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 paper 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
Donna Roberts

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

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages ≥ 2 Years to < 12 Years) With Atopic Dermatitis

Date Added
November 16th, 2021
PRO Number
Pro00115393
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The purpose of this research study is to determine if an investigational cream, ruxolitinib cream (0.75% and 1.5% strengths), is safe and effective to treat Atopic Dermatitis. In this study, ruxolitinib cream will be compared to a "vehicle cream." The vehicle cream looks like the ruxolitinib cream but contains no ruxolitinib. This study can last up to 55 weeks. For the first 8 weeks participants will be randomly assigned to receive either the ruxolitinib cream or vehicle cream. For the following 44 weeks participants will receive the ruxolitinib cream.

Institution
MUSC
Recruitment Contact
Alyson Winter
843-876-3209
wintera@musc.edu