This study is being conducted in women who are at least 22 years old,+ and will be undergoing either a unilateral or bilateral mastectomy with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction (initial insertion of a tissue expander on top of the chest wall muscle followed by change-over to a breast implant after a period of tissue expander inflation).

The purpose of this research study is to evaluate the safety and effectiveness of the Melodi Matrix. .

The Melodi Matrix is an absorbable mesh that contains antibacterial agents (medicines that fight infections caused by bacteria) and is wrapped around tissue expanders before being implanted. After approximately 9 weeks, the mesh will fully absorb into the body.

This study is enrolling participants with heart disease or at high risk of developing heart disease who are already taking a cholesterol lowering medication referred to as a statin. This study is specifically seeking participants who are historically underrepresented in cardiovascular clinical trials including females, and racial/ethnic minorities, as well as those living in rural areas. This study involves the medication inclisiran which is an approved medication to help lower "bad" cholesterol. In this study participants will be randomized meaning assigned by chance to receive inclisiran along with usual care or not receive inclisiran and will continue usual care for the first 360 days. You will have a 50:50 chance, like flipping a coin, to receive inclisiran. Those participants who are randomized to not receive inclisiran initially will then receive it after day 360 and continue in the study for another 360 days so up to day 720. Participation will take up to 7 study visits.

Study related procedures include collecting medical history, demographics, questionnaires and blood work, as well as receive inclisiran as a shot just under the skin every 4 months. Study related risks include injection site reactions, joint pain or stiffness, bronchitis or an allergic reaction. There is also a risk of loss of confidentiality.

This study involves collecting data and physician feedback while using the ViewFlex X System during a routine electrophysiology (EP) procedure. An electrophysiology procedure is done to correct an electrical abnormality in the heart. The ViewFlex X System is considered investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). The ViewFlex System will obtain and integrate heart images with the mapping information obtained during your procedure. There is also an option to have the procedure videotaped. Study participation lasts until hospital discharge post procedure. Study related risks include risks associated with using the ViewFlex X System, loss of confidentiality and unknown risks.

This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. Participants randomized to receive the therapy will attend four 60-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 6 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the therapy program, participants will receive access to a mobile application, which will be accessible for the duration of the study. Participants randomized to medication monitoring will be asked to log each time the medication is taken for a two month period. All participants will also be asked to complete questionnaires at enrollment and again at 3-month postpartum and 6-months postpartum, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 8-12 months depending on when enrollment occurs (early second trimester-mid third trimester). Compensation up to $310 is provided.

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.

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.

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

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.

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.

We are looking to examine the various factors that contribute to the changes seen with Physical Therapy for chronic neck pain. These factors include the components of care involving the way a patient perceives their pain or disability, as well as the interaction with their care giver, which contribute to the effect of the Physical Therapy (PT) treatment. The study will assign subjects to one of three groups. The first group will receive a manual therapy treatment approach, the second will receive a simulated manual therapy treatment approach and the third will receive no treatment and act as a waitlist control. This design will allow us to tease out the effects of the treatment itself compared with the other factors which may contribute to change as well as any improvement which occurs as result of natural history. You will be seen for an initial assessment where you will complete surveys and measurements will be performed looking at how far you can move and the way that you move your neck. You will then be seen for 3 additional visits weekly over the next three weeks if you are assigned to the manual therapy or simulated manual therapy group. You will be seen for an initial visit and a follow up after three weeks if you are assigned to the waitlist/control group. All groups will complete the surveys and have repeat measurements performed at the final follow up visit.