[{"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:":584},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,54,0,25,[9,42,69,94,120,142,163,189,213,237,258,280,302,323,343,362,383,403,425,448,468,498,520,547,570],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":22},"100609217","phase-2-a-study-to-learn-about-how-well-bay-3401016-works-in-adults-with-alport-syndrome-100609217",false,"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), that, in the investigator's judgment, could interfere with or confound the evaluation of local infusion\u002Finjection-site reactions to the study intervention.\n* Systolic blood pressure above 140 mmHg\n* Diastolic blood pressure above 90 mmHg","ALL","18 Years","45 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29],"Alport Syndrome","RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-20","ACTUAL",{"date":36,"type":34},"2025-11-19",{"date":38,"type":23},"2027-11-29",{"name":40,"class":41},"Bayer","INDUSTRY",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"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","80 Years",{"count":51,"type":23},36,[53],"PHASE1","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)",[56,57],"Sepsis","Coagulopathy",[59,60,61],"DIC","Disseminated intravascular coagulation","Sepsis induced coagulopathy",{"date":33,"type":34},{"date":64,"type":34},"2025-03-12",{"date":66,"type":23},"2027-01-17",{"name":40,"class":41},20,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":77,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":24,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"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":79,"type":23},100,[81],"PHASE3","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.",[84,85,86],"Chronic Kidney Disease","Proteinuria","Children",{"date":33,"type":34},{"date":89,"type":34},"2022-11-08",{"date":91,"type":23},"2028-11-07",{"name":40,"class":41},133,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":24,"phases":104,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100550838","phase-3-a-study-to-learn-more-about-how-well-sevabertinib-works-and-how-safe-it-is-compared-with-standard-treatment-in-participants-who-have-advanced-non-small-cell-lung-cancer-nsclc-with-mutations-of-the-human-epidermal-growth-factor-receptor-2-her2-100550838","NCT06452277","A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)","A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations","SOHO-02","Inclusion Criteria:\n\n* Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.\n* Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).\n* Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.\n* No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant\u002Fneoadjuvant therapy was completed at least 12 months prior to the start of screening.\n* Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin\u002Fpemetrexed or carboplatin\u002Fpemetrexed) and pembrolizumab in accordance with the SmPC\u002FProduct Information.\n\nExclusion Criteria:\n\n* Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:\n\n  * a. in situ cancers of cervix, breast, or skin,\n  * b. superficial bladder cancer (Ta, Tis and T1),\n  * c. limited-stage prostate cancer,\n  * d. basal or squamous cancers of the skin.\n* Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.\n* Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \\>4 weeks prior to planned start of study intervention.\n* Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).\n* History of severe hypersensitivity reaction to treatment with a monoclonal antibody.\n* Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.",{"count":103,"type":23},444,[81],"Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly.\n\nThe study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing.\n\nThe main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation.\n\nThe study participants will receive one of the study treatments:\n\n* Sevabertinib as a tablet taken by mouth twice a day\n* Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover.\n\nParticipants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment.\n\nDuring the study, the research team will:\n\n* do scans such as CT, PET, MRI, or X-rays to check the cancer\n* Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram.\n* do pregnancy tests when needed\n* ask how the participants are feeling and whether they have had any adverse events or other health problems An 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.",[107],"Advanced Non-small Cell Lung Cancer, HER2 Mutation",[109,110,111],"NSCLC","ERBB2 mutation","HER2 mutation","2026-08-18",{"date":31,"type":34},{"date":115,"type":34},"2024-08-28",{"date":117,"type":23},"2029-06-27",{"name":40,"class":41},270,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":18,"minAge":19,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":24,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100648546","phase-1-a-study-to-learn-about-how-a-new-nurandociguat-tablet-is-absorbed-and-processed-in-the-body-compared-to-an-old-tablet-and-how-food-affects-the-way-the-new-tablet-is-absorbed-and-processed-in-the-body-100648546","NCT07722585","A Study to Learn About How a New Nurandociguat Tablet is Absorbed and Processed in the Body Compared to an Old Tablet and How Food Affects the Way the New Tablet is Absorbed and Processed in the Body","A Single Center, Open-label Study Assessing the Relative Bioavailability of a New Nurandociguat Tablet Formulation Versus an Existing Formulation and Investigating the Food Effect of the New Tablet Formulation","Inclusion Criteria:\n\n* Participant must be 18 to 58 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs (blood pressure and heart rate), electrocardiogram (ECG), body temperature, and laboratory tests.\n* Body Mass Index (BMI) within the range 18.0 and 29.9 kg\u002Fm\\^2 (inclusive).\n* Body weight above or equal 60 kg.\n* Male and female.\n\nExclusion Criteria:\n\n* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.\n* Acute diarrhea or constipation within 14 days before the first intake of study intervention.\n* Regular use of medicines within the last 14 days before the first study intervention administration.\n* Special diets preventing the participants from eating the standard meals during the study.\n* Participant is unable or unwilling to comply with study restrictions.",true,"58 Years",{"count":130,"type":23},18,[53],"Researchers conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. It is often caused by high blood glucose levels.\n\nThe main purposes of the study are\n\n* To learn how the new nurandociguat tablet is absorbed and processed in the body (which is also known as \"pharmacokinetics \\[PK\\]\" measurement) compared to an old tablet when taken without food.\n* To learn how food affects the way the new tablet is absorbed and processed in the body when taken with a high-fat, high-calorie meal (like a big breakfast).\n\nTo do this, researchers will take blood samples from the participants and measure:\n\n* Maximum observed concentration (Cmax): the highest concentration of nurandociguat in participants' plasma\n* Area under the concentration time curve (AUC): the total amount of nurandociguat in participants' plasma over time Another purpose of this study is to learn how safe the new nurandociguat tablet is. Therefore researchers will monitor the number of participants who experience medical problems during this study. These medical problems are called adverse events.\n\nOnly healthy participants are taking part in this study. During the study, participants will receive 2 different types of nurandociguat tablets. These include the newly developed tablet and an existing tablet that has already been used in previous clinical studies. Each participant will receive 3 different treatments:\n\n* Treatment A: Nurandociguat old tablet, taken without food\n* Treatment B: Nurandociguat new tablet, taken without food\n* Treatment C: Nurandociguat new tablet, taken with food Researchers have proposed 5 optional dosing schemes for this clinical study, however only one scheme will be selected based on the findings from an ongoing clinical study. Afterwards, the study will start.\n* For Optional Scheme 1-3, each participant will receive the three treatments A, B, and C, one at a time, in a different order for each participant with a break of at least 7 days between treatments.\n* The Optional Schemes 4-5 follow a fixed sequence design. Each participant will first receive the nurandociguat new tablet formulation at a lower dose for 7 days, then receive the higher dose for in total 11 days. The higher dose will be administered for 5 days using the old tablet formulation followed by 6 days using the new tablet formulation. PK measurement will be assessed after 5 days of treatment with the old tablet formulation (without food), after 5 days of treatment with the new tablet formulation (without food) and after 6 days of treatment with the new tablet formulation (with food).\n\nThe researchers will closely monitor and manage any medical problems that the participants may have during the study.",[84],"2026-08-17",{"date":31,"type":34},{"date":137,"type":34},"2026-07-28",{"date":139,"type":23},"2026-11-04",{"name":40,"class":41},1,{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":150,"minAge":19,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":141},"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":152,"type":23},800,"OBSERVATIONAL","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.",[156],"Non-metastatic Castration-resistant Prostate Cancer",{"date":112,"type":34},{"date":159,"type":34},"2026-07-31",{"date":161,"type":23},"2030-01-30",{"name":40,"class":41},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":24,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"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":172,"type":23},148,[53],"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.",[176],"Hepatocellular Carcinoma",[178,179,180,181],"Hepatocellular carcinoma (HCC)","Locally advanced HCC","Metastatic HCC","Unresectable HCC",{"date":112,"type":34},{"date":184,"type":34},"2025-02-28",{"date":186,"type":23},"2031-08-31",{"name":40,"class":41},24,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100635781","single-arm-multi-center-study-evaluating-the-acceptance-and-feasibility-of-a-digital-remote-monitoring-tool-configured-for-patients-with-attr-cm-aco-monitor-100635781","NCT07557147","Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor","An Observational Study to Learn More About How Acceptable and Practical a Digital Remote Monitoring Tool (Luscii) is in People With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","ACO-MONITOR","Inclusion Criteria:\n\nFor patients:\n\n* Adult (≥18 years at the date of signing the informed consent form (ICF)).\n* Diagnosis of either wild-type or variant ATTR-CM.\n* Treatment with a drug approved for ATTR-CM, including newly prescribed therapy at the initial visit.\n* Signed ICF.\n* Access to and basic ability to use a personal smartphone with internet connectivity sufficient to install and operate the Luscii contact application.\n\nFor medical professionals:\n\n* Directly involved in the treatment or clinical management of the enrolled ATTR-CM participants and having access to and reviewing the Luscii-captured data for routine care.\n* Agreement to ICF within the EDC system for the purpose of using Luscii or to complete the HCP Experience Questionnaire.\n\nExclusion Criteria:\n\nFor patients:\n\n* Participation in an investigational program with interventions outside of routine clinical practice.\n* Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.\n\nFor medical professionals:\n\n* Any current affiliation with Luscii, Bayer, or any of their affiliates.",{"count":22,"type":23},"Transthyretin amyloid cardiomyopathy (ATTR-CM) is a heart condition caused by a protein called transthyretin (TTR) building up as amyloid in the heart muscle. This build-up makes the heart stiff and can lead to symptoms of heart failure, such as difficulty breathing, tiredness, swelling in the legs, and reduced ability to be physically active. ATTR-CM occurs in two forms: a hereditary (variant) type caused by changes in genes, and a wild-type form that usually develops with aging.\n\nPeople living with ATTR-CM are usually cared for at specialist centers, which may require them to travel long distances for appointments. Because of this, visits may be infrequent, and sometimes people only see their doctor once a year. This can make it harder to notice if the disease is getting worse or if there are problems with following their treatment plan. As a result, important changes in health may go unnoticed for several months, which can be risky.\n\nRemote monitoring offers a way for people living with ATTR-CM and their healthcare professionals to stay connected between clinic visits. Recent studies have shown that remote monitoring can help by making it easier to share health information, spot problems earlier, and support people to follow their treatment plans. This can lead to fewer hospital visits and better health outcomes.\n\nLuscii is a digital remote monitoring tool designed to help people living with ATTR-CM and their healthcare professionals stay connected between clinic visits. Luscii has two main parts: Luscii contact, a smartphone app that allows secure messaging and video calls, and Luscii vitals, a clinical software system that organizes health data and can alert the healthcare team if there are changes that need attention. Luscii vitals is a CE-marked medical device used within its approved purpose and does not replace a doctor's judgement.\n\nBy making it easier to communicate and share information, Luscii aims to support earlier detection of problems, better management of ATTR-CM, and a more positive experience for people living with this condition.\n\nThe main purpose of this observational study, called ACO-MONITOR, is to learn how acceptable and practical Luscii is for people living with ATTR-CM and their healthcare professionals. The study will take place in Austria, Germany, and Italy at three specialist centers. About 60 adults with a diagnosis of hereditary or wild-type ATTR-CM will be invited to take part. There will be no treatments given as part of this study. Instead, participants will use the Luscii app and devices at home to track their health and share information with their healthcare professionals. The study team will provide training on how to use Luscii and will help participants get started.\n\nThe study team will look at:\n\n* How quickly and how often participants and healthcare professionals use Luscii\n* How long Luscii is used by each person\n* How many times participants use Luscii after being reminded\n* How easy Luscii is to use, based on questionnaires for both participants and healthcare professionals\n\nThe study will last about 18 months in total, including a 6-month period to invite participants and a 12-month follow-up period. During the study, the study team will:\n\n* Support participants in using Luscii to share health information from home\n* Monitor how often and how easily Luscii is used\n* Ask participants and healthcare professionals about their experiences using Luscii, including what worked well and what could be improved\n* Record any problems or technical issues with using Luscii By collecting this information, the researchers hope to learn if Luscii can help improve communication, support earlier detection of health problems, and make it easier for people living with ATTR-CM to manage their condition between clinic visits.",[200],"Transthyretin Amyloid Cardiomyopathy (ATTR-CM)",[202],"Remote monitoring, Digital health, ATTR-CM","NOT_YET_RECRUITING","2026-08-13",{"date":206,"type":34},"2026-08-14",{"date":208,"type":23},"2026-08-31",{"date":210,"type":23},"2028-03-28",{"name":40,"class":41},3,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":24,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"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":221,"type":23},400,[53,26],"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.",[225,226,227],"Advanced Non-small Cell Lung Cancer","EGFR Mutation","HER2 Mutation","2026-08-10",{"date":230,"type":34},"2026-08-12",{"date":232,"type":34},"2021-10-25",{"date":234,"type":23},"2031-06-30",{"name":40,"class":41},92,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":127,"sex":244,"minAge":19,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":24,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":141},"100651646","phase-1-evaluation-of-possible-ways-the-body-may-process-two-different-forms-of-elinzanetant-in-healthy-study-participants-100651646","NCT07762287","Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants","A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants","Inclusion Criteria:\n\n* Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent.\n* Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.\n* Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg\u002Fm² (inclusive) at screening.\n* Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.\n* Signed informed consent obtained prior to any study-specific procedures.\n\nExclusion Criteria:\n\n* Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).\n* Known or suspected hypersensitivity to the study intervention(s) or their excipients.\n* Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).\n* Febrile illness within 2 weeks prior to first administration of study intervention.\n* History of clinically relevant seizures or endometrial tumors.\n* Use of moderate or strong CYP3A4 inhibitors or inducers within 4 weeks prior to first study intervention.\n* Participation in another clinical study within 30 days prior to first study intervention or concurrent participation in another trial.\n* Clinically relevant abnormal laboratory findings at screening, including elevated liver enzymes or positive virology tests.\n* Positive pregnancy test at screening or prior to dosing, or breastfeeding. Positive drug abuse or alcohol test at screening.\n* Smoking more than 10 cigarettes per day within 3 months prior to screening.\n* Special diets incompatible with study requirements or inability to comply with study procedures.","FEMALE","65 Years",{"count":79,"type":23},[53],"This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.\n\nAbout 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.",[250],"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women","2026-08-08",{"date":204,"type":34},{"date":254,"type":34},"2026-07-22",{"date":256,"type":23},"2027-02-22",{"name":40,"class":41},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":150,"minAge":19,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":24,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},"100627589","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.","A China Interventional Phase II, Single Arm, Multicenter Study Evaluating the Effectiveness and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment in Treatment-naïve Patients 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":267,"type":23},250,[26],"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 2years 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.",[271],"High-risk Localized Prostate Cancer","2026-08-06",{"date":228,"type":34},{"date":275,"type":34},"2026-04-27",{"date":277,"type":23},"2030-10-15",{"name":40,"class":41},23,{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":127,"sex":18,"minAge":19,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":24,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":141},"100650883","phase-1-phase-1-study-in-healthy-adults-to-see-how-sevabertinib-changes-metformin-levels-in-the-body-100650883","NCT07753252","Phase 1 Study in Healthy Adults to See How Sevabertinib Changes Metformin Levels in the Body","Phase 1, Open-label, Fixed-sequence Crossover Study to Investigate the Effect of Sevabertinib on the Pharmacokinetics of Metformin in Healthy Participants","Inclusion:\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, physical examination, 12-lead ECG, and clinical laboratory tests.\n* Participant is a non-smoker who has not used tobacco- or nicotine-containing products for at least 6 months before the first study intervention administration.\n* Body mass index (BMI) within the range 18.5 to 30.0 kg\u002Fm² (inclusive) and a body weight of at least 50 kg at screening.\n* Female, of non-childbearing potential only (see Section 10.4.1). Females must not be pregnant or breastfeeding, and must be documented as of non-childbearing potential (WONCBP). A negative pregnancy test is required\n\nExclusion:\n\n* Existing relevant diseases of vital organs (e.g., cardiovascular, liver, gastrointestinal, renal, respiratory, or central nervous system diseases) or other organs (e.g., diabetes mellitus).\n* Known history of hypersensitivity to sevabertinib, metformin, or any of their excipients.\n* History of known or suspected malignant tumors.\n* Regular use of medicines within 4 weeks prior to screening.\n* Administration of strong or moderate inhibitors or inducers of CYP3A4, P-gp, MATE1\u002F2-K, or OCT2 within 4 weeks or 5 half-lives prior to the first study intervention administration, whichever is longer.\n* Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks or 5 half-lives of the prescription medication prior to the first study intervention administration (whichever is longer), except for occasional use of acetaminophen (up to 2 g\u002Fday) within 7 days prior to the first study intervention administration.\n* Use of supplements or herbal remedies within 2 weeks prior to the first study intervention administration, except for vitamins.\n* Excessive intake of methylxanthine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the investigator. Excessive intake of methylxanthine is defined as the regular consumption of more than 600 mg of caffeine per day (e.g., \\>5 cups of coffee) or would likely be unable to refrain from the use of methylxanthine-containing beverages and food during confinement at the clinic.\n* Clinically relevant findings in the ECG such as a second- or third-degree atrio-ventricular block, prolongation of the average QRS complex over 120 msec or of the QTc (Fridericia correction) interval over 450 msec or any other finding which in the opinion of the investigator will hinder participant's safety at screening or check-in (Day-1).\n* Positive results for hepatitis B virus surface antigen, hepatitis B virus core antibody, hepatitis C virus antibodies, human immunodeficiency virus antibodies 1 and\u002For 2 at screening.\n* Estimated creatinine clearance \\\u003C90 mL\u002Fmin according to Cockcroft-Gault formula (at screening).\n* Positive urine drug and cotinine screening at screening or check-in (Day-1).\n* Positive urine alcohol test at screening or check-in (Day-1).\n* Unable\u002Funwilling to comply with study restrictions.","55 Years",{"count":289,"type":23},40,[53],"This Phase 1 study in healthy adults looks at whether sevabertinib changes how the body handles metformin. The study is based on the idea that sevabertinib may block kidney transporters (proteins that move medicines) called MATE1 and MATE2-K, which help remove metformin from the body. Each participant receives a single dose of metformin alone, and later receives sevabertinib for several days and then takes metformin again while still taking sevabertinib. The study aims to learn how metformin, gets into, moves through, and out of the body when it is administered with sevabertinib. This is called \"Pharmacokinetics\". Furthermore, the study will help us learn about the safety and tolerability of sevabertinib and metformin when given alone or in combination.",[293],"Healthy Participants","2026-08-04",{"date":296,"type":34},"2026-08-07",{"date":298,"type":23},"2026-08-21",{"date":300,"type":23},"2026-09-28",{"name":40,"class":41},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":150,"minAge":19,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":322,"locationsCount":141},"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":79,"type":23},"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.",[313,314],"Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Low-volume Metastasis",[316],"mHSPC",{"date":318,"type":34},"2026-08-03",{"date":320,"type":34},"2024-11-18",{"date":186,"type":23},{"name":40,"class":41},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":24,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"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":331,"type":23},104,[53],"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.",[335],"Advanced Solid Tumors Harboring KRAS G12C Mutation",{"date":318,"type":34},{"date":338,"type":34},"2024-11-08",{"date":340,"type":23},"2027-07-30",{"name":40,"class":41},10,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":150,"minAge":350,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":141},"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":352,"type":23},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.",[156,355],"Metastatic Hormone-sensitive Prostate Cancer",{"date":318,"type":34},{"date":358,"type":34},"2024-09-25",{"date":360,"type":23},"2028-06-30",{"name":40,"class":41},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":77,"enrollmentInfo":369,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":371,"conditions":372,"keywords":375,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":141},"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":370,"type":23},200,"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.",[373,374],"Retinopathy of Prematurity","Preterm Infants",[376],"ROP",{"date":318,"type":34},{"date":379,"type":34},"2024-03-05",{"date":381,"type":23},"2027-04-30",{"name":40,"class":41},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":127,"sex":18,"minAge":19,"maxAge":287,"enrollmentInfo":390,"targetDuration":4,"studyType":24,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":141},"100641223","phase-1-a-study-to-learn-about-how-safe-bay3389934-is-and-how-it-affects-blood-clotting-when-given-alone-or-with-aspirin-in-healthy-participants-100641223","NCT07652723","A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants","Open-label Randomized, Three-fold Cross-over, Single-center Interaction Study to Investigate the Influence of Multiple Doses of Acetylsalicylic Acid (ASA) (Aspirin) on the Pharmacodynamics of BAY 3389934 in Healthy Participants.","Inclusion Criteria:\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring.\n* Body mass index within the range 18.0 to 29.9 kg\u002Fm\\^2 (inclusive) at screening visit.\n* Male or female (Women of Non-Childbearing Potential \\[WONCBP\\]) Contraceptive use by participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nMale participants: Participants are eligible to participate if they agree to the following during the study intervention period up to at least 1 day after end of infusion of study intervention to ensure sufficient elimination of BAY3389934 (5 times the elimination half-life of BAY3389934 is approximately 5 hours):\n\n* Refrain from donating sperm\n\nPLUS, either:\n\n* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n* Must agree to use contraception \u002Fbarrier as detailed below:\n\n  * Agree to use a male condom with female partner use of an additional highly effective contraceptive method with a failure rate of \\\u003C 1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant\n  * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person\n* Female participants: A female participant is eligible to participate if she is a WONCBP.\n* A WONCBP must have a negative highly sensitive pregnancy test (serum) within 24 hours before the first dose of study intervention, the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator.\n* Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.\n* Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.\n* Known severe allergies, e.g. allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions.\n* Aspirin hypersensitivity\u002F allergy.\n* Febrile illness within 2 weeks before the start of the first study intervention.\n* Known or suspected liver disorders and bile secretion\u002Fflow (cholestasis, also history of it).\n* History of Morbus Meulengracht (Gilbert´s syndrome) or total bilirubin levels above ULN at screening.\n* History of known or suspected malignant tumors.\n* Tendency to develop keloids or major scars after injuries.\n* Participants experienced surgery (6-months prior to first study intervention), or IM injection (2-week prior to first study intervention).\n* Known disorders with increased bleeding risk (e.g., periodontosis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, vascular malformations and also history of it).\n* Known sensitivity to common causes of bleeding or bruises (e.g., nasal).\n* Known congenital or acquired coagulation disorders (e.g. von Willebrand's disease, hemophilia, platelet dysfunction, etc.).",{"count":391,"type":23},16,[53],"The study treatment BAY3389934 is under development for people with blood clotting problems that occur due to sepsis. Sepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. It can eventually lead to tiny blood clots formation throughout the body. BAY3389934 aims to work by blocking two important blood clotting proteins, called Factor IIa (thrombin) and Factor Xa, both of which help in blood clotting. By blocking them, BAY3389934 may slow down or stop excessive clotting. Aspirin is a drug that prevents platelets from clumping together. People with sepsis are often given aspirin for underlying heart-related problems. Since aspirin and BAY3389934 both affect how the blood clots, each in a different way, it is important to check whether using them together is safe and whether they change each other's effects on blood clotting. The main purpose of this study is to find out how safe BAY3389934 is when given together with aspirin and to see how the two affect blood clotting in healthy participants. To do this, the researchers will assess the number and severity of medical problems in healthy adult participants after receiving BAY3389934 alone and in combination with aspirin and compare them with the medical problems when participants received either drug alone. 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 are related to study treatments. All participants will receive a single dose of aspirin tablet prior to the study. Researchers will check their response to decide whether they can participate in the study. Eligible participants will then receive the following three treatments, each at different time and in a different order assigned randomly. Treatment A: • no treatment the day prior to receiving study treatment. • BAY3389934 as an infusion into a vein on Day 1. Treatment B: • a single high-dose aspirin tablet on the day prior to receiving study treatment. • a single-low dose aspirin tablet on Day 1. Treatment C: • a single high-dose aspirin tablet on the day prior to receiving study treatment. • a single low-dose aspirin tablet followed by BAY3389934 4 hours continuous infusion into a vein on Day 1. There will be a gap of 3 days after Treatment A, and 14 days after Treatments B and C, when participants will not be given any treatment. Each participant will be in the study for around 2 months with up to 6 visits to the study clinic. They will visit the study clinic: • twice, before the treatment starts •once, during each of the three treatment periods •once, at the end of the treatment During the study, the doctors and their study team will •check participants' health by performing tests such as blood and urine tests, measuring blood pressure, heart rate and checking heart health using an electrocardiogram (ECG). •ask the participants questions about how they are feeling and any adverse events they are having. In this study, the participants will not benefit from taking of BAY3389934. However, the study will provide information on how BAY3389934 may be helpful in people with blood clotting problems caused due to sepsis.",[395],"Drug-drug Interaction","2026-07-30",{"date":318,"type":34},{"date":399,"type":34},"2026-05-29",{"date":401,"type":23},"2026-10-15",{"name":40,"class":41},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":24,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":421,"leadSponsor":423,"locationsCount":424},"100637645","phase-2-a-study-to-test-how-well-bay-3670549-works-and-how-safe-it-is-in-patients-with-atrial-fibrillation-100637645","NCT07625215","A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation","A Placebo-controlled, Parallel-group, Double Blind, Randomized, Multi-cohort Phase 2 Study to Investigate Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BAY 3670549 in Adult Participants With Atrial Fibrillation.","CARDIOVERT","Inclusion Criteria:\n\n* Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.\n* Participant is hemodynamically stable and does not require emergency cardioversion, as determined by the investigator.\n* Participant has a current episode of atrial fibrillation (AF) ongoing for at least 3 hours and no more than 30 days at the time of randomization.\n* Participant has an indication for electrical cardioversion of AF, as determined by the investigator according to standard clinical practice and national\u002Finstitutional guidelines.\n* At randomization, successful initiation and achievement of therapeutic levels of anticoagulation therapy, as well as completion of imaging evaluation for left atrial thrombi, as appropriate for the duration of the AF episode and risk for the participant according to national guideline and institution-specific routine practice.\n* BMI within range \\[18 - 39.9\\] kg\u002Fm2.\n* Contraceptive use by participants or participant partners should be consistent with the study protocol and local regulations regarding the methods of contraception for those participating in clinical studies.\n* Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Willing and able to comply with the receipt, home use, and return of the continuous ECG recording device, as well as with the participation in scheduled telephone follow-up assessments.\n\nExclusion Criteria:\n\n* Current atrial flutter (AFL) or combined AF\u002FAFL\n* Contraindication for electrical cardioversion on planned treatment day\n* Documented severely dilated left atrium (left atrial diameter, LAD \\>5 cm) measured by any modality within the 6 months prior to screening; if several values are available, the most recent one shall be reported. If left atrium diameter was not measured in the last 6 months or a major cardiovascular event occurred within the last 6 months, a new measurement must be done at screening\n* Unsuccessful conversion of current AF episode (pharmacologically or electrically)\n* Known severe valvular heart disease (e.g., severe mitral regurgitation, severe aortic stenosis)\n* Patients with NYHA Class ≥ III heart failure, or with active management of acute heart failure decompensation on treatment day.\n* History within the preceding 3 months prior to randomization of any of the following events, or any other significant cardiovascular event as judged by the investigator:\n\n  * Stroke\n  * Myocardial infarction\n  * Unstable angina pectoris or other signs of myocardial ischemia\n  * Cardiac surgery\n  * Transcatheter valve replacement\n  * Percutaneous coronary intervention (PCI)\n  * Coronary artery bypass graft (CABG) or other revascularization procedure\n* Severe renal impairment, i.e., estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m² (using CKD-EPI formula) or requiring dialysis\n* Severe hepatic impairment, i.e. Child Pugh Class C\n* Use of anti-arrhythmic class I or III drugs within 5 half-lives before study drug administration (oral amiodarone in the previous 3 months)\n* Hypertension with SBP ≥ 180 mmHg or hypotension (SBP \\\u003C 90 mmHg) at randomization (based on the second BP measurement)\n* Stressor-associated AF, i.e., in the setting of an acute and reversible stressor (e.g., cardiac surgery, myocarditis, endocarditis, sepsis, pneumonia, etc.). This includes ablation procedure within the preceding one month prior to randomization.","85 Years",{"count":413,"type":23},360,[26],"The main goal of this study is to find out how well BAY 3670549 works, how safe it is, how well people can tolerate it, and how the body handles the medicine. The study will compare BAY 3670549 to a placebo (a dummy treatment with no active medicine) in people with AF who need a treatment called electrical cardioversion.\n\nElectrical cardioversion is a procedure that helps the heart return to a normal rhythm. In this study, each participant will get a single intravenous (IV) infusion of either BAY 3670549 or a placebo. Participants will then be observed to see whether the heart rhythm returns to a normal rhythm. If it does not, electrical cardioversion can still be performed as planned. The study will look at how many participants return from AF to a normal rhythm, without needing electrical cardioversion and how long it takes. It will also show how many participants experience medical problems after treatment and how BAY 3670549 move into, through and out of the participants' body.\n\nThe total duration of the study for an individual participant may be up two months.\n\nThe findings from this study may contribute to the development of a new treatment option for people with AF.",[417],"Atrial Fibrillation","2026-07-29",{"date":396,"type":34},{"date":208,"type":23},{"date":422,"type":23},"2030-05-16",{"name":40,"class":41},27,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":24,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},"100636495","phase-2-a-study-of-ab-1005-gene-therapy-in-japanese-adults-with-moderate-parkinsons-disease-j-regenerate-pd-100636495","NCT07566429","A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)","A Phase 2, Open-label, Single Group, Fixed-dose Study to Evaluate the Safety and Efficacy of a Single Bilateral Intraputaminal Administration of AB-1005 (AAV2-GDNF Gene Therapy) in Japanese Participants With Moderate Stage Parkinson's Disease","Inclusion Criteria:\n\n* Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent\n* Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria:\n\n  1. Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability\n  2. Presence of motor fluctuations as measured by the PD Motor Diary\n  3. Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening\n  4. Responsiveness to levodopa therapy\n\nExclusion Criteria:\n\n* Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis\n* Presence or history of significant vascular and\u002For cardiovascular disease\n* Presence of clinically significant cognitive impairment\n* Presence or history of psychosis or impulse control disorder\n* History of malignancy other than treated cutaneous squamous or basal cell carcinomas\n* Presence of clinically relevant conditions that could compromise surgical suitability and\u002For subject safety\n* Contraindication to magnetic resonance imaging and\u002For use gadolinium-based contrast agents\n* Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure\n* Chronic immunosuppressive therapy","75 Years",{"count":434,"type":23},8,[26],"The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).",[438],"Parkinson Disease",[440],"Gene therapy",{"date":418,"type":34},{"date":443,"type":23},"2027-01-25",{"date":445,"type":23},"2032-12-15",{"name":40,"class":41},6,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":455,"maxAge":49,"enrollmentInfo":456,"targetDuration":4,"studyType":24,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":467},"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",{"count":51,"type":23},[53],"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.",[460],"Stable Coronary Artery Disease",{"date":418,"type":34},{"date":463,"type":23},"2026-10-01",{"date":465,"type":23},"2027-05-07",{"name":40,"class":41},4,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":432,"enrollmentInfo":475,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":497},"100618333","a-us-study-that-observes-how-parkinsons-disease-changes-over-time-in-patients-who-still-have-movement-symptoms-despite-taking-parkinsons-medications-100618333","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.",{"count":476,"type":23},300,"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.",[479],"Parkinson's Disease",[481,482,483,484,485,486,487,488,489],"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","2026-07-27",{"date":137,"type":34},{"date":493,"type":34},"2026-07-21",{"date":495,"type":23},"2033-06-01",{"name":40,"class":41},26,{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":150,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":141},"100624180","a-study-to-learn-about-real-world-utilization-and-outcomes-of-darolutamide-and-other-androgen-receptor-pathway-inhibitors-arpis-for-newly-diagnosed-metastatic-hormone-sensitive-prostate-cancer-de-novo-mhspc-in-us-urology-clinics-100624180","NCT07406282","A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics","Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA","Double-DARE","Inclusion Criteria:\n\n* Male patients with evidence of de novo mHSPC during the study period\n* Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis\n* Age ≥18 years at index date (ARPI initiation for mHSPC)\n* Initiation of ADT and\u002For docetaxel therapy within ±90 days from index date\n* At least 90 days of EMR activity prior to the index date\n* At least 90 days of EMR activity post-index, unless the patient died earlier.\n\nExclusion Criteria:\n\n* History of other primary cancers (except non-melanoma skin cancer)\n* Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date\n* Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis\n* Clinical trial participation during the study period.",{"count":507,"type":23},1400,"Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a \"triplet\" combination with ADT and docetaxel. It is also used in a \"doublet\" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.",[510,511],"Prostatic Neoplasms","Metastatic Hormone-Sensitive Prostate Cancer","2026-07-03",{"date":514,"type":34},"2026-07-07",{"date":516,"type":34},"2025-07-22",{"date":518,"type":23},"2026-09-30",{"name":40,"class":41},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":546},"100615368","study-on-hydrotalcite-for-relief-of-acid-symptoms-due-to-acid-rebound-after-stopping-long-term-ppi-therapy-100615368","NCT07291700","Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy","A Non-Interventional Study to Investigate the Effectiveness of Hydrotalcite to Relieve Acid-Related Symptoms Due to an Acid Rebound After Discontinuation of a Non\u002FNo Longer Indicated Long-Term PPI Therapy.","Eligibility Criteria:\n\nAdult female or male subjects aged ≥ 18\n\n* Subjects who have discontinued daily PPI therapy (≥ 8 weeks of therapy) for which there is no current indication according to guidelines and approval status, e.g.\n\n  * irritable bowel syndrome\n  * subjects who receive Non-Steroidal Anti-Inflammatory drug (NSAID) treatment with no warning signals\\* regarding ulcers\n  * polymedication\\*\\* with no warning signals\\* or side effects regarding ulcers\n  * unclarified upper abdominal discomfort\n  * mild forms of GERD; like Non-Erosive Reflux Disease (NERD), Los Angeles (LA) grade A\u002FB esophagitis\n* Suffer from acid-rebound due to a discontinuation of a non\u002Fno longer indicated long-term PPI therapy (≥ 8 weeks of therapy)\n* No endoscopically diagnosed GERD\\*\\*\\*\n* No indication for a PPI-therapy according to guidelines.\n\nExamples for guideline recommendations for a PPI-therapy:\n\n* moderate - severe forms of reflux esophagitis\n* gastric ulcer, duodenal ulcer\n* Helicobacter pylori eradication\n* moderate\u002Fsevere forms of GERD - Los Angeles (LA) grade C\u002FD esophagitis\n* Zollinger-Ellison-Syndrome\n\nNo Talcid® contraindications or warnings as:\n\n* pregnancy and lactation\n* severe renal impairment\n* hypophosphatemia\n* existing myasthenia gravis\n* impaired renal function\n* Alzheimer's disease or other forms of dementia\n* patients under low-phosphate diet\n* hypersensitivity to the ingredients of Talcid®\n\n  * Subjects who voluntarily agree to use Talcid® Chewable Tablets for relief of acid-related symptoms due to acid-rebound\n  * Decision to initiate on-demand treatment of acid-related symptoms due to acid-rebound with Talcid® was made as per investigator's routine recommendation practice and by the subject\n  * Subject purchases Talcid® for her\u002Fhis own use\n  * Signed informed consent\n  * No participation in an investigational program with interventions outside of routine clinical practice\n  * No contraindications according to the local marketing authorization\n\n    \\* Warning signals:\n  * Age \\> 60 (with one additional warning signal)\n  * Previous history or family history of ulcers\n  * Helicobacter pylori positive status \\*\\* Polymedication: defined as at least five medicinal products at the same time for a continuous therapy \\*\\*\\* Endoscopy: LA grade C\u002F D esophagitis, Barrett esophagus, peptic stricture; pH- Impedance measurement: acid exposure \\> 6%\n\nExclusion Criteria: not applicable",{"count":528,"type":23},167,"This observational study aims to explore the effectiveness of hydrotalcite, marketed as Talcid, in alleviating acid-related symptoms that occur due to an acid rebound after discontinuing a non-\u002Fno-longer-indicated long-term proton pump inhibitor (PPI) therapy. PPIs are commonly prescribed to reduce stomach acid to alleviate symptoms such as heartburn and for the treatment of, for example, duodenal and stomach ulcers. Discontinuation after prolonged use can lead to a rebound effect where dyspeptic complaints such as heartburn occur once the medication is stopped. This study is conducted in Germany and involves adult participants who have stopped using non-\u002Fno-longer-indicated PPIs and are experiencing these rebound symptoms.\n\nHydrotalcite is recommended by physicians as an on-demand treatment for managing acid-related symptoms. The study seeks to gather real-world evidence on its effectiveness, consumer experience, and acceptance to support claims about its use to relieve acid related symptoms due to an acid rebound. Participants will use hydrotalcite as needed (on demand when symptoms occur) over a four-week period, and will record information about symptom relief, the time it takes for relief to occur, and overall satisfaction with the treatment. Additionally, their doctors rate the suitability, tolerability, and effectiveness of the treatment.\n\nThe primary objective of the study is to assess the effectiveness of hydrotalcite by the number and percentage of patients not having used PPIs during the study period. Secondary objectives include evaluating relief from specific symptoms (heartburn, reflux, epigastric pain, feeling of fullness, and nausea, as well as improvements in quality of life due to hydrotalcite treatment. The study will also assess participants' satisfaction with hydrotalcite as an on-demand treatment and its suitability for managing these symptoms.\n\nParticipants will be adults aged 18 and older who have discontinued a long-term PPI therapy (≥8 weeks) for which there is no current indication according to indication and guidelines and who are experiencing acid rebound symptoms after stopping the PPI therapy. The study will exclude individuals with endoscopically diagnosed gastroesophageal reflux disease (GERD) (LA grade C\u002F D esophagitis) or those with hydrotalcite contraindications or warnings, such as pregnancy, severe renal impairment, or allergies to its ingredients.\n\nData will be collected through standardized questionnaires completed by participants after they consent to join the study. The study aims to enroll approximately 167 participants, anticipating a 40% drop-out rate, to ensure around 100 completed questionnaires. Statistical analyses will be exploratory and descriptive, focusing on categorical and continuous variables.\n\nThe study is designed to be observational, meaning there will be no direct intervention or randomization of participants. Instead, it will collect primary data directly from participants and investigators across approximately twenty sites in Germany. The results will provide valuable insights into the effectiveness of hydrotalcite in managing acid rebound symptoms and may inform future treatment recommendations for participants discontinuing long-term PPI therapy.",[531],"Gastroesophageal Reflux",[533,534,535,536,537,538,539],"Heartburn,","Gastroesophageal Reflux,","Nausea,","Epigastric Pain,","Feeling of Fullness,","Acid-related Symptoms,","Acid Rebound",{"date":514,"type":34},{"date":542,"type":34},"2025-11-18",{"date":544,"type":23},"2026-10-31",{"name":40,"class":41},2,{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":141},"100611044","a-study-to-learn-about-the-use-of-acoramidis-in-patients-with-a-heart-condition-called-transthyretin-amyloid-cardiomyopathy-attr-cm-in-a-real-world-setting-100611044","NCT07235462","A Study to Learn About the Use of Acoramidis in Patients With a Heart Condition Called Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in a Real-world Setting","ACO-REAL - A Non-interventional Study Providing Insights Into the Use of Acoramidis in Patients With ATTR Amyloidosis With Cardiomyopathy (ATTR-CM) in Routine Clinical Practice","ACO-REAL","Inclusion Criteria:\n\n* \\- Adults (≥18 years at the date of signing the informed consent form (ICF)).\n* Diagnosis of either wild-type or variant ATTR-CM.\n* Signed ICF.\n* Decision to initiate treatment with acoramidis was made as per treating investigator's routine treatment practice before signature of ICF.\n* Treatment start with acoramidis within 90 days after signing the ICF, with the possibility of starting acoramidis on the same day as signing the ICF.\n\nExclusion Criteria:\n\n* Participation in an investigational trial with interventions outside of routine clinical practice, except for participation in potential sub-studies related to this observational study. Please note: In addition to this observational study, separate sub-studies may be conducted to collect additional data. Participation in these sub-studies is voluntary and will be governed by separate protocols and informed consent processes. The main observational study does not include interventional procedures beyond routine clinical practice.\n\n  * Contra-indications according to the local SmPC of acoramidis.\n  * Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.",{"count":556,"type":23},2000,"Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a serious and life-threatening condition where a protein called transthyretin (TTR) misfolds and builds up as amyloid fibrils in the heart muscle. This buildup causes the heart to become stiff, leading to restrictive cardiomyopathy and progressive heart failure. There are two forms of ATTR-CM: a hereditary or 'variant' form (vATTR-CM) caused by a gene mutation, and a 'wild-type' form (wtATTR-CM) which is associated with aging. Because its symptoms can be similar to other heart conditions, ATTR-CM is often diagnosed late. However, recent advances in medical imaging are helping doctors to identify the disease earlier. Acoramidis is a new medication designed to treat ATTR-CM. It works by stabilizing the TTR protein, preventing it from misfolding and forming the harmful amyloid deposits. Acoramidis has been shown to be effective and safe in a major clinical trial (the ATTRibute-CM study), which led to its approval for use in both the United States and Europe. While clinical trials provide valuable information, data on how a new medicine performs in everyday clinical practice is also very important. This type of information is called real-world evidence. Currently, there is limited real-world information about the use of acoramidis. This study, called ACO-REAL, is an observational study, which means researchers will observe patients who are receiving acoramidis as part of their normal clinical care, without introducing any experimental interventions. The study will take place in approximately 20 European countries and aims to enroll up to 2,000 adults who have been diagnosed with either wild-type or variant ATTR-CM and are starting treatment with acoramidis. This includes patients who have not been treated for ATTR-CM before, as well as those who have been treated with other therapies. The main goals of the study are to understand the characteristics of patients being treated with acoramidis and to document how the treatment is used in routine medical practice. The study will also collect information on the safety of acoramidis. Furthermore, researchers will assess how the treatment affects patients' heart function, their functional capacity (such as their ability to walk), their overall health status, and their quality of life. The study will also track how often patients need to use healthcare resources like hospitals or emergency rooms. This information will help to improve the understanding and management of ATTR-CM in a real-world setting, ultimately aiming to optimize care for patients with this progressive disease.",[200],[560,561,562,563],"Transthyretin Amyloidosis","Cardiomyopathy","Heart Failure","Wild-type Amyloidosis",{"date":514,"type":34},{"date":566,"type":34},"2025-10-29",{"date":568,"type":23},"2028-07-03",{"name":40,"class":41},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":577,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":581,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":582,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":583,"locationsCount":4},"100574645","expanded-access-to-provide-sevabertinib-bay-2927088-for-the-treatment-of-locally-advanced-or-metastatic-nsclc-with-her2-mutation-100574645","NCT06761976","Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation","An Expanded Access Program to Provide Oral Sevabertinib (BAY 2927088) in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring an HER2 (Human Epidermal Growth Factor Receptor 2) Activating Mutation","Inclusion Criteria\n\n* Signed and dated written informed consent\n* Age ≥18 years\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Documented disease progression after treatment with at least one prior systemic therapy for advanced disease\n* Documented HER2 activating mutation\n* Expected minimum life expectancy of 12 weeks\n* Performance status of 0 or 1\n* Participants must be able to take oral medication\n* Blood test results within certain ranges\n* Adequate coagulation as assessed by lab tests or on stable anticoagulation treatment\n* Adequate cardiac function\n* Negative serum pregnancy test in women of childbearing potential within 72 hours of the first dose\n* Ability to receive prescription of loperamide from the treating physician\n\nExclusion Criteria\n\n* Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy\n* Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2\n* Symptomatic or unstable brain metastases\n* Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP\n* Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease\n* Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation\n* Any uncontrolled intercurrent illness or condition including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, ongoing or active infection (including active clinical tuberculosis), renal transplant or psychiatric illness\u002Fsocial situations that would limit compliance\n* Pregnancy or lactation\n* History of clinically significant cardiac disease","EXPANDED_ACCESS","The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option.",[225,580],"Cancer","AVAILABLE",{"date":514,"type":34},{"name":40,"class":41},""]