This is a treatment plan to provide recombinant Bacillus Calmette-Guérin (rBCG) to patients with bladder cancer who are eligible to receive TICE® BCG and may benefit from its use. The treatment plan will end if the product is approved for use in the United States or if a Food and Drug Administration (FDA) clinical trial proves rBCG treatment to be ineffective. The drug is not currently FDA approved for bladder cancer.
Subjects will receive rBCG. They will have tests, exams and procedures that are part of standard of care (SoC) and for treatment plan purposes. Participants will receive treatment based on TICEBCG protocol at their local institutions.
This study is for patients that have been diagnosed with platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study is testing and investigational drug called INCB123667. "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 efficacy and safety of INCB123667 in terms of objective response rate (ORR) as assessed by an independent review committee (IRC). The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months.
This study is being conducted to determine how well participants with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer (NSCLC), that has certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C) respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of your cancer getting worse and improves your survival (i.e. increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. In this study, participants will be screened and if they meet criteria will be enrolled into the main study and assigned, by chance, into one of 2 groups. You will have an equal chance of taking sotorasib platinum doublet combination chemotherapy or pembrolizumab platinum doublet combination chemotherapy. It is hoped that the information gained from the study will help refine future chemotherapy programs.
Up to 40% of people who want to reduce their drinking have thought about suicide. However, currently there are no treatments that create a plan to manage cravings for alcohol and to manage suicide ideation. This study consists of three studies: Study 1 aims to conduct interviews with adults with lifetime alcohol misuse and thoughts of suicide and with providers who have worked with patients with alcohol misuse. The interviews obtain feedback on a newly developed brief (single appointment) treatment for alcohol craving and thoughts of suicide. Study 2 aims to pilot test the single-appointment treatment and 1 week of text messages with adults with recent alcohol misuse and recent thoughts of suicide. Adults will provide feedback in a brief interview. Study 3 aims to test the single-appointment treatment and 4 weeks of text messages with adults with recent alcohol misuse and recent thoughts of suicide. Specifically, different types of text messages will be tested.
This study is to compare the usual treatment (radiation plus temozolomide alone) to using the study treatment (usual treatment plus the study drug, vorasidenib). The addition of the study drug, vorasidenib, to the usual treatment could shrink or stabilize your cancer. The study drug is FDA (Food and Drug Administration approved. The study drug will be given orally. The study will randomize (the computer will pick the group that the participant will be enrolled in) participant to Group 1 or Group 2. Participants can expect to be on the trial for 10 years or more. There will 4 participants enrolled locally.
The purpose of this research study is to learn how the nervous system functions in individuals with and without spinal cord injury, and examine how this relates to function. As part of this study, procedures may include nerve stimulation, brain stimulation, imaging (MRI), walking assessments, measures of brain activity, sensation testing, measures of arm or leg function, and self-report measures regarding daily activities and quality of life. The duration of participation depends on the number of procedures to which an individual is consented.
The study will examine the effects of a 10-week resistance training program, with or without creatine monohydrate supplementation, on changes in body composition, physical function, cancer-related fatigue, quality of life, and symptom burden in head and neck cancer (HNC) survivors. All participants will undergo screening that includes completion of questionnaires, exercise testing and physical function assessments before and after the treatment period as well as at a 10-week follow up evaluation. We hypothesize that group that completes resistance training with creatine monohydrate supplementation will achieve greater improvements in body composition, physical function, cancer-related fatigue, quality of life, and symptom burden when compared to the group that completes resistance training alone.
Researchers at the Medical University of South Carolina are studying speech and language in people with Parkinson's disease (PD), progressive supranuclear palsy (PSP), and multiple system atrophy (MSA), and in healthy adult volunteers. These conditions can change how a person speaks and uses language, and the changes may differ from one condition to another. The study uses a tablet-based set of short speech and language tasks, called SLANG, together with computer software that measures features of the recorded speech, such as pitch, timing, and word choice. Participants also complete standard speech, language, and thinking tests and a brief exam by a neurologist, which researchers compare against the tablet measurements. The purpose of this study is to gather early research data: to build a database of these measurements across the groups, to check whether the tablet captures them reliably, and to explore whether they differ between conditions. SLANG is not used to diagnose participants or to guide their medical care in this study. The long-term goal of this research is to develop a tool that could someday help clinicians recognize and tell these conditions apart earlier, but testing such a tool for diagnosis is beyond the scope of the current study.
This study will include 2 groups of participants with subjective cognitive complaints (1) individuals diagnosed with Ehlos Danlos Syndrome (EDS), and older adults without EDS. Participants will complete a 6-week cognitive + occupational therapy tele-rehabilitation program (first 4 weeks: 2 sessions per week, last 2 weeks: 1 session per week), for a total of 10 treatment visits. This study integrates cognitive training with an evidence based OT-led tele-rehabilitation program. We will complete a comprehensive battery of cognitive assessments as well as participant reported outcome measures at the pre and post visits to characterize subjective cognitive difficulties and test the feasibility and initial effect of this personalized intervention.
This study is for patients that have been diagnosed with metastatic or advanced solid tumors. The study is testing an investigational drug called JZP898. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to characterize the safety and tolerability profile of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab. The drug is given to participants by infusion. The length of your participation in this study may vary depending on the number of treatment cycles you receive. This will depend on whether there are any changes in your health during the study and whether the study doctor feels you should continue receiving the study drug.