The primary objective of this study is to demonstrate the safety and effective use of Stryker's PEEK Customized Implants in patients receiving craniofacial (head and facial) surgery. Other objectives include using a CT scan to assist surgeons with providing a solution to complex and simple reconstruction challenges and reducing them to a single or two-stage procedure, thereby minimizing the overall surgery time and limiting the number of surgeries. Patient questionnaires and health information will be used during the study to demonstrate the safety and effectiveness of the implants. We will be enrolling ages 4 - 75 years old.
This is a randomized, double-blind, parallel group, vehicle-controlled phase to evaluate the efficacy and safety of diacerein 1% ointment applied topically once daily for 8 weeks for the treatment of adult and pediatric (age ≥ 6 months) patients with generalized EBS. The duration of study participation is anticipated to be approximately ~16 to 20 weeks per patient consisting of a Screening Period of up to 4 weeks, a Treatment Period of 8 weeks and a No Treatment Follow-up Period of 8 weeks. Patients that complete this portion of the study will be eligible to participate in an open-label, 24-week extension phase to evaluate the long-term safety of diacerein 1% ointment for the treatment of generalized EBS.
This study is being done to learn more about apremilast (AMG 407) in mild to moderate plaque psoriasis in participants (children and adolescents) aged 6 to 17 years. It will see whether it causes any side effects. About 50 people are expected to take part in this study. The duration of the study is approximately 285 days. This includes 3 phases: 35 days of screening phase, 225 days (32 weeks) of treatment phase, and 60 days of observational follow-up phase after the last dose of study drug – this means drug is still being tested to see if it is safe and works.
The study is being conducted in order to assess the long-term safety of rocatinlimab in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD). The study population will include subjects who completed an end of treatment duration visit in a parent study and meet eligibility criteria. Subjects will be randomized to receive a dosage of rocatinlimab based on age and their previous dosage from the parent study. The total duration of participation, including the parent study, will be up to 2.5 to 3 years, with a safety follow-up period after the last dose of investigational product at week 104.
The ECHO Cohort is a longitudinal prospective multi-site study aiming to understand how the environment and things that happen early in children's lives - even before they are born - affect their development, health, and well-being. This research program includes many study sites across the United States. ECHO will combine information about 20,000 pregnant participants, more than 50,000 children, and their families. With so many participants from across the country, researchers can answer important childhood health questions.
This Phase 3 study is designed to assess the long-term safety and efficacy of lebrikizumab in participants 6 months to <18 years of age with moderate-to-severe AD. Participants who have completed Study KGBI through Week 16 without requiring the use of systemic rescue medication will be eligible to enroll into Study KGBJ. All participants will receive active lebrikizumab treatment during Study KGBJ. The planned duration of treatment for each participant is approximately 52 weeks. All participants will enter a post-treatment safety follow-up period approximately 12 weeks after the last dose of lebrikizumab. This study will include both on-site (in clinic) and remote visits (telephone calls).
The goal of this study is to develop a biorepository to store pediatric biospecimens from nephrology cohorts for on-going and future research studies. These studies plan to advance the state of science in the hopes to find more information that potentially leads to developing novel diagnostic approaches and identify therapeutic targets to prevent and/or treat pediatric disease involving the kidneys.
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 observational, multi-center cohort study of pediatric cardiac arrest management will contribute to a clinical CPR Learning Laboratory. The objectives of this study are to characterize the quality of CPR and post-cardiac arrest care delivered to children across a broad spectrum of hospitals, to determine the association between quantitative CPR quality measures (depth, rate, compression release, flow fraction) and survival to hospital discharge, and to determine the association of survival with site-specific post-cardiac arrest care (PCAC). The study will enroll pediatric cardiac arrests requiring chest compressions for ≥1 minute identified as part of standard clinical operations. The CPR quantitative measures, defibrillator data (when available), monitor data (when available), and post-arrest care will be de-identified and submitted to a central database.
This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.