Prospective Non-Interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer Treated with Larotrectinib

Date Added
September 17th, 2020
PRO Number
Pro00090298
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Adolescents, Cancer, Pediatrics
Summary

This is an observational study, which means that only information is collected on treatment, examinations or diagnostic tests which are a part of the routine standard of care. The participant is being asked to volunteer because they have been diagnosed with locally advanced or metastatic TRK fusion cancer treated with larotrectinib. The purpose of this study is to learn more about the safety profile and the effectiveness of VITRAKVI® under routine practice conditions.
Participants will be followed for a minimum of 5 years from the time they agree to participate in the study.

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

Transition to Telemental Health: Assessing the Transition from In-Person to Telemental Health Delivery of Trauma-Focused Treatment During the COVID-19 Pandemic in Puerto Rico

Date Added
July 14th, 2020
PRO Number
Pro00099684
Researcher
Andel Nicasio

List of Studies

Keywords
Adolescents, Coronavirus, Non-interventional
Summary

This study will document the transition from in-person to telemental health delivery of trauma-focused psychotherapy during the COVID-19 pandemic in Puerto Rico. The study includes interviews and online surveys with health providers, caregivers and youth.

Institution
MUSC
Recruitment Contact
Andel Nicasio
843-806-8018
nicasio@musc.edu

Targeting Parenting to Prevent HIV and Substance Use Among Trauma-Exposed Youth: A Mixed-Methods Needs Assessment

Date Added
March 16th, 2020
PRO Number
Pro00096161
Researcher
Nada Goodrum

List of Studies

Keywords
Adolescents, Alcohol, HIV / AIDS, Mental Health, Psychiatry, Sexually Transmitted Infections (STI), Substance Use
Summary

Many adolescents experience traumatic events, such as child abuse, physical or sexual assault, or witnessing violence. Teens who experience trauma are more likely to have problems with substance use and risky sexual activity. We want to understand how parents can support their teens and help keep them safe after traumatic events.

Institution
MUSC
Recruitment Contact
Nada Goodrum
843-792-8067
goodrumn@musc.edu

Feasibility and efficacy of a remote behavioral intervention for electronic cigarette use among youth

Date Added
February 4th, 2020
PRO Number
Pro00095441
Researcher
Erin McClure

List of Studies

Keywords
Adolescents, Smoking
Summary

This study is recruiting youth between the ages of 12 and 21 who use electronic cigarettes (e-cigs, vaping) and are interested in quitting. The purpose of this research study is to explore if youth vapers can quit using a smartphone application that delivers incentives. This study is completely remote (no in-person visits) with phone call visits and the use of a mobile app. If enrolled, participants will have brief weekly phone call visits for 4 weeks and a follow-up call on week 8. Participants will be encouraged to quit vaping during the study. Participants will be asked to submit selfie videos via the app providing saliva cotinine (by product of nicotine) samples to confirm that they have quit vaping.

Institution
MUSC
Recruitment Contact
Patrick Cato
843-792-4215
catop@musc.edu

ATHN 9: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People With Severe Von Willebrand Disease (VWD)

Date Added
January 27th, 2020
PRO Number
Pro00092790
Researcher
Stephanie Ambrose

List of Studies

Keywords
Adolescents, Blood Disorders, Children's Health, Circulation, Dental, Genetics, Infant, Joint, Men's Health, Minorities, Muscle, Non-interventional, Nose, Obstetrics and Gynecology, Pain, Pediatrics, Periodontal Disease, Rare Diseases, Rheumatoid, Surgery, Women's Health
Summary

ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.

Institution
Palmetto
Recruitment Contact
Shannon Cearley
803-434-4088
shannon.cearley@prismahealth.org

A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared with the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1 – 16 Years)

Date Added
January 13th, 2020
PRO Number
Pro00092124
Researcher
Steven Kahn

List of Studies

Keywords
Adolescents, Pediatrics, Skin, Surgery
Summary

The purpose of the study is to see if use of the RECELL device will help heal your
partial-thickness burn faster and decrease the need for skin grafting compared with a standardized wound dressing. The data collected in this current study will provide additional information about the safety and effectiveness of the RECELL® device for treatment of partial-thickness burns. The duration of each participant will last up to 12 months. Visits will include photograph documentation of the wound and various health assessments.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

Managing AsThma AnD Obesity Related Symptoms (MATADORS) study: An mHealth intervention to facilitate symptom self-management among youth

Date Added
August 8th, 2019
PRO Number
Pro00090560
Researcher
Michelle Nichols

List of Studies

Keywords
Adolescents, Asthma, Children's Health, Depression, Obesity, Pain
Summary

Youth with one or more chronic diseases are at increased risk of further complications, disease, or even early death as they enter their adult years. Recent increases in both asthma and obesity among youth have led to high health care utilization, increased health-related complications, and expanded risks of subsequent cardiovascular disease burden. The research team will develop educational content in core areas (e.g., fatigue, physical activity) for Managing AsThma AnD Obesity Related Symptoms (MATADORS), an mHealth technology-enhanced nurse-guided intervention. Youth with asthma and obesity and their primary caregivers will participate in interviews to explore their perspectives on barriers, facilitators, needs, and preferences toward adopting health behaviors, medication adherence, disease awareness, symptom self-management behaviors, and utilization of a mobile smartphone platform. Additional details on content availability, delivery approaches, system needs, and functionality will be explored through semi-structured interview questions. Health care providers (physicians, nurses, nurse practitioners, dietitians, and respiratory and exercise therapists) will be invited to participate in interviews to seek their input on patient-caregiver needs, priority clinical focal areas, recommendations for symptom self-management, and preferences for intervention delivery. Interview findings will be used to inform intervention and app design. Providing youth with strategies to enhance symptom self-management may result in decreased symptom prevalence, improved quality of life, and long-term reduction of cardiovascular morbidity and mortality as they move into adulthood.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843-792-4771
prenticm@musc.edu

Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies

Date Added
July 9th, 2019
PRO Number
Pro00087746
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with advanced solid tumors and hematological malignancies that have stopped responding to standard therapy. The investigational drugs in this study are durvalumab and tremelimumab. The purpose of this research study to find out if the study drugs called durvalumab and tremelimumab will work and be safe for the treatment of advanced cancer in children. Participants can expect to be on this study for up to 6 years.

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

A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Germ Cell Tumors

Date Added
July 3rd, 2019
PRO Number
Pro00089975
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed metastatic germ cell tumors. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen using the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. Participants can expect to be on study for about 3 months and continue to be followed for up to 5 years.

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

Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma

Date Added
July 3rd, 2019
PRO Number
Pro00090359
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients who have been diagnosed with osteosarcoma and were once treated with a chemotherapy drug called cisplatin with or without ifosafamide. The purpose of this study is to look at potential effects on fertility in male osteosarcoma survivors treated with cisplatin with or without ifosfamide compared to male controls without a history of cancer. Participants can expect to be on this study for up 3 months.

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



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