The purpose of this research is to test the safety, tolerability and effects of the investigational drug JANX014 in adults with metastatic castration-resistant prostate cancer. The study will also look at how the body processes JANX014, how the immune system responds, and whether the drug shows signs of effectiveness against prostate cancer. JANX014 is an investigational drug created by Janux Therapeutics, Inc. This study is to be conducted in 2 parts. Which part someone is assigned to will be determined by the study progress, and when the subject is eligible to participate. Dose Escalation (Part 1), participants will receive increasing doses of JANX014 by intravenous (IV) infusion to find the safest and most effective dose. Expansion (Part 2), once safe doses are identified, more participants will receive JANX014 to further evaluate safety and early signs of benefit.
This study aims to evaluate real-world effectiveness of pacritinib through a site-based retrospective chart review of medical records of adult patients with myelofibrosis treated with pacritinib in routine clinical settings with platelet count ≥50 x 10^9/L at the time of treatment initiation. Treatment effectiveness will be based on spleen size and symptom burden, hematological parameters, progression to leukemia, survival, pacritinib treatment patterns, patient demographic and clinical characteristics, and allogenic-hematopoietic stem cell transplant (allo-HSCT)-related outcomes. Data will be collected from medical charts of patients with pacritinib initiation between 01 June 2022 and 31 December 2025 with an end of study observation on 30 June 2026.
The purpose of this Study is to find out if dabogratinib, also known as TYRA-300 (which is also known as "Study Drug") is safe and effective at treating low grade upper tract urothelial cancer. Some patients have a certain alteration, or mutation, in the FGFR3 gene (a protein in the body) that can lead to cancer. The Study Drug is an experimental treatment (not approved by the United States Food and Drug Administration [FDA] or any other regulatory agencies) that blocks the abnormal activity of FGFR3 in cancer cells which might be "driving" this type of cancer.
Most patients with this type of cancer have the FGFR3 alteration in their tumor(s) but there are some patients who do not. Participants that join this study could be on it for a few months up to 24 months.
OBSERVE-ARDS is a prospective, multi-center, observational human subjects research study designed to collect longitudinal clinical data and remnant biological specimens from adults with clinically defined ARDS. The study is non-interventional and does not introduce, modify, or recommend any diagnostic, therapeutic, or management decisions. All participant care is determined solely by the treating clinical teams in accordance with routine clinical practice and dictated by any other clinical studies in which they are enrolled. The study is conducted to support efforts to improve understanding of biological heterogeneity in ARDS and to enable the development and evaluation of biomarker-driven endotyping and treatment-prediction algorithms.
This registry will be used to collect data that may be used by other IRB-approved studies to investigate how VNS (vagus nerve stimulation) can help people who have difficulty using their arm or hand after a stroke. It uses a device called Vivistim®, which is already approved by the FDA, that is paired with neurorehabilitation to improve arm and function in patients following stroke. The study will collect information from people who choose to receive the device as part of their regular care. Researchers will track progress before and after the device is implanted to better understand how well the therapy works. The goal is to gather real-world information that can help improve stroke recovery in the future.
DROP-FPF is a clinical study that will assess whether an investigational medication called nerandomilast can reduce the risk of interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) getting worse over time. By learning more about people with early lung abnormalities, it may inform researchers how to reduce the risk of developing progressive pulmonary fibrosis.
This study aims to explore how painful and non-painful stimuli are processed in people with and without nerve pain with chronic SCI. We are recruiting individuals with spinal cord injury at T11 and above, with or without neuropathic pain in the leg, and who are able to stand with or without an assistive device. Study participation involves 3 in-person visits, each of which will last 2-3 hours. Compensation and mileage reimbursement are available for all study visits.
The purpose of this research study is to determine potential subjects eligibility for participation in the Alcohol Research Center clinical projects based on the results of the screening assessments, which they will complete during this protocol.
Participants will undergo 1 day screening procedures. Subjects will be asked to fill out questionnaires, they will be interviewed, will need to provide medical history and have physical exam done and provide a blood sample. Total study consists one 2-3 hours visit.
The purpose of this study is to better understand how ear stimulation techniques may impact how people think about themselves in social situations. The goal is to identify how the addition of ear stimulation can impact cognitive processes, including the ways that people think about themselves in social situations and attend to or process social information, that underly an activity known as "self-imagery rescripting." Eligible individuals who are between the ages of 18 and 65 years will complete a variety of activities after providing consent to study participation. These include: (1) completing questionnaires on the computer, (2) completing tasks similar to a video game on the computer, (3) having an electrode attached to their ear that will stimulate nerve activity, (4) completing an interview about how they feel in social situations, and (5) engaging in an activity during which they will be prompted about how they see themselves in social situations. Throughout these activities, participants also will be asked to wear a variety of sensors, bundled together in a cap for their head and individually on other parts of their body, that will collect information about brain activity, heart rate, and eye blinking. Participation in this research study is entirely voluntary and will last approximately 3 hours during a single session at the Medical University of South Carolina in Charleston. Participants will be compensated for their time.
There are some risks associated with this study. Some survey questions ask about personal thoughts and feelings. Ear stimulation may cause tingling sensations or irritation around the ear. Thinking and talking about how one sees themselves in social situations may be distressful.
There are no direct benefits to participants. This study will help researchers better understand how ear stimulation can improve the strategies that can help the way that people think about themselves in social situations.
The aim of this study is to assess the efficacy and safety of an investigational medication, Inebilizumab, in patients with autoimmune hepatitis (AIH) who inadequately respond to at least 9 months of standard-of-care (SOC) treatment, or who are intolerant to SOC within 6 months of screening.