Incisional negative pressure wound therapy for preoperatively irradiated lower extremity soft tissue sarcoma wounds. A prospective randomized clinical trial.

Date Added
August 18th, 2015
PRO Number
Pro00028423
Researcher
Lee Leddy

List of Studies


Keywords
Cancer, Cancer/Sarcoma, Infectious Diseases
Summary

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

We will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

Institution
MUSC
Recruitment Contact
Robert McClam
843 8462210
McClam, Grayson (mcclamr@musc.edu)

Prospective, observational, longitudinal study in pediatric patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not medically advisable

Date Added
December 20th, 2018
PRO Number
Pro00084090
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This study will assess the features of children, younger than 12 years old, with moderate to severe eczema, also known as atopic dermatitis, when their condition is not adequately controlled with topical therapies (creams or lotions) or when those therapies are not medically advisable.

This is not a treatment study. You and your child will complete questionnaires describing how their condition effects them. Information related to your child's illness will be collected by reviewing their medical chart and by assessments performed by the study team. Participation in this study will involve at least 12 visits that will take place over a period of 10 years.

The information collected in this study may lead to an improved understanding of your child's illness and may provide healthcare providers with important information for treating atopic dermatitis in the future.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-5935
dermresearch@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Severe or Very Severe Alopecia Areata

Date Added
March 12th, 2019
PRO Number
Pro00085379
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is to treat patients with alopecia areata for whom topical treatments have not been effective. This study will evaluate the safety and efficacy of systemic treatment with baricitinib.

Participation in the study will take about 25 visits over a period of about 48 months.

Institution
MUSC
Recruitment Contact
Charnele Handy
843-792-8008
handyc@musc.edu

Medication treatment for Opioid use disorder in expectant Mothers (MOMS): a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations

Date Added
August 27th, 2019
PRO Number
Pro00091146
Researcher
Constance Guille

List of Studies


Keywords
Obstetrics and Gynecology, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The primary purpose of this study is to compare extended-release buprenorphine (CAM2038) to buprenorphine placed under the tongue (sublingual) in pregnant women with opioid use disorder to see if CAM2038 is as effective as sublingual buprenorphine. We are looking to recruit pregnant women who are between 18-41 years old; are between 6-30 weeks pregnant and are not planning to terminate the pregnancy; have opioid use disorder, and are enrolled or are planning to enroll in outpatient buprenorphine treatment at The Medical University of South Carolina. Participation in the study would last between 13 and 21 months total with up to between about 63-102 total visits, including weekly medication check visits and research visits.

Institution
MUSC
Recruitment Contact
Savannah Lee
8437920376
leesav@musc.edu

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

Date Added
December 3rd, 2019
PRO Number
Pro00093832
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a 5-year, longitudinal, observational study of adult and pediatric patients (all ages) being treated for Immune-Mediated Inflammatory Skin Conditions. In addition to the study database, a biospecimen repository will be included in order to perform studies on biomarkers of response.

Patients being prescribed medical therapy for IMISC will be eligible for enrollment. Treatment algorithms will follow each site's local standard of care and no specific treatments, assessments, and/or laboratory tests will be dictated by enrollment in the main TARGET-DERM Program. Patients will be screened and enrolled at a regularly scheduled clinic visit. Up to three years of retrospective
medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, laboratory reports, clinic notes, telephone contact reports, medication lists, reasons for medication initiation and/or discontinuation, biopsy results, and imaging. Patients may
also be linked to external databases (such as patient support programs). Patients will also be asked to provide biological samples and complete patient reported outcome (PRO) surveys, although participation in these two portions is optional.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 6 to 12 months, for up to 5 years. Patients/legal representatives ("parent proxy") will be asked to complete PRO surveys at regular intervals during this follow-up period.

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

Identification of Molecular and Genetic Variations Underlying Skin Diseases

Date Added
November 3rd, 2020
PRO Number
Pro00096209
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer, Genetics, Infectious Diseases, Inflammation, Rare Diseases, Skin
Summary

Genetic changes to human skin contribute to a wide variety of conditions and diseases that affect over 20% of the population. However, the genes and molecules that are responsible for human skin development and disease are not fully understood, preventing the development of treatment options. This proposal seeks to better understand one disease in particular, linear morphea, a form of Sclerederma that can affect the skin, muscle, and bone. This study will recruit subjects to collect and use skin tissue for the purpose of identifying the genetic causes of linear morphea.

Institution
MUSC
Recruitment Contact
Alexandra Richmond
757-777-6673
ritteral@musc.edu

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis

Date Added
June 17th, 2021
PRO Number
Pro00110858
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Children's Health, Skin
Summary

This study is being done to evaluate the long term safety of ARQ-151 cream 0.15% and ARQ-151 cream 0.5% in subjects with mild to moderate eczema (atopic dermatitis). Eligible subjects will enroll in the long term safety study after they have successfully completed the preceding study. Study medication will be applied topically for 52 weeks at home. All affected areas, except on the scalp, will be treated. For the first 4 weeks of study, all subjects will apply study medication once a day in the areas identified and treated during the preceded study. Beginning at the Week 4 visit, any subject who achieves vIGA-AD of ‘0-clear' as confirmed by the Investigator at a scheduled or unscheduled clinic visit, will switch to twice weekly (BIW) maintenance treatment. For maintenance therapy, study medication will be applied on two nonconsecutive days per week.

Institution
MUSC
Recruitment Contact
Lauren Parsons
(843) 792-1436
parsonla@musc.edu

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects with Atopic Dermatitis

Date Added
July 6th, 2021
PRO Number
Pro00111522
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

This study is being done to evaluate the safety and efficacy of ARQ-151 cream in subjects with mild to moderate eczema (atopic dermatitis) after application once every day for a month. Results will be compared against a vehicle (placebo). The vehicle is a dummy drug made from the same base product used to make ARQ-151 cream, but it does not contain any active study drug. ARQ-151 is a cream that contains the active ingredient roflumilast. Roflumilast is marketed in Canada, the United States, and other countries as a tablet (pill taken by mouth) for flares of a specific chronic lung disease. You will apply the study drug on your eczema lesions once a day for 28 days. The study doctor will tell you which lesions to treat. Any newly appearing eczema lesions that arise during the study must also be treated.

Institution
MUSC
Recruitment Contact
Lauren Parsons
843-792-1436
parsonla@musc.edu

A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to Severe Plaque Psoriasis

Date Added
September 14th, 2021
PRO Number
Pro00111592
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of investigational drug risankizumab to the active control, ustekinumab, on pediatric plaque psoriasis. Subjects that meet all eligibility criteria will be randomized 2:1 to receive 150 mg dose of risankizumab and 45mg or 90 mg dose of ustekinumab - both drug dosages are determined by weight. At Week 16, subjects receiving ustekinumab or are unresponsive to risankizumab, will be switched to or continue to receive 150 mg risankizumab every 12 weeks. Subjects that are responsive to risankizumab at Week 16, will be re-randomized 1:1 to continue risankizumab or withdrawal from the study drug. Subjects randomized to withdrawal will receive no study drug until a flare occurs, after which they will enter a 16-week re-treatment period.

Institution
MUSC
Recruitment Contact
Alyson Winter
8438763209
wintera@musc.edu

Multicenter Phenotype-Genotype Analysis of Vascular Anomalies and Related Syndromes

Date Added
December 24th, 2021
PRO Number
Pro00116848
Researcher
Lara Wine Lee

List of Studies


Keywords
Genetics, Pediatrics, Skin, Vascular
Summary

The purpose of this research study is to develop a better understanding of the cause and natural history of vascular anomalies and related syndromes. This study is being done in order to develop a better understanding of the cause of vascular anomalies in order to to improve care for people who are affected by these anomalies and related syndromes.

This study is being done at the University of Wisconsin-Madison (UW-Madison) and other sites in North America and Europe. A total of about 1000 people will participate in this study. About 20 – 30 people will take part in the study here at the Medical University of South Carolina.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu



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