This study is for patients with bladder cancer. The study is being done to see if by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual BCG therapy can lower the chance of the patient's bladder cancer from growing or spreading.
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 enrolling subjects who need a pacemaker implant for a heart rhythm disorder. A pacemaker is a device implanted under the skin in the upper chest, and is designed to send electrical signals to tell the heart to squeeze (contract) through wires called leads. A conventional pacemaker has a lead placed in the right ventricle (lower chamber of the heart) which is referred to as ventricular pacing. This study will investigate conduction system pacing which is pacing from the part of the ventricle that normally carries electricity through the heart. The specific name for this part of the ventricle is the left bundle branch block area. The heart's conduction system initiates impulses that tells the heart muscle to contract in a coordinated fashion. This study will use the Solia S lead, which is considered investigational, meaning it is not yet approved by the Food and Drug Administration (FDA) for conduction system pacing. The Solia S lead is approved for ventricular pacing.
Participation in this study will last about one year and include 4-5 visits, some of which may be done virtually. The study involves collecting data from your pacemaker implant, Solia S placement, completing questionnaires, electrocardiogram, medical history and medications.
Risks include those associated with the pacemaker implant procedure such as potentially longer implant time, a tear in the interventricular septum (the wall separating the lower chambers of the heart) or unsuccessful lead placement. Other study related risks may include the risk of loss of confidentiality, risks of answering a questionnaire or unknown risks. There may be no benefit to you but the information learned may benefit others in the future who need conduction system pacing.
The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the Inter Atrial Shunt Device (IASD) in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. This study involves the use of an investigational medical device called the Corvia Atrial Shunt (CAS) System. The CAS is permanently implanted in the heart to reduce the increased pressure in the left side of the heart by creating a small opening between the two upper chambers of the heart. Participants will have a 50% chance of being in either group A having the CAS placed or group B and not receiving the device. Subjects will have 7 research clinic visits, and multiple telephone calls for a total of 5 years of follow-up. The research clinic visits will include medical exams, health questionnaires, ECG and echocardiogram of the heart and 6 minute hall walk tests.
The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the Inter Atrial Shunt Device (IASD) in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. This study involves the use of an investigational medical device called the Corvia Atrial Shunt (CAS) System. The CAS is permanently implanted in the heart to reduce the increased pressure in the left side of the heart by creating a small opening between the two upper chambers of the heart. Participants will have a 50% chance of being in either group A having the CAS placed or group B and not receiving the device. Subjects will have 7 research clinic visits, and multiple telephone calls for a total of 5 years of follow-up. The research clinic visits will include medical exams, health questionnaires, ECG and echocardiogram of the heart and 6 minute hall walk tests.
The purpose of this research study is to determine how well and safe deucravacitinib, an investigational/non-approved United States Food and Drug Administration (US FDA) medication, is in treating Systemic Lupus Erythematosus (SLE, lupus).
Participation in the study will involve being assigned deucravacitinib or a placebo (a drug that looks likes the study medication but does not contain any medication) and completing a series of in person clinic visits much like those completed as part of standard of care. Blood and urine samples will be collected for both routine health and safety tests as well as research/experimental testing.
The study will require 16 visits over a period of 14 months. There is an optional extension to the study possible, should you wish to continue and the study doctor feels that you remain a good candidate for participation. Study medication is provided and compensation is available for participation.
This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.
This study is for patients with cancer in the stomach, esophagus, or gastroesophogeal junction. The study is being done to see if by adding a third chemotherapy drug to the usual combination of two chemotherapy drugs is better or worse than the usual approach for treatment.
Early intervention for infants and toddlers with or at an elevated likelihood for autism spectrum disorder can promote developmental skills and improve lifelong outcomes. Yet, many children with ASD are not diagnosed until after age 3. In order to improve early detection of ASD, we are investigating very early predictors of social communication challenges in infants as young as 1 week to 4 months of age.
This research study examines how the development of attention and motor skills in the first year of life is associated with the emergence of social and communication skills in three groups of infants: infants who are first born or who have a sibling with no developmental delays, infants who have an older sibling diagnosed with autism spectrum disorder, and infants who were born preterm.