This study is enrolling subjects with an abnormal heart rhythm called ventricular tachycardia (VT - rapid heart beat coming from the bottom of the heart) that has come back despite treatment. This is a randomized study meaning subjects will be assigned to one of two groups and then undergo either a standard catheter ablation or a new treatment called cardiac radioablation for their VT. You will have a 50:50 chance of being assigned to either group. A standard catheter ablation is done by placing catheters (long hollow tubes) into a large blood vessel at the top of the leg, guiding them to the heart to first identify the signals causing the VT and then use radiofrequency (heat) energy to burn and stop these signals to stop the VT. The cardiac radioablation is an investigational treatment meaning it is not yet approved for routine clinical use by the Food and Drug Administration (FDA). Cardiac radioablation is performed in the radiation oncology department and uses radiation therapy to treat the signals causing the VT. Participation in this study will last up to 5 years and inlcude about 15 visits. Study related procedures include medical record review and data collection, electrocardiogram (tracing of heart's electrical activity), echocardiogram (ultrasound test of the heart), CT scans, blood work, questionnaires, implantable cardioverter defibrillation (ICD - device implanted in your chest that monitors and treats abnormal heart rhythms), and ablation procedure per randomization. Risks include fatigue, changes in the appearance of the lungs in the cardiac radioablation group, fatigue, pain, low or high blood pressure or excessive bruising or bleeding at the catheter insertion side in the cardiac ablation arm. There are also study procedure related risks, and risks that are not known. There is potential benefit to you and to others in learning how to better treat others in the future with this condition.

This research study is being done to see the effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. Participation in this study is expected to last approximately 18 to 20 weeks, or about 4 months.

This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

Adherence to home exercise is important to achieve upper limb recovery after stroke. However, adherence is typically low. Therefore, a new home exercise program with an Apple Watch and iPhone app was created to improve adherence to upper limb exercises for stroke survivors at home. Participants will come to our lab to experience the new home exercise program. Participants who opt for home use will bring the device home to try the new home exercise program at home. The purpose of this study is for researchers to examine usability and feasibility of participants using the new home exercise program.

The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.

Approximately 105 subjects will take part in this research at approximately 30 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.

Phenylketonuria (PKU) is an autosomal recessive inborn error of L-phenylalanine (L-Phe) metabolism which is caused by deleterious variants in the gene coding for the phenylalanine hydroxylase (PAH) enzyme. The PAH enzyme catalyses the conversion of phenylalanine (Phe) to tyrosine (Tyr), a precursor of several neurotransmitters, hormones, skin, hair, and eye pigments. Elevated concentration of Phe and secondary metabolites and lower Tyr concentration in blood and in brain cause degenerative neuropathology, neurological symptoms, and intellectual deficits, together with poorly or non-pigmented skin and hair, and musty odor which are characteristic in untreated patients with PKU (1, 2).
This Phase 1/Phase 2 study is designed to assess the safety and efficacy of escalating doses of SAR444836 treatment in participants with PKU. The data collected will help to evaluate whether this adeno-associated virus (AAV) vector which delivers the functional human PAH gene into hepatocytes is effective in the treatment of PKU disease. The expression of PAH gene in hepatocytes is expected to provide steady low plasma levels of Phe similar to those observed in healthy individuals, preventing marked fluctuations caused by normal dietary protein intake.
The study is divided into 2 parts including a dose escalation phase (Stage 1A) and a dose expansion phase (Stage 1B).

The APEX 3D™ Total Ankle Replacement System is intended to reduce pain and restore motion to a failing ankle joint due to rheumatoid, post-traumatic, or degenerative arthritis. In 2020, the APEX 3D™ Total Ankle Replacement System received 510(K) clearance from the FDA, demonstrating that the device is marketed as safe and effective. The primary objective of this research study is to determine implant survivorship. Enrollment is expected to take approximately one to two years. All subjects will be followed for ten years post-operatively. Study follow-up visits will occur at 6-weeks, 6-months, and annually for ten years after surgery. During the pre-operative visit and each follow-up visit, subjects will be asked to complete a series of questionnaires that assess their levels of pain, function, mobility, and quality of life. Comparison of pre-operative scores to post-operative scores can be used to assess the improvement in patient function, thus supporting the benefit and clinical performance of the intervention. As with any clinical research study, there is a risk of unintended personal health information disclosure.

This study is an open label extension study for those who participated in the ION 682884-CS2 clinical trial for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a disease caused by change in a protein called transthyretin (TTR) which can result in a build up of this protein in parts of the body including the heart. This build up is called an amyloid deposit, and when this occurs in the heart it can lead to a condition called cardiomyopathy. This study involves the medication eplontersen, which is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration (FDA). Eplontersen is aimed at preventing production of the TTR protein to slow or reverse disease progression. Eplontersen is given as an injection under the skin in the upper arm, stomach or thigh. This study will last about 3 1/2 years and include 16 clinic visits. Study procedures include physical exams, blood work, questionnaires, hall walk tests, electrocardiograms (tracing of the heart's electrical activity), echocardiogram (ultrasound test of the heart) and taking a Vitamin A supplement.

The study will test OATD-01, an experimental medicine, for the first time in patients with pulmonary sarcoidosis (swollen tissue in the lungs). The study goal is to evaluate OATD-01 in the reduction of inflammation and assessing OATD-01 safety.

Everyone who participates in this study will receive OATD-01 or matching placebo (inactive mock tablet). Subjects will be randomly assigned to receive either OATD-01 or placebo for 12 weeks.

The study will run in several hospitals or outpatient clinics, in different countries in Europe and in the USA. In this study, there will be about 98 study subjects in total.

For all patients whether taking OATD-01 or matching placebo, there will be a screening period, a treatment period which will commence after randomization has taken place and will last for 12 weeks and then a follow up visit approximately 4 weeks post last dose of OATD-01.

The total duration of the study is 18 weeks.

The purpose of this study is to evaluate ABBV-400 in subjects with select solid tumors. This study will consist of
multiple cohorts with each cohort investigating ABBV-400 at 3 mg/kg Q3W.
The study will consist of a Screening, a Treatment, and a Follow-Up period.
All screening procedures must be performed within 28 days of first dose with the exception of tumor
tissue biopsy, which may occur during screening or any time after disease progression on the most
recent treatment. Subjects will continue treatment with ABBV-400 3 mg/kg Q3W until documented disease progression,
intolerable toxicity, or the subject meets other protocol criteria for discontinuation of treatment
(whichever occurs first). The maximum treatment duration will be 2 years.