Influenza Vaccine Effectiveness for Preventing Laboratory-Confirmed Severe Influenza-Associated Illness and Understanding Coronavirus Disease 2019 (Overcoming COVID-19) in US Children

Date Added
September 17th, 2020
PRO Number
Pro00102181
Researcher
Elizabeth Mack

List of Studies

Keywords
Coronavirus, Pediatrics
Summary

The Overcoming Cohort study is a studies looking for variations in DNA,for populations less than or 25 years of age, that either protect people from COVID-19 disease or make them more susceptible. The study will sequence patients' entire genome or the smaller group of genes that code for proteins (exome). The study would gain a better understanding of COVID-19 that would improve diagnostic, prevention, and treatment measures.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

Prospective Non-Interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer Treated with Larotrectinib

Date Added
September 17th, 2020
PRO Number
Pro00090298
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Adolescents, Cancer, Pediatrics
Summary

This is an observational study, which means that only information is collected on treatment, examinations or diagnostic tests which are a part of the routine standard of care. The participant is being asked to volunteer because they have been diagnosed with locally advanced or metastatic TRK fusion cancer treated with larotrectinib. The purpose of this study is to learn more about the safety profile and the effectiveness of VITRAKVI® under routine practice conditions.
Participants will be followed for a minimum of 5 years from the time they agree to participate in the study.

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

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

Date Added
September 2nd, 2020
PRO Number
Pro00102404
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Brain, Cancer, Pediatrics
Summary

This study is for patients that have been newly diagnosed with BRAF v600-Mutant High-Grade Glioma (HGG). The overall goal of this study is to see if using two drugs called dabrafenib and trametinib after radiation treatment will be better than treatments used in the past in helping to get rid of or shrink HGG. The treatment involves cancer fighting medicines plus radiation. The treatment on this study takes a little over 2 years. It is divided into 2 phases of therapy.

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

Expanded Access to Convalescent Plasma for the Treatment of Pediatric Patients with COVID-19

Date Added
August 4th, 2020
PRO Number
Pro00102411
Researcher
Andrew Atz

List of Studies

Keywords
Coronavirus, Pediatrics
Summary

People who recover from COVID-19 do so, at least in part, because their blood contains substances called antibodies, which are capable of fighting the virus that causes the illness. It turns out that for some other diseases caused by respiratory viruses, giving people the liquid portion of blood, called plasma, obtained from those who have recovered from the virus, leads to more rapid improvement of the disease. We think that patients with COVID-19 may improve faster if they receive plasma from those who have recovered from COVID-19, because it may have the ability to fight the virus that causes COVID-19.
We are performing this study to see if children admitted to the hospital with COVID-19 may have an improved chance of recovery by receiving plasma from someone who has recovered from COVID-19.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

Intermediate-size Expanded Access of Remestemcel-L, Human Mesenchymal Stromal Cells, for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease (COVID-19)

Date Added
July 28th, 2020
PRO Number
Pro00102047
Researcher
Allison Eckard

List of Studies

Keywords
Coronavirus, Pediatrics
Summary

Remestemcel-L will be evaluated in children or adolescents with multisystem inflammatory syndrome (MIS-C) associated with coronavirus disease (COVID-19) who have baseline myocardial complications. The primary objective of this study is to assess the safety and tolerability of remestemcel-L in Multisystem Inflammatory Syndrome in Children (MIS-C) associated with coronavirus disease (COVID-19).

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600 Mutations

Date Added
April 24th, 2020
PRO Number
Pro00099128
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Brain, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with newly diagnosed High-Grade Glioma (HGG). The investigational drug in this study is veliparib. The purpose of this study is to see if veliparib given with radiation therapy followed by veliparib with temozolomide given as maintenance therapy works better than treatments that have been tried in the past. Participants can expect to be in this study for about 1 year and be followed for up to 10 years.

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

Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children with Inflammatory Bowel Disease

Date Added
March 25th, 2020
PRO Number
Pro00098243
Researcher
Robert Cina

List of Studies

Keywords
Pediatrics, Surgery
Summary

This study will implement and evaluate the Enhanced Recovery in Children Pathway (ENRICH-P) for pediatric patients with inflammatory bowel disease. Participants (or participants' parent) will be asked to complete quality of life surveys pre-operatively and up to 6 weeks after surgery.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

Date Added
February 26th, 2020
PRO Number
Pro00093213
Researcher
Aaron Lesher

List of Studies

Keywords
Pediatrics, Surgery
Summary

To evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with thermal burns of 1-30% total body surface area as compared to standard of care. Patients enrolled in this trial will undergo daily assessments in hospital after their treatment until they are discharged. They will then have weekly follow-ups until completed wound closure. Once this is achieved, there will be a 6 week, 12 week, 6 month, 12 month, 18 month, and 24 month follow up visit.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis

Date Added
February 11th, 2020
PRO Number
Pro00092458
Researcher
Kelli Williams

List of Studies

Keywords
Esophagus, Pediatrics
Summary

The main purpose of this study is to see if taking dupilumab is effective in treating Eosinophilic Esophogitis (EoE). The study will determine if dupilumab is an effective treatment compared with placebo in adult and adolescent patients. Dupilumab is administered through a subcutaneous injection (shot). Dupilumab is is an investigational drug, which means that it is not yet approved to treat EoE. Participation in the study will last up to 48 weeks.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8352
wakefies@musc.edu

ATHN 9: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People With Severe Von Willebrand Disease (VWD)

Date Added
January 27th, 2020
PRO Number
Pro00092790
Researcher
Stephanie Ambrose

List of Studies

Keywords
Adolescents, Blood Disorders, Children's Health, Circulation, Dental, Genetics, Infant, Joint, Men's Health, Minorities, Muscle, Non-interventional, Nose, Obstetrics and Gynecology, Pain, Pediatrics, Periodontal Disease, Rare Diseases, Rheumatoid, Surgery, Women's Health
Summary

ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.

Institution
Palmetto
Recruitment Contact
Shannon Cearley
803-434-4088
shannon.cearley@prismahealth.org



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