This clinical trial is studying a new approach to how we calculate the dose of infliximab for patients with IBD. Participants are randomized to either the iDose Dashboard, which is a computer program that helps determine the infliximab dosage, or to currently accepted standard of care. All participants will receive IV doses similar at the beginning of the study, but will then be randomized to receive either the treatment arm in which they will use the iDose dashboard or the Standard of care arm in which they will receive dosing every 8 weeks, which is in accordance for the usual care of the patient.
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.
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 study is being conducted to learn more about rocatinlimab in people with AD. It will see if rocatinlimab is effective to treat people with AD and whether it causes side effects. It will also help to establish the beneficial impact of the study treatment with rocatinlimab on the related outcomes including skin itching, skin pain, sleep loss, and impaired quality of life in people with AD. The study duration will last a maximum of 68 weeks (about 1 year 3 months), including a screening period of minimum of 8 days and up to 30 days, a 52-week study treatment period, and a safety follow-up (SFU) visit 16 weeks after the last dose of study drug in case you do not continue into the long-term maintenance study.
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.
The purpose of this study to test a smartphone app with a breathing device that aims to help patients monitor and manage their COPD and improve their quality of life. This device measures how well the lungs are working, like a lung function test. This study lasts for 6 months and study procedures can be conducted remotely with no required study clinic visits. Eligible participants will be given a breathing device called a remote spirometer and will be asked to download an app to their phone and use the device to monitor their lung function and symptoms. A total of 120 individuals with COPD who live in rural areas of SC will be enrolled in this study.
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.
This study is designed to provide further longer-term evidence and
understanding of the efficacy, safety, and tolerability of the study drug UCB0599 in slowing the progression of Parkinson's Disease only in study participants who have completed 18 months of treatment in PD0053 Study. This study requires previous participation in the PD0053 study. There are 11 visits spanning over 30 months. Main study activities include; electrocardiograms, vital sign assessments, physical exam, neurological exam, blood and urine collection, and UCB0599 administration and follow-up.
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.