ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE

Date Added
December 8th, 2022
PRO Number
Pro00121704
Researcher
Sanford Zeigler

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this research study is to find out if AMDS is safe and effective in the treatment of acute dissection (sudden tear). For patients whose aortic anatomy is suitable for treatment with AMDS, the use of this device may promote healing of the aortic walls and possibly reduce the need for additional aortic surgeries. If conventional surgery, in combination with AMDS, is effective, it is believed that this could lead to improved aortic healing; an improvement in healing could reduce the risk of hospitalization and reoperation in the chest compared to conventional surgery alone.

Institution
MUSC
Recruitment Contact
ShaVon Capers
843-792-7244
caperssh@musc.edu

A MULTICENTER, RANDOMIZED, VEHICLE-CONTROLLED, DOUBLE-BLIND, PARALLEL COMPARISON, PROOF-OF-CONCEPT STUDY OF QRX003 LOTION IN SUBJECTS WITH NETHERTON SYNDROME

Date Added
December 20th, 2022
PRO Number
Pro00123486
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to assess the dose dependent safety, tolerability and potential efficacy of QRX003 lotion in subjects with Netherton Syndrome (NS). This is a multi-center, randomized, vehicle-controlled, double-blind, parallel group comparison study of QRX003 lotion in adult subjects 18 years of age or older with NS. Approximately 18 subjects will be enrolled at approximately 7 sites. Subjects will be randomized (1:1:1) to treatment as follows:

1. QRX003 (dipalmitoyl hydroxyproline) lotion, 2% (Low dose)
2. QRX003 (dipalmitoyl hydroxyproline) lotion, 4% (High dose)
3. Vehicle lotion

Subjects will apply the assigned test article once daily in the morning to a designated Treatment Area for 12 weeks. Subjects will attend 5 clinic visits for up to 20 weeks.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
8438762281
didonato@musc.edu

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO

Date Added
March 2nd, 2023
PRO Number
Pro00126424
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. The duration of this study is a maximum of 60 weeks. There will be an initial screening period of 30 days where the study doctor will determine eligibility. If eligible, participants will be randomly assigned to receive the study drug or a placebo during a 52 week study treatment period. At the end of the treatment period, participants will enter a 4 week Follow Up Period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 days

Date Added
April 20th, 2023
PRO Number
Pro00124286
Researcher
Thomas Curran

List of Studies


Keywords
Surgery
Summary

The purpose of this study is to demonstrate that the continuous use of negative pressure dressings for up to 14 days has similar benefits and risks to the continuous use for up to 7 days. The 3M study product being used in this study includes the PREVENA Plus Incision Management System with PREVENA Dressings (Peel & Place, Customizable and ARTHRO●FORM). The study product is considered investigational because it has not been approved by the FDA for continuous use for up to 14 days. It is currently approved for use for up to 7 days.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
(843) 792-8896

Targeting the Shared Substrates of Alcohol Misuse and Cognitive Impairment: Accelerated rTMS for Older Adults with Alcohol Use Disorder

Date Added
May 2nd, 2023
PRO Number
Pro00127570
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Psychiatry, Substance Use
Summary

Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to drinking escalation. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognition in Alzheimer's Disease and Related Dimentias (ADRD) and separately reduce heavy drinking in alcohol use disorder. Our objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
843-792-1222
alcoholstudy@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

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 Lancaster Medical Center
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu



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