The purpose of this research is to assess a stepped care model of a telehealth parenting program for children ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based tele-health Parent-Child Interaction Therapy (PCIT) sessions, and an online post intervention assessment. Some families may receive additional individual virtual booster sessions and will complete a second online post assessment.
This study is recruiting pediatric patients who have been diagnosed with osteosarcoma. Osteosarcoma is the most common primary bone malignancy of childhood and adolescence. The goal of the study is to determine the feasibility of adding cabozantinib to standard MAP (high dose methotrexate, doxorubicin, and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor and to compare the effects, good and/or bad, of cabozantinib in combination with MAP versus MAP alone on people with newly diagnosed OST to find out which is better. Common side effects of chemotherapy include nausea, vomiting, hair loss, and fatigue (tiredness). Participants will receive the medications through an IV in their arm and PO. Study participation is expected to last up to 16 months.
Study 812P310 is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 in the treatment of ADHD in pediatric subjects who have participated in a previous blinded study of SPN-812.
All subjects who complete a blinded study of SPN-812 will have the option to participate in the OLE study in which all subjects receive SPN-812 (Study Medication, SM). Starting dose, dose range, and dose adjustments are all based on which double blind study the subject completed and, if applicable, the current age of the subject (Table 1). A subject who completed Study 812P202, 812P301 or 812P303, enters this OLE study at age 11 years, and then turns 12 while still in the study, their upper potential dose limit will then be raised from 400 mg to 600 mg and titration may occur at either 100 or 200 mg/week, as specified for the 12-17 year-old age group.
The flu is caused by a virus that can sometimes change. This can make the flu resistant to treatment, which means drugs, like baloxavir marboxil, can become less effective for treating the flu (also known as "resistance").
The purpose of this study is to monitor changes in the flu virus before and after study treatment with baloxavir marboxil in children. The resistance of the flu virus to study treatment with baloxavir marboxil will also be monitored.
This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel group, efficacy, and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with a DSM-IV-TR diagnosis of ADHD. Approximately 286 subjects will be randomized to either SPN-812 or matching placebo in a 1:1 ratio (143 subjects per arm). Following up to 4 weeks of screening, subjects will be treated with study medication (SM) for 6 weeks, then will either be enrolled in a separate OLE study or followed for an additional 1 week for safety. The total duration of the study is up to 10 weeks.
This study is recruiting pediatric patients who have been diagnosed with rhabdomyosarcoma (RMS). RMS is a type of cancer that occurs in the soft tissues of the body. The goal of the study is to compare the effects, good and/or bad, of giving less chemotherapy drugs to people with very low risk-RMS to find out which is better. Patients will be separated into two groups based on their tumor type: Low Risk and Very Low Risk. Participants in the Low Risk group will receive Vincristine, Dactinomycin and Cyclophosphamide. Participants in the Low Risk group will receive Vincristine and Dactinomycin. All participants will be tested for genetic differences (called MYOD1 and TP53). If any participant is found to have these genetic differences, they will receive Vincristine, Dactinomycin and Cyclophosphamide. Common side effects of chemotherapy include nausea, vomiting, hair loss, and fatigue (tiredness). Participants will receive the medications through an IV in their arm. Study participation is expected to last up to one year.
This study is a double‑blind, placebo‑controlled research study to evaluate the safety and effectiveness of a skin patch treatment for peanut allergy in children ages 1 to 3. The patch delivers a very small amount of peanut protein through the skin and is designed to help the immune system become less sensitive to peanuts over time.
Participation in the study will last approximately 34 weeks. Participation is voluntary, and participants may withdraw at any time.
The investigational varicella vaccine (hereafter referred to as VNS vaccine) is a new
candidate varicella vaccine derived from the Oka strain. The main rationale for the
development of VNS vaccine is to provide an additional alternative varicella vaccine as an advantage from a public health perspective to prevent varicella disease
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.
Children with amblyopia (lazy eye) are often treated with patch therapy. Patch therapy often results in leftover amblyopia and has many challenges associated with its use. This study will determine how traditional patch therapy results compare to those achieved with the Luminopia digital therapeutic system.