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.
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.
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.
This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active UC. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active UC due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 822 adult and 60 adolescent participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).
Adult subjects with rectal cancer undergoing sphincter sparing resection and colonic anastomosis. Post-operative follow-up will occur at 7-10 days, 30 days, 90 days, 180 days, and 270 days.
The 16-week main phase of the study is designed to assess the efficacy and safety of the once daily pitolisant, administered orally upon wakening, in comparison to a placebo. The effects of HBS-301 on excessive daytime sleepiness, sleep inertia (slow to wake up/groggy), and fatigue will be examined.
After the main phase period, there is an option to be in the second part of the study, which will span 1 year. During this period, subjects will receive open label of the active drug, HBS-301.
A germ called Streptococcus pneumoniae (also known as S pneumoniae) is a leading cause of serious diseases including infection of the lungs (pneumonia), infection of the brain lining (meningitis), infection of the blood (bacteremia) and infection of the ears (otitis). There are more than 90 different types of S pneumoniae, some of which cause more serious infections than others. 20-valent (meaning the vaccine protects against 20 different types of S. pneumoniae) pneumococcal conjugate vaccine (Prevnar 20®; 20vPnC) was approved in 2021 first in adults then in children in the United States in 2023, to prevent pneumococcal disease.
The study vaccine, 25-valent pneumococcal conjugate vaccine (25vPnC, PG4 vaccine, pneumococcal fourth-generation vaccine) contains the same components found in 20vPnC, one of which has been changed, but with 5 additional components to help expand protection against 25 types of S pneumoniae. The study vaccine is not approved by the United States Food and Drug Administration (FDA) or elsewhere around the world.
This study will look at how a new pneumococcal vaccine will work in healthy infants while expanding protection against pneumococcal disease due to the germ called S pneumoniae; and, how the new study pneumococcal vaccine will work together with recommended childhood shots.
This study will last for about 16 to 19 months and will have at least 6 visits and 1 telephone contact, about 6 months after your child's last study vaccination.