This observational, non-medication study's purpose is to help learn more about the immune system's inflammation process involved in lupus. The study will be enrolling both lupus and non-lupus (healthy control) females aged 18 and older who identify as Black/African American and Non-Hispanic or White and Non-Hispanic for this comparison study. Participation involves a one-time blood collection.
There are no direct benefits in participating, but it is hoped information learned may help us to develop a better understanding of lupus. Compensation is available for participation.
Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition in which infants undergo withdrawal after exposure to opioids in utero. The current standard of care uses oral morphine and/or methadone which can lead to harmful side effects in the infant. We propose a non-drug based, adjunct treatment that stimulates nerves around the ear, and may help reduce withdrawal symptoms while using less morphine.
The purpose of this study is to understand whether there may be certain characteristics or patterns that might predict seizure events in patients undergoing EEG monitoring and at home. Researchers will also be assessing the comfort and usability of a new device called NextSense EEG earbud device at the same time as routine inpatient epilepsy monitoring unit (EMU) admissions, as well as device use in the home environment. In order to enroll in the at-home extension, the participant must be enrolled in the inpatient EMU admission portion of the study. Participants will be asked to assess their mood, sleep quality, and the comfort and usability of the device during their inpatient admission at regular intervals. If participating in the at-home extension, these same assessment questionnaires, in addition to a seizure diary, will be completed by participants at regular intervals.
This research study is enrolling participants that have been diagnosed with advanced gastric cancer (a disease in which cancer cells form in the lining of the stomach) or gastroesophageal junction cancer (a type of cancer forming in the area where the tube that connects the mouth and the stomach join together) and have not received prior treatment for advanced cancer and the tumor has already tested positive for fibroblast growth factor receptor 2b (FGFR2b) expression. FGFR2b is a protein that possibly causes cells to grow more quickly and multiply abnormally. The purpose of this study is to see if bemarituzumab is safe, tolerable, and effective when administered along with mFOLFOX6 (a combination of 5 fluorouracil [5 FU], oxaliplatin and leucovorin) and nivolumab and whether it causes any side effects. Bemarituzumab is not approved by the Food and Drug Administration (FDA). Participants will be pre-screening to see if they qualify to participate in Part 2. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample in order to test for FGFR2b proteins. If the test results show an excessive amount of FGFR2b proteins in the tumor, participants may be asked to consider participating in the Part 2 study involving bemarituzumab, an investigational drug for people with advanced gastric or gastroesophageal junction cancer. Participants in this study will receive either bemarituzumab with mFOLFOX6 and nivolumab or placebo with mFOLFOX6 and nivolumab. The placebo will look like bemarituzumab but it will not contain active ingredients and has no effect on participants' condition. This study involves pharmacokinetic testing which is a blood test to determine how much study drug is in the blood. Bemarituzumab is not approved by the Food and Drug Administration (FDA). Participants could be in this study for up to 40 months and up to 57 visits.
The purpose of this study is to collect blood samples to determine if a blood-based test can be used to identify lung cancers that may or may not also be seen on images of lungs. Additionally, the study aims to see if a blood-based test can identify other types of cancers and health conditions.
Sensory stimulation has been shown to enhance rehabilitation outcomes. However, most sensory stimulation devices interfere with natural hand tasks. Thus, a new wearable stimulation device has been developed to deliver imperceptible vibration to wrist skin. This study is to evaluate the community use of the device for patients with neurologic movement disorders. Participation will include wearing the provided device and charging the device every night. The knowledge regarding community use of the device may contribute to improving the device functionality and usability for future users of the device.
This study is for subjects that have been newly diagnosed with diffuse large B cell lymphoma (DLBCL). This study is testing an "investigational" (not yet approved by the Food and Drug Administration (FDA)) combination of the drug zanubrutinib (BRUKINSAâ„¢) and a standard chemotherapy treatment called R-CHOP. This study will test the how well the drug combination works and how safe it is. The subject will be given the study drug combination in 21 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, bone marrow biopsies, and imaging scans. The subject may remain in the study for up to approximately 2 years.
Both withdrawal symptoms and external stressors can contribute to relapse in people that are trying to quit using marijuana. These negative feelings may be more severe in people that also have Major Depressive Disorder, making it especially hard for them to quit. The purpose of this study is to examine differences in withdrawal symptoms and stress response in people with Cannabis Use Disorder that do or do not also have major depression. Study participation will involve 3 on-site laboratory visits over 6 days. Participants will be asked to not use marijuana for 3 of those days. Participants will complete mobile phone surveys multiple times each day, wear a watch to assess sleep quality, and provide blood samples for testing at each laboratory visit. At the final laboratory visit, participants will complete a stress task.
This randomized, double-blind, placebo-controlled Phase 2/3 adaptive study involves an initial investigational blood test to determine if you have a specific variation related to kidney disease. The investigational blood test is to see if you have changes in your DNA of a gene called APOL1. People who have this gene variation may be at risk of losing their kidney function faster than others. If you have the variants (changes in DNA) you may be eligible to continue participation in the study. If you do not have the variants, you will not be eligible, and the study doctor will discuss your other options with you. If you decide to participate, there will be no cost to you and you will be compensated. This study will start by comparing two doses of VX-147 against placebo in subjects with APOL1-mediated kidney disease for 12 weeks. Subjects in Phase 2 will continue to Phase 3 once a dose for Phase 3 is selected. Then the Phase 3 dose of VX-147 will be evaluated for safety and effectiveness. If you meet the requirements and choose to take part in the study, you will be randomly assigned to a treatment group. You will not know which study treatment group you are assigned to and it is possible that you will receive placebo instead of VX-147. The study includes a screening, treatment, and follow-up period. The study will end after the last patient enrolled has completed 2 years in the study. This means some patients enrolling earlier could be in the study for up to 4 years.
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.