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

A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB COMPARED TO USTEKINUMAB IN CHILDREN AND ADOLESCENTS FROM 6 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Date Added
June 24th, 2024
PRO Number
Pro00136667
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared to active control (ustekinumab) in children and adolescents (from 6 to <18 years of age) with moderate to severe plaque PSO. This study will consist of the following periods:
• Screening Period: up to 5 weeks
• Initial Treatment Period: 16 weeks
• Maintenance Period: 32 weeks
• OLE Period: 104 weeks
• SFU Period: 20 weeks after final dose of IMP
After the Screening Period of up to 5 weeks, eligible study participants will be randomized in a 2:1 ratio of bimekizumab to ustekinumab. Study participants will participate in a 16-week double-blinded Initial Treatment Period and continue into a 32-week double-blinded Maintenance Period. After completion of the Maintenance Period, study participants will be offered the opportunity to continue in a 104-week open label extension period and receive bimekizumab.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
(843) 792-4091
mcleodke@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

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo

Date Added
March 28th, 2024
PRO Number
Pro00135212
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalised vitiligo.
Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
• Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total));
• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).
To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

Date Added
March 25th, 2024
PRO Number
Pro00135007
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of upadacitinib for the treatment of adults and adolescents with Non-Segmental Vitiligo who are eligible for systemic therapy. This study is comprised of a 35-day Screening Period; a 48-week placebo-controlled, double-blinded treatment period (Period A); a 112-week open-label extension period (Period B); and a 30-day follow-up period. In Period A, adult and adolescent subjects who meet eligibility criteria will be randomized 2:1 to receive daily oral doses of upadacitinib 15 mg or matching placebo. Subjects who complete Period A will continue into Period B and will receive open-label upadacitinib 15 mg.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata

Date Added
February 7th, 2024
PRO Number
Pro00132680
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of upadicitinib in adults and adolescents with severe alopecia areata. Participation in this research study will take approximately 168 weeks with 17 visits in that time. This research study includes three phases; a screening phase, treatment phase, and a follow-up phase. The length of the screening period varies from 1 to 35 days, depending on therapies that must be washed out or discontinued before initiation of treatment. Patients who meet all eligibility criteria will be randomized to receive upadicitinib or placebo for the first 24 weeks. At week 24, all patients will receive upadicitinib until week 160. The post-treatment follow-up visit will occur approximately 30 days after the last study drug dose.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the treatment of anxiety comorbid with autism spectrum disorder (ASD)

Date Added
December 5th, 2023
PRO Number
Pro00128238
Researcher
Stewart Cox

List of Studies

Keywords
Adolescents, Anxiety, Autism, Psychiatry
Summary

This is a research study to find out if anxiety in patients with autism spectrum disorder are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will learn how to self-administer ear stimulation treatments at home before starting the study. Over the course of a month, participants will self-administer ear stimulation treatments twice a day for a month. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. There will also be a smaller number of questionnaires completed electronically on a weekly basis. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

Fontan Udenafil Exercise Longitudinal Assessment Trial (the FUEL-2 Study)

Date Added
October 2nd, 2023
PRO Number
Pro00130325
Researcher
Andrew Atz

List of Studies


Keywords
Adolescents, Cardiovascular, Drug Studies, Pediatrics
Summary

This will be a 26-week, prospective, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of udenafil 87.5 mg tablets versus placebo (both taken twice daily in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption [VO2] (mL/kg/min).

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

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Date Added
June 6th, 2023
PRO Number
Pro00128800
Researcher
Lindsay Squeglia

List of Studies


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

This study is testing citicoline as a possible medication to treat alcohol use disorder. Youth (ages 16-22) will be randomly assigned to receive either citicoline (2000mg per day) and or a placebo for four weeks.

All participants will receive brief counseling from a trained clinician and will undergo a brain scan and cognitive testing at the beginning and end of the treatment.

Participants must provide informed consent and youth under 18 must have parental consent to participate. The full study will last approximately one month.

Compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Cori Herring
843-792-8207
herrinco@musc.edu

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



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