[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Guatemala\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":672},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,43,72,99,120,146,168,190,210,231,255,282,303,327,349,375,409,438,466,489,520,559,589,622,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100596349","a-clinical-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-011-100596349",false,"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",true,"ALL","16 Years",{"count":21,"type":22},4390,"ESTIMATED","INTERVENTIONAL",[25],"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 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",[28,29],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis","RECRUITING","2026-08-21",{"date":33,"type":34},"2026-08-24","ACTUAL",{"date":36,"type":34},"2025-07-31",{"date":38,"type":22},"2027-07-22",{"name":40,"class":41},"Merck Sharp & Dohme LLC","INDUSTRY",81,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100570795","phase-3-phase-iii-extension-study-of-efficacy-and-safety-of-ianalumab-with-or-without-study-treatment-withdrawal-in-participants-with-lupus-nephritis-sirius-ln-extension-100570795","NCT06711887","Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","SIRIUS-LN ext","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.","18 Years","100 Years",{"count":54,"type":22},348,[25],"The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR\u002FPRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.",[58],"Lupus Nephritis",[60,61,62,63],"Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736",{"date":33,"type":34},{"date":66,"type":34},"2025-05-19",{"date":68,"type":22},"2035-08-01",{"name":70,"class":41},"Novartis Pharmaceuticals",47,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":80,"type":22},3500,[25],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[84,85],"Solid Tumors","Hematologic Malignancies",[87,88,89,90],"PD1","PD-1","PDL1","PD-L1",{"date":92,"type":34},"2026-08-25",{"date":94,"type":34},"2018-08-21",{"date":96,"type":22},"2043-08-04",{"name":40,"class":41},782,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100607568","phase-3-a-clinical-study-of-calderasib-mk-1084-and-other-treatments-for-participants-with-non-small-cell-lung-cancer-mk-1084-007kandlelit-007-100607568","NCT07190248","A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007\u002FKANDLELIT-007)","A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed\u002FPlatinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c\n* If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a gastrointestinal disorder affecting absorption\n* Is HIV positive and has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy except those specified by protocol\n* Has history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":107,"type":22},675,[25],"Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.\n\nThe goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.",[111],"Non-small Cell Lung Cancer","2026-08-20",{"date":31,"type":34},{"date":115,"type":34},"2025-10-08",{"date":117,"type":22},"2032-08-06",{"name":40,"class":41},200,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100590383","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-people-with-breast-cancer-mk-2870-032-100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..",{"count":128,"type":22},2400,[25],"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[132,133,134],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[136,137,138],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":33,"type":34},{"date":141,"type":34},"2025-06-30",{"date":143,"type":22},"2034-12-29",{"name":40,"class":41},321,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":153,"minAge":51,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100587234","a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100587234","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE",{"count":155,"type":22},1440,[25],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[159,160],"Prostate Cancer","Prostatic Neoplasms",{"date":31,"type":34},{"date":163,"type":34},"2025-05-13",{"date":165,"type":22},"2031-01-06",{"name":40,"class":41},294,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100571215","phase-3-a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-with-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone-r-chop-in-participants-with-previously-untreated-dlbcl-mk-2140-010-100571215","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":176,"type":22},1046,[25],"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[180],"Diffuse Large B-Cell Lymphoma",[182],"Lymphoma, Large B-Cell, Diffuse",{"date":31,"type":34},{"date":185,"type":34},"2025-01-27",{"date":187,"type":22},"2032-03-29",{"name":40,"class":41},268,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100526585","phase-3-a-study-of-opevesostat-mk-5684-versus-alternative-next-generation-hormonal-agent-nha-in-metastatic-castration-resistant-prostate-cancer-mcrpc-post-one-nha-mk-5684-004-100526585","NCT06136650","A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)","MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease shown by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \\[mHSPC\\] or non-metastatic hormone-sensitive prostate cancer \\[nmHSPC\\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \\[mCRPC\\] or non-metastatic castration-resistant prostate cancer \\[nmCRPC\\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel\n* Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment\n* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \\\u003C50 ng\u002FdL (\\\u003C1.7 nM)\n* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization\n* Has adequate organ function\n* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia\u002Fosteoporosis are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has presence of gastrointestinal condition\n* Is unable to swallow capsules\u002Ftablets\n* Has history of pituitary dysfunction\n* Has poorly controlled diabetes mellitus\n* Has clinically significant abnormal serum potassium or sodium level\n* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \\\u003C110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy\n* Has a history of active or unstable cardio\u002Fcerebrovascular disease, including thromboembolic events\n* History or family history of long QTc syndrome\n* Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment\n* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n* Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures\n* Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention\n* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention\n* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat\n* Has a \"superscan\" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed\n* Active infection requiring systemic therapy\n* Has concurrent active Hepatitis B virus and Hepatitis C virus infection",{"count":198,"type":22},1314,[25],"The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.",[202,160],"Metastatic Castration-resistant Prostate Cancer (mCRPC)",{"date":33,"type":34},{"date":205,"type":34},"2023-12-18",{"date":207,"type":22},"2030-12-02",{"name":40,"class":41},330,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100449940","phase-2-a-study-of-zilovertamab-vedotin-mk-2140-in-combination-with-standard-of-care-in-participants-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-rrdlbcl-mk-2140-003-100449940","NCT05139017","A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)","A Phase 2\u002F3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)","Inclusion Criteria:\n\n* Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).\n* Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.\n* Has adequate organ function.\n* Is able to provide new or archival tumor tissue sample not previously irradiated.\n\nZilovertamab vedotin plus R-GemOx, or R-GemOx study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.\n* Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.\n\nNot applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy.\n* Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.\n\nExclusion Criteria:\n\n* Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL\n* Has received solid organ transplant at any time.\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).\n* Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.\n* Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.\n* Has clinically significant pericardial or pleural effusion.\n* Has ongoing Grade \\>1 peripheral neuropathy.\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n* Has a demyelinating form of Charcot-Marie-Tooth disease.\n* Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.\n* Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.\n* Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has ongoing corticosteroid therapy.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n* Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known active Hepatitis C virus infection.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.",{"count":218,"type":22},290,[220,25],"PHASE2","The purpose of this Phase 2\u002F3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.\n\nWith protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \\[BR\\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.",[223,180],"DLBCL",{"date":31,"type":34},{"date":226,"type":34},"2022-01-14",{"date":228,"type":22},"2027-09-24",{"name":40,"class":41},135,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100579098","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-and-maintenance-therapy-with-afimkibart-ro7790121-in-participants-with-moderately-to-severely-active-crohns-disease-100579098","NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy","80 Years",{"count":241,"type":22},600,[25],"This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[245],"Moderately to Severely Active Crohns Disease","2026-08-18",{"date":112,"type":34},{"date":249,"type":34},"2025-03-17",{"date":251,"type":22},"2033-12-31",{"name":253,"class":41},"Hoffmann-La Roche",373,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":262,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},"100482471","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qmf149-indacaterol-acetatemometasone-furoate-versus-budesonide-in-children-from-6-to-less-than-12-years-of-age-with-asthma-100482471","NCT05562466","A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate\u002FMometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate \u002F Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\\u003C12 years in age at randomization.\n2. Parents\u002Flegal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed\u002Fdocumented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug\u002Fday) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\\u003C1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS\u002FLABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS\u002FLABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and\u002For = 12% (performed according to ATS\u002FERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent\u002Flegal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent\u002Flegal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and\u002For urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma\u002FCOPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and\u002For during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and\u002For during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition\u002Fdisease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol\u002Falbuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","6 Years","11 Years",{"count":119,"type":22},[25],"The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) \u002F mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.",[268],"Asthma",[268,270,271,272,273],"Pediatric","Breezhaler","QMF149","Budesonide",{"date":275,"type":34},"2026-08-19",{"date":277,"type":34},"2023-05-11",{"date":279,"type":22},"2028-05-30",{"name":70,"class":41},64,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":262,"maxAge":263,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":302},"100456356","phase-2-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-glycopyrronium-bromide-in-children-6-to-less-than-12-years-with-asthma-100456356","NCT05222529","Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma","A Phase II, Double-blind, Randomized, Multiple Dose, Cross Over, Three-treatment, Three-period, Six Sequence Placebo Controlled Trial to Evaluate Efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety and Tolerability of Glycopyrronium (Bromide) in Children From 6 to Less Than 12 Years of Age With Asthma.","Inclusion Criteria:\n\n* Confirmed diagnosis of asthma for at least 6 months\n* Signed informed consent by parent(s)\u002Flegal guardian(s) and assent by the pediatric participant (depending on local requirements)\n* Participant on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to run-in\n* Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in and randomization. If FEV1 eligibility criteria are not met at -45min pre-dose of the End of Run-in (Visit 30), the visit can be rescheduled once within 5 days from the previous attempt.\n* FEV1 reversibility, done using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in visit (Visit 20): increase \\> and\u002For = 12% (performed according to American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS) 2019 guidelines). All participants must perform a reversibility test at start of Run-in. If reversibility is not demonstrated at Run-in, it may be attempted at up to two ad hoc, unscheduled separate visits within 5 days from previous attempt. If reversibility is still not demonstrated after repeated assessment participants must be screen failed\n* Demonstrated acceptable inhaler use technique for Diskus\u002FAccuhaler (prior to run-in) and Breezhaler (prior to randomization) and able to complete spirometry procedures prior to randomization.\n* A parent\u002Flegal guardian must be designated to complete all e-Diary entries and attend all clinic visits with the participant.\n* Parents\u002Flegal guardian must be willing and able to assist the child with the procedures outlined in the protocol, e.g. compliance with study medication, completion of electronic participant diary\n* Female participants of child-bearing potential, who might become sexually active, must be informed of the need to prevent pregnancy during the study using effective contraceptive methods. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.\n\nExclusion Criteria:\n\n* Systemic corticosteroid use for any reason within 3 months of Run-in\n* Participants on low to medium mono ICS alone\n* Participants requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Screening (Visit 1) and\u002For in the four weeks prior to the Run-in visit\n* Participants who have had an asthma attack\u002Fexacerbation requiring a) systemic corticosteroids (SCS) or b) hospitalization or c) emergency room visit, within 3 months prior to Screening (Visit 1), or more than 3 separate exacerbations in the 12 months preceding the Screening visit\n* Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other conditions where anticholinergic treatment is contraindicated prior to Screening (Visit 1)\n* Participants with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in and confirmed at Baseline (prior to randomization) (Fridericia method) is prolonged (\\> 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened)\n* Suspected or documented active infections (bacterial, viral, fungal, mycobacterial or other, including active SARS-CoV-2, tuberculosis or atypical mycobacterial disease) of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 6 weeks of Screening (Visit 1)\n* History of Type I diabetes or uncontrolled Type II diabetes\n* Participants who are sexually active at screening\n* Hemoglobin levels outside normal ranges at Run-in (Visit 20)\n* Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if they become sexually active during study participation, do not agree to the use of contraception as defined in the inclusion criteria.\n\nAdditional protocol-defined inclusion \u002F exclusion criteria may apply.",{"count":290,"type":22},42,[220],"The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety\u002Ftolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol\u002Fmometasone\u002Fglycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.",[268],[295],"Glycopyrronium, pediatric, asthma, Breezhaler, PK",{"date":275,"type":34},{"date":298,"type":34},"2022-08-29",{"date":300,"type":22},"2027-08-30",{"name":70,"class":41},23,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":262,"maxAge":52,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100411524","phase-4-secukinumab-open-label-roll-over-extension-protocol-100411524","NCT04638647","Secukinumab Open Label Roll-over Extension Protocol","An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment","Inclusion Criteria:\n\n1. Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).\n2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.\n3. Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical \u002F administrative reasons).\n4. Participant is deriving benefit from secukinumab, investigator believes he\u002Fshe would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.\n5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and\u002For reimbursement guidelines.\n\nExclusion Criteria:\n\n1. Participant has prematurely discontinued study treatment in the parent protocol.\n2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).",{"count":311,"type":22},1000,[313],"PHASE4","The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.",[316],"Autoimmunity, Inflammation",[318],"Secukinumab, Post trial access","2026-08-17",{"date":246,"type":34},{"date":322,"type":34},"2020-12-22",{"date":324,"type":22},"2030-04-04",{"name":70,"class":41},168,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":348},"100613456","a-clinical-study-of-islatravir-and-ulonivirine-for-people-with-hiv-1-who-have-not-been-treated-before-mk-8591b-062-100613456","NCT07266831","A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)","A Phase 2\u002F3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1","Inclusion Criteria:\n\n* Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies\u002FmL.\n* Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies\u002FmL.\n* Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells\u002Fmm\\^3.\n* Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.\n\nExclusion Criteria:\n\n* Has human immunodeficiency virus type 2 (HIV-2) infection.\n* Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.\n* Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.\n* Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.\n* Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.",{"count":335,"type":22},570,[220,25],"Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.",[339],"Human Immunodeficiency Virus Type 1 (HIV-1) Infection","2026-08-07",{"date":342,"type":34},"2026-08-10",{"date":344,"type":34},"2025-12-18",{"date":346,"type":22},"2030-04-03",{"name":40,"class":41},55,{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":374},"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":357,"type":22},1050,[25],"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.",[361],"Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer",[363,364,365],"oral Selective Estrogen Receptor Degrader (SERD)","CDK4\u002F6 inhibitor (CDK4\u002F6i)","ESR1 mutation","2026-08-03",{"date":368,"type":34},"2026-08-05",{"date":370,"type":34},"2023-12-11",{"date":372,"type":22},"2029-02-12",{"name":253,"class":41},352,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":17,"sex":18,"minAge":383,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":408},"100622423","the-inicio-guatemala-study-100622423","NCT07383428","The INICIO-Guatemala Study","IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study","INICIO","The investigators will offer enrollment to pregnant in the Trifinio region of southwest Guatemala and will enroll their newborns after birth.\n\nInclusion Criteria:\n\n* Pregnant woman in the second trimester of pregnancy\n* Pregnant woman =\\>15 years of age\n* Plan to live in the study area during pregnancy and up to 24 months after giving birth\n* Newborns born to enrolled women will join the study at birth\n\nExclusion Criteria:\n\n* Pregnant woman less than 15 years of age\n* Planning to move during the study\n* Not willing or able to participate in the interventions, including following instructions for preparing the food, completing the adherence forms, participating in the caregiving sessions\n* Women who do not sign the consent form for their or their child's participation\n* Infants who require a hospital stay after birth of 21 days or longer","0 Days","50 Years",{"count":386,"type":22},400,[388],"NA","The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala.\n\nThe main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefit of a caregiver intervention on child ND.\n\nThe primary endpoint is the Mullen Scales of Early Learning (MSEL) Early Learning Composite (ELC) Score at 24 months. Secondary endpoints include MSEL subdomain scores (gross motor, fine motor, expressive language, receptive language, visual reception).\n\nResearchers will compare child ND between the four study arms using a factorial design: (1) intestinal health-targeted nutritional intervention, (2) caregiving training program, (3) combined intestinal health-targeted nutritional intervention and caregiving training program, and (4) active control.\n\nParticipants will be randomized as mother-child dyads at 6 months of age and followed until 24 months of age.",[391],"Development, Child",[393,394,395,396,397],"Nutritional intervention","Microbiome","Caregiving","Rice bran","Bean flour","2026-07-22",{"date":400,"type":34},"2026-07-24",{"date":402,"type":34},"2026-07-02",{"date":404,"type":22},"2030-06-15",{"name":406,"class":407},"University of North Carolina, Chapel Hill","OTHER",1,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":418,"phases":4,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":437},"100540241","interstellar---international-study-evaluating-lupus-outcomes-after-anifrolumab-real-world-use-100540241","NCT06314282","INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use","INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice","INTERSTELLAR","Inclusion Criteria:\n\n1. Aged 18 years or older at study enrolment.\n2. Fulfilled the 2019 EULAR\u002FACR criteria1 for SLE at the time of study entry.\n3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.\n4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.\n5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.\n6. Provided informed consent to participate in the study.\n7. Willing and able to participate in all required study evaluations and procedures.\n\nExclusion Criteria:\n\n1. Currently participating in an anifrolumab early access\u002Fcompassionate use program or an interventional clinical trial with an investigational product.\n2. Previous exposure to anifrolumab as part of a clinical trial or early access program.\n3. Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \\[MMF\\]\u002Fcyclophosphamide \\[CYC\\] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.\n4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.",{"count":119,"type":22},"OBSERVATIONAL","INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion\u002Fexclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.",[421],"Systemic Lupus Erythematosus (SLE)",[423,424,425,426,427],"SLE","Systemic lupus erythematosus","autoimmune disease","Lupus","Anifrolumab","2026-07-16",{"date":430,"type":34},"2026-07-17",{"date":432,"type":34},"2024-10-22",{"date":434,"type":22},"2027-12-31",{"name":436,"class":41},"AstraZeneca",32,{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":446,"maxAge":52,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":465},"100526379","phase-3-phase-3-extension-study-to-evaluate-long-term-safety-of-ianalumab-in-participants-with-systemic-lupus-erythematosus-sirius-sle-extension-100526379","NCT06133972","Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).","A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)","SIRIUS-SLE LTE","Key Inclusion Criteria:\n\n* Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \\\u003C18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.\n* Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.\n* In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.\n\nKey Exclusion Criteria:\n\n* Use of prohibited therapies.\n* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.\n* Plans for administration of live vaccines during the study period.\n* Pregnant or nursing (lactating) women.\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).\n* United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","12 Years",{"count":448,"type":22},550,[25],"The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).",[452],"Systemic Lupus Erythematosus",[452,423,61,454,455,456,62,63],"SLEDAI-2K","BILAG-2004","SRI-4, ANA","2026-07-07",{"date":459,"type":34},"2026-07-08",{"date":461,"type":34},"2024-05-21",{"date":463,"type":22},"2032-04-05",{"name":70,"class":41},143,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":473,"minAge":4,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":418,"phases":4,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":479,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":488},"100475978","an-observational-pregnancy-safety-study-in-women-who-were-exposed-to-the-drug-nifurtimox-during-pregnancy-to-learn-about-the-risk-of-pregnancy-complications-and-about-the-mothers-and-babys-health-100475978","NCT05477953","An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health","Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant","Inclusion Criteria:\n\n* Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period \u002F time of conception to pregnancy outcome).\n* Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None","FEMALE",{"count":475,"type":22},50,"This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.\n\nChagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems.\n\nNifurtimox has been used for more than 50 years to treat Chagas disease in children and adults.\n\nIt is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans.\n\nIn this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information:\n\n* Birth defects (abnormal and problematic structures or functions, a child is born with)\n* Pregnancy outcomes (like live birth, preterm birth, still birth\u002Fdeath of the unborn baby, miscarriage, or abortion)\n* Certain health problems of the child up to 12 months of age\n* Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population.\n\nThe study will run for approximately 10 years.",[478],"Chagas Disease","NOT_YET_RECRUITING",{"date":481,"type":34},"2026-07-06",{"date":483,"type":22},"2026-12-31",{"date":485,"type":22},"2032-01-31",{"name":487,"class":41},"Bayer",12,{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":519},"100581807","phase-3-caffeine-for-hypoxic-ischemic-encephalopathy-100581807","NCT06855108","Caffeine for Hypoxic Ischemic Encephalopathy","Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)","CHIME","Participant Inclusion Criteria:\n\nInfants who meet all the following criteria are eligible for enrollment as study participants:\n\n1. Liveborn infants ≥36 weeks\n2. Birth weight ≥1800 grams\n3. Meets physiologic criteria for moderate to severe HIE, defined as meeting either of the following two criteria:\n\n   1. Criterion #1: Severe acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n\n      * pH \\\u003C7.0; or\n      * Base Deficit ≥16 mmol\u002FL; or\n      * Lactate \\>8 mmol\u002FL.\n   2. Criterion #2: Participant must meet all of the following three criteria:\n\n   i. Moderate acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n   * POC pH 7.0-7.15; or\n   * Base Deficit 10.0-15.9 mmol\u002FL; or\n   * Lactate 6-8 mmol\u002FL.\n\n   ii. Evidence of an acute perinatal event (i.e., placental abruption, intrapartum hemorrhage, cord prolapse, severe fetal heart rate abnormality, uterine rupture).\n\n   iii. Any of the following criteria:\n   * 10-minute Apgar \\\u003C5; or\n   * Need for assisted ventilation initiated at birth and continued for ≥10 minutes\n4. Meets neurologic criteria for moderate to severe HIE, defined as a physical exam conducted between one and six hours after birth that meets either of the following criteria:\n\n   1. Moderate to severe encephalopathy in at least three out of six modified Sarnat categories (level of consciousness, spontaneous activity, muscle tone, posture, primitive reflexes, autonomic function); or\n   2. A clinical diagnosis of seizure in the first six hours after birth.\n\nParticipant Exclusion Criteria:\n\nInfants who meet any of the following criteria are not eligible for enrollment as study participants:\n\n1. Home births\n2. Infants who cannot be enrolled, randomized and receive study medication within 6 hours post-delivery\n3. Infants with a recognized major congenital anomaly or genetic syndrome that would affect their neurodevelopment.\n4. Infants for whom medical care will not be provided based on the severity of their condition or any other condition that would preclude participation per clinical judgement.\n5. Infant has received therapeutic hypothermia or there is a clinical plan to initiate active or passive hypothermia for the infant.\n6. Infants who will be unavailable to complete follow-up visits.\n7. Infants who have received caffeine after delivery.\n8. Infants whom the health care team deem ineligible for the study based on likelihood to receive caffeine outside of the study protocol.\n9. Enrollment in another trial that will impact participation in this trial.","6 Hours",{"count":499,"type":22},830,[25],"CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \\[\\\u003C1 hour\\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg\u002Fkg dose of oral caffeine followed by two additional 10 mg\u002Fkg doses at 24-hour intervals or placebo of the same regimen (three total doses).\n\nThe goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.",[503],"Hypoxic Ischemic Encephalopathy (HIE)",[505,506,507,508],"Caffeine","Hypoxic Ischemic Encephalopathy","HIE","AKI","2026-06-19",{"date":511,"type":34},"2026-06-24",{"date":513,"type":34},"2026-04-08",{"date":515,"type":22},"2030-07",{"name":517,"class":518},"NICHD Global Network for Women's and Children's Health","NETWORK",7,{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":527,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":418,"phases":4,"briefSummary":531,"conditions":532,"keywords":537,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":558},"100643783","caya-cancer-prospective-cohort-study-100643783","NCT07632014","CAYA Cancer Prospective Cohort Study","Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Prospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries.","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this study:\n\n1. Age 0 to 21 years at study enrollment.\n2. Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.\n\n   a. Note: Patients seen solely for consultation or diagnostic evaluations without subsequent treatment and those who have been off treatment for more than 5 years and are seen only for survivorship follow-up are not considered as meeting this criterion.\n3. Willingness to provide informed consent\u002Fassent. For minors incapable of providing assent, or individuals unable to provide consent, consent must be obtained from a legal representative and in accordance with local requirements.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria must be excluded from this study:\n\n1\\. Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent\u002Finformed consent\u002Fassent.","0 Years","21 Years",{"count":530,"type":22},6000,"Cancer is a leading cause of illness and death among children, adolescents, and young adults(CAYAs), especially in low- and middle-income countries(LMICs), where access to timely diagnosis and treatment is often limited. As a result, patients in these settings may experience higher rates of treatment complications, interruptions, and poorer outcomes compared with those in high-income countries (HICs).\n\nThis is a prospective, multicenter observational study that will follow children, adolescents, and young adults(CAYAs) with cancer who are receiving routine care at participating hospitals in low - and middle - income countries(LMICs). The study does not involve experimental treatments or changes to standard medical care. Information will be collected from medical records and from questionnaires that address access to care and social factors affecting treatment.\n\nBy describing treatment outcomes and the challenges patients and families face during cancer care, this study aims to provide data that can help inform future efforts to improve access to care and cancer outcomes in resource-limited settings.",[533,534,535,536],"Cancer","Pediatric Cancer","Lymphoblastic Lymphoma (LBL)","Acute Lymphoblastic Leukemia (ALL)",[538,539,540,541,542,543,544,545,546,547,548],"Children, Adolescents, and Young Adults (CAYA)","Low- and middle-income countries (LMIC)","Observational Study","Cancer Outcomes","Treatment-Related Toxicity","Treatment Failure","Treatment Abandonment","Diagnostic Delay","Socioeconomic Factors","High-income countries (HICs)","Central Nervous System(CNS)","2026-06-03",{"date":551,"type":34},"2026-06-08",{"date":553,"type":34},"2025-11-11",{"date":555,"type":22},"2032-11-11",{"name":557,"class":407},"Resonance, Inc.",3,{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":473,"minAge":19,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":573,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":408},"100573733","addressing-the-double-burden-of-malnutrition-in-guatemala-100573733","NCT06750120","Addressing the Double Burden of Malnutrition in Guatemala","An Integrated Intervention to Address the Double Burden of Malnutrition in Guatemala","Inclusion Criteria:\n\n* Pregnant women aged 16 years or older\n* Gestational age less than 28 weeks\n\nExclusion Criteria:\n\n* History of pregestational diabetes (type 1 or type 2), history of gestational diabetes in a previous pregnancy, or diagnosis of gestational diabetes in the current pregnancy\n* Multifetal gestation (twins or higher-order pregnancies)\n* Currently participating in another research study involving an intervention\n* Has a family member who has already been invited to participate in this study and\u002For shares a kitchen with such a person\n* Has a serious underlying medical or psychiatric condition requiring specialized clinical care, including active cancer, severe renal or hepatic disease, symptomatic heart disease, autoimmune disorders requiring immunosuppressive therapy, active thromboembolism or coagulopathy, or severe mental health condition, or other conditions at the discretion of the investigators\n* Plans to move out of the study area within the next two years",{"count":567,"type":22},1532,[388],"Globally, populations are experiencing increases in the double burden of malnutrition, commonly defined as maternal overweight\u002Fobesity and child stunting in the same household. This study will evaluate an integrated intervention combining food supplementation for pregnant and postpartum women and their infants with behavioral counseling to promote healthy maternal weight, nutrition, physical activity, and infant feeding practices. The goal is to reduce the double burden of malnutrition in rural Indigenous communities in Guatemala.",[571,572],"Maternal Obesity Complicating Pregnancy, Birth,or Puerperium","Child Malnutrition",[574,575,576,577,578,579],"Guatemala","stunting","maternal obesity","food supplementation","lifestyle counseling","child malnutrition","2026-05-20",{"date":582,"type":34},"2026-05-22",{"date":584,"type":34},"2026-05-14",{"date":586,"type":22},"2029-08",{"name":588,"class":407},"Brigham and Women's Hospital",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":418,"phases":4,"briefSummary":597,"conditions":598,"keywords":604,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":621},"100613110","epidemiology-and-processes-of-care-for-renal-replacement-therapy-in-acute-kidney-injury-in-latin-america-100613110","NCT07262320","Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America","LATAM-AKID","Inclusion Criteria:\n\n* Adult patient (≥18) admitted to the ICU\n* First ICU admission during current hospitalization\n* Diagnosis of acute kidney injury stage 3 according to KDIGO guidelines\n* RRT initiated no earlier than 3 days before or no later than 7 days after ICU admission\n\nExclusion Criteria:\n\n* Transfer from outside hospital with ongoing RRT\n* RRT exposure of less than 2 days (if CRRT or PD was provided) or less than 2 HD\u002FSLED sessions\n* Kidney failure (ESRD) patients on maintenance dialysis\n* Kidney transplant recipients\n* Previous or new diagnosis of glomerulonephritis",{"count":311,"type":22},"This is an international, multicenter, observational study aimed at investigating acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The main questions this study aims to answer are:\n\n* What is the epidemiology, outcomes, and processes of care for patients with AKI-RRT in Latin America?\n* How do outcomes differ across different countries in Latin America?\n* What factors (demographics, clinical, socioeconomic) influence outcomes in patients with AKI-RRT in Latin America?\n\nThe main aims of this study are to:\n\n* Establish a comprehensive database containing clinical, laboratory, treatment, process, and outcome data of patients with AKI-RRT in Latin America\n* Describe current epidemiology of AKI-RRT in Latin America\n* Compare processes of care and outcomes across different countries in Latin America\n* Provide data resources to facilitate and promote clinical research in AKI-RRT",[599,600,601,602,603,508],"Dialysis","Critically Ill Acute Kidney Injury","Renal Replacement Therapy for Acute Kidney Injury in ICU","Acute Kidney Injury","Renal Replacement Therapy",[508,605,606,607,608,609,610,611],"ICU","RRT","Latin America","acute kidney injury","renal replacement therapy","intensive care unit","dialysis","2026-03-11",{"date":614,"type":34},"2026-03-12",{"date":616,"type":34},"2026-03-01",{"date":618,"type":22},"2027-06-30",{"name":620,"class":407},"University of Alabama at Birmingham",15,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":418,"phases":4,"briefSummary":631,"conditions":632,"keywords":635,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":647},"100559548","emus-enhanced-monitoring-using-sensors-after-surgery-100559548","NCT06565559","EMUs: Enhanced Monitoring Using Sensors After Surgery","EMUs","Participant Inclusion Criteria:\n\n* Adults 18 years and older.\n* Undergoing an elective or emergency major surgery procedure with a planned skin incision of 5 cm or greater. Any indication for surgery can exist, including benign, malignant, and trauma.\n* Willing and able to provide written informed consent.\n\nParticipant Exclusion Criteria:\n\n* Those under the age of 18.\n* A documented or suspected allergy to adhesive dressings.\n* Obstetric patients\n* Unwilling or unable to provide written informed consent.",{"count":630,"type":22},1332,"Patients can become critically unwell following surgical operations. Delay in recognition of this deterioration can result in patient harm and even death. Wearable wireless sensors that record patients vital signs such as heart rate could help improve recognition of patient deterioration. The goal of this observational study: Enhanced Monitoring Using Sensors After Surgery (EMUs) is to determine if data from wearable physiological monitors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff. The study participants and surgical inpatients undergoing open surgery. There are 3 objectives which each represent a stage of the study:\n\n1. To perform usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.\n2. To determine baseline postoperative monitoring practice across our network and perform device usability testing in clinical environment.\n3. To perform a shadow-mode cohort study with collection of time-stamped sensor clinical event data to determine relationships between physiological waveforms and patient deterioration.\n\nThis registration focuses on the shadow-mode cohort study.\n\nParticipants will wear wireless sensors on their chest and fingers, pre-, intra-, and post-operatively for up to 10 days. The sensors will record their vital signs such as heart rate, and oxygen levels. This will then be analysed, and used to aid the design of early detection algorithms that may be able to predict clinical illness or complications in this patient group. This is an observational study gathering real time data only. No changes in patient care will result, and in Stages 2 and 3 no sensor data will be available to clinical teams. This study will be performed in departments of general surgery in Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the United Kingdom.",[633,634],"Surgery","Inpatients",[633,636,637],"Wearable Devices","Global Surgery","2026-02-06",{"date":640,"type":34},"2026-02-10",{"date":642,"type":34},"2024-02-28",{"date":644,"type":22},"2027-07-31",{"name":646,"class":407},"University of Edinburgh",17,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":23,"phases":657,"briefSummary":658,"conditions":659,"keywords":661,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":408},"100550225","community-health-worker-led-hypertension-management-100550225","NCT06444308","Community Health Worker-led Hypertension Management","Assessing the Efficacy and Safety of Community Health Worker-led Hypertension Management Enabled by a Mobile Clinical Decision Support Application Compared to Physician Care: a Randomized, Controlled, Noninferiority Trial","Inclusion Criteria:\n\n* Adults age 18 or greater with diagnosis of hypertension AND blood pressure (BP) greater than or equal to 140\u002F90 OR currently taking antihypertensive medication.\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Severe comorbid condition(s) with life expectancy less than 1 year",{"count":656,"type":22},460,[388],"This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. The target population is patients with hypertension in rural Guatemala. Study duration will be 12-24 months.",[660],"Hypertension",[662],"community health worker","2026-01-26",{"date":665,"type":34},"2026-01-28",{"date":667,"type":34},"2024-09-09",{"date":669,"type":22},"2026-09",{"name":671,"class":407},"University of Wisconsin, Madison",""]