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.
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.
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 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.
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.
The purpose of this study is to learn more about late-onset epilepsy of unknown etiology (LOEU), which is defined as an onset of seizure activity in late life (age 55 or above) without a clear neurological cause. That is, many older adults will experience seizures due to neurological conditions such as stroke, brain injury, tumor, or infection. However, other individuals will also develop seizures with no identified cause.
Participation entails a single study visit lasting 2-3 hours including a blood draw, completion of standardized cognitive testing, and several questionnaires. The goals of the study include to examine blood markers that can help us to better understand the condition including dementia risk, and how these markers may impact the clinical presentation of the condition. No interventions/treatments are included with this study.
Eligible participants (ages 18+ whom have daily cigarette use) will attend an in-person assessment (though some aspects of the study, including consent, can be completed remotely). Participants will submit a breath sample for assessment of expired carbon monoxide. Approximately 5-7 days after completion of the in-person assessment, participants will meet with research staff. A medical clinician will meet with the participant to present a smoking cessation treatment recommendation along with resources. Participants will also complete surveys to assess their treatment preferences, motivation, and self-efficacy following receipt of the recommendation.
This is a research study to help see if a new interview for posttraumatic stress disorder (PTSD), called the Revised Clinician-Administered PTSD Scale for DSM-5, or the CAPS-5-R for short, is accurate and reliable for veterans. By doing this study, we hope to learn if the CAPS-5-R can be used in VA to diagnose PTSD. Participation will all be done remotely. Joining this study will involve (1) completing some questionnaire measures and (2) completing an interview remotely by videoconference over 2 days at most.
Participants must be Veterans, aged 18 or older in the Ralph H. Johnson VA Health Care System who have experienced trauma or at least one PTSD symptom.
This study will compare the safety, tolerability, and efficacy of inhaled study drug LTI-03 to placebo in participants diagnosed with IPF within 5 years of Screening who may be receiving standard of care (SoC) antifibrotic therapy. Taking part in this research is expected to last up to 32 weeks, which includes a 4-week screening period, a 24-week treatment period, and 4-week post-treatment follow-up period. The general procedures include review of eligibility; review of medical and medication history and changes in health; completing questionnaires; undergoing physical exams and having vital signs measured; collecting blood samples; examinations such as ECG, spirometry, HRCT, and DLCO and using an inhaler to take the study drug.