Pelvic Floor Disorders Registry - Research Registry (PFDR-R) Save

Date Added
November 21st, 2016
PRO Number
Pro00053947
Researcher
Autumn Edenfield
Keywords
Obstetrics and Gynecology, Urinary, Women's Health
Summary

This is a national database to track patient information and outcomes from surgical and non-surgical treatment for pelvic floor disorders. This will allow for best practices to be identified, and will also track surgeons and institutions in order to recognize clinical centers of excellence. Individual practitioners will be able to track their own data on outcomes for reporting purposes.

Institution
MUSC
Recruitment Contact
Autumn Edenfield
843-876-3292
edenfie@musc.edu

The impact of percutaneous minitracheostomy on patients with spontaneous intracerebral hemorrhage and acute respiratory insufficiency: a pilot study Save

Date Added
October 24th, 2016
PRO Number
Pro00054147
Researcher
William Owens
Keywords
Hypertension/ High Blood Pressure, Men's Health, Nervous System, Stroke, Women's Health
Summary

Patients with spontaneous non-traumatic intracerebral bleeding and acute respiratory insufficiency will be considered for a minitracheostomy to help facilitate suctioning and airway clearance. Selected patients will be adults who are intubated for at least 24 hours, who are not candidates for surgical evacuation of the hematoma, and who are considered to be higher risk for extubation failure based on depressed mental status and airway secretions. After obtaining informed consent for the procedure, a spontaneous breathing trial will be performed to make sure that the patient is capable of breathing without the assistance of the mechanical ventilator. A small, 1 cm incision will be made over the cricothyroid membrane using standard aseptic precautions and local anesthesia. The endotracheal tube will be withdrawn, and the minitracheostomy catheter will be passed through the incision into the airway. The minitracheostomy catheter will remain in place until the patient's attending physician feels that it is no longer needed for airway clearance.

Institution
Palmetto
Recruitment Contact
Alisha Henderson
803-799-5022
alisha.henderson@uscmed.sc.edu

A Screening Study to Detect Tumor Antigen Expression Save

Date Added
October 4th, 2016
PRO Number
Pro00058438
Researcher
John Wrangle
Keywords
Cancer, Disease Prevention, Men's Health, Women's Health
Summary

This is a cross-sectional, observational study. This study is for subjects with specific histologically confirmed malignancies
Cancer subjects will undergo testing of their tumor tissue for tumor antigen expression, which may consist of the submission of an archived or fresh tumor specimen for appropriate testing. For instance, subjects who may be considering enrollment in a trial involving rovalpituzumab tesirine, an antibody-drug conjugate targeting delta-like protein 3 (DLL3), will undergo tumor expression testing for DLL3 by immunohistochemistry (IHC). Subjects may be observed for progression and survival.
The investigator and subject will be made aware of the results of this testing, to guide consideration for clinical research protocols where interventions include the use of testing for target specific tumor antigens.

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

Phase 1b/2 Study Of Pf-04136309 In Combination With Gemcitabine And Nab-paclitaxel In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Save

Date Added
September 13th, 2016
PRO Number
Pro00057607
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Pancreas, Women's Health
Summary

The purpose of this study is to learn about the safety and effectiveness of the investigational (not yet approved by the FDA) study drug, PF-04136309, when given in combination with nab-paclitaxel plus gemcitabine, and to find the best dose for treating metastatic pancreatic cancer.
Nab-paclitaxel and gemcitabine are approved in the United States and are available by prescription for metastatic pancreatic cancer. However, the use of nab-paclitaxel and gemcitabine in combination with PF-04136309 are investigational in this research study because they are not currently approved to metastatic pancreatic cancer in combination with PF 04136309.
This research study will be conducted in 2 parts as a Phase 1b (Part 1) and Phase 2 (Part 2).
In Phase 1, different doses of PF-04136309 in combination with nab-paclitaxel plus gemcitabine will be used in a small group of patients in order to determine the highest safe dose that can be taken and to select the dose that will be used for the next part of the study, Phase 2.
The study is sponsored by Pfizer. The investigator in charge of this study is Carolyn Britten. For Phase 1b (Part 1), there will be up to about 20 people at least 18 years old enrolled in this study. The study is being done at about 4 different research sites in the United States. About 2 to 4 people will be enrolled at MUSC.

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

The Attitudes and Experiences of Advanced Practice Nurse Practitioners on Point of Care Ultrasonography Save

Date Added
August 12th, 2016
PRO Number
Pro00056005
Researcher
Calla Sanders
Keywords
Education, Men's Health, Non-interventional, Women's Health
Summary

Our belief is that point-of-care ultrasound has not transcended into the nurse practitioner?s clinical practice in the form of formal or informal training. This survey aims to determine the accessibility to and utility of point-of-care ultrasound amongst nurse practitioners for patient evaluation as well as gauge their interest in formalized training.

Institution
Palmetto
Recruitment Contact
Alisha Henderson
545-5453
alisha.henderson@uscmed.sc.edu

A Multi-center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma Save

Date Added
August 9th, 2016
PRO Number
Pro00055991
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

The purpose of this study is to evaluate the progression free survival (PFS) , based on investigator radiologic review, of AGS-16C3F compared to axitinib in adult subjects with metastatic renal cell carcinoma. The time frame for PFS is 24 months.

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

A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia Save

Date Added
August 9th, 2016
PRO Number
Pro00057288
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patient that has been diagnosed with Acute Myeloid Leukemia (AML). The experimental (investigational) drug that is being tested for treatment of acute myeloid leukemia (AML), called CX-01. The purpose of this study is to find out whether or not the addition of the study drug, CX-01, to standard of care treatment for AML increases the rate of remission. Participants can expect to be in this study for approximately 18 months.

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

An open-label, multi-center, Expanded Treatment Protocol of Midostaurin (PKC412) in adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy Save

Date Added
August 9th, 2016
PRO Number
Pro00057572
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with acute myeloid leukemia with mutations in the Fms-like tyrosine kinase receptor (FLT3). The investigational drug in this study is midostaurin. The purpose of this study is to provide access to midostaurin and gather additional safety data on the combination of midostaurin and standard chemotherapy in subjects 18 years of age, or older, with newly diagnosed AML that have a FLT3 mutation (ITD or TKD). Participants can expect to be in this study for about 1 year.

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

A Randomized, Double-Blinded, Phase II Study of Maintenance Pembrolizumab versus Placebo after First-line Chemotherapy in Patients with Metastatic Urothelial Cancer Save

Date Added
August 9th, 2016
PRO Number
Pro00057764
Researcher
Theodore Gourdin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.

Institution
MUSC
Recruitment Contact
HCC Clincial Trials Office
843-792-9321
hcc-clinical-trials@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

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