participant agrees to maintain contraception\n* If female, participant agrees to take a pregnancy test\n* If female, participant agrees to a pregnancy waiver\n\nExclusion Criteria:\n\n* Women of childbearing potential who are unwilling or unable to use effective contraception for the duration of the study\n* History of cancer diagnosis\n* Preexisting medical issues that may be exacerbated by the treatment\n* Has received any gene therapy within the past 12 months\n* Unwilling or unable to provide written informed consent","23 Years","90 Years",{"count":453,"type":23},24,[26],"The purpose of this study is to investigate the safety and efficacy of a gene therapy for Klotho, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of the Klotho gene therapy.",[457],"Healthy Adults",[327,459,460],"plasmid","gene therapy",{"date":462,"type":67},"2026-02-17",{"date":464,"type":67},"2025-10-06",{"date":466,"type":23},"2026-08",{"name":468,"class":74},"Minicircle",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":17,"sex":83,"minAge":346,"maxAge":374,"enrollmentInfo":477,"targetDuration":4,"studyType":24,"phases":479,"briefSummary":480,"conditions":481,"keywords":482,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":491,"leadSponsor":492,"locationsCount":75},"100624570","left-lateral-position-vs-supine-position-to-reduce-active-labor-duration-100624570","NCT07411352","Left Lateral Position vs Supine Position to Reduce Active Labor Duration","Left Lateral Position Versus Supine Position in Reducing the Duration of the Active Phase of Labor: A Randomized, Single-Blind Clinical Trial","DLI-SP","Inclusion Criteria:\n\n* Signed and dated informed consent form.\n* Nulliparous woman.\n* Singleton pregnancy at ≥37 weeks of gestation.\n* Intact amniotic membranes.\n* Cephalic presentation.\n* In the active phase of labor (cervical dilation ≥6 cm).\n* Age ≥18 years.\n* No contraindication for vaginal delivery.\n* Possession of a mobile phone (for potential follow-up contact).\n\nExclusion Criteria:\n\n* Previous uterine surgery.\n* Maternal condition preventing vaginal delivery.\n* Fetal anomaly.\n* Premature rupture of membranes.\n* Multiple pregnancy.\n* Fetal demise.\n* Uterine myomas.\n* Maternal comorbidities (e.g., chronic hypertension, diabetes mellitus type -1\u002F2\u002Fgestational, hypothyroidism).\n* Anemia.\n* Age \\\u003C18 years.\n* Preterm gestation (\\\u003C37 weeks).",{"count":478,"type":23},188,[211],"This randomized clinical trial aims to compare the effect of the left lateral decubitus position versus the supine position on the duration of the active phase of labor in nulliparous women. A total of 188 participants will be randomly assigned to one of two groups. The intervention group will be placed in the left lateral decubitus position, while the control group will remain in the supine position. Both positions will be maintained for 30-minute intervals with 5-minute rest periods, continuing until delivery. The primary outcome is the duration of the active phase of labor. Secondary outcomes include rates of cesarean section, use of oxytocin and analgesics, and maternal and neonatal complications.",[381],[483,484,485,486],"Maternal Position","Left Lateral Position","Active Phase of Labor","Randomized Controlled Trial","2026-02-10",{"date":489,"type":67},"2026-02-13",{"date":362,"type":23},{"date":364,"type":23},{"name":198,"class":138},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":17,"sex":83,"minAge":346,"maxAge":179,"enrollmentInfo":501,"targetDuration":4,"studyType":24,"phases":503,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":515,"locationsCount":392},"100623786","umbilical-cord-drainage-to-prevent-postpartum-hemorrhage-100623786","NCT07401160","Umbilical Cord Drainage to Prevent Postpartum Hemorrhage","Relationship Between Umbilical Cord Drainage and Postpartum Hemorrhage: A Randomized Single-Blind Clinical Trial.","CORD-PPH","Inclusion Criteria:\n\n* Pregnant women aged 18-49 years.\n* Singleton pregnancy.\n* Gestational age ≥37 weeks.\n* active labor with cephalic presentation.\n* Planned for vaginal delivery.\n* Capable of providing informed consent.\n\nExclusion Criteria:\n\n* Planned or emergent cesarean section.\n* Instrumental delivery (e.g., forceps, vacuum).\n* Antepartum hemorrhage.\n* Severe anemia (Hemoglobin \\\u003C8 g\u002FdL) or specific hematological disorders (e.g., sickle cell disease, thalassemia, hemophilia, thrombocytopenia \\\u003C100,000\u002FµL).\n* Use of anticoagulant medication.\n* Non-cephalic fetal presentation (e.g., breech, transverse).\n* Refusal to participate or inability to provide informed consent.",{"count":502,"type":23},400,[211],"This study aims to analyze whether there is a significant difference in the occurrence of postpartum hemorrhage between women who underwent umbilical cord drainage and those who did not. Variables such as estimated blood loss volume, drop in hemoglobin levels, and the need for additional maneuvers or treatments to control hemorrhage will be examined. The research will be conducted under a parallel-group clinical trial design at the Hospital Escuela Universitario. Post-birth umbilical cord drainage may contribute to a lower frequency of postpartum hemorrhage compared to not performing it.",[506],"Postpartum Hemorrhage",[508,509,510,511],"Cord Drainage","Third Stage of Labor","Obstetric Hemorrhage","Labor Stage",{"date":489,"type":67},{"date":362,"type":23},{"date":364,"type":23},{"name":198,"class":138},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":17,"sex":83,"minAge":346,"maxAge":374,"enrollmentInfo":524,"targetDuration":4,"studyType":24,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":537,"leadSponsor":539,"locationsCount":392},"100623785","transcutaneous-electrical-nerve-stimulation-tens-for-pain-management-during-labor-100623785","NCT07401147","Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.","Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical Trial.","TENS-LABOR","Inclusion Criteria:\n\n* Signed informed consent.\n* Women aged 18-45 years.\n* Nulliparous.\n* Term singleton pregnancy (37-42 weeks).\n* Cephalic presentation.\n* Spontaneous onset of labor or induced\u002Fconducted labor under adequate control.\n* Cervical dilation of at least 5 cm at enrollment.\n* Normal amniotic fluid volume and reassuring fetal monitoring.\n* Uncomplicated pregnancy.\n\nExclusion Criteria:\n\n* Multiple pregnancy.\n* Non-cephalic presentation.\n* Severe obstetric complications (e.g., preeclampsia, placental abruption).\n* Maternal chronic or acute diseases interfering with safety.\n* History of neurological\u002Fpsychiatric disorders contraindicating TENS.\n* Abnormal fetal monitoring or amniotic fluid.\n* Pre-pregnancy BMI \\>30 kg\u002Fm².\n* Fetal demise.\n* Illiteracy.",{"count":525,"type":23},132,[211],"This is a randomized, double-blind, crossover clinical trial to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapeutic intervention for reducing pain in women during the active phase of labor. Nulliparous women with term pregnancies will be randomly assigned to sequences involving TENS intervention and placebo (device off) periods, separated by a washout. The primary outcome is labor pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include duration of the active labor phase, maternal and neonatal safety profile, and childbirth experience satisfaction. The study will be conducted at the Hospital Escuela Universitario from feb 2026 to Ago 2026.",[381],[530,531,532,533,534],"labor pain","Transcutaneous Electric Nerve Stimulation","Analgesia","Pain Management","Natural Childbirth",{"date":489,"type":67},{"date":362,"type":23},{"date":538,"type":23},"2026-09-15",{"name":540,"class":138},"Ricardo A Gutierrez Ramirez, MD, MSc, FACOG",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":17,"sex":18,"minAge":318,"maxAge":548,"enrollmentInfo":549,"targetDuration":4,"studyType":24,"phases":551,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":392},"100614902","early-phase-1-safety-and-efficacy-of-klotho-and-follistatin-gene-therapy-100614902","NCT07285629","Safety and Efficacy of Klotho and Follistatin Gene Therapy","Evaluating the Safety and Efficacy of Injectable Combination Klotho and Follistatin Plasmid Gene Therapy in Humans -- An Interventional, Non-Placebo Controlled Pilot Phase Study","Inclusion Criteria:\n\n* Adults aged 50 to 80 years\n* General good health\n* Willing to comply with all study-related procedures and visits\n* Participant is open to morphological change\n* If female, participant agrees to maintain contraception\n* If female, participant agrees to take a pregnancy test\n* If female, participant agrees to a pregnancy waiver\n\nExclusion Criteria:\n\n* Currently enrolled in another clinical trial\n* History of cancer, autoimmune disease, or chronic kidney\u002Fliver disease\n* Use of immunosuppressive therapy\n* Pregnant or breastfeeding\n* Women of childbearing potential who are unwilling or unable to use effective contraception for the duration of the study.\n* Regular use of NMDA (N-methyl-D-aspartate) antagonists (i.e., memantine, ketamine, etc.)\n* Regular use of antiplatelet medications (i.e., aspirin)\n* Any medical or psychiatric condition that could interfere with participation or pose safety concerns\n* Unwilling or unable to provide informed consent","80 Years",{"count":550,"type":23},30,[552],"EARLY_PHASE1","The purpose of this study is to investigate the safety and efficacy of a combination klotho and follistatin gene therapy, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of this gene therapy.",[457],[556,557,558,460,459],"klotho","follistatin","nonviral","2026-01-06",{"date":561,"type":67},"2026-01-08",{"date":563,"type":67},"2025-12-16",{"date":565,"type":23},"2026-06",{"name":468,"class":74},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":574,"maxAge":575,"enrollmentInfo":576,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":578,"conditions":579,"keywords":587,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":226},"100611871","caya-cancer-retrospective-cohort-study-100611871","NCT07246213","CAYA Cancer Retrospective Cohort Study","Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Retrospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this registry:\n\n1. Participants must be willing and able to provide informed consent prior to enrollment in the registry.\n\n   1. For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.\n   2. Note: Exemption applies to this criterion when waiver of informed consent\u002Fassent is granted by Institutional Review Board(IRB)\u002FIndependent Ethics Committee(IEC)\u002FCompetent Authorities(CAs).\n2. A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.\n3. Age 0 to 21 years at the time of diagnosis.\n4. Received substantial anti-cancer treatment at the participating center, including but not limited to:\n\n   1. Chemotherapy\n   2. Surgery\n   3. Radiation therapy\n   4. Immunotherapy\n5. Medical records are available and accessible for review\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from this registry:\n\n  1. Patients who only visited the participating center for:\n\n     1. Consultation without subsequent primary anti-cancer treatment at the participating center\n     2. Pathology, radiology, or other diagnostic evaluations without treatment","0 Years","21 Years",{"count":577,"type":23},18000,"Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies.\n\nAcute lymphoblastic leukemia(ALL)\u002Flymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare.\n\nThis study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia\u002Flymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.",[580,581,582,583,584,585,586],"Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma","Young Adult Cancer","Adolescent Cancer","Childhood Cancers","Acute Lymphoblastic Leukemia (ALL)","Lymphoblastic Lymphoma (LBL)",[588,589,590,591,592,593,594,595,596,597],"Cancer outcomes","Low- and Middle-Income Countries (LMICs)","Childhood cancer","Adolescent and young adult cancer (CAYA)","Treatment failure","Therapy-related toxicities","Retrospective cohort","Leukemia outcomes","Oncology disparities","High-Income Countries (HICs)","2025-12-12",{"date":600,"type":67},"2025-12-19",{"date":602,"type":67},"2025-06-04",{"date":604,"type":23},"2028-12-04",{"name":606,"class":138},"Resonance, Inc.",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":17,"sex":83,"minAge":178,"maxAge":374,"enrollmentInfo":615,"targetDuration":4,"studyType":24,"phases":616,"briefSummary":617,"conditions":618,"keywords":621,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":75},"100528733","phase-2-use-of-cinnamomum-verum-for-induction-of-labor-double-blind-randomized-clinical-trial-100528733","NCT06164613","Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial","Use of Cinnamomum Verum Extract Versus Placebo for Induction of Labor and Reduction of Physiological Phase 2-3 of Labor. Double-blind Randomized Clinical Trial. CINNALAB TRIAL","CINNALAB","Inclusion Criteria:\n\n1. Delivery of an informed consent form signed and dated by parents or guardian and patient\n2. Declared willingness to comply with all study procedures and availability for the duration of the study.\n3. provision of appropriate consent and assent\n4. Willingness and ability to participate in study procedures\n5. Patients under 18 years of age\n6. Full-term pregnancies (37-41 Weeks of Gestation).\n7. Nulliparity\n8. Have your own cell phone\n9. Know how to read and write\n10. Residing in Tegucigalpa\n11. Be in good general health, as evidenced by your medical history\n12. Ultrasound with amniotic fluid index \\> 5 cm\n13. Non Stress Test Reactive\n14. Ability to take oral medication and be willing to comply with the cinnamon capsule regimen\n\nExclusion Criteria:\n\n1. Current use of antihypertensive or hypoglycemic medications\n2. Presence of non-curable chronic diseases prior to pregnancy or during pregnancy such as hypertension, diabetes, hypothyroidism\n3. Premature rupture of membranes\n4. Infections (urinary tract infection, chorioamnionitis) present at the time of the study (diagnosed with symptoms or leukocytes \\>12,500 or pathological urine examination)\n5. Allergies to cinnamaldehyde or cinnamon, canola oil\n6. Multiple pregnancy\n7. Major fetal malformations\n8. Fetal death\n9. Non-cephalic presentation\n10. Severe oligohydramnios (amniotic fluid index \\\u003C 2 cm)\n11. Having consumed or being consuming cinnamon products 7 days before the start of the study\n12. Febrile illness within 7 days before starting to take cinnamon\n13. Treatment with another investigational drug or other intervention within 7 days prior to the start of the intervention\n14. Current smoker or tobacco use",{"count":402,"type":23},[27],"The purpose of the research protocol is to evaluate the effectiveness of Cinnamomum verum extract for the initiation of labor. Cinnamaldehyde ((E)-3-Phenylprop-2-enal) is an α, β unsaturated aromatic aldehyde, derived from cinnamon (Cinnamomum Verum oil) used as a flavoring; It is a clear yellowish liquid substance, with a strong odor and flavor. It is the main component of cinnamon (63%), giving it its physicochemical properties. Cinnamon has been an element of empirical use for the beginning of labor, however, its effectiveness has not been demonstrated.\n\nCinnamon has been reported for its ethnopharmacological properties in pregnancy, being used to facilitate childbirth, as a lactagogue and for postpartum recovery. In Honduras, its use has been reported to relieve nausea and vomiting during pregnancy, to reduce abdominal pain. , reduction of lower limb edema, to relieve anxiety during labor, as well as a lactagogue without convergent opinions.",[619,620],"Labor Onset and Length Abnormalities","First Birth",[622,623,624],"cinnamon oil, bark","labor onset","nulliparity","2025-11-26",{"date":627,"type":67},"2025-12-04",{"date":629,"type":67},"2023-12-04",{"date":631,"type":23},"2026-12-30",{"name":198,"class":138},{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":17,"sex":83,"minAge":641,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":654,"locationsCount":656},"100610805","prevention-of-cervical-cancer-using-the-genotyping-screening-and-same-day-self-sampling-100610805","NCT07232355","Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling","PROGRESS: Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling","PROGRESS","Inclusion Criteria:\n\n* Presence of a cervix\n\nExclusion Criteria:\n\n* Pregnancy\n* Cervical cancer screening in the past 2 years\n* Prior diagnosis or treatment of cervical cancer\n* Inability to tolerate a speculum exam","30 Years","64 Years",{"count":644,"type":23},5000,"In May 2018, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer. While this strategy seeks to achieve coverage of 70% in disease testing and 90% in treatment by 2030, it is estimated that these goals will not be achieved by most low- and middle- income (LMICs) countries until 2120 under existing conditions. Presently, more than 90% of worldwide cervical cancer cases occur in LMICs. To accelerate this timeline, there is an urgent need for accurate, affordable and rapid testing that can facilitate same-day screening-and-treatment of cervical precancer. The AmpFire® human papillomavirus (HPV) test (Atila Biosystems, CA) has the potential to meet these needs. The test has been adapted to classify HPV positive women into four categories according to their risk for cervical cancer development based on the specific HPV type found during the test. Moreover, results can be delivered in less than 20 minutes for the highest risk HPV type, and less than an hour for the remaining HPV types. This is a potential game changer for countries where treating all HPV positive women is unfeasible. A combination of HPV test with other image-based triage strategies can further reduce overtreatment while reaching the most at-risk women. The goal of this project is to evaluate the performance and feasibility of an innovative same-day screening-and-treatment strategy in Honduras based on the AmpFire® HPV test combined with imaging triage using artificial intelligence via the Automated Visual Evaluation (AVE). Additionally, the investigators will evaluate the cost-effectiveness of the proposed approach vs. the current strategy based on visual inspection with acetic acid (VIA). The investigators believe that the AmpFire® test will have the potential to detect at least 90% of women with cervical precancer (performance). Similarly, the investigators anticipate that combining AmpFire® with AVE triage in a same-day screening-and-treatment strategy will be feasible and acceptable to patients and providers. The successful completion of this project will provide crucial data on the effectiveness of a self-sample, same-day screening-and-treatment approach with the potential to increase early detection while reducing loss to follow-up, ultimately resulting in increased adoption of this technology.",[647],"Human Papilloma Virus","2025-11-17",{"date":650,"type":67},"2025-11-19",{"date":652,"type":67},"2023-08-24",{"date":565,"type":23},{"name":655,"class":74},"Atila Biosystems Inc.",4,{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":661,"acronym":662,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":664,"targetDuration":666,"studyType":86,"phases":4,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":679},"100272903","computerized-registry-of-patients-with-venous-thromboembolism-riete-100272903","NCT02832245","Computerized Registry of Patients With Venous Thromboembolism (RIETE)","RIETE","Inclusion Criteria:\n\n* Confirmed VTE (acute deep-vein thrombosis, pulmonary embolism and\u002For superficial venous thrombosis) by objective tests.\n* Informed consent to the participation in the study, according to the requirements of the ethics committee within each hospital.\n\nExclusion Criteria:\n\n* Participation in a therapeutic clinical trial with an unknown drug.\n* Inability to the 3 month follow-up",{"count":665,"type":23},120000,"3 Years","The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism.\n\nThe main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events.\n\nAs an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications.\n\nThe primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.",[669],"Venous Thromboembolism","2025-09-23",{"date":672,"type":67},"2025-09-24",{"date":674,"type":4},"2001-03",{"date":676,"type":23},"2027-12",{"name":678,"class":138},"Manuel Monreal",257,{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":18,"minAge":666,"maxAge":346,"enrollmentInfo":688,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":704},"100510710","international-childhood-leukemia-microbiomemetabolome-cohort-100510710","NCT05929976","InterNatIonal CHildhood Leukemia Microbiome\u002FMEtabolome Cohort","Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome\u002FMEtabolome Cohort","NICHE","Inclusion Criteria:\n\n* Patients must be between 3 years and 18 years of age at time of assent\u002Fconsent.\n* Patients must have newly diagnosed B- or T-cell ALL, or mixed phenotype acute leukemia confirmed by pathology report.\n* Patients must be receiving treatment at one of the participating centers.\n\nExclusion Criteria:\n\n\\- Patients receiving hematopoietic cell transplant.",{"count":689,"type":23},4900,"Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent\u002Fconsent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.",[580,692,693,694],"Nutrition Aspect of Cancer","Microtia","Genetic Predisposition","2025-07-17",{"date":697,"type":67},"2025-07-22",{"date":699,"type":67},"2022-10-26",{"date":701,"type":23},"2029-10-01",{"name":703,"class":138},"Columbia University",8,{"id":706,"slug":707,"hasResults":12,"nctId":708,"briefTitle":709,"officialTitle":710,"acronym":711,"eligibilityCriteria":712,"healthyVolunteers":12,"sex":18,"minAge":713,"maxAge":147,"enrollmentInfo":714,"targetDuration":4,"studyType":24,"phases":716,"briefSummary":717,"conditions":718,"keywords":720,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":729,"startDateStruct":731,"completionDateStruct":733,"leadSponsor":735,"locationsCount":737},"100482776","benchmark-evidence-led-by-latin-america-trial-of-intracranial-pressure---pediatrics-100482776","NCT05566431","Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics","Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols","BELA TRIPP","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form by the parent(s) or guardian(s)\n2. Non-penetrating TBI\n3. Admission to study hospital within 24 hours of injury\n4. Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children \\\u003C 2 years old and standard GCS for older children)\n5. Age 1 through 12 years\n6. Able to randomize:\n\n   * Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR\n   * Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)\n\nExclusion Criteria:\n\n1. Motor GCS score of 6\n2. GCS of 3 with bilaterally fixed and dilated pupils\n3. Injury thought to be intentionally inflicted by a family member or caregiver.","1 Year",{"count":715,"type":23},428,[211],"Narrative:\n\nWorldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.",[719],"Severe Traumatic Brain Injury",[721,722,723,724,725,726,727],"sTBI","ICP monitoring","randomized controlled trial","TBI management","Latin America","pediatric","Phase III","2025-06-25",{"date":730,"type":67},"2025-06-27",{"date":732,"type":67},"2023-03-22",{"date":734,"type":23},"2028-01-31",{"name":736,"class":138},"University of Washington",11,""]