This is a 24-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, APL-18881, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to APL-18881 or a matched placebo
The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
The purpose of this research study is to determine the best treatment goals for patients with active CD. Researchers are investigating how treating and monitoring CD to meet specific treatment goals will keep your disease under control (remission) and decrease complications such as hospitalizations and surgeries. Group 1 treatment goals include IUS response (if the drug is improving your CD) and IUS assessed transmural healing (healing of all bowel layers), clinical remission (normalization of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission. Comparing the treatment goals in these groups may inform doctors how best to manage CD in the future. Approximately 304 people will be enrolled in this study. This research study will involve receiving 300 mg of vedolizumab as an intravenous (IV) infusion into your arm at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.
This study will see if the experimental medicine MTX-463 can slow or stop idiopathic pulmonary fibrosis (IPF) from worsening in people at least 40 years of age or older. Participants will receive either MTX-463 or a placebo (which contains no active drug) through an intravenous infusion once every 4 weeks, for a total of 6 infusions. Overall, participants will attend a total of 9 visits over the course of approximately 32 weeks, or roughly 8 months.
This study is enrolling participants with risk factors for heart or blood vessel events (e.g. heart attack, stroke, etc) who also have an elevated lipoprotein a (Lp(a)), which is a sticky particle in the blood that carries cholesterol. The first part of the study involves testing the Lp(a) level and if elevated then participants will be invited to be a part of a study testing the investigational medication olpasiran. Investigational means it has not been approved for commercial use by the Food and Drug Administration. The study medication is given as a shot just under the skin every 3 months. This study is a randomized study meaning participants are assigned by chance to either receive olpasiran or placebo. Placebo looks like the real medication but has no active ingredients. Participants have a 50:50 chance of being assigned to either group but will not know which group they are in. Study related procedures include physical exams, blood work, vital signs, electrocardiogram (ECG - a tracing of the heart's electrical activity) and study medication administration. This study is expected to last about three and a half to five and a half years and involve between 16 to 28 visits.
This project aims to identify and evaluate internal barriers that inhibit engagement with pharmacological treatment for opioid use disorder (OUD). Participants, consisting of adults diagnosed with OUD, will complete a series of surveys that will take approximately 30 minutes. In conducting this study, investigators intend to identify barriers that could be improved by future interventions.
This study will examine sex differences in how the brain processes reward in people that regularly use cannabis. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1.5-hour brain scan.
This study is for adults aged 18 to 39 who have a history of cancer and have not had inherited cancer genetic testing. The purpose of this study is to find out if a digital tool can be used as an alternative to meeting with a genetic counselor before inherited cancer genetic testing, and whether this approach can help support patients through the testing process. The study will compare the digital tool to the usual approach for genetic testing, which involves meeting with a genetic counselor before and after testing.
Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive pre-test education through a digital tool, and the other group will meet with a genetic counselor through a telehealth visit. All participants will receive their genetic test results through a telehealth visit with a genetic counselor. Participants in the digital tool group will also have access to a chatbot called the Genetics Journey Chatbot that provides educational support, reminders, and answers to questions during the study.
The study involves completing surveys at several time points: before genetic testing, after the testing decision, after receiving results, and again about 6 and 12 months later. The total duration of participation is about 18 months.
This study does not involve an investigational drug. Participants may benefit from learning whether they have a genetic change that could increase their risk of cancer, which could inform their future screening or prevention options. The information learned from this study may also help improve genetic testing delivery for future patients.
There will be a total of 10 patients enrolled locally over the course of 24 months.
The goal of the current project is to gather preliminary data from adults across the United States using an online survey study regarding alternative cannabinoid use, motivations, and experiences. We will also conduct interviews with some participants to gather more open-ended responses regarding the targets of interest in order to inform future work about alternative cannabinoids.
Ritlecitinib has been approved for treating severe alopecia areata (AA) in adults and adolescents aged 12 and older in the US, EU, and other countries, based on a positive benefit/risk assessment. However, there are no approved treatments for AA in children aged 6 to under 12. Study B7981027 is being conducted to evaluate the efficacy and safety of ritlecitinib in this younger group. This study is part of the EU Pediatric Investigation Plan (PIP) and fulfills a post-marketing requirement in the US.