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

Sex Differences in the Interface between Cannabis Use and Stress among Emerging Adults

Date Added
May 2nd, 2023
PRO Number
Pro00127995
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Drug Studies, Psychiatry, Substance Use
Summary

This study is enrolling emerging adults (ages 18-25) with cannabis use disorder (CUD) to examine sex differences in (a) cannabis withdrawal symptoms during short-term cannabis abstinence, (b) cannabidiol (CBD) versus placebo effects on stress reactivity during short-term cannabis abstinence, and (c) the relationship between stress reactivity and time to cannabis relapse after short-term cannabis abstinence. The proposed study is designed to reveal sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Participants will complete an assessment visit to determine eligibility. Eligible participants will be scheduled for their next visit and will be instructed to abstain from cannabis use for 3 days. Participants will be set up with a phone application (app) and given instructions on its use. This app will send twice daily, random surveys everyday throughout study participation with questions about cannabis use, cravings, and overall mood. Participants will also complete twice daily saliva samples.

At the end of the 3 days, participants will return to the clinic for their second visit. Participants will complete a urine and blood sample at each visit. After eating a snack, participants will receive one dose of CBD (800mg) or placebo and then participate in a stress task. Upon completion of the stress task, participants will complete 3 saliva samples and then be discharged after evaluation by research staff. After the completion of Visit 2, participants will continue to complete twice daily surveys for 10 days. The study will last approximately 14 days.

There are risks involved with participating in this study, including risks associated with CBD, risks associated with the stress task and study procedures, emotional distress from answering personal questions, and loss of confidentiality. There is a risk of experiencing cannabis withdrawal symptoms during the 3-day period of cannabis abstinence. Some potential risks related to CBD include dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. There is a risk of loss of confidentiality, but the researchers will code the samples and research information to protect privacy. There are no direct benefits to the participant, but we hope the knowledge gained will help us inform future clinical strategies to address cannabis use in emerging adults.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-792-5239
bourne@musc.edu

Impact of stress and craving on return to cannabis use in postpartum women

Date Added
May 2nd, 2023
PRO Number
Pro00128029
Researcher
Constance Guille

List of Studies


Keywords
Drug Studies, Hormones, Non-interventional, Pregnancy, Substance Use, Women's Health
Summary

Cannabis is the most commonly used illicit substance among pregnant and postpartum women, with the postpartum period being a common time for relapse to cannabis. Currently there are no interventions for preventing return to cannabis use during this vulnerable time. The goal of this research is to better understand risk factors such as stress, craving, anxiety, mood, sleep, and hormone levels that may contribute to return to cannabis use during the postpartum period in order to help develop targeted prevention and treatment interventions in the future.

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

A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis

Date Added
March 7th, 2023
PRO Number
Pro00126501
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Drug Studies, Immune System, Inflammation, Kidney, Lupus
Summary

The purpose of this study is to determine if the investigational (not FDA approved) drug VIB4920 can be an effective treatment for patients with active Lupus Nephritis (LN).

This study will compare treatment with MMF (mycophenolate mofetil), Prednisone, plus the study medication VIB4920 to treatment with MMF and Prednisone alone.

Participants will have up to 15 scheduled visits that will involve routine monitoring of disease activity, up to two kidney biopsies, and blood and urine specimen collections. Participation in this study will last approximately 1 year and 2 months. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Stephanie Dezzutti
843-792-8997
brays@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu



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