Physician Order for Scope of Treatment (POST): PILOT STUDY Save

Date Added
July 15th, 2016
PRO Number
Pro00022252
Researcher
Walter Limehouse
Keywords
Aging, Alzheimers, Cancer, Dementia, Ethnicity and Disease, Geriatrics, Heart, HIV / AIDS, Infectious Diseases, Kidney, Liver, Men's Health, Minorities, Nervous System, Pulmonary, Rare Diseases, Women's Health
Summary

South Carolina Coalition for Care of Serious Illness (SCC CSI) sponsors development of Physician Orders for Scope of Treatment (POST) in South Carolina. The SC POST follows the national POLST (www. polst.org) paradigm creating an advance treatment planning physician order that migrates as valid across institutional boundaries: from physician office, to home/nursing home/hospice to EMS to hospital emergency/inpatient services. The POST form encourages a conversation between a physician and the patient regarding treatment options available to seriously ill patients for whom death within a year would not be a surprise. These choices primarily include whether to attempt cardiopulmonary resuscitation in the event of cardiac or pulmonary arrest or not (a ?DNR? or ?Allow Natural Death? order) and whether during acute illness to provide full treatment including endotracheal intubation and intensive care, supportive treatment such as noninvasive ventilation and no intensive care, or comfort care only. The Charleston and Greenville areas will pilot POST. Investigators by area will survey providers completing POST documents for patients or treating patients with POST about the utility of this form and how use of the form affected their patient's treatment. A chart reviews of patients presenting with a POST form to a hospital emergency or inpatient unit will address whether providers respected patient treatment choices. SCC CSI plans to publish the results of the pilot in appropriate journals and present the results at medical meetings and to interested persons. The results of the study may provide the supporting documentation for subsequent legislation supporting POST. POST represents a coordinated statement of a seriously ill patient?s treatment choices to be honored across multiple treatment settings.

Institution
MUSC
Recruitment Contact
Walter Limehouse
792-9705
limehouw@musc.edu

Prevalence and Attitudes Regarding Withdrawal Use for Pregnancy and HIV Prevention in Sexually Active HIV Positive and Negative Young Adults in Charleston, South Carolina Save

Date Added
June 29th, 2016
PRO Number
Pro00044763
Researcher
Anna Powell
Keywords
Sexually Transmitted Infections (STI), Women's Health
Summary

The purpose of this study is to survey young adults (18-25) on their attitudes about HIV and pregnancy prevention, and about the use of the withdrawal method to prevent pregnancy and HIV infection. Researchers hope that the information that is gathered from the study will help to develop better risk reduction counseling that can be used in the future to help educate at-risk young adults.

Institution
MUSC
Recruitment Contact
Tamara Pfeffer
843.792.0316
pfeffer@musc.edu

Validating simulation and evaluation tools for the management of shoulder dystocia protocols in physician evaluation and education at the Medical University of South Carolina. Save

Date Added
June 29th, 2016
PRO Number
Pro00026863
Researcher
Christopher Goodier
Keywords
Obstetrics and Gynecology, Women's Health
Summary

Shoulders dystocia (SD) is an obstetric emergency resulting from a discrepancy in size between the fetal shoulders and maternal pelvic inlet, resulting in impaction of the fetal shoulder(s) against maternal pelvic bone(s) following delivery of the fetal head.

Obstetric providers need to be adequately trained to manage this emergency effectively. Traditionally, trainees are taught how to perform these maneuvers with lectures/articles describing maneuvers with pictorial representations. There is no currently accepted ?best practice? regarding which sequence of alleviating maneuvers is preferred to resolve a shoulder dystocia.

What is needed is an effective method to train providers for management of shoulder dystocia. Additionally, there are tools needed to assess the competency of providers in the management of shoulder dystocia. Theoretically, stimulation training could fulfill both of these roles. This study will assess the simulation of shoulder dystocia during vaginal delivery.

Institution
MUSC
Recruitment Contact
Amanda Sibai
843.792.6654
sibai@musc.edu

Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) with or without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer Save

Date Added
June 21st, 2016
PRO Number
Pro00053734
Researcher
David Marshall
Keywords
Cancer, Cancer/Gastrointestinal, Men's Health, Pancreas, Women's Health
Summary

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). SBRT is a type of highly focused and precise x-ray treatment done in a total of 5 treatments. We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.

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

Adapting Web-Based ASAP (Alcohol and Sexual Assault Prevention) for Veterans Save

Date Added
June 7th, 2016
PRO Number
Pro00053156
Researcher
Amanda Gilmore
Keywords
Alcohol, Healthy Volunteer Studies, Mental Health, Military, Substance Use, Women's Health
Summary

The goal of this study is to receive Veteran feedback on an intervention being developed for female Veterans to reduce their risk of alcohol misuse and sexual assault. We are recruiting 20 female Veterans who engage in alcohol misuse to receive feedback on the intervention content. Feedback will be integrated into the intervention prior to being used with female Veterans.

Institution
MUSC
Recruitment Contact
Amanda Gilmore
843-792-8348
gilmoram@musc.edu

A PHASE 1/2 STUDY OF VADASTUXIMAB TALIRINE (SGN-CD33A) IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH PREVIOUSLY UNTREATED INTERNATIONAL PROGNOSTIC SCORING SYSTEM (IPSS) INTERMEDIATE-2 OR HIGH RISK MYELODYSPLASTIC SYNDROME (MDS) Save

Date Added
May 24th, 2016
PRO Number
Pro00053610
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with previously untreated Intermediate or High-risk myelodysplastic syndrome (MDS). The investigational drug in this study is vadastuximab talirine (SGN-CD33A). The purpose of this study is to evaluate escalating doses of vadastuximab talirine and compare the overall response rate between 2 study arms. Participants can expect to be in the study for up to approximately 39 months.

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

A Phase 1B Open-Label Three-Arm Multi-Center Study to Assess the Safety and Tolerability of PF-05212384 (PI3K/mTOR Inhibitor) in Combination with Other Anti-Tumor Agents Save

Date Added
May 24th, 2016
PRO Number
Pro00027912
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is enrolling male and female patients with a diagnosis of advanced solid tumor. The purpose of this research study is to learn about the effects of and to find the best dose of the study drug, PF 05212384, when given in combination with other drugs. This study will determine the highest dose of PF-05212384 that can be tolerated when given in combination with other drugs; this PF-05212384 dose is called the maximum tolerated dose or MTD. Enrolled patients can expect to be in this study for about 6 months. They will need to visit the research site at least 12 times during the study. Patients may stay in the study until the disease gets worse or they decide to stop participating.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Cervical pessary to prevent preterm birth in singleton pregnancies with a sonographically measured short cervix: an open-label randomized controlled trial Save

Date Added
May 18th, 2016
PRO Number
Pro00044532
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to determine if a pessary, a silicone device placed within the vagina to support the cervix, could be a good way to help pregnant women who are at risk for preterm delivery. The pessary that is used in this study, called the Arabin pessary, has not been approved by the United States Food and Drug Administration (FDA) for the prevention of preterm delivery. It is an investigational device, which means it is still being studied to find out whether or not it is safe and effective in patients with a short cervix who are at risk for preterm delivery.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
843.792.6323
yeadon@musc.edu

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications Save

Date Added
May 17th, 2016
PRO Number
Pro00011805
Researcher
Robert Stuart
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
?Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
?Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

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

A pilot study evaluating vitamin D deficiency and risk of aggressive uterine cancer in African American as compared to White women Save

Date Added
May 4th, 2016
PRO Number
Pro00030938
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to evaluate vitamin D levels in African American and White women who present with a new diagnosis of uterine cancer.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

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