[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bayer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":578},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,54,0,25,[9,50,75,99,126,152,171,194,215,239,262,282,309,332,355,375,396,416,436,456,474,497,520,539,557],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053447","a-us-study-that-observes-how-parkinsons-disease-changes-over-time-in-patients-who-still-have-movement-symptoms-despite-taking-parkinsons-medications-100053447",false,"NCT07330258","A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications","A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications","Inclusion Criteria for Patient:\n\n* Individual of any sex ≥45 to ≤75 years of age at informed consent (at least 30% ≤60 years of age).\n* Diagnosis of clinically established Parkinson's disease (PD) as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD ≥4 and \\\u003C12 years from time of PD diagnosis at informed consent.\n* Modified H\\&Y stage II-III in the practically defined OFF-medication state (≥12 hours from last dose of antiparkinsonian medications).\n* Score of ≥30 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in the OFF-medication state.\n* Presence of motor fluctuations with ≥1 hour of absolute time in the OFF state per day as assessed by clinician\u002Fpatient at screening.\n* Receiving stable antiparkinsonian medication regimen for ≥4 weeks prior to screening with a levodopa daily dose ≥300 mg or a dosing frequency of ≥3 times per day.\n* Responsiveness to levodopa as determined by change in the following measures from the practically defined OFF state to ON state after taking typical first-daily dose of PD-medications: i. any degree of improvement (≥0.5 point) in modified H\\&Y stage OR. ii. ≥30% improvement in MDS-UPDRS part III score.\n* Montreal Cognitive Assessment (MoCA) score of ≥24.\n* Agree to participate and provide signed informed consent.\n\nExclusion Criteria for Patient:\n\n* Known history or presence of conditions that may provide an alternative to a PD diagnosis including but not limited to: multiple system atrophy, progressive supranuclear palsy, striatonigral degeneration, corticobasal syndrome\u002Fdegeneration, vascular Parkinsonism, drug-induced Parkinsonism, essential tremor, diffuse Lewy body disease, Lewy body dementia, Huntington's disease, Wilson's disease, Fahr's disease, Alzheimer's disease, cerebrovascular disease, brain tumor, trauma, and infection.\n* Known history or presence of significant vascular and\u002For cardiovascular disease limited to: stroke, transient ischemic attacks, poorly controlled hypertension, poorly controlled diabetes, unstable angina pectoris, or unstable myocardial infarction.\n* Known history or presence of significant psychosis or impulse control disorder, or untreated or sub optimally treated depression.\n* Known history or presence of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, syphilis, or tuberculosis.\n* Current or previously active malignant disease within the past 5 years, except definitively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or in situ uterine cervical carcinoma.\n* Currently pregnant, nursing, lactating, breastfeeding, or plan to be during study duration.\n* Known history or current use of percutaneous levodopa\u002Fcarbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump.\n* Prior history of brain surgery, including but not limited to: deep brain stimulation (DBS), pallidotomy, focused ultrasound thalamotomy, or other experimental neurosurgical procedure.\n* Known history or current participation in cell or gene therapy procedures.\n* Current participation in any interventional clinical trial.\n\nInclusion Criteria for Care Partner:\n\n* ≥18 years of age at informed consent.\n* Identified by the PD patient as their primary care partner.\n* Agree to participate and the ability to provide signed informed consent independently, without the need for a legal representative.\n\nExclusion Criteria for Care Partner:\n\n* Not applicable.","ALL","45 Years","75 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","This is an observational study in which data are collected and studied from Parkinson's disease patients who have movement symptoms despite taking standard Parkinson's medications. In observational studies, observations are made without any changes to the participant's healthcare or treatment plan. No investigational product will be administered in this study, as participants will be treated with the standard of care that medical experts currently consider most appropriate.\n\nParkinson's disease (PD) is a condition that affects the brain and causes problems with movement and other body functions. The symptoms of Parkinson's disease can worsen over time. People with Parkinson's disease may experience shaking (tremor), slow movements, stiff muscles, trouble walking, and problems with balance. They can also have other symptoms, such as difficulty thinking clearly, changes in mood, or difficulty sleeping. Parkinson's disease mostly affects older adults, but it can happen to younger people too. There is no cure, but treatments can help manage the symptoms and improve quality of life.\n\nWhile doctors and researchers know that Parkinson's disease affects people in different ways and can worsen over time, there are still many things they don't fully understand-especially for people who experience movement symptoms despite taking their usual Parkinson's medicines. Earlier studies did not follow these patients long enough or collect all the important information needed. This study is being done to fill those gaps.\n\nThe main purpose of this study is to better understand how Parkinson's disease changes over time in patients who experience movement symptoms while taking standard oral Parkinson's medications, what challenges patients and their care partners face, and how their treatments are working in real life. To do this, researchers will collect data on:\n\n* Sociodemographics (e.g. age, gender, race\u002Fethnicity, insurance provider).\n* Medical history and vital signs (e.g. comorbidities, family history of Parkinson's, height, weight, blood pressure).\n* Medications and treatments (e.g. Parkinson's and non-Parkinson's medications and other treatments, rehabilitation therapy sessions, use of mobility assistance devices).\n* Movement symptoms (e.g. tremor, slow movement, balance).\n* Non-movement symptoms (e.g. cognition, mood, sleep, activities of daily living).\n* Molecular data (e.g. genetics, α-synuclein).\n* Burden of care (e.g. economic cost).\n\nData will come from questionnaires or rating scales conducted by the doctor with the patient during study visits, diaries and logs completed by the patient, medical records, health insurance claims records, blood samples and skin biopsies, a digital device that records movement\u002Fnon-movement symptoms, and questionnaires completed by the care partner.\n\nData will be collected from December 2025 to December 2032. Each participant may be followed for up to 5 years.",[26],"Parkinson's Disease",[28,29,30,31,32,33,34,35,36],"Natural history study","Parkinson's disease","PD Motor (Hauser) Diary","MDS-UPDRS","Electronic health\u002Fmedical records","Administrative claims data","Biological samples","Digital health technology","Care partner","RECRUITING","2026-07-10",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":22},"2026-07-22",{"date":45,"type":22},"2033-06-01",{"name":47,"class":48},"Bayer","INDUSTRY",26,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":60},"100609217","phase-2-a-study-to-learn-about-how-well-bay-3401016-works-in-adults-with-alport-syndrome-100609217","NCT07211685","A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome","A Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 2a Study With an Extension Phase to Evaluate the Efficacy and Safety of BAY 3401016 in Participants Aged 18 to 45 With Alport Syndrome","ASSESS","Inclusion Criteria:\n\n* Participants must be 18 to 45 years of age inclusive\n* Participants with AS, either XLAS (male) or ARAS (male or female)\n* eGFR ≥ 45 mL\u002Fmin\u002F1.73m2\n* UACR ≥ 500mg\u002Fg\n\nExclusion Criteria:\n\n* Chronic kidney disease is different from AS\n* Clinically significant illness that could have influence on the safety of the participant and\u002For interfere with the study objectives\n* History or current existence of malignancy\n* Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids or urticaria\n* Participants with active skin disorders (e.g. atopic dermatitis, severe acne)\n* Systolic blood pressure above 140 mmHg\n* Diastolic blood pressure above 90 mmHg","18 Years",{"count":60,"type":22},60,"INTERVENTIONAL",[63],"PHASE2","Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5). These genes help in producing an important protein called collagen. People with AS have a high risk of developing chronic kidney disease (CKD), a condition in which there is progressive loss in kidney function over time. The kidneys soon lose their ability to remove waste products from the body properly, resulting in end-stage kidney disease. A common sign of decreasing kidney function is the presence of excess protein in the urine that is not usually found with healthy kidneys. This condition is known as proteinuria. The study drug, BAY 3401016 (a monoclonal antibody), is a type of medicine that blocks a protein called Semaphorin 3A (Sema3A), which is thought to be involved in causing kidney damage in AS. By blocking the action of the Sema3A protein, BAY 3401016 may prevent proteinuria and slow down the loss in kidney function due to AS.\n\nThe main purpose of this study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly progressing AS.",[66],"Alport Syndrome","2026-07-01",{"date":69,"type":41},"2026-07-02",{"date":71,"type":41},"2025-11-19",{"date":73,"type":22},"2028-07-27",{"name":47,"class":48},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":61,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100446879","phase-1-first-in-human-study-of-bay2927088-in-participants-who-have-advanced-non-small-cell-lung-cancer-nsclc-with-mutations-in-the-genes-of-epidermal-growth-factor-receptor-egfr-andor-human-epidermal-growth-factor-receptor-2-her2-100446879","NCT05099172","First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and\u002For Human Epidermal Growth Factor Receptor 2 (HER2)","An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and\u002For HER2 Mutation","Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).\n* Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.\n\nNote: Except for participants eligible for Group F and Group H (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease.\n\n* Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.\n* Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G and Group H, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable.\n* Documented activating EGFR and\u002For HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States \\[US\\] sites) or an equally accredited (outside of the US) local laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Hemoglobin ≥ 9.0 g\u002FdL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing.\n  2. Platelets ≥ 100 × 10\\^9 cells\u002FL.\n  3. Absolute neutrophil count ≥ 1.5 ×10\\^9 cells\u002FL. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing.\n* Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:\n\n  a. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin per 1.73 m\\^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula.\n* Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis).\n  2. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor).\n\nExclusion Criteria:\n\n* Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n* Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.\n* Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.\n* Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.\n* Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.\n* Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).\n* History of spinal cord compression or brain metastases with the following exceptions:\n\n  1. Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of sevabertinib are eligible to enroll in Dose Escalation and Backfill.\n  2. Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion\u002FExtension (with the exception of Group G and Group H) if all of the following criteria are met:\n\n     * there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.\n     * Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib.\n  3. Participants with history of spinal cord compression \\>3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic.\n  4. Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg\u002Fday dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible.\n* History of congestive heart failure (CHF) Class \\>II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec).\n* Participants with:\n\n  1. Known human immunodeficiency virus (HIV), except as noted below: Participants with history of HIV infection are eligible at the Investigator's discretion provided that: • CD4+ T-cell (CD4+) counts are ≥ 350 cells\u002FuL • The participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to the start of study drug and has an HIV viral load less than 400 copies\u002FmL prior to start of the study treatment • The ART being used does not contain strong inducers or inhibitors of CYP3A4, and is not anticipated to cause overlapping toxicities with study drug • The participant has not had an opportunistic infection within the past 12 months\n  2. Active Hepatitis B infection (positive for Hepatitis B surface antigen \\[HbsAg\\]) and Hepatitis B virus \\[HBV\\] DNA).\n  3. Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay).\n\n     NOTE: Participants with history of chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.\n* Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug.",{"count":83,"type":22},400,[85,63],"PHASE1","Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.\n\nEpidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and\u002For HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and\u002For HER2 mutations exist in the cancer cells. The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.\n\nThe main purpose of this study is to learn:\n\nEscalation, Backfill, and Expansion Part:\n\n* How safe is BAY2927088 for the participants?\n* What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants?\n* How does BAY2927088 move into, through, and out of the bodies of the participants?\n\nFor this, the researchers will measure the followings:\n\n* The number of participants with medical problems, also called adverse events and serious adverse events, and their severity\n* The number of participants who discontinue study treatment due to an adverse event.\n* The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088\n* Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level\n* The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088\n* The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part\n* How well does BAY2927088 work in participants?\n\nFor this, the researchers will measure the following:\n\n• Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor.\n\nThis study has 4 parts:\n\n* The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive.\n* The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part.\n* The expansion part aims to determine the dose of BAY2927088 to be tested in further studies.\n* The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well.\n\nThe participants in this study will take the study treatment BAY2927088 in 3-week periods called \"cycles\". They will in general take BAY2927088 once or twice daily as a liquid\u002Ftablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle.\n\nDuring the study, the study team will:\n\n* take blood and urine samples,\n* check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans,\n* check the participants' overall health and heart health,\n* ask the participants questions about how they are feeling and what adverse events they are having.\n\nAn adverse event is considered \"serious\" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.",[88,89,90],"Advanced Non-small Cell Lung Cancer","EGFR Mutation","HER2 Mutation","2026-06-30",{"date":67,"type":41},{"date":94,"type":41},"2021-10-25",{"date":96,"type":22},"2029-06-29",{"name":47,"class":48},94,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":61,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100574825","phase-1-a-first-in-human-study-to-learn-about-the-safety-of-bay-3547926-and-how-well-it-works-in-participants-with-advanced-liver-cancer-100574825","NCT06764316","A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer","A Multicenter, Open Label, Non-randomized First-in-human Phase 1 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BAY 3547926 Alone, and in Combination, in Participants With Advanced Hepatocellular Carcinoma (HCC)","BANTAM-01","Inclusion Criteria:\n\n* Locally advanced or metastatic and\u002For unresectable HCC (hepatocellular carcinoma) with histological or cytological confirmation, or non-invasive diagnosis as per American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis.\n* Demonstrated positive centrally confirmed GPC3 expression by immunohistochemistry (IHC) on tumor sample.\n* Disease not amenable to, or progressive disease after, curative surgery and\u002For locoregional therapies of established efficacy such as resection, local ablation, chemoembolization.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. as assessed by local site Investigator within 28 days prior to the start of the study treatment.\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular\u002Fcholangiocarcinoma subtypes.\n* Participants with a history or clinical evidence of CNS metastases, unless they meet specific criteria\n* History of encephalopathy ≥ Grade 2 within the past 12 months\n* Clinically significant ascites",{"count":108,"type":22},148,[85],"In this study, researchers want to learn about the safety of a new drug, BAY 3547926, and how well the drug works in people with a type of liver cancer called advanced hepatocellular carcinoma (HCC), which has a special protein called Glypican 3 (GPC3). Researchers want to find the best dose of BAY 3547926 for people with advanced HCC and look at the way the body absorbs and distributes the drug.\n\nThe study drug, BAY 3547926, delivers a radioactive agent to cancer cells. The radioactive agent emits radiations which can damage the cancer cells and cause them to die. These radiations travel a small distance, so are expected to cause little damage to surrounding healthy tissues. This is the first study of BAY 3547926 in humans.\n\nParticipants will take part in one of the 4 different parts of the study. In Part 1, participants will receive different doses of BAY 3547926 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3547926 alone in Part 2 or with other treatments in Parts 3 and 4 of the study.\n\nDuring the study, the doctors and their study team will do health check-ups, take pictures (scans) of the body, collect blood and urine samples, and ask participants questions about how they are feeling and what health problems they are having.",[112],"Hepatocellular Carcinoma",[114,115,116,117],"Hepatocellular carcinoma (HCC)","Locally advanced HCC","Metastatic HCC","Unresectable HCC","2026-06-29",{"date":91,"type":41},{"date":121,"type":41},"2025-02-28",{"date":123,"type":22},"2031-08-31",{"name":47,"class":48},20,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":61,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100575418","a-study-to-understand-how-cardiac-surgery-associated-acute-kidney-injury-develops-in-participants-who-undergo-heart-surgery-with-the-use-of-heart-lung-machine-100575418","NCT06772025","A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine","Methodology Study in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass to Investigate Mechanisms Involved in Cardiac Surgery-associated Acute Kidney Injury.","Inclusion Criteria:\n\n* Participant must be at least 18 years of age at the time of signing the informed consent form (ICF).\n* Participants who are scheduled for hospital admission for any of the following cardiovascular surgery interventions, alone or in combination, involving cardiopulmonary bypass (CPB):\n\n  * Aortic, mitral, or tricuspid valve surgery (repair or replacement)\n  * Aortic surgery\n  * ≥3 coronary artery bypass grafts\n* Participant with: chronic kidney disease (CKD): 30 ≤ estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m\\^2\n\nExclusion Criteria:\n\n* Emergency surgery situation\n* Anemia - hemoglobin \\\u003C10 g\u002FdL\n* Clinical signs of systemic infection or other infection requiring anti-infective treatment (viral, bacterial, fungal, parasitic; single-dose prophylaxis allowed)\n* Systemic immunosuppressive or anti-inflammatory treatment including corticosteroids \\>10 mg prednisolone equivalent\u002Fday\n* Any anti-cancer treatment within 3 months (e.g. immunotherapy, chemotherapy, radiotherapy)\n* Major surgery within 2 months\n* AKI within the last month\n* Prior renal transplants or RRT\n* Planned use of contrast media within 5 days prior to surgery or during surgery\n* Patient included in an interventional clinical trial involving a pharmacological intervention\n* Any reason that would make participation unadvisable, at the discretion of the investigator.\n* Autoimmune disorders such as anti-glomerular basement membrane (anti-GBM) diseases, systemic lupus erythematosus, chronic rheumatic heart diseases, acute rheumatic heart pericarditis, endocarditis, myocarditis, rheumatic mitral valve diseases, rheumatic aortic valve diseases",{"count":134,"type":22},200,[136],"NA","Researchers are looking for a better way to treat and prevent cardiac surgery-associated acute kidney injury (CSA-AKI) in people who undergo heart surgeries.\n\nCSA-AKI is a common complication in people undergoing heart surgeries, where the kidneys stop working properly. CSA-AKI risk factors include older age and alongside diseases such as kidney disease and diabetes. Longer time with heart-lung machine during heart surgeries also increases the occurrence of CSA-AKI.\n\nIn this study, researchers want to better understand how CSA-AKI develops (also known as the mechanisms involved in the development of CSA-AKI) in people under heart surgeries, the presence of certain biomarkers in the body, especially with a focus on the early hours and days after the surgery. (A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.) These biomarkers will be compared in participants who develop CSA-AKI within a week after heart surgery with the participants who do not develop CSA-AKI. The relationship with biomarkers will be determined by examining participants' blood and urine samples before and after surgery.\n\nThis may help researchers better understand CSA-AKI, identify potential treatment targets and develop possible treatments to prevent CSA-AKI.\n\nParticipants in this study will be people who have heart surgery already scheduled by their own doctors and have a risk of developing CSA-AKI. Participants will not receive any treatment as part of this study. They will undergo the heart surgery and related medical processes as per their normal medical treatment and management.\n\nEach participant will be in the study for up to 2 months. During the study, the doctors and their study team will:\n\n* collect participants' blood and urine samples before and after surgery\n* assess participants' medical records and test reports during hospitalization\n* monitor overall health of the participants throughout the study",[139],"Cardiac Surgery-associated Acute Kidney Injury",[141,142,143],"CSA-AKI","Cardiac surgery","Cardiopulmonary bypass","2026-06-27",{"date":91,"type":41},{"date":147,"type":41},"2025-02-03",{"date":149,"type":22},"2027-01-31",{"name":47,"class":48},4,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100402388","study-to-learn-more-about-safety-of-aflibercept-injection-in-japanese-patients-with-neovascular-glaucoma-nvg-100402388","NCT04519619","Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)","Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)","Inclusion Criteria:\n\n* Diagnosis of NVG\n* Patients who have received IVT-AFL treatment according to Japanese labeling.\n\nExclusion Criteria:\n\n* Patients who are contraindicated based on approved label\n* Diagnosis of other indication",{"count":160,"type":22},480,"This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.\n\nThe objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).",[163],"Neovascular Glaucoma",{"date":91,"type":41},{"date":166,"type":41},"2020-11-27",{"date":168,"type":22},"2028-06-30",{"name":47,"class":48},1,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":170},"100635575","an-observational-study-called-finexplorer-to-learn-more-about-how-well-finerenone-works-in-adults-in-spain-with-chronic-kidney-disease-ckd-linked-to-type-2-diabetes-by-looking-at-changes-in-a-ckd-risk-score-100635575","NCT07554469","An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score","An Observational Prospective Study to Analyse Changes in the Klinrisk Chronic Kidney Disease Progression Model Score in a Cohort of Patients With CKD Associated With Type 2 Diabetes Treated With Finerenone in Spain","FINEXPLORER","Inclusion Criteria:\n\n* Patients who sign the written informed consent to participate in the study.\n* Men or women aged ≥18 years.\n* Patients with CKD associated with type 2 diabetes and albuminuria (UACR \\>30 mg\u002Fg).\n* Patients initiated on finerenone in routine clinical practice, according to the Summary of Product Characteristics (SmPC), within the 2 months prior to inclusion.\n\nExclusion Criteria:\n\n* eGFR \\\u003C 25 mL\u002Fmin\u002F1.73 m².\n* Severe hepatic impairment.\n* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms.\n* Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis.\n* Uncontrolled arterial hypertension (mean sitting systolic blood pressure \\[SBP\\] ≥160 mmHg or diastolic blood pressure \\[DBP\\] ≥100 mmHg at inclusion).\n* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or a potassium-sparing diuretic that has not been discontinued at least 4 weeks prior to inclusion.",{"count":180,"type":22},500,"This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed.\n\nChronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model.\n\nThe study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine.\n\nFinerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes.\n\nThe main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on:\n\n* Clinical characteristics of participants, including their medical history related to CKD and T2D.\n* Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN).\n* Participants' glucose, hemoglobin and potassium levels.\n\nThe study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment.\n\nData will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).",[183,184],"Chronic Kidney Disease","Type 2 Diabetes Mellitus",[186,183,184],"Finerenone","2026-06-26",{"date":118,"type":41},{"date":190,"type":41},"2026-05-26",{"date":192,"type":22},"2029-04-30",{"name":47,"class":48},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":202,"minAge":58,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":170},"100634373","an-observational-study-conducted-in-china-to-evaluate-the-efficacy-and-safety-of-darolutamide-in-combination-with-androgen-deprivation-therapy-adt-for-men-with-non-metastatic-prostate-cancer-that-progressed-following-prior-bicalutamide--adt-treatment-100634373","NCT07538843","An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment","A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage","DARE","Inclusion Criteria:\n\n* Males Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Patients receiving ≥6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators.\n* Serum testosterone level\\\u003C1.7 nmol\u002FL.\n* Decision to initiate treatment with ADT + Darolutamide as per investigator's routine treatment practice.\n* No evidence of metastasis as assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease.\n* The informed consent form must be signed by the patient or his legal guardian (as applicable).\n* Patients who are fertile must use an effective method of contraception during the study and must refrain from donating sperm during the study or for 3 months after the end of treatment, unless they have undergone a radical prostatectomy.\n\nExclusion Criteria:\n\n* Participation in an investigational program with interventions outside of routine clinical practice.\n* Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement.\n* Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor).\n* Previous treatment with 2nd-generation ARIs.\n* Previous treatment with CYP17 inhibitors.\n* Previous treatment with radiopharmaceuticals, immunotherapy, or other investigational treatment for nmCRPC.\n* Severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias.\n* Gastrointestinal diseases affecting absorption.","MALE",{"count":204,"type":22},800,"In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC).\n\nProstate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies.\n\nThis study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment.\n\nThe study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months.\n\nTo learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.",[207],"Non-metastatic Castration-resistant Prostate Cancer","NOT_YET_RECRUITING",{"date":118,"type":41},{"date":211,"type":22},"2026-07-30",{"date":213,"type":22},"2030-01-30",{"name":47,"class":48},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":61,"phases":226,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":125},"100615856","phase-4-a-study-to-learn-more-about-the-change-in-the-blood-levels-of-transthyretin-when-participants-with-transthyretin-amyloidosis-with-cardiomyopathy-switch-from-tafamidis-to-acoramidis-100615856","NCT07298044","A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis","A Prospective, Single-arm, Phase 4 Study to Evaluate the Course of Serum Transthyretin (TTR) Level With Acoramidis in Adult Patients With Variant or Wild-type Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) Previously Treated With Tafamidis","ACO-SWITCH","Inclusion Criteria:\n\n* Participants must be 18 to 90 years of age inclusive, at the time of signing the informed consent.\n* Diagnosis of ATTR-CM; disease defining examination, i.e., Single Photon Emission Computed Tomography (SPECT) or SPECT\u002FComputed Tomography (CT) or biopsy, within 24 months prior to Visit 1 (V1).\n* Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to tafamidis therapy.\n* New York Heart Association (NYHA) class ≤ II at V1.\n* Estimate glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m\\^2 at V1.\n* N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) \\> 300 and ≤ 7000 pg\u002FmL at V1.\n\nExclusion Criteria:\n\n* Prior liver or heart transplantation or planned within the next 12 months.\n* Current or planned use of ventricular assist device.\n* Active cancer or other disease that decreases the life expectancy to less than one year.\n* Heart failure due to ischemic heart disease.\n* Myocardial infarction, cardiovascular (CV) surgery, or unstable angina within the last 90 days prior to V1.\n* Confirmed diagnosis of light-chain amyloidosis.\n* Dialysis or severe renal impairment as reflected by Urinary Albumin Creatinine Ratio (UACR) \\> 300 mg\u002Fg at V1.\n* Major surgery 90 days prior to V1.\n* Recent initiation of Sodium-Glucose-Cotransporter-2 inhibitors (SGLT2i) within 3 months before V1.\n* Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1.\n* Treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis.\n* Recent CV hospitalization within 3 months before V1.\n* Known hypersensitivity to acoramidis or to any of the excipients.\n* A condition that, as judged by the investigator, would preclude compliance with the study protocol, such as a history of substance abuse, alcoholism, or a psychiatric condition.\n* Known or suspected liver disorder and bile secretion\u002Fflow (cholestasis, also history of it).\n* Abnormal liver function tests at V1, defined as ALT (GPT) or AST (GOT) ≥ 3 x ULN or total bilirubin ≥ 3 x ULN at V1.","90 Years",{"count":225,"type":22},50,[227],"PHASE4","Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid. TTR amyloid gets deposited in the heart wall and stops it from pumping blood properly, which may lead to heart failure. The breakage in TTR protein can be age-related (wild-type ATTR-CM), or genetic (variant ATTR-CM).\n\nThe study drug, acoramidis, works by attaching itself to the TTR protein, making TTR more stable and less likely to break down and form amyloid (clumps). This helps to slow down the progression of the disease, improve heart function, and increase the TTR levels in the blood. Acoramidis is an approved treatment for wild-type or variant ATTR-CM in Europe and the United States.\n\nTafamidis is another drug that stabilizes TTR and prevents it from breaking down.\n\nIn this study, acoramidis will be studied in participants with ATTR--CM who were previously treated with tafamidis. The main purpose of this study is to assess the change in blood TTR levels after participants are switched from tafamidis to acoramidis. This will be studied to understand if acoramidis causes an increase in blood TTR levels beyond the levels achieved with tafamidis.\n\nFor this, the researchers will measure the change in the levels of TTR protein in participants' blood after 6 months of the treatment with acoramidis, or earlier if a participant stops the treatment before reaching that six-month mark.\n\nAll participants will continue taking tafamidis during the screening period. In the treatment period of the study, participants will take acoramidis as two tablets twice daily by mouth, for up to 6 months.\n\nAt the start of this study, the study doctors will review each participant's medical history and check their overall health. The study doctors will perform electrocardiograms (ECG), and measure blood pressure and heart rate. Researchers will also take blood and urine samples from the participants to measure levels of TTr, NT-proBNP, hs-TnT, hs-CRP, RBP4, eGFR, creatinine, cystatin-C, UACR, and TSH at the start of the study, and at various time points thereafter (during the study) to assess heart, kidney and thyroid function.\n\nThere will be a total of 9 study check-ins. Participants will visit the study site twice: at screening and at the end of treatment period. A study nurse will visit the participant's home 6 times, at the start of treatment, Weeks 1, 2, 3 and 4, then again at 3 months. The final check-in will be done by phone.\n\nThe study doctors will monitor the health of the participants regularly for any medical problems during follow-up visits. Participants will know the treatment they will receive during the study. Each participant could be in the study for about 8 months.",[230],"Transthyretin Amyloid Cardiomyopathy",[232],"ATTR-CM",{"date":118,"type":41},{"date":235,"type":41},"2026-02-13",{"date":237,"type":22},"2027-07-15",{"name":47,"class":48},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":58,"enrollmentInfo":247,"targetDuration":4,"studyType":61,"phases":249,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},"100607776","phase-3-a-study-to-learn-more-about-how-safe-finerenone-is-when-it-is-taken-for-a-longer-time-with-standard-treatment-in-children-and-young-adults-with-heart-failure-and-left-ventricular-systolic-dysfunction-100607776","NCT07192952","A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction","A Phase 3, Single-arm, Open-label Extension Study to Evaluate the Safety of Finerenone in Addition to Standard of Care, in Pediatric Heart Failure Patients, From Birth to 18 Years of Age, With Left Ventricular Systolic Dysfunction (LVSD)","FIORELLO","Inclusion Criteria:\n\n* For participants rolling over from randomized controlled trial (RCT): Prior participation in the finerenone Phase 3 study FIORE (21466) and not permanently discontinued from the study intervention prior to the end of treatment (EoT) visit in FIORE.\n* For newly enrolled infants \\\u003C6 months of age: Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.\n* For newly enrolled infants \\\u003C6 months of age: Elevated NT-pro BNP levels (\\> 500 mg\u002FL) at screening.\n* For newly enrolled infants \\\u003C6 months of age: Heart failure (HF) etiologies include congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial\u002Finherited and\u002For genetic CM; history of myocarditis (diagnosis of an acute episode at least 3 months prior to treatment assignment); neuromuscular disorder; inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (e.g., Kawasaki disease and postoperative HF); LV noncompaction.\n* For newly enrolled infants \\\u003C6 months of age: Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion (on a stable regimen for 30 days before baseline).\n* Newly enrolled newborns and infants \\\u003C 6 months of age must have a body weight of ≥3 kg at Visit 1.\n\nExclusion Criteria:\n\n* For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) \\>5.5 mmol\u002FL. After unblinding:\n\n  * For participants who received finerenone in FIORE: K+ \\>5.5 mmol\u002F L\n  * For participants who received placebo in FIORE: K+ \\>5.0 mmol\u002FL for children ≥2 years of age, and \\>5.3 mmol\u002FL for children \\\u003C2 years of age (if eGFR is \\\u003C60 mL\u002Fmin\u002F1.73m² for participants \\\u003C2 years of age, the serum potassium threshold of \\>5.0 mmol\u002FL will be used for exclusion)\n* For newly enrolled newborns and infants \\\u003C 6 months of age: Potassium ≥ 5.3 mmol\u002Fl (if eGFR is \\\u003C60 mL\u002Fmin\u002F1.73m², the serum potassium threshold of \\>5.0 mmol\u002FL will be used for exclusion).\n* For participants rolling over from RCT: Severe renal dysfunction with estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m² at FIORE EoT or Visit 1.\n* For newly enrolled infants \\\u003C 6 months of age: Severe renal dysfunction with eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2 at screening or Visit 1.\n* Treatment with a mineralocorticoid receptor antagonist, other than the study intervention, (e.g., spironolactone, eplerenone) within 30 days of Visit 1.\n* Requirement of any intravenous (IV) vasoactive agents; mechanical ventilation; mechanical circulatory support; sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to study treatment.",{"count":248,"type":22},117,[250],"PHASE3","Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth.\n\nThe study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively.\n\nThe main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD.\n\nTo understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as \"treatment emergent adverse events\" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR).\n\nIn this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study.\n\nThe participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants \\\u003C6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will:\n\n* have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured\n* have blood samples taken\n* have physical examinations\n* have their heart examined by an electrocardiogram and echocardiography\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer\n* for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback.\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nThe doctors will check the participants' health a month after the participants take their last treatment.",[253,254],"Left Ventricular Systolic Dysfunction","Heart Failure (Pediatric)",{"date":118,"type":41},{"date":257,"type":41},"2026-06-01",{"date":259,"type":22},"2030-12-30",{"name":47,"class":48},132,{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100599743","an-observational-study-to-learn-more-about-how-well-damoctocog-alfa-pegol-works-in-previously-treated-children-with-hemophilia-a-100599743","NCT07088458","An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A","HEM-POWR Kids","Inclusion Criteria:\n\n* Diagnosis of hemophilia A\n* Patients must be 7 to \\\u003C 12 years of age at enrollment\n* Patients previously treated for hemophilia A ((≥50 exposure days to FVIII)\n* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor\n* Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry\n* Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks\u002Fyear)\n* Signed informed consent\u002Fassent.\n\nExclusion Criteria:\n\n* Presence of a FVIII inhibitor\n* Concurrent participation in an investigational program with interventions outside of routine clinical practice\n* Diagnosis of any other bleeding\u002Fcoagulation disorder other than hemophilia A\n* Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period\n* Contra-indications according to the local marketing authorization\n* Current immune tolerance induction (ITI) treatment for a FVIII inhibitor","7 Years","12 Years",{"count":272,"type":22},40,"This is an observational study of children with mild, moderate, or severe hemophilia A who are receiving damoctocog alfa pegol, and are between 7 to \\\u003C12 years of age at the time of enrolment. Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study.\n\nIn this study, the data will be collected from participants who are receiving their usual treatment with damoctocog alfa pegol as prescribed by their doctor. These children have previously received damoctocog alfa pegol or other factor 8 (FVIII) products.\n\nHemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. At times, there is spontaneous bleeding into the joint spaces that leads to joint damage.\n\nThe drug observed in this study, damoctocog alfa pegol, is approved for doctors to prescribe to children who are at least 7 years old with hemophilia A. It is used to prevent or treat bleeding episodes and works by replacing missing FVIII in the body of people with hemophilia A.\n\nThe participants will receive damoctocog alfa pegol as prescribed independently by their own doctors during routine practice, not as a part of the study. Participants may choose to enroll in the study at any time after their doctor has prescribed damoctocog alfa pegol to prevent bleeding episodes.\n\nThe main purpose of this study is to learn more about how a treatment with damoctocog alfa pegol works to prevent bleeding episodes in routine medical practice. To answer this question, doctors will collect:\n\n* information about bleeding episodes including the type and the location of the bleed\n* information about the treatment with damoctocog alfa pegol and other FVIII products\n* the overall health status of the participants\n\nData will be collected from participants over two years after they enroll in the study or until they choose to leave the study or switch to another hemophilia A treatment. Historical data will come from the participants' medical records or by interviewing the patient and parent\u002F legal guardian. The children's parents\u002F guardians will be asked to maintain a health diary to record details of bleeding episodes and treatment with damoctocog alfa pegol. The children's parents\u002F guardians will also be asked to answer a questionnaire (Hemo QoL-SF and PedHAL) to assess the effect of hemophilia on their child's daily life.\n\nIn this study, only available data from routine care will be collected. No additional visits or tests are required as part of this study.",[275],"Hemophilia A","2026-06-25",{"date":187,"type":41},{"date":91,"type":22},{"date":280,"type":22},"2030-03-01",{"name":47,"class":48},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":61,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":60},"100586342","phase-1-a-study-of-prmt5-inhibitor-bay-3713372-in-participants-with-mtap-deleted-solid-tumors-100586342","NCT06914128","A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors","A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, in Participants With MTAP-deleted Solid Tumors.","Inclusion Criteria:\n\n* Participant must be ≥ 18 years old of age, or the legal age of consent in the jurisdiction of the country in which the study takes place, at the time of signing the informed consent.\n* At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).\n* Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Previous additional cancer other than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.\n* A marked prolongation of QT\u002FQTc interval at screening (e.g., repeated demonstration of a QTc interval \\>450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible based on the investigator's clinical assessment and discretion.\n* Cardiac history comprising:\n\n  * History of congestive heart failure Class \\>II according to the New York Heart Association Functional Classification.\n  * Myocardial infarction less than 6 months before the start of study intervention.\n  * Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers.\n* Unstable angina within 4 weeks before start of study intervention.",{"count":290,"type":22},450,[85,63],"The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells.\n\nThe main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors.\n\nFor this, the researchers will study and analyze:\n\n* the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity.\n* the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose.\n* the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses.\n* the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses.\n\nOther than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse.\n\nThe study participants will take part in one of the eight distinct groups or \"intervention cohorts\" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase.\n\nParticipants may take the study treatment as long as they benefit from the treatment without any severe medical problems.\n\nParticipants will visit the study site:\n\n* at least twice before the treatment starts\n* multiple times when they start taking the treatment\n* once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason\n\nDuring the study, the doctors and their study team will:\n\n* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram\n* check if the participants' cancer has grown and\u002For spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan\n* take tumor samples\n\nThe study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.",[294],"MTAP-deleted Solid Tumors",[296,297,298,299,300,301,302],"Solid Tumors","Non-small cell lung cancer","NSCLC","Pancreatic adenocarcinoma","PDAC","Glioblastoma","GBM",{"date":187,"type":41},{"date":305,"type":41},"2025-03-21",{"date":307,"type":22},"2029-06-17",{"name":47,"class":48},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":317,"maxAge":58,"enrollmentInfo":318,"targetDuration":4,"studyType":61,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100474390","phase-3-a-study-to-learn-more-about-how-safe-the-study-treatment-finerenone-is-in-long-term-use-when-taken-with-an-ace-inhibitor-or-angiotensin-receptor-blocker-over-18-months-of-use-in-children-and-young-adults-from-1-to-18-years-of-age-with-chronic-kidney-disease-and-proteinuria-100474390","NCT05457283","A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","FIONA OLE","Inclusion Criteria:\n\n* Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent\u002Fassent.\n* Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.\n* Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as\n\n  * CKD stages 1-3 (estimated glomerular filtration rate \\[eGFR\\] ≥30 mL\u002Fmin\u002F1.73m\\^2) for children ≥1 year to \\\u003C19 years of age at FIONA EoT and at Visit 1\n* Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.\n* K+ ≤5.0 mmol\u002FL for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol\u002FL for children \\\u003C2 years of age at both FIONA EoT and Visit 1\n* Participants who have reached legal age of consent: Capable of giving signed informed consent.\n* Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.\n\nExclusion Criteria:\n\n* Planned urological surgery expected to influence renal function\n* Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame\n* Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.\n* Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants \\\u003C18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) \\\u003C90 mmHg in participants ≥18 years at Visit 1.\n* Known hypersensitivity to the study treatment (active substance or excipients)\n* Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.\n* Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids\n* Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril\u002Fvalsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)\n* Concomitant therapy with both ACEI and ARBs together\n* Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers\n* Previous assignment to treatment during this study\n* Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).\n* Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study.\n* Pregnant or breastfeeding or intention to become pregnant during the study","1 Year",{"count":319,"type":22},100,[250],"Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.\n\nThe kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and\u002For proteinuria. These include \"angiotensin-converting enzyme inhibitors\" (ACEI) and \"angiotensin receptor blockers\" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.\n\nThe study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.\n\nSo, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.\n\nThe main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term.\n\nTo see how safe the treatment is, the study team will collect information on medical problems which are also known as \"treatment emergent adverse events\" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study.\n\nThe secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care.\n\nTo see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function.\n\nThe study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years.\n\nThe participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone.\n\nIn the visit, the study team will:\n\n* have their blood pressure, heart rate, temperature, height and weight measured\n* have blood and urine samples taken\n* have physical examinations\n* have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer\n* answer questions about how they are feeling, or have their parents or guardian's answer\n* answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nThe doctors will check the participants' health about 30 days after the participants take their last treatment.",[183,323,324],"Proteinuria","Children",{"date":187,"type":41},{"date":327,"type":41},"2022-11-08",{"date":329,"type":22},"2028-12-28",{"name":47,"class":48},179,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":339,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":61,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},"100626104","phase-1-a-study-to-learn-about-how-safe-nitroglycerin-is-and-how-it-affects-the-body-when-taken-along-with-nurandociguat-in-people-with-coronary-artery-disease-100626104","NCT07431294","A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease","A Randomized, Placebo-controlled, Single Blind Drug-drug Interaction Study to Investigate the Influence of 0.4 mg Nitroglycerin Spray on the Safety, Tolerability and Pharmacodynamic Effects of Nurandociguat in Participants With Stable Coronary Artery Disease.","Inclusion Criteria:\n\n* Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent\n* Participants with stable CAD defined by coronary artery stenosis in any of the 3 main coronary vessels greater than 50 percent documented by coronary angiography within the last 36 months or history of myocardial infarction more than 6 months prior to the screening visit\n* Estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL per min per 1.73 m2 at screening\n* Body weight greater than or equal to 60 kg and body mass index within the range greater than or equal to 18 and less than or equal to 36 kg per m2 at screening.\n\nExclusion Criteria:\n\n* Ejection fraction less than 30 percent at screening as determined by echocardiography\n* Progressive angina with symptoms of worsening of angina in the 3 months prior to the first screening examination and\u002For interventions such as revascularization by percutaneous coronary intervention and or coronary artery bypass graft during the last 3 months\n* Documented current relevant coronary stenosis greater than or equal to 90 percent in any of the main 3 coronary vessels without bypass graft\n* Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis any other moderate or severe valvular failures hypertrophic obstructive cardiomyopathy\n* Symptomatic carotid stenosis or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement\n* Atrial fibrillation pacemaker defibrillator atrial ventricular block II and III\n* History of sustained ventricular tachycardia or ventricular fibrillation within 12 months prior first screening visit\n* History of CNS diseases such as seizures neurodegenerative diseases\n* Lung diseases such as COPD GOLD stage 2-4 pulmonary arterial hypertension or asthma\n* Medical disorder condition or history of such that would impair the participant's ability to participate or complete the study in the opinion of the investigator.","40 Years","80 Years",{"count":342,"type":22},36,[85],"This study is designed to find out how safe nitroglycerin is and how it affects the body when it is taken together with another medicine called nurandociguat in people who have coronary artery disease (CAD). CAD is a condition where the arteries that supply blood to the heart become narrowed or blocked, often causing chest pain or even heart attacks. Many people with CAD also have chronic kidney disease (CKD), a long-term condition where the kidneys do not work as well as they should.\n\nPeople with CAD often use nitroglycerin to help improve blood flow to the heart. Nurandociguat is a new medicine being studied to help people with CKD by widening blood vessels and improving blood flow. Both nitroglycerin and nurandociguat work in similar ways in the body, so taking them together could have a stronger effect on blood vessels. This might lead to a sudden drop in blood pressure or other side effects. The main goal of this study is to learn how safe it is to use nitroglycerin and nurandociguat together, and to understand how they interact in the body.",[346],"Stable Coronary Artery Disease","2026-06-24",{"date":276,"type":41},{"date":350,"type":22},"2026-10-01",{"date":352,"type":22},"2027-05-07",{"name":47,"class":48},5,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":202,"minAge":362,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":170},"100644617","a-study-to-learn-about-heart-related-risks-in-elderly-men-with-advanced-prostate-cancer-treated-with-enzalutamide-or-darolutamide-100644617","NCT07672119","A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide","MACED: Major Adverse Cardiovascular Events Among Elderly Patients Treated With Enzalutamide or Darolutamide Among Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Male diagnosed with prostate cancer\n* Evidence of ≥2 prescription claims for enzalutamide or darolutamide during the identification period with the first occurrence of ARPI treatment defined as the index date\n* Male patients with a diagnosis of mHSPC or nmCRPC before or on the index date\n* Aged ≥55 years on the index date\n\nExclusion Criteria:\n\n* Use of any of the ARPIs (abiraterone, apalutamide, enzalutamide, and darolutamide), Evidence of CRPC prior to the index date for mHSPC\n* Evidence of metastasis before index date + 30 days for nmCRPC","55 Years",{"count":364,"type":22},3000,"This observational study aims to better understand the risk of serious heart-related problems in older men with advanced prostate cancer who are treated with certain commonly used medicines.\n\nProstate cancer is the most commonly diagnosed malignancy in United States (US) men and a leading cause of cancer mortality, with disease progression spanning multiple clinical states, including non-metastatic castrate resident prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).\n\nMen with advanced prostate cancer are often treated with medicines such as darolutamide or enzalutamide. While these treatments can help control cancer, they may also increase the risk of heart-related side effects, such as heart attack, stroke, or death related to heart and blood vessel disease. However, it is not yet clear whether these risks differ between the two treatments or which patients may be more likely to experience them.\n\nThe main goal of the study is to compare how often serious heart-related events (such as heart attack, stroke, or death due to heart problems) occur in patients treated with these two medicines. The study will also explore other heart-related conditions and identify factors that may increase this risk.\n\nIn this study, researchers will use existing healthcare data from the United States to look at men aged 55 years and older with advanced prostate cancer who have already been treated with either darolutamide or enzalutamide in routine clinical practice. No new treatments will be given as part of this research. Because this is a retrospective database study, there are no extra study visits, no extra blood tests, and no extra health check-ups required for participants.",[367],"Prostate Cancer","2026-06-23",{"date":187,"type":41},{"date":371,"type":41},"2026-06-04",{"date":373,"type":22},"2027-04-29",{"name":47,"class":48},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":202,"minAge":58,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":61,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},"100627589","phase-2-a-study-to-learn-how-well-a-combination-of-darolutamide-and-androgen-deprivation-therapy-adt-works-as-a-treatment-before-surgery-for-men-who-have-high-risk-localized-prostate-cancer-100627589","NCT07450599","A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.","CHINANEO: A China Phase 2, Open-Label, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment for 12 Weeks vs 24 Weeks in Treatment-Naïve Participants Who Have Planned for Radical Prostatectomy (RP) With High-Risk Localized Prostate Cancer","CHINANEO","Inclusion Criteria:\n\n* Participants must be 18 years or older at the time of signing the informed consent.\n* Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high risk with National Comprehensive Cancer Network (NCCN) criteria (version 1.2025).\n* No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days prior to start of study treatment.\n* Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.\n* Participants must have at least one of the following features according to NCCN definition of high-risk:\n\n  * Biopsy Gleason score ≥8, and\u002For\n  * Prostate-specific antigen (PSA) \\>20 ng\u002FmL measured during Screening and prior to randomization, or\n  * Clinical stage ≥ T3a.\n* Participants with pelvic lymph node involvement (N1) can be included.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\nExclusion Criteria:\n\n* Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.\n* Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and the abdomen (CT or MRI with intravenous \\[IV\\] contrast), and WBBS. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.\n* Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.\n* History of\n\n  * Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or\n  * Significant cardiovascular disease within 6 months prior to randomization.\n  * Any contraindications for RP.\n* Uncontrolled or treatment-resistant hypertension.\n* History of another malignancy within 5 years prior to randomization.",{"count":384,"type":22},250,[63],"Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.\n\nThe study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body.\n\nThe main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).\n\nThe study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.\n\nEach participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery.\n\n2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.\n\nDuring the study, the doctors and their study team will:\n\n* take blood and urine samples\n* check the participants' health parameters\n* do physical examinations\n* check if the participants' cancer has grown and\u002For spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan\n* take tumor samples\n* ask the participants questions about how they are feeling and what adverse events they are having.\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.\n\nAbout 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.",[388],"High-Risk Localized Prostate Cancer",{"date":347,"type":41},{"date":391,"type":41},"2026-04-27",{"date":393,"type":22},"2030-10-15",{"name":47,"class":48},23,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":61,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":415},"100566758","phase-1-a-phase-i-study-of-bay3498264-given-together-with-sotorasib-in-participants-who-have-advanced-solid-cancers-with-specific-genetic-changes-called-krasg12c-mutation-100566758","NCT06659341","A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation","Phase 1 Study of a SOS1 Inhibitor, BAY 3498264, in Combination in Participants With Advanced KRASG12C-mutated Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed solid tumor malignancy with documented KRAS\\^G12C mutation as assessed by an appropriately accredited laboratory.\n* Documented disease progression after treatment with at least 1 prior standard of care (SoC) systemic therapy other than a G12C inhibitor for locally advanced or metastatic disease, and with no further standard treatment options available, or when standard treatment options are not acceptable and this study is a reasonable option.\n\n  * Participants whose access to SoC therapies is limited due to regional access, refusal, intolerance, or eligibility may participate.\n  * Prior G12C inhibitor treatment is permitted. Participants receiving prior G12C inhibitor therapy must have documented disease progression after treatment, or have discontinued that treatment due to intolerance.\n* Adequate archival formalin-fixed paraffin-embedded tumor tissue available (preferably no older than 6 months, obtained after the last targeted therapy). If archival material is not available, a fresh tumor biopsy should ideally be obtained if safe and feasible.\n* Eastern Cooperative Oncology Group (ECOG) of 0 to 2 and life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n\\- Active central nervous system (CNS) tumors including metastatic brain disease, at the time of screening.\n\n1. 'Active' is defined as untreated brain lesions (new or progressing) or symptomatic brain lesions (as determined by the investigator).\n2. Participants who have received treatment (e.g. surgery or radiotherapy) for brain metastases ending at least 4 weeks before the start of study intervention may be eligible if, at the point of study entry:\n\ni. their condition is considered stable by the investigator. ii. they have no residual neurological symptoms (Grade \\>2). iii. a follow-up Magnetic resonance imaging (MRI) scan during the screening period shows no progression or new lesions.\n\niv. they do not need systemic corticosteroids to treat symptoms of brain metastasis.\n\n* Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of:\n\n  1. Grade ≥2 ILD,\n  2. Drug-induced ILD,\n  3. Radiation pneumonitis that required steroid treatment within the last 12 months.\n* Additional malignancy within the past 3 years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, in agreement with the Sponsor, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.\n* Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of virus.\n\n  * Active HBV (chronic or acute; defined as having a known positive HBsAg test at the time of screening) except for participants on antiviral therapy for HBV with an undetectable or low viral load.\n  * Participants with past HBV infection or resolved HBV infection (defined as the presence of HBcAb and absence of HBsAg) are eligible if HBV DNA is negative.\n  * Participants positive for HCV antibody unless polymerase chain reaction is negative for HCV RNA. Any prior antiviral therapy must be completed at least 28 days before the first dose of study intervention.",{"count":404,"type":22},104,[85],"Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation.\n\nSotorasib is a drug that targets cancer cells which contain mutated KRASG12C protein; it can stop the cancer cells from growing and can lead to their death. Sotorasib is already approved to be used by doctors. However, when sotorasib works, it normally only works for a period of time, after which the cancer starts to grow again, and the patient may need a different treatment.\n\nBAY3498264 is a drug that is currently under development. It is expected to prevent the activity of a protein called son of sevenless 1 (SOS1). The SOS1 protein works together with KRAS; by blocking the activity of SOS1 with BAY3498264, it is hoped that the benefit offered by treatment with sotorasib may be increased - for example, resulting in a longer or deeper response.\n\nThe main purpose of this first-in-human study is to learn how safe BAY3498264 is when given together with sotorasib and what is the maximum dose of BAY3498264 that can be safely given to participants together with sotorasib.\n\nDuring the study, participants will receive the following treatments:\n\n* BAY3498264: participants will first receive BAY3498264 alone for seven days and then BAY3498264 in combination with sotorasib. These combination treatments will be given in cycles, each lasting 21 days.\n* Sotorasib: participants will receive a standard, approved dose of Sotorasib once every day with BAY3498264.\n\nThe treatment will continue for as long as participants benefit from it without any severe medical problems or until they or their doctor decide to stop the treatment, or until their cancer starts to grow again despite the treatment (also called 'progression').\n\nThis study has 3 parts, the dose escalation part, the backfill part and the expansion part.\n\nDuring the study, researchers will collect blood, urine, and take imaging scans like CT, PET, MRI, and X-rays, and examine the participants' heart health using an electrocardiogram (ECG). Participants' health is monitored throughout the study.",[408],"Advanced Solid Tumors Harboring KRAS G12C Mutation",{"date":347,"type":41},{"date":411,"type":41},"2024-11-08",{"date":413,"type":22},"2027-06-15",{"name":47,"class":48},10,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":202,"minAge":58,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":425,"conditions":426,"keywords":429,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":170},"100566895","a-study-to-learn-about-how-safe-darolutamide-is-and-how-well-it-works-in-combination-with-androgen-deprivation-therapy-and-docetaxel-in-routine-medical-care-for-japanese-men-with-low-volume-metastatic-hormone-sensitive-prostate-cancer-100566895","NCT06661122","A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer","An Observational Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Low-volume Metastatic Hormone-sensitive Prostate Cancer","HAYATE","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of prostate.\n* Patients have low-volume of metastatic disease documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal\u002Fpelvic\u002Fchest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Low-volume metastasis criteria is defined as \"not\" meeting the high-volume criteria of the CHAARTED trial; high-volume meet the presence of visceral metastases, or four or more bone lesions including at least one outside the vertebral column or pelvis.\n* Documented diagnosis of mHSPC.\n* Patients on triplet regimen previously decided by the investigator irrespective of enrollment in the study.\n* Start ADT within 6 months before or at the index date.\n* Signed informed consent: If an eligible patient is deceased at the time of study initiation, informed consent from the legally representative(s) of the patient is required. Opt-out consent is acceptable in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects only when it is difficult to obtain signed informed consent from the patient or their legal representative.\n\nExclusion Criteria:\n\n* Patients treated with docetaxel before darolutamide start.\n* Participation in an investigational program with interventions outside of routine clinical practice.\n* Contra-indications to darolutamide, docetaxel and ADT according to the local marketing authorization.\n* Participation in the PASS of darolutamide in patients with mHSPC (DADOX \\[NCT06010914\\]).",{"count":319,"type":22},"This is an observational study in which medical records of Japanese men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC), who received treatment with a combination therapy of darolutamide with an androgen deprivation therapy (ADT) and docetaxel, will be collected and studied.\n\nThe study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for another type of prostate cancer. To better understand the impact of this combination therapy on low-volume mHSPC and make better treatment choices, more knowledge is needed. ADT is a hormone therapy that lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Darolutamide blocks androgen signals to slow the growth of the cancer cells. Docetaxel is a type of chemotherapy used to treat different types of cancer. It works by stopping the growth and spread of cancer cells.\n\nThe prostate gland is a male reproductive gland found below the bladder. Low-volume mHSPC is a cancer of the prostate gland that has spread beyond the gland to three or fewer bones but has not reached organs like the lungs and liver. The prostate cancer is considered hormone sensitive when it responds to an anti hormonal therapy.\n\nIn this study, only observations from routine clinical practices will be made. Participants will receive darolutamide, in combination with ADT and docetaxel as prescribed by their doctors during routine medical care. The participants will not receive any advice on treatment or any changes to healthcare as a part of the study.\n\nThe main purpose of this study is to learn more about how safe darolutamide is and how well it works in combination with ADT and docetaxel in adult Japanese men with mHSPC in routine medical care.\n\nTo do this, researchers will assess the following information about participants after one year of receiving the combination therapy by their doctors:\n\n• the number of participants who achieve normal levels of prostate specific antigen (PSA).\n\nPSA is a protein found in the blood that helps doctors monitor prostate cancer.\n\n• the number of participants who have adverse events (AEs), serious adverse events (SAEs), and adverse events of special Interest (AESIs) that lead to discontinuation or change in the dose of darolutamide or docetaxel during the study.\n\nAEs are medical problems that the participants had during the study that may or may not be related to the study treatment.\n\nSAEs are AEs that lead to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby to be born with medical problems, or is medically important.\n\nAESIs are specific medical problems the participants had during the study that may be related to heart, lung, liver etc.\n\nThe data will come from the participant's medical records and will be collected between October 2024 and June 2031. Researchers will only look at the health records from adult men with mHSPC in Japan. No separate visits are required as part of the study. The participants will only visit their doctor at the study clinic as part of their routine medical care.",[427,428],"Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Low-volume Metastasis",[430],"mHSPC",{"date":347,"type":41},{"date":433,"type":41},"2024-11-18",{"date":123,"type":22},{"name":47,"class":48},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":317,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":444,"conditions":445,"keywords":448,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":170},"100540339","an-observational-study-to-collect-data-on-how-aflibercept-eylea-given-using-a-paediatric-dosing-device-is-used-in-preterm-babies-with-retinopathy-of-prematurity-in-the-united-kingdom-uk-100540339","NCT06315556","An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)","Drug Utilization Study for Eylea 40 mg\u002FmL Using the PICLEO Paediatric Dosing Device in Preterm Infants With Retinopathy of Prematurity in the UK","Inclusion Criteria:\n\n* Eligible infants within the NNRD include those who were:\n\n  * 1\\. Born during the study period, i.e. from Q4\u002F2023 following market introduction of Eylea PFS+PDD and 31st December 2026, and\n  * 2\\. Received care in a neonatal unit that contributes data to the NNRD and the unit has agreed to participate in the study, and\n  * 3\\. Diagnosed with ROP in any stage in at least one eye.\n\nExclusion Criteria:\n\n* Infants with missing data for gestational age at birth will be excluded.",{"count":134,"type":22},"This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied.\n\nROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth.\n\nAflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina.\n\nAflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner.\n\nSince there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown.\n\nThe main purpose of this study is to:\n\n* find the number of preterm babies who are treated with aflibercept using a PDD in the UK\n* inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP\n\nAn additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD.\n\nThe data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027.\n\nIn this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.",[446,447],"Retinopathy of Prematurity","Preterm Infants",[449],"ROP",{"date":347,"type":41},{"date":452,"type":41},"2024-03-05",{"date":454,"type":22},"2027-04-30",{"name":47,"class":48},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":202,"minAge":463,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":170},"100541765","an-observational-study-to-learn-more-about-the-safety-of-darolutamide-in-men-with-prostate-cancer-in-korea-100541765","NCT06334120","An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea","Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients","Inclusion Criteria:\n\n* Male aged ≥19 years\n* Patients with high risk nmCPRC\n\n  * Castrate level of serum testosterone (\\\u003C 1.7 nmol\u002Fl \\[50 ng\u002FdL\\])\n  * PSA doubling time \\\u003C 10 months\n* Patients with mHSPC\n\n  * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI).\n  * be candidates for androgen-deprivation therapy with\u002Fwithout docetaxel.\n* Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice\n* Written informed consent from subject or legal representative; assent from subject when appropriate\n\nExclusion Criteria:\n\n* Patients participating in an investigational program with interventions outside of routine clinical practice\n* Participants with contraindication according to the locally approved prescribing information","19 Years",{"count":465,"type":22},600,"This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.\n\nThis study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.\n\nTo learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.\n\nDuring this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.\n\nEach participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.",[207,468],"Metastatic Hormone-sensitive Prostate Cancer",{"date":347,"type":41},{"date":471,"type":41},"2024-09-25",{"date":168,"type":22},{"name":47,"class":48},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":482,"minAge":58,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":61,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":496},"100585585","phase-3-mirena-for-the-treatment-of-nonatypical-endometrial-hyperplasia-for-6-months-100585585","NCT06904274","Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months","A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Medroxyprogesterone Acetate for 6 Months","SUNFLOWER","Inclusion Criteria:\n\n* Post-menarchal women (≥18 years) at the time of signing the informed consent.\n* Women with histologically confirmed NAEH independent of their parity or menopausal status. Endometrial samples will be obtained either at screening or no more than 42 days prior to the signing of the informed consent form.\n\nExclusion Criteria:\n\n* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.\n* Congenital or acquired uterine or cervical anomaly including fibroids, or cervical stenosis that in the opinion of the investigator, would interfere with insertion and\u002For retention of the intrauterine system (i.e., if they distort the uterine cavity).\n* Use of any long-acting injectable sex-hormone preparations within 6 months prior to the start of study intervention, and \u002For short acting hormonal medication within 6 weeks prior to the start of study intervention.\n* Pregnancy\n* Participants with either known family or personal history of genetic predisposition to uterine, ovarian or colorectal cancers (e.g. Lynch syndrome).","FEMALE",{"count":484,"type":22},207,[250],"Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH).\n\nEndometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer.\n\nCurrently, there are no approved treatments for NAEH and that is why there is still an unmet medical need.\n\nThe study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone.\n\nIn this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body.\n\nThe main purpose of this study is to show that uterine lining goes back to completely normal lining after treatment with Mirena and that its use is safe in this population.\n\nFor this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral MPA.\n\nThe study participants will be randomly assigned into one of two treatment groups. The randomization will be done 2:1 ratio, meaning that for every two participants assigned to Mirena, one will be assigned to oral medroxyprogesterone acetate (MPA). Based on their group, participants will receive Mirena, which is inserted into the uterus at the start of the study, or they will take progestins once daily by mouth for 6 months.\n\nEach participant will be in the study for around 10 months with up to 5 visits to the study clinic\u002Fsite.\n\nParticipants will visit the study clinic:\n\n* once before the treatment starts\n* 3 times with a gap of 3 months between the visits during the treatment\n* then 1 more time after the treatment ends\n\nDuring the study, the doctors and their study team will:\n\n* check participant's health by performing tests such as blood and urine tests\n* perform vaginal ultrasound and hysteroscopy. Hysteroscopy is a minor surgical procedure where a thin camera will be inserted into the womb to check for any abnormality. Sampling of the endometrial lining (cells in the womb) will be done with a thin tube at the same time.\n* take samples of womb (endometrial) lining\n* ask the participants questions about how they are feeling and what adverse events they are having\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.",[488],"Endometrial Hyperplasia","2026-06-22",{"date":368,"type":41},{"date":492,"type":41},"2025-11-24",{"date":494,"type":22},"2027-11-01",{"name":47,"class":48},89,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":340,"enrollmentInfo":504,"targetDuration":4,"studyType":61,"phases":505,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":125},"100581771","phase-1-a-study-to-learn-about-how-safe-bay-3389934-is-its-suitable-dose-and-how-it-affects-the-participants-with-sepsis-induced-coagulopathy-100581771","NCT06854640","A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy","First in Patient, Dose Escalation, Open Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion of BAY 3389934 to Patients With Sepsis Induced Coagulopathy","Inclusion Criteria:\n\n* Participant must be ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.\n* Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.\n* participants with suspected or documented origin of infection.\n* Participants with coagulopathy defined by at least one of the following within 24 hours prior start of study intervention: INR ≥1.40, platelet count in the range of ≥ 30,000\u002Fmm3 to \\\u003C 150,000\u002Fmm3 OR greater than 30% decrease in platelets in 24 hours without other known etiology. The platelet count after decrease should not be \\\u003C 30,000\u002Fmm3.\n* Participants must be receiving treatment in an ICU.\n* Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.\n\nExclusion Criteria:\n\n* Clinically significant active bleeding; known bleeding disorder, history of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months.\n* Low platelets level or abnormal coagulation status due to any other reason than sepsis.\n* Participants with indication for therapeutic dose of: anticoagulation (heparin, argatroban, vitamin K antagonists\u002Fwarfarin, dabigatran, apixaban, rivaroxaban, edoxaban), oral antiplatelet agents (clopidogrel, ticagrelor, ticlopidine, prasugrel) except low dose (≤100mg) acetyl salicylic acid (ASA), digoxin, metformin\n* Any active malignancy\n* Pregnancy or breastfeeding.\n* Chronic liver disease Child-Pugh Class C.\n* Participants experienced major surgery or major trauma (intrathoracic, intra-abdominal, pelvic or femur) or surgery\u002Ftrauma in any other area with potentially clinically significant consequences due to bleeding within 28 days before study drug administration.\n* Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedic surgery in spine within 6 months before study drug administration",{"count":342,"type":22},[85],"Researchers are looking for a better way to treat people who have sepsis induced coagulopathy.\n\nSepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death.\n\nThe main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU).\n\nFor this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as \"adverse events\". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.\n\nParticipants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934.\n\nEach participant will be in the study for around 28 days. During the study, the doctors and their study team will:\n\n* Take blood and urine samples,\n* Do physical examinations,\n* Check vital signs such as body temperature, blood pressure and heart rate,\n* Examine heart health using electrocardiogram (ECG)",[508,509],"Sepsis","Coagulopathy",[511,512,513],"DIC","Disseminated intravascular coagulation","Sepsis induced coagulopathy",{"date":368,"type":41},{"date":516,"type":41},"2025-03-12",{"date":518,"type":22},"2027-02-15",{"name":47,"class":48},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":170},"100616671","data-insight-is-a-project-that-looks-at-health-data-in-germany-to-find-out-how-many-patients-suffer-from-eye-disease-the-project-also-explores-new-ways-to-collect-and-use-publicly-available-healthcare-information-100616671","NCT07308639","DATA-INSIGHT is a Project That Looks at Health Data in Germany to Find Out How Many Patients Suffer From Eye Disease. The Project Also Explores New Ways to Collect and Use Publicly Available Healthcare Information.","DATA-INSIGHT: Data Analysis for Treatment Assessment and Evaluation of New Sources for Evidence Generation in German Healthcare System","Inclusion Criteria:\n\n* At least one diagnosis of nAMD, DME and RVO in the timeframe 01 JAN 2009 until 31 DEC 2024\n* nAMD patients aged ≥ 50 years\n* DME patients aged ≥18 years\n* RVO patients aged ≥18 years\n* Participants living in Germany covered by statutory health insurance or private health insurance\n\nExclusion Criteria:\n\n* none",{"count":528,"type":22},50000,"The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are:\n\nnAMD (neovascular age-related macular degeneration): a condition that affects the central part of the retina and can cause vision loss in older adults.\n\nDME (diabetic macular edema): a swelling in the central part of the retina caused by diabetes, which can also lead to vision problems.\n\nRVO (retinal vein occlusion): a blockage of the veins in the retina, which can cause sudden vision loss.\n\nResearchers will look at data collected from 2009 to 2024 to see how often these diseases occur (incidence) and how many people have them at a given time (prevalence). They will use two large sets of health data from Germany, called FDZ and FDGP.\n\nThe main question is: How do the numbers of new and existing cases of nAMD, DME, and RVO compare between the two data sources (FDZ and FDGP) in Germany from 2009 to 2024? The study also wants to find out if factors like age, other health problems, and medications affect how common these eye diseases are.\n\nAnother goal is to see how many people with these eye diseases are treated with a type of medicine called anti-VEGF, which is used to slow down or stop vision loss.\n\nIn summary, this study will help us understand how these eye diseases affect people in Germany, how they are treated, and whether different groups of people are more likely to get them.",[531],"Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)","2026-06-18",{"date":489,"type":41},{"date":535,"type":41},"2026-03-03",{"date":537,"type":22},"2026-12-31",{"name":47,"class":48},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":270,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":170},"100533198","a-study-to-learn-more-about-the-safety-of-damoctocog-alfa-pegol-when-used-in-routine-medical-care-in-korean-participants-with-hemophilia-a-100533198","NCT06222697","A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A","Post Marketing Surveillance Study for Jivi (Damoctocog Alfa Pegol) in Korean Patients With Hemophilia A","Inclusion Criteria:\n\n* ≥12 years of age with hemophilia A\n* Previously treated with FVIII concentrate(s) (plasma derived or recombinant)\n* Patients who have been treated with Jivi (damoctocog alfa pegol) and those for whom the decision to initiate treatment with Jivi was made as per physician's routine treatment practice with any kind of treatment modality (on-demand, prophylaxis, etc.)\n* Written informed consent from subject or legal representative; assent from subject when appropriate\n\nExclusion Criteria:\n\n* Contraindication according to the local authorized indication (including known hypersensitivity to the drug substance or any of its components (e.g., mouse or hamster protein))\n* Patients participating in an investigational program with interventions outside of routine clinical practice\n* Patients with any other diagnosis of bleeding\u002Fcoagulation disorder other than hemophilia A\n* Patients on immune tolerance induction treatment at the time of enrollment",{"count":125,"type":22},"In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study.\n\nHemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery.\n\nThe study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments.\n\nThrough this study, researchers want to learn more about its safety in a real-world setting.\n\nThe participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information.\n\nThe main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment.\n\nData will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits.\n\nIn this study, only available data from routine care will be collected. No visits or tests are required as part of this study.",[275,549,550],"Prophylaxis of Bleeding","Treatment of Bleeding",{"date":489,"type":41},{"date":553,"type":41},"2024-01-24",{"date":555,"type":22},"2028-03-31",{"name":47,"class":48},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":151},"100508435","a-study-to-observe-the-pattern-of-use-and-safety-of-rivaroxaban-in-children-under-2-years-old-with-venous-thromboembolism-vte-100508435","NCT05900388","A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)","Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism","XAPAEDUS","Inclusion Criteria:\n\n* Evidence of initiation of an anticoagulant therapy (index drug), either rivaroxaban oral suspension or other anticoagulation therapies (heparins, Vitamin K antagonists (VKAs), other Direct oral anticoagulants (DOACs)). Initiation will be defined as a first record of any anticoagulation therapy (rivaroxaban or SOC) without any anticoagulation therapy in the previous 6 months, or since date of birth for children less than 6 months\n* Evidence of a prior VTE diagnosis (index VTE), defined as the presence of at least one primary\u002Fmain or secondary diagnosis code for VTE recorded in inpatient setting in the previous 30 days\n* Age less than two years on index date.\n* Baseline period for availability of patient data history in the data source. A minimal baseline period of six months before index date for children aged between six months and two years, and a baseline period since birth for children less than six months of age will be required.\n\nExclusion Criteria:\n\n\\- None","2 Years",{"count":567,"type":22},850,"This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).\n\nVTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.\n\nRivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.\n\nThe purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.\n\nThe main information that researchers will collect in this study:\n\n* Age, gender, and other information about the child and their illness\n* Type of VTE treatment given to the child\n* Occurrence of medically important bleeding and its severity\n\nFurther information that researchers will collect:\n\n* Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE\n* Return of VTE symptoms\n* Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.\n\nThe data for this study will be collected from electronic health records and health insurance claims data until 2026.\n\nResearchers will observe each child during treatment until:\n\n* end of the anticoagulation treatment period e.g. discontinuation of all study drugs,\n* their information is no longer available, or\n* the study ends.",[570,571],"Venous Thromboembolism","Children Under 2 Years",{"date":489,"type":41},{"date":574,"type":22},"2026-09-01",{"date":576,"type":22},"2029-06-30",{"name":47,"class":48},""]