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.
The study is designed to look at the usefulness and safety of Solriamfetol (versus placebo) for the treatment of excessive sleepiness associated with shift work disorder (SWD). Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-65 years old with a diagnosis of SWD. The study will last approximately 17 weeks, with 6 in-person visits and 8 remote visits for each participant.
This research study is testing a new treatment plan for patients with a type of lung cancer that can be surgically removed. The study focuses on patients who have not had complete success with initial treatments before surgery. The treatment plan includes a combination of chemotherapy and a drug called pembrolizumab before surgery, followed by surgery to remove the cancer, and then more pembrolizumab with or without another drug called MK-2870 after surgery.
The goal is to see if adding MK-2870 can help improve the chances of recovery and prevent the cancer from coming back in patients who didn't respond fully to the initial treatment. This study aims to find better ways to treat lung cancer and improve the survival rates of these patients.
The purpose of this research is to gather information about the effectiveness and safety of Left Atrial Appendage Occlusion (LAAO) device procedures in patients using a Watchman device performed on days where doctors perform a large number of procedures.
The study primary outcome is to evaluate complications during the procedure up to 30 days after the procedure.
The final outcome is to determine successful placement within 31 - 90 days after implant.
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.
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of sonelokimab in adults with moderate to severe HS. Following a Screening Period of up to 28 days, each participant will enter a Placebo-controlled Period of 16 weeks (Part A) and subsequently a Crossover/Maintenance Period of 36 weeks (Part B). In Part A subjects will be randomly assigned in a 2:1 ratio to sonelokimab 120 mg or placebo. In Part B, participants who were initially randomized to placebo will cross over to sonelokimab and will receive this treatment for the remainder of the study. An End of Treatment (EOT) Visit will be performed at Week 52. After the EOT Visit, all participants who complete Week 52 will be offered the opportunity to enter an optional long-term open label extension (OLE) study under a separate protocol. For participants who do not progress to the OLE study, a Safety Follow-up Visit will be required 8 weeks after the last dose of study treatment.
The is a Phase 3 study for children, ages 0-17 years old, with severe von Willebrand disease (VWD). In this study, the study drug will be used prophylactically for the treatment of bleeding events. Prophylactic treatment means the study drug will be used to prevent or stop a bleed before it happens.
This study is going to look at how safe the study drug is and how well the study drug (recombinant von Willebrand factor (rVWF, vonicog alfa)), works to prevent and control bleeding.
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 will examine the effects of 3 different physical activity goals on arthritis-related outcomes in adults with arthritis. Participants will be randomized to either 45 minutes/week, 90 minutes/week, or 150 minutes/week. Additionally, this study will examine how daily activity can influence arthritis-related outcomes such as pain and fatigue.