Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children with Sleep-Disordered Breathing: the REPOSE Navigation Intervention

Date Added
October 1st, 2024
PRO Number
Pro00138323
Researcher
Phayvanh Pecha

List of Studies


Keywords
Pediatrics, Sleep Disorders
Summary

This research study aims to compare usual care with a patient navigation intervention for children with sleep-disordered breathing (SDB). SDB is a range of symptoms from snoring to severe obstructive sleep apnea. In the REPOSE intervention, a centralized patient navigator will find out the dynamic individual barriers that families face in caring for their child with SDB. They will also provide resources and social support for parent-child dyads. In addition, the navigator facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. The patient navigation intervention group will be compared to the group of children receiving standard of care.

Institution
MUSC
Recruitment Contact
Danielle Beaufort
803-378-9735
beaufoda@musc.edu

Safety and effectiveness of Pradaxa oral pellet formulation for treatment of acute venous thromboembolic events (VTE) and/or for risk reduction of recurrence of VTE in pediatric patients aged 3 months to less than 12 years in a real world setting: a prospective non-interventional study conducted in the United States

Date Added
September 23rd, 2024
PRO Number
Pro00138643
Researcher
Shayla Bergmann

List of Studies


Keywords
Pediatrics
Summary

A study in the United States that looks at the safety and effectiveness of Pradaxa Pellets in children aged 3 months to less than 12 years who need treatment of a blood clot or who have had a blood clot and are at risk of developing another blood clot. This study is for children prescribed Pradaxa oral pellet as a standard of care.
Research visits will occur when your child starts taking Pradaxa Pellets and at 6 weeks, 3 months, 6 months, and 12 months. During those visits questions about your child's medical history and current medication and health during the study will be asked.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

Group Parenting Program for Managing Disruptive Behavior in Young Children

Date Added
September 8th, 2024
PRO Number
Pro00138994
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
ADD/ADHD, Autism, Pediatrics
Summary

The purpose of this research is to assess a group-based telehealth parenting program for child ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based telehealth PCIT sessions, and an online post intervention assessment. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Alexandra Marsden
843-714-1352
autismresearch@musc.edu

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Date Added
August 8th, 2024
PRO Number
Pro00134887
Researcher
Jacqueline Kraveka

List of Studies


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

This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

The Effects of Adolescents Alcohol Use on Oral Microbiota and the Brain.

Date Added
August 6th, 2024
PRO Number
Pro00138324
Researcher
Anna Kirkland

List of Studies

Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

Adolescence is a time of development in the brain and microbiome, including the microbiome present in the mouth called the oral microbiome. Alcohol use often begins and escalates during adolescence, which can cause changes to the oral microbiome leading to changes in the brain. The alcohol specific changes to the oral microbiome and the brain may make adolescents more vulnerable to a lifelong struggle with alcohol use disorder. This study will collect (1) saliva to assess the composition of the oral microbiome and (2) brain measurements using magnetic resonance imaging (MRI) across adolescents who may or may not use alcohol. Findings from this study will help form a more thorough understanding of the biological consequences of adolescent alcohol use, with the long-term goal of informing novel prevention and intervention efforts.

Institution
MUSC
Recruitment Contact
Anna Kirkland
(843) 792-5453
kirklaan@musc.edu

Cardiac Surgery Recovery in Infants Using Neoneur Feeding System

Date Added
July 19th, 2024
PRO Number
Pro00137012
Researcher
Frances Woodard

List of Studies


Keywords
Heart, Pediatrics
Summary

This study will evaluate the association between feeding recovery and clinical assessment of infant behaviors as measured in a brief survey to assess irritability, ability to be soothed, alertness, non-nutritive sucking, and muscle tone. Forty infants will be recruited from the PCICU-CSD at MUSC. This data will be assessed using the Neoneur Feeding System to create a model of feeding recovery.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@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

Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections In Pediatric Transplant Recipients.

Date Added
March 21st, 2024
PRO Number
Pro00134622
Researcher
Lauren Powell

List of Studies

Keywords
Infectious Diseases, Pediatrics, Transplant
Summary

Hematopoietic cell transplantation (HCT) and solid organ transplantation (SOT) recipients are at high risk for respiratory viral infection (RVI). This study aims to establish a comprehensive RVI diagnostic and disease progression predictive model in children undergoing HCT and SOT. Findings will result in the first ever evidence-based pediatric guidelines.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-901-4153
alsarral@musc.edu

A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immunooncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma.

Date Added
February 12th, 2024
PRO Number
Pro00133635
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Pediatrics
Summary

This study is for patients that have been diagnosed with early-stage (Stage I or II) Hodgkin lymphoma (HL)(cHL). The main purpose of this study is to compare the effects, good and/or bad, of brentuximab vedotin and nivolumab (Bv-NIVO) against standard therapy for people with HL to find out which is better. Participants can expect to be in the study for up to 54 months.

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

A Retrospective Follow-up Study of the Durability of Antiviral Therapy on Long-term Hearing and Neurodevelopmental Outcomes Among Patients Treated for Congenital Cytomegalovirus Infection as Infants or Toddlers

Date Added
December 18th, 2023
PRO Number
Pro00129725
Researcher
Stephen Thacker

List of Studies

Keywords
Pediatrics
Summary

Patients who previously had been treated with either intravenous ganciclovir or oral
valganciclovir as an infant or toddler, either as part of a previous Collaborative Antiviral Study Group (CASG) study or through routine clinical care at a current or former CASG study site, will be offered enrollment on this retrospective follow-up study.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu



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