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.
The purpose of this study is to observe and capture demographic characteristics,
treatment patterns, and clinical outcomes of interest for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment. This study will follow patients for up to 5 years after enrollment.
The purpose of this study is to compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone in patients with PD-L1-negative metastatic TNBC, who have not received prior therapy for metastatic breast cancer and who have not received a prior PD-1/L1 inhibitor.
Subjects can remain on study for as long as they are benefitting from treatment - there are no set number of visits required to participate in this study. Sacituzumab govitecan and pembrolizumab are taken via intravenous (IV) infusion. Risks include decrease in white blood cell count, anemia, nausea, joint pain, and headache.
The U.S. Food and Drug Administration (FDA) has approved Sacituzumab govitecan for metastatic triple-negative breast cancer, however, it is considered experimental in this study because it is currently only approved for patients who have had more treatment than patients eligible to participate in this study. The FDA has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is also considered experimental in this study because it is not currently approved for patients with PD-L1 negative cancer.
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.
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.
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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.
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This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE.
Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward.
This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomized design. We will evaluate the clinical outcome of advanced liver fibrosis detection and the implementation outcomes of adoption, penetration, fidelity, and sustainability. This work will generate generalizable data to dramatically enhance MASLD management in primary care.
This study is for patients that have been diagnosed with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC). The study is testing an investigational drug called DB-1311. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to determine the recommended phase II dose of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 by assessing the safety and tolerability. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study for 72 months.
The study is for patients that have been diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung. The study will examine the association between cannabis and/or cannabinoid use and cancer-related symptoms assessed monthly for one year in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung. 40 participants will be enrolled locally. Participants can expect to remain in the study for 12 months.
This is a research study among women living with HIV about their choices in how they feed their infants and the different factors that contribute to those decisions, as well as how those decisions change after giving birth and as their baby grows. This study includes surveys at 2 different time points- once while still pregnant, once approximately 4-6 weeks postpartum. We hope to gain understanding on womens choices about breastfeeding while living with HIV.