This is an international, multicenter, study that will not prescribe elafibranor. It is designed primarily to collect data and assess real-world effectiveness of treatment with elafibranor 80mg/day on adult patients with PBC, and to describe the safety of this treatment and its impact on their quality of life, over a period of 24 months.
Hearing loss is common, but many people don't realize they have it until years after it begins. This study will explore whether everyday speech and conversation can reveal early signs of hearing loss. In one part of the study, we will record conversations between participants and healthcare professionals to study how speech patterns may differ in people with and without hearing loss. In another part, we will review transcripts from past clinic visits to see if certain patterns, like pauses or asking for things to be repeated, are linked to hearing problems. The goal is to develop tools that can help identify hearing loss earlier and more easily, using conversations that happen naturally during clinic visits.
The TEAM-HF trial aims to find out whether measuring pressure in the heart and lungs using an implantable device called a CardioMEMS can help identify heart failure patients who are getting worse and may benefit from earlier treatment with a heart pump called an LVAD. It also seeks to determine if patients with advanced heart failure, who are not on IV medications for their heart failure but still have high pressures in their heart and lungs can improve with LVAD therapy.
Depression is common among cancer survivors, but current ways to address this area of care are lacking. In this project, we will work with cancer survivors and oncology providers to build a text-message based approach to screen cancer survivors for depression. Long term, we hope this research can be used to improve screening for depression for cancer survivors
This study will examine genetic factors that contribute to the different ways people feel after consuming cannabis. People that use cannabis at least 4 days per week will participate in a study involving 1 in-person visit followed by a 5-day remote assessment period. The in-person visit will determine if an individual is eligible for study participation and their blood will be drawn to assess genetics. During the remote assessment period, participants will complete multiple short surveys per day describing their feelings and their recent cannabis use.
The long-term objective of this proposed R24 program is to enhance our understanding of how circadian rhythm disruption contributes to vulnerability to alcohol-induced organ damage, and to explore the underlying mechanisms (e.g. microbiota) that could lead to the identification of novel therapeutic targets. This knowledge aims to inform the development of innovative strategies to prevent and to treat alcohol-related pathologies.
An international research registry called the CorEvitas International Adolescent Alopecia Areata (AA) Registry (the "CorEvitas Registry"). This observational registry studies adolescent patients with AA between 12-17 years of age under the care of a dermatology provider diagnosed with moderate to severe alopecia areata.
The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.
Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 2:1 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned. Participants from the placebo group in CADENCE who enter HARMONIZE at Visit 9a will be randomized 1:1 to one of the active treatment groups. Participants from an active treatment group in CADENCE entering HARMONIZE after Visit 9a will be allocated to continue in the same treatment group (ie, sotatercept dose level) as in CADENCE.
This study is enrolling subjects who are undergoing a planned radiofrequency catheter ablation (RFCA) to treat ventricular tachycardia (VT). VT is a type of irregular heart rhythm originating from the lower chambers of the heart and is commonly treated with RFCA. During a catheter ablation procedure, flexible tubes are guided through blood vessels in your heart where the location of the source of your abnormal arrhythmia is identified. One of the flexible catheters, called an ablation catheter, is then used to deliver energy from its tip to burn the areas of abnormal tissue within the scar which may be causing the ventricular tachycardias. The ablation procedure utilized in this study will be guided by an Ablation Index; a formula developed to assist physicians performing ablation procedures to guide the duration of applications of radiofrequency energy delivery. Participants will be randomized into the control group, where the study doctor will utilize traditional, non-AI guided ablation, or the intervention group, where the study doctor will utilize AI-guided ablation.
This study will last up to 1 year post-ablation procedure for participants and will include up to 4 visits (ablation procedure and 3 follow-up standard of care follow-up visits). Study procedures include the initial, planned ablation procedure, and collection of medical history and images.
The proposed research will qualitatively examine adolescent perspectives on adapting Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD) among adults, for use with adolescents. The present study will take the first step in adapting WET for adolescents by conducting interviews with adolescents with PTSD. Interview questions will focus on identifying perceptions of WET and recommendations for adapting WET for the needs of adolescents. A brief survey will also be conducted. Participation in the interview and survey will involve a one-time study visit that lasts up to 60 minutes and can be conducted in person or virtually. Adolescent participants need be accompanied by a caregiver either in person or virtually.