Home-based pulmonary function testing for graduates of growth friendly surgery for early onset scoliosis

Date Added
January 21st, 2022
PRO Number
Pro00116381
Researcher
Robert Murphy

List of Studies


Keywords
Adolescents, Bone, Breathing
Summary

Growth friendly surgery for early onset scoliosis is meant to control spinal deformity, and allow for continued growth of the spine and chest, thereby providing the patient with as much lung function as possible. Once patients have completed their growth friendly surgery, they either undergo a final spinal fusion, or observation, and at this point are referred to as "graduates" of growth friendly surgery. Pulmonary function tests can objectively assess the pulmonary function of patients. PFTs are commonly performed in an outpatient clinic, but require a clinic appointment, transportation, test administration and insurance billing with or without a copay. Several home-based surrogates for PFTs are available on the market. These devices can be used within the convenience of the patients home, and are compatible with apps on most smartphones. The data can be uploaded to a clinician in real time for review and analysis.
The purpose of this study is to evaluate the ease of use and effectiveness of a home based PFT surrogate (Spirobank smart device) for "graduates" of growing programs with early onset scoliosis.

Institution
MUSC
Recruitment Contact
Maxwell Marshall
8433299346
marshmax@musc.edu

The role of estrogen receptor alpha variant size and localization in modulating TLR7-induced inflammation.

Date Added
January 21st, 2022
PRO Number
Pro00113082
Researcher
Melissa Cunningham

List of Studies


Keywords
Autoimmune disease, Healthy Volunteer Studies, Lupus
Summary

This observational, non-medication study's purpose is to help learn more about the immune system's inflammation process involved in lupus. The study will be enrolling both lupus and non-lupus (healthy control) females aged 18 and older who identify as Black/African American and Non-Hispanic or White and Non-Hispanic for this comparison study. Participation involves a one-time blood collection.

There are no direct benefits in participating, but it is hoped information learned may help us to develop a better understanding of lupus. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
MUSC Lupus Research Group
843-792-3926
lupusresearch@musc.edu

A RANDOMIZED TRIAL ADDRESSING CANCER-RELATED FINANCIAL HARDSHIP THROUGH DELIVERY OF A PROACTIVE FINANCIAL NAVIGATION INTERVENTION (CREDIT)

Date Added
January 19th, 2022
PRO Number
Pro00116815
Researcher
Andrea Abbott

List of Studies


Keywords
Cancer
Summary

This study is for patients with cancer and the purpose of the study is to find out if receipt of online financial education about cancer care costs and financial concerns during cancer treatment plus financial navigation is more effective than the receipt of online financial education alone at helping households avoid financial problems after a cancer diagnosis.

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

Accuracy and Patient Acceptability of Flash Glucose Monitoring in Low Income Women with Diabetes in Pregnancy

Date Added
January 18th, 2022
PRO Number
Pro00117649
Researcher
Matthew Finneran

List of Studies


Keywords
Obstetrics and Gynecology
Summary

This study will access the accuracy of the FreeStyle Libre system when compared to a finger stick blood glucose test. We will also look at a patients satisfaction with the Freestyle Libre system.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

KEEP IT (Keeping Each Other Engaged via IT): An Innovative Digital Literacy Training Program for Community Health Workers about Hereditary Breast and Ovarian Cancer among Black Women

Date Added
January 13th, 2022
PRO Number
Pro00116925
Researcher
Caitlin Allen

List of Studies


Keywords
Cancer/Breast, Genetics
Summary

The purpose of this study is to develop, deliver, and evaluate the KEEP IT (Keep Each Other Engaged via IT) CHW Training to increase resources and support for identifying Black women at risk for hereditary breast and ovarian cancer (HBOC). My goals are to conduct focus groups with community health workers to identify topics of interest for the initial curriculum, use a three-round Delphi process to refine and finalize an educational curriculum for CHWs focused on building trainee's digital health literacy to enhance identification and navigation of Black women at high-risk for HBOC, and to use implementation science methods to deliver and evaluate the educational training program consisting of a 1.5-day virtual workshop followed by five online modules.

Aim 1: Conduct focus groups with up to 10 community health workers to explore the topics that need to be covered as part of the KEEP IT training.

Aim 2: Use a three-round Delphi process to refine and finalize an educational curriculum for CHWs focused on building trainee's digital health literacy to enhance identification and navigation of Black women at high-risk for HBOC

Aim 3: Use implementation science methods to deliver and evaluate the educational training program consisting of a 1.5-day virtual workshop followed by five online modules

Institution
MUSC
Recruitment Contact
Caitlin Allen
873-792-4216
allencat@musc.edu

Relationship Conflict, Psychophysiological Responding, and Heavy Episodic Drinking among Emerging Adults.

Date Added
December 23rd, 2021
PRO Number
Pro00113790
Researcher
Jasara Hogan

List of Studies

Keywords
Alcohol, Nervous System, Women's Health
Summary

Emerging Adulthood is a developmental phase associated with escalating alcohol use and peak levels of Heavy Episodic Drinking (HED). While alcohol misuse is normative at this stage, HED is associated with both short-term (i.e., unprotected sex, alcohol poisoning, sexual assault, etc.) and long-term (i.e., developing alcohol use disorder (AUD), cancer, liver disease, etc.) consequences. The role of peers in EA alcohol use is well established, but research on peer influence tends to assume homogeneity among peer relationships. It is likely, however, that romantic partners play an important and unique part in EA alcohol use above and beyond that of platonic peers. Heart rate variability (HRV), a measure of autonomic nervous system functioning linked to emotion regulation, is a sensitive biomarker of AUD processes such as craving, consumption, and relapse. Although the relevance of HRV to alcohol use has not been frequently studied among dyads or EA, separate literatures suggest that it may be of fundamental importance linking alcohol use and adaptive versus maladaptive conflict in EA. The primary objective of the proposed study is to examine sex differences in the behavioral and physiological mechanisms underlying the relationship between adaptive and maladaptive conflict behaviors and alcohol demand intensity among EA couples.

Institution
MUSC
Recruitment Contact
Jasara Hogan
843-792-6068
hoganja@musc.edu

The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
December 16th, 2021
PRO Number
Pro00115395
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is Buparlisib (AN2025) that will be given in combination with Paclitaxel (an approved drug). The study will also use alone.

The main purpose of this research study is to assess the effectiveness and safety of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone head and neck cancer that has progressed after prior immunotherapy (treatment that uses your immune system to attack your cancer, such as antiPD1/antiPDL1 treatments) with or without prior platinum-based chemotherapy. Participants can expect to be on this study for about 5 years.

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

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated with Epidiolex® Cannabidiol Oral Solution

Date Added
December 15th, 2021
PRO Number
Pro00111927
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This is a study designed to assess whether there will be injury to the liver in participants who are already being treated Epidiolex or who are about to begin treatment with Epidiolex
Participants ages 18 and above on existing Epidiolex treatment for FDA-approved indications and participants with no previous experience of Epidiolex and who are about to be prescribed Epidiolex for an FDA-approved indication will be recruited from multiple sites in the US.
This study will include a screening period of up to 21 (┬▒ 7) days to assess participant eligibility. A physical exam, blood/serum laboratory tests, laboratory
scoring and transient elastography ( a type of imaging test ) by FibroScan® to assess liver fibrosis will be performed in all participants entering into the study and repeated annually thereafter for up to 5 years.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843 792-1115
bulgarino@musc.edu

Inhaled RLF-100 for the Treatment of Severe COVID-19 without respiratory failure

Date Added
December 14th, 2021
PRO Number
Pro00117349
Researcher
John Tejada

List of Studies

Keywords
COVID-19, Coronavirus
Summary

NeuroRx is a study of Inhaled RLF-100 for the treatment of severe COVID-19 without respiratory failure. The objective is to demonstrate the safety and efficacy of the inhaled RLF-100 in preventing progression from severe to critical covid-19. This is an inhaled treatment given three times daily for 7 days.

Institution
Self Regional
Recruitment Contact
Erin Wallace
864-323-6866
erin.smith@selfregional.org

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI: Phase II Clinical Trial

Date Added
December 14th, 2021
PRO Number
Pro00116913
Researcher
Donna Roberts

List of Studies


Keywords
Children's Health, Infant
Summary

This is a Phase II (determine the safety and response of a drug) study that is looking at how long the contrast agent Gadopiclenol stays in the plasma (part of blood not including red cells) after a single injection during an MRI in children aged up to and including 23 months. Gadopiclenol is an investigational drug, which means that it is not approved by the FDA. This study will be assessing the safety of gadopiclenol for up to 3 months following the administration of gadopiclenol at the MRI, and will evaluate the quality of the images obtained from when gadopiclenol was used at the MRI. Blood samples will be collected three times within the 8 hours following the MRI for analysis of how much gadopiclenol is left in the blood.

Institution
MUSC
Recruitment Contact
Elise Zhao
843-792-2354
zhaoel@musc.edu



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