Patients are matched with this clinical trial based on their biomarker test results in the myeloMATCH study. This treatment trial is for adults (ages 18-59) with high-risk AML who have not started treatment yet. Doctors consider AML high risk if it has certain biomarkers that can make it harder to treat. Treatment plans for AML often involve several phases of treatment. The first phase aims to get rid of as many leukemia cells as possible. It helps make it easier for further treatment to keep the cancer under control. Usually, the first treatment patients receive for AML is a combination of 2 chemotherapy drugs, daunorubicin and cytarabine. The purpose of this study is to learn if other options for first treatment may work better for people with high-risk AML. The study doctors will test 4 new treatments and compare them to the usual chemotherapy. This is important because knowing AML is high-risk gives doctors more information about the cancer and how to treat it. People with high-risk AML may benefit from a different approach to treatment. Improving options for people in the first phase of treatment could make further phases of treatment more successful.
The purpose of this research is to assess a stepped care model of a telehealth parenting program for children ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based tele-health Parent-Child Interaction Therapy (PCIT) sessions, and an online post intervention assessment. Some families may receive additional individual virtual booster sessions and will complete a second online post assessment.
Youth participation in healthcare is becoming more prevalent, and outcomes are improved when youth have a voice in decisions. Little is known about how much adolescents participate in decision-making about vaccinations including "optional" vaccines or those not required for school attendance. This is a survey to evaluate the extent to which adolescents were involved in the decision to be vaccinated for 4 common vaccines: FLU (influenza), COVID (SARS-CoV-2 virus), MEN (meningococcemia), and HPV (Human Papilloma Virus).
Optic neuritis (ON) is a rare inflammatory disorder of the optic nerve that results in vision loss. It is characterized by rapid and variable vision loss, pain in, around and behind the eye, and changes in color vision. Subjects in this study will be followed for 12 months total and randomized in a 2:1 ratio to receive either an IV infusion medication or a placebo infusion. Low Contrast Visual Acuity will be tracked at 3 months. After 3 months, participants will continue the study
through Month 12 in the safety follow-up part of the study intended to provide longer
term safety information.
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.