A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Date Added
May 16th, 2023
PRO Number
Pro00128723
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer/Leukemia
Summary

This study is for patients with acute leukemia or myelodysplastic syndrome (MDS). This study is being done to help understand whether a haplo related donor or a MUD HCT for people with acute leukemia or MDS is better or if there is no difference at all.

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

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Date Added
May 2nd, 2023
PRO Number
Pro00125254
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients that have been diagnosed with relapsed/refractory neuroblastoma. The investigational drug given is eflornithine (DFMO) along with etoposide. DFMO is the investigational drug being used along with etoposide for treatment of neuroblastoma. Participants will undergo a number of standard tests and research-related procedures before being able to enroll in this study. Some risks include but are not limited to: fewer red and white blood cells, diarrhea, abdominal pain, loss of appetite, skin rash, seizure, difficulty swallowing and blurred vision. Participants can expect to be on this study for approximately 2 years. Participants will then be followed for up to 5 years after study completion.

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

Sex Differences in the Interface between Cannabis Use and Stress among Emerging Adults

Date Added
May 2nd, 2023
PRO Number
Pro00127995
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Drug Studies, Psychiatry, Substance Use
Summary

This study is enrolling emerging adults (ages 18-25) with cannabis use disorder (CUD) to examine sex differences in (a) cannabis withdrawal symptoms during short-term cannabis abstinence, (b) cannabidiol (CBD) versus placebo effects on stress reactivity during short-term cannabis abstinence, and (c) the relationship between stress reactivity and time to cannabis relapse after short-term cannabis abstinence. The proposed study is designed to reveal sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Participants will complete an assessment visit to determine eligibility. Eligible participants will be scheduled for their next visit and will be instructed to abstain from cannabis use for 3 days. Participants will be set up with a phone application (app) and given instructions on its use. This app will send twice daily, random surveys everyday throughout study participation with questions about cannabis use, cravings, and overall mood. Participants will also complete twice daily saliva samples.

At the end of the 3 days, participants will return to the clinic for their second visit. Participants will complete a urine and blood sample at each visit. After eating a snack, participants will receive one dose of CBD (800mg) or placebo and then participate in a stress task. Upon completion of the stress task, participants will complete 3 saliva samples and then be discharged after evaluation by research staff. After the completion of Visit 2, participants will continue to complete twice daily surveys for 10 days. The study will last approximately 14 days.

There are risks involved with participating in this study, including risks associated with CBD, risks associated with the stress task and study procedures, emotional distress from answering personal questions, and loss of confidentiality. There is a risk of experiencing cannabis withdrawal symptoms during the 3-day period of cannabis abstinence. Some potential risks related to CBD include dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. There is a risk of loss of confidentiality, but the researchers will code the samples and research information to protect privacy. There are no direct benefits to the participant, but we hope the knowledge gained will help us inform future clinical strategies to address cannabis use in emerging adults.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-792-5239
bourne@musc.edu

Self-Management for Youth Living with Sickle Cell Disease: SMYLS Multi-site Trial

Date Added
April 4th, 2023
PRO Number
Pro00127137
Researcher
Shannon Phillips

List of Studies


Keywords
Adolescents, Blood Disorders, Minorities, Pain, Pediatrics, Rare Diseases
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms. 300 teens and adults with SCD will be enrolled in this study which is being conducted at the Medical University of South Carolina in Charleston SC., East Carolina University in Greenville NC., University of Miami in Miami FL., and the University of Alabama in Birmingham AL.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

Impact of Systemic Tetracyclines in Adolescence on Metabolism, Adiposity, and Skeletal Maturation

Date Added
April 4th, 2023
PRO Number
Pro00120674
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

In clinical practice, standard of care for treatment of adolescent acne includes extended courses, i.e., 3 months or longer, of systemic tetracyclines, a type of antibiotic.The gut is home to many bacteria. Administration of antibiotics kills these bacteria and prevents them from repopulating during critical developmental periods. The lack of these bacteria has effects on metabolism, fat, and bone mass
accrual in adolescent mice. Given what we have observed in mouse studies,
we are interested to observe the impact of systemic tetracycline acne therapy in adolescents on fat deposition and the skeleton.

Institution
MUSC
Recruitment Contact
Courtney Linkous
8435662453
linkousc@musc.edu

A randomized, double-blind, placebo-controlled, multisite, Phase 3 study to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P) in children and adolescents with epilepsy with myoclonic-atonic seizures

Date Added
February 28th, 2023
PRO Number
Pro00122447
Researcher
Dalila Lewis

List of Studies

Keywords
Adolescents, Brain, Epilepsy, Nervous System
Summary

EMAS, also known as Doose syndrome, myoclonic-astatic epilepsy, or myoclonic-atonic epilepsy, is a childhood-onset idiopathic generalized seizure disorder. EMAS is characterized by multiple seizure types; however, myoclonic-atonic seizures are the hallmark seizure type and are mandatory for the diagnosis of EMAS.

This is a multisite, double-blind, randomized, placebo-controlled, parallel-group study (Part A) to evaluate the safety and efficacy of GWP42003-P compared to placebo as a treatment for children and adolescents with EMAS, followed by an open-label extension phase (Part B).

Institution
MUSC
Recruitment Contact
Tania Pegues
843-876-1439
peguest@musc.edu

OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1)

Date Added
November 17th, 2022
PRO Number
Pro00122906
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

This is a Phase 3 multicenter, single-arm, open-label extension (OLE) study designed to investigate the long-term safety, tolerability, and efficacy of risankizumab 150 mg or 55 mg by weight every 12 weeks (Q12W) in the treatment of moderate to severe plaque Ps in eligible subjects who have completed all assessments in Study M19-977 and elect to participate in Study M19-973. The study is comprised of a 216-week treatment period and a follow-up phone call for safety approximately 140 days (20 weeks) after the last dose of study drug.

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

The Cultural Adaptation of an Alcohol and Other Drug Use Treatment for Black Justice Involved Youth.

Date Added
September 14th, 2022
PRO Number
Pro00122199
Researcher
Brittany Bryant

List of Studies