The study will include 9 key informant interviews discussing how patients developed their impression of the benefit of an implant and how patients prefer expectation data be relayed. No video recordings will be performed during interviews. Interview notes or audio recordings will be taken and uploaded into a password protected network server. The results of interviews will mainly be descriptive. To test the plasticity of preoperative patient expectations and the impact of the CI evaluation the CIQOL expectations form will be administered prior to CI evaluation, directly after the CI evaluation, and prior to surgery for all patients who are undergoing cochlear implantation and meet inclusion/exclusion criteria and agree to participate. The decisional conflict scale will also be administered directly after the CI evaluation and prior to surgery for the above patient group. The 9 patients who undergo key informant interviews will also be part of the larger study group of 200 patients and have the same surveys administered and be subject to the same inclusion/exclusion criteria. The group of patients will also be asked about how they prefer expectation and QOL data to be relayed. All survey data will be collected in a secure RedCap database. Patients expectations at the three preoperative timepoints will be compared using paired T-tests. Data regarding how patients develop expectations and how they prefer expectation data to be presented to them will be mainly qualitative and discussed in terms of the most common themes from patient surveys and interviews. When exploring how patients prefer expectations and QOL data to be relayed we intend to include numbered clinical vignettes relaying differing levels of hearing capability. We will compare relaying information through vignettes to more conventional outcome measures such as speech recognition and QOL scores to determine which is the more effective means of communication.

This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart. This five year study will include a screening process to determine you meet eligibility criteria. If you qualify you will then be seen for a baseline visit, undergo the procedure to place the device, day after procedure, at hospital discharge, 1,3,6, 12 months, then yearly for up to 5 years. Study related testing includes physical exams, medication review, 6 minute hall walk test, questionnaires, blood work, CT scans, electrocardiogram or ECG (recording of your heart's electrical activity) and echocardiogram (ultrasound test of your heart).

The purpose of this study is to test the safety of an investigational drug product, IBI-10090 (DEXYCU), in children to treat eye inflammation (redness) caused by cataract surgery. DEXYCU was approved by the FDA in February 2018 for use in adults, however; has not yet been approved for use in children. The active ingredient in DEXYCU is dexamethasone. Instead of being an eye drop containing dexamethasone, DEXYCU remains in the eye as a tiny droplet and slowly releases dexamethasone over a period of approximately two to three weeks. After that time the droplet is absorbed by the body. Subjects 0 to 3 years of age who are undergoing cataract surgery will be eligible for this study. The study starts at screening visit which is 3-29 days before surgery. Any study-related procedures will be performed only after obtaining informed consent. Child will be in the study for about 90 days after signing informed consent. Enrollment in this study requires a total of 8 visits. If child is eligible he/she will be randomly assigned (like the flip of a coin) to either study group DEXYCU or control group, prednisolone acetate. Child will have study visits 1 day following cataract surgery, and then at approximately 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months after surgery. All visits are standard of care visits for all cataract surgery patients except 2 weeks and 6 weeks after surgery visits.

The purpose of this two-visit brain imaging (magnetic resonance imaging, MRI) study is to identify brain targets for improving treatment and preventative interventions for individuals at risk for co-occurring bipolar disorder and alcohol use disorder. The preliminary visit for a parent and his/her biological child will include completion of clinical interviews, surveys, and labwork to determine study eligibility. If they are considered eligible for the study, brain imaging visits will occur within 1-2 weeks at which a 1-hour MRI will be completed along with additional clinical interviews, surveys, and labwork. Brief follow-up phone call interviews will be completed with participants every 3 months for 1 year. Study participation is confidential and compensated.

This study aims to improve access of Veterans with epilepsy living in rural areas to the most important diagnostic procedure for the care of patients with epilepsy: the routine electroencephalogram (EEG). We will test a new method for recording EEG which uses a novel dry electrode system headset that does not require an EEG technologist to operate. The headset integrates the EEG electrodes and amplifier into a compact system which is easily placed on the head. This approach could make it possible for a nurse or nurse assistant with minimal training to record an EEG in a rural community based outpatient clinic (CBOC) as part of an epilepsy telemedicine outreach program along with clinical interviews. We will compare performance of this dry electrode system to standard EEG when it is used by EEG technologists in three VA medical centers. This project has the potential to improve access of Veterans to the EEG procedure and decrease cost to the Veterans Health Care System.

The purpose of this research is to evaluate whether the Relivion®DP device is safe and helpful in alleviating Major Depressive Disorder (MDD) symptoms. The research study includes up to 6 visits, each visit could be performed either at the clinic or remotely using digital means such as a video call or the use of another dedicated platform.In this research study the participant will randomly receive either an active device or a non-active (sham) device and the participant will be asked to preform daily treatments with the device for 8 weeks after which the participant will have the option to continue to an additional 8 week open-label extension with the active device.
We expect that the time commitment for taking part in this research will last up to 20 weeks (including the screening period).

The goal of this study is to determine the differences in severity and disparities of lupus in Black lupus patients, focusing on the highest risk group, Black females. We are interested in enrolling Black females with lupus as well as smaller numbers of White females with lupus, White females as Healthy Controls and Black males with lupus.

Study participation involves the collection of 4 tablespoons of blood. Patients with lupus will have their study participation during a standard of care (SOC) visit with their rheumatologist as part having routine blood drawn for their lupus care. After the initial study visit, patients with lupus may have an additional 2-3 visits. Controls will have a single study visit at the MUSC Nexus clinical research center.

This is not a clinical trial and does not involve study medications. Compensation is available for participation.

This study is designed to evaluate a new therapy formulation 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.

This study is being conducted to evaluate the safety and tolerability of 2 different doses of Alpha-1 drugs (Alpha-1 15% and Liquid Alpha1-PI) in participants with AATD. Participants will be placed into one of two groups. Each group will receive both drugs at different points in the treatment period and because this is an "open label", study participants and the study staff know which dose of study drug participants receive. The study will last up to 486 days (16 months). Many visits are able to be conducted through home health care, lessening the need to come into the clinic.

Alpha-1 15% is an investigational product, meaning it is not approved by the U.S. Food and Drug Administration (FDA). The other drug in this study is Liquid Alpha1-PI (licensed as Prolastin®-C Liquid) and is an FDA approved treatment for adults with emphysema due to AATD. However, it is only approved for the recommended dose of 60 mg/kg. This study includes both the FDA approved 60mg/kg of Liquid Alpha1-PI and an experimental dose of 120 mg/kg that is not FDA approved. Alpha-1 15% is given as an injection under the skin and Liquid Alpha1-PI is given as an infusion into the veins.

You may or may not directly benefit from participation. However, you may help advance scientific knowledge in the treatment of AATD. Currently, the only FDA approved treatment for AATD is IV infusions of Liquid Alpha1-PI. Since the drug being studied, Alpha-1 15%, is injected with a small needle under your skin, there may be a benefit to future patients by providing flexibility of treatment route options as well as stability in serum alpha1-antitrypsin levels.

This study is enrolling participants with severe aortic stenosis, which is narrowing of one of the heart valves. This condition reduces the amount of blood that can get to the body. This study is collecting data on the safety and effectiveness of an investigational (not yet approved for commercial use by the US FDA (Food and Drug Administration)) device called the ACURATE Aortic Valve System. The procedure to place the device, referred to as TAVR - transcatheter replacement of aortic valve is done in place of open heart surgery. In this study the ACURATE Aortic Valve System will be compared to two commercially available Aortic Valve Systems (valve replacement systems). Participants will be randomized (assigned by choice, like a flip of a coin, in a 1:1 fashion so 50% chance of being assigned to either group like the flip of a coin) to one of two groups. One group will receive the ACURATE Aortic Valve System while the other group will receive one of the commercially available systems. This study will last up to 10 years. Pre-procedure testing is done and reviewed by an eligibility committee to confirm you qualify. Study visits will occur prior to your procedure, during the procedure and throughout your hospital stay, and prior to discharge. Additional visits will occur 1 month and 6 months after your discharge, and then you will either seen or telephoned once per year for the next ten years. Study related testing includes CT scans, physical exams, echocardiograms (ultrasound test of the heart), blood work, and questionnaires.

This is a prospective, multi-center, observational study in pregnant women with cystic fibrosis (CF) to characterize forced expiratory volume in 1 second (FEV1) changes based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The key factors contributing to the change in lung function during pregnancy and for 2 years post-delivery will be evaluated along with assessment of fetal and maternal outcomes.
The total duration of participation for each participant is expected to be about 3 years (up to 35 months). Women will be enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Over the course of the study, CF clinical data, patient-reported outcomes, questionnaires, obstetrical outcomes, infant growth, child development outcomes, baseline CF-related therapies and co-morbidities will be collected to enable evaluation of changes from before pregnancy to during pregnancy and post-delivery.
MAYFLOWERS participants will be provided an opportunity to participate in an optional continuous glucose monitoring (CGM) sub-study to evaluate glucose control in pregnancy. Participants will undergo CGM sensor placement and data collection as part of the MAYFLOWERS study.