This is a double‑blind, placebo‑controlled study, meaning participants may receive either the study medication, Ibuzatrelvir, or a placebo. The goal is to see whether the study medication helps participants recover faster and lowers the risk of hospitalization or severe illness. Participant safety is closely monitored.
You can change your mind and stop taking part in the study at any time and for any reason. You will not lose any benefits or care you would normally receive.
If you would like more information about this study, please contact the study team.
This study is for adult patients with Triple Negative Breast Cancer (TNBC) who have high levels of tumor infiltrating lymphocytes (TIL), a specific type of white blood cell. The purpose of this study is to evaluate a non-anthracycline-based treatment regimen to determine if this approach is effective in patients with high TIL levels. Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. Participation in this study is anticipated to last approximately 6 months with follow up over 5 years.
This study is for adult female patients that have been diagnosed with recurrent ovarian cancer. The purpose of this study is to evaluate whether therapy with tumor-infiltrating lymphocytes (TILs) enhances the immune response against cancer cells. Participants will undergo standard procedures such as blood collection for laboratory testing, physical exams, and imaging. In addition to standard of care treatment, TILs will be collected from the tumor, grown in a lab, and infused back into the body. Participants will also take three drugs (oral cyclophosphamide, bevacizumab, and pembrolizumab) following the TIL infusion. Participation in this study is expected to last approximately one year.
The purpose of this research study is to evaluate the safety and effectiveness of a
physician-modified endograft (tubular medical device used to reinforce weakened or damaged blood vessels) for repairing serious diseases of the aorta (largest artery in the human body, responsible for blood from the heart to the rest of the body). This device is considered investigational, and this research study received an Investigational Device Exemption (IDE) from the FDA.
Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of organ dysfunction, usually occurring after 20 weeks of pregnancy. It can lead to serious health problems for both the pregnant person and the baby. Although some risk factors for preeclampsia are known, effective strategies to prevent the condition remain limited.
The purpose of this research study is to determine whether vaginal progesterone can help prevent preeclampsia in pregnant individuals. Progesterone is a hormone that is naturally produced during pregnancy and is already used for certain pregnancy-related conditions.
Participants who choose to join the study will be randomly assigned (by chance, like flipping a coin) to receive either vaginal progesterone or no medication. Participants will use the study medication as directed during pregnancy and will continue to receive their routine prenatal care.
Researchers will collect information from prenatal visits, medical records, and delivery outcomes to determine whether progesterone reduces the risk of developing preeclampsia and improves pregnancy outcomes. The information gained from this study may help identify a safe and effective way to prevent preeclampsia and improve the health of pregnant individuals and their babies in future pregnancies.
This study is enrolling subjects with heart failure and a preserved fraction meaning the heart is too stiff to fill properly to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.
This study is designed to evaluate a new therapy formulation for Alpha-1 Antitrypsin Deficiency (AATD). AATD is an inherited condition in which a person has low blood levels of a protein known as alpha-1 protease inhibitor (called Alpha1-PI). AATD causes an increased risk of chronic obstructive pulmonary disease (COPD) in the form of emphysema (long term lung disease) and, less frequently, other diseases.
This study is being conducted to evaluate the safety and tolerability of 2 different doses of Alpha-1 drugs (Alpha-1 15% and Liquid Alpha1-PI) in participants with AATD. Participants will be placed into one of two groups. Each group will receive both drugs, but different doses of each, at different points in the treatment period (8 Weekly IV infusions of Liquid Alpha1-PI 60 mg/kg followed by 8 Weekly SC (subcutaneous) infusions Alpha1-PI 90 mg/kg OR 8 Weekly IV infusions of Liquid Alpha1-PI 120 mg/kg followed by 8 Weekly SC (subcutaneous) infusions Alpha1-PI 180 mg/kg).
This is an "open label" study, meaning participants and the study staff know which dose of study drug participants receive. The study will last up to 161 days (23 weeks). Many visits are able to be conducted through home health care, lessening the need to come into the clinic.
Alpha-1 15% is an investigational product, meaning it is not approved by the U.S. Food and Drug Administration (FDA). The other drug in this study is Liquid Alpha1-PI (licensed as Prolastin®-C Liquid) and is an FDA approved treatment for adults with emphysema due to AATD. However, it is only approved for the recommended dose of 60 mg/kg. This study includes both the FDA approved 60mg/kg of Liquid Alpha1-PI and an experimental dose of 120 mg/kg that is not FDA approved. Alpha-1 15% is given as an injection under the skin and Liquid Alpha1-PI is given as an infusion into the veins.
Individuals with obesity and a history of heart failure (condition where heart does not effectively pump) with a preserved or mildly reduced ejection fraction (measure of the heart's pumping ability) will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (NNC0487-0111) or control (placebo) group. NNC0487-011 and placebo will be delivered in an injectable pen device for a subcutaneous, once weekly injection. Placebo means there is no active study treatment) Study participation will last approximately three years and begin with a screening period to ensure correct patient selection. After the screening period, research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram (test that records the heart's electrical activity) The study's primary objective is to demonstrate that study drug vs. once weekly placebo, with standard of care, reduces the risk of a composite heart failure outcome consisting of cardiovascular death, heart failure hospitalization, or urgent heart failure visit in patients with heart failure with a preserved or mildly reduced ejection fraction and obesity.
This study is enrolling patients with uncontrolled high blood pressure. This study will see if a medication called Zilebesiran can help lower blood pressure. Zilebesiran is an investigational medication meaning it is not approved for commercial use by the Food and Drug Administration (FDA) but it is approved for use in this study. This is a randomized study meaning if you are eligible, you will be assigned by chance, like the flip of a coin to receive Zilebesiran or placebo. Placebo will look like the study medication but will not contain any active ingredients. You and the study team will not know if you are taking Zilebesiran or placebo, both of which are given as an injection under the skin every six months. This study will last between 2.5 and 5 years and include 10-14 visits. Study related procedures include physical exams, medical history including medications, vital signs, blood and urine collection. and electrocardiogram (ECG - a recording of your heart's electrical activity)
This study is being conducted to evaluate the drug AZD0292, including how safe it is, how long it stays in the blood, and if it may help in reducing the number of exacerbations in people with Pseudomonas aeruginosa in their lungs. These patients have more frequent lung exacerbations and reduced quality of life. Pseudomonas aeruginosa is a bacteria that can make the symptoms of bronchiectasis worse. The study drug (AZD0292) works by attaching to Pseudomonas aeruginosa, thereby reducing its effects on the lungs and improving symptoms.
This study aims not only to test AZD0292 but is also being done to better understand bronchiectasis disease and its associated health problems.
Study drug (AZD0292) or placebo, will be given to participants as an intravenous (IV) infusion. The study is double-blinded.
About 435 participants with bronchiectasis 12 years of age and older, weighing at least 35kg will take part in this study. This study will be conducted globally in approximately 25 countries.