The main reason for this research study is for researchers to evaluate the relationship between congenital heart disease and development. Currently, there is not enough long-term information available to researchers to predict a child's development if they have been diagnosed with Ductal Dependent Pulmonary Blood Flow (DDPBF), a type of congenital heart disease.
This study is enrolling subjects with severe aortic regurgitation (when blood leaks back in the heart because the aortic valve does not close properly) into a randomized study. Typically valve replacement is performed to correct this condition. This study will compare a transcatheter aortic valve replacement (TAVR) using the JenaValve Trilogy Heart Valve System to open heart aortic valve surgery (SAVR). the JeneValve Trilogy Heart Valve System is considered investigational meaning it has not been approved yet by the Food and Drug Administration (FDA). A TAVR procedure is done by accessing a large blood vessel at the top of your leg and delivering the new valve as opposed to open heart surgery. This study will randomize subjects in a 1 to 1 fashion to TAVR or SAVR. Randomized means assigned by chance, so you will have a 50% chance of being assigned to the TAVR group and a 50% chance of being assigned to the SAVR group. The SAVR group will have the aortic valve replacement done by open heart surgery using a commercially available device.
Participation in this study will last about 10 years and include 15 visits. Study related testing includes physical exam, echocardiograms (ultrasound test of the heart), electrocardiograms (recording of heart's electrical activity), 6 minute hall walk, bloodwork and a questionnaire.
There are risks including risks related to the procedure and to study testing. There may be no benefit but the information learned may help in treating others in the future.
This research study is being done to see the effectiveness and safety of a new drug called prasinezumab as a possible treatment for Parkinson's Disease. It has not been approved by the Food and Drug Administration. Eligible participants will be randomly assigned to received either prasinezumab or placebo (an inactive substance) The drug or placebo is given as an intravenous infusion every 4 weeks. Participation in the study is expected to last approximately 3 years. There is a Screening period that will last up to six weeks and a study treatment period that can last 104 weeks. There are two options at the end of the study, 1. Safety follow-up 70 days after last dose or Option 2: Two years of Open label prasinezumab and safety follow-up 70 days after last dose. The Screening, Randomization and Treatment period, Year 1 is 19 visits and treatment period Year 2 is 17 visits. Each visit will last to 4 to 6 hours. The OLE Year 1 is 16 visits and OLE Year 2 is 15 visits, and each visit will last 4 to 6 hours.
This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
The purpose of this study is to understand how exposure to harmful substances during military service may affect the health of Veterans with or without lupus. Lupus is an autoimmune disease that can increase the risk of cardiovascular problems.
We believe that Veterans who were exposed to toxic substances during their military service may develop more harmful antibodies that attack the lining of their blood vessels. These antibodies may contribute to poorer blood vessel and heart health, and could contribute to the development of lupus.
This study aims to improve our understanding of how toxic military exposures may increase the risk of blood vessel complications in Veterans with and without lupus. Ultimately, this research may help identify new ways to better prevent, monitor, or treat cardiovascular disease in this population.
Research procedures for this study will include:
1. The study team will check subject medical records to gather information about medical history and medications being taking. The study team may continue to follow updates in the medical record.
2. Subjects will be given a survey to assess military and occupational toxic inhalant exposures.
3. Subjects will have a brief physical examination during which vitals will be recorded (height, weight, heart rate, respiration, temperature). Women of childbearing ages will be asked for the date of their last menstrual cycle within the past 2 months.
4. Subjects will have blood pressure taken three times three minutes apart.
5. Subjects will then provide a urine sample. Urine collection will occur in a private restroom using a sterile container provided by the study team. For women of childbearing ages, a pregnancy dipstick test will be undertaken on urine to confirm subjects are not pregnant.
6. Subjects will undergo a blood draw where approximately 4 teaspoons of blood will be drawn.
Zasocitinib (TAK-279) is an oral TYK2 inhibitor being studied as a potential treatment for moderate-to-severe plaque psoriasis in children and adolescents, a group with limited safe and effective oral options. TYK2 plays a crucial role in immune pathways involved in psoriasis, especially through IL-23's activation of Th17 cells and production of proinflammatory cytokines. Current treatments include injectable biologics and the oral agent apremilast, but few oral therapies match the efficacy of biologics. In phase 2b trials, zasocitinib showed promising results, with over two-thirds of adult participants achieving PASI-75 at certain doses by week 12 and no major safety concerns. Ongoing phase 3 trials are evaluating zasocitinib as a potential new oral treatment for pediatric plaque psoriasis.
This is a Phase 3 randomized study to compare two new drug combinations of teclistamab with daratumumab and lenalidomide and talquetamab with daratumumab and lenalidomide versus standard of care in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. The study is expected to continue for approximately 9 years.The Medical University plans to enroll 12 participants. The duration of participation will depend on the response of the study treatment. Subjects will receive treatment weekly or every 2 weeks. Medical history and physical examination, including lab tests like blood work and imaging, as well as questionnaires will be completed. Known risks include Cytokine Release Syndrome (CRS) as a complication that can happen due to the activation of immune cells.
This is a Phase 1/2, open-label, multi-center clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TSRA-196, a gene editing compound, in adults with severe alpha-1 antitrypsin deficiency (PiZZ genotype) and associated lung and/or liver disease. Participants will receive a single intravenous dose of TSRA-196 in a dose-escalation phase followed by dose-expansion cohorts.
The study will assess safety outcomes, pharmacokinetics, and changes in serum alpha-1 antitrypsin levels and lung function to determine whether TSRA-196 can safely increase functional AAT levels and inform selection of an appropriate dose for further clinical development.
Chronic obstructive pulmonary disease (COPD) is a leading cause of death and decreased quality of life, particularly among individuals living in rural areas. This project will test a home-based, technology-supported respiratory muscle training program designed to reduce shortness of breath and improve daily functioning and quality of life in adults with COPD. Findings from this research will support development of scalable approaches to improve respiratory health for individuals with COPD living in rural communities.
This study will examine the factors that contribute to changes in swallowing as people age. Over the next ten years, researchers will follow healthy adults (age 18 and older) to see if swallowing becomes more difficult with age. They will also look at whether changes in the brain, thinking skills, and body chemistry are connected to swallowing problems. The information from this study may help doctors find ways to address problems such as choking or aspiration pneumonia in older adults.
Participants can change their mind and stop participating at any time, for any reason. Leaving the study will not affect any benefits or care they are entitled to.
If you would like to learn more, please contact the study team.