Listening to Women and Pregnant and Postpartum People: Qualitative Research with American Indian and Hispanic Women

Date Added
December 1st, 2023
PRO Number
Pro00133257
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Pregnancy, Women's Health
Summary

The purpose of this research study is to gather feedback via focus groups/individual interviews and surveys from American Indian and Hispanic pregnant and postpartum people about 1) mental health and substance use concerns and 2) a text message based mental health and substance use disorder screening, referral and treatment program for pregnant and postpartum people called Listening to Women & Pregnant and Postpartum People (LTWP). By gaining the feedback of American Indian and Hispanic people we hope to improve accessibility and efficacy of this program for these populations. Participation involves one individual interview or focus group (a small group discussion) and surveys.

Institution
MUSC
Recruitment Contact
Tychia Brown
843-872-2439
broty@musc.edu

Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)

Date Added
December 1st, 2023
PRO Number
Pro00132788
Researcher
Anbukarasi Maran

List of Studies


Keywords
Cardiovascular, Women's Health
Summary

This observational study is enrolling women only who are undergoing a heart catheterization with planned percutaneous coronary intervention (PCI) using the Shockwave . A heart catheterization is a procedure in which a long thin tube called a catheter is directed through an artery to your heart, to look for blockages in the heart arteries. If there is a blockage that needs opening, a PCI can be performed to open the blockage. This study involves collecting data only from women participants who undergo a heart catheterization and PCI using the Shockwave IVL System. IVL stands for intravascular lithotripsy. The Shockwave IVL System is approved for use and commercial sale by the Food and Drug Administration. (FDA). Participation in this study will take about 3 years. Participants will be seen before the procedure, during the procedure, before hospital discharge following the procedure, and then seen in clinic or contacted by phone at 30 days, 1,2 and 3 years. This study will collect data from each of these visits including demographic data, medical history and medications, lab results, ECG results, procedure details, and any complications if applicable.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Date Added
November 22nd, 2023
PRO Number
Pro00130522
Researcher
Praneeth Baratam

List of Studies

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

This project is being conducted in subjects that have been diagnosed with myelodysplastic syndromes (MDS), MDS/myeloproliferative neoplasms (MPN) including chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who are candidates to receive treatment with single agent azacitidine based on local country approvals and/or local The study is designed to move efficiently from Phase 1 to Phase 3. This study is testing investigational drug called ASTX030. Investigational means that it is not approved by the Food and Drug Administration (FDA), but it is undergoing testing to find out if it is safe and effective. ASTX030 is a combination of two medicines, azacitidine and cedazuridine, given by mouth. The primary purpose is to test the levels of the investigational drug ASTX030 in your blood, including if food has an effect (Phase 1B only), the safety and tolerability of the drugs, and how subjects respond to the drug. The subject may remain in the study about 3 years. If you benefit from treatment, you may receive study drugs as long as you continue to benefit. If you develop side effects to the study drugs that prevent you from continuing treatment, or if your study doctor believes it is in your best interest to stop the study drug(s), you may be asked to stop the study treatment. After you stop treatment, the Sponsor will continue to collect health information to evaluate long-term effects of the study drugs.

Institution
MUSC
Recruitment Contact
Shanta Salzer
8437929321
HCC-CLINICAL-TRIALS@MUSC.EDU

Multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers following 1 prior line of platinum-based chemotherapy

Date Added
November 14th, 2023
PRO Number
Pro00130452
Researcher
Whitney Graybill

List of Studies


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

This study is for female subjects that have a very specific type of recurrent ovarian, peritoneal, or fallopian tube cancer. These patients must have completed 1 round of chemotherapy for their cancer type. The study is testing an "investigational" (not yet FDA approved) drug called MIRV (Mirvetuximab Soravtansine). The primary purpose of this study is to determine the effectiveness and safety of the study drug to determine what effects, if any, it has on subjects. Subjects may remain in the study for up to 2 years.

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

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC
Recruitment Contact
Katie Tremont
843-792-5958
tremontk@musc.edu

A Phase III, Single-Arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) Administered Intravesically to Patients with BCG-unresponsive Carcinoma in Situ of the Bladder with or without Ta-T1 Papillary Disease

Date Added
October 24th, 2023
PRO Number
Pro00128893
Researcher
Stephen Savage

List of Studies


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

The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.

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

A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients with EGFRmutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Date Added
September 13th, 2023
PRO Number
Pro00130566
Researcher
Mariam Alexander

List of Studies

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

The study is for patients who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC). The investigational drug in this study is ivonescimab (AK112). The study drug is an antibody, it blocks two proteins in the body that help cancer cells live, grow and spread. The study drug will be given in addition to pemetrexed and carboplatin. There are two groups that a participant may be assigned to, which group a subject is assigned on will be determined by type of cancer treatments that they have previously received. Treatment Group A will receive the study drug along with pemetrexed and carboplatin. Treatment Group B will receive placebo along with pemetrexed and carboplatin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will last about 36 months. The study consist of a screening visit, treatment visits, and a safety follow up visit.

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

A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer

Date Added
September 12th, 2023
PRO Number
Pro00128530
Researcher
Mariam Alexander

List of Studies

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

The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.

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

A Phase 0 Master Protocol Using the CIVO Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies

Date Added
August 22nd, 2023
PRO Number
Pro00128477
Researcher
Jason Newman

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This research is being done to better understand how anti-cancer drugs affect cells within a tumor. Injecting very small amounts (microdoses) of pembrolizumab alone or in combination with MK-0482 or MK-4830 above may help the developer of these drugs to understand more about how these drugs work and what changes they make on the tumor. Subjects in this study will have their tumor injected with anti-cancer drugs using a CIVO device. The CIVO device delivers microdoses of multiple drugs or drug combinations directly into the tumor. Some of the procedures in this study include ultrasound assisted placement for tumor injection, a mucrodose injection of anti-cancer drugs into the tumor, and surgery to remove the tumor. Participation in the study will take 5 visits over a period if 56 days. The screening portion will be 28 days and the treatment portion will be 28 days from the time of the injection to the time of follow-up contact by the study team.

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

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Date Added
August 2nd, 2023
PRO Number
Pro00128890
Researcher
Frank Brescia

List of Studies


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

The study is for patients that have been diagnosed with with a certain type of breast cancer, characterized as HER2 (Human Epidermal Growth Factor Receptor 2)-negative and hormonal receptor (HR)-positive, and with a specific characteristic (molecular subtype) called HeER2-Enriched. The investigational drugs used in this study are Ribociclib and Palbociclib. The main purpose of this study is to learn determine if participants with the specific HER2-Enriched subtype will have delayed progression of the disease when treated with ribociclib compared to palbociclib. Participants can expect to be in this study for up to 5 years.

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



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