A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime/GOG-3076 Study)

Date Added
January 4th, 2024
PRO Number
Pro00132648
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

They study is for patients that have have been diagnosed with platinum-resistant or platinum-refractory ovarian cancer (PRROC) which includes fallopian tube cancer and peritoneal carcinomatosis (a form of cancer that affects the thin membrane that surrounds your abdominal organs). The investigational drug used in this study is Olvi-Vec. The main purpose of the study is to determine how women diagnosed with PRROC will best respond to receiving Olvi-Vec followed by platinum-doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm. Participants can expect to be in this study for up to 36 months.

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

Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)

Date Added
January 2nd, 2024
PRO Number
Pro00130123
Researcher
Kelly Barth

List of Studies


Keywords
Drug Studies, Pain, Psychiatry, Substance Use
Summary

This study aims to investigate innovative approaches to managing chronic pain and opioid use. This study consists of two phases, each offering different treatment options. Participation is voluntary.

This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) transcranial magnetic stimulation by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at follow-up.

Phase 1:
In this initial phase, all participants will have a 1-week open-label trial of buprenorphine (worn as a patch on the arm, shoulder or upper-back). This trial aims to assess the safety and effectiveness of buprenorphine in managing chronic pain and opioid use. During this phase, participants will have the opportunity to experience the effects of buprenorphine under close monitoring.

Phase 2:
After completing Phase 1, participants will have the opportunity to choose their next course of treatment. They can decide to continue with buprenorphine, and undergo a 1-week trial of either real buprenorphine or a placebo (an inactive substance). They will be randomly assigned to receive either real or placebo buprenorphine. If participants respond well to buprenorphine treatment, they may continue the medication under the care of their physician.

Alternatively, participants can explore an alternative treatment called repetitive transcranial magnetic stimulation (rTMS) in Phase 2. If they opt for rTMS, they will receive either real rTMS or a sham version interspersed with cognitive-behavioral therapy for pain. Participants will be randomly assigned to receive either real or sham rTMS.

In both phases, participants will receive close monitoring and attend regular study visits to assess safety and progress. Throughout the study, they will be asked to complete questionnaires about pain, functioning and opioid use, undergo physiological monitoring and blood samples will be collected at specific points.

It's important to note that there are potential risks associated with the study medication, such as difficulty sleeping, nausea, and dizziness. Additionally, for the rTMS arm, there is risk of mild headache, pain at the stimulation site, and there may be unknown risks related to the brain stimulation.

Participants' experience in Phase 1 will involve an open-label trial of buprenorphine, and participants' decisions in Phase 2 will determine the treatment path. While the effectiveness of these treatments is uncertain, participants will receive thorough monitoring throughout the study, and have the option to withdraw at any time. Improvement in participant symptoms is possible but not guaranteed.

Institution
MUSC
Recruitment Contact
Georgia Mappin
843-764-7316
mappin@musc.edu

STEMCAP-1: Safety and Efficacy of Mesenchymal Stem Cells Associated with Chronic Pancreatitis Pain

Date Added
December 19th, 2023
PRO Number
Pro00132905
Researcher
Hongjun Wang

List of Studies


Keywords
Pain
Summary

Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of donor derived mesenchymal stem cells to relieve chronic pain. After cell infusion into the vein, the participant will be followed for 6 months to evaluate their pain and other outcomes. There are a total of 5 clinic visits with a total study participation of up to 7 months.

Institution
MUSC
Recruitment Contact
Leah Benn
843-792-2813
bennle@musc.edu

uTRACT Jelmtyo® Registry

Date Added
December 19th, 2023
PRO Number
Pro00132320
Researcher
Karthik Tanneru

List of Studies

Keywords
Cancer/Genitourinary
Summary

The purpose of this registry study is to gather more information to answer research questions about upper tract urothelial carcinoma (UTUC) and the use of Jelmyto as a treatment. Jelmyto is not an experimental medication. It has been approved by the Food and Drug Administration (FDA) in the United States for the treatment of low grade UTUC since April 2021. For this study, data will be collected from the medical record including type and location of UTUC, treatments and surgeries received, and health status following treatments and surgeries. Approximately 400 people will participate in this study. Participation in this study will last three (3) years.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Karthik Tanneru
843-673-7525
tanneru@musc.edu

A Retrospective Follow-up Study of the Durability of Antiviral Therapy on Long-term Hearing and Neurodevelopmental Outcomes Among Patients Treated for Congenital Cytomegalovirus Infection as Infants or Toddlers

Date Added
December 18th, 2023
PRO Number
Pro00129725
Researcher
Stephen Thacker

List of Studies

Keywords
Pediatrics
Summary

Patients who previously had been treated with either intravenous ganciclovir or oral
valganciclovir as an infant or toddler, either as part of a previous Collaborative Antiviral Study Group (CASG) study or through routine clinical care at a current or former CASG study site, will be offered enrollment on this retrospective follow-up study.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

Causes and Consequences of Preschooler's Digital Media Use: The Role of Sleep, Physical Activity, Sedentary Behavior and Social Emotional Health

Date Added
December 15th, 2023
PRO Number
Pro00133829
Researcher
Bridget Armstrong

List of Studies

Keywords
Children's Health, Disease Prevention, Healthy Volunteer Studies, Mental Health, Non-interventional, Pediatrics
Summary

Children spend more time than ever using screens — increasingly on portable digital media devices like tablets and smartphones, but our understanding about how these devices impact health is lagging. This project proposes to uncover how patterns of digital media use are formed and maintained and examine how those patterns predict mental health and cardiovascular health risk over time. The novel forms of media measurement used in this project – including passive mobile sampling, ecological momentary assessment and accelerometry – will allow us to uncover the unique and complex ways in which digital media impacts health behaviors.

Institution
USC
Recruitment Contact
Michal Talley
8032501730
BA12@mailbox.sc.edu

A Phase 2, Randomized Study to Evaluate the Safety, Efficacy and Optimal dose of ABBV-400 in Combination with Fluorouracil (5-FU), Folinic Acid and Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer (mCRC)

Date Added
December 13th, 2023
PRO Number
Pro00133837
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH)

Date Added
December 12th, 2023
PRO Number
Pro00131756
Researcher
Michele Esposito

List of Studies

Keywords
Pulmonary Hypertension
Summary

This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary arterial hypertension (PAH). The device will be implanted in the pulmonary artery and the gas reservoir of the device will be in the abdominal cavity. The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH. Some procedures involved in the study include but not limited too: Questionnaires, physical exams, right heart catherization, echocardiograms, blood work and more. The study will be conducted in a maximum of 10 centers in the United States. Up to 45 patients will be consented, and up to 15 patients will receive implants. There is a total of 11 visits over the course of 2.5 years for the study. Because this is an investigational device under the FDA, there may be risk that include but are not limited to: arrhythmia, device infection, endocarditis, and heart failure. If the Aria CV device performs as intended, you may potentially benefit from reduction in or relief of symptoms caused by PH, and depending on your overall health conditions, prolonged life expectancy and/or improvement in your overall quality of life.

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

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu



-- OR --