This study systematically evaluates the efficacy of a highly promising neuromodulation strategy - continuous theta burst (cTBS) transcranial magnetic stimulation - as a tool to change alcohol use behavior (Aim 1) and neurobehavioral concomitants of that behavior (Aim 2) in non-treatment seeking individuals with alcohol use disorder (AUD). In addition, we can begin to test prediction of individual treatment response based on an electrocortical signature of sign tracking (exploratory aim). This study is a double-blind, active sham-controlled study in community dwelling, non-treatment seeking individuals who meet DSM 5 criteria for AUD. Participants will be randomized to one of three groups: cTBS to ventromedial prefrontal cortex, cTBS to pre-supplementary motor area, or sham stimulation (10 sessions in one day). Participants will undergo comprehensive outcomes assessment, with measures including pre- and immediately post-cTBS clinical assessments (e.g., interview, Timeline Follow-back), alcohol craving tests, structural and fMRI, MRS, and EEG/ERP during salience- and cognitive flexibility-related tasks. To test alcohol craving and also use in alcohol-available settings, participants will complete a bar-lab session post-cTBS only (to avoid potential habituation to alcohol cues within the laboratory setting). Finally at 1-week post-treatment participants will complete craving and Timeline Follow-back measures remotely via REDCap.
Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.
This study is for patients diagnosed with early-stage melanoma and are the age of 75 or older. The usual approach for patients who are not in a study is treatment with two surgical procedures, a wide local excision (WLE) plus a sentinel lymph node (SLN) biopsy, followed by immunotherapy. The purpose of this study is to find if performing the WLE alone is just as effective as the usual approach and if it leads to improvements in patients' overall well-being.
A wide local excision (A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue; this is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. Immunotherapy is a type of cancer treatment that uses your body's immune system to identify and attack cancer cells.
Patients may participate in this study for up to 5 years. Procedures include a surgical biopsy, surveys, and regular visits with your doctor including follow-up study visits or phone calls every 6 months. There will be about 428 people taking part in this study, approximately 39 participants will be enrolled at MUSC.
Risks include infection, scarring, and bleeding. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This study is for patients who have been diagnosed with low grade, intermediate risk non-muscle invasive bladder cancer. It is testing an investigational drug called TYRA-300. "Investigational" means that the drug has not been approved by the United States Food and Drug Administration (FDA).
The purpose of the study is to see whether TYRA-300 can shrink or eliminate bladder tumors without surgery. Normally, standard care involves a surgery called transurethral resection of bladder tumor (TURBT), but in this study at least one tumor will remain in place to see if the study drug works. The study will also evaluate the genetics of the cancer to see if certain mutations or changes in proteins affect how the drug works.
TYRA-300 is taken by mouth once daily. The dose level will be assigned by the study doctor. Participants may be in the study for about 36 months, which includes a screening period (up to 28 days), a study treatment phase (with visits every 4 weeks and more frequent visits during the first 8 weeks), an end-of-treatment visit, a safety follow-up about 28 days later, and long-term follow-up every 12 weeks. There will be a total of 3 patients enrolled locally over the course of 12 months.
Many people use both cigarettes and e-cigarettes (dual use) and want to quit both. However, little is known about the best way to support individuals who want to quit dual use. This study will test different doses of nicotine replacement therapy (patches and lozenges), a medication typically used for quitting smoking, to see which dose is best for people using both cigarettes and e-cigarettes. This study will also see if quitting cigarettes and e-cigarettes can lead to changes in health that might prevent cancer.
This study is for patients who have been diagnosed with prostate cancer that is prostate-specific membrane antigen (PSMA)-positive and has spread despite treatment with another androgen receptor pathway inhibitor (ARPI). This study is testing an investigational drug called AAA817. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In this study, participants will be randomly assigned (like flipping a coin) to receive AAA817 alone, AAA817 with an androgen receptor pathway inhibitor (ARPI), or standard of care treatment. The primary purpose of this study is to determine whether AAA817, given alone or in combination with an ARPI, is safe and effective compared to standard of care treatments. This drug is given to participants as a radioligand therapy infusion. Participants in this study can expect to be in the study for up to 6.1 years, including two visits before starting treatment, visits every 4 weeks during treatment, and visits every 12 weeks during long-term follow-up for up to 5 years after treatment ends.. There will be a total of 9 patients enrolled locally.
This study is for patients that have been diagnosed with squamous cell, adenocarcinoma, or adenosquamous cervical cancer. This study is testing an investigational drug called pembrolizumab. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). A computer will be used to assign you to one of the study groups. This process is called "randomization." Like flipping a coin, everyone has an equal chance of being placed in any group. The primary purpose of this study is to determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiotherapy plus immunotherapy (CCRT+IO) improves progression-free survival (PFS) compared to CCRT+IO alone. The study drug is given by infusion. Participants in this study can expect to be on the study for 7 years.
This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.
This is a Phase 1/2, open-label, multi-center clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TSRA-196, a gene editing compound, in adults with severe alpha-1 antitrypsin deficiency (PiZZ genotype) and associated lung and/or liver disease. Participants will receive a single intravenous dose of TSRA-196 in a dose-escalation phase followed by dose-expansion cohorts.
The study will assess safety outcomes, pharmacokinetics, and changes in serum alpha-1 antitrypsin levels and lung function to determine whether TSRA-196 can safely increase functional AAT levels and inform selection of an appropriate dose for further clinical development.
The flu is caused by a virus that can sometimes change. This can make the flu resistant to treatment, which means drugs, like baloxavir marboxil, can become less effective for treating the flu (also known as "resistance").
The purpose of this study is to monitor changes in the flu virus before and after study treatment with baloxavir marboxil in children. The resistance of the flu virus to study treatment with baloxavir marboxil will also be monitored.