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

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

Randomized, Double-Blind, Placebo-Controlled clinical trial of post-operative steroids and pain control after tonsillectomy

Date Added
October 2nd, 2018
PRO Number
Pro00081346
Researcher
Phayvanh Pecha

List of Studies


Keywords
Pain, Surgery
Summary

Pain control after tonsillectomy is imperative but often difficult. Current post-operative pain medication regimens include opioid analgesics and are often still inadequate. Though not standard of care, it is our practice to prescribe a single dose of oral steroid medication on the third day after surgery, when pain and swelling are at their peak, in order to assist with pain control and reduce opioid consumption. Though this practice has a rational theoretical basis, there is no prospective data supporting or discounting it. We aim to compare pain control, opioid consumption, and complication rates in children receiving post-operative steroids versus those who do not.

Institution
MUSC
Recruitment Contact
Joshua Horton
843-792-2300
hortojos@usc.edu

Evaluation of a Web-Based Tool for Alcohol Use Following Interpersonal Violence

Date Added
September 23rd, 2018
PRO Number
Pro00080368
Researcher
Christine Hahn

List of Studies


Keywords
Alcohol, Substance Use, Women's Health
Summary

The purpose of this study is to gather feedback to inform the development of a web-based tool that provides screening and education about alcohol use following interpersonal violence. People who have experienced sexual assault or domestic violence in the last year and drink alcohol, or are currently in treatment for alcohol use, will be asked to provide feedback about a web-based tool for alcohol use. 60-minute interviews will be conducted and will involve viewing the content of the web-based tool and providing feedback. Additionally, feedback given during interviews will be analyzed and then individuals who have used the web-based tool will complete a survey following the tool use if they report using substances. The tool will be tested for use with English and Spanish speakers.

Additionally, the web-based tool will be adapted for use among SMW and TGD survivors of sexual assault. Two areas of the original tool will be adapted: 1) psychoeducation and normative feedback will be made specific to SMW and TGD people's experiences, and 2) sexual and gender minority stress content will be added (i.e., information about sexual and gender-identity related stressors and their association with distress and alcohol use). We will gather feedback via qualitative interviews from 30 SMW and TGD survivors of sexual assault who report alcohol misuse or heavy drinking in the past month.

Institution
MUSC
Recruitment Contact
Christine Hahn
843-792-0259
hahnc@musc.edu

Cardiac biopsies in pulmonary hypertension

Date Added
August 21st, 2018
PRO Number
Pro00077070
Researcher
Brian Houston

List of Studies


Keywords
Pulmonary Hypertension, Scleroderma
Summary

Patients with systemic sclerosis (SSc) related pulmonary arterial hypertension (SScPAH) have a worse prognosis than those with idiopathic PAH. We have recently discovered that heart cells in SScPAH do not contract or squeeze as well as in other forms of pulmonary hypertension. However, the mechanism leading to this dysfunction is not understood. To better study this and in hopes of developing a future therapy, we plan to collect tissue samples via a heart biopsy at the time of a clinically indicated heart catheterization.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-792-1105
sykesb@musc.edu

Human Samples Biorepository

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica del Monte

List of Studies


Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

Integrated Analysis of Vision Quality with Aberrometry

Date Added
March 27th, 2018
PRO Number
Pro00074857
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this study is to identify and measure refractive errors of the eye as well as visual symptoms after cataract surgery.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

CureGN: Cure Glomerulonephropathy

Date Added
February 20th, 2018
PRO Number
Pro00072900
Researcher
Milos Budisavljevic

List of Studies


Keywords
Kidney
Summary

If you have a glomerular disease, have had kidney biopsy in the last 5 years, are not on dialysis, and have not had a kidney transplant or was previously enrolled in the NEPTUNE study, you may be eligible to take part in this research study. The purpose of this study is to gather a group of patients with glomerular disease to create a source of information along with your kidney biopsy slides, blood, and urine samples so that researchers can easily and effectively study glomerular disease.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia

Date Added
February 13th, 2018
PRO Number
Pro00071934
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with High Risk B-Lymphoblastic Leukemia (HR B-ALL). The investigational drug in this study is Ruxolitinib. The purpose of this study is to find out if the study drug, ruxolitinib, in combination with standard HR B-ALL treatment is safe and effective in children, adolescents, and young adults with HR B-ALL. Participants can expect to be in this study for the treatment period of approximately 26 months (females) or 38 months (males) plus the post-treatment follow-up. Subjects are considered on study during the post-treatment follow-up period until the subject is deceased, lost to follow-up, or until the study is completed. Subjects in this study will be followed until all enrolled subjects have been followed for 3 years from Day 1 or are deceased or lost to follow-up.

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



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