This is a research study to find out if anxiety in patients with autism spectrum disorder are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will learn how to self-administer ear stimulation treatments at home before starting the study. Over the course of a month, participants will self-administer ear stimulation treatments twice a day for a month. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. There will also be a smaller number of questionnaires completed electronically on a weekly basis. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep.
Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.
This is a Phase 3b, multicenter, open-label study to evaluate transmural healing and the disease modifying effect of guselkumab in participants aged 18 years or older, with active Crohn's disease. Eligible participants must be diagnosed with luminal Crohn's disease (confirmed by radiography, histology, and/or endoscopy) for a minimum of 3 months, have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or Advanced therapy (for example, biologic or jak inhibitor), or have medical contraindications to such therapies. Participants with active moderate‐to‐severe Crohn's disease will be enrolled in this study. About 112 participants will take part in this study worldwide at approximately 90 study sites. Participants will be in the study for about 104 weeks and will need to visit the study site approximately 28 times, this number may also vary depending on the study treatment group and whether the option of self-administration of the study drug at home at certain timepoints.
Eligible participants (ages 18+ whom have daily cigarette use) will attend an in-person assessment (though some aspects of the study, including consent, can be completed remotely). Participants will submit a breath sample for assessment of expired carbon monoxide. Approximately 5-7 days after completion of the in-person assessment, participants will meet with research staff. A medical clinician will meet with the participant to present a smoking cessation treatment recommendation along with resources. Participants will also complete surveys to assess their treatment preferences, motivation, and self-efficacy following receipt of the recommendation.