The purpose of this research study is to determine whether rosuvastatin is safe and can help people living with cirrhosis lead longer, healthier lives. The study drug, rosuvastatin, is investigational, meaning it has not yet been approved for market use for this disease condition by the United States Food and Drug Administration (FDA). Participants will…
Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
The purpose of this study is to learn more about the mechanisms of hearing loss, specifically to learn how abnormalities in the brain may produce certain experiences that are common in patients with hearing loss. Individuals with hearing loss will be compared to individuals with normal hearing.
LCN Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months for a total of 3 years. Some of the visit…
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
The Red-C 3131 Study is a phase 3 study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE in adults who have been diagnosed with advanced liver cirrhosis. Adults who have been diagnosed with advanced liver cirrhosis, but who don't yet have HE may be eligible to join. About 466 patients will be enrolled across 200 sites.…
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learnmore about which anti-rejection (or immunosuppressive) medications best protect infants, children,adolescents, and young adults after they have had a heart transplant. Two different drug regimens will bewill be compared. All of these drugs are FDA-…
Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an…
The purpose of this study is to evaluate whether cirrhosis occurs as a result of NASH. NASH is a disease that results when fat accumulates in the liver. GS-6624 is an experimental medication designed to help reverse the scarring process, and the purpose of this study is to see if GS-6624 can reverse the scarring in the liver and heal cirrhosis.
Over time, children and young adults who have had a Fontan operation may find they are more tired, have difficulty breathing and cannot exercise as well as before. Currently, there are no approved medicines to prevent this decline. The purpose of this research study is to learn whether children who have had the Fontan operation can improve their ability to…
The purpose of this study is to evaluate the efficacy of the drug OCR-002 for the treatment of an acute hepatic encephalopathy episode in cirrhotic patients requiring hospitalization. Subjects who have been recently hospitalized will potentially receive OCR-002 via infusion on top of their standard care for 5 days. Patients will be assessed 24-hours after…
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…