[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Kenya\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":660},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,112,0,25,[9,42,70,89,112,138,178,211,233,264,284,307,328,351,373,396,420,458,479,506,532,557,578,605,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100555869","phase-1-safety-and-pharmacokinetics-study-of-pgt121414ls-alone-and-in-combination-with-vrc07-523ls-in-infants-exposed-to-hiv-1-100555869",false,"NCT06517693","Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Inclusion Criteria:\n\n* Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study.\n* Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.\n* Infant was singleton or twin.\n* Infant's gestational age at birth was at least 36 weeks.\n* At birth, infant's weight was at least 2 kg.\n* At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth.\n* At screening, infant has the following laboratory test results:\n\n  * Hemoglobin, normal or grade 1 (≥13 g\u002FdL or ≥8.05 mmol\u002FL)\n  * Platelets, normal or grade 1 (≥100,000 cells\u002Fmm3 or ≥100.000 x10\\^9 cells\u002FL)\n  * Absolute neutrophil count (ANC), normal or grade 1\n\n    1. ≤24 hours old (≥4,000 cells\u002Fmm3 or ≥4.000 x10\\^9 cells\u002FL)\n    2. \\>24 hours old (≥1,250 cells\u002Fmm3 or ≥1.250 x10\\^9 cells\u002FL)\n  * Alanine transaminase (ALT), normal (\\\u003C1.25 x ULN)\n* At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.\n* Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding.\n* Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed.\n* At entry, infant is at increased risk of HIV acquisition.\n\nCohorts 1 and 2, Strata FF only:\n\n* Birthing parent had acute HIV during this pregnancy; or\n* Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies\u002FmL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies\u002FmL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or\n* Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records.\n\nCohorts 1 and 2, BF only:\n\n* Per birthing parent's report, intends to breastfeed\n\nExclusion Criteria:\n\n* Birthing parent has received any investigational product during this pregnancy.\n* Infant has received any active or passive HIV immunotherapy or any investigational product.\n* At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.\n* Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.",true,"ALL","72 Hours",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.",[28],"HIV-1","RECRUITING","2026-08-24",{"date":32,"type":33},"2026-08-25","ACTUAL",{"date":35,"type":33},"2026-01-05",{"date":37,"type":22},"2028-06-30",{"name":39,"class":40},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",17,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":17,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100598448","phase-3-a-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-010-100598448","NCT07071623","A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)\n* Was assigned female sex at birth and is cisgender.\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1","FEMALE","16 Years","30 Years",{"count":53,"type":22},4580,[55],"PHASE3","Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[58,59],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis","2026-08-21",{"date":30,"type":33},{"date":63,"type":33},"2025-11-10",{"date":65,"type":22},"2027-10-18",{"name":67,"class":68},"Merck Sharp & Dohme LLC","INDUSTRY",30,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":17,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100596349","a-clinical-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-011-100596349","NCT07044297","A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed HIV-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person\n* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1\n* Is expecting to donate eggs at any time during the study",{"count":78,"type":22},4390,[55],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[58,59],{"date":30,"type":33},{"date":84,"type":33},"2025-07-31",{"date":86,"type":22},"2027-07-22",{"name":67,"class":68},81,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964","NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye","18 Years",{"count":99,"type":22},230,[55],"This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).",[103],"Metastatic Breast Cancer",{"date":32,"type":33},{"date":106,"type":33},"2023-09-08",{"date":108,"type":22},"2032-12-28",{"name":110,"class":68},"Hoffmann-La Roche",192,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":17,"sex":49,"minAge":4,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"100393642","measuring-adverse-pregnancy-and-newborn-congenital-outcomes-100393642","NCT04405700","Measuring Adverse Pregnancy and Newborn Congenital Outcomes","Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study","MANGO","C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:\n\nInclusion criteria for women\n\n1. Pregnant and enrolled in ANC at the study site;\n2. Understands English or Swahili.\n\nExclusion criteria for women a. Any physical or mental disability that prevents the woman from providing informed consent\n\nInclusion criteria for infants\n\na. All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none)\n\nC2. Data collection for all deliveries at the site:\n\nInclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site\n\nExclusion criteria for women (none)\n\nInclusion criteria for live\u002Fstillborn infants\n\na. Infant is delivered at the site and results in the infant\u002Fstillbirth being registered at the site\n\nExclusion criteria for infants (none)\n\nC3. Photos\u002Fvideos of infants with CAs:\n\nInclusion criteria for infants\n\n1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age\n2. The infant has a suspected CA on surface exam\n\nExclusion criteria for infants (none)",{"count":121,"type":22},2800,"OBSERVATIONAL","The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).",[125,126,127,128],"HIV\u002FAIDS","Pregnancy Related","Congenital Disorders","Newborn Morbidity",{"date":30,"type":33},{"date":131,"type":33},"2020-09-29",{"date":133,"type":22},"2031-05-31",{"name":135,"class":136},"Indiana University","OTHER",1,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100549825","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-crizanlizumab-5-mgkg-compared-with-placebo-in-adolescent-and-adult-sickle-cell-disease-patients-who-experience-frequent-vaso-occlusive-crises-sparkle-100549825","NCT06439082","A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)","A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Versus Placebo, With or Without Hydroxyurea\u002FHydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises","SPARKLE","Key Inclusion Criteria:\n\n1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \\\u003C18 years old and adults include participants aged 18 years and older.\n2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.\n3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.\n4. If the participant is on HU\u002FHC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU\u002FHC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU\u002FHC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.\n\nParticipants who have not been receiving HU\u002FHC, and\u002For erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.\n\nKey Exclusion Criteria:\n\n1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.\n2. History of stem cell transplant and\u002For gene therapy.\n3. Received blood products within 30 days prior to Week 1 Day 1 dosing.\n4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.\n5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and\u002For planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.\n6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.","12 Years","100 Years",{"count":149,"type":22},354,[55],"A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg\u002Fkg) versus placebo, with or without hydroxyurea\u002Fhydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.",[153],"Sickle Cell Disease",[153,155,156,157,158,159,160,161,162,163,164,165,166,167],"SCD","SEG101","Crizanlizumab","Hydroxyurea\u002F Hydroxycarbamide Therapy","Vaso-Occlusive Crises","Sickle Cell Anemia","blood disorders","hemoglobin","red blood cells","sickle-like shape","mutation in hemoglobin gene","sickle-cell trait","sickle-cell crisis","2026-08-18",{"date":170,"type":33},"2026-08-19",{"date":172,"type":33},"2024-10-24",{"date":174,"type":22},"2030-07-29",{"name":176,"class":68},"Novartis Pharmaceuticals",34,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915","NCT07595042","A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)","A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB","Inclusion Criteria:\n\n* Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.\n* Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.\n* Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.\n* Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.\n* If living with HIV, has a CD4+ cell count of at least 50 cells\u002Fmm3 within 60 days before study entry.\n* If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.\n* Has laboratory test results within 7 days before study entry that meet all of the following:\n\n  * alanine aminotransferase (ALT) no more than 3 times the upper limit of normal\n  * total bilirubin no more than 2.5 times the upper limit of normal\n  * creatinine no more than 2 times the upper limit of normal\n  * potassium between 3.5 and 5.5 mEq\u002FL\n  * absolute neutrophil count at least 1000\u002Fmm3\n  * hemoglobin at least 7.0 g\u002FdL\n  * platelet count at least 100,000\u002Fmm3\n* If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.\n* If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:\n\n  * condoms\n  * intrauterine device (IUD) or intrauterine system (IUS)\n  * cervical cap with spermicide\n  * diaphragm with spermicide\n* If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.\n* Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.\n* Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.\n\nExclusion Criteria:\n\n* TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.\n* Received more than 5 days of treatment for active TB within the 24 weeks before study entry.\n* Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.\n* Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.\n* Has a past history of suspected or confirmed drug-resistant TB of any type.\n* Is currently pregnant or breastfeeding.\n* Cannot take medicines by mouth.\n* Has an HIV\u002FAIDS-related opportunistic infection at study entry.\n* Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.\n* Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.\n* Has alcohol-related liver disease.\n* Has liver cirrhosis.\n* Has a history of aortic aneurysm or aortic dissection.\n* Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.\n* Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.\n* Has a known history of acute intermittent porphyria.\n* Weighs less than 30 kg.\n* Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.\n* Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.\n* Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.\n* Is currently taking part in another interventional clinical trial.","13 Years",{"count":187,"type":22},900,[189],"PHASE2","The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.",[192],"Tuberculosis",[192,194,195,196,197,198,199,200,201],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","NOT_YET_RECRUITING","2026-08-17",{"date":170,"type":33},{"date":206,"type":22},"2026-10-30",{"date":208,"type":22},"2029-10-22",{"name":39,"class":40},29,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":185,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100602518","phase-1-a-study-of-daily-rifapentine-combined-with-isoniazid-1hp-for-tuberculosis-prevention-in-children-less-than-13-years-of-age-with-and-without-hiv-100602518","NCT07124559","A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Phase I\u002FII Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Inclusion Criteria:\n\n1. A parent or legal guardian must be willing and able to give written permission for the child to participate in the study. If required by local policies, the child must also be willing and able to give written assent to participate. All sites must follow local policies and procedures.\n2. Age requirements at entry:\n\n   * Cohort 1: Children under 13 years old.\n   * Cohort 2: Children aged 12 weeks to under 13 years old.\n3. For Cohort 1 participants under 28 days old: The child must have been born at or after 37 weeks of pregnancy, as determined by the site investigator using parent\u002Fguardian report or medical records.\n4. Weight requirements at entry:\n\n   * Cohort 1: 3 kg to under 45 kg.\n   * Cohort 2: 6 kg to under 45 kg.\n5. HIV status:\n\n   * Cohort 1: Must be living without HIV.\n   * Cohort 2: Must be living with HIV.\n6. At risk of TB disease, defined as meeting at least one of the following:\n\n   * Having close contact with someone with infectious pulmonary TB within the past six months.\n   * A positive tuberculin skin test (TST) or, for those over two years old, a positive interferon gamma release assay (IGRA) if TST is not available.\n   * For Cohort 2 only: Living in a high TB burden area (≥ 60 TB cases per 100,000 people per year).\n7. Normal or mild (grade 1 or 2) test results for the following at screening (within 21 days before entry):\n\n   * ALT (liver enzyme)\n   * Estimated glomerular filtration rate (kidney function)\n   * Absolute neutrophil count (white blood cells)\n   * Hemoglobin (red blood cells)\n8. For Cohort 2 participants:\n\n   * Must have been on antiretroviral therapy (ART) for at least 12 weeks before entry.\n   * Must have been on a specific ART regimen (once-daily DTG and two NRTIs) for at least 14 days before entry.\n   * Must have used the same formulation of DTG (tablet or dispersible tablet) for at least three days before entry.\n   * Must agree to continue the same formulation of DTG for the study duration.\n   * Must have an HIV-1 RNA level below 200 copies\u002FmL at screening.\n9. Must intend to stay in the same area for the study duration.\n10. Must have access to at least one meal per day during the 28-day treatment period.\n\nExclusion Criteria:\n\n1. The child has active TB, confirmed by medical records, parent\u002Fguardian report, or tests during screening, indicated by:\n\n   * Currently being treated for active TB.\n   * Symptoms like poor growth, poor weight gain, weight loss, cough for at least 11 days, or fever for at least eight days.\n   * X-ray or CT scan showing TB.\n   * Positive TB test results (e.g., culture, Xpert MTB\u002FRIF Ultra, Truenat M.tb, other nucleic acid tests, urine tests).\n2. The child has been exposed to an adult with drug-resistant TB (resistant to Rifampicin or Isoniazid) within the past six months.\n3. The child has taken the following medications:\n\n   * Daily Isoniazid in the 28 days before entry.\n   * Any prohibited medications listed in the study within three days before entry.\n4. The child has any of the following conditions:\n\n   * Acute or chronic hepatitis.\n   * Allergy to Isoniazid or rifamycins.\n   * Porphyria.\n   * Severe peripheral neuropathy.\n5. The child has severe acute malnutrition (weight-for-height\u002Flength less than -3 z-scores of WHO standards). Note: Children who are stunted (height-for-age more than two standard deviations below WHO standards) are eligible.\n6. For Cohort 2: The child has an active AIDS-defining opportunistic infection.\n7. The child has started menstruation.\n8. The child has taken NVP, EFV, lopinavir\u002Fritonavir, and\u002For raltegravir within 14 days before entry.\n9. The child has received long-term immunosuppressive therapy (more than eight days) within 30 days before entry. Note: Short courses of steroids (seven days or less) may be allowed with approval.\n10. The child is a result of a multiple birth (e.g., twins, triplets).\n11. The child has any other significant medical condition that would make participation unsafe, complicate data interpretation, or interfere with study objectives, as determined by the site investigator.",{"count":219,"type":22},144,[25,189],"This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.",[192],[224,192,225],"HIV","Latent Tuberculosis",{"date":170,"type":33},{"date":228,"type":22},"2026-10-15",{"date":230,"type":22},"2028-05-31",{"name":39,"class":40},11,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":17,"sex":18,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":247,"conditions":248,"keywords":251,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100580855","a-trial-testing-a-two-way-sms-platform-to-recognize-and-prevent-wasting-among-hiv-infected-and-hiv-exposed-uninfected-children-in-kenya-100580855","NCT06842732","A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","A Mixed Methods Randomized Controlled Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","MAMMS IYCF R33","Inclusion Criteria (HIV-exposed caregiver-child pairs):\n\n* Children aged 6 to 24 months all-inclusive with a MUAC ≥ 12.5cm at the date of recruitment\n* Children living with HIV or HIV-exposed uninfected children seen as outpatients in early infant detection (EID) or HIV-care clinics at the participating hospitals\n* The child's caregiver is willing and able to provide informed consent\n* The child's caregiver can read or write or has someone to help them read or write\n* The child's caregiver is planning to remain in the catchment area with their child for \\> 6 months and willing to return to the health facility for 6-month follow up visits\n* The child's caregiver has access to a Safaricom phone line and provides a mobile phone number\n\nInclusion Criteria (healthcare workers):\n\n\\- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients\n\nExclusion Criteria:\n\n* Children with moderate or severe wasting (MUAC \\\u003C12.5cm, weight-for-height z-score \\\u003C-2, or nutritional edema) at the time of eligibility screening\n* Children with a congenital condition that limit feeding or syndromes that prevents age-appropriate feeding\n* Child is enrolled in another study that the PI judges to compromise the aims of this study\n* Child's caregiver does not pass the second training after being unable to satisfactorily complete the first MUAC training.\n* Child's caregiver is under the age of 18 years.","6 Months","24 Months",{"count":244,"type":22},776,[246],"NA","The goal of this study is to test if a two-way text-message (SMS) maternally administered malnutrition monitoring system (MAMMS) that delivers infant and young child feeding (IYCF) education and supports caregivers in monitoring their child's nutritional status at home can improve nutritional outcomes for HIV-exposed children.\n\nThe aims include 1) to determine whether the MAMMS IYCF intervention lowers the incidence of malnutrition, leads to a shorter time to recover for those that become malnourished and results in a lower incidence of hospitalizations, severe malnutrition and death, 2) to determine the cost and cost-effectiveness of the MAMMS IYCF intervention, and 3) to determine the effect of the MAMMS IYCF intervention on the behavior and attitudes of participants through change in age-appropriate feeding, IYCF knowledge, trust in the healthcare system, and intention to seek care if the child becomes wasted.\n\nThe study team will enroll 776 caregiver-child pairs aged between 6 and 24 months in Migori and Homa Bay County, Kenya. Each caregiver-child pair will be randomly assigned to either the MAMMS IYCF intervention or standard of care (SOC) and followed for 180 days (about 6 months).\n\nCaregivers assigned to the intervention arm will be asked to respond to weekly messages with the color of the MUAC tape after measuring their child's arm after being trained on how to use the MUAC measuring tape. Weekly messages will include IYCF education and other age-appropriate child health related information. Caregivers in the SOC arm will receive clinic appointment and study visit reminders only. Caregivers in the intervention arm and the SOC arm will be asked to attend the study clinic for follow-up visits at Day 90 and Day 180. At enrollment and follow-up visits, the study team will administer a survey including a child's medical history, a standardized child clinical examination, and anthropometry.",[249,250],"Malnutrition in Children","Children Exposed to HIV",[252,253,254,255],"maternally administered malnutrition monitoring system (MAMMS)","infant and young child feeding practices","wasting","two-way SMS system",{"date":170,"type":33},{"date":258,"type":33},"2025-06-05",{"date":260,"type":22},"2027-07-15",{"name":262,"class":136},"University of Washington",2,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":23,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":210},"100530851","phase-2-trial-of-novel-regimens-for-the-treatment-of-pulmonary-tuberculosis-100530851","NCT06192160","Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","RAD-TB","Inclusion Criteria:\n\n1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of \"medium\" or \"high\" from Xpert MTB\u002FRIF Ultra are required.\n2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB\u002FXDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB\u002FRIF or Xpert MTB\u002FRIF Ultra or other validated molecular test) within 7 days prior to study entry.\n3. Documentation of HIV-1 infection status, as below:\n\n   Presence or absence of HIV-1 infection, as documented by:\n   * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following:\n   * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or\n   * HIV-1 antigen, or\n   * Plasma HIV-1 RNA viral load, or\n   * A licensed Western blot\n4. For individuals with HIV: CD4+ cell count ≥100 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n6. Individuals age ≥18 years.\n7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:\n\n   * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n   * Serum or plasma total bilirubin ≤2 times ULN\n   * Serum or plasma creatinine ≤2 times ULN\n   * Serum or plasma potassium ≥3.5 mEq\u002FL\n   * Serum or plasma magnesium ≥1.0 mEq\u002FL (≥0.500 mmol\u002FL)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Platelet count ≥100,000\u002Fmm\\^3\n   * Negative for, hepatitis B surface antigen (HBsAg)\n   * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR)\n8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n   Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications:\n   * Male or female condoms\n   * Diaphragm or cervical cap (with spermicide, if available)\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants)\n\n   Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception.\n\n   Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.\n9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation.\n\n   For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.\n10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.\n11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.\n12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.\n13. Chest x-ray obtained within 14 days prior to study entry.\n14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.\n15. Ability and willingness of individual to provide informed consent.\n\nExclusion Criteria:\n\n1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.\n2. Current extrapulmonary TB, in the opinion of the investigator.\n3. QTcF interval \\>450 ms within 7 days prior to study entry.\n4. History of or ongoing heart failure.\n5. Personal or family history of congenital QT prolongation.\n6. History of known, untreated, ongoing hypothyroidism.\n7. History of or ongoing bradyarrhythmia.\n8. History of torsades de pointes.\n9. Current Grade 2 or higher peripheral neuropathy.\n10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.\n11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months.\n12. Weight \\\u003C35 kg.\n13. Unable to take oral medications.\n14. Taking any of prohibited medications.\n15. Known allergy\u002Fsensitivity or any hypersensitivity to components of investigational agents or their formulation.\n16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.",{"count":273,"type":22},315,[189],"A5409\u002FRAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).\n\nA5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \\[(SOC) isoniazid\u002Frifampicin\u002Fpyrazinamide\u002Fethambutol (HRZE)\\].\n\nThe study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.",[277],"Pulmonary Tuberculosis",{"date":168,"type":33},{"date":280,"type":33},"2025-03-11",{"date":282,"type":22},"2027-08-11",{"name":39,"class":40},{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100219916","phase-1-very-early-intensive-treatment-of-infants-living-with-hiv-to-achieve-hiv-remission-100219916","NCT02140255","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I\u002FII Proof of Concept Study","Maternal Inclusion Criteria\n\n1. Presumed or confirmed maternal HIV infection:\n\n   * Mothers will be eligible to enroll with EITHER:\n\n     * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR\n     * Confirmed HIV infection defined as positive results from two samples collected at different timepoints\n2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB\u002FEC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.\n3. Was not previously enrolled in this study with another infant.\n4. Did not receive ARVs during the current pregnancy.\n5. Infant is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 1\n\n1. Less than or equal to 48 hours of age.\n2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).\n3. Greater than or equal to 2 kilograms (kg) at birth.\n4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n6. Mother is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 2\n\n1. Enrolled in Step 1.\n2. Confirmed in utero HIV infection.\n3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2.\n\nInfant Inclusion Criteria for Step 3\n\n1. Enrolled in Step 2.\n2. Has reached Step 2 Week 96.\n3. Has the following results based on testing:\n\n   * No confirmed plasma HIV RNA ≥200 copies\u002FmL at Step 2 Week 24 and up to but excluding Step 2 Week 48.\n   * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions\n\n     * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \\\u003C200 copies\u002FmL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test).\n     * If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \\\u003C200 copies\u002FmL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2.\n     * If HIV RNA is detected on the confirmatory test with a result ≥200 copies\u002FmL, the infant will not be eligible for Step 3.\n     * (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \\\u003CLOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \\\u003CLOD after Week 48. However, infants with detectable RNA with a result \\\u003CLOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected.\n     * Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.\n4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.\n5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):\n\n   * Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.\n   * Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.\n   * CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells\u002FmL if 2 to less than 3 years of age; ≥750 cells\u002FmL if 3 to less than 5 years of age; ≥500 cells\u002FmL if 5 years of age or older).\n   * Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.\n   * Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.\n6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.\n\nInfant Inclusion Criteria for Step 4\n\n1. Enrolled in Step 3.\n2. Has met at least one of the following:\n\n   * Plasma HIV RNA ≥LOD based on two assays.\n   * Plasma HIV RNA ≥1000 copies\u002FmL in the presence of fever or other sign or symptom of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.\n   * Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\\\u003C1000 cells\u002FmL if 2 to less than 3 years of age; \\\u003C750 cells\u002FmL if 3 to less than 5 years of age; \\\u003C500 cells\u002FmL if 5 years of age or older).\n   * Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.","48 Hours",{"count":293,"type":22},1120,[25,189],"The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.",[297],"HIV Infection",[299],"HIV Remission",{"date":170,"type":33},{"date":302,"type":33},"2015-01-23",{"date":304,"type":22},"2031-12-31",{"name":39,"class":40},46,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":146,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100472377","phase-2-a-phase-23-study-in-adult-and-adolescent-participants-with-scd-100472377","NCT05431088","A Phase 2\u002F3 Study of Osivelotor in Adult and Adolescent Participants With SCD","A PHASE 2\u002F3 RANDOMIZED, MULTICENTER STUDY OF OSIVELOTOR ADMINISTERED ORALLY TO ADULT AND ADOLESCENT PARTICIPANTS WITH SICKLE CELL DISEASE","Inclusion Criteria:\n\nPart A and Part B:\n\n* Male or female with SCD, HbSS and HbSB-zero\n* Participants with Hemoglobin ≥ 5.5 and ≤ 10.5 g\u002FdL during Screening and considered stable by the Investigator.\n* For participants taking hydroxyurea and\u002For L-glutamine, the dose must be stable for at least 90 days prior to signing the ICF or assent and with no anticipated need for dose adjustments during the study in the opinion of the Investigator.\n\nPart B:\n\n* Participants with SCD ages 12 years and older, inclusive at screening.\n* Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening.\n\nOLE:\n\n\\- Participants who have completed the Part B successfully will be eligible.\n\nExclusion Criteria:\n\nPart A and Part B:\n\n* Participants who had more than 10 VOC within 12 months of screening\n* Female participant who is breastfeeding or pregnant\n* Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1\n* Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF or anytime during the screening period.\n* Participants in Sub-Saharan Africa or who have relocated from Sub-Saharan Africa within 6 months.\n\nOLE:\n\n* Have any unresolved clinically significant adverse event, laboratory abnormality, or safety finding from Part B that, in the opinion of the Investigator, increases the risk of study drug administration.\n* Met permanent treatment discontinuation criteria during Part B.\n* Have withdrawn consent or are unable to comply with study procedure",{"count":315,"type":22},389,[189,55],"The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.",[153],"2026-08-14",{"date":168,"type":33},{"date":322,"type":33},"2022-09-22",{"date":324,"type":22},"2032-12-31",{"name":326,"class":68},"Pfizer",80,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":146,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100563138","phase-3-a-study-to-evaluate-how-well-etavopivat-works-in-people-with-sickle-cell-disease-100563138","NCT06612268","A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease","A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease","Hibiscus 2","Inclusion Criteria:\n\n* Male or female.\n* Age 12 years or above at the time of signing the informed consent.\n* Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.\n* Have 1-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g\u002FdL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 g\u002FL) at screening.\n\nExclusion Criteria:\n\n* More than 15 VOCs within the past 12 months prior to screening documented in the participant's medical record. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.\n* Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.\n* Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).\n* Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.\n* Receiving or use of concomitant medications that are strong inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.\n* Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.\n* Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).\n* Hepatic dysfunction characterized by:\n\n  * Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or\n  * Direct bilirubin greater than 3.0 × ULN.\n* Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.\n* Severe renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] at screening, calculated by the central laboratory greater than 30 mL\u002Fmin\u002F1.73 m\\^ 2) or on chronic dialysis.\n* Travelled distance on standardized 6MWT below 100m at screening.",{"count":337,"type":22},408,[55],"This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.",[153],"2026-08-12",{"date":343,"type":33},"2026-08-13",{"date":345,"type":33},"2025-02-17",{"date":347,"type":22},"2029-08-12",{"name":349,"class":68},"Novo Nordisk A\u002FS",175,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":359,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"100562904","phase-3-a-research-study-looking-at-long-term-treatment-with-etavopivat-in-people-with-sickle-cell-disease-or-thalassaemia-100562904","NCT06609226","A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia","An Open-label, Multi-centre, Rollover Study to Characterise Long-term Safety and Efficacy of Etavopivat in Adults, Adolescents and Children Who Have Sickle Cell Disease or Thalassaemia and Have Completed a Treatment Period in an Etavopivat Study","FLORAL","Inclusion Criteria:\n\n* Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.\n* Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.\n* Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the full dose of etavopivat before transferring.\n* Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have been on a stable dose in the parent study as defined at the investigator's discretion. Necessary adjustments related to weight or age are accepted. Participants with temporary dose reductions or pauses due to medical reasons may still be considered to have a stable dose, as determined by the investigator, who will assess the impact of these adjustments based on clinical context and the participant's overall health status.\n\nExclusion Criteria:\n\n* Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.\n* Participants on permanent dose reduction (greater than \\[\\>\\] 28 days or more) or ongoing temporary treatment discontinuation.\n* Use of any of the following within the timeframes prior to the transfer visit as stated:\n* Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study.\n* Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.\n* Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need of such agents for a maintenance treatment during this study.\n* Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.\n* Current participation in a study that is not a designated parent study, or planned participation in any other clinical study, for the duration of FLORAL.","2 Years",{"count":361,"type":22},480,[55],"Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.",[153,365],"Thalassemia",{"date":343,"type":33},{"date":368,"type":33},"2025-01-10",{"date":370,"type":22},"2030-12-30",{"name":349,"class":68},106,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":17,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":137},"100504457","msaada-a-mobile-health-tool-100504457","NCT05848557","mSaada: A Mobile Health Tool","mSaada: A Mobile Health Tool to Improve Cervical Cancer Screening in Western Kenya","R21\n\nAim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials\n\nInclusion Criteria:\n\n* 18 years or older\n* be employed by a government clinic\n* be working in cervical cancer screening\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nWomen\n\nInclusion Criteria:\n\n\\- between 30 and 65 years old\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nAim 2 Community health volunteers (CHVs)\n\nInclusion Criteria:\n\n* 18 years or older\n* be employed by a government clinic\n* be working in cervical cancer screening\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nWomen\n\nInclusion Criteria:\n\n* between 30 and 65 years old\n* intact cervix and uterus\n* able to provide informed consent.\n\nExclusion Criteria:\n\n* Does not understand the study purpose and details\n* Is not willing to provide informed consent\n\nR33\n\nWomen (knowledge and risk perception surveys) We plan to enroll approximately 600 women (50 per health facility) to complete a survey about cervical cancer and HPV knowledge, risk perception and screening awareness, acceptability and self-efficacy.\\\\\n\nEligibility criteria for women participants include:\n\n* Reside within Siaya County, in one of the study communities\n* Eligible for cervical cancer screening per the Kenya Ministry of Health guidelines and\n* Ability to provide informed consent.\n\nCHPs in both arms will be asked to complete a survey about their self-efficacy, knowledge of HPV and cervical cancer, and the usability of the mSaada app (CHPs in the intervention arm only).\n\nInclusion:\n\n* CHV participants must be employed by government clinics in Siaya County, and\n* be able to provide informed consent.\n\nExclusion:\n\n* Does not understand the study purpose and details\n* Is not willing to sign an informed consent",{"count":381,"type":22},6000,[246],"In the R21 phase of this project, investigators will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness in assisting community health volunteer-led home-based HPV screening, and implementation factors. Investigators will carry out a six-month pilot of mSaada with community units in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a to determine effectiveness.\n\nIn the R33 phase of the project, investigators plan to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. Investigators anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.",[385,386,387],"Cervical Cancer","HPV","mHealth","2026-08-11",{"date":343,"type":33},{"date":391,"type":33},"2024-02-19",{"date":393,"type":22},"2027-06-30",{"name":395,"class":136},"Duke University",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":403,"minAge":97,"maxAge":4,"enrollmentInfo":404,"targetDuration":406,"studyType":122,"phases":4,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":69},"100480992","bph-global-registry-100480992","NCT05543200","BPH Global Registry","A Global Registry of Treatments and Outcomes for Benign Prostatic Hyperplasia","Inclusion Criteria:\n\n* Primary diagnosis of BPH with LUTS with prescribed medical treatment or surgical intervention\n\nExclusion Criteria:\n\n* Non-symptomatic BPH\n* No treatment prescribed for BPH","MALE",{"count":405,"type":22},7500,"3 Years","Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.",[409,410],"Benign Prostatic Hyperplasia","Lower Urinary Tract Symptoms",[412],"BPH, Registry, LUTS",{"date":343,"type":33},{"date":415,"type":33},"2023-03-13",{"date":417,"type":22},"2028-12",{"name":419,"class":136},"Société Internationale d'Urologie",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":17,"sex":49,"minAge":97,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":443,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":137},"100592937","enhanced-mentor-mother-strategy-for-pregnant-and-postpartum-women-living-with-hiv-100592937","NCT06999928","Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV","Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy","PIE-eMMs","Inclusion Criteria:\n\n* Pregnant and postpartum women living with HIV (and their infants born during the study)\n* ≥18 years of age\n* Enrolled in PMTCT services at BFSDH\n* Able to understand and provide informed consent in English or Kiswahili\n\nExclusion Criteria:\n\n* Women who are not pregnant or postpartum\n* \\\u003C18 years of age\n* Not enrolled in PMTCT services at BFSDH\n* Unable to understand and provide informed consent in English or Kiswahili\n* Cognitive impairment that would interfere with ability to participate in the study",{"count":429,"type":22},200,[246],"Mentor Mothers (MMs) are peer supporters who help pregnant and postpartum women living with HIV (WLHIV) as they receive prevention of mother-to-child transmission of HIV (PMTCT) services in resource-limited settings like Kenya. Differentiated service delivery (DSD) is a care model that tailors services based on clients' needs, helping to improve both the quality and efficiency of care.\n\nThis hybrid implementation-effectiveness study will test whether an enhanced MM strategy that uses DSD can be successfully carried out and improve health outcomes for mothers and infants. The study will take place at Burnt Forest Sub-District Hospital (BFSDH) in Kenya.\n\nResearchers will ask:\n\n* Can the enhanced MM strategy be delivered as planned and accepted by patients and staff?\n* Does the strategy improve clinical outcomes like keeping mothers in PMTCT care, achieving HIV viral suppression, completing infant HIV testing, and preventing HIV transmission to infants? Researchers will compare health outcomes before and after the strategy is introduced at BFSDH, and also compare outcomes at other similar clinics that continue with standard MM services.\n\nWomen who choose to participate will meet with a MM during their routine antenatal and postnatal clinic visits. They will be offered the enhanced MM support, but can choose to receive standard care if they prefer.",[433,434,435,436,437,438,439,440,441,442],"Hiv","Transmission Vertical","Viremia","Adherence, Treatment","Stigmatization","Socioeconomic Adversity","Health Care Utilization","Health Care Acceptability","Peer Group","Mothers",[444,445,446,447,448,449,450],"prevention of mother-to-child transmission","retention","implementation","mentor mothers","differentiated service delivery","maternal-child health","Kenya","2026-08-07",{"date":388,"type":33},{"date":454,"type":33},"2025-07-10",{"date":456,"type":22},"2026-10-12",{"name":135,"class":136},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":241,"maxAge":97,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":478},"100531354","phase-2-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-etavopivat-in-pediatric-patients-with-sickle-cell-disease-100531354","NCT06198712","A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease","A Single Arm, Open Label, Phase 1\u002F2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease","HIBISCUS KIDS","Inclusion Criteria:\n\n* Type of Participant and Disease Characteristics\n\n  1. Patient's parent, legal guardian, or legal representative has provided documented informed consent and patients have provided age-appropriate assent\n  2. Age greater than or equal to (≥) 6 months and lesser than (\\\u003C) 18 years of age at time of enrollment, according to the enrolling cohort:\n\n     * Cohort 1: age 12 to \\\u003C 18 years (adolescents)\n     * Cohort 2: age 6 to \\\u003C 12 years\n     * Cohort 3: age 2 to \\\u003C 6 years\n     * Cohort 4: age 6 months to \\\u003C 2 years\n  3. Patient has confirmed diagnosis of SCD\n\n     • Documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing. Molecular genotyping is not required. SCD genotype may be determined from the results of Hb electrophoresis, high-performance liquid chromatography (HPLC), or similar testing. Note that Hb electrophoresis is performed by the local laboratory at Screening.\n  4. Hemoglobin ≥ 5.5 and lesser than or equal to (≤) 10.5 grams per deciliter (g\u002FdL)\n  5. Pediatric patients with severe SCD, as defined by at least 1 of the following:\n\n     * 2-15 episodes of documented VOC within the 12 months prior to screening. Documentation must exist in the patient's medical record prior to screening. Events based solely on patient recall without supporting documentation should not be counted towards eligibility.\n     * Hospitalization for any SCD-related complication in the last 12 months prior to starting study treatment\n     * Proteinuria, defined as an albumin:creatinine ratio (ACR) \\> 100 mg\u002Fg on 2 measures (separated by ≥ 1 month) as an indicator of early renal disease\n     * History of a conditional TCD in the last 12 months prior to starting study treatment, but not currently being treated with chronic transfusion therapy (applicable to participants \\> 2 years of age). Conditional TCD is defined as a TAMMV of 170-199 cm\u002Fs by TCD or 155-184 cm\u002Fs by imaging TCD (TCDi).\n  6. For participants taking hydroxyurea (HU), the dose of HU (mg\u002Fkg) must be stable (no more than a 20% change in dosing) for at least 90 days prior to start of study treatment with no anticipated need for dose adjustments during the study, in the opinion of the Investigator\n  7. Patients on crizanlizumab or L-glutamine treatment at the time of consent may be eligible if they:\n\n     * Have been on a stable dose for ≥ 12 months at the time of consent (ie, no changes to the dose except for changes to weight or for safety reasons)\n     * For patients on crizanlizumab, have been ≥ 80% compliant with the planned regimen during the 12 months prior to the time of consent\n  8. Female patients of childbearing potential who are using acceptable methods of contraception and agree not to donate ova from study start to 90 days after the last dose of study drug, and male patients who are willing to use acceptable methods of contraception and agree not to donate sperm, from study start to 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  1. Female who is breastfeeding or pregnant\n  2. More than 15 VOCs within the 12 months prior to starting study treatment that required a hospital, emergency room (ER), or clinic visit\n  3. Hospitalized for sickle cell crisis or other vaso-occlusive event occurring in the 14 days prior to starting study treatment\n  4. Abnormal TCD in the 12 months prior to starting study treatment\n\n     Prior\u002FConcomitant Therapy\n  5. Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)\n  6. Received any blood products within 30 days of starting study treatment\n  7. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4\u002F5 within 2 weeks of starting study treatment\n  8. Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study\n  9. Receipt of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study\n  10. Receipt of prior cellular based therapy (eg, hematopoietic cell transplant, gene modification therapy)",{"count":467,"type":22},95,[189],"The purpose of this study is to evaluate the pharmacokinetics and safety of etavopivat in paediatric participants with sickle cell disease (SCD). Participants will receive etavopivat and will be enrolled in a staggered manner, starting with the oldest age group and followed sequentially by younger cohorts after review of pharmacokinetic and safety data from the preceding cohort. All participants will undergo a 24-week primary treatment period followed by a 72-week extension treatment period to further evaluate long-term safety and pharmacokinetics of etavopivat. The total duration of the study will be approximately 96 weeks.",[153],{"date":341,"type":33},{"date":473,"type":33},"2023-01-12",{"date":475,"type":22},"2029-08-08",{"name":477,"class":68},"Forma Therapeutics, Inc.",18,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":493,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":137},"100649272","adaptation-and-testing-of-a-novel-text-based-tobacco-cessation-and-education-intervention-in-kenyan-emergency-department-patients-100649272","NCT07734727","Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients","Text2Quit","Inclusion Criteria:\n\n* Current tobacco users (self-identified smokers).\n* Presenting to the Emergency Department (ED) at Kenyatta National Hospital (KNH).\n* Own a mobile phone capable of receiving text messages.\n* Willing to quit tobacco use.\n* Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Individuals unwilling or unable to provide consent.\n* Non-tobacco users.\n* Those without access to a mobile phone.\n* Patients who are critically ill or otherwise unable to participate (practically excluded at triage).",{"count":487,"type":22},285,[246],"In this study, investigators will adapt and implement Text2Quit in a Kenyan ED population will increase knowledge and cessation. Investigators will use a mixed-methods, hybrid implementation-effectiveness approach to assess these outcomes. Results will inform a randomized, controlled trial in a nationally representative sample of EDs in future. This study will be the first to target tobacco use in this population, the first to use mobile cessation, and will contribute to advancing implementation science on tobacco cessation globally. It will also provide a novel approach to implementation for mHealth interventions, with findings that can be generalized to other Non-Communicable Diseases and risk factors, such as alcohol use, hypertension and diabetes.",[491,492],"Tobacco Use","Tobacco Use Cessation",[450,494,495,496],"Africa","Noncommunicable disease","global health","2026-08-04",{"date":499,"type":33},"2026-08-06",{"date":501,"type":22},"2026-08",{"date":503,"type":22},"2028-06",{"name":505,"class":136},"Yale University",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":531},"100521142","phase-3-a-study-to-evaluate-efficacy-and-safety-of-giredestrant-compared-with-fulvestrant-plus-a-cdk46-inhibitor-in-participants-with-er-positive-her2-negative-advanced-breast-cancer-resistant-to-adjuvant-endocrine-therapy-pionera-breast-cancer-100521142","NCT06065748","A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4\u002F6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4\u002F6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy","Inclusion Criteria:\n\n* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent\n* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)\n* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing\n* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \\>\u002F=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4\u002F6i is allowed (if relapse occurred \\>\u002F=12 months since completion).\n* No prior systemic anti-cancer therapy for advanced disease\n* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* For pre\u002Fperimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment\n\nExclusion Criteria:\n\n* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer\n* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term\n* Active cardiac disease or history of cardiac dysfunction\n* Clinically significant history of liver disease",{"count":514,"type":22},1050,[55],"This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4\u002F6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.",[518],"Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer",[520,521,522],"oral Selective Estrogen Receptor Degrader (SERD)","CDK4\u002F6 inhibitor (CDK4\u002F6i)","ESR1 mutation","2026-08-03",{"date":525,"type":33},"2026-08-05",{"date":527,"type":33},"2023-12-11",{"date":529,"type":22},"2029-02-12",{"name":110,"class":68},352,{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":263},"100576826","phase-3-optimizing-treatment-of-co-occurring-smoking-and-unhealthy-alcohol-use-among-pwh-in-nairobi-kenya-100576826","NCT06790342","Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya","Inclusion Criteria:\n\n1. Confirmed chart diagnosis of HIV\n2. At least 18 years or age\n3. Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.\n4. Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)\n5. Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse\u002Fheavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or \\>7 drinks\u002Fweek over the past 30 days\n6. Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)\n7. Willingness to accept behavioral and\u002For pharmacologic tobacco and alcohol treatment\n8. Willingness and ability to provide informed consent to participate.\n\nExclusion Criteria:\n\n1. Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment\n2. Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)\n3. History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations\n4. Pregnant, nursing, or becoming pregnant during the study\n5. Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician\n6. Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale\n7. Unstable psychiatric illness\n8. Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period\n9. Expected survival of less than 6 months.","80 Years",{"count":540,"type":22},300,[55],"People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.",[224,491,544],"Alcohol Use Disorder",[224,546,547],"Tobacco Cessation","Alcohol Reduction","2026-07-29",{"date":550,"type":33},"2026-07-30",{"date":552,"type":22},"2026-07-31",{"date":554,"type":22},"2029-06-01",{"name":556,"class":136},"University of Chicago",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":18,"minAge":146,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":137},"100564040","bridging-the-treatment-gap-by-expanding-access-to-care-for-people-with-epilepsy-in-kenya-beacon-100564040","NCT06623994","Bridging the Treatment Gap by Expanding Access to Care for People With Epilepsy in Kenya (BEACON)","BEACON","Inclusion Criteria:\n\n* Individuals ≥12 years\n* Residents of Busia or Trans Nzoia County\n* Diagnosed with possible epilepsy through initial screening and confirmed diagnosis by an epilepsy-trained professional with the BEACON project or physician\n* Have a diagnosis of epilepsy but are not adherent to antiseizure medication treatment.\n\nExclusion Criteria:\n\n* Individuals receiving care from a neurosurgeon or neurologist for a serious brain disorder\n* Unable or unwilling to provide voluntary informed consent or assent (12-18 years)",{"count":565,"type":22},650,[246],"This cluster randomized trial aims to learn about the effectiveness of task-sharing supported by an epilepsy medical records system (EMRS) (hereafter referred to as BEACON) with patient-tracking data in improving treatment adherence and retention in care in people with epilepsy in western Kenya.",[569],"Epilepsy","2026-07-28",{"date":548,"type":33},{"date":573,"type":33},"2025-08-04",{"date":575,"type":22},"2028-10",{"name":577,"class":136},"University of Virginia",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":17,"sex":49,"minAge":97,"maxAge":51,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":137},"100598788","phase-4-multi-product-prep-delivery-to-young-women-seeking-reproductive-health-services-and-coverage-of-hiv-prevention-100598788","NCT07076043","Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention","PrEMIA","Inclusion Criteria for Adolescent Girls and Young Women seeking reproductive health services:\n\nAge ≥18 years and ≤30years. Seeking a reproductive health service from one of the project facilities (reproductive health services include but are not limited to family planning, maternal and child health, postnatal care).\n\nAGYW receiving reproductive health-related services through OPD, or other departments are eligible. AGYW receiving reproductive health-related services through other departments are eligible.\n\nWilling and able to partake in an informed consent process. Able to speak and read in Kiswahili or English.",{"count":586,"type":22},1400,[588],"PHASE4","Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, investigators will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya. Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. investigators will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. The primary aim of the study will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.",[433],[592,593,594,450,595],"HIV prevention","PrEP","Adolescent girls and young women","stepped wedge cluster randomized trial","2026-07-20",{"date":598,"type":33},"2026-07-22",{"date":600,"type":33},"2025-06-03",{"date":602,"type":22},"2029-12-30",{"name":604,"class":136},"University of Alabama at Birmingham",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":625,"locationsCount":627},"100452890","treatment-outcomes-of-esophageal-cancer-100452890","NCT05177393","Treatment Outcomes of Esophageal Cancer","Inclusion Criteria:\n\n* Participants with histopathologically confirmed or presumptive clinical diagnosis of EC. For patients who do not have histopathologically confirmed disease, presumptive clinical diagnosis may be based upon barium swallow or endoscopy without biopsy.\n* Age 18 years of age or older;\n\nExclusion Criteria:\n\n* Unable to provide informed consent",{"count":612,"type":22},2476,"This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.",[615],"Esophageal Cancer",[617,618,619,620],"Treatment outcomes","Quality of life","Comparative effectiveness","Palliation",{"date":598,"type":33},{"date":623,"type":33},"2019-02-28",{"date":393,"type":22},{"name":626,"class":136},"University of California, San Francisco",6,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":636,"targetDuration":406,"studyType":122,"phases":4,"briefSummary":638,"conditions":639,"keywords":644,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":659},"100327946","icareme-global-registry-multinational-real-world-evidence-in-cardiorenal-and-metabolic-diseases-100327946","NCT03549754","iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases","Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and\u002For Chronic Kidney Diseases","iCaReMe","Inclusion Criteria:\n\n1. Being 18 years or older\n2. Having type 2 diabetes, Hypertension, Heart Failure and\u002For chronic kidney disease\n3. Providing written informed consent to participate in the registry\n\nExclusion Criteria:\n\n1. Having a life-threatening co-morbidity with life expectancy below 1 year\n2. Participating in an interventional trial requiring informed consent",{"count":637,"type":22},35000,"To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and\u002For Chronic kidney diseases",[640,641,642,643],"Type 2 Diabetes","Hypertension","Chronic Kidney Disease","Heart Failure",[645,640,646,642,647,641,648,649,643,650,651],"Registry","T2DM","CKD","HTN","Adult population","HF","Early cardiorenal complications",{"date":598,"type":33},{"date":654,"type":33},"2018-02-17",{"date":656,"type":22},"2030-12-31",{"name":658,"class":68},"AstraZeneca",76,""]