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.

Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. This study will enroll hEDS patients to test a new ear stimulation system to help reduce symptoms associated with hEDS, including pain and GI problems. Ear stimulation will be applied twice daily, for four weeks at home, and we will collect electronic behavioral data to track progress.

As people get older, understanding speech in a noisy environment can become more difficult. The MUSC Hearing Research Program is seeking healthy adults between 25 and 89 years of age to participate in a research study to investigate the connection between listening difficulties and the brain. Payment is provided for participation and scheduling is flexible. The study involves two visits. Participants must be able to complete an MRI. Please contact us if you would like to participate in this research or learn more about our study.

The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.

Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.

Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.

An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.

Nontuberculous mycobacteria (NTM) cause a chronic pulmonary infection associated with cough, fatigue, and shortness of breath. Our primary objectives are to better understand the trajectory of patient-reported outcomes (PROs), e.g.
respiratory symptoms and health-related quality of life (HRQoL), across the entire disease course and measure toxicity and tolerability using patient-reported symptomatic adverse events in treated patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).

Evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcomes measured as a composite endpoint

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861, the study drug, in subjects who have World Health Organization (WHO) Group 1 & 3 Pulmonary Hypertension. The purpose of this research study is to evaluate the long-term safety and tolerability of LIQ861 in patients with WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD). The investigational form of Treprostinil in this study is called LIQ861, it is delivered to your lungs using a hand-held device called a dry powder inhaler (DPI). Dose levels may be adjusted by the Study Doctor between 26.5 micrograms to 318 micrograms based on your PH-ILD symptoms. The study will include approximately 60 subjects and participation will last 52 weeks.

This is a prospective, multi-center, two-arm, randomized clinical trial for Stage 5 Chronic Kidney Disease (CKD5) or End Stage Renal Disease (ESRD) patients who are undergoing fistula creation for hemodialysis in order to evaluate the safety and effectiveness of the EchoMark® ultrasound marker and the EchoSure® AVF Diagnostic System for assessing fistula maturation and reducing time to Clinical Maturation when used under a biweekly protocol as compared to the standard of care follow-up.

The EchoMark is a small device that is implanted in the soft tissue near the site where the fistula is created and can measure the fistula blood flow, diameter, and depth. The device can be easily seen by EchoSure, the ultrasound equipment which can provide measurements and information about blood flow and vessel diameter and depth.

This study will involve approximately 304 participants. Half of the subjects in this trial will receive the EchoMark implant, while the other half will receive traditional fistula creation. Participants will be followed for a duration of 12 months.

In this study, researchers are testing a drug called Alisertib in people with a specific type of lung cancer that has spread extensively. These patients have already undergone the first round of treatment, but unfortunately, their cancer has started growing again. The drug alisertib works by targeting certain molecules involved in cell division, which are often overactive in cancer cells.

Patients will take alisertib as pills twice a day for a week, followed by a break. To manage side effects, they'll also receive another medication to support their blood cell production. Throughout the study, researchers will closely monitor how much alisertib is in the patients' blood and how they're responding to treatment.

The study will continue until patients either see their cancer progress, experience intolerable side effects, or decide to leave the study. Even if the cancer spreads to the brain during the study, patients might still be able to continue treatment if it's deemed helpful by their doctor. This research hopes to find out if alisertib can offer a new option for people whose lung cancer has come back after initial treatment.

In this study, all eligible study participants will have a clinically indicated reason to undergo a bronchoscopy procedure, using a EBUS-TBNA scope, before enrolling in the study. EBUS-TBNA stands for "endobronchial ultrasound-guided transbronchial needle aspiration" which is a procedure to collect lymph node tissue from within the lungs by inserting a flexible tube-like camera through the mouth, then down into the lungs.

After providing consent to participate in this study, each subject will be randomly assigned (by chance, like the flip of a coin) to either have or not have a cytopathology technologist (person who looks at samples under a microscope) in the room during your bronchoscopy, and then randomly assigned again (by chance, like the flip of a coin) to either have your tissue specimen prepared with clot or liquid preparation. Clot preparation is placing the tissue biopsy in a gel prior to being viewed under a microscope, whereas liquid preparation is placing the tissue biopsy in a liquid prior to being viewed under a microscope.

It is important to note that, by participating in this study, subjects will still receive the standard of care with a proven track record for obtaining lymph node tissue.

The reason for this research study is to determine whether rapid on-site cytopathologic evaluation, or the clot based method, can increase the chances of gathering adequate tissue for Next Generation Sequencing. Next generation sequencing is a test which detects molecular markers from tissue, or blood, samples and can provide possible treatment options for specific forms of lung cancer.