A Randomized, Double Blind, Placebo-Controlled, Multicenter Phase II Study To Evaluate Efficacy And Safety Of Roniciclib In Subjects With Extensive-Stage Disease Small Cell Lung Cancer (SCLC) Who Are Receiving Cisplatin + Etoposide Or Carboplatin + Etoposide As First-Line Therapy Save

Date Added
August 11th, 2015
PRO Number
Pro00037205
Researcher
Keisuke Shirai
Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to see if subjects diagnosed with small cell lung cancer will benefit from treatment with a study drug called RONICICLIB in combination with chemotherapy.

Institution
MUSC
Recruitment Contact
Jason Dority
843-792-5853
dority@musc.edu

A phase 2 study of brentuximab vedotin in combination with standard of care treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [RCHOP]) or RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) as front-line therapy in patients with diffuse large B-cell lymphoma (DLBCL) Save

Date Added
July 28th, 2015
PRO Number
Pro00045219
Researcher
Saurabh Chhabra
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diffuse large B-cell lymphoma (DLBCL), which has never been treated. The drug in this study is brentuximab vedotin. The purpose of the first part of the study was to test the safety and effectiveness of 2 different doses of brentuximab vedotin when given with a combination of drugs called RCHOP [rituximab, cyclophosphamide, hydroxydaunorubicin (also called doxorubicin), vincristine (Oncovin), and prednisone]. The purpose of the second part of the study is to test the safety and effectiveness of brentuximab vedotin when given with a combination of drugs that does not include vincristine called RCHP [rituximab, cyclophosphamide, hydroxydaunorubicin (also called doxorubicin), and prednisone]. Participants can expect to be in this study for up to 2-3 years.

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine with or without Birinapant with a Single Arm Open-Label Run-In Phase in Subjects with Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia. Save

Date Added
July 28th, 2015
PRO Number
Pro00036608
Researcher
Valeriy Sedov
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is a Phase IIa and IIb for patients that have been diagnosed with with myelodysplastic syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMMoL). The investigational drug in this study is Birinapant. The purpose of this research study is to obtain further information about the safety and efficacy (how well it works) of azacitidine plus birinapant (the investigational drug), in Subjects with higher-risk myelodysplastic syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMMoL).

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

A phase 3, double-blind, multicentre, randomised, placebo-controlled study to determine the efficacy and safety of SPL7013 Gel (VivaGel 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 3, single arm, clinical trial to study the contraceptive efficacy and safety of the MK-8342B (etonogestrel + 17?-estradiol) vaginal ring in healthy women 18 years of age and older, at risk for pregnancy. Save

Date Added
July 14th, 2015
PRO Number
Pro00045836
Researcher
Angela Dempsey
Keywords
Obstetrics and Gynecology, Women's Health
Summary

The purpose of this study is to test the safety and performance of an investigational drug (ENG-E2 vaginal ring) to prevent pregnancy. The investigational drug is the two hormones that are released into your body through the vaginal ring. An investigational drug is one that is currently being tested. It has not been approved the Food and Drug Administration (FDA) for sale in the United States. Volunteer participation in the study will involve 7 research visits over a period of 7 months but participation may take up to 13 months..

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843-792-3330
yeadon@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

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