Group Parenting Program for Managing Disruptive Behavior in Young Children

Date Added
September 8th, 2024
PRO Number
Pro00138994
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
ADD/ADHD, Autism, Pediatrics
Summary

The purpose of this research is to assess a group-based telehealth parenting program for child ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based telehealth PCIT sessions, and an online post intervention assessment. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Alexandra Marsden
843-714-1352
autismresearch@musc.edu

A TWO-PART, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Date Added
September 6th, 2024
PRO Number
Pro00136714
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of APG777 in adult patients with moderate-to-severe atopic dermatitis. Part A will evaluate the safety and efficacy of one induction dose regimen of APG777 compared to placebo. In addition, two maintenance regimens will be evaluated in Part A. Part B will evaluate the benefit-risk of 3 dose regimens of APG777 compared to placebo. Both parts (Part A and Part B) will consist of 4 periods:
o Screening Period of up to 6 weeks
o Induction Period of up to approximately 16 weeks
o Maintenance Period of up to approximately 36 weeks
o Post-treatment Follow-up Period

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@musc.edu

Mobile Health Reaction Time and Behavior Study

Date Added
September 3rd, 2024
PRO Number
Pro00138757
Researcher
Austin Hahn

List of Studies

Keywords
Alcohol
Summary

This study tests a mobile app that aims to reduce alcohol use and risky sexual behavior.

Interested individuals will complete an online screener to see if they are eligible. Eligible participants will complete six mobile sessions over the course of about 45 days.

The first and the last session will be completed via video conference with a member of the research staff. The second through fifth sessions are completed independently on the mobile app. Sessions involve survey questionnaires, clinical interviews, and computerized tasks. Participants will be compensated for completed study sessions.

Institution
MUSC
Recruitment Contact
Amy Boatright
843-779-2552
boatrigh@musc.edu

A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa

Date Added
September 3rd, 2024
PRO Number
Pro00137485
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a pivotal Phase 3, global, randomized, double-blinded, placebo-controlled, multicenter study to evaluate efficacy and safety of lutikizumab in subjects 16 years of age and older with moderate to severe HS. The study comprises a 35-day Screening Period, a 16-week placebo-controlled double-blinded period (Period 1), a 36-week double-blinded extension (Period 2), and a 10-week (70 days) Follow-Up Period after last study drug dosing or an option to enter a separate long term extension study.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Date Added
August 30th, 2024
PRO Number
Pro00136410
Researcher
Theodore Gourdin

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

This research study primarily aims to determine if BT8009 alone and when given in combination with pembrolizumab works against urothelial cancer for patients who previously received treatment for their locally advanced or metastatic cancer.
This research study also aims to understand the side effects of BT8009 when given alone and in combination with pembrolizumab.
The study drug BT8009 is investigational (i.e., experimental). An investigational drug is one that has not been approved by the Regulatory Authority to treat a certain condition or illness or a certain type of patient.

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

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Date Added
August 29th, 2024
PRO Number
Pro00136755
Researcher
Sami Al Kasab

List of Studies


Keywords
Stroke
Summary

This study aims to establish the best clinical practice for the management of acute ischemic stroke related to narrowing or blockage of the neck vessels. Currently, the treating physicians use one of two surgical approaches based on their preference. However, we do not know which technique is the best. In this study, you will undergo mechanical thrombectomy using one of the techniques (stenting vs. non-stenting approaches) to determine which technique is better compared to the other.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@musc.edu

Phase III Randomized Trial of Stereotactic ablative radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)

Date Added
August 27th, 2024
PRO Number
Pro00138907
Researcher
David Marshall

List of Studies


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

This study is for patients with metastatic renal cell carcinoma (RCC). The study is being done to compare overall survival (OS) between patients receiving standard systemic therapy (ST) right away versus delaying systemic therapy and instead starting with irradiation (SAbR) to all metastatic sites and reserving systemic therapy when/if the patient progresses. Also, compare the average AE score between SAbR+ST arm and ST only arm. The study drugs being used as ST are standard of care. Patients will expect to remain in the study for up to 24 months.

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

TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study (TRICURE EFS)

Date Added
August 27th, 2024
PRO Number
Pro00138879
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

You are invited to volunteer in this clinical research study because you have been diagnosed with tricuspid valve regurgitation.

The type of research study you are being asked to join is called an Early Feasibility Study. This means the device and procedure you are receiving (the treatment) have not been previously studied in humans, and that you will be among the first patients in the world to undergo this treatment. The Device you are receiving is not approved by the United States Food and Drug Administration and its safety and effectiveness are unknown.

Participants will undergo right heart catheterizations, computed tomography (CT) scans without iodinated contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits. You will have a screening right heart catheterization (RHC) to check the pressures and function of your heart. The research procedure and placement of the TRIcares Topaz Transfemoral Tricuspid heart Valve (Topaz Tricuspid Valve) will be placed in a hybrid operating room. This procedure is done by entering a vein in your groin known as the femoral vein. The purpose of this device is to eliminate the regurgitation or leaking in the tricuspid valve of the heart to help reduce the symptoms caused by this leaky valve.

The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and Topaz Tricuspid valve procedure. Major risks include bleeding and damage to the heart or surrounding blood vessels. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by tricuspid regurgitation. The information that we obtain from your participation in this study will help us learn more about how safe and effective this approach is in treating the symptoms of individuals similar to yourself.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

A PHASE I, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SUBCUTANEOUS ADMINISTRATION OF UMBILICAL CORD DERIVED - MESENCHYMAL STROMAL CELL THERAPY IN ADDITION TO STANDARD OF CARE AS A TREATMENT FOR ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Date Added
August 27th, 2024
PRO Number
Pro00136482
Researcher
Kathleen Maksimowicz-McKinnon

List of Studies

Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

The goal of this study is to determine if an investigational product (a substance not approved by the US Food and Drug Administration) made from mesenchymal stromal cells (MSC) and taken as a single subcutaneous injection, is safe and well tolerated in individuals with active lupus while also receiving standard of care treatment for their lupus.

The MSCs used in this trial are cells that were obtained from the umbilical cords of healthy donors having an elective Caesarean section and who have been screened to be sure that they are free of any infectious diseases.

Participation in the study will take about 9 visits and 2 telephone calls over a period of 7 months. With participation, compensation is available.

At study visits you will have blood and urine labs collected, physical exam/lupus specific assessments, and be asked to complete a questionnaire. These procedures are much like those completed at your routine standard of care visits with your rheumatologist.

The risks to study participation are that only a few hundred people worldwide have been treated with MSCs. So far, there have been no serious side effects when MSCs have been used. Potential risks could however include an allergic reaction to the cells, development of infection, or MSCs changing into cancer cells.

Prior to any use of the MSC injection, participants will have a thorough review of the study and given an opportunity to consider their options and have all questions/concerns answered. A screening visit will be completed to ensure that participation is appropriate - participant safety is a priority of the study.

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

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma (INTERCON)

Date Added
August 26th, 2024
PRO Number
Pro00136417
Researcher
Katherine Antel

List of Studies

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

This study is for subjects that have been diagnosed with mantle cell lymphoma. The purpose of this study is to compare continuous treatment with zanubrutinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted at the first time your disease gets worse following the initial six 28-day cycles of chemotherapy. The subject may remain in the study for up to 10 years.

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



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