The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.

Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.

This study is designed to learn about the safety and effectiveness of a new gene therapy called KB408 for Alpha-1 Antitrypsin Deficiency (AATD). AATD is an inherited condition in which a person has low blood levels of a protein known as alpha-1 protease inhibitor (called Alpha1-PI). AATD causes an increased risk of chronic obstructive pulmonary disease (COPD) in the form of emphysema (long term lung disease) and, less frequently, other diseases.
KB408 delivers copies of the genes that produce AAT to the lungs and is given by inhaling a mist (called nebulization). The genes are carried and delivered by a modified herpes simplex virus type 1 (HSV-1). This virus is not harmful and simply acts as a vehicle to deliver the genes to the lungs. The genes that are delivered by KB408 do not change a person's own DNA. This is an open-label study, meaning that the participants, the study doctor, and the sponsor all know that the participants are receiving KB408. KB408 is an investigational product, meaning it is not approved for commercial use by the FDA.
Eligible participants will receive one of three doses of KB408. Participants will have a screening visit first to make sure that they are able to participate in the study. After the screening visit, participants will need to return to the study center 6 more times over 2 months. At the second visit, participants will receive the study drug. Each visit will take between 2 and 6 hours to complete. Study procedures include medical history collection, vitals, physical exam, ECG, spirometry and DLCO, urine cotinine test, blood work, cheek swab, sputum sample, and bronchoscopy (only for participants in cohorts 3a and 3b).
Possible side effects of KB408 include temporary increases in certain cell types in the lungs and temporary increases in the breathing rate after dosing. Since this is the first time that KB408 has been given to humans, it is possible that participants may have an immune reaction to the study drug. There is also a risk with genetic testing and a risk to confidentiality. Participants may not receive any personal benefit from being in this study. There is no guarantee that the Study Drug will help. The information that is collected from the study may help other people in the future.

The proposed research study evaluates the potential of an oral FDA-approved medication, suvorexant, as compared with a placebo control to improve symptoms of sleep disturbance and insomnia in breast cancer survivors currently on hormonal based therapies. Eligible participants will randomly be selected to receive either the suvorexant or a placebo control for a duration of 4 Weeks. Participation in the study will include a screening process for eligibility including information on medical history and surveys regarding symptoms at the start of the study and additionally at 2 and 4 weeks. Potential benefits include improved sleep for individuals randomized to the study medication and potential study risks include loss of confidentiality of health information and a risk of sedation and complex sleep behaviors associated with the medication, suvorexant.

This study is enrolling subjects with advanced solid tumors with the TP53 Y220C alteration in cancer cells. This alteration is a mutation of the tumor that can be found through laboratory tests that use a sample of tissue, blood, or other fluids to check for signs of cancer. This study involves research testing the safety, best dose, side effects and timing of the study drug called PC1486. You will take the study drug, PC14586, in the form of a tablet. If assigned to the combination treatment arm (Part 1), you will also be given pembrolizumab as an intravenous (IV) infusion. Pembrolizumab is a type of immunotherapy that is FDA approved to treat your kind of cancer. The study drug PC1486 is not approved by the Food and Drug Administration (FDA). This study drug targets the TP53 Y220C genetic alteration in tumor cells. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample to test for the genetic alteration. If the participants show the genetic tumor alteration in the cancer cells, they may be asked to participate in the trial. Treatment arms are groups or subgroups of participants in a clinical trial. This study will have two arms: one studies PC1486 alone and the second arm studies PC1486 in combination with Pembrolizumab against advanced solid tumors. PC14586 is a small molecule (chemical) that is designed to act on the genetic alteration TP53 Y220C in cancer cells to slow the growth of cancer, and it is taken orally. This study involves blood tests, a possible tumor biopsy, CT, and MRI scans. The study will last approximately 6 months of treatment, followed up by a check-up after the first 3 weeks and every 3 months after. Some common risks (observed in greater than 20% of people) include: Nausea, Vomiting, Abnormal liver tests, Abnormal kidney test (possible kidney damage

This NIH sponsored research study with an industry collaborator (MAGNUS) is being conducted at up to five study centers throughout the United States. MUSC is the lead site. Up to 100 inpatient participants with a diagnosis of MDD will be enrolled in this double-blind, randomized, study. There are 2 study arms: active SAINT® and sham "fake" SAINT®. Patients will be randomly assigned, like the flip of a coin (50:50 chance), to active or sham SAINT®.

The purpose of this study is to test whether a drug called efzofitimod (the study drug) is a potential treatment for patients with Systemic Sclerosis associated with Interstitial Lung Disease (SSc-ILD).

Efzofitimod is an investigational drug that is given by infusion every 4 weeks for a total of 6 doses. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, efzofitimod will be compared with a placebo (dummy drug). The placebo will be a saline solution that does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of efzofitimod or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know what you are receiving, the study efzofitimod or placebo.

The study is sponsored by aTyr Pharma, Inc. Participation in the study will require 9 visits to the MUSC main campus and will have the following procedures completed over the course of your participation: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as asked to complete surveys.

Compensation is available for participation

IBD affects over 1.5 million individuals in the US with an estimated direct cost of $6.1 billion. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potential modifiable risk factor. The hypothesis is that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL). A Re-Timer device will be used to administer BLT efficiently and safely to test this hypothesis. Prior to treatment subjects will be screened for subclinical inflammation using a validated questionnaire and fecal calprotectin level. They will also complete questionnaires about their dietary habits, fatigue, sleep habits, quality of life, and severity of their underlying disease. The subjects will be randomized and given BLT or the placebo non -BLT device for 4 weeks. The proposed studies will assess whether BLT has an impact on IBD patients' inflammation, intestinal permeability, and intestinal microbiota.

This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary arterial hypertension (PAH). The device will be implanted in the pulmonary artery and the gas reservoir of the device will be in the abdominal cavity. The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH. Some procedures involved in the study include but not limited too: Questionnaires, physical exams, right heart catherization, echocardiograms, blood work and more. The study will be conducted in a maximum of 10 centers in the United States. Up to 45 patients will be consented, and up to 15 patients will receive implants. There is a total of 11 visits over the course of 2.5 years for the study. Because this is an investigational device under the FDA, there may be risk that include but are not limited to: arrhythmia, device infection, endocarditis, and heart failure. If the Aria CV device performs as intended, you may potentially benefit from reduction in or relief of symptoms caused by PH, and depending on your overall health conditions, prolonged life expectancy and/or improvement in your overall quality of life.

Patients who previously had been treated with either intravenous ganciclovir or oral
valganciclovir as an infant or toddler, either as part of a previous Collaborative Antiviral Study Group (CASG) study or through routine clinical care at a current or former CASG study site, will be offered enrollment on this retrospective follow-up study.