The purpose of the study is to evaluate the safety of this single administration. After the infusion, participants are followed for about a year, with regular visits that include physical exams, vital sign checks, blood tests, and heart rhythm recordings (ECG). Doctors will watch for any side effects and will also test the blood to see if at least 10 % of the white blood cells show restored granulocyte function, indicating that the gene therapy is working. The study does not involve a comparison group.

The purpose of the study is to see if the new combination can keep the cancer from getting worse for a longer time than the standard treatments. Participants are randomly assigned to receive either the new three‑drug regimen or the standard therapy, and they take the medicines in repeated cycles while visiting the clinic for regular check‑ups and imaging scans. The main result being measured is progression‑free survival (PFS), which means the time until the cancer grows or the patient dies, and it is evaluated using standard imaging rules called RECIST and analyzed with the Kaplan‑Meier statistical method. Safety and side‑effects are recorded and graded according to the CTCAE system.

The purpose of the study is to understand how safe and tolerable the new treatment is for patients, as well as to see how well it works in reducing the size of the cancer. Participants in the study will receive the investigational treatment, and their response to the treatment will be monitored over time. The study will also look at how long any positive effects of the treatment last.

Throughout the study, researchers will keep track of any side effects experienced by participants and whether these side effects lead to stopping the treatment. The study aims to gather important information that could help in developing new treatment options for people with this type of cancer. The trial is expected to continue until early 2028.

The purpose of the study is to compare how the body absorbs and processes the test formulation compared to the reference formulation and to show that they work in a similar way in the body. This type of study is called a bioequivalence study, which means researchers want to demonstrate that the two formulations behave similarly when taken by healthy volunteers.

The study follows a crossover design, which means that participants will receive both formulations at different times with a break between doses. Volunteers will take a single dose of each medication under fasting conditions, meaning they will not have eaten before taking the tablets. Blood samples will be collected to measure the levels of sacubitril and valsartan in the body over time. This allows researchers to compare how quickly and how much of each active substance enters the bloodstream with each formulation.

Participants in the study will receive either Dupilumab, which is administered as a solution for injection in a pre-filled syringe, or a matched placebo. The purpose of the study is to see if Dupilumab can significantly reduce the itchiness of LSC over a period of 24 weeks. The study will monitor changes in the severity of itching and its impact on sleep and quality of life. Additionally, the study will track any side effects or adverse reactions to the treatment.

The trial is designed to be a randomized, double-blind, placebo-controlled study, meaning neither the participants nor the researchers will know who is receiving Dupilumab or the placebo. This approach helps ensure the results are unbiased. The study will last for approximately 24 weeks, during which participants will be regularly assessed to measure the effectiveness of the treatment and any changes in their condition.

The study will be conducted in two phases. In the first phase, the goal is to determine the safest and most effective dose of the combination of selinexor and gemcitabine. In the second phase, the study will evaluate how well this combination works in preventing the cancer from getting worse over a period of six months. Participants will receive the treatment and be monitored regularly to assess their response to the medication and any side effects they may experience.

Throughout the study, participants will undergo various assessments to monitor their health and the progress of their cancer. These assessments will include regular check-ups and tests to ensure the treatment is working as intended and to manage any potential side effects. The study aims to provide valuable information on the effectiveness and safety of using selinexor and gemcitabine together for treating advanced soft-tissue sarcomas.

Participants in the study will receive injections of either the vaccine or a placebo over a period of up to 12 months. The study will monitor the participants’ symptoms and any medication they use during the grass and olive tree pollen season, which typically occurs in April, May, and June. The study will also look at the number of days participants are free from symptoms and medication, any worsening of asthma symptoms, and overall quality of life related to rhinitis. Additionally, the study will assess the safety of the vaccine by tracking any side effects or reactions at the injection site.

The trial aims to provide valuable information on whether the vaccine can help reduce symptoms and improve the quality of life for people with allergies to grasses and olive trees. By comparing the vaccine to a placebo, researchers hope to determine its effectiveness in managing these allergic conditions. The study will also gather data on various health measures, including levels of specific antibodies in the blood, to better understand the vaccine’s impact on the immune system.

The study aims to determine if RLS-0071 is safe and effective for treating this condition. Patients will receive different doses of RLS-0071 over a period of up to 14 days. Some patients will also receive another medication called ruxolitinib as part of their treatment. The treatment will be given to patients while they are in the hospital.

During the study, doctors will monitor how well patients respond to the treatment by checking their symptoms, particularly those affecting the skin, liver, and digestive system. They will also track changes in the patients’ condition for up to 180 days after starting treatment. The study will measure various aspects of patient recovery, including pain levels, ability to eat, and overall well-being.

The purpose of the study is to see how well Nemtabrutinib works compared to the other two treatments in people who have not yet received treatment for their CLL or SLL. Participants will be randomly assigned to receive either Nemtabrutinib or one of the other two medications chosen by the study doctor. The study will last for a period of up to 108 weeks, during which participants will take the medication daily and attend regular check-ups to monitor their health and the progress of the disease.

Throughout the study, doctors will assess how the disease responds to the treatment and how long participants remain free from disease progression. They will also monitor overall survival and any side effects experienced by participants. The study aims to provide valuable information on the effectiveness and safety of Nemtabrutinib compared to the current standard treatments for CLL and SLL.

Participants in the study will receive AL8326 as a second-line treatment, which means it is given after the initial treatment has been completed. The study will explore different doses of the medication to find the best balance between effectiveness and safety. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will last for a period of up to 12 months, during which the health and response of the participants will be closely monitored.

The trial aims to determine the optimal dose of AL8326 that provides the best results for patients with SCLC. This includes looking at how well the cancer responds to the treatment and how long the benefits last. The study will also gather information on how the body processes the medication and any potential side effects. This research is important for improving treatment options for patients with Small Cell Lung Cancer who need further therapy after their initial treatment.

The study is divided into two phases. In the first phase, participants will receive either PLS240 or a placebo to compare the effects. This phase is designed to see if PLS240 can effectively lower PTH levels by at least 30%. In the second phase, which is open-label, all participants will receive PLS240 to further assess its long-term safety. Participants will receive the medication through an intravenous injection, which means it will be administered directly into a vein using a pre-filled syringe.

The trial will last for a maximum of 53 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. These check-ups will include laboratory tests, physical exams, and monitoring of vital signs. The goal is to ensure the treatment is both effective and safe for individuals with secondary hyperparathyroidism undergoing hemodialysis.

Participants in the study will be randomly assigned to receive either Upadacitinib or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The study will last for a period of time, during which participants will take the medication orally in the form of a modified-release tablet. The goal is to observe any changes in the severity of eczema symptoms and overall skin condition over the course of the study.

Throughout the study, participants will be monitored for any improvements in their eczema symptoms, such as reduced itching and inflammation, as well as any potential side effects. The study aims to provide valuable information on whether Upadacitinib can be an effective treatment option for those suffering from moderate to severe eczema. By participating in this study, researchers hope to gain insights that could lead to better management and treatment options for individuals with this challenging skin condition.

The purpose of this study is to compare the effectiveness, safety, and tolerability of the two treatment options over a period of time. Participants will be randomly assigned to one of the two groups and will not know which treatment they are receiving, as the study is double-blind. This means that neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. The study will last for a total of 96 weeks, with regular check-ups and assessments to monitor the participants’ health and the virus’s response to the treatment.

Throughout the study, the main focus will be on how well the treatments reduce the amount of HIV-1 RNA in the blood, which is a measure of the virus’s activity. Safety will also be closely monitored by reviewing any side effects or adverse events that participants may experience. The study aims to provide valuable information on the best treatment options for people newly diagnosed with HIV-1, helping to improve their health outcomes and quality of life.

The purpose of the study is to see how well the combination treatment works compared to the single medication in preventing the return of melanoma after it has been surgically removed. Participants in the study will be randomly assigned to receive either the combination treatment or the single medication. Some participants may receive a placebo, which is a substance with no active medication. The study will last for up to 12 months, during which time participants will receive regular infusions and be monitored for any changes in their condition.

Throughout the study, researchers will keep track of how long participants remain free from melanoma returning, as well as other important health outcomes. These include how long participants live without the cancer spreading to other parts of the body, overall survival rates, and any side effects experienced. The study will also assess changes in participants’ quality of life and physical functioning. This information will help determine the effectiveness and safety of the combination treatment compared to the single medication.

The purpose of the study is to learn about the safety of BIIB080 and whether it can improve symptoms in participants. Participants will receive the treatment through an injection into the spinal fluid, a method known as intrathecal use. The study will last for a period of 76 weeks, during which participants will be monitored for changes in their cognitive abilities and overall health. The study aims to understand how different doses of the treatment affect the symptoms of Alzheimer’s disease.

Throughout the study, participants will undergo various assessments to track their progress. These assessments include tests to measure memory and thinking skills, as well as monitoring for any side effects or adverse events. The study is designed to provide valuable information on the potential benefits and safety of BIIB080 for individuals with early stages of Alzheimer’s disease.

The purpose of this study is to assess the safety of using Durvalumab in combination with chemotherapy for patients who have not received prior treatment for their advanced biliary tract cancer. Participants in the study will receive these treatments over a period of time, and their health will be monitored closely to observe any effects of the treatment. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Throughout the study, participants will undergo regular health check-ups and assessments to monitor their response to the treatment. The study aims to provide valuable information on how well the combination of Durvalumab and chemotherapy works in treating advanced biliary tract cancers and to ensure the safety of the treatment for patients. The study is expected to continue until March 2025, with recruitment having started in September 2023.

Participants in the study will receive either XTMAB-16 or a placebo, which looks like the treatment but does not contain the active ingredient. The study is divided into two parts. In the first part, the focus is on determining the safe dosage levels of XTMAB-16. In the second part, the study will assess how well XTMAB-16 works in reducing the use of corticosteroids. Throughout the study, participants will be monitored for any side effects and changes in their condition.

The study aims to find out if XTMAB-16 can help patients with pulmonary sarcoidosis by allowing them to reduce their reliance on corticosteroids, which can have significant side effects when used long-term. The trial will also gather information on how the body processes XTMAB-16 and its impact on various health markers. This research could lead to new treatment options for those living with this condition.

The trial is testing an oral capsule called NB-4746 and also includes the already approved medicine Riluzole. Some participants will receive a dummy pill, known as a placebo, so that researchers can compare how the real medicines work. The main goal of the study is to find out whether the new drug is safe for people with the disease, meaning it does not cause unacceptable side effects.

People who join the study will take the assigned capsule each day and will visit the clinic several times for simple check‑ups. During these visits doctors will look at basic health information such as blood pressure and heart rate, draw small amounts of blood for laboratory testing, and perform a quick heart rhythm test. The early part of the study lasts about four weeks, and later phases continue for a longer period to keep monitoring safety.

The purpose of the trial is to determine whether the new drug works at least as well as the existing treatment in preserving or improving vision. Vision will be assessed using a standard test called Best-Corrected Visual Acuity, which measures how many letters a person can read on an eye chart, reported in ETDRS letters.

Participants will receive a series of eye injections over roughly one year, with regular visits to check eye health, vision scores, and any side effects. The study is designed so that neither the participants nor the doctors know which medication is being given at each visit.

The main aim of the trial is to assess whether the drug improves daytime alertness in participants with this condition. Volunteers will be randomly assigned to receive either the active medication or the inactive comparator, and they will take the assigned tablet each day for approximately twelve weeks. Throughout the study period, participants will attend regular visits where simple questionnaires and brief safety checks will be performed to monitor how they feel and to ensure the treatment is well tolerated.

Participants will receive one of the two treatments for a 12‑week period and then switch to the other treatment for another 12‑week period. The design is double‑blind, meaning neither the participants nor the study staff know which inhaler is active, and a double‑dummy approach ensures each person uses two inhalers (one containing the active drug and one containing a placebo) so the experience is the same. During the study, lung function is measured with a test called FEV1, which assesses how much air can be exhaled in one second, and participants complete a short questionnaire about asthma control called ACQ‑5 and another questionnaire about quality of life called PAQLQ. Safety is monitored by recording any side effects and by checking basic blood tests and other routine examinations.

The main goal of the study is to see if the two tablet forms deliver the medicines to the body in the same amount and at the same speed, a concept known as bioequivalence. This helps determine whether the new tablet works just as well as the already available version.

Volunteers will come to the study site, fast for a short period, take one of the tablets, and then have a few short check‑ins where a small blood sample may be taken to measure how much of the medicines entered the bloodstream. After a wash‑out period, the participants will return to receive the other tablet and repeat the same short monitoring. The whole process involves only a single dose of each tablet and a brief follow‑up, without any long‑term treatment.

The purpose of the study is to evaluate the relative bioavailability of the test formulation compared with the commercial reference and to demonstrate their bioequivalence according to health‑authority criteria. Healthy adults will receive a single dose of one formulation after an overnight fast, then, after a short break, will receive the other formulation. Blood samples will be taken over several hours to measure how much of the drug reaches the bloodstream, looking at total exposure (AUC), the highest concentration reached (Cmax) and the time it takes to reach that peak (Tmax).

Volunteers will be monitored for any side effects while staying in a comfortable setting, and the study will be completed in a short period of time with only a few clinic visits. No disease is being treated in the participants; the goal is simply to confirm that the two tablet types behave the same way in the body.

The purpose of the trial is to find out whether adding orelabrutinib to the usual regimen can keep the disease from getting worse for a longer period of time. After a screening visit, participants are randomly assigned to one of the two groups, and neither the participants nor the doctors know which group they are in. Treatment is given in repeated cycles over several months, with regular check‑ups that include blood tests, heart checks, and questionnaires about quality of life. The study follows participants for several years to see how long they stay free of disease progression and to monitor safety.

Participants will take both tablets each day for several months while attending regular clinic visits for blood draws and bone‑marrow checks. A molecular response 2, abbreviated MR2, means the level of the genetic marker BCR::ABL1 in the blood is 1 % or lower, indicating a low amount of disease. A complete cytogenetic response, meaning no cancer‑related chromosome changes are seen in a sample of bone marrow cells, will also be assessed. Safety will be monitored by recording any adverse events, which are side effects that may range from mild to serious. The study will conclude after the final safety and effectiveness evaluations are completed.