Kentucky Paid Clinical Trials

Research indicates that perceived stigma within medical encounters is prevalent and problematic for lung cancer patients' well-being and quality of cancer care. Promoting empathic communication appears to be a potentially effective intervention target to help reduce patients' perceptions of stigma within clinical encounters; however, no formal trainings exist that focus on teaching empathic communication to oncology care providers (OCPs). Building upon favorable findings from a prior R21 (R21CA202793) and the importance of developing interventions to address lung cancer stigma, our goal is to conduct a national trial of empathic communication skills (ECS) training to facilitate improvements in the medical and psychosocial care of patients through de-stigmatizing interactions with OCPs for patients diagnosed with lung cancer. Read Less

A study of the Streamline Surgical System versus competitor Read Less

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line. Read Less

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer. Read Less

Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on. Early studies have shown that ASP1570 can switch T-cells back on to attack tumors. This study will provide more information on this potential new treatment in adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. People will either be treated with ASP1570 by itself, or together with another medicine called pembrolizumab. This study will be in 2 parts. In Part 1, the best dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570 by itself or with pembrolizumab. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 dose of pembrolizumab. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group on the lowest dose had no major medical problems. This will continue in the same way for each group. This means each group will take the next highest dose of ASP1570 as long as the previous group did not have any major medical problems. Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People taking part in Japan will stay in hospital for up to 21 days during the first treatment cycle only. People will continue with more treatment cycles on the same dose unless they have major medical problems, their cancer gets worse or the study doctor decides that person should stop treatment. People who are also receiving treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). In Part 2, different small groups of people with advanced solid tumors will take the best dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people took in Part 1 without getting major medical problems. Some groups of people will have specific advanced tumors. These include tumors from metastatic melanoma or non-small cell lung cancer (NSCLC for short). Other groups will have solid tumors that showed a response in Part 1. Again, each group will take tablets of ASP1570 once or twice every day in a 21-day cycle. Only people with NSCLC will also be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). All groups will continue with more treatment cycles with ASP1570 by itself or with pembrolizumab, unless they have major medical problems, their cancer gets worse or the study doctor decides that person should stop treatment. After treatment with ASP1570, people in the study will visit their clinic 45 days after their last dose of ASP1570. People who were treated with ASP1570 and pembrolizumab will visit their clinic either 45 days after their last dose of ASP1570 or 30 days after their last dose of pembrolizumab. It will depend on which treatment was the last one they had. Then, the study clinic will contact each person in the study at least every 12 weeks until the end of the study or if they decide to leave the study. Read Less

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration. Read Less

The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Read Less

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness. Read Less

This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Read Less

This is a prospective, non-interventional, Long-term, multinational cohort safety study of patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). The overarching goal of this study is to further characterize the long-term safety of TEGSEDI (inotersen) in patients with hATTR-PN under real-world conditions. Read Less

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone. Read Less

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma. Read Less