Comparison of Length of Stay for Infants with GBS Unknown Mothers with Adequate vs Inadequate Treatment Save

Date Added
April 6th, 2018
PRO Number
Pro00077255
Researcher
Rachel Sigrest
Keywords
Children's Health, Disease Prevention, Infant, Non-interventional, Obstetrics and Gynecology, Pediatrics, Pregnancy, Women's Health
Summary

The primary investigators/residents have noted during clinical rotations that a significant number of GBS unknown mothers at SRHS are being treated with intrapartum antibiotics even without the presence of risk factors, presumably to decrease postpartum/neonatal length of stay.
Our study, a retrospective chart review, will determine whether or not length of stay is affected by treating GBS unknown mothers with intrapartum antibiotics in the absence of the aforementioned risk factors.
Potential benefits include the cost-effectiveness of decreased length of stay for these patients as well as decreased exposure to nosocomial infections for neonates. However, antibiotic stewardship and patient safety are also considerations. Another potential option for these patients is rapid GBS testing with PCR which can provide results in 1-2 hours compared with 24-48 hours for the standard culture. PCR is not currently available at SMC.

Institution
Spartanburg
Recruitment Contact
Rachel Sigrest
8643800885
racheljames1985@gmail.com

A randomized, double-blind Phase II study of pembrolizumab versus placebo in patients with head and neck cancers at high risk for recurrence or low-volume residual disease ? the PATHWay Study Save

Date Added
March 27th, 2018
PRO Number
Pro00076352
Researcher
John Kaczmar

Silhouette
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with squamous cell carcinoma of the head and neck (SCCHN). The investigational drug in this study is Pembrolizumab. The main purpose of this study is to attempt to reduce the risk of cancer recurrence using a drug called pembrolizumab. Participants can expect to be in this study for approximately 5 years.

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

A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Save

Date Added
March 13th, 2018
PRO Number
Pro00072764
Researcher
Brian Hess

Silhouette
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with relapsed or refractory diffuse large B cell lymphoma (DLBCL). The investigational drugs in this study are blinatumomab and pembrolizumab. The purpose of this study to learn more about the combination of blinatumomab and pembrolizumab in people with DLBCL. It will see if blinatumomab and pembrolizumab cause any side effects and how well they work.The duration of treatment will vary for each participant, but could last up to 3 years.

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

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth

Silhouette
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

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

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML Save

Date Added
February 13th, 2018
PRO Number
Pro00072488
Researcher
Robert Stuart

Silhouette
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with acute myeloid leukemia (AML) with a genetic mutation called FLT3/ITD. The investigational drug in this study is called gilteritinib (ASP2215). The main purpose of this study is to learn if it is safe and effective to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. The sponsor wants to know if this drug works better than a placebo to stop the AML from coming back. Participants can expect to be in this study for up to 7 years after they start the study drug.

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

Positive Psychotherapy for Emerging Adult Females with Obesity Save

Date Added
January 2nd, 2018
PRO Number
Pro00072810
Researcher
Lillian Christon arnold

Silhouette
Keywords
Obesity, Women's Health
Summary

Emerging adults with obesity are at risk of developing further health problems as they progress into adulthood. There are limited interventions developed for this population, and no interventions specifically study the role of mood and positive affect on improving motivation for healthy lifestyles. Positive psychological wellbeing is linked to improved cardiometabolic risk and health via improved health behaviors and biological functioning. Given biological and psychological differences between males and females during this transition period, targeted interventions for each gender are needed. In this small pilot study, Quality of Life Therapy (QOLT), an empirically-supported and manual-guided intervention combining CBT and positive psychology techniques, will be adapted for emerging adult females with obesity. For this small pilot, we will use a sample of emerging adult females with obesity (EAO) 18-25 years to refine and test feasibility of QOLT adapted for this specific population (QOLT-EAO), with a focus on developing motivation for healthy lifestyles.

Institution
MUSC
Recruitment Contact
Lillian Christon Arnold
843-792-0686
christon@musc.edu

A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin (ASG-22CE) in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer Save

Date Added
December 12th, 2017
PRO Number
Pro00072223
Researcher
Theodore Gourdin

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Urinary, Women's Health
Summary

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

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

A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies Save

Date Added
November 14th, 2017
PRO Number
Pro00067774
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this first in human study is to find a safe dose level of the investigational drug REGN3767 alone or in combination with REGN2810. Other purposes of this study are to measure the levels of REGN3767 and REGN2810 in the subject's blood and to collect any evidence of tumor shrinkage when given alone or in combination with REGN2810.
REGN3767 and REGN2810 are both a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in your blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target a specific protein in the body that may be involved in the subject's cancer.
In this part of the study each participant will receive 1 of 3 different doses of REGN3767 alone or in combination with one dose of REGN2810. There will be a total of 6 different groups of participants the study team plans to study based on what dose of REGN3767 they receive and whether they receive it alone or with REGN2810.
The study is sponsored by Regeneron. The investigator in charge of this study at MUSC is Carolyn Britten, MD. Part 1 of this study is being done at 4-5 sites. Approximately24-48 people will take part study-wide.

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

A Phase 1b, Randomized, Open-Label Study Of PEGylated Recombinant Human Hyaluronidase (PEGPH20) In Combination With Cisplatin Plus Gemcitabine And PEGPH20 In Combination With Atezolizumab And Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine In Hyaluronan-High (HA-high) Subjects With Previously Untreated Unresectable, Locally Advanced Or Metastatic Intrahepatic And Extrahepatic Cholangiocarcinoma And Gallbladder Cancer Save

Date Added
October 24th, 2017
PRO Number
Pro00071570
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Men's Health, Women's Health
Summary

The purpose of this study is to study test investigational drugs PEGPH20 and Atezolizumab in combination with the current standard of care medications Cisplatin and Gemcitabine.

Subjects are being asked to participate in this study because they are/have intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma which are types of cancers associated with the liver or biliary system. The study is sponsored by Halozyme.

This study involves the adiminstration of an invetigational drug (not approved by the FDA) PEGPH20 in order to determine what a safe dose is when given with Cisplatin and Gemcitabine, what the side effects are, and whether or not it will help treat the kind of cancer you have. PEGPH20 is an enzyme (protein that can speed biochemical reactions) that breaks down a specific substance called hyaluronan produced by some tumors. The removal of hyaluronan from tumors has been shown to inhibit tumor growth.

Atezolizumab is an immunotherapy drug which means it assists your immune system in fighting your cancer. This drug has been approved by the United States Food and Drug Administration (FDA) to treat bladder and lung cancer, but is investigational with the drugs described above and for the diagnosis of intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma . The other therapy that is given in this study is standard of care chemotherapy drugs Cisplatin and Gemcitabine, which are drugs that are routinely given to treat patients with cholangiocarcinoma or gallbladder adenocarcinoma cancers who are not in research studies.

The investigator in charge of this study at MUSC is Dr. Carolyn Britten. Approximately 70 subjects will take part study wide at about 20 centers in the United States and 10 centers in Asia. Halozyme will be providing funding to MUSC and Dr. Britten for conducting this research.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-4271
hcc-clinical-trials@musc.edu

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors Save

Date Added
October 10th, 2017
PRO Number
Pro00069285
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study to learn more about a new experimental drug called TSR-022 and its effect on the subject's cancer when used either alone or with another experimental drug called TSR-042. TSR-022 is considered investigational, which means that TSR-022 alone or in combination with TSR-042 has not been approved by any regulatory authorities, including the United States Food and Drug Administration (FDA), and is not available in stores or by prescription.
The main purposes of Part 2 are to:
Look at the ability of TSR-022 when taken alone or in combination with TSR-042 to make the cancer smaller
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken by itself
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken with TSR-042 as Combination Therapy.
This study will enroll patients with advanced melanoma, advanced colorectal cancer and advanced non-small cell lung cancer (NSCLC).

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-4271
hcc-clinical-trials@musc.edu

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