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

Introducing Palliative Care (PC) within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial

Date Added
December 18th, 2018
PRO Number
Pro00084674
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Cancer/Gastrointestinal, Liver, Pain
Summary

This is a two armed multicenter cluster randomized controlled trial (RCT), to assess the effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained hepatologist led PC). To prevent bias at the level of providers, randomization will take place at the level of clinical centers; however patients will be the unit of inference. Parallel to this cluster-RCT, a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.

To execute this project, Duke has identified 19 clinical centers to participate; 8 Veterans Health Administration (VHA) systems and 11 non-VHA, Academic Medical Centers.

Comparative Approaches:
1.Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person visits at initial, 1 and 3 months.
2.Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person visits utilizing the same PC checklist as utilized in Model 1. The in-person visits will occur at initial, 1 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.

MUSC has been assigned to the Model 2 approach, "Hepatologist led Palliative Care" to be lead by Dr. Don Rockey and Dr. Heather Simpson.

Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver dyads will be enrolled.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu

Age-related changes in neuroplasticity impede recovery in post-stroke depression: a novel exercise and brain stimulation paradigm to prime neuroplastic potential

Date Added
December 4th, 2018
PRO Number
Pro00083079
Researcher
Ryan Ross

List of Studies

Keywords
Brain, Depression, Exercise, Stroke, Stroke Recovery
Summary

Stroke affects millions of Americans and is a leading cause of disability. In addition to chronic disability, many survivors experience depressive symptoms such as reductions in mood and motivation. Post-stroke depression (PSD) is associated with poorer recovery from stroke, increased health care costs and higher mortality. Additionally, PSD may interfere with the recovery of the nervous system after stroke. Effective treatment options for PSD are limited and often come with side effects, highlighting the need for alternative treatment approaches. Aerobic exercise (AEx) has positive effects on the nervous system, is a powerful anti-depressant, and has limited side effects, yet remains underutilized in stroke survivors with PSD. This study will examine the short-term effects of AEx on the nervous system in stroke survivors with and without PSD. The results will serve as a foundation for the study of AEx as a treatment for PSD.

Institution
MUSC
Recruitment Contact
Ryan Ross
843-792-3477
rossre@musc.edu

Collaborative, National Quality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients

Date Added
November 20th, 2018
PRO Number
Pro00080285
Researcher
Faye Hant

List of Studies


Keywords
Autoimmune disease, Non-interventional, Rare Diseases, Scleroderma, Skin
Summary

The goal of this study is to develop an early systemic sclerosis (SSc) registry in the United States (US). A registry is a group of patients that are observed over time. This is a non-interventional study, meaning that they are no study specific medications to take or procedures to undergo. The specific aims include ongoing assessment of the natural history of early SSc patients by capturing and analyzing clinical data, patient reported outcomes, and laboratory data as seen in the clinic as part of their routine care needs. Additional study visits are not required. This is a multi-center study with sites spread across the U.S. This study is funded by the Scleroderma Research Foundation.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-8613
frasibri@musc.edu

Predicting the Emergence of Social Communication Across the First Three Years of Life

Date Added
November 9th, 2018
PRO Number
Pro00081992
Researcher
Jessica Bradshaw

List of Studies

Keywords
Autism, Children's Health, Infant, Language, Pregnancy
Summary

Early intervention for infants and toddlers with or at-risk for autism spectrum disorder can promote developmental skills and improve lifelong outcomes. Yet, many children with ASD are not diagnosed until after age 3. In order to improve early detection of ASD, we are investigating very early predictors of social communication challenges in infants as young as 1 week to 6 months of age.

This research study examines how the development of attention and motor skills in the first year of life is associated with the emergence of social and communication skills in three groups of infants: infants who are first born or who have a sibling with no developmental delays, infants who have an older sibling diagnosed with autism spectrum disorder, and infants who were born preterm.

Institution
USC
Recruitment Contact
Emma Platt
803-993-8356
esdilab@mailbox.sc.edu

Oxytocin to Enhance Alcohol Behavioral Couple Therapy

Date Added
November 6th, 2018
PRO Number
Pro00082233
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol, Mental Health, Military, Psychiatry, Substance Use
Summary

This study will examine the efficacy of intranasal oxytocin versus placebo in combination with Alcohol Behavioral Couples Therapy (ABCT) to reduce alcohol use disorder severity. We will also use observational coding and neuroimaging to examine behavioral and neural mechanisms underlying treatment outcomes.

Institution
MUSC
Recruitment Contact
Jessica Brower
843-300-9577
Browerj@musc.edu

Measurement of gait mechanics and movement in the lower extremity amputee

Date Added
October 30th, 2018
PRO Number
Pro00082064
Researcher
Aaron Embry

List of Studies

Keywords
Exercise, Movement Disorders, Physical Therapy, Rehabilitation Studies
Summary

Walking after a lower extremity amputation is often difficult. It is important that researchers and clinicians understand the mechanisms that inhibit normal walking function. In this study, we are recruiting individuals with lower extremity limb loss for a walking and balance investigation. We will also be studying matched healthy controls to do similar study procedures. All study procedures will occur on the campus of MUSC by a licensed Physical Therapist and experienced researcher. Any questions should be directed to the coordinator listed.

Institution
MUSC
Recruitment Contact
Aaron Embry
843-792-8198
embry@musc.edu

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Date Added
October 8th, 2018
PRO Number
Pro00082427
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Germ Cell Tumors. The purpose of this study is to evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients (ages 0- 50 years) with Stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma. The drugs used in this study are carboplatin and cisplatin. Participants will be followed for up to 10 years.

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

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Date Added
October 8th, 2018
PRO Number
Pro00082422
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients who have been diagnosed with a neuroblastoma (NBL). The purpose of this study is to find out if we can improve the treatment for subjects with high-risk NBL by adding the experimental drug 131I-MIBG or the experimental drug Crizotinib to recommended therapy. The secondary purpose is to find out if we can reduce the number of stem cell transplants from two to one if we give the experimental drug 131I-MIBG during Induction, and use different drugs as part of the transplant chemotherapy given prior to stem cell infusion during Consolidation. Participants can expect to be in this study for up to 2 years. Researchers would like to continue to follow participants health for up to 10 years.

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

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Date Added
October 3rd, 2018
PRO Number
Pro00082665
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients who have been diagnosed with a form of Acute Lymphoblastic Leukemia (ALL) called Philadelphia chromosome positive (Ph+) ALL. The purpose of this study is to compare disease free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a high-risk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. A drug called imatinib in combination with chemotherapy will be given. Participants can expect to be in this study for up to 2 years and their health followed for up to 10 years.

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



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