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 16th, 2014
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

An open-label phase II study of BKM120 in patients with relapsed and refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma + save

Date Added
July 14th, 2014
PRO Number
Pro00024660
Researcher
Alice Mims
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to learn if the study drug BKM120 can slow the progression of cancers found in the lymph nodes, including diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma, which have worsened despite treatment.The potential harmful effects of BKM120 will also be studied. The subjects functional status, symptoms, the changes in the size of tumors and laboratory results obtained while the subject is receiving the study drug will help the research team to determine if BKM120 is safe and effective in subjects.
BKM120 is a medicine that is being developed for the treatment of different tumor types. It has not been approved yet by the health authorities, for example FDA in US or EMEA for the European Union. The medicine being tested in this study is currently not “on the market” (available for purchase) in any country. So far, approximately 250 patients with different types of tumors have received BKM120, either alone or in combination with another anti-cancer drug in other studies.

Institution
MUSC
Recruitment Contact
Jennifer Clarke
843-792-9579
clarkejh@musc.edu

Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma + save

Date Added
July 14th, 2014
PRO Number
Pro00019706
Researcher
Harry Drabkin
Keywords
Cancer, Men's Health, Women's Health
Summary

This is a study for subjects with transitional cell carcinoma. Transitional cell carcinoma (TCC) is a type of cancer that is usually from the bladder, but can also be from organs associated with the bladder, such as the ureters (tubes connecting the bladder with the kidneys). This research study is evaluating a drug called Everolimus, also known as RAD001, which will be used either alone or with another drug called Paclitaxel as a possible treatment for TCC. Patients with this type of cancer routinely receive Cisplatin-based cancer treatment. However, the study doctor may think that this routine Cisplatin-based cancer treatment will not be good for the patient due to the disease or health condition. After discussing with the study doctor, the patient has the option of participating in this study to receive either Everolimus alone (cohort1) or Everolimus in combination with Paclitaxel (cohort2).
If the patient chooses to take part in cohort 1 of this study, the patient will take Everolimus 10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis. The patient will be provided with an adequate supply of Everolimus for self-administration at home.
If the patient chooses to take part in cohort 2 of this study, the patient will receive Everolimus 10 mg daily orally, as described above, along with Paclitaxel 80mg/m2 given intravenously (in your veins), over one hour on days 1,8 and 15 of a 28-day cycle
The study team would like to keep track of the patient's medical condition for the rest of their life. The study team would like to do this by calling the patient on the telephone once every few months (every 3 months for 2 years from registration for protocol therapy, every 6 months for years 3 - 5 and annually thereafter) to see how the patient is doing. Keeping in touch with the patient and checking the condition helps the study team look at the long-term effects of the research study.

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

Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma + save

Date Added
July 14th, 2014
PRO Number
Pro00021940
Researcher
Saurabh Chhabra
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been been newly diagnosed with advanced (Stage III or IV) classical Hodgkin lymphoma (HL) (a cancer of the lymph nodes) and have not received any treatment for the disease. In this study, patients will receive one of two regimens (or treatment plans), either a regimen that includes an investigational drug called brentuximab vedotin (also known as ADCETRIS®) or the current standard of care treatement (this regimen/group is referred to as Arm B). The main purpose of this study is to measure how well treatment in Arm A works compared to treatment in Arm B for Hodgkin lymphoma. This study is split up into 4 different periods: Screening, Treatment, End of Treatment, and Post-Treatment Follow up. Depending upon how patients respond, their treatment period (the portion of the study where you will continue to receive study treatment) can last approximately 6 months. Patients' study participation, including post-treatment follow-up, can last up to 7 years, depending on when they start the study.

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

A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND #15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM) + save

Date Added
July 8th, 2014
PRO Number
Pro00026934
Researcher
Scott Lindhorst
Keywords
Cancer/Brain, Drug Studies, Men's Health, Surgery, Vaccine, Women's Health
Summary

This study is for subjects who have a type of brain tumor called a glioblastoma multiforme, which has grown after treatment with the drug temozolomide and radiation therapy. The purpose of this study is to compare the effects on the brain tumor of a vaccine called HSPPC-96 given along with a drug called bevacizumab and compare it to the treatment of receiving bevacizumab alone. The use of HSPPC-96 in combination with bevacizumab is investigational. In this study, participants will be randomized to one of three treatment groups. The group a participant is assigned to will determine the treatment combination that will be given. Participants will be asked to take HSPCC-96 and/or bevacizumab until their tumor comes back. After participants are finished taking HSPCC-96 and/or bevacizumab, the study doctor will ask him/her to visit the office for follow-up exams to keep track of his/her medical condition every 8 weeks up to 18 months from the date of the surgery. After that, participants will be followed for about 5 years so doctors can track their medical condition.

Institution
MUSC
Recruitment Contact
John Keller
843-792-1286
kellej@musc.edu

A Multicenter Phase 1/2b Study of the Bruton’s Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination with Carfilzomib (Kyprolis™) in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma + save

Date Added
July 1st, 2014
PRO Number
Pro00031755
Researcher
Saurabh Chhabra
Keywords
Cancer, Men's Health, Women's Health
Summary

This study if for patients that have been diagnosed with muliple myeloma. Pharmacyclics, Inc. (the Sponsor) is studying an investigational new drug called ibrutinib. Ibrutinib is a type of drug called a “kinase inhibitor”. “Kinases” are proteins inside cells that help cells live and grow. The specific kinase inhibited or “blocked” by ibrutinib is believed to help blood cancer cells live and grow. By inhibiting the activity of this specific kinase, it is possible that the ibrutinib may kill the cancer cells or stop them from growing.

The study has two parts:
• Phase 1 tests different doses of ibrutinib and carfilzomib together to study what dose to use in Phase 2b
• Phase 2b will study the effects of the treatment. All subjects will receive carfilzomib, only half of the subjects will receive ibrutinib, to test if there is a benefit to adding ibrutinib to carfilzomib treatment
Participation in this study will last approximately two years. This will include coming to the study center for treatment and follow-up after the study treatment ends.

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

A Multi-centre, Double-blind, Randomised Trial Investigating the Efficacy and Safety of a Combination Therapy, Desmopressin and Tolterodine, for Treatment of Overactive Bladder with Nocturia in Women + save

Date Added
June 23rd, 2014
PRO Number
Pro00022960
Researcher
Ross Rames
Keywords
Bladder, Women's Health
Summary

The purpose of this trial is to investigate how well a combination of two well-known products works on urinary symptoms associated with overactive bladder and nocturia in women. Overactive bladder happens when you cannot control your bladder muscle. If you have symptoms of overactive bladder, you may find that you are unable to control urination, need to rush to the toilet with no advance warning and/or go to the toilet frequently. Overactive bladder is a common condition which is usually accompanied by nocturia. Nocturia is a condition where you have to wake up at night to urinate. Waking up at night to urinate can lead to sleep deprivation with a risk of affecting your quality of life. The two drugs to be studied is Tolterodine and Desmopression. Tolterodine is thought to work mainly on day time symptoms whereas desmopressin works on night time symptoms. A combination of these two products may be an effective treatment of overactive bladder with nocturia as it is expected to address both day and night time symptoms.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

A Phase I-II trial of Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas + save

Date Added
June 23rd, 2014
PRO Number
Pro00021241
Researcher
Scott Lindhorst
Keywords
Cancer, Men's Health, Women's Health
Summary

This study is being performed in patients who have malignant glioma (which includes different types of glioma called “glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma) that has gotten worse after previous treatment or is getting worse despite treatment. There are two phases to this study:
The goal of Phase I of this clinical research study is to find the highest tolerable dose and best schedule of the combination of everolimus and sorafenib that can be given to patients with malignant glioma.
The goal of Phase II of this study is to learn if the combination of everolimus and sorafenib can help control malignant glioma. The safety of this combination will also be studied in both phases.
Sorafenib is designed to stop cell growth and to block the formation of new blood vessels (the tubes that carry blood around the body), which are involved in the growth and development of tumors.
Everolimus is designed to block a special protein in tumor cells and block the formation of new blood vessels, which is important in tumor growth.

Institution
MUSC
Recruitment Contact
Michele DeCandio
843-792-9016
decandio@musc.edu

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

Date Added
June 17th, 2014
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

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 17th, 2014
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