A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

Date Added
March 22nd, 2023
PRO Number
Pro00125074
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared with dupilumab, as monotherapy, in adolescents and adult subjects who have inadequate response to systemic therapy. The study will consist of a 35-day Screening Period; Period 1, a 16-week randomized, open-label, efficacy assessor blinded treatment period for all subjects, and a 30-day or 12-week follow-up visit for subjects on upadacitinib and dupilumab respectively, who will not enter the Period 2; Period 2, a 16-week open-label, efficacy assessor blinded extension period for those subjects with a < EASI 75 response at Week 16 (total duration 32 weeks) and a 30-day follow-up visit.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
8438762281
didonato@musc.edu

Examining Provider and Caregiver Perceptions of an Automated Clinical Support Tool to identify Child Risk in Primary Care

Date Added
February 12th, 2023
PRO Number
Pro00125560
Researcher
Hannah Espeleta

List of Studies

Keywords
Children's Health, Pediatrics
Summary

This study wants to understand how we can better identify children who have experienced or are at risk to experience child maltreatment. We will be interviewing caregivers of children and primary care providers (nurses, pediatricians, social workers) to understand their perspectives on screening for child safety risks in primary care settings. Interviews with providers will also focus on their feedback on a new tool to designed to detect child safety risks within health care settings. Findings will help inform best practice in integrated health care settings.

Institution
MUSC
Recruitment Contact
Hannah Espeleta
843-792-6098
espeleta@musc.edu

Abdominal ultrasound in staging pediatric inflammatory bowel disease as compared to endoscopy at diagnosis.

Date Added
February 12th, 2023
PRO Number
Pro00123592
Researcher
Hamza Khan

List of Studies

Keywords
Bowel, Children's Health, Inflammatory Bowel Disease, Pediatrics
Summary

The purpose of this study is to evaluate the findings of Abdominal Ultrasound (AU) and to determine the effectiveness and safety in diagnosing Inflammatory Bowel Disease (IBD) in children. An AU provides a cost-effective, radiation-free, noninvasive method while a colonoscopy, endoscopy, and biopsy are invasive procedures. A secondary aim of the study is to compare the AU findings with blood markers and advanced imaging, when available. The department of Radiology will be conducting this study at the Shaw Jenkins Children's Hospital and MUSC Children's Health R. Keith Summey Medical Pavilion.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
8437922305
bidwells@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis

Date Added
December 8th, 2022
PRO Number
Pro00123135
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

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.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
8438762281
didonato@musc.edu

A multi methods study to explore the feasibility of assessing the bereavement needs of parent-child dyads following sibling death.

Date Added
August 2nd, 2022
PRO Number
Pro00121605
Researcher
Shannon D'Alton

List of Studies


Keywords
Adolescents, Children's Health, Pediatrics
Summary

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.

Institution
MUSC
Recruitment Contact
Shannon D'Alton
843-518-3500
vaillan@musc.edu

3D-Printed versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial

Date Added
April 19th, 2022
PRO Number
Pro00115646
Researcher
Ildeu Andrade

List of Studies

Keywords
Children's Health, Dental
Summary

Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.

Institution
MUSC
Recruitment Contact
Ildeu Andrade
843-792-3913
andradei@musc.edu

Can we change the paradigm in children with Non-Alcoholic Fatty Liver disease using Ultrasound Shear wave elastography as a non-invasive point of care tool?

Date Added
March 1st, 2022
PRO Number
Pro00116969
Researcher
Nagraj Kasi

List of Studies


Keywords
Children's Health, Liver
Summary

This investigator-initiated research study supported by a pilot grant from MUSC-Siemens research collaboration, aims to test the feasibility and reproducibility of Ultrasound Shear wave elastography as a point of care tool in screening for hepatic fibrosis and steatosis in children 9-17 years of age with Non-Alcoholic Fatty Liver Disease.

Institution
MUSC
Recruitment Contact
Nagraj Kasi
843-876-0444
kasi@musc.edu

NEPTUNE

Date Added
February 22nd, 2022
PRO Number
Pro00115978
Researcher
David Selewski

List of Studies


Keywords
Children's Health, Kidney, Pediatrics
Summary

A prospective parallel cohort study generating two groups of participants will be performed in NEPTUNE. The two groups are: (1) Cohort A which includes the FSGS/MCD Cohort; and the MN Cohort, both incipient and prevalent biopsied patients; and (2) Cohort B – a non-biopsy, treatment-naïve, pediatric cohort less than 19 years of age, cNEPTUNE. The sample size for the combined FSGS/MCD and MN Cohorts is a minimum of 800 participants, with a minimum of 375 new patients recruited under Protocol V5.0. The sample size for the second group, cNEPTUNE, will be a minimum of 200 participants. Participants will be recruited into each subgroup concurrently. All participants who meet the inclusion criteria at the participating centers will be enrolled if the participants or their legally authorized representative(s) provide comprehensive written informed consent. A recruit-to-replace strategy will be employed throughout the enrollment phase. Cohort A study visits including screening/eligibility, baseline, biopsy, and follow-up visits, and SMS texting. Study visits for Cohort B, cNEPTUNE, including screening/eligibility, baseline, follow-up visits, and SMS texting.

Institution
MUSC
Recruitment Contact
Christian Conley
843-792-1213
conleyc@musc.edu

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI: Phase II Clinical Trial

Date Added
December 14th, 2021
PRO Number
Pro00116913
Researcher
Justin Chetta

List of Studies

Keywords
Children's Health, Infant
Summary

This is a Phase II (determine the safety and response of a drug) study that is looking at how long the contrast agent Gadopiclenol stays in the plasma (part of blood not including red cells) after a single injection during an MRI in children aged up to and including 23 months. Gadopiclenol is an investigational drug, which means that it is not approved by the FDA. This study will be assessing the safety of gadopiclenol for up to 3 months following the administration of gadopiclenol at the MRI, and will evaluate the quality of the images obtained from when gadopiclenol was used at the MRI. Blood samples will be collected three times within the 8 hours following the MRI for analysis of how much gadopiclenol is left in the blood.

Institution
MUSC
Recruitment Contact
Elise Zhao
843-792-2354
zhaoel@musc.edu

THRIVE-ASD: Telehealth Rapid Intervention for Externalizing Behaviors in ASD

Date Added
December 3rd, 2021
PRO Number
Pro00114600
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
Autism, Children's Health, Pediatrics
Summary

The purpose of this research study is to evaluate Parent Child Interaction Therapy (PCIT) delivered via telehealth for young children with autism spectrum disorder (ASD) and disruptive behavior problems. Participants will go through a screening to determine eligibility. Eligible families who choose to participate will complete 3 in-person visits at MUSC and may receive 10 telehealth therapy sessions, at no cost. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Jessie Montezuma
843-714-1352
autismresearch@musc.edu



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