Impact of Disparities in Food Security on Glycemic Control and Health Care Utilization Among Youth and Young Adults with Diabetes Save

Date Added
March 19th, 2018
PRO Number
Pro00075894
Researcher
Angela Liese
Keywords
Adolescents, Diabetes, Environmental Factors, Ethnicity and Disease, Nutrition
Summary

Many youth and young adults (YYAs) with type 1 diabetes (T1D) and type 2 diabetes (T2D), particularly those of minority race/ethnicity, do not achieve optimal glycemic control and household food insecurity (HFI) may be a key barrier. HFI is the limited or uncertain availability of nutritionally adequate and safe foods. The SEARCH Food Security (SFS) cohort study is designed as an ancillary study to the ongoing NIH/NIDDK-funded SEARCH for Diabetes in Youth 4 Cohort study. The aims of the SFS study are to (1) Initiate a food insecurity cohort study of 1,187 YYAs aged 15-35 years (53% minority) with T1D and T2D by adding two data collection time points to the ongoing SEARCH 4 study in three of the five SEARCH sites, including South Carolina, Colorado and Washington; (2) Evaluate how HFI influences changes in glycemic control in YYAs with T1D and T2D; (3) Identify the pathways through which food insecurity may act; and (4) Evaluate the influence of HFI on changes in health care utilization and medical and non-medical health care costs in YYAs with T1D and T2D.

Institution
Greenville
Recruitment Contact
Jessica Stucker
803-777-1961
jstucker@mailbox.sc.edu

Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin Save

Date Added
September 26th, 2017
PRO Number
Pro00051279
Researcher
Alejandro Spiotta

Silhouette
Keywords
Adolescents, Brain, Drug Studies, Men's Health, Minorities, Obesity, Pain, Stroke, Women's Health
Summary

The purpose of this study is to determine if giving the medicine "heparin" intravenously (through the veins) continuously for up to 14 days to subjects after a brain aneurysm has burst will help improve the chances of subjects having a good recovery after the bleed compared to subjects who get routine brain aneurysm care (standard of care). Patients who get routine care would also get heparin, but they would typically get an overall lower dose and the heparin would be injected under the skin (heparin shot) instead of in the veins.

Institution
MUSC
Recruitment Contact
Amora Mayo-Perez
843-792-1737
mayoaper@musc.edu

Phase Ib/II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies Save

Date Added
August 22nd, 2017
PRO Number
Pro00066806
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Adolescents, Brain Tumor, Cancer, Cancer/Brain
Summary

This study is for patients that have been diagnosed with Central Nervous System (CNS) Tumors. The investigational drugs in this study are Nivolumab and Ipilimumab. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab when given alone or when combined with Ipilimumab. The duration of patient participation may be more than 3 years. If enrolled in treatment, the exact length of time will depend on the patients response to treatment.

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

Translating an Evidence-based Urban Asthma Program for Rural Adolescents: Testing Its Effectiveness & Cost-effectiveness and Understanding Implementation Factors Save

Date Added
August 1st, 2017
PRO Number
Pro00069047
Researcher
Phillippe Cunningham

Silhouette
Keywords
Adolescents, Asthma, Education
Summary

Asthma has high morbidity and mortality among adolescents and among youth from rural communities, both of whom are seldom included in asthma intervention research. This study will test the effectiveness and cost-effectiveness of high school-based intervention delivered by Community Health Workers (CHWs) to rural adolescents with uncontrolled asthma, and will examine factors associated with delivery of the intervention.

Institution
MUSC
Recruitment Contact
Phillippe Cunningham
843-876-1800
cunninpb@musc.edu

A multicenter, multinational, randomized, double-blind, pharmacokinetic and pharmacodynamic (PK/PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Save

Date Added
July 25th, 2017
PRO Number
Pro00067181
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with cancer and are receiving chemotherapy. The investigational drugs in this study are netupitant and palonosetron. The purpose of this study is to learn more about how well the combination of oral netupitant and oral palonosetron works in preventing nausea and vomiting associated with chemotherapy in children. Participation in the study will last for a maximum of 31 days, which includes a screening period up to 14 days before randomization (up to 7 days for patients aged less than 2 years), the day of enrollment/randomization, administration of study drugs and chemotherapy (Study Day 1), and the control visits (Study Days 2 to 5).

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

Improving Quality of Care in Child Mental Health Service Settings Save

Date Added
July 5th, 2017
PRO Number
Pro00066446
Researcher
Kenneth Ruggiero

Silhouette
Keywords
Adolescents, Mental Health
Summary

We recently completed an NIMH R34 in which we piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) ? a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model. The tablet-based toolkit was very well received by children, caregivers, and providers in our pilot work. Moreover, all benchmarks for feasibility outlined in our NIMH R34 application were met or exceeded. We now propose to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes. We will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators. Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses. We will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives. Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact. The return on investment of these initiatives will ultimately rest on their potential to improve the spread of best-practice treatments and the quality with which they are delivered to the children who need them.

Institution
MUSC
Recruitment Contact
Tonya Hazelton
843-792-2517
hazelto@musc.edu

Risk and Resistance Factors for Depression and Anxiety among Youth with Sickle Cell Disease Save

Date Added
June 14th, 2017
PRO Number
Pro00066397
Researcher
Laura Reinman
Keywords
Adolescents, Anxiety, Blood Disorders, Depression, Mental Health
Summary

The this study will examine how fatigue level impacts symptoms of depression and anxiety among adolescents with SCD on a daily basis. It will further examine how cognitive appraisal of stress and self-concept moderate the relationship between fatigue and symptoms of depression and anxiety among adolescents with SCD on a daily basis to better understand mechanisms driving internalizing in this population.

Institution
Palmetto
Recruitment Contact
Laura Reinman
803-997-0366
lreinman@email.sc.edu

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection Save

Date Added
December 6th, 2016
PRO Number
Pro00060294
Researcher
Michelle Hudspeth

Silhouette
Keywords
Adolescents, Children's Health, Immune System, Lung, Pediatrics, Transplant
Summary

This study is for patient that have been diagnosed with suspected lower respiratory tract infection. The purpose of this study is to evaluate a new test that may be able to find more lung infections than current tests can. This new test is called next-generation sequencing and looks in respiratory secretions for bacteria, viruses, fungi, and other organisms that may cause infection. We hope to learn more about the usefulness of this new test in identifying infections.

Institution
MUSC
Recruitment Contact
Thomas Hortman
864-792-9579
hortman@musc.edu

Developing an integrated exposure-based therapy for co-occurring PTSD and substance use among adolescents: Teen COPE focus groups Save

Date Added
December 6th, 2016
PRO Number
Pro00060455
Researcher
Sudie Back

Silhouette
Keywords
Adolescents, Alcohol, Anxiety, Mental Health, Psychiatry, Substance Use
Summary

This study aims to conduct focus groups with adolescents and parents (30 adolescents and 30 parents) to gather feedback to help design an integrated psychological therapy for co-occurring PTSD and substance use among adolescents (Teen COPE). This information will be used to make revisions to the new Teen COPE Therapist Guide and Patient Workbook.

Institution
MUSC
Recruitment Contact
Emma Barrett
843-792-5594
barrette@musc.edu

Evaluating smoking and relapse in adolescents and emerging adults using remote monitoring technology Save

Date Added
November 1st, 2016
PRO Number
Pro00060290
Researcher
Erin Mcclure

Silhouette
Keywords
Adolescents, Smoking
Summary

This is a research study that will test a new remote monitoring technology to assess smoking in the natural environment among adolescents and young adults ages 15-25. After assessment and inclusion in the study, participants will be asked to report on their smoking by answering questions on a mobile phone for 35 days. Participants will also be asked to make a brief quit attempt lasting for approximately 48 hours. There is no cost to participate and compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Intake Team
843-792-4097
mymobilemonitor@musc.edu

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