Clinical trials

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. Parkinson'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. While 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. The 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: * Sociodemographics (e.g. age, gender, race/ethnicity, insurance provider). * Medical history and vital signs (e.g. comorbidities, family history of Parkinson's, height, weight, blood pressure). * Medications and treatments (e.g. Parkinson's and non-Parkinson's medications and other treatments, rehabilitation therapy sessions, use of mobility assistance devices). * Movement symptoms (e.g. tremor, slow movement, balance). * Non-movement symptoms (e.g. cognition, mood, sleep, activities of daily living). * Molecular data (e.g. genetics, α-synuclein). * Burden of care (e.g. economic cost). Data 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/non-movement symptoms, and questionnaires completed by the care partner. Data will be collected from December 2025 to December 2032. Each participant may be followed for up to 5 years.

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. The 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.

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. Epidermal 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/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or 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. The main purpose of this study is to learn: Escalation, Backfill, and Expansion Part: * How safe is BAY2927088 for the participants? * What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants? * How does BAY2927088 move into, through, and out of the bodies of the participants? For this, the researchers will measure the followings: * The number of participants with medical problems, also called adverse events and serious adverse events, and their severity * The number of participants who discontinue study treatment due to an adverse event. * 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 * Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level * The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088 * The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part * How well does BAY2927088 work in participants? For this, the researchers will measure the following: • 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. This study has 4 parts: * The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive. * 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. * The expansion part aims to determine the dose of BAY2927088 to be tested in further studies. * The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well. The 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/tablet 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. During the study, the study team will: * take blood and urine samples, * check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans, * check the participants' overall health and heart health, * ask the participants questions about how they are feeling and what adverse events they are having. An 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.

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. The 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. Participants 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. During 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.

Researchers are looking for a better way to treat and prevent cardiac surgery-associated acute kidney injury (CSA-AKI) in people who undergo heart surgeries. CSA-AKI is a common complication in people undergoing heart surgeries, where the kidneys stop working properly. CSA-AKI risk factors include older age and alongside diseases such as kidney disease and diabetes. Longer time with heart-lung machine during heart surgeries also increases the occurrence of CSA-AKI. In this study, researchers want to better understand how CSA-AKI develops (also known as the mechanisms involved in the development of CSA-AKI) in people under heart surgeries, the presence of certain biomarkers in the body, especially with a focus on the early hours and days after the surgery. (A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.) These biomarkers will be compared in participants who develop CSA-AKI within a week after heart surgery with the participants who do not develop CSA-AKI. The relationship with biomarkers will be determined by examining participants' blood and urine samples before and after surgery. This may help researchers better understand CSA-AKI, identify potential treatment targets and develop possible treatments to prevent CSA-AKI. Participants in this study will be people who have heart surgery already scheduled by their own doctors and have a risk of developing CSA-AKI. Participants will not receive any treatment as part of this study. They will undergo the heart surgery and related medical processes as per their normal medical treatment and management. Each participant will be in the study for up to 2 months. During the study, the doctors and their study team will: * collect participants' blood and urine samples before and after surgery * assess participants' medical records and test reports during hospitalization * monitor overall health of the participants throughout the study

This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment. The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).

This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed. Chronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model. The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine. Finerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes. The main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on: * Clinical characteristics of participants, including their medical history related to CKD and T2D. * Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN). * Participants' glucose, hemoglobin and potassium levels. The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment. Data will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).

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). Prostate 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. This 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. The 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. To 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.

Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid. TTR amyloid gets deposited in the heart wall and stops it from pumping blood properly, which may lead to heart failure. The breakage in TTR protein can be age-related (wild-type ATTR-CM), or genetic (variant ATTR-CM). The study drug, acoramidis, works by attaching itself to the TTR protein, making TTR more stable and less likely to break down and form amyloid (clumps). This helps to slow down the progression of the disease, improve heart function, and increase the TTR levels in the blood. Acoramidis is an approved treatment for wild-type or variant ATTR-CM in Europe and the United States. Tafamidis is another drug that stabilizes TTR and prevents it from breaking down. In this study, acoramidis will be studied in participants with ATTR--CM who were previously treated with tafamidis. The main purpose of this study is to assess the change in blood TTR levels after participants are switched from tafamidis to acoramidis. This will be studied to understand if acoramidis causes an increase in blood TTR levels beyond the levels achieved with tafamidis. For this, the researchers will measure the change in the levels of TTR protein in participants' blood after 6 months of the treatment with acoramidis, or earlier if a participant stops the treatment before reaching that six-month mark. All participants will continue taking tafamidis during the screening period. In the treatment period of the study, participants will take acoramidis as two tablets twice daily by mouth, for up to 6 months. At the start of this study, the study doctors will review each participant's medical history and check their overall health. The study doctors will perform electrocardiograms (ECG), and measure blood pressure and heart rate. Researchers will also take blood and urine samples from the participants to measure levels of TTr, NT-proBNP, hs-TnT, hs-CRP, RBP4, eGFR, creatinine, cystatin-C, UACR, and TSH at the start of the study, and at various time points thereafter (during the study) to assess heart, kidney and thyroid function. There will be a total of 9 study check-ins. Participants will visit the study site twice: at screening and at the end of treatment period. A study nurse will visit the participant's home 6 times, at the start of treatment, Weeks 1, 2, 3 and 4, then again at 3 months. The final check-in will be done by phone. The study doctors will monitor the health of the participants regularly for any medical problems during follow-up visits. Participants will know the treatment they will receive during the study. Each participant could be in the study for about 8 months.

Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth. The study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively. The main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD. To understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as "treatment emergent adverse events" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR). In this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study. The participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants \<6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will: * have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured * have blood samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography * answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer * for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback. 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 doctors will check the participants' health a month after the participants take their last treatment.

This is an observational study of children with mild, moderate, or severe hemophilia A who are receiving damoctocog alfa pegol, and are between 7 to \<12 years of age at the time of enrolment. Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study. In this study, the data will be collected from participants who are receiving their usual treatment with damoctocog alfa pegol as prescribed by their doctor. These children have previously received damoctocog alfa pegol or other factor 8 (FVIII) products. Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. At times, there is spontaneous bleeding into the joint spaces that leads to joint damage. The drug observed in this study, damoctocog alfa pegol, is approved for doctors to prescribe to children who are at least 7 years old with hemophilia A. It is used to prevent or treat bleeding episodes and works by replacing missing FVIII in the body of people with hemophilia A. The participants will receive damoctocog alfa pegol as prescribed independently by their own doctors during routine practice, not as a part of the study. Participants may choose to enroll in the study at any time after their doctor has prescribed damoctocog alfa pegol to prevent bleeding episodes. The main purpose of this study is to learn more about how a treatment with damoctocog alfa pegol works to prevent bleeding episodes in routine medical practice. To answer this question, doctors will collect: * information about bleeding episodes including the type and the location of the bleed * information about the treatment with damoctocog alfa pegol and other FVIII products * the overall health status of the participants Data will be collected from participants over two years after they enroll in the study or until they choose to leave the study or switch to another hemophilia A treatment. Historical data will come from the participants' medical records or by interviewing the patient and parent/ legal guardian. The children's parents/ guardians will be asked to maintain a health diary to record details of bleeding episodes and treatment with damoctocog alfa pegol. The children's parents/ guardians will also be asked to answer a questionnaire (Hemo QoL-SF and PedHAL) to assess the effect of hemophilia on their child's daily life. In this study, only available data from routine care will be collected. No additional visits or tests are required as part of this study.

The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors. For this, the researchers will study and analyze: * the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity. * the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose. * the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses. * the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses. Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse. The study participants will take part in one of the eight distinct groups or "intervention cohorts" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase. Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems. Participants will visit the study site: * at least twice before the treatment starts * multiple times when they start taking the treatment * once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason During the study, the doctors and their study team will: * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram * check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan * take tumor samples The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.

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. The 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/or 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. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, 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. The 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. To 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. The 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. To 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. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The 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. In the visit, the study team will: * have their blood pressure, heart rate, temperature, height and weight measured * have blood and urine samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) * answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer * answer questions about how they are feeling, or have their parents or guardian's answer * 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. The doctors will check the participants' health about 30 days after the participants take their last treatment.

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. People 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.

This observational study aims to better understand the risk of serious heart-related problems in older men with advanced prostate cancer who are treated with certain commonly used medicines. Prostate cancer is the most commonly diagnosed malignancy in United States (US) men and a leading cause of cancer mortality, with disease progression spanning multiple clinical states, including non-metastatic castrate resident prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Men with advanced prostate cancer are often treated with medicines such as darolutamide or enzalutamide. While these treatments can help control cancer, they may also increase the risk of heart-related side effects, such as heart attack, stroke, or death related to heart and blood vessel disease. However, it is not yet clear whether these risks differ between the two treatments or which patients may be more likely to experience them. The main goal of the study is to compare how often serious heart-related events (such as heart attack, stroke, or death due to heart problems) occur in patients treated with these two medicines. The study will also explore other heart-related conditions and identify factors that may increase this risk. In this study, researchers will use existing healthcare data from the United States to look at men aged 55 years and older with advanced prostate cancer who have already been treated with either darolutamide or enzalutamide in routine clinical practice. No new treatments will be given as part of this research. Because this is a retrospective database study, there are no extra study visits, no extra blood tests, and no extra health check-ups required for participants.

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. The 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. The 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). The 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. Each participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery. 2 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. During the study, the doctors and their study team will: * take blood and urine samples * check the participants' health parameters * do physical examinations * check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan * take tumor samples * ask the participants questions about how they are feeling and what adverse events they are having. 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 treatments. About 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.

Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation. Sotorasib 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. BAY3498264 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. The 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. During the study, participants will receive the following treatments: * 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. * Sotorasib: participants will receive a standard, approved dose of Sotorasib once every day with BAY3498264. The 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'). This study has 3 parts, the dose escalation part, the backfill part and the expansion part. During 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.

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. The 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. The 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. In 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. The 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. To do this, researchers will assess the following information about participants after one year of receiving the combination therapy by their doctors: • the number of participants who achieve normal levels of prostate specific antigen (PSA). PSA is a protein found in the blood that helps doctors monitor prostate cancer. • 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. AEs are medical problems that the participants had during the study that may or may not be related to the study treatment. SAEs 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. AESIs are specific medical problems the participants had during the study that may be related to heart, lung, liver etc. The 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.

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. ROP 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. Aflibercept 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. Aflibercept 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. Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown. The main purpose of this study is to: * find the number of preterm babies who are treated with aflibercept using a PDD in the UK * 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 An 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. The 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. In 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.

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. This 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. To 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. During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors. Each 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.

Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH). Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer. Currently, there are no approved treatments for NAEH and that is why there is still an unmet medical need. The study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone. In this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body. The main purpose of this study is to show that uterine lining goes back to completely normal lining after treatment with Mirena and that its use is safe in this population. For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral MPA. The study participants will be randomly assigned into one of two treatment groups. The randomization will be done 2:1 ratio, meaning that for every two participants assigned to Mirena, one will be assigned to oral medroxyprogesterone acetate (MPA). Based on their group, participants will receive Mirena, which is inserted into the uterus at the start of the study, or they will take progestins once daily by mouth for 6 months. Each participant will be in the study for around 10 months with up to 5 visits to the study clinic/site. Participants will visit the study clinic: * once before the treatment starts * 3 times with a gap of 3 months between the visits during the treatment * then 1 more time after the treatment ends During the study, the doctors and their study team will: * check participant's health by performing tests such as blood and urine tests * perform vaginal ultrasound and hysteroscopy. Hysteroscopy is a minor surgical procedure where a thin camera will be inserted into the womb to check for any abnormality. Sampling of the endometrial lining (cells in the womb) will be done with a thin tube at the same time. * take samples of womb (endometrial) lining * ask the participants questions about how they are feeling and what adverse events they are having 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.

Researchers are looking for a better way to treat people who have sepsis induced coagulopathy. Sepsis 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. The 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). For 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. Participants 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. Each participant will be in the study for around 28 days. During the study, the doctors and their study team will: * Take blood and urine samples, * Do physical examinations, * Check vital signs such as body temperature, blood pressure and heart rate, * Examine heart health using electrocardiogram (ECG)

The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are: nAMD (neovascular age-related macular degeneration): a condition that affects the central part of the retina and can cause vision loss in older adults. DME (diabetic macular edema): a swelling in the central part of the retina caused by diabetes, which can also lead to vision problems. RVO (retinal vein occlusion): a blockage of the veins in the retina, which can cause sudden vision loss. Researchers will look at data collected from 2009 to 2024 to see how often these diseases occur (incidence) and how many people have them at a given time (prevalence). They will use two large sets of health data from Germany, called FDZ and FDGP. The main question is: How do the numbers of new and existing cases of nAMD, DME, and RVO compare between the two data sources (FDZ and FDGP) in Germany from 2009 to 2024? The study also wants to find out if factors like age, other health problems, and medications affect how common these eye diseases are. Another goal is to see how many people with these eye diseases are treated with a type of medicine called anti-VEGF, which is used to slow down or stop vision loss. In summary, this study will help us understand how these eye diseases affect people in Germany, how they are treated, and whether different groups of people are more likely to get them.

In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study. Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. The study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments. Through this study, researchers want to learn more about its safety in a real-world setting. The participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information. The main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment. Data will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits. In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: * Age, gender, and other information about the child and their illness * Type of VTE treatment given to the child * Occurrence of medically important bleeding and its severity Further information that researchers will collect: * Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE * Return of VTE symptoms * Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: * end of the anticoagulation treatment period e.g. discontinuation of all study drugs, * their information is no longer available, or * the study ends.