This study aims to evaluate the efficacy and safety of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment, compared with placebo, in pediatric participants with moderate-to-severe atopic dermatitis. Participants found to be eligible according to all of the study entry criteria will be randomly assigned in a 2:1 ratio to receive either lebrikizumab or placebo. This study can last up to 32 weeks, with 4 study periods. Screening Period: up to 4 weeks (≤30 days), TCS Standardization Period: 2 weeks, Treatment Period: 16 weeks, Post-Treatment Safety Follow-up Period: 12 weeks.
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.
This study explores the best way to teach two-year-old toddlers new verbs, and whether there are differences in what is best between late talkers and typically developing children. In a series of two, one-hour visits, children will watch videos on an eye-tracker, which will capture their face and gaze patterns. This data will be analyzed to see how children are making sense of what they are hearing. In one task, we ask whether it is better for children to hear a new verb before they see the action it denotes, or whether it is better to see the new action before hearing the verb. In the second task, we consider how quickly children are able to make sense of the language they hear, and whether this has any relationship to how they learn new verbs (Task 1). Results will help shape new clinical interventions for late talkers.
The purpose of this study is to learn how well a new mobile app helps families manage their child's nephrotic syndrome. We will be asking what parents think of the new app and how we can improve the design of the app. We will look for 60 parents to participate in the study, from 4 children's kidney clinics in the United States. The study will last 12 months. Participants will be asked to check their child's urine protein levels at home daily and answer surveys. If participants are randomly assigned to the mobile app study arm, they will be asked to use the app. The risks associated with participating in this study include loss of privacy and breach of confidentiality. There are no anticipated benefits to your child from participating in the study, but we hope that in the future the app will help families manage nephrotic syndrome. The alternative is to not participate in this study. Participants will be compensated for their participation in the study.
This study aims to evaluate the safety and efficacy of isotretinoin ointment (TMB-001 0.05%) in treating subjects > or = to 6 years of age with lamellar ichthyosis, and aims to assess the bodily absorption of the cream across application frequencies. Subjects with ARCI/RXLI will be randomized 2:1, to either receive the TMB-001 0.05% isotretinoin ointment or a vehicle ointment - applied daily - for 3 weeks. Subsequently, dosing will be increased to twice daily for 9 weeks. If significant improvement is observed at the end of the 9 weeks, subjects will be randomized 1:1 to receive the TMB-001 0.05% ointment, either applied daily or twice-daily, for 12 weeks. Prior to the Phase III trial, subjects will have the option to participate in a 14 day treatment period with TMB-001 0.05% - twice daily - followed by continued treatment with TMB-001 0.05% twice daily for 10 weeks.
In the United States, nearly 62,000 children and adolescents are bereaved by the death of a sibling each year. Bereaved siblings and parents are at a lifelong risk for negative physical and psychological outcomes, yet little is known about the support and resource needs in the first 6 months following death. The purpose of this study is to determine the best ways to identify bereavement needs and barriers to grief support for parents and children following sibling death and to assess how bereavement needs impact parental distress and child quality of life and grief.
This study is for children between 8 and 17 years of age who have experienced the death of a sibling in the past 24 months. Children must have a parent or primary care giver actively take part in the study with them as a parent-child dyad. Information from this study will be used to help understand how to improve the care and support of parents and siblings that have experienced a loss.
Learning new words is challenging for all toddlers, and it may be particularly challenging for toddlers who are late talkers. In this study, we ask whether late talkers use the same cues to figure out the meanings of new words as do their typically developing peers. Toddlers ages 2.0-2.5 will watch videos of people doing new actions and hear made-up words. An eye-tracking device will capture their face and their gaze patterns, and we will use this data to determine how they are making sense of the new words they are hearing. Results will provide insights into how toddlers learn new words and whether this process relates to toddlers' current language abilities.
Patients between the ages of 12 months and 11 years who are undergoing ureteral reimplantation surgery will be randomized to receive intrathecal morphine, or bilateral quadratrus lumborum block. We will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.
This research study aims to learn more about children and adolescents who have a shiga toxin-producing E. coli (STEC) infection. E. coli is a type of bacteria found in the intestines. Although most types of E. coli are harmless, some produce toxins that can make children sick. This study will assess what type of treatment is best for this infection.