[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"El Salvador\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":391},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,69,92,116,155,183,206,246,269,310,332,366],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100634312","single-visit-clinical-validation-of-screenfire-a-low-cost-hpv-test-efficacy-and-cost-effectiveness-phase-2-100634312",false,"NCT07538050","Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)","Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)","SCALE AIM 2","Inclusion Criteria:\n\n* Women between 30-59 years of age\n* Willing to conduct HPV self-sampling\n\nExclusion Criteria:\n\n* Prior hysterectomy\n* HPV testing in at least 5 years\n* Previous diagnosis or treatment of invasive cancer",true,"FEMALE","30 Years","59 Years",{"count":22,"type":23},1000,"ESTIMATED","INTERVENTIONAL",[26],"NA","In high-income countries, prevention strategies have led to declines in cervical cancer rates by more than 75% in high-income countries. In contrast, low- and middle-income countries (LMICs) carry the global burden of cervical cancer with about 85% of new cases and 90% mortality. Screening is an essential component of effective prevention to reduce this disease burden. The World Health Organization recommends human papillomavirus (HPV) testing as the most effective screening method. However, HPV testing can be expensive and complex to implement. Most tests require central laboratory processing, which means women must come back for a different visit to obtain results and potential treatment. In LMICs, this often results in high loss to follow up because many women face transportation and other challenges. The development of new, low-cost HPV tests that can be processed locally as the potential to improve adherence in screening programs. In this study, the research team will assess the feasibility of a same-day screen-and-treat approach compared to the standard two-visit regime in the context of the cervical cancer prevention program in El Salvador. This will be a cross-sectional study that will enroll 1,000 women in remote areas of the country over 10-15 weeks. The hypothesis is that at least 10% fewer women lost to follow-up at six months using the single visit approach compared to the \\>20% historical loss to follow-up using the standard two-visit approach.",[29],"Cervical Cancer Screening","RECRUITING","2026-07-31",{"date":33,"type":34},"2026-08-03","ACTUAL",{"date":36,"type":34},"2026-04-16",{"date":38,"type":23},"2027-12-31",{"name":40,"class":41},"The Cleveland Clinic","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100561511","the-vizio-clinical-study-100561511","NCT06591117","The Vizio Clinical Study","The Vizio Clinical Study: A Prospective, Multicenter, Feasibility Clinical Study to Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma","Inclusion Criteria:\n\n1. Age 22-85 years\n2. Refractory glaucoma describes eyes diagnosed with glaucoma specific to one of the following:\n\n   * uncontrolled by maximally tolerated medical therapy\n   * failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt)\n   * failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)\n   * or have any other condition (e.g., conjunctival scarring, uveitis) in which conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle glaucoma.\n3. Primary open-angle or traumatic glaucoma.\n4. Medicated DIOP ≥25 mmHg and ≤45 mmHg on maximum-tolerated medical therapy that is stable for at least 30 days.\n5. Best-corrected baseline visual acuity of light perception or better in study eye.\n6. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:\n\n   * Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;\n   * Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or\n   * Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue\n7. Visual field mean deviation (MD) by Humphrey Visual Field:\n\nVisual field defects consistent with glaucomatous optic nerve damage and mean deviation worse than -3 dB in the study eye; and at least one of the following two findings:\n\n* A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot;\n* Glaucoma hemi-field test \"outside normal limits\". 8. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 10:00 and 02:00 in the study eye. 9. Adequate space in the anterior chamber by Spaeth Grade C, D or E for iris insertion (with indentation). 10. Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions. 11. Participant understands, is capable and competent to sign the informed consent. Exclusion Criteria\n\n  1. Active neovascular conditions such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.\n  2. Pigmentary glaucoma in study eye.\n  3. Angle-closure glaucoma in study eye.\n  4. Pseudoexfoliation syndrome in study eye\n  5. Iridocorneal endothelial syndrome in study eye.\n  6. Uveitic glaucoma in the study eye.\n  7. Epithelial or fibrous downgrowth in the study eye.\n  8. Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of implant inside the anterior chamber.\n  9. Prior intraocular surgery in study eye within ≤6 months before the preoperative visit (including phacoemulsification).\n  10. Central corneal endothelial cell count of less than 1600 cells\u002Fmm2 in study eye.\n  11. Anticipated need for ocular surgery or retinal laser procedure in the study eye within the 12-month follow-up period.\n  12. Need for glaucoma surgery combined with other ocular procedures in study eye at implant (e.g. cataract surgery, penetrating keratoplasty, or retinal surgery).\n  13. Unwilling to discontinue contact lens use in the study eye after surgery.\n  14. Central corneal thickness ≤490μm or ≥620μm in the study eye.\n  15. Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.\n  16. Any condition that prevents the device implantation in the superior region of the study eye.\n  17. Vitreous in the study eye anterior chamber for which a vitrectomy is anticipated.\n  18. Functionally significant cataract in the study eye.\n  19. Other clinical conditions:\n\n      1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c \\>8 within 3 months of implant.\n      2. Cancer requiring treatment during the duration of the study.\n      3. Any drugs (e.g.: immunosuppressive drugs) or co-morbidity that might inhibit wound healing.\n  20. Participation in any other clinical study during participation in this study.\n  21. Engage in activities that involve submerging their head under water, such as diving or swimming.\n  22. Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception.\n  23. Life expectancy \\\u003C1 year. Note: If both eyes are eligible, the eye with the worse BCVA should be selected","ALL","22 Years","85 Years",{"count":54,"type":23},50,[26],"Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma",[58],"Refractory Glaucoma","2026-07-08",{"date":61,"type":34},"2026-07-10",{"date":63,"type":34},"2026-03-21",{"date":65,"type":23},"2029-03",{"name":67,"class":68},"Ocumedex","INDUSTRY",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"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",{"count":54,"type":23},"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.",[80],"Chagas Disease","NOT_YET_RECRUITING","2026-07-02",{"date":84,"type":34},"2026-07-06",{"date":86,"type":23},"2026-12-31",{"date":88,"type":23},"2032-01-31",{"name":90,"class":68},"Bayer",12,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":24,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100604259","feasibility-study-of-an-accommodating-iol-design-100604259","NCT07147192","Feasibility Study of an Accommodating IOL Design","Key Inclusion Criteria:\n\n* Able to understand and sign an Informed Consent Form.\n* Willing and able to attend all scheduled study visits required per protocol.\n* Diagnosed with bilateral cataracts requiring removal by phacoemulsification.\n* Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes.\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding.\n* Taking medications that could increase risk or may affect accommodation.\n* Eye conditions as specified in the protocol, including glaucoma or ocular hypertension.\n* Medical conditions that could increase operative risk as specified in the protocol.\n* Other protocol-defined exclusion criteria may apply.",{"count":99,"type":23},85,[26],"The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will be conducted in Central America.",[103],"Aphakia",[105],"Cataract","2026-05-18",{"date":108,"type":34},"2026-05-19",{"date":110,"type":34},"2025-12-03",{"date":112,"type":23},"2028-01",{"name":114,"class":68},"Alcon Research",4,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":18,"minAge":124,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100598171","organ-dysfunction-score-for-obstetric-patients-100598171","NCT07068022","Organ Dysfunction Score for Obstetric Patients","Development and Validation of an Obstetric Organ Dysfunction Score to Predict Mortality in Intensive Care Unit: A Multicenter, Prospective, Cohort Study","SOFA-OBS","Inclusion Criteria:\n\nAll of the following=\n\n* Pregnant (at any gestational age) or post-partum patients (at ≤3 days postpartum)\n* ≥ 18 years old\n* Requiring admission to ICU for any reason\n* Staying in the ICU for ≥ 24h\n* Giving her consent to participate. Patients will be recruited consecutively until reaching the sample size.\n\nExclusion Criteria:\n\nAny of the following=\n\n* Patients \\\u003C18 years old\n* Non-pregnant patients\n* ≥ 4 days postpartum\n* Patients or surrogates not giving consent to participate\n* ICU-LOS \\\u003C 24 h","18 Years",{"count":126,"type":23},130,"The goal of this observational study is to develop and evaluate an organ dysfunction score adapted to pregnancy and early puerperium (SOFA-OBS) that also incorporates a non-invasive tool to evaluate respiratory function (pulse oximeter).\n\nThe main question it aims to answer is: Does an organ dysfunction score adapted to pregnant and postpartum patients have a higher capacity to predict mortality than a non-adjusted organ dysfunction score? Participants: Patients requiring ICU (Intensive Care Units) admission, who are either pregnant or postpartum (up to 3 days after giving birth). The investigators aimed to include 130 participants.\n\nThe investigators will only collect participants' data and laboratory results that ICU doctor usually need for clinical practice. No additional interventions are required. Moreover, the investigators will evaluate if measuring participants' oxygenation through a non-invasive tool (pulse oximeter) is equally effective as measuring oxygenation by an arterial puncture.\n\nBackground: When managing severely ill patients in ICU, the investigators often use what it is called scores. Scores refer to a numerical value assigned to a patient's condition, which often predict outcome. The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assess severity of organ dysfunction (in liver, kidney, blood pressure, respiratory, neurologic and platelets). It also identifies patients with severe infections (sepsis) and patients with bad outcomes.\n\nPatients undergoing pregnancy or early postpartum develop physiological changes, such us a decrease in creatinine (a laboratory test measuring kidney function) and a decrease in blood pressure during the second trimester. These changes are not considered by the SOFA score. Actually, there is not an organ dysfunction score adapted to pregnant\u002Fpostpartum patients to be used in the ICU. Moreover, a blood sample taken by arterial puncture is required to evaluate respiratory function by the SOFA score, which is a painful procedure. Instead, the investigators could evaluate respiratory function using a pulse oximeter, which measures peripheral oxygen saturation without needing an arterial puncture.\n\nPotential benefits: A SOFA-OBS would hopefully become a more precise tool than general SOFA to evaluate organ dysfunction and to predict outcome among these patients. It would also help to detect sepsis earlier and treat it promptly, which might help reducing its mortality.",[129,130,131,132,133],"Pregnancy","Postpartum","Organ Dysfunction","Critical Care, Intensive Care","Sepsis",[135,129,130,136,137,138,139,140,141,142,133,143,144],"Sequential Organ Failure Assessment score","Critical care","Intensive Care Unit","Creatinine","Peripheral oxygen saturation","Hypotension","Maternal mortality","Mortality","Septic shock","Multicenter study","2026-04-22",{"date":147,"type":34},"2026-04-28",{"date":149,"type":34},"2025-10-06",{"date":151,"type":23},"2027-02-28",{"name":153,"class":41},"Daniela Vasquez",18,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":24,"phases":166,"briefSummary":167,"conditions":168,"keywords":172,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":42},"100628452","point-of-care---triage-and-treatment-for-cervical-pre-cancer-100628452","NCT07461818","Point of Care - Triage and Treatment for Cervical Pre-cancer","POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency","POC","Inclusion Criteria:\n\n* Women aged 30-49 years\n* Non-pregnant (determined by urine pregnancy test)\n* HPV-positive per Ministry of Health (MOH) records\n* Willing to undergo colposcopy and biopsies\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Plans to become pregnant during the study\n* History of LEEP or cervical ablation procedure in the past 5 years\n* History of total hysterectomy (verified by medical record or pelvic evaluation)\n* History of cervical cancer\n* Unable or unwilling to provide a permanent and reliable address\n* Unable or unwilling to provide informed consent","49 Years",{"count":165,"type":23},5000,[26],"This study evaluates a modified two-probe thermal ablation protocol using the IRIS™ device and retrospectively assesses an AI-based Automated Visual Evaluation (AVE) triage algorithm among HPV-positive women in El Salvador. The primary objective is to estimate 1-year cure rates of CIN2+ following treatment. A secondary objective is to evaluate the diagnostic performance of AVE compared with histopathology.",[169,170,171],"Cervical Precancer","Cervical Intraepithelial Neoplasia","Human Papillomavirus Infection",[173],"Cervical Cancer","2026-03-09",{"date":176,"type":34},"2026-03-11",{"date":178,"type":23},"2026-03",{"date":180,"type":23},"2029-08",{"name":182,"class":41},"Basic Health International, Inc.",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":50,"minAge":124,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":24,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":42},"100624229","ai-telemedicine-support-for-primary-care-physicians-in-el-salvador-100624229","NCT07406919","AI Telemedicine Support for Primary Care Physicians in El Salvador","Pragmatic Randomized Clinical Trial of AI-Assisted Telemedicine to Improve Diagnostic Accuracy Among Primary Care Physicians in El Salvador","Inclusion Criteria:\n\n* Must be a physician employed by the DoctorSV telemedicine program\n* Must provide written informed consent to participate in the study\n* Consultations must be for acute pathologies of the digestive, respiratory, or urinary systems, or acute ophthalmic infections manageable in primary care\n* Consultation must be the first medical contact (first visit) for the current acute episode\n* The condition must correspond to specific ICD-11 codes defined in the study protocol\n\nExclusion Criteria:\n\n* Physicians who are inactive on the platform for more than 4 consecutive weeks\n* Physicians who transition to work modalities other than telemedicine or reduce their working hours to less than 20 hours per week\n* Physicians whose employment contract ends (resignation, dismissal, or contract completion) during the data collection period\n* Consultations classified by the physician as requiring immediate in-person attention\n* Consultations requiring referral to another level of care or specialty for definitive management\n* Consultations interrupted or incomplete due to connectivity or system failures\n* Consultations solely for administrative purposes (e.g., certificates, repeat prescriptions without clinical evaluation)\n* Consultations that are follow-up visits or controls for a previously evaluated episode",{"count":191,"type":23},180,[26],"The goal of this clinical trial is to learn whether access to an artificial intelligence (AI) clinical decision support assistant can improve diagnostic accuracy during real-world telemedicine consultations among primary care physicians in El Salvador.\n\nThe main questions it aims to answer are:\n\n* Does access to the AI assistant increase the proportion of correct diagnoses compared to telemedicine without AI assistance?\n* Does the effect of the AI assistant differ according to the physician's prior experience using AI in telemedicine?\n\nResearchers will compare physicians with the AI assistant enabled to physicians with the AI assistant temporarily disabled to see if access to AI improves diagnostic accuracy.\n\nParticipants (physicians) will:\n\n* Provide telemedicine consultations as part of their routine clinical duties.\n* Be randomly assigned to either have the AI assistant enabled or disabled during the study period.\n* Continue documenting clinical encounters in the electronic platform as usual.\n* Have their anonymized consultation notes reviewed by an independent expert panel to determine diagnostic accuracy.",[195],"Artificial Intelligence (AI) in Diagnosis","2026-02-13",{"date":198,"type":34},"2026-02-17",{"date":200,"type":23},"2026-02",{"date":202,"type":23},"2026-08",{"name":204,"class":205},"Hospital El Salvador","OTHER_GOV",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":214,"targetDuration":4,"studyType":24,"phases":216,"briefSummary":217,"conditions":218,"keywords":222,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":42},"100578795","validation-of-a-lab-free-low-cost-screening-test-for-prevention-of-cervical-cancer-100578795","NCT06815939","Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer","Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer: Automated Visual Evaluation","OPTICS","Inclusion Criteria:\n\n* Women between 30 and 59 years of age\n\nExclusion Criteria:\n\n* Pregnancy at the time of colposcopy\u002Fbiopsy\n* Hysterectomy with surgically absent cervix\n* HPV test in the last 5 years independently of negative or positive result\n* Previous cervical cancer diagnosis or treatment in the last 5 years\n* Lack of willingness or capacity to provide informed consent",{"count":215,"type":23},10000,[26],"The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool for cervical cancer based on the assessment of digital images through artificial intelligence. Several teams around the world have developed versions of AVE as a triage technology but none as a screening tool.",[219,170,220,221],"Human Papillomavirus (HPV)","Uterine Cervical Neoplasms","Cervical Cancers",[223,173,224,225,226,227,228,229,230,231,232,233,234,235,236,237,220],"Human Papillomavirus","Screening","Neoplasms","Precancerous Conditions","Uterine Diseases","Uterine Cervical Diseases","Genital Diseases, Female","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Genital Diseases","Uterine Neoplasms","Genital Neoplasms, Female","Urogenital Neoplasms","Neoplasms by Site","Uterine Cervical Dysplasia","2026-01-27",{"date":240,"type":34},"2026-01-29",{"date":242,"type":34},"2025-02-12",{"date":86,"type":23},{"name":245,"class":68},"DL Analytics",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":50,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":24,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":42},"100592180","an-early-feasibility-prospective-single-arm-study-of-the-polaris-system-100592180","NCT06990074","An Early Feasibility, Prospective, Single-Arm Study of the Polaris System","Inclusion Criteria:\n\n* Male or female, between 40 and 75 (inclusive) years of age (measured at baseline)\n* A slit-lamp diagnosis of uncomplicated, age-related visually significant cataract that is not posterior polar or congenital\n* Eligible to undergo cataract extraction by phacoemulsification with intraocular lens (IOL) implantation\n* Able and willing to comply with all study procedures\n* Able to return for scheduled follow-up examinations\n* Willing to adhere to the prescribed medication regimen (to prevent inflammation and infection)\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Contraindication to general anesthesia\n* Posterior polar or congenital cataract\n* Previous history of vitrectomy, corneal, refractive, or cataract surgery\n* Concurrent participation in another ophthalmological clinical study\n* Allergies to any medications required in surgery, pre- and post-operative treatment\n* Diagnosis of corneal disease or pathology that precludestransmission of optical coherence tomography (OCT) laser wavelength (e.g., corneal opacity), distorts OCT laser light (e.g., corneal scarring or history of radial keratotomy), or compromises engagement of the patient interface (e.g., megalocornea or pterygium), in the opinion of the Investigator\n* History of poor pupil dilation, demonstration of poor reaction to pupil-dilation drugs (minimum 7 mm dilation should be targeted for study), diagnosis of a pupillary defect that precludes the iris from adequate peripheral retraction, and\u002For diagnosis of floppy iris syndrome or iris dyscoria\n* Current or prior use of concomitant medications known to cause floppy iris syndrome (e.g., alpha-blockers, such as Flomax)\n* Compromised cornea (e.g., Fuchs endothelial dystrophy)\n* History of lens or zonular instability\n* Immunocompromised or diagnosis of ophthalmic disease: ocular herpes zoster or simplex, lupus, collagenosis or other acute or chronic illnesses that increase the risk to the subject or confounds the outcomes of this study, in the opinion of the Investigator\n* Developmental disability or cognitive impairment that would make informed consent and the assessment of visual acuity impossible, in the opinion of the Investigator\n* History of significant ocular trauma\n* History of iritis or uveitis\n* Pregnant women, as confirmed via urine pregnancy test for women of child-bearing age at screening","40 Years","75 Years",{"count":255,"type":23},30,[26],"A multicenter, single-arm, prospective, non-randomized, non-masked study.",[259],"Cataract, Age-Related","2025-12-31",{"date":262,"type":34},"2026-01-05",{"date":264,"type":34},"2025-09-23",{"date":266,"type":23},"2026-10",{"name":268,"class":68},"Horizon Surgical Systems Inc.",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":50,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":280,"conditions":281,"keywords":289,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"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":279,"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.",[282,283,284,285,286,287,288],"Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma","Young Adult Cancer","Adolescent Cancer","Childhood Cancers","Acute Lymphoblastic Leukemia (ALL)","Lymphoblastic Lymphoma (LBL)",[290,291,292,293,294,295,296,297,298,299],"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":302,"type":34},"2025-12-19",{"date":304,"type":34},"2025-06-04",{"date":306,"type":23},"2028-12-04",{"name":308,"class":41},"Resonance, Inc.",5,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":115},"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","64 Years",{"count":165,"type":23},"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.",[322],"Human Papilloma Virus","2025-11-17",{"date":325,"type":34},"2025-11-19",{"date":327,"type":34},"2023-08-24",{"date":329,"type":23},"2026-06",{"name":331,"class":68},"Atila Biosystems Inc.",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":50,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":24,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"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","12 Years",{"count":343,"type":23},428,[26],"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.",[347],"Severe Traumatic Brain Injury",[349,350,351,352,353,354,355],"sTBI","ICP monitoring","randomized controlled trial","TBI management","Latin America","pediatric","Phase III","2025-06-25",{"date":358,"type":34},"2025-06-27",{"date":360,"type":34},"2023-03-22",{"date":362,"type":23},"2028-01-31",{"name":364,"class":41},"University of Washington",11,{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":17,"sex":50,"minAge":124,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":24,"phases":376,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100551027","phase-2-randomized-study-using-sm-030-gel-for-adults-with-melasma-100551027","NCT06454747","Randomized Study Using SM-030 Gel for Adults With Melasma","A Randomized, Observer-Blinded, Placebo-Controlled Study on the Safety and Efficacy of Twice Daily Application of SM-030 Gel 0.64% Vs. SM-030 Gel 0.08% Vs. Placebo Gel in Adults With Melasma","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be included in the study:\n\n1. Subjects must meet all of the following criteria to be included in the study:\n2. Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma\n3. Subjects with moderate to severe Melasma using the following guidelines:\n\n1\\. Stable (unchanged per subject reporting) melasma for at least 3 months 2. Macular lesions, neither depressed nor atrophic 3. Melasma Severity Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin 3. Ability to understand, agree to, and sign the study informed consent form (ICF).\n\n4\\. For female or childbearing subjects, they must be on an agreeable form of birth control (oral contraceptive therapies, estrogen replacement therapies, other non-oral hormonal therapies, IUDs, be abstinent, or have a vasectomized partner) and who have not added and\u002For changed the method of birth control in the last 6 months, and have no intention of adjusting or changing the method of birth control 5. Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted.\n\n6\\. Agree not to change their sun exposure at work, home, or leisure and apply study supplied sunscreen daily.\n\n7\\. Technical ability and willingness to apply Investigational product. 8. Willing to allow digital photos of treatment and comparison areas to be taken and stored.\n\n9\\. Willing to apply study-supplied mineral sunscreen, moisturizer, and cleanser to the face daily throughout the duration of the study\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded in the study:\n\n1. Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study.\n2. Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to vitiligo affecting the treatment and comparison sites.\n3. Severe photodamage as assessed by the 10-point photo damage assessment scale (Griffiths et al., 1992); (McKenzie et al., 2011).\n4. Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).\n5. Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.\n6. Current or past use of monobenzyl ether to depigment skin.\n7. Use of the following topical preparations within a 28-day washout period: topical corticosteroids, topical bleaching products (hyroquinone, niacinamide, kojic acid, ascorbic acid, chemical peels, topical tranexamic acid (TXA)), UV light therapy and sunbathing, topical retinoids.\n8. Use of the following systemic agents within the specified washout periods:\n\n1\\. Systemic corticosteroids (28 days) 2. Systemic cyclosporine, interferon (6 months) 3. Systemic acitretin, etretinate, isotretinoin (6 months) 4. Systemic methotrexate (6 months) 5. Systemic tranexamic acid (TXA) 6. Systemic photoallergic, phototoxic, and or photosensitizing drugs (6 months including psoralens, sulfonamide drugs, tetracycline antibiotics, thiazide diuretics, phenothiazines, coal tar and derivatives, and tricyclic antidepressants, chlorpromazine, benoxaprofen, piroxicam, nalidixic acid, procainamide, phenytoin, antimalarial medications, some cystostatic agents)\n\n9\\. Laser (ablative or non-ablative), microneedling, PRP, or light-based treatment of the treatment areas within 3 months of Screening.\n\n10\\. Any dermatological conditions within the designated application area that could interfere with clinical evaluations or any disease state or physical condition which might expose the subject to an unacceptable risk by study participation (neurodermatitis, eczema, psoriasis, atrophy, rosacea, seborrheic dermatits, etc.).\n\n11\\. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see Exclusion criteria 6, 7, and 8).\n\n12\\. Known high daily exposure to the sun (\\>4 hours of sun exposure through work or daily activities) and\u002For frequent sunbathing\u002FUV tanning.\n\n13\\. Unwilling to discontinue applying any prescription or over the counter (OTC) topical product creams and ointments, other than makeup and moisturizers, on treatment area(s) at Baseline through their last day of study.\n\n14\\. Treatment of any type of cancer within 6 months of Screening, with the exception of superficial skin cancers such as basal cell or squamous cell carcinoma outside of treatment area.\n\n15\\. Known allergy to any of the Investigational product(s) or any components in the Investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.\n\n16\\. Unable to meet the study attendance requirements.\n\n17\\. Any history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.\n\n18\\. Participation in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.","65 Years",{"count":375,"type":23},138,[377],"PHASE2","Brief Summary This is a phase 2b, observer-blinded, randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 0.64% and SM-030 gel 0.08% compared against placebo gel in healthy adult male and female subjects with Melasma. The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period. Approximately 138 subjects who meet the eligibility criteria, notably with a clinical diagnosis of Melasma will be randomized in a 3:2:1 ratio to one of three treatment arms: SM-030 gel 0.64% (N=69), Placebo gel (N=46), or SM-030 gel 0.08% (N=23). Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites (4 sites in Mexico and 1 in El Salvador). Subjects will be assessed for safety and efficacy at each visit.",[380],"Melasma","2024-12-10",{"date":383,"type":34},"2024-12-13",{"date":385,"type":34},"2024-06-27",{"date":387,"type":23},"2025-10",{"name":389,"class":68},"DermBiont, Inc.",2,""]