[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"New Zealand\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":621},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,375,0,25,[9,40,62,92,123,150,176,200,230,255,286,307,336,358,379,399,422,442,465,487,523,546,568,589,612],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100054056",false,"NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","ALL","12 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[26],"Proteinuric Kidney Diseases","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2026-03-23",{"date":35,"type":20},"2028-02-17",{"name":37,"class":38},"Boehringer Ingelheim","INDUSTRY",161,{"id":41,"slug":4,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100054317","NCT07544654","DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","Inclusion Criteria:\n\n1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)\n2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg\u002Fm2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg\u002Fm2) prior to randomisation\n5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n3. Patients with neuroendocrine prostate cancer\n4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition\n5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)\n6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and\u002For CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.","18 Years",{"count":48,"type":20},390,[50],"PHASE3","This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).\n\nParticipants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.\n\nDuring the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.",[53],"Extrapulmonary Neuroendocrine Cancer (epNEC)","NOT_YET_RECRUITING",{"date":30,"type":31},{"date":57,"type":20},"2026-07-07",{"date":59,"type":20},"2031-03-11",{"name":37,"class":38},165,{"id":63,"slug":4,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100054019","NCT04771130","A Study of BGB-11417 in Participants With Myeloid Malignancies","A Phase 1b\u002F2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:\n\n   * AML, nonacute promyelocytic leukemia\n   * MDS\n   * MDS\u002FMPN\n2. Eastern Cooperative Oncology Group performance status of 0 to 2.\n3. Adequate organ function defined as:\n\n   * Creatinine clearance ≥ 50 milliliters\u002Fminute (mL\u002Fmin) (or between 30 and 49 mL\u002Fmin in unfit AML cohort)\n   * Adequate liver function\n4. Life expectancy of \\> 12 weeks.\n5. Ability to comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n1. A diagnosis of acute promyelocytic leukemia.\n2. History of prior malignancy, with the exception of either a history of MDS or MDS\u002FMPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)\n3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n4. Prior therapy with a B-cell lymphoma-2 inhibitor\n5. Known central nervous system involvement by leukemia.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":69,"type":20},260,[71,23],"PHASE1","The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS\u002Fmyeloproliferative neoplasm (MPN) .",[74,75,76],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Myelodysplastic\u002FMyeloproliferative Neoplasm",[78,79,80,81,82,83],"BGB-11417","Azacitidine","Posaconazole","AML","MDS","MDS\u002FMPN",{"date":30,"type":31},{"date":86,"type":31},"2021-05-24",{"date":88,"type":20},"2028-02-08",{"name":90,"class":38},"BeOne Medicines",46,{"id":93,"slug":4,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100053442","NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":100,"type":20},810,[50],"The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[104],"Relapsed or Refractory Multiple Myeloma",[106,107,108,109,110,111,112,113,114],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide",{"date":30,"type":31},{"date":117,"type":31},"2022-09-20",{"date":119,"type":20},"2033-11-30",{"name":121,"class":38},"Celgene",266,{"id":124,"slug":4,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100053519","NCT07284459","Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","Key Inclusion Criteria:\n\n* Male or female ≥ 40 years of age at the time of Randomization.\n* A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS\u002FERS\u002FJRS\u002FALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.\n* Percent predicted (pp) FVC ≥ 40% on Screening spirometry.\n* Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.\n\nKey Exclusion Criteria:\n\n* Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.\n* Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.\n* Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.\n* Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml\u002Fmin\u002F1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.\n* Female participants must not be of childbearing potential.\n\nAdditional inclusion and exclusion criteria apply.","40 Years",{"count":131,"type":20},324,[23],"This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.",[135],"Idiopathic Pulmonary Fibrosis",[135,137,138,139,140,141],"PIPE 791","Pulmonary Fibrosis","IPF","ILD","Interstitial lung disease",{"date":30,"type":31},{"date":144,"type":31},"2026-01-08",{"date":146,"type":20},"2028-06",{"name":148,"class":38},"Contineum Therapeutics",49,{"id":151,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100054201","NCT06012240","A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata","A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata","Up-AA","Inclusion Criteria:\n\n* Adult individuals must be \\\u003C 64 years old at Baseline Visit. Where permitted outside United States (US)\u002FEuropean Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.\n* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \\>= 50 scalp hair loss at Screening and Baseline.\n* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.\n* Current episode of AA of less than 8 years.\n\nExclusion Criteria:\n\n* Current diagnosis of primarily diffuse type of AA.\n* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.\n* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.","63 Years",{"count":159,"type":20},1500,[50],"Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.\n\nUpadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.\n\nParticipants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[163],"Alopecia Areata",[163,165,166,167],"Upadacitinib","Rinvoq","ABT-494",{"date":30,"type":31},{"date":170,"type":31},"2023-10-11",{"date":172,"type":20},"2030-04",{"name":174,"class":38},"AbbVie",281,{"id":177,"slug":4,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":199},"100053484","NCT06064097","A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)","A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)","Inclusion Criteria:\n\n* Patients must be ≤ 21 years of age at the time of study enrollment\n* Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma (NPC)\n\n  * Patients must have had histologic verification of the malignancy at original diagnosis\n  * Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended\n* Patients must have had histologic verification of the malignancy at original diagnosis\n* Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended\n* Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients \\> 16 years of age) performance status score of ≥ 60%\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FuL (within 7 days prior to start of protocol therapy)\n* Platelet count ≥ 100,000\u002FuL (transfusion independent) (within 7 days prior to start of protocol therapy)\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 or (within 7 days prior to start of protocol therapy)\n* A serum creatinine based on age\u002Fsex (within 7 days prior to start of protocol therapy) Age: Maximum serum creatinine (mg\u002FdL)\n\n  1 month to \\\u003C 6 months: 0.4 mg\u002FdL (male); 0.4 mg\u002FdL (female) 6 months to \\\u003C 1 year: 0.5 mg\u002FdL (male); 0.5 mg\u002FdL (female)\n\n  1 to \\\u003C 2 years: 0.6 mg\u002FdL (male); 0.6 mg\u002FdL (female) 2 to \\\u003C 6 years: 0.8 mg\u002FdL (male); 0.8 mg\u002FdL (female) 6 to \\\u003C 10 years 1 mg\u002FdL (male); 1 mg\u002FdL (female) 10 to \\\u003C13 years: 1.2 mg\u002FdL (male); 1.2 mg\u002FdL (female) 13 to \\\u003C 16 years: 1.5 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n\n  ≥ 16 years: 1.7 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days prior to start of protocol therapy)\n* Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) ≤ 135 U\u002FL\\* (within 7 days prior to start of protocol therapy)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* Shortening fraction of ≥ 27% by echocardiogram, or\n* Ejection fraction of ≥ 50% by radionuclide angiogram\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and T-cell count above the lower limit of normal are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\nExclusion Criteria:\n\n* Patients who received prior radiotherapy to the head or neck\n* Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission\n* Patients with a diagnosis of immunodeficiency\n* Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n\n  * Note: Patients with well-controlled asthma and no need for systemic steroids for the treatment of asthma in the last 12 months will not be excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 0.25 mg\u002Fkg (10 mg) daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 0.25 mg\u002Fkg (10 mg) daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or active tuberculosis\n* Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time\n* Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of nivolumab, 6 months after the last dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is longer\n* Males of childbearing potential that are sexually active must agree to either practice a medically accepted highly-effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 3 months after the last dose of gemcitabine, and 11 months after the last dose of cisplatin, whichever is longer\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of nivolumab\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","21 Years",{"count":184,"type":20},50,[23],"This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and\u002For bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.",[188,189,190],"Stage II Nasopharyngeal Carcinoma AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8",{"date":30,"type":31},{"date":193,"type":31},"2024-06-25",{"date":195,"type":20},"2026-12-31",{"name":197,"class":198},"National Cancer Institute (NCI)","NIH",85,{"id":201,"slug":4,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":229},"100054239","NCT05376267","Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)","Inclusion criteria:\n\n* Age 2 days to \\\u003C 18 years with corrected gestational age of at least 38 weeks\n* Chest compressions for at least 2 minutes\n* Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)\n* Requires continuous mechanical ventilation through endotracheal tube or tracheostomy\n* Definitive temperature control device initiated\n* Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)\n* Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours\n\nExclusion criteria:\n\n* Glasgow Coma Motor Score (GCMS) = 6\n* LAR does not speak English or Spanish\n* Duration of Cardiopulmonary Resuscitation (CPR) \\> 60 minutes\n* Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg\u002Fkg\u002Fminute) or initiation of Extracorporeal membrane oxygenation (ECMO)\n* Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy\n* Pre-existing terminal illness, unlikely to survive to one year\n* Cardiac arrest associated with brain, thoracic, or abdominal trauma\n* Active and refractory severe bleeding prior to randomization\n* Extensive burns or skin lesions incompatible with surface cooling\n* Planned early withdrawal of life support before 120 hours\n* Sickle cell anemia\n* Pre-existing cryoglobulinemia\n* Non-fatal drowning in ice covered water\n* Central nervous system tumor with ongoing chemotherapy\n* Previous enrollment in P-ICECAP trial\n* Prisoner\n* Chronic hypothermia\n* New post-cardiac arrest diabetes insipidus\n* Pregnancy","2 Days","17 Years",{"count":208,"type":20},900,[210],"NA","This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest.\n\nThe study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.",[213,214,215],"Cardiac Arrest, Out-Of-Hospital","Hypothermia, Induced","Hypoxia-Ischemia, Brain",[217,218,219,220],"Bayesian Adaptive Clinical Trial","Hypothermia, therapeutic","Coma","Pediatric",{"date":30,"type":31},{"date":223,"type":31},"2022-08-05",{"date":225,"type":20},"2028-03-31",{"name":227,"class":228},"University of Michigan","OTHER",62,{"id":231,"slug":4,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":243,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100053834","NCT06742996","A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed\u002FRefractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)","A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)\n* Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis\n* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator\n* Relapsed or refractory disease after the last line of therapy\n* Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)\n* Prior therapy with BTK degraders\n* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.\n* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug\n* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug\n* Known central nervous system involvement by lymphoma\n* Clinically significant cardiovascular disease\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":237,"type":20},300,[50],"The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed\u002Frefractory (R\u002FR) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.",[241,242],"Mantle Cell Lymphoma","B Cell Lymphoma",[244,245,246,247,78],"mantle cell lymphoma","MCL","relapsed\u002Frefractory mantle cell lymphoma","sonrotoclax",{"date":30,"type":31},{"date":250,"type":31},"2025-03-05",{"date":252,"type":20},"2032-03-30",{"name":90,"class":38},155,{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":270,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":263,"type":20},11000,[50],"The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.",[267,268,269],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[271,272,273,274,275,276,277],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":30,"type":31},{"date":280,"type":31},"2025-09-22",{"date":282,"type":20},"2030-09-30",{"name":284,"class":38},"Alnylam Pharmaceuticals",995,{"id":287,"slug":4,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100053785","NCT06172296","Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131\n* ≤ 30 years at the time of initial diagnosis with high-risk disease\n* \\* Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines\n\n  * Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:\n\n    * Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification\n    * Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)\n    * Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy\n    * Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)\n* Patients must have a body surface area (BSA) ≥ 0.25 m\\^2\n* No prior anti-cancer therapy except as outlined below:\n\n  * Patients initially recognized to have high-risk disease treated with topotecan\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing, and with consent\n  * Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria\n  * Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis\n* Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Male 0.4 mg\u002FdL and female 0.4mg\u002FdL\n  * 6 months to \\\u003C 1 year: Male 0.5 mg\u002FdL and female 0.5 mg\u002FdL\n  * 1 to \\\u003C 2 years: Male 0.6 mg\u002FdL and female 0.6 mg\u002FdL\n  * 2 to \\\u003C 6 years: Male 0.8 mg\u002FdL and female 0.8 mg\u002FdL\n  * 6 to \\\u003C 10 years: Male 1 mg\u002FdL and female 1 mg\u002FdL\n  * 10 to \\\u003C 13 years: Male 1.2 mg\u002FdL and female 1.2 mg\u002FdL\n  * 13 to \\\u003C 16 years: Male 1.5 mg\u002FdL and female 1.4 mg\u002FdL\n  * ≥ 16 years: Male 1.7 mg\u002FdL and female 1.4 mg\u002FdL\n\n    * The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)\n  * or a 24-hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 or\n  * or a GFR ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n\n    * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \\[ALT\\]) ≤ 10 x ULN\\*\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* \\* Shortening fraction of ≥ 27% by echocardiogram, or\n\n  * Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n* Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:\n\nNo known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and\u002For the apheresis procedure\n\nExclusion Criteria:\n\n* Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features\n* Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features\n* Patients with known bone marrow failure syndromes\n* Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention\u002Ftreatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable\n* Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","30 Years",{"count":294,"type":20},478,[50],"This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.",[298,299],"Ganglioneuroblastoma, Nodular","Neuroblastoma",{"date":30,"type":31},{"date":302,"type":31},"2024-04-19",{"date":304,"type":20},"2029-12-31",{"name":197,"class":198},178,{"id":308,"slug":4,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":315,"briefSummary":316,"conditions":317,"keywords":320,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100053702","NCT06164730","A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease","Open-label, Phase 1b, Single Ascending Dose Study to Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia or Premature Coronary Artery Disease Who Require Additional Lowering of Low-density Lipoprotein Cholesterol","Inclusion Criteria:\n\n* Diagnosis of HeFH or premature CAD\n\nExclusion Criteria:\n\n* Homozygous familial hypercholesterolemia\n* Active or history of chronic liver disease\n* Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe\n* Clinically significant or abnormal laboratory values as defined by the protocol","70 Years",{"count":199,"type":20},[71],"VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease (CAD) Who Require Additional Lowering of LDL-C. VERVE-102 Uses Base-editing Technology Designed to Disrupt the Expression of the PCSK9 Gene in the Liver and Lower Circulating PCSK9 and LDL-C. This Study is Designed to Determine the Safety and Pharmacodynamic Profile of VERVE-102 in This Patient Population.",[318,319],"Heterozygous Familial Hypercholesterolemia","Premature Coronary Heart Disease",[321,322,323,324,325,326,327],"VERVE-102","Familial Hypercholesterolemia","Coronary Artery Disease","Dose Escalation","Gene Editing","Base Editing","heart-2",{"date":30,"type":31},{"date":330,"type":31},"2024-04-30",{"date":332,"type":20},"2027-08",{"name":334,"class":38},"Verve Therapeutics, Inc.",24,{"id":337,"slug":4,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":342,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":21,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years","80 Years",{"count":345,"type":20},1200,[50],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[349],"Crohn's Disease",{"date":30,"type":31},{"date":352,"type":31},"2024-06-05",{"date":354,"type":20},"2029-11-12",{"name":356,"class":38},"Merck Sharp & Dohme LLC",499,{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":16,"minAge":364,"maxAge":206,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},"100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days",{"count":366,"type":20},342,[23,50],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[370,371],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":30,"type":31},{"date":374,"type":31},"2023-05-31",{"date":376,"type":20},"2032-04-15",{"name":356,"class":38},107,{"id":380,"slug":4,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":21,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100054176","NCT07223658","Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia","Phase 1\u002F2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia","Inclusion Criteria:\n\n* Willing to follow diet counseling as per Investigator judgment based on local standard of care\n* Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening\n* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later\n\nExclusion Criteria:\n\n* Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA\n* Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy\n* Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab)\n* Uncontrolled hypertension\n* History of bleeding diathesis or coagulopathy\n* Current diagnosis of nephrotic syndrome\n\nNote: Additional inclusion\u002Fexclusion criteria may apply per protocol.",{"count":386,"type":20},78,[71,23],"Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia.",[390],"Hyperlipidemia; Mixed",{"date":30,"type":31},{"date":393,"type":31},"2025-12-22",{"date":395,"type":20},"2027-07",{"name":397,"class":38},"Arrowhead Pharmaceuticals",15,{"id":400,"slug":4,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":16,"minAge":404,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":21,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100053900","NCT07228117","GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes","Inclusion Criteria:\n\n1. Age at time of screening according to diabetes type:\n\n   1. T1D: Age 7-85 years\n   2. T2D: Age 18-85 years\n2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below:\n\n   1. T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.\n   2. T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis\n3. Is willing to provide informed consent\u002Fassent for participation.\n4. Subject or parent\u002Fcaregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.\n5. Is willing to wear the system continuously throughout the study.\n6. Has results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:\n\n   1. T1D adults (Age 18-85 years):\n\n      I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.\n   2. T2D adults (Age 18-85 years):\n\n      I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.\n   3. T1D pediatric (Age 7-17 years):\n\n   I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.\n\n   II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study.\n\n   Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.\n7. Is willing to upload study pump data via an app or computer.\n8. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:\n\n   1. Humalog™\\* (insulin lispro injection)\n   2. NovoLog™\\* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™\\*)\n   3. NovoRapid™\\* (insulin aspart solution for injection)\n   4. Admelog™\\* (insulin lispro injection)\n   5. Merilog™\\* (insulin aspart)\n   6. Fiasp™\\* (ultra-rapid-acting insulin aspart)\n   7. Lyumjev™\\* (ultra-rapid-acting insulin lispro)\n   8. Authorized generic insulin aspart\n   9. Authorized generic insulin lispro\n\nExclusion Criteria:\n\n1. Unable to consent due to a mental or intellectual disability.\n2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:\n\n   1. Medical assistance (i.e., Paramedics, Emergency Room \\[ER\\] or Hospitalization)\n   2. Coma or\n   3. Seizures\n3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.\n4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.\n5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n6. Currently pregnant or planning to become pregnant during the time period of study participation\n\n   1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening\n   2. For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable\n7. At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.\n8. Has diagnosis of adrenal insufficiency.\n9. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.\n10. T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and\u002For Glucagon-like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) containing medications (e.g., Mounjaro), in the 8 weeks prior to screening.\n\n    1. Participants who have stopped using metformin and\u002For GLP-1\u002FGIP have done so at least 8 weeks prior to screening.\n    2. Participants currently taking metformin and\u002For GLP-1\u002FGIP must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study.\n11. T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 \u002FGIP containing medications (e.g., Mounjaro), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.\n\n    1. Participants who have stopped using metformin, GLP-1\u002FGIP or SGLT2 have done so at least 8 weeks prior to screening.\n    2. Participants currently taking metformin, GLP-1\u002FGIP or SGLT2 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study\n12. Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.\n13. Is using inhalable insulin in the 8 weeks prior to screening.\n14. Is using hydroxyurea at time of screening or plans to use it during the study\n15. Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study.\n16. Is, at the discretion of the investigator, abusing drugs or alcohol.\n17. Is, in the opinion of the investigator, not able to perform all study procedures safely.\n18. Has a history of visual impairment which would not allow subject, even with the help of a caregiver, to participate in the study and perform all study procedures safely, as determined by the investigator.\n19. Has elective surgery planned that requires general anesthesia during the course of the study.\n20. Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.\n21. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.\n22. Is diagnosed with current eating disorder such as anorexia or bulimia.\n23. Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c\n24. Is on dialysis.\n25. Has an estimated Glomerular Filtration Rate (eGFR) \\\u003C30.\n26. Has celiac disease that is not adequately treated as determined by the investigator.\n27. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.\n28. Has had any of the following cardiovascular events more than 1 year prior to screening and should not participate at the discretion of the investigator: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.\n29. Is a member of the research staff involved with the study.\n30. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and\u002For adult siblings).","7 Years","85 Years",{"count":407,"type":20},400,[210],"The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5\u002FSimplera Sync in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Participants will use their current therapy while also wearing the DS5\u002FSimplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if participants like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.",[411,412],"Type 1 Diabetes Mellitus","Type 2 Diabetes Mellitus","2026-07-09",{"date":30,"type":31},{"date":416,"type":31},"2026-02-02",{"date":418,"type":20},"2027-01",{"name":420,"class":38},"Medtronic MiniMed, Inc.",38,{"id":423,"slug":4,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":21,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":441},"100053948","NCT06077760","A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)","INTerpath-002","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has no evidence of disease before randomization.\n* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.\n* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.\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 prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis.\n* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\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 to the first dose of study medication.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.",{"count":430,"type":20},868,[50],"The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \\[N2\\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.",[434],"Non-small Cell Lung Cancer",{"date":30,"type":31},{"date":437,"type":31},"2023-12-06",{"date":439,"type":20},"2035-12-21",{"name":356,"class":38},229,{"id":443,"slug":4,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":21,"phases":450,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":61},"100053910","NCT05943535","Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)","A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)","Inclusion Criteria:\n\n1. Subject gives voluntary informed consent to participate in the study.\n2. Subject is ≥18 years of age, inclusive, at the time of signing informed consent.\n3. Subject has radiological evidence of pulmonary fibrosis of \\>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).\n4. Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:\n\n   1. Clinically significant decline in % predicted FVC based on ≥10% relative decline\n   2. Marginal decline in % predicted FVC based on ≥5% to \\\u003C10% relative decline combined with worsening of respiratory symptoms\n   3. Marginal decline in % predicted FVC based on ≥5% to \\\u003C10% relative decline combined with increasing extent of fibrotic changes on chest imaging\n   4. Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging\n5. FVC ≥45% predicted at Screening (confirmed by central review).\n6. Subjects must be on 1 of the following:\n\n   1. On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study\n   2. Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study.\n\n   Concomitant use of both nintedanib and pirfenidone is not permitted.\n7. Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment.\n8. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following:\n\n   1. Abstain from intercourse (when it is in line with their preferred and usual lifestyle)\n   2. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.\n\n   i. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide.\n\n   Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.\n9. Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.\n10. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.\n\nExclusion Criteria:\n\n1. Subject is pregnant or lactating.\n2. Subject has primary obstructive airway physiology (forced expiratory volume in 1 second\u002FFVC \\\u003C0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).\n3. Subject has a diagnosis of IPF.\n4. Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.\n5. Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), soluble guanylate cyclase stimulators, or activin signaling inhibitors (sotatercept) within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours prior to any study-related efficacy assessments.\n6. Subject is receiving \\>10 L\u002Fmin of oxygen supplementation by any mode of delivery at rest at Baseline.\n7. Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.\n8. Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.\n9. Use of any other investigational drug\u002Fdevice or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication\u002Fsupplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible.\n10. Acute pulmonary embolism within 90 days prior to Baseline.\n11. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.\n12. In the opinion of the Investigator, life expectancy \\\u003C12 months due to ILD or a concomitant illness.\n13. Subject has received nerandomilast within 60 days prior to Baseline.",{"count":449,"type":20},698,[50],"Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.",[453,454],"Progressive Pulmonary Fibrosis","Interstitial Lung Disease",[456,457,140],"Treprostinil","PPF",{"date":30,"type":31},{"date":460,"type":31},"2023-10-30",{"date":462,"type":20},"2027-11",{"name":464,"class":38},"United Therapeutics",{"id":466,"slug":4,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":16,"minAge":471,"maxAge":206,"enrollmentInfo":472,"targetDuration":4,"studyType":21,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100597406","NCT07058077","A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)","An Operationally Seamless Phase 2\u002F3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia","Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\n* Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results\n* Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg\u002FdL\n* Is receiving either:\n\n  * An optimized daily dose of statin (± nonstatin LLT)\n  * A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative\n* Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\n* Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH\n* Has a history of nephrotic syndrome\n* Has any clinically significant malabsorption condition based on investigator assessment\n* Was previously treated\u002Fis being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin\u002Fkexin type 9 (PCSK9) inhibitors without adequate washout","6 Years",{"count":473,"type":20},153,[23,50],"This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.\n\nThe goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.",[477],"Heterozygous Familial Hypercholesterolemia (HeFH)","2026-07-01",{"date":480,"type":31},"2026-07-02",{"date":482,"type":31},"2025-08-21",{"date":484,"type":20},"2037-01-23",{"name":356,"class":38},33,{"id":488,"slug":4,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":493,"maxAge":494,"enrollmentInfo":495,"targetDuration":4,"studyType":21,"phases":497,"briefSummary":498,"conditions":499,"keywords":501,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":522},"100588961","NCT06948214","Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency","A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)","Inclusion Criteria:\n\n* Subjects must be naïve to treatment and prepubertal\n* Subjects must have a maximal GH response of \\\u003C 10 ng\u002FmL from 2 prior GH stimulation tests conducted within the preceding 12 months\n* Impaired height defined as ≥ 2.0 standard deviations (SDs) below the mean height for chronological age and sex\n* Morning or random cortisol level of ≥ 7.0 μg\u002FdL\n* ≥ 3.0 years and age ≤ 10.0 years for girls and ≤ 11.0 years for boys\n* Baseline height velocity (HV) based on ≥ 6 months of growth assessments \\\u003C 25th percentile for age and sex\n* Bone Age delay of ≥ 12 months compared to the chronological age\n* In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative.\n* Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 3 months prior to Day 1\n* Baseline IGF-1 standard deviation score (SDS) ≤ -1.0\n\nExclusion Criteria:\n\n* Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and\u002For limit the response to exogenous growth factor treatment.\n* Arm span to height ratio \\> 2 SDs below the mean for age and sex\n* A medical or genetic condition that, in the opinion of the Investigator and\u002For MM, adds unwarranted risk to use of LUM-201\n* Use of any medication that, in the opinion of the Investigator and\u002For MM, can independently cause short stature or limit the response to exogenous growth factors\n* Current inflammatory diseases requiring systemic corticosteroid treatment for \\> 2 consecutive weeks within the last 3 months prior to the Screening Visit\n* Use of hormone replacement therapy for any hormone deficiency other than thyroid deficiency\n* Any ECG at the Screening Visit noted to have a clinically significant abnormality, as confirmed by the MM\n* Any subjects suspected of having past or present intracranial tumor growth as confirmed by brain imaging prior to the Screening or Day 1 Visit\n* Any subject suspected of having intracranial hypertension (IH) as confirmed by fundoscopy and other assessments\n* Any subject with serum alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin \\> upper limit of normal (ULN)\n* Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3.0 ng\u002FmL on any prior standard of care GH stimulation test completed within 12 months\n* Body weight ≤ 14.0 kg\n* BMI \\\u003C -2 or \\> +2 SDs for age and sex based on WHO standards\n* Birth weight for gestational age \\\u003C 3rd percentile based on WHO standards\n* Treatment with medications known to be moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A\u002F4\n* History of spinal, cranial, or total body irradiation\n* Attention deficit hyperactivity disorder (ADHD) diagnosis","3 Years","11 Years",{"count":496,"type":20},150,[50],"The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.",[500],"Growth Hormone Deficiency (GHD)",[502,503,504,505,506,507,508,509,510,511,512,513,514],"GHD","Pediatric Growth Hormone Deficiency","LUM-201","Growth hormone secretagogue","Height","Catch-up growth","PEM","Oral","Predictive Enrichment Marker","ibutamoren mesylate","OraGrowtH Phase 3 Trial","LUM-201 PEM","GH secretagogue",{"date":480,"type":31},{"date":517,"type":31},"2026-05-20",{"date":519,"type":20},"2028-01",{"name":521,"class":38},"Lumos Pharma",37,{"id":524,"slug":4,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":21,"phases":532,"briefSummary":533,"conditions":534,"keywords":536,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":545},"100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":531,"type":20},15100,[50],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[535],"Cardiovascular Disease",[537],"Atherosclerotic Cardiovascular Disease",{"date":480,"type":31},{"date":540,"type":31},"2025-06-04",{"date":542,"type":20},"2029-10-26",{"name":544,"class":38},"AstraZeneca",1365,{"id":547,"slug":4,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":21,"phases":554,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":421},"100589945","NCT06961006","A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012\u002FINTerpath-012)","A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein \\[CTLA-4\\], anti-programmed cell death 1 protein \\[PD-1\\] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation.\n* Have documentation of serine\u002Fthreonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible).\n* Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator\u002Fradiology assessment.\n* Provides tumor tissue (preferably from a metastatic site and, if not available, from the primary tumor) that is suitable for next generation sequencing and biomarker analysis as required for this study.\n* Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral therapy (ART).\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 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\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has ocular or mucosal melanoma.\n* Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the Screening blood sample (including the blood sample for V940 generation).\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, lymphocyte activation gene 3 \\[LAG-3\\], tumor necrosis factor receptors \\[OX-40 or CD137\\]), with some exceptions.\n* Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.\n* Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Received prior treatment with another universal or personalized cancer vaccine.",{"count":553,"type":20},160,[23],"Researchers want to learn if intismeran autogene with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Intismeran autogene is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy.\n\nThe goal of this study is to learn if people who receive intismeran autogene with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.",[557],"Malignant Melanoma",[559,560,561],"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":480,"type":31},{"date":564,"type":31},"2025-05-29",{"date":566,"type":20},"2031-09-05",{"name":356,"class":38},{"id":569,"slug":4,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":21,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":588},"100589192","NCT06951217","An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)","A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])","SAIL","Inclusion Criteria:\n\n* Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.\n\nPrevious participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).\n\n* Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.\n\nExclusion Criteria:\n\n* Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.\n* Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening\u002FBaseline Visit).\n* Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening\u002FBaseline Visit).\n* Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.\n* History of hypersensitivity and\u002For allergic reaction to pirfenidone or the excipients to be used in this study.",{"count":576,"type":20},340,[23],"This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.",[453,580],"Idiopathic Pulmonary Fibrosis (IPF)",{"date":480,"type":31},{"date":583,"type":31},"2025-04-17",{"date":585,"type":20},"2031-12-31",{"name":587,"class":38},"Avalyn Pharma Inc.",54,{"id":590,"slug":4,"hasResults":11,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":21,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":608,"leadSponsor":610,"locationsCount":229},"100589831","NCT06959524","AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions","AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease","Clinical Inclusion Criteria:\n\n* Subject must be at least 18 years of age.\n* Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.\n* Subject is eligible for percutaneous coronary intervention (PCI).\n* Subject is willing to comply with all protocol-required follow-up evaluation.\n* Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.\n\nAngiographic Inclusion Criteria:\n\n* Target lesion is a de novo lesion located in a native coronary artery\n* Target lesion must have visually estimated stenosis \\> 50% and \\\u003C 100% in symptomatic subjects (\\>70% and \\\u003C100% in asymptomatic subjects) prior to lesion pre-dilation.\n* Target lesion must be successfully pre-dilated.\n* If a non-target lesion is treated, it must be treated first and must be deemed a success.\n\nClinical Exclusion Criteria:\n\n* Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months.\n* Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).\n* Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.\n* Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.\n* Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.\n* Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.\n* Subject has left ventricular ejection fraction known to be \\\u003C 30%.\n* Subject had PCI or other coronary interventions within the last 30 days.\n* Subject has planned PCI or CABG after the index procedure.\n* Subject had STEMI or QWMI \\\u003C72h prior to the index procedure.\n* Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable.\n* Subject has cardiogenic shock (SBP \\\u003C 80 mmHg requiring inotropes, IABP or fluid support).\n* Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure.\n* Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion.\n* Subject has known allergy to paclitaxel or other components of the used medical devices.\n* Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.\n* Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure.\n* Subject has platelet count \\\u003C 100k\u002Fmm3 (risk of bleeding) or \\> 700k\u002Fmm3.\n* Subject with renal insufficiency (creatinine ≥2.0 mg\u002Fdl) or failure (dialysis dependent).\n\nAngiographic Exclusion Criteria:\n\n* In-stent restenosis.\n* Target lesion is located within a saphenous vein or arterial graft.\n* Target lesion is a total occlusion or has evidence of thrombus present in the target vessel.\n* Target lesion is severely calcified by angiography or has \\> 270° calcium arc on intravascular imaging or requires atherectomy.\n* Subject has unprotected left main coronary artery disease (\\>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels.\n* Subject with planned treatment of lesion involving aortic ostial location.",{"count":596,"type":20},1616,[210],"AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and\u002For balloon angioplasty in patients with de novo coronary lesions.\n\nSubjects must have a de novo target lesion located in a native coronary artery.",[600,601],"Coronary Arterial Disease (CAD)","de Novo Lesions in Native Coronary Arteries",[603,604,605],"Drug Coated Balloon","de novo","97279374",{"date":480,"type":31},{"date":482,"type":31},{"date":609,"type":20},"2032-03",{"name":611,"class":38},"Boston Scientific Corporation",{"id":613,"slug":4,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":292,"enrollmentInfo":614,"targetDuration":4,"studyType":21,"phases":615,"briefSummary":296,"conditions":616,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":619,"leadSponsor":620,"locationsCount":306},"100529324",{"count":294,"type":20},[50],[298,299],{"date":480,"type":31},{"date":302,"type":31},{"date":304,"type":20},{"name":197,"class":198},""]