A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826) Save

Date Added
May 20th, 2019
PRO Number
Pro00082686
Researcher
Whitney Graybill

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

This clinical trial hopes to test the safety and effectiveness of the study drug, pembrolizumab (MK-3475), in combination with chemotherapy, and if this combination will improve survival in women with persistent, recurrent, or metastatic cervical cancer. You may be able to join this study if you are a female at least 18 years of age with persistent, recurrent, or metastatic cervical cancer and have not been treated with systemic chemotherapy, other than chemotherapy that was received with radiation. Participation will be based on specific criteria.
The study duration is estimated at about 2 years, and in some cases may be longer.

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

Evaluation of the Women's Reproductive Behavioral Telehealth (WRBT) Program Save

Date Added
April 4th, 2019
PRO Number
Pro00086783
Researcher
Constance Guille

List of Studies


Profiles_link
Keywords
Mental Health, Obstetrics and Gynecology, Pregnancy, Psychiatry, Women's Health
Summary

Staff at sites who participate in the MUSC Women's Reproductive Behavioral Telehealth (WRBT) Program will be asked to participate in individual interviews or focus groups (group discussions) about their experience with the telemedicine program and fill out surveys. Patients in the WRBT Program will be asked to fill out surveys about their telemedicine experience.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Save

Date Added
March 12th, 2019
PRO Number
Pro00085004
Researcher
John Kaczmar

List of Studies

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

This study is for patients who have been diagnosed with Head and Neck Squamous Cell Carcinoma (HNSCC). The investigational drug used in this study is Ficlatuzumab. The main goals of this research study is to study the safety and effectiveness of Ficlatuzumab with or without Cetuximab, to determine which strategy will be more effective, as well as to learn the potential side effects of Ficlatuzumab alone or in combination with Cetuximab. It is unknown exactly how long participants can expect to be in the study. Subjects will receive treatment until the drug is no longer effective on their cancer.

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

Web-Based Treatment for Perinatal Opioid Use Disorder Save

Date Added
March 2nd, 2019
PRO Number
Pro00085580
Researcher
Constance Guille

List of Studies


Profiles_link
Keywords
Mental Health, Obstetrics and Gynecology, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

This purpose of this research study is to collect feedback from participants about a web-based program for opioid misuse and opioid use disorder. Participants will be asked to review web-based content and take part in focus groups (group discussions) and individual interviews to provide feedback on the content. The study team is looking for pregnant women or women who have been pregnant in the past 2 years who misuse opioids or have opioid use disorder, as well as obstetric providers who treat pregnant women with opioid misuse and opioid use disorder to participate.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

Identifying functional regulatory marks underlying monocyte dysfunction in scleroderma Save

Date Added
February 19th, 2019
PRO Number
Pro00085936
Researcher
Paula Ramos

List of Studies


Profiles_link
Keywords
Autoimmune disease, Ethnicity and Disease, Genetics, Healthy Volunteer Studies, Immune System, Inflammation, Minorities, Scleroderma, Women's Health
Summary

Scleroderma (systemic sclerosis) is a chronic autoimmune disease, characterized by dysregulation of immune cells in the blood and subsequent fibrosis and vascular dysfunction, associated with significant mortality and morbidity, disproportionately affecting women and African Americans, and without satisfactory treatments. Monocytes, a type of blood immune cells, are critically involved, but the mechanisms responsible for their deregulation in scleroderma remain largely unknown. The goal of this project is to understand how the regulation of monocytes differs between scleroderma and healthy individuals. Volunteers will be asked to provide a blood sample, for which modest compensation will be provided. This is not a drug study.

Institution
MUSC
Recruitment Contact
Nathan Wilson
843-792-8272
wilsonn@musc.edu

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer Save

Date Added
January 22nd, 2019
PRO Number
Pro00084301
Researcher
Antonio Giordano

List of Studies

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

This is an open-label, nonrandomized, dose escalation and dose expansion, safety, efficacy, PK and PD evaluation study of SAR439859 administered orally as monotherapy, then in combination with palbociclib. The study will last approximately 26 months, and participation in the study may last 4 to 8 weeks or longer. The length of participation in this study will depend on how well subjects tolerate the study drug and the condition of their disease.

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

A Phase 2b, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults with Newly-Diagnosed Acute Myeloid Leukemia, Not Eligible for Standard Induction Therapy Save

Date Added
January 8th, 2019
PRO Number
Pro00083544
Researcher
Robert Stuart

List of Studies


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

This study is for subjects with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. The investigational drug in this study is BST-236, which is given via IV. The purpose of this research study is to measure the safety of BST-236 and how effective it is in treating subjects. Visits will be required for 6 consecutive days during each cycle of treatment. The number of courses you receive will depend on whether you are benefiting from the study drug. Participants can expect to be in this study for 2 years (including treatment and post study follow-up).

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

The Use of Vaginal Photoplethysmography (VPP) to Assess Female Sexual Arousal Save

Date Added
January 4th, 2019
PRO Number
Pro00081702
Researcher
Emily Gottfried

List of Studies

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Keywords
Women's Health
Summary

This study uses Vaginal Photoplethysmography (VPP), which is a small, tampon-like device that the participant inserts in a private setting, to study female sexual arousal. The study's goal is measuring subjective and objective sexual arousal.

The study involves completing a series of questionnaires and listening to audiotape stories describing sexual activities between adult women and males and females of varying ages (from children to adults).

Institution
MUSC
Recruitment Contact
Emily Gottfried
2-8235
cpspd-research@musc.edu

A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors Save

Date Added
November 27th, 2018
PRO Number
Pro00080265
Researcher
Theodore Gourdin

List of Studies

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

The purpose of this study is to assess how effective the combination of avelumab and NHS-IL12 is in subjects with solid tumors. It will also collect more information on how safe and well-tolerated the combined study drugs are. Subjects will undergo a series of treatment cycles, each lasting 28 days. On Day 1 of each cycle, you will receive NHS IL12 immediately followed by avelumab on scheduled days. You will be assigned to receive avelumab every two weeks or to receive avelumab once a week. Both you and your study doctor will know which dose of study drugs you are receiving during the study.

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

A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Save

Date Added
November 13th, 2018
PRO Number
Pro00083282
Researcher
Brian Hess

List of Studies

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

This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL). The investigational drug in this study is loncastuximab tesirine (ADCT-402). The purpose of this Phase 2 study is to evaluate the effectiveness and safety of loncastuximab tesirine in subjects with DLBCL that has not responded to treatment or has come back after treatment.Treatment will occur every 3 weeks. The follow up treatment period will last up to approximately 3 years.

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

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