Cutaneous lupus is a common manifestation of childhood-onset Systemic Lupus Erythematosus (cSLE), affecting up to 85% of patients. Skin involvement can cause irritation, scarring, hair loss, changes in skin color and appearance, which may negatively impact quality of life and mental health. This study aims to assess the impact of cutaneous lupus on quality of life and mental health in diverse pediatric populations, with the goal of identifying disparities and improving individualized care. We will use validated surveys to assess disease burden on quality of life.
This study aims to evaluate the remote delivery of self-regulation assessments in young children with autism and their parents. Parents will complete online surveys. Parents and children will complete two virtual visits. At the second visit, participants will wear a heart rate monitor while completing study tasks. This study will inform research on behavioral therapies for children with autism.
This study is for patients who have completed curative-intent treatment for colorectal cancer. It is testing an educational website called Current Together After Cancer (CTAC) to see if it improves follow-up care, including knowledge about cancer recurrence, recommended tests, and self-management of health. Participants will be randomly assigned to one of two versions of the website, with or without additional features for engaging a support person, and can use it on a computer, tablet, or smartphone. The study will last up to 16 months, including website use, surveys, and optional interviews, with participation completely voluntary. The goal is to determine whether CTAC helps patients better understand follow-up care and engage their supporters to improve adherence to recommended surveillance. There will be a total of 21 patients enrolled locally over the course of 36 months.
This study is for patients who have completed curative-intent treatment for colorectal cancer. It is testing an educational website called Current Together After Cancer (CTAC) to see if it improves follow-up care, including knowledge about cancer recurrence, recommended tests, and self-management of health. Participants will be randomly assigned to one of two versions of the website, with or without additional features for engaging a support person, and can use it on a computer, tablet, or smartphone. The study will last up to 16 months, including website use, surveys, and optional interviews, with participation completely voluntary. The goal is to determine whether CTAC helps patients better understand follow-up care and engage their supporters to improve adherence to recommended surveillance. There will be a total of 21 patients enrolled locally over the course of 36 months.
This study is for patients who have completed curative-intent treatment for colorectal cancer. It is testing an educational website called Current Together After Cancer (CTAC) to see if it improves follow-up care, including knowledge about cancer recurrence, recommended tests, and self-management of health. Participants will be randomly assigned to one of two versions of the website, with or without additional features for engaging a support person, and can use it on a computer, tablet, or smartphone. The study will last up to 16 months, including website use, surveys, and optional interviews, with participation completely voluntary. The goal is to determine whether CTAC helps patients better understand follow-up care and engage their supporters to improve adherence to recommended surveillance. There will be a total of 21 patients enrolled locally over the course of 36 months.
Half of caregivers in the US are adults caring for a parent, and many of these are young adults, between the ages of 18-35. This presents communication and quality of life challenges for both the young adult child caregiver and parent with cancer; however, this dyad (e.g., two people together) has not been well studied. We will conduct interviews with young adult child caregivers and parents with cancer to learn more about communication challenges and support needs in this dyad. Dyad members will also complete self-report measures asking about mood, coping, communication and quality of life. Findings will inform the development of an intervention to improve dyadic communication and quality of life.
M1095-HS-303 is a Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe HS who were previously enrolled in a parental study.
Rollover to this OLE study will occur at the time of the End-of-Treatment (EOT) visit of the parental study. Upon enrollment into this study, each participant can continue to receive sonelokimab 120 mg every 4 weeks (Q4W) for up to 2 years, with a safety follow-up (SFU). Visit 8 weeks after the last dose of study treatment. Following successful training and supervision, sonelokimab will be self-administered by the participant (or caregiver if required) at home and at the study center.
This is an open-label pilot study firstly assessing safety and feasibility of a form of ear stimulation called transcutaneous auricular neuromodulation, or tAN, in women with postpartum depression (PPD). Secondly, we will be assessing the impact of at-home tAN on mood, empathy, and physiological markers of sympathetic activity in women with PPD. Participants will learn how to self-administer ear stimulation treatments in the lab before starting the at-home study. Over the course of one week, participants will self-administer ear stimulation treatments three times a day. 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, as well as undergo heart rate variability (HRV) assessments and provide salivary samples. There will also be a smaller number of questionnaires completed electronically at the midpoint of the study. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and feelings towards their newborn.
Individuals with obesity and a history of heart failure (condition where heart does not effectively pump) with a preserved or mildly reduced ejection fraction (measure of the heart's pumping ability) will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (NNC0487-0111) or control (placebo) group. NNC0487-011 and placebo will be delivered in an injectable pen device for a subcutaneous, once weekly injection. Placebo means there is no active study treatment) Study participation will last approximately three years and begin with a screening period to ensure correct patient selection. After the screening period, 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 (test that records the heart's electrical activity) The study's primary objective is to demonstrate that study drug vs. once weekly placebo, with standard of care, reduces the risk of a composite heart failure outcome consisting of cardiovascular death, heart failure hospitalization, or urgent heart failure visit in patients with heart failure with a preserved or mildly reduced ejection fraction and obesity.
The purpose of this research study is to learn how the nervous system functions in individuals with and without spinal cord injury, and examine how this relates to function. As part of this study, procedures may include nerve stimulation, brain stimulation, imaging (MRI), walking assessments, measures of brain activity, sensation testing, measures of arm or leg function, and self-report measures regarding daily activities and quality of life. The duration of participation depends on the number of procedures to which an individual is consented.