MSC2363318A is an investigational drug that is being evaluated for the treatment of subjects with advanced malignancies. Investigational means that it has not been approved by the Food and Drug Administration (FDA), and is still being tested for safety and effectiveness. This study will be divided into 2 parts. MUSC will participate in Part 2. The investigational drug will be given as a monotherapy, in combination with Tamoxifen (an FDA approved drug) and will be given in combination with Trastuzumab (also an FDA approved drug). The study is sponsored by EMD Serono. The investigator in charge of this study is Dr. Sara Giordano. The study is being done at 12 sites nationally. Approximately 64 people will take part, and 5 will take part at MUSC. In order to be eligible, subjects must be older than 18, have advanced maliginancies and specific genetic mutations.
The duration of the study will depend on how the subjects cancer responds to the medication and how it is tolerated.
The purpose of this study is to study the safety and efficacy of the investigational drug, C6 Ceramide NanoLiposome (CNL). Investigational means that it is not approved by the U.S. Food and Drug Administration (FDA). Study subjects are being asked to participate in this study because they have been diagnosed with an advanced solid tumors and their cancer has not responded to standard treatment. Treatment with the study drug has been shown in animal studies to slow the growth of cancers. These effects may result from cancer cell death or inhibition of tumor blood vessel formation triggered directly by the study drug. An investigational new drug application has been filed at US Food and Drug Administration (FDA) and the FDA has allowed the use of the study drug in this study.
The study team will learn how the drug is handled in the subject's body by measuring the levels of the drug in your blood. They study team will also learn if the treatment is slowing or stopping the growth of the subject's tumor. This is the first time study drug will be given to humans.
This is a dose escalation study which means patients who take part in this study will be treated with different doses of the study drug. Each new dose of study drug will be assessed for safety and to see how well patients can tolerate it. If the new dose does not cause severe side effects, a higher dose will be given. This process will continue until the highest dose that can be given to patients with acceptable, manageable, and reversible side effects has been reached.
The study is sponsored by Keystone Nano, INC and is funded by the National Institutes of Health. The investigator in charge of this study at MUSC is Carolyn Britten, MD. The study is being done at 3 sites. Approximately 48 people will take part study-wide and 8 will take part at MUSC.
This study is for adult patients that are suspected to have or were recently diagnosed with acute myeloid leukemia (AML) and have not yet received treatment for AML. The investigational drug in this study is vosaroxin. The participants can expect to be in this study until they have completed both induction therapies. However, after treatment, they will be in follow-up that consists of disease status updates every 3 months indefinitely.
This a study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects diagnosed with severe and moderate postpartum depression(PPD). The study will consist of an up to 5-day Screening Period, 3-day Treatment Period, and 30-day Follow-up Period. Subjects must remain as inpatient during the study Treatment Period, which is approximately 60 hours in duration. Assessments and laboratory samples will be collected during the Treatment Period and the Follow-up Period.
The purpose of this study is to evaluate the impact of smart adherence technologies for medication monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with CF who are homozygous for the F508del-CFTR mutation, and to collect subject and physician feedback on the use of smart adherence technology to monitor LUM/IVA adherence.
This is a national database to track patient information and outcomes from surgical and non-surgical treatment for pelvic floor disorders. This will allow for best practices to be identified, and will also track surgeons and institutions in order to recognize clinical centers of excellence. Individual practitioners will be able to track their own data on outcomes for reporting purposes.
Patients with spontaneous non-traumatic intracerebral bleeding and acute respiratory insufficiency will be considered for a minitracheostomy to help facilitate suctioning and airway clearance. Selected patients will be adults who are intubated for at least 24 hours, who are not candidates for surgical evacuation of the hematoma, and who are considered to be higher risk for extubation failure based on depressed mental status and airway secretions. After obtaining informed consent for the procedure, a spontaneous breathing trial will be performed to make sure that the patient is capable of breathing without the assistance of the mechanical ventilator. A small, 1 cm incision will be made over the cricothyroid membrane using standard aseptic precautions and local anesthesia. The endotracheal tube will be withdrawn, and the minitracheostomy catheter will be passed through the incision into the airway. The minitracheostomy catheter will remain in place until the patient's attending physician feels that it is no longer needed for airway clearance.
This is a cross-sectional, observational study. This study is for subjects with specific histologically confirmed malignancies
Cancer subjects will undergo testing of their tumor tissue for tumor antigen expression, which may consist of the submission of an archived or fresh tumor specimen for appropriate testing. For instance, subjects who may be considering enrollment in a trial involving rovalpituzumab tesirine, an antibody-drug conjugate targeting delta-like protein 3 (DLL3), will undergo tumor expression testing for DLL3 by immunohistochemistry (IHC). Subjects may be observed for progression and survival.
The investigator and subject will be made aware of the results of this testing, to guide consideration for clinical research protocols where interventions include the use of testing for target specific tumor antigens.