A phase 3, double-blind, multicentre, randomised, placebo-controlled study to determine the efficacy and safety of SPL7013 Gel (VivaGel®) to prevent the recurrence of bacterial vaginosis Save

Date Added
July 28th, 2015
PRO Number
Pro00035843
Researcher
Gweneth Lazenby
Keywords
Obstetrics and Gynecology, Sexually Transmitted Infections (STI), Women's Health
Summary

Starpharma, is sponsoring this study of an investigational drug to be used in the treatment of bacterial vaginosis (BV). The name of this investigational drug (study drug) is 1% SPL7013 Gel. The study drug has been shown to kill some types of bacteria which are found in the vagina of women with bacterial vaginosis (BV), but has no or little effect on the “good” bacteria in the vagina. It is hoped that information from this study will help us to learn more about the study drug and how to treat people with BV in the future.

Institution
MUSC
Recruitment Contact
JacKetta Cobbs
843.792.3330
cobbsj@musc.edu

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

Date Added
July 22nd, 2015
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

Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC) Save

Date Added
July 22nd, 2015
PRO Number
Pro00019998
Researcher
Rochelle Ringer
Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study is for patients with multiple ipsilateral breast cancers (MIBC). The purpose of this research study is to see if removing only the tissues from the 2 or 3 cancers in the patient's breast (breast conservation surgery) in combination with radiation to the breast, instead of removing the patient's entire breast (mastectomy) is safe in keeping the patient's cancer from coming back in the patient's breast. Patients will be asked to visit the study doctor for follow-up exams for up to 5 years after patients have completed WBI.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

PROSPECTIVE PHASE III EVALUATION OF FETAL FIBRONECTIN IN A HIGH RISK ASYMPTOMATIC POPULATION FOR THE PREDICTION OF SPONTANEOUS PRETERM BIRTH Save

Date Added
July 14th, 2015
PRO Number
Pro00026710
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Fetal fibronectin (also known as fFN) is a “glue-like” protein that bonds your developing baby to your uterus. Fetal fibronectin is detectable in vaginal secretions in the very beginning of pregnancy, when this bond is first forming, and then again at the end of pregnancy, when your body is getting ready to deliver your baby.

fFN is a special protein that literally holds your baby in place in the womb. After the 35th week of pregnancy, it begins to break down naturally, and is detectable. If your body is getting ready to give birth prematurely, fFN may be detected before week 35.

Identifying women at high risk of giving birth prematurely can be challenging. It is believed that higher levels of fFn measured in vaginal fluid suggest a woman is at a greater risk for delivering early. fFN testing is already approved for use in women from weeks 22 to 35 of pregnancy.

The goal of the study is to evaluate the benefits of collecting fFN measurements from a vaginal fluid specimen taken during early pregnancy (from 16 weeks to 22 weeks) to assess the risk of pre-term birth.

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

A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma Save

Date Added
July 14th, 2015
PRO Number
Pro00033373
Researcher
Daniel Reuben
Keywords
Cancer, Drug Studies, Men's Health, Skin, Women's Health
Summary

The purpose of this study is to find out more about talimogene laherparepvec (formerly known as OncoVEXGM-CSF), in people with advanced melanoma when given in combination with another drug called ipilimumab.
Talimogene laherparepvec is a modified herpes simplex type-1 virus (the ‘cold sore’ virus) that has a medicine called human granulocyte macrophage colony-stimulating factor (GM-CSF) added to it. Human GM-CSF is a medicine used to treat patients with white blood cell counts that are low. Talimogene laherparepvec is still experimental and is not approved by the FDA.

Institution
MUSC
Recruitment Contact
Jason Dority
843-792-6429
dority@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
July 8th, 2015
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

A Phase 1 Trial of SGN-CD70A in Patients with CD70-Positive Malignancies Save

Date Added
July 8th, 2015
PRO Number
Pro00036276
Researcher
Saurabh Chhabra
Keywords
Cancer, Men's Health, Women's Health
Summary

This clinical trial uses an investigational drug called SGN-CD70A in patients that have Non-Hodgkin lymphoma (NHL) or renal cell carcinoma (RCC). This study is being done to find out what side effects (unwanted effects) are caused in subjects with NHL or RCC who are given SGN-CD70A. This study will also look at other effects of SGN-CD70A, including its effect on the subject's cancer.
Subjects will be enrolled to receive low doses of SGN-CD70A in the beginning. If the subjects given low doses do not have bad side effects, the next subjects will be given a higher dose of SGN-CD70A. After this, subjects just starting SGN-CD70A will be given higher or lower doses, depending on the side effects subjects have already had. This will continue until the highest dose of SGN-CD70A that does not cause bad side effects is found.
Approximately 95 people will take part in this research study.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Cognitive Impairment and Obstructive Sleep Apnea Syndrome in Post-Menopausal Women Save

Date Added
June 16th, 2015
PRO Number
Pro00025410
Researcher
Chitra Lal
Keywords
Memory Loss, Sleep Disorders, Women's Health
Summary

Early postmenopausal women are vulnerable to memory loss and other cognitive deficits. Obstructive Sleep Apnea Syndrome (OSAS) has been associated with memory loss and cognitive decline. OSAS is also more common after menopause. This study seeks to define the prevalence of these cognitive deficits in postmenopausal women with OSAS as compared to postmenopausal women who don't have OSAS with the use of screening questionnaires. We are seeking postmenopausal women, between 45-60 years of age, within 5 years of natural menopause. Interested participants may also qualify for a brain imaging study to perform visual tasks in the MRI scanner.

A survey is required to initiate your interest. The 15 minute survey can be completed by going to this link:

https://redcap.musc.edu/surveys/?s=usDfDc

Institution
MUSC
Recruitment Contact
Chitra Lal
843-792-7776
lalch@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
June 16th, 2015
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-Osaboma
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
June 16th, 2015
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
Jessica Simons
843-792-2708
simonsjl@musc.edu

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