This is a 3-part study, with each part having a unique set of objectives for male
adolescents aged 12 to < 18 years with fragile X syndrome (FXS). Part 1 is an openlabel,
single-dose, pharmacokinetics (PK) assessment of BPN14770 25 mg and
50 mg; Part 2 is double-blind (DB) and randomized; and Part 3 is an open-label
extension (OLE) for patients who complete Part 2.
The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin will have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery.
This study is for patients with invasive cancer I-IV and be scheduled to receive anti-PD-1/-L1 ICI-containing therapy. This study is being done to see if we can understand which patients will develop side effects from immune checkpoint inhibitors, and what kind of side effects they will get and can we predict long-term treatment outcomes after immune checkpoint inhibitor treatment, like which patients will have a cancer that shrinks or disappears.
This study is for subjects that have been diagnosed with prostate cancer that can be removed by surgery. The purpose of this study is to determine whether a group of drugs called statins can help to reduce the risk of prostate cancer returning after surgery. The drug used in this study is a particular type of statin called simvastatin. Simvastatin is approved by the Food and Drug Administration (FDA) to help lower cholesterol (fatty deposits in your blood) and decrease the risk of heart disease. Its use in this research study is considered investigational, and not FDA approved for the subject's cancer. Subjects can expect to be in the active participation portion of this study for about 3 months. Afterwards, the study team may contact them or their medical providers every 6 months to follow their cancer care and collect information on their current health status.
This study is for subjects that have been diagnosed with prostate cancer that can be removed by surgery. The purpose of this study is to determine whether a group of drugs called statins can help to reduce the risk of prostate cancer returning after surgery. The drug used in this study is a particular type of statin called simvastatin. Simvastatin is approved by the Food and Drug Administration (FDA) to help lower cholesterol (fatty deposits in your blood) and decrease the risk of heart disease. Its use in this research study is considered investigational, and not FDA approved for the subject's cancer. Subjects can expect to be in the active participation portion of this study for about 3 months. Afterwards, the study team may contact them or their medical providers every 6 months to follow their cancer care and collect information on their current health status.
The purpose of this study is to obtain long-term diabetes control information after patients' participation in the MSC in T1D trial. Specifically, the goal of this study is to determine if patients receiving an MSC infusion in addition to the standard of care for diabetes have a long-term beneficial effect in slowing disease progression than patients receiving placebo infusion.
This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.
This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.
This study is for patients who have been diagnosed with locoregionally advanced squamous cell carcinoma. The purpose of this study is to compare two usual treatment approaches to head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The usual approach for patients who are not in this study is treatment with radiation therapy combined with the chemotherapy drug cisplatin. Cisplatin is a drug approved by the Food and Drug Administration (FDA) to treat your head and neck cancer. Cisplatin can be given at different doses and at different times during radiation, but the most common way to give cisplatin is either as a high-dose every 3 weeks or a low-dose weekly during radiation. Participants can expect to be on this study for up to 7 weeks and then followed annually until disease progression.
The purpose of this study is to identify domains in which stroke suvivors may have struggled since experiencing a stroke. These include things like emotional, family and work function. This study entails an interview and questionnaires that ask about functioning in these areas.
The longer-term goal of this work is to identify areas these areas so that we can develop a psychotherapy that could be helpful for individuals recovering from and living with the aftermath of stroke.