Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness.

Date Added
September 23rd, 2024
PRO Number
Pro00136394
Researcher
Mark Miller

List of Studies

Keywords
Bone, Children's Health, Surgery
Summary

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.

Institution
MUSC
Recruitment Contact
Monicagail Reyes
843-792-7333
reyesmo@musc.edu

Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)

Date Added
August 9th, 2024
PRO Number
Pro00135409
Researcher
Ronald Teufel

List of Studies


Keywords
Children's Health, Vaccine
Summary

Infants and young children are at increased risk for respiratory syncytial virus (RSV) infections because of their maturing immune system and lack of prior exposure to RSV. A genetically stable live-attenuated RSV vaccine (from the US National Institutes of Health) has been shown to be safe and immunogenic in RSV-seronegative children in Phase I studies. A Phase II study is ongoing to evaluate vaccine virus transmissibility to close contacts of study participants (VAD00014 study). Study VAD00004 will be initiated as part of the Phase III development of the RSVt vaccine. The objective of this study is RSVt clinical efficacy, while also further investigating the safety and immunogenicity of the RSVt vaccine in a global context. Vaccine efficacy against lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD) will be assessed separately, which will provide evidence of protection against RSV respiratory disease if efficacy against both LRTD and URTD is demonstrated.

Institution
MUSC
Recruitment Contact
Trudy Spuller
843-876-0000
pctg@musc.edu

A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

Date Added
May 29th, 2024
PRO Number
Pro00136652
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Sarcoma, Children's Health, Drug Studies, Men's Health, Pediatrics, Women's Health
Summary

This study is for patient that have been diagnosed with rhabdomyosarcoma (RMS). The investigational drug in this study is vinorelbine, vincristine, dactinomycin, and cyclophosphamide (together called VINO-AC with vincristine). The purpose of this study is to compare the effects, good and/or bad, vinorelbine has on people with high risk RMS. Also, to find out if adding maintenance therapy will help get rid of the cancer and/or lower the chance that the cancer comes back. Participants can expect to be in this study for 12 months and will include chemotherapy, radiation and possibly surgery.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study with Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)

Date Added
May 2nd, 2024
PRO Number
Pro00135115
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Children's Health, Skin
Summary

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.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

Philips FAST picoSAT convenience sampling for SpO2 accuracy in neonate, infant, and pediatric patients

Date Added
March 19th, 2024
PRO Number
Pro00129656
Researcher
Allison Whalen

List of Studies


Keywords
Children's Health
Summary

The primary purpose of this clinical investigation is to evaluate the SpO2
accuracy of neonatal, infant, and pediatric Philips SpO2 sensors with the Philips
FAST Pulse Oximetry System. Accuracy will be evaluated against the gold
standard, SaO2 obtained from arterial blood samples and assessed by COOximetry.

Additionally, this study will be used to determine if skin pigmentation impacts
SpO2 accuracy and to identify the occurrence of occult hypoxemia, defined as an
SaO2 <88% with an SpO2 ≥92%, with consideration to skin pigmentation.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
8438765403
alsarraf@musc.edu

A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Subjects from 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis

Date Added
January 31st, 2024
PRO Number
Pro00130368
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

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.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Date Added
January 17th, 2024
PRO Number
Pro00131403
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

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.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
843-876-2281
didonato@musc.edu

Causes and Consequences of Preschooler's Digital Media Use: The Role of Sleep, Physical Activity, Sedentary Behavior and Social Emotional Health

Date Added
December 15th, 2023
PRO Number
Pro00133829
Researcher
Bridget Armstrong

List of Studies

Keywords
Children's Health, Disease Prevention, Healthy Volunteer Studies, Mental Health, Non-interventional, Pediatrics
Summary

Children spend more time than ever using screens — increasingly on portable digital media devices like tablets and smartphones, but our understanding about how these devices impact health is lagging. This project proposes to uncover how patterns of digital media use are formed and maintained and examine how those patterns predict mental health and cardiovascular health risk over time. The novel forms of media measurement used in this project – including passive mobile sampling, ecological momentary assessment and accelerometry – will allow us to uncover the unique and complex ways in which digital media impacts health behaviors.

Institution
USC
Recruitment Contact
Michal Talley
8032501730
BA12@mailbox.sc.edu

A South Carolina ECHO Pregnancy Cohort

Date Added
October 31st, 2023
PRO Number
Pro00131971
Researcher
Kelly Hunt

List of Studies