Assess the safety and effectiveness of the ASG device in
the treatment of lesions involving the ascending aorta and
aortic arch.

The purpose of this study is to measure the effects of hormone replacement therapy (HRT) on the female voice. Female individuals who are receiving hormone replacement therapy, which includes testosterone therapy, will be eligible to participate. We will track the pitch of these individuals' speaking voices during HRT in attempts to see whether HRT, specifically testosterone, can lead to changes in womens' speaking voices. We will be recruiting participants who have already received approx 6-9 months of HRT and compare these to age-matched individuals not receiving HRT. This is a cross-sectional study and we will give participants the option of continued follow-up for 9 more months to assess whether there are longer-term voice changes secondary to HRT. This could provide patients and medical providers with more information regarding the risks/benefits of pursuing hormone replacement therapy.

The purpose of this study is to learn more about long-term safety (good or bad effects) of avacopan and its efficacy (how well it is working) in treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

Avacopan is currently approved as an adjunctive (another treatment used along with primary treatment) treatment in adult people with severe active ANCA-associated vasculitis in the US and is also approved in the EU, Canada, Japan, and other countries.

In this study, avacopan will be compared with a placebo (a drug that looks likes the study medication but does not contain any medication). This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) into a treatment group. You will have an equal chance of being placed in either of the 3 following groups: treatment with avacopan for 5 years in group A, or treatment with avacopan for 1 year followed by placebo for 4 years in group B, or treatment with placebo for 5 years in group C. The study is also a double-blinded study, meaning you and your study doctor will not know what you are receiving, the avacopan or placebo.

The study is sponsored by Amgen, Inc. Participation in the study will require 27 visits to the MUSC main campus over approximately 63 months, and visits will include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), and health questionnaires. You will also be provided with a paper diary to record any missed doses/overdoses of the study drug.

Compensation is available for participation.

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the VDyne Transcatheter Tricuspid Replacement System will be used to treat the tricuspid regurgitation. The VDyne Transcatheter Tricsupid Replacement System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study all eligible participants will be treated with the device.

Participation in this study will last about 5 years and involve up to 13 visits. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

There are risks associated with this study including potential risks with the device, implant procedure and study related procedures. There is also the risk of loss of confidentiality. The study may or may not benefit you but the information learned may benefit others with this condition in the future.

The purpose of this study is to evaluate the safety of combined zibotentan/dapagliflozin, zibotentan by itself, and a placebo in patients with cirrhosis to evaluated which treats fluid retention the best.

This study is for patients that have been diagnosed with high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. The main purpose of this study is to find out if giving heated chemotherapy into the belly, known as heated intraperitoneal chemotherapy (HIPEC), improves the treatment of this type of cancer. Participants can expect to be in the study for up to 40 months.

This study is for patients with invasive breast cancer among premenopausal, early-stage breast cancer with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 and 0-25. The study is being done to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal patients. The drug being used in this study are aromatase inhibitors. Patients will expect to remain in the study for up to 5years.

This is a multi-center, randomized, controlled, open-label, Phase 2a
proof of concept study of VS-01 in adult patients with ACLF grades 1
and 2 and ascites. Approximately 60 patients will be enrolled. Sample
size was calculated to meet the study objectives assuming a 10% dropout rate.

This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalised vitiligo.
Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
• Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total));
• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).
To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, efficacy and safety study of subjects with PPF (Progressive Pulmonary Fibrosis) treated with inhaled treprostinil over a 52-week period. This study is investigating whether a drug called inhaled treprostinil (brand name Tyvaso®) works to help people with PPF improve their lung function tests. The purpose of this research study is to see how well inhaled treprostinil works in participants with PPF and to gather information on how safe it is. This study will look at changes in your breathing tests, also called lung function tests. About 698 people will participate in this study from about 150 medical centers. Your participation in this study is voluntary and will last approximately 58 weeks. This time includes a Screening Period that could last up to approximately 6 weeks plus a 52-week Treatment Period.