This study will evaluate possible new treatments for advanced stage head and neck cancer. Patients who have undergone surgery to remove their tumor may qualify if the tissue is positive for a specific type of squamous cell cancer. The purpose of this study is to compare the current standard treatment, radiation therapy along with chemotherapy with a drug called cisplatin, to two other treatments. One experimental treatment is radiation therapy along with two chemotherapy agents, docetaxel and cetuximab, and the other experimental treatment is the standard treatment currently used along with the addition of an immunotherapy drug atezolizumab. Patients who qualify for participation will be randomly assigned to one of the 3 treatment groups (done with a computerized system). In the current standard treatment group, participants will receive radiation therapy 5 days per week for 6 weeks, and cisplatin once a week through a vein for the 6-week treatment period. The group receiving doxetaxel and cetuximab (both FDA approved medications for the treatment of certain cancers) will receive the same 6 weeks of radiation along with cetuximab through a vein 1 week prior to the start of radiation therapy, and then once a week for the 6 weeks of radiation and the doxetaxel will also be given through a vein once a week for the 6 weeks of radiation therapy. The final group will get the current standard treatment with 6 weeks of radiation and 6 weeks of cisplatin, along with atezolizumab through a vein 1 week prior to your starting radiation and then every 3 weeks for a total of 8 doses, There will be twice as many patients in this last group than the other two groups.

Follow-up will be at Month 1 & 3 and then every 3 months for 2 years, and then every 6 months for 3 more years, and then annually for as long as a participant is willing and able. There will be blood tests and CT scans that will occur throughout the study, however they are standard for the type of cancer being treated and how each individual responds to the treatment. The benefit of participation is there may be improved outcomes in this group of patients however the risks involved with receiving new treatments may be more than with the usual standard treatment. Some of the most common side effects that the study doctors know about are infection, nausea, vomiting, diarrhea, pain, tiredness, kidney problems, numbness/tingling in hands and feet. There may be some risks that the study doctors are not aware of at the moment. There will be a total of up to 480 participants across all sites and approximately 24 participants at MUSC.

The goal of this randomized controlled trial is to analyze return to pre-injury activity level on subjects with lateral ankle instability undergoing a modified Broström reconstruction procedure for repair of the anterior talofibular ligament (ATFL). The subjects undergoing ATFL reconstructive procedure using the Artelon FLEXBAND® system as an augmentation device will be compared to subjects undergoing a standard modified Broström procedure alone. Artelon FLEXBAND is a commercially available, polycaprolactone (PCL) polyurethane urea (PUUR) multipolymer synthetic knitted mesh that is used for soft tissue reinforcement procedures. The device is biocompatible and degradable and has been used as an augmentation device in over 50,000 Orthopedic tendon and ligament reconstructive procedures. Artelon FLEXBAND has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1 year. All subjects will be followed for 2 years post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 2-, 6-, 12-, 18- and 26-weeks, and 1- and 2-years after surgery. Possible, anticipated procedure-related risks associated with using the FLEXBAND device include, but are not limited to, infections, both deep and superficial, allergies or other reaction to device materials, dislocation, subluxation or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant, bone fractures as a result of one-sided overload or weakened bone structure, temporary or permanent nerve damage as a result of pressure or hematoma, wound hematoma, and delayed wound healing. Benefits include improvement in function, including return to pre-injury activity levels.

This study is for patients who have heart failure with pulmonary hypertension. Heart failure means that the heart cannot pump blood as well as normal. Pulmonary hypertension happens when the pressure in the blood vessels leading from the heart to the lungs is too high, blood flowing through the lungs is limited, and the pressure in the lungs increases when you are physically active, causing symptoms of shortness of breath and tiredness.

The study uses the Gradient device to see if can help treat heart failure with pulmonary hypertension. This device and therapy is still investigational, which means it is currently not approved by a regulatory agency (such as U.S Food and Drug Administration) for regular hospital use and it includes only individuals who choose to take part. Risks in this study include those for standard cardiac catheterization techniques and the administration of anesthesia including allergic reactions, low blood pressure, skin rash, or difficulty breathing; however, all of the risks may not be known. The study will last approximately 3 years and includes the following visits: Baseline/Screening, Procedure, Discharge, 1 month, 6 months and visits annually for 3 years. Study related procedures include a physical exam, blood testing, 6 minute walk test, echocardiogram, CT scan and a Right heart catheterization.

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.

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 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 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 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 is a research study to examine if and how patterns of use change over time among three different groups of tobacco users: 1) adults who exclusively smoke combustible cigarettes, 2) adults who exclusive use e-cigarettes, and 3) adults who use both. This is a naturalistic survey study, there is nothing required or requested of participants, other than to complete our surveys. Participants do not need to quit or reduce their smoking/e-cigarette use if they do not want to. They do not need to travel for this study; it is completely remote and they can participate from your home.
Participation in the study will take place over a period of 12 months in the form of: 1) Monthly Surveys (13 total), 2) Daily Diaries for the first 90 days, 3) Follow-Up Diaries in each of the 7 days leading up to each monthly follow-up survey, and 4) Submission of Breath Samples (13 total).