LiveWell is a telehealth-delivered coping skills training program for people living with advanced lung cancer. LiveWell teaches skills from dialectical behavioral therapy, a type of evidence-based psychotherapy, that have been specifically adapted for people living with advanced lung cancer. The skills (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) are designed to help you live as well as possible, with cancer. We are interested in seeing whether the program can help you to balance your emotions and better manage distress (e.g., anxiety, sadness) and symptoms (e.g., fatigue, breathlessness, pain) that can be common when living with lung cancer.
 
If you participate in this study, you will be randomly assigned to one of two groups: the LiveWell group, or usual care. LiveWell involves meeting with a skills trainer once per week for eight weeks via telemedicine, in addition to receiving your usual cancer care. Meetings last 45-60 minutes and are scheduled at a time that works best for you. You will not know whether you will be in the LiveWell group or the usual care group before enrolling in the study, but you will know which group you are in after enrolling. Participants in both groups will complete questionnaires three times: at baseline, 8 weeks later, and 3 months after that. For most people, your participation will last approximately 5 months.  You will be compensated for completing study questionnaires.
 

This study is evaluating the clinical safety and efficacy of Prevail Drug-Coated Balloon (DCB) in the treatment of in-stent restenosis (ISR) which is the narrowing of heart arteries (blood vessels) previously treated with stents (mesh like medical device that helps keep arteries open) and in new narrowing of arteries in small vessels. The DCB is a small balloon that has medication on it. The medication is designed to reduce the re-occurrence of narrowing in blood vessels. All participants who have a previous stent will be chosen at random to be treated with either the Prevail DCB or the Agent DCB. You will have a 50:50 chance of being assigned to either DCB. The Prevail DCB is considered investigational meaning it has not yet been approved by the Food and Drug Administration (FDA). The Agent DCB is FDA approved. If you are being treated due to a new lesion in a small blood vessel, you will be treated with the Prevail DCB. Study related procedures include the following: electrocardiograph (known as an ECG, which is a test that shows your heart's electrical activity), blood draws, physical examinations, a review of chest pain, and medication history. Participation in this study will take about 5 years and include about 9 visits. Risks include risks related to the DCBs including allergic reaction, GI symptoms or changes to blood counts.

This is a phase 2 study for patients that have been diagnosed with recurrent glioblastoma, a type of brain cancer. This study is testing an investigational combination of two drugs, reltalimab and nivolumab."Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to see if there is a difference in overall survival rate in patients who receive a combination of retatlimab and nivolumab versus those who receive the standard of care treatment, lomustine, in patients with recurrent brain cancer. Participants in this study can expect to be in this study for up to five years from the day study participation starts. Subjects with investigational project being given on day 1 of each cycle, a cycle being 28 days. Cycles will continue until disease gets worse or study doctor decides it is in the subject's best interest to stop. Study will be divided into group 1 and 2. Group 1 will receive investigational drugs and group 2 will receive the standard of care. A computer will be used to assign groups in a process called randomization. Much like a toss of a coin, subjects will have equal opportunity to randomized to either group 1 or 2.

This study will evaluate the efficacy and safety of RO7790121 compared with placebo in patients with moderately to severely active CD. Data on currently available treatments highlights the need for new medications in addressing the high unmet need in CD. The total maximum duration of study participation for an individual is expected to be approximately 70 weeks without OLE participation. With OLE participation, treatment will continue until RO7790121 is commercially available in that region or until the Sponsor decides to terminate the study, whichever is earlier. Approximately 600 patients will be enrolled in the study.

Sharing Our Stories: The Realities of Living with Ehlers Danlos Syndromes (EDS) is a research study to help better understand what it is like to live with EDS. Adults with EDS will complete a one-time video interview with a member of the research team. We hope to better understand the challenges adults with EDS face and learn from them things that make it more difficult and easier to receive care, what their needs are and recommendations for improving an earlier diagnosis, care, and treatment.

This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called BNT317. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety, tolerability, absorption of BNT317. BNT317 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. Researchers will continue to follow-up with patients long-term.

The purpose of this study is to test the effectiveness and safety of the combination of an investigational vaccine, PDS0101, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA), given intravenously ("IV;" into the vein) compared to pembrolizumab (KEYTRUDA) alone for those with unresectable recurrent or metastatic head and neck cancer and high risk papillomavirus infection. "Investigational" means the combination of the study vaccine and pembrolizumab being tested has not been approved by the US Food and Drug Administration (FDA) nor any other Health Authority.

This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.

This phase 2 study is enrolling patients who have acute myeloid leukemia (AML) with certain biomarkers. This study is being done to see the effectiveness of different combinations of drugs to treat AML. It will involve 3 groups of patients receiving different combinations of Gilteritinib, Azacitidine and Venetoclax. Gilteritinib is an investigational drug, Azacitidine and Venetoclax are FDA approved. The main purpose of the study is to see if the amount of leukemia in the patient's body can be lowered by adding the drug Gilteritinib to the Standard of Care of treating AML with Azacitidine and Venetoclax. The study will include approximately 147 patients. The patients will be randomized into the three groups (like flipping a coin), Group 1 will receive just Azacitidine + Venetoclax, Groups 2 and 3 will also receive Gilteritinib but Group 2 will receive it for more time within a treatment cycle. Patients will complete screening after participating in this treatment trial or SOC therapies. Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that the study drugs may not be as good as the usual approach for their cancer or condition at shrinking or stabilizing their cancer. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Currently, there are no FDA-approved medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD). This study is designed to look at the usefulness and safety of lumateperone (CAPLYTA) for the treatment of irritability associated with ASD among pediatric participants between the ages of 5 to 17 years. The study will last approximately 26 weeks and the participants will receive the study drug, lumateperone.