The purpose of this research study is to confirm the safety of the study drug (Prismocitrate 18) and the study device for patients with acute kidney injury receiving a type of dialysis treatment known as Continuous Renal replacement Therapy (CRRT). When a patient receives CRRT, a blood thinner (also known as an "anticoagulant") is frequently given. In the United States (U.S.), an anticoagulant called, Heparin, is commonly used for CRRT. Some patients have a high risk of bleeding and cannot be given heparin, because it can cause harm to them. For these patients, an anticoagulant, called citrate, can be used. The study drug being tested contains citrate. The study drug works as an anticoagulant and may also help cleanse your blood during the CRRT treatment.
To improve the diagnosis of metabolic dysfunction-steatotic liver disease (MASLD) in primary care, this study will develop, test, and internally validate a predictive model for MASLD in a cross-sectional sample of patients with no known chronic liver disease. Patient metabolic variables, like weight, blood pressure, and blood sugar will be considered for inclusion in the model, and ultrasound-based vibration-controlled elastography will be used for determining the outcome. This work will dramatically enhance MASLD diagnosis and management in primary care.
This is an open-label pilot study firstly assessing safety and feasibility of a form of ear stimulation called transcutaneous auricular neuromodulation, or tAN, in women with postpartum depression (PPD). Secondly, we will be assessing the impact of at-home tAN on mood, empathy, and physiological markers of sympathetic activity in women with PPD. Participants will learn how to self-administer ear stimulation treatments in the lab before starting the at-home study. Over the course of one week, participants will self-administer ear stimulation treatments three times a day. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study, as well as undergo heart rate variability (HRV) assessments and provide salivary samples. There will also be a smaller number of questionnaires completed electronically at the midpoint of the study. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and feelings towards their newborn.
Written Exposure Therapy (WET) is a five-session mental health therapy for post-traumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and formally tested in individual therapy with people aged 12 to 18. Our study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, first we will talk with PTSD experts and people aged 12 to 18 to learn what changes might make WET more suitable for young people. We'll also deliver WET to five people aged 12 to 18 following the manual as it is written for people over age 18 to see what needs adjusting.
In the next part of the study, we will recruit 48 adolescents aged 12 to 18 in a pediatric primary clinic who have symptoms of PTSD and randomize them to either receive the adapted version of WET or to receive gold-standard PTSD treatment: Trauma-Focused Cognitive Behavior Therapy. If assigned to receive adapted WET, participants will take part in five to seven weekly therapy sessions and five study visits (before therapy, and 6-week, 10-week, 20-weeks, and 30 weeks after starting the therapy). If assigned to receive TF-CBT, participants will take part in 12 to 16 weekly therapy sessions and five study visits (before therapy, and 6-week, 10-week, 20-weeks, and 30-weeks after starting the therapy). The purpose of the study visits for a 30-week time period is to better understand who they are as a person and their current mental health symptoms and diagnoses. All therapy and study visits can be completed remotely or in person, per your preference. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Our goal is to find the best way to provide effective PTSD treatment for young people that can be delivered in real-world pediatric primary care settings, so that ultimately more people can get the help they need after traumatic experiences.
This study investigates the factors contributing to cognitive load among emergency medicine physicians at the Medical University of South Carolina's Main Emergency Department during clinical shifts and identifies those with the greatest impact.
Cognitive load will be measured before and after shifts using a validated survey tool, while corresponding heart rate metrics will be recorded and voluntarily shared throughout and immediately following each shift via personal smartwatches. These physiological and survey data will then be analyzed in the context of clinical events occurring during the shift to assess how specific experiences influence overall cognitive load.
The events under consideration were selected based on findings from a prior study in which MUSC emergency medicine physicians ranked the perceived contributors to their cognitive load. The occurrence of these predetermined events will be documented through direct observation of physicians during shifts and, if applicable, obtained via shift-level operational reports.
Epidermolysis Bullosa (EB) is a rare, inherited skin condition that makes the skin extremely fragile, causing painful blisters and wounds from even minor friction or injury. There is currently no cure, and because EB is uncommon, doctors still have limited high-quality data to guide the best treatment and long-term care. This study is part of a large North American effort to collect and organize health information from people with EB into a secure database. By tracking how the disease progresses over time, along with symptoms, complications, and treatments, researchers hope to better understand EB and improve care for future patients. Participation involves consenting to share medical record information and optionally completing brief questionnaires during routine clinic visits or by email. No experimental treatments or extra medical procedures are involved. While there is no direct benefit to participants, the knowledge gained may help improve care and support the development of new treatments in the future.
Dystonia is a movement disorder that causes muscles to contract and/or spasm. This may be painful and can affect the person's ability to complete daily tasks. Dystonia may affect one or multiple parts of the body. Botulinum toxins (BoNT) are the only approved drug in the United States to treat dystonia, and this is only for dystonia of the neck or the eye. There are currently no approved oral treatments for dystonia. Most current treatments only provide relief of symptoms.
The purpose of this study is to learn about the effects of the research drug (VIM0423), to find the best dose for treating dystonia, and to see how safe VIM0423 is for patients with dystonia.
This research study is studying VIM0423 as a possible treatment for dystonia. It is being developed to be a combination dose of: VMA-1001 given with VMA-1002.
• VMA-1001 and VMA-1002 will be taken in separate oral doses at the same time.
• VMA-1001 is an extended release (ER) modified version of trihexyphenidyl (THP).
• VMA-1002 is a formulation of bethanechol (BTC).
THP and BTC are medicines approved by the U.S. Food and Drug Administration (FDA); however, the Sponsor is investigating a different formulation of THP referred to as VMA-1001 and a different formulation of BTC referred to as VMA-1002. The purpose is to attempt to minimize some side effects of THP and is therefore considered an investigational drug in this study. An investigational use is one that is not approved by the FDA.
You may be in this study for up to 32 weeks from the time you consent until the last study visit.
You will be seen at the study site 6 times (Screening, Day 1, Day 30, Day 60, Day 95, and Day 125) and will complete 4 telephone calls (Day 6, Day 13, Day 20 and Day 105). You may be asked to come for extra visits at any time during the study if the study doctor decides that extra tests are needed for your safety.
Side effects associated with the study drug are dry mouth, dry eyes, blurred vision, dizziness, mild nausea and feeling nervous.
You do not need to take part in this study to receive treatment for your isolated dystonia. The study doctor will explain other options that are available to you. Your other choices may include treatment with other medicines for isolated dystonia, another investigational treatment, treatment that makes you feel more comfortable but will not have an effect on your isolated dystonia, or no treatment.
Study B7981028 is a Phase 3 long-term, double-blind extension study aimed at evaluating the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA). This study includes individuals who have completed previous ritlecitinib studies, B7981031 or B7981027, and are eligible to enroll in the B7981028 study. The research seeks to gather more comprehensive data on the treatment's effects over an extended period.
This study is a double‑blind, placebo‑controlled research study to evaluate the safety and effectiveness of a skin patch treatment for peanut allergy in children ages 1 to 3. The patch delivers a very small amount of peanut protein through the skin and is designed to help the immune system become less sensitive to peanuts over time.
Participation in the study will last approximately 34 weeks. Participation is voluntary, and participants may withdraw at any time.
This study is for male subjects that have been diagnosed with prostate cancer. Subjects are expected to remain in the study for a minimum of 12years or longer. There will be a total of 6 subjects locally enrolled. Subjects may experience the following risks: Bladder or prostate capsule perforation, Bladder neck contracture, Bleeding or blood in the urine, Bruising, Cancer progression, Electric shock/burn, Embolism, Incontinence or overactive bladder, and Infection.