The purpose of this research is to evaluate the safety and effectiveness of the EchoMark/EchoSure System for AVF (arteriovenous fistula) for assessing AV fistula maturation when used under a protocol of biweekly use as compared to the standard of care follow-up. Target subject population are subjects presenting with Stage 5 Chronic Kidney Disease (CKD5) or End Stage Renal Disease (ESRD) undergoing upper arm autologous arteriovenous fistula creation for hemodialysis access who are on dialysis or will imminently require dialysis (GFR <10).
This is a prospective, multicenter, observational study designed to evaluate the clinical utility and prognostic relevance of serial TRAC and T-ID monitoring in kidney transplant recipients under routine clinical care.
The study compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk. Participants can expect to remain in the study for 10 years.
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.
We are testing a new investigational drug that may help patients with cancer gain and/or maintain their weight. "Investigational" means the "treatment has not been approved for sale by the United States Food and Drug Administration (FDA). The purpose of this study is to evaluate safety and the effects of different doses of an investigational drug called B07 on a patient's weight to see if their weight can be maintained, or increased slightly while they are receiving chemotherapy for their advanced colorectal cancer. In addition to their weight, the study will also look at the effects of B07 on their BMI (a measure of weight divided by height that is useful for determining who is underweight, normal, overweight, or obese), appetite, food intake, physical and psychological well-being, and quality of life as they undergo your cancer treatment.
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.