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.
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.
ZL-1310 is a new experimental treatment designed to tackle small cell lung cancer (SCLC), a particularly aggressive form of lung cancer. The drug is an antibody-drug conjugate (ADC) that specifically targets a protein called delta-like protein 3 (DLL3), found in high amounts in SCLC and other neuroendocrine tumors. The study aims to evaluate the safety, effectiveness, and other characteristics of ZL-1310 in patients with SCLC that has relapsed or is resistant to platinum-based treatments. Previous attempts to target DLL3 faced challenges, and ZL-1310 seeks to overcome these issues, providing a potential breakthrough in treating SCLC, where current options are limited, and relapse rates are high. The study hopes to shed light on ZL-1310's potential as a novel and more effective therapy for patients facing few alternatives and poor prognoses.
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.
Hematopoietic cell transplantation (HCT) and solid organ transplantation (SOT) recipients are at high risk for respiratory viral infection (RVI). This study aims to establish a comprehensive RVI diagnostic and disease progression predictive model in children undergoing HCT and SOT. Findings will result in the first ever evidence-based pediatric guidelines.
The purpose of this study is to better understand how surgical factors affect the length of the vagina after pelvic surgery. This will be accomplished by measuring the length of the vagina during routine surgical steps as well as at the postoperative visit. This information will be used to help continue improving pelvic surgical technique.
This research study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for hemodialysis in patients with end stage renal disease (ESRD). Data from clinic visits will be collected for up to 2 years after treatment begins.
The purpose of this study is to test the effectiveness of a treatment called Transdiagnostic Behavior Therapy (TBT) for reducing symptoms of adjustment disorder compared to the standard treatment, or treatment as usual (TAU) for adjustment disorder called Moving Forward Problem-Solving Therapy (TAU-PST).
Participants will be randomly selected to receive 10-14 weekly sessions of TBT or TAU-PST with a licensed therapist.
This study is open to Veterans and Active-Duty service personnel in the Ralph H. Johnson VA Health Care System catchment area (including Savannah, Myrtle Beach, Hinesville and Beaufort community-based outpatient clinics).
This study is for patients that have been diagnosed with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III breast cancer. The drug being used Durvalumab, Cyclophospharmide, Doxorubicin, and Paclitaxel. The study is being done to compare breast cancer event-free survival between patients randomized to standard of care neoadjuvant chamotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. Patients are expected to be in the study for XXmonths.