Integrated Treatment for Women with Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder

Date Added
July 16th, 2021
PRO Number
Pro00111570
Researcher
Tanya Saraiya

List of Studies

Keywords
Psychiatry, Women's Health
Summary

We are seeking women who have used or currently use opioids, are between the ages of 18-65, and a have experienced a traumatic event. A traumatic event is something incredibly frightening, such as physical assault, domestic violence, or sexual assault. We will interview participants for their preferences in treatment for 60-90 minutes. Interviews are confidential. Participants will be compensated $25 for their time.

Institution
MUSC
Recruitment Contact
Tanya Saraiya
347 961 8252
saraiya@musc.edu

The effects of time restricted feeding on AGE-RAGE signaling in women at high risk for breast cancer

Date Added
June 15th, 2021
PRO Number
Pro00109489
Researcher
Harsha Karanchi

List of Studies


Keywords
Disease Prevention, Nutrition, Women's Health
Summary

The purpose of this research study is to learn about time restricted feeding and breast cancer risk markers in post-menopausal women with prediabetes. Time restricted feeding involves changing the daily eating period for consumption of meals and snacks.

Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist to assist with the eating schedule. The study will take about 3 1/2 months. There is no cost to participate. Compensation for the 2 in-person visits is provided..

Institution
MUSC
Recruitment Contact
Lori Spillers
8438760977
spillerl@musc.edu

Maternal Mental Health Screening and Referral to Treatment in South Carolina Pee Dee Region Healthy Start Programs

Date Added
June 1st, 2021
PRO Number
Pro00110639
Researcher
Constance Guille

List of Studies


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

This study involves partnering with Healthy Start Programs in the SC Pee Dee region to evaluate Listening to Women (LTW), a text message based mental health and substance use screening and referral to treatment program, compared to usual care (Screening, Brief Intervention, and Referral to Treatment (SBIRT)), among pregnant and postpartum women. The study also involves doing interviews and focus groups (group discussions) with women in the Healthy Start programs, community health workers (CHWs), and key local and state stakeholders.

Institution
MUSC
Recruitment Contact
Edie Douglas
8437920403
douglaed@musc.edu

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

Date Added
May 11th, 2021
PRO Number
Pro00105780
Researcher
Brian Hess

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 an advanced type of Hodgkin lymphoma (HL) that hasn't been treated yet. Parts B and C are studying brentuximab vedotin given with 3 other drugs. Two of the drugs are chemotherapy drugs that have been used to treat cancer for a long time. One chemotherapy drug is called doxorubicin and the other is called dacarbazine. The third drug is an immunotherapy drug called nivolumab or Opdivo®. This will be the first time brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine have been tested together to treat HL. The primary purpose of this study is to assess the complete response (CR) rate (the disappearance of all signs of cancer in response to treatment) at End Of Treatment with the combination of drugs in subjects with previously untreated cHL .The subject may remain in the study for up to 2 years.

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

Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release

Date Added
May 11th, 2021
PRO Number
Pro00107699
Researcher
Brian Hess

List of Studies


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

This study is for patients who have been diagnosed with relapsed (came back) and/or refractory (not responding to treatment) large B-cell lymphoma (LBCL). The investigational product is Lisocabtagene Maraleucel and is administered by infusion. Participants will have had the blood collection (leukapheresis - a laboratory procedure where white blood cells are separated from a sample of blood) procedure, where the T cells (white blood cells) were collected and genetically modified in a laboratory in order to manufacture the lisocabtagene maraleucel T cells for disease treatment. The lisocabtagene maraleucel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the Food and Drug Administration (FDA). This is called a nonconforming lisocabtagene maraleucel. The purpose of this study is to allow participants to be treated with their nonconforming lisocabtagene maraleucel. Participants can expect to be on the study for up to 3 months following the infusion of nonconforming lisocabtagene maraleucel.

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

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

Date Added
April 27th, 2021
PRO Number
Pro00104445
Researcher
Michelle Hudspeth

List of Studies


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

This study is for children and adults that have been diagnosed with a disease that is associated with Epstein-Barr Virus (EBV) infection.The investigational treatment in this study is called tabelecleucel (also known as ATA129), this treatment is given in the vein. Participants will receive tabelecleucel on Day 1, Day 8 and Day 15 of every 35-day (5-week) period, the number of cycles depends on the response to treatment. The purpose of this study is to assess the safety of tabelecleucel and to assess the effects of tabelecleucel on EBV disease. Participants can expect to be in this study for about 2 years for an estimated 17-20 study visits.

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

A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Date Added
March 19th, 2021
PRO Number
Pro00105076
Researcher
Irl Greenwell

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 diffuse large B-cell lymphoma (DLBCL) that has come back or did not get better with your last treatment. The investigational drug in this study is brentuximab vedotin. The purpose of this study is to test if brentuximab vedotin, lenalidomide, and rituximab given together work to treat DLBCL and what the side effects are. Participants can expect to be in this study for up to 2.5 years.

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

PTSD Treatment and Emotion Regulation Skills Training for Veterans with Military Sexual Trauma

Date Added
March 2nd, 2021
PRO Number
Pro00107912
Researcher
Wendy Muzzy

List of Studies


Keywords
Anxiety, Mental Health, Military, Psychiatry, Women's Health
Summary

The purpose of this study is to learn ways to improve treatments for Veterans with military sexual trauma (MST). The researchers want to learn whether combining evidence-based emotion regulation skills training with a trauma-focused therapy improves treatment outcomes. An evidence-based trauma treatment known as Prolonged Exposure will be used. Emotion regulation skills will also be included in treatment. Veterans with a positive or sub threshold diagnosis of PTSD who experienced a military sexual trauma (MST) will be included. Participants will complete up to twelve 90 minute sessions of PE with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training followed by a post-treatment assessment. All aspects of the project including consent, baseline, treatment and follow-up will be completed either in person or via videoconferencing. Fifteen participants will be enrolled.

Institution
MUSC
Recruitment Contact
Stephanie Hart
(843) 789-6519
zeigls@musc.edu

A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Date Added
February 23rd, 2021
PRO Number
Pro00106203
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.

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

A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)

Date Added
February 23rd, 2021
PRO Number
Pro00106645
Researcher
Praneeth Baratam

List of Studies

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

This study is for subjects with Myelofibrosis. This study is testing an "investigational" (not yet FDA approved drug) drug called Navitoclax. The primary purpose of this study is to evaluate how well the study drug works alone OR in combination with ruxolitinib on spleen volume.The subject may remain in the study until the end of clinical benefit, occurrence of unacceptable side effects or discontinuation criteria have been met.

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



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