A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis

Date Added
April 6th, 2023
PRO Number
Pro00124137
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Liver
Summary

To evaluate the efficacy of an investigational medication (INT-787) as assessed by disease progression in severe alcohol-associated hepatitis (sAH).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults with Locally Advanced Head and Neck Squamous Cell Carcinoma (The ENDURE Trial)

Date Added
April 6th, 2023
PRO Number
Pro00123953
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck
Summary

For patients with head and neck cancer, delays starting adjuvant radiation therapy are common, disproportionately burden racial minorities, and contribute to poor survival and racial disparities in mortality. However, effective therapies to improve the delivery of timely, equitable, guideline-adherent adjuvant radiation therapy are lacking. We have developed a navigation-based multilevel intervention to enhance care coordination, communication, and key cancer care delivery processes that could provide the first effective treatment in this population, thereby improving survival, decreasing racial disparities in outcomes, and developing new standards of clinical care.

Institution
MUSC
Recruitment Contact
Walker Hadwin
843-791-0719
hadwinw@musc.edu

Advancing Couple and Family Alcohol Treatment through Patient-Oriented Research and Mentorship

Date Added
April 4th, 2023
PRO Number
Pro00127577
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.

This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA). EMA includes very short surveys (5 minutes or less) that participants respond to on a smartphone application. Participants will be asked to respond to these surveys in the morning and three additional times throughout the day.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Self-Management for Youth Living with Sickle Cell Disease: SMYLS Multi-site Trial

Date Added
April 4th, 2023
PRO Number
Pro00127137
Researcher
Shannon Phillips

List of Studies


Keywords
Adolescents, Blood Disorders, Minorities, Pain, Pediatrics, Rare Diseases
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms. 272 teens and adults with SCD will be enrolled in this study which is being conducted at the Medical University of South Carolina in Charleston SC., East Carolina University in Greenville NC., University of Miami in Miami FL., and the University of Alabama in Birmingham AL.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@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 Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed/Refractory Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma

Date Added
March 23rd, 2023
PRO Number
Pro00127531
Researcher
Brian Hess

List of Studies


Keywords
Cancer/Lymphoma
Summary

This is a study for patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma. Patients who have either stable disease or a partial response to CD19 CAR T-Cell therapy may be eligible. The purpose of the study is to compare groups of patients who either receive therapy after CAR T-cells and patients that do not receive further therapy after CAR T-cells.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

Transcranial Magnetic Stimulation for MCI: A Phase II Dose-Ranging Study

Date Added
March 21st, 2023
PRO Number
Pro00127160
Researcher
Andreana Benitez

List of Studies


Keywords
Aging, Alzheimers, Depression, Memory Loss
Summary

This is a Phase II research study to determine dosing of non-invasive brain stimulation for patients with Mild Cognitive Impairment (MCI) and current or past depression. The brain stimulation treatment used in this study is called repetitive transcranial magnetic stimulation (rTMS). rTMS is a Food and Drug Administration (FDA)-approved treatment for depression. The goal of the study is to see if brain stimulation can be used for MCI patients to improve memory, thinking, and mood, and what dose of stimulation works best.

The study uses a form of rTMS called intermittent theta burst rTMS (accelerated iTBS). This treatment has not been FDA-approved for MCI patients. This double-blind study requires 11 study visits over the course of six months.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
maddenka@musc.edu

A CONTROLLED, RANDOMIZED PHASE II TRIAL OF DOCETAXEL PLUS TRASTUZUMAB VERSUS ADO-TRASTUZUMAB EMTANSINE FOR RECURRENT, METASTATIC, OR TREATMENT-NAÏVE, UNRESECTABLE HER2-POSITIVE SALIVARY GLAND CANCER

Date Added
March 16th, 2023
PRO Number
Pro00127553
Researcher
John Kaczmar

List of Studies


Keywords
Cancer/Head & Neck
Summary

This study is for men and women with HER2-positive salivary gland cancer (SGC) that has come back, spread outside of their salivary gland, or cannot be removed by surgery. This study is being done to find out if ado-trastuzumab emtansine (T-DM1) extends the length of time without the cancer getting worse compared to the usual approach.

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



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