The purpose of this study is to determine the clinical efficacy of a novel, bioresorbable hydrogel sheet and wetting solution, VersaWrap®, in surgeries of the foot and ankle. This is a prospective, multi-center, controlled case series with patients identified by the Investigator in his practice. Patients who are scheduled to have procedures of the Achilles tendon will be reviewed to determine if they meet the inclusion/exclusion criteria. If eligible, patients may be enrolled in the study, and the operative surgeon will use VersaWrap® during the procedure. Patients are considered enrolled when VersaWrap® is placed intraoperatively. VersaWrap® has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1-2 years. All subjects will be followed for 1 year post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 6 weeks, 3 months, 6 months, and 1 year after surgery. Patients enrolled in this study are receiving a standard of care surgical procedure (with or
without VersaWrap) and therefore there is no increased risk of the surgical procedure when participating in the study. The study collects patient data, and therefore there is a risk data privacy loss. Patients will also receive remuneration for their participation.

This study is for participants who have moderate or severe chronic graft-versus-host disease (cGVHD). cGVHD is a condition in which the healthy transplanted (graft) stem cells see the recipient's (host) cells as foreign and start to destroy them.
This Study is being done to learn the effects of the drug INCA034176 (also known as axatilimab) in combination with corticosteroids.

This research seeks to gather important insights about patients' experiences of NCFBE-related exacerbations and brensocatib treatment by conducting semi-structured qualitative interviews in the USA. A total of up to 30 interviews of approximately one hour are planned. Patient must be at least 18 years old and currently participating in the brensocatib PTA program for at least 3 months.

The purpose of this study is to evaluate investigational treatments (study drug) in people with recurrent or metastatic PD-L1-positive, HPV-negative head and neck squamous cell carcinoma without prior treatment. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BCA101. This is a phase 2 study; BCA101 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 5 years. The procedures include taking study drug intravenously, blood and urine samples, and CT scans. Risks include diarrhea, nausea, vomiting, mouth sore, nose bleed, headache, and skin rash. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

Alpha-1 antitrypsin (AAT) deficiency is a condition in which the body does not make enough of AAT, a protein that protects the lungs and liver from damage. This condition is inherited, meaning you get the faulty gene from one or both of your parents.

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral administration of BMN 349 in adult participants with the PiZZ genotype (also defined as having a severe deficiency or AAT ≤ 60mg/dL) or PiMZ genotype with metabolic dysfunction-associated steatohepatitis (MASH). Participants will receive an oral single dose of BMN 349 (250 mg), a medication designed to assist Z-alpha-1 antitrypsin to get out of the liver cell. The study drug BMN 349 has not been approved by the Federal Drug Administration (FDA).

This is a phase 1 study in which participants will get a single pill dose of drug or placebo to measure the amount of alpha-1 that gets out of the liver cells and into the bloodstream. Study details include:
• Study duration: up to 78 days
• Treatment duration: 1 day (single dose).
• Observations: The study will collect data on medical history, physical examination, vital signs, electrocardiogram readings, clinical laboratory parameters, pulmonary function tests, and drug distribution.
• Visit frequency: The Screening Visit, dosing, and post dosing evaluations will be conducted at MUSC on 3 consecutive days. Visits at days 8 and 36 days will occur at study site. Other procedures/assessments may be performed at the study site or at home by a healthcare professional and/or by telemedicine.

This study involves a procedure called renal denervation with an investigational device called the TIVUS™ system for the treatment of resistant hypertension (high blood pressure). Investigational means it is not yet approved for commercial use by the Food and Drug Administration (FDA). Renal denervation is a procedure done by introducing a catheter (long tube) into the large blood vessel in your groin (top of leg) and guiding it to your renal arteries, which are the blood vessels that go to your kidneys. The catheter will be placed in the renal arteries and ultrasound energy will be delivered to the renal arteries.
This study is randomized, meaning you will be assigned to one of two groups, by chance, like drawing straws. Two out of three participants will be randomized to renal denervation while one out of three will be randomized to sham. Sham means you will go through all the steps of the procedure but will not receive the treatment. Those participants randomized to sham will have the option to crossover and have the procedure after the 6 month follow up.
This study will involve at least 12 visits over the course of 36 months. Study related procedures include CT scan, ultrasound test of your heart and kidneys, blood work, urine studies, physical exams, questionnaire, and keeping home blood pressure diaries.
Study related risks include risks related to the procedure including pain, bleeding, damage to the blood vessels, risks related to the study related testing such as radiation risks, blood draw risks and loss of confidentiality. There may be benefit to you as well as others in the future with high blood pressure.

This study is designed to learn more about the effects of Petosemtamab, an investigational drug not FDA approved, compared to standard of care treatment for people with head and neck cancer that has been previously treated with immunotherapy and chemotherapy. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receiving petosemtamab or one of the three standard of care choices. In the follow up period the side effects after completion of petosemtamab administration or assigned standard of care treatment will be evaluated. Also, approximately every 12 weeks after study treatment stopped, either petosemtamab or assigned standard of care, participants will receive a phone call for long term follow-up for up to 1.5 years. Participation in this study may last up to two years. The participants will complete questionnaires to evaluate the differences in the quality of life for participants that received petosemtamab versus standard of care treatment. Some serious risk related to this study are infusion related reactions, rash and diarrhea. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well Petosemtamab works at curing this type of cancer. The study results may be used to help others in the future.

This study is investigating the drug, called mosliciguat, for the treatment of PH-ILD. Participation in the study may last for about 4 ½ years, although the actual time of participation may be shorter or longer. Part 1 of the study will take about 6 months. Part 2 of the study could last up to about 4 years. During the study, participants will be required to make clinic visits in person and at times will need to meet with study staff over the phone/video. At some of the clinic visits, participants will have blood drawn and have procedures to test their lungs and heart function. Participants will be randomly assigned to get mosliciguat or placebo in Part 1. In Part 2, all participants will get mosliciguat. Approximately 120 people will participate in this study.

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 in adult participants with locally advanced or metastatic selected solid tumors.

This study utilizes adjuvant therapy in patients identified with urothelial cancer. Patients will be tested and screened to determine eligibility. Once they are deemed eligible and have consented to treatment, the study will begin. There are regular CT / MRI scans, blood draws, testing and drug administration that occurs while on this study, including while in post-treatment follow up. The study has seperated patients into Cohorts A and B. The study lasts approximately 5 years, with 2 years dedicated to regular treatment, and 3 to post-treatment follow up observation.