A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Postpartum Depression and Adult Female Subjects with Moderate Postpartum Depression. Save

Date Added
December 13th, 2016
PRO Number
Pro00061434
Researcher
Constance Guille
Keywords
Depression, Drug Studies, Mental Health, Post Partum Depression, Psychiatry, Women's Health
Summary

This a study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects diagnosed with severe and moderate postpartum depression(PPD). The study will consist of an up to 5-day Screening Period, 3-day Treatment Period, and 30-day Follow-up Period. Subjects must remain as inpatient during the study Treatment Period, which is approximately 60 hours in duration. Assessments and laboratory samples will be collected during the Treatment Period and the Follow-up Period.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation Save

Date Added
November 22nd, 2016
PRO Number
Pro00059262
Researcher
Jennifer Hucks
Keywords
Men's Health, Pulmonary, Women's Health
Summary

The purpose of this study is to evaluate the impact of smart adherence technologies for medication monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with CF who are homozygous for the F508del-CFTR mutation, and to collect subject and physician feedback on the use of smart adherence technology to monitor LUM/IVA adherence.

Institution
Palmetto
Recruitment Contact
Jennifer Hucks
8035455453
alisha.henderson@uscmed.sc.edu

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

A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor Save

Date Added
September 13th, 2016
PRO Number
Pro00058989
Researcher
Sara Giordano
Keywords
Cancer, Cancer/Breast, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to find out if the drug ribociclib (LEE011), when taken with standard treatment, everolimus (Afinitor®) and exemestane (Aromasin®), is safe and beneficial in men and postmenopausal women who have advanced breast cancer that has recently become resistant to anti-estrogen therapy (meaning that your tumor progressed while on or being recently treated with anti-estrogen treatment). Participants in this study will remain on this study until his/her disease gets worse, or he/she no longer wish to participate.

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

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, 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

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