This is a is a Phase 1, open-label, dose-escalation, and dose-expansion multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed Acute Myeloid Leukemias harboring alterations in KMT2A, NPM1, or NUP98 genes. The primary purpose of this study is to identify the maximum tolerated dose of SNDX-5613 (Revumenib) to be used in both a combination with intensive chemotherapy and alone. SNDX-5613 (Revumenib) is an "investigational" (not yet FDA approved) treatment. The study will enroll approximately 76 patients in 3 phases with each receiving cycles of chemotherapy followed by SNDX-5613 in the Induction and Consolidation phases followed by SNDX-5613 alone in the Maintenance Monotherapy phase if eligible. The study includes screening, treatment, safety follow-up, and survival follow-up periods over the course of 18 months. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

This study is for subjects that have been diagnosed with advanced high grade serious ovarian cancer. The investigational drug used in this study is Sovilnesib. The main purpose of this study is to is to establish the recommended phase 2 dose, which will be considered the optimal dose, of Sovilnesib. Additionally, this study will examine the safety, tolerability and preliminary efficacy of Sovlinesib. The total time you will be on the study treatment will depend on if you have any unwanted side effects and how your cancer is responding to treatment.

The purpose of this study is to evaluate the safety and efficacy of the study drug ZILRETTA (Triamcinolone Acetonide, extended release) compared to a placebo (saline solution). The study drug is administered through an ultrasound-guided injection to the affected shoulder. 66.6 percent of participants will receive Zilretta and 33 percent will receive placebo.
The study Drug ZILRETTA, is currently FDA-approved for knee osteoarthritis and is being investigated in this study for treatment of shoulder osteoarthritis. The study population consists of adults 50-80 years of age who have been diagnosed with Osteoarthritis of the shoulder by x-ray. The study has 9 study visits over 24-week's and will include, but is not limited to a questionnaire, medical examination, shoulder x-ray and blood draws. Each visit should last less than 1 hour, depending on the procedures performed. The most common side effects of the study drug are joint pain, headaches, upper respiratory infections, back pain, joint swelling, and cold symptoms.

The goal of this study is to determine if an investigational product (a substance not approved by the US Food and Drug Administration) made from mesenchymal stromal cells (MSC) and taken as a single subcutaneous injection, is safe and well tolerated in individuals with active lupus while also receiving standard of care treatment for their lupus.

The MSCs used in this trial are cells that were obtained from the umbilical cords of healthy donors having an elective Caesarean section and who have been screened to be sure that they are free of any infectious diseases.

Participation in the study will take about 9 visits and 2 telephone calls over a period of 7 months. With participation, compensation is available.

At study visits you will have blood and urine labs collected, physical exam/lupus specific assessments, and be asked to complete a questionnaire. These procedures are much like those completed at your routine standard of care visits with your rheumatologist.

The risks to study participation are that only a few hundred people worldwide have been treated with MSCs. So far, there have been no serious side effects when MSCs have been used. Potential risks could however include an allergic reaction to the cells, development of infection, or MSCs changing into cancer cells.

Prior to any use of the MSC injection, participants will have a thorough review of the study and given an opportunity to consider their options and have all questions/concerns answered. A screening visit will be completed to ensure that participation is appropriate - participant safety is a priority of the study.

This study is for subjects that have been diagnosed with mantle cell lymphoma. The purpose of this study is to compare continuous treatment with zanubrutinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted at the first time your disease gets worse following the initial six 28-day cycles of chemotherapy. The subject may remain in the study for up to 10 years.

The purpose of this study is to test IMP1734 in humans for the first time and to assess the safety, tolerability, PK, PD, and anti-tumor activity of IMP1734 in patients with advanced solid tumors. The study will be conducted in 3 parts. Part 1 (dose escalation): Dose-escalation phase where the MTD (or MAD) will be
determined and safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMP1734. Part 2 (dose optimization): Further evaluation of the safety, tolerability, PK, PD, and preliminary anti-tumor activity of selected dose levels of IMP1734. Part 3 (dose expansion): Efficacy, safety, and PK of IMP1734 with the dose(s) selected based on accumulated data will be assessed in either patients who have not received prior therapy with a PARPi containing treatment.

This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.

Adolescence is a time of development in the brain and microbiome, including the microbiome present in the mouth called the oral microbiome. Alcohol use often begins and escalates during adolescence, which can cause changes to the oral microbiome leading to changes in the brain. The alcohol specific changes to the oral microbiome and the brain may make adolescents more vulnerable to a lifelong struggle with alcohol use disorder. This study will collect (1) saliva to assess the composition of the oral microbiome and (2) brain measurements using magnetic resonance imaging (MRI) across adolescents who may or may not use alcohol. Findings from this study will help form a more thorough understanding of the biological consequences of adolescent alcohol use, with the long-term goal of informing novel prevention and intervention efforts.

The purpose of this study is to evaluate the effect of pegozafermin compared to placebo to see how well pegozafermin might improve liver fibrosis after 52 weeks.

This study is for subjects that have been diagnosed with lung cancer and the disease has progressed on prior therapy. The purpose of the study is to determine the safety and efficacy of Fingolimod and whether it can aid in treatment against lung cancer tumors. Fingolimod is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 8 months, with routine visits occurring at MUSC.