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.

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 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 primary purpose of this clinical investigation is to evaluate the SpO2
accuracy of neonatal, infant, and pediatric Philips SpO2 sensors with the Philips
FAST Pulse Oximetry System. Accuracy will be evaluated against the gold
standard, SaO2 obtained from arterial blood samples and assessed by COOximetry.

Additionally, this study will be used to determine if skin pigmentation impacts
SpO2 accuracy and to identify the occurrence of occult hypoxemia, defined as an
SaO2 <88% with an SpO2 ≥92%, with consideration to skin pigmentation.

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.

The study aims to investigate the impact of Magnetic Resonance Angiography (MRA) fusion on the safety and efficiency of Uterine Fibroid Embolization (UFE). UFE is a medical procedure used to treat uterine fibroids. MRA fusion provides a detailed three-dimensional roadmap of blood vessels in the pelvis during the procedure. This technology has the potential to reduce radiation exposure, procedure time, and contrast volume. .