The purpose of this study is to evaluate investigational treatments (study drug) in people with gastroesophageal adenocarcinoma that has progressed (become worse) after at least 2 prior treatments.
The goal is to determine the optimal dose level, safety, and tolerability for the study drug MK2870-015. This is a phase 3 study; MK2870-015 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug intravenously, blood and urine samples, MUGA scans and CT scans. Risks include diarrhea, nausea, vomiting, hair loss, weight loss, high blood sugar, and sore throat. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
While cigarette smoking is detrimental to health and a known risk factor for cancer, e-cigarettes are thought to be less harmful but not entirely risk-free, and less is known about e-cigarette use and changes to health. The purpose of the present study is to evaluate changes in health that may occur when people stop using e-cigarettes. Participants who use e-cigarettes (and who never smoked, smoked in the past, or currently smoke) will be recruited to participate in a laboratory session followed by a week of abstaining from any nicotine use. Throughout the study, participants will provide biological samples for analysis of DNA damage, immune functioning, inflammation, and respiratory functioning at the MUSC Charleston campus. Results will provide insight into the health benefits of quitting vaping.
This is a research study to evaluate the safety and effectiveness of Niyad (nafamostat mesylate) as a blood thinner used during continuous renal replacement therapy (CRRT). CRRT is a standard treatment much like dialysis that is used to temporarily take the place of kidney function when one's kidneys are injured. Like your kidneys, CRRT helps to clean your blood and remove waste products.
Niyad is experimental which means that it is being tested and is not approved by the United States Food and Drug Administration (FDA). There is no guarantee that you will receive direct benefit as a result of your participation in this study. Possible benefits of Niyad include preventing your blood from clotting the dialysis filter so that the CRRT machine works more effectively and it also may reduce your need for a transfusion. The study results may help people in the future.
Participation voluntary and is expected to last up to 28 days. The length of time you may be exposed to Niyad is up to 7 days and safety assessments may last up to 28 days.
There will be no additional cost to you for procedures required in this research study. All routine clinical care that you would have undergone without participation in the study, including testing and procedures, will be billed to you/your insurance company. All study-related tests and procedures will be paid for by the Sponsor.
Some insurance plans will not pay for these services for people taking part in research studies. You will be responsible for any charges that your insurance does not cover including co-payments and deductibles.
This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.
This is a study to learn more about the use of a study medicine for the treatment of Idiopathic Hypersomnia (IH). The total duration of the study is approximately 3 1/2 months. Men and women between the ages of 18-75, with a primary diagnosis of IH, may be eligible.
The purpose of this study is to determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after surgery for colon cancer? ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.
This study seeks to find if this approach is better or worse than standard of care for colon cancer.
Treatment and follow up for this study may be up to 8 years. The procedures include blood samples, tissue samples, and chemotherapy. Risks include diarrhea, nausea, vomiting, hair loss, mouth sores, loss of appetite, tingling or pain in hands/feet/arms/legs, and anemia. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This study if for patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body or it cannot be removed by surgery. This study compares the effect of pembrolizumab plus doxorubicin to doxorubicin alone in treating patients. Doxorubicin damages the cell's DNA and may kill tumor cells. Doxorubicin also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to the standard chemotherapy, doxorubicin, may help patients with UPS or a related poorly differentiated sarcoma live longer without having disease progression. The duration of the study will be about 12 years, with 6 months of active treatment for those receiving doxorubicin alone and 2 years active treatment for those receiving doxorubicin and pembrolizumab. Each participant will be in follow up for 10 years. Some of the main side effects are nausea, vomiting, low blood count, fatigue and mild diarrhea.
This phase III study evaluates whether a new drug, dostarlimab, can delay or reduce the risk of cancer returning when administered for a year, shortly after receiving a combination of radiotherapy and chemotherapy (CRT). This study will enroll adults diagnosed with head and neck cancer who are treated with CRT. This study is divided into three parts: the screening period begins shortly after CRT and lasting 4-6 weeks where tests will be conducted to determine eligibility, followed by a 12-month treatment period where participants will receive either dostarlimab or an inactive substance (salt solution) with no effect on your body (placebo), and a follow up period when they will continue to be assessed to see if their cancer has returned or gotten worse. Participants may be on the study for approximately up to 5 years in total. The main risks are anaemia, nausea, vomiting, and diarrhea. Alternatives to this treatment is standard of care CRT because for this type of head and neck cancer, at the present time, there are no other approved therapies administered shortly after CRT that may prevent or delay the return of the cancer. The study benefit is dostarlimab may help slow or stop the growth of your cancer.
The purpose of this research study is to determine the effectiveness of Atomoxetine, a medication approved for attention deficit hyperactivity disorder (ADHD), in improving quality of life as well as attention and mental skills such as memory, daily planning, and impulse control in Veterans with ADHD and post-traumatic stress disorder (PTSD). Reduced attention span, concentration difficulties, impaired inhibition and decision-making abilities, and memory problems are all symptoms of ADHD, and may be a factor in the current issue of PTSD treatment-resistance. Therefore, this study is aimed to examine the effect of atomoxetine on attention and executive function, which may lead to a significant improvement in overall ADHD and PTSD outcomes.
This study is for subjects that have been diagnosed with mantle cell lymphoma that has spread and has not responded to treatment. This study is testing an "investigational" (not yet FDA approved) study drug called glofitamab. The purpose of this study is to compare the effects, good or bad, of glofitamab (experimental arm) versus bendamustine plus rituximab (BR) or rituximab plus lenalidomide (R-Len;the control arm) on subjects with relapsed/refractory mantle cell lymphoma. Your total time in the study and the number of assessments in the follow up visits, will depend on how your MCL responds to study treatment. This could range from 1 day to more than 24 months. The screening period may last up to 28 days (4 weeks) and may involve more than one visit to the clinic.