A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis

Date Added
June 19th, 2023
PRO Number
Pro00128287
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

This Phase 3 study is designed to assess the long-term safety and efficacy of lebrikizumab in participants 6 months to <18 years of age with moderate-to-severe AD. Participants who have completed Study KGBI through Week 16 without requiring the use of systemic rescue medication will be eligible to enroll into Study KGBJ. All participants will receive active lebrikizumab treatment during Study KGBJ. The planned duration of treatment for each participant is approximately 52 weeks. All participants will enter a post-treatment safety follow-up period approximately 12 weeks after the last dose of lebrikizumab. This study will include both on-site (in clinic) and remote visits (telephone calls).

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
843-876-2281
didonato@musc.edu

A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects with Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas aeruginosa Infection

Date Added
June 14th, 2023
PRO Number
Pro00128304
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of AP-PA02 administered by inhalation. This study will evaluate AP-PA02 administration in stable NCFB (non-cystic fibrosis bronchiectasis) patients. Subjects will either be included in Cohort A or Cohort B. For Cohort A, subjects will be randomized to receive either inhaled AP-PA02 or placebo. Cohort A will include individuals with NCFB and confirmed chronic P. aeruginosa infection but not on chronic inhaled antibiotics. These individuals will receive wither AP-PA02 or placebo for 10 days twice a day.
Cohort B will include individuals who with NCFB and confirmed P. aeruginosa infection but who are on chronic antibiotics. These individuals will receive either AP-PA02 or placebo for 10 days plus their current inhaled antibiotics for 28 days.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Mechanisms of New-Onset Autoimmunity/Longitudinal Immune Systems Analysis (MONA-LISA)

Date Added
June 14th, 2023
PRO Number
Pro00127526
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Lupus, Non-interventional
Summary

This is an observational non-medication study. The purpose of this study is to understand the immune system in people who are at risk for developing systemic lupus erythematosus ("lupus" or "SLE"). The investigators hope to develop better ways to predict who will get lupus and possibly come up with ideas for new treatments that can prevent or treat the disease.

Participants will be asked to complete 4 annual study visits and monthly telephone contacts with the study team over the course of 3 years. Visits will include a physical exam, collection of blood and urine, and the completion of some surveys/questionnaires about your health and wellbeing. The monthly phone calls will be a brief contact to check on any changes in your health and should take no longer than 15 minutes to complete.

Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Lusawasra King
843-792-7645
kinglu@musc.edu

Encore PFO Closure Device US IDE Randomized Trial - The PerFOrm Trial

Date Added
June 13th, 2023
PRO Number
Pro00128910
Researcher
Christopher Nielsen

List of Studies


Keywords
Heart
Summary

This study is enrolling adults between the ages of 18-60 who have a Patent Foramen Ovale (PFO). A PFO is a slit-like opening between the upper chambers (called atria) of the heart. This opening allows blood to flow between these chambers which can lead to a stroke. This study is examining an investigational device called the Encore PFO closure device. An investigational device is one that is not yet approved for commercial use by the US Food and Drug Administration (FDA) but is approved for use in this study. This study will last approximately 5 years and involve 9 visits. This is a randomized study meaning participants will be randomly assigned to receive the investigational PFO closure device or an FDA approved PFO closure device. Participants have a 50:50 chance to receive either device. Study related testing includes physical exams, blood test, echocardiogram (ultrasound test of the heart) electrocardiograms or ECG (test of the electrical activity of the heart) and the procedure to place the PFO closure device. There are risks involved with this study including access site related risks, bleeding and bruising, incomplete closure of the PFO with the closure device or other device related complications. There is potential benefit including reduced risk of a recurrent stroke.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Identifying the Effects of Race-Related Stressors on Laboratory-Induced Stress and Craving among African Americans with Alcohol Use Disorder

Date Added
June 7th, 2023
PRO Number
Pro00128977
Researcher
Delisa Brown

List of Studies


Keywords
Alcohol
Summary

This study will examine the association between race-related stress and alcohol use disorder on alcohol craving, and stress markers. Participants who identify as African American will complete a total of three visits, including a 1-month follow-up visit. Participants will be asked to complete questionnaires about their mood, anxiety, drug use, craving, and experiences of racial discrimination. They will listen to personalized scripts about a stressful situation related to their race, a time when they drank alcohol, and a relaxing situation. Participants will also be asked to complete mobile assessments for 1 month following their last visit. These mobile assessments will include links to surveys that will be sent via text. Compensation is available.

Institution
MUSC
Recruitment Contact
Delisa Brown
843-723-2388
browdg@musc.edu

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Date Added
June 6th, 2023
PRO Number
Pro00128800
Researcher
Lindsay Squeglia

List of Studies


Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

This study is testing citicoline as a possible medication to treat alcohol use disorder. Youth (ages 16-22) will be randomly assigned to receive either citicoline (2000mg per day) and or a placebo for four weeks.

All participants will receive brief counseling from a trained clinician and will undergo a brain scan and cognitive testing at the beginning and end of the treatment.

Participants must provide informed consent and youth under 18 must have parental consent to participate. The full study will last approximately one month.

Compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Cori Herring
843-792-8207
herrinco@musc.edu

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)

Date Added
June 6th, 2023
PRO Number
Pro00126684
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

The main purpose of this study is to see if taking benralizumab is effective in treating Severe Eosinophilic Asthma in patients 6 to 17 years old compared with placebo. Benralizumab is administered through a subcutaneous injection (shot). Participation in the study is divided into two parts. The first part will last up to 16 weeks or until an asthma attack or flare is experienced. The second part will last up to two years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Date Added
June 1st, 2023
PRO Number
Pro00118327
Researcher
Robert Grubb

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

The study is for patients that have been diagnosed with low-grade non-invasive upper tract urothelial cancer. The investigational drug used in this study is padeliporfin which is injected into a vein. The main purpose of this study is to learn about the effects and safety of an investigational treatment named padeliporfin Vascular Targeted Photodynamic (VTP) Therapy, in treating low-grade non-invasive upper tract urothelial cancer. Participants can expect to be in this study for up to 18 months. The completion of the study will include up to 9 study visits to the study site and 8 phone visits.

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

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu



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