This study is for patients who have been diagnosed with Head and Neck Cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent), and test positive for High-risk Human Papillomavirus-16 (HPV16) Infection.

The investigational vaccine in this study is called PDS0101. "Investigational" means the study vaccine being tested has not been approved by the United States Food and Drug Administration (FDA). The purpose of this research is to find out if the combination of the investigational vaccine, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA®), given by IV, are effective and safe. The PDS0101 vaccine designed to boost the body's immune response against HPV 16.Participants can expect to receive treatment for about 2 years. Each person who agrees to take part in the study will be asked to come in for a minimum of 18 cycles and a maximum of 35 cycles.

The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS) study treatment on patient-reported symptoms in subjects newly diagnosed with NTM lung infection caused by MAC who have not started standard treatment. Around 250 subjects 18 years and older with newly diagnosed NTM lung infection caused by MAC who have not started standard treatment are expected to participate in this study. The study will last around 17.5 months from the Screening visit to the end of the study.

This is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with emotional situations. The study is recruiting people who recently started treatment for anxiety or a related concern. The study involves 3 visits to MUSC. At the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. At the next two visits, participants receive rTMS that uses a magnet placed on top of the head to alter brain activity temporarily (for about an hour). After rTMS, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head.

Each visit in this study is expected to last between 2 – 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time.

The purpose of this study is to explore the use of a new treatment program to improve medication adherence for people with HIV and PTSD for patients at local HIV care clinics. Participants will be assigned to one of two groups. Participants in Group A will be asked to attend 12 clinic sessions (twice a week for 6 weeks, 90-minute sessions) via telehealth or in person at a HIV care clinic. Participants in Group B will receive a one session adherence intervention (60 minutes) and get the same standard treatment that someone with a trauma history and co-occurring HIV and PTSD symptoms would receive at a local HIV care clinic. The study is provided at no-cost, and participants may learn useful information and coping skills while being in the study. It is hoped the information that we get from this study will help researchers and clinicians better design treatment programs for people living with HIV and PTSD. Participants will receive study compensation for their time.

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced arm and leg function, difficulty thinking, and depression.
Developing treatments that address these problems is necessary to improve long-term recovery for stroke survivors. Aerobic exercise (AEx) can improve physical and mental function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to a rehabilitation treatment. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple parts of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention we aim to advance the rehabilitative care of Veteran stroke survivors.

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.

The purpose of this study is to see whether Ozanimod is safe and effective for treating Crohn's disease. Participants who are aged 18 to 75 years with moderately to severely active Crohn's disease may be eligible.

To do this, a comparison will be made between subjects who receive active drug and subjects who receive placebo (a ‘dummy treatment' that looks like the active drug but contains no active ingredient). The chance of being randomized (like drawing names out of a hat) into ozanimod group and receiving ozanimod is 67%. The chance of being randomized into placebo group and receiving placebo is 33%.

This study is designed to last up to 30 weeks, including 2 screening visits, 4 study visits, and 2 follow-up visits. The study drug may improve participant's Crohn's disease condition, but this cannot be guaranteed.

This study is for patients who have low risk breast cancer as indicated by their Oncotype DX Recurrence Score. The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy.

This study is for patients who have been diagnosed with a respiratory viral infection, like respiratory syncytial virus (RSV), influenza, human metapneumovirus, and/or parainfluenza virus, after a hematopoietic cell transplant. The investigational drug in this study is ALVR106. The purpose of this study is to determine if ALVR106 is safe and to determine the best dose (amount) for treating respiratory infections. Participants can expect to be in this study for approximately 1 year.

The purpose of this study is to test the effectiveness of a comprehensive treatment for African-American adolescents with obesity and their overweight or obese caregiver (e.g., parent). Families who decide to participate in this study will be randomly assigned to one of two intervention groups: the FIT Families group or the Home-Based Family Support (HBFS) group. This means participants have a 50/50 chance (like flipping a coin) of being in either group. Participants randomized to FIT Families will have sessions with a community health worker (CHW) in the home or community once or twice weekly based on the family's preference for the first three months, and weekly for the second three months. Some of the sessions might occur virtually (online) if needed. Participants randomized to HBFS will receive six months of weekly family counseling in their home or community with a community health worker (CHW). Some of these sessions might occur virtually (online) if needed. Participants in both groups will receive education and support for healthier lifestyles.
The study will last 18 months. During the 18-month study period, youth and caregivers will wear a FitBit activity tracker during the six months of the intervention and then for 2 weeks at the fourth assessment, complete study assessments, have their height, weight, and blood pressure measured, and provide finger prick blood samples to be tested for blood sugar and cholesterol levels.
Potential benefits to caregivers and youth who participate in the study include: positive changes in healthy lifestyle behaviors and weight loss, decrease in health risks associated with obesity, and improved family relations, though these cannot be guaranteed.