Effect and safety of subcutaneous semaglutide 2.4 mg once weekly compared to liraglutide 3.0 mg once daily on weight management in subjects with overweight or obesity Save

Date Added
September 18th, 2019
PRO Number
Pro00091527
Researcher
Patrick O'neil

List of Studies


Profiles_link
Keywords
Drug Studies, Obesity, Weight Control
Summary

This is a 76-week trial comparing semaglutide 2.4 mg taken once weekly with liraglutide 3.0 mg taken once daily as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity . This is a randomized, double-blinded trial. Each active medication will be compared against a placebo and be administered per a dosing schedule.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity Save

Date Added
September 17th, 2019
PRO Number
Pro00091981
Researcher
Brett Froeliger

List of Studies


Profiles_link
Keywords
Drug Studies
Summary

The overarching goal of this project is to examine the effect of combining theta burst
stimulation (TBS) and N-acetylcysteine (NAC) on cocaine craving and brain response to cocaine images. Participants (N=96) will undergo a baseline MRI visit to assess craving and brain function, then be randomized to one of four SHAM / Placebo-controlled TBS / NAC treatment conditions. Following 3-days of medication (NAC or Placebo), return to the lab for a second MRI visit where brain function will be assess immediately before and after TBS or SHAM stimulation. Participants will be contacted via phone over the following 3-weeks to assess mood and craving.

Institution
MUSC
Recruitment Contact
Katherine Lastrapes
843-882-7916
lastrape@musc.edu

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN) Save

Date Added
September 12th, 2019
PRO Number
Pro00090077
Researcher
John Wrangle

List of Studies

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

This study is for patients that have been diagnosed with Resectable Stages II and III Non-small Cell Lung Cancer (NSCLC). The investigational drug in this study is durvalumab. The purpose of this study is to see if durvalumab will work and be safe for the treatment of resectable NSCLC. Participants can expect to be on this study for about 5 years.

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

A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study) Save

Date Added
September 7th, 2019
PRO Number
Pro00090813
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed to have metastatic Castration-resistant Prostate Cancer (mCRPC). The purpose of this study is to find out if experimental medication called olaparib in combination with approved drug called abiraterone, will work and be safe for the treatment of the disease (mCRPC). Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. Olaparib (tradename Lynparza™) is approved, by the US Food and Drug Administration (FDA) and other countries for the treatment of certain types of ovarian cancer and breast cancer. Abiraterone is already an approved medication for the treatment of some subjects with prostate cancer. This medication is indicated in combination with prednisone or prednisolone for the treatment of mCRPC. The research study is planned to go on for approximately 4 years, with visits lasting three to six hours each. Olaparib, abiraterone, and prednisone are all taken orally.

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

A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer Save

Date Added
September 1st, 2019
PRO Number
Pro00083993
Researcher
Whitney Graybill

List of Studies

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

The purpose of this study is to determine if adding the investigational drugs (TSR-042 and Niraparib) to Standard Of Care delays or prevents ovarian cancer recurrence (prevents the ovarian cancer from coming back). Once eligibility is determined, participants will begin with one of two treatment periods. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. The first treatment period is the chemotherapy treatment period, and the second one is the maintenance treatment period. It is not known how long participation in this study may last.
The Sponsor and Study Doctors cannot and do not guarantee or promise that participants will receive any benefits from this study. There is a chance by taking the study drug participants cancer may not return or the return of cancer may be delayed. It is not known whether participants would benefit from the Study Drug. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. Therefore, participants may not get any direct benefit from taking part in this study. However, what is learned in this study may help in the treatment of ovarian cancer for women around the world and may advance scientific knowledge.

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

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment in Patients with Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma Save

Date Added
August 28th, 2019
PRO Number
Pro00086110
Researcher
Daniel Reuben

List of Studies

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, good or bad, of tislelizumab (also known as BGB-A317) plus chemotherapy against placebo (an inactive substance) plus chemotherapy for adults with locally advanced recurrent or metastatic esophageal squamous cell carcinoma to find out which is better. Subjects may continue study treatment during their participation in the study as long as there is no worsening of disease and they don't have intolerable side effects from the study treatment

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

An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study) Save

Date Added
August 27th, 2019
PRO Number
Pro00091006
Researcher
Charles Greenberg

List of Studies


Profiles_link
Keywords
Blood Disorders, Drug Studies
Summary

The purpose of this study is to evaluate the likely safety and effectiveness of danaparoid sodium versus argatroban for patients suffering from heparin-induced thrombocytopenia (HIT). Patients with HIT will have low blood platelet counts due to being given the medication heparin. Adult and pediatric participants who are determined to be eligible to participate will be assigned by chance to treatment with danaparoid sodium or argatroban. The study drugs are administered through intravenous therapy (IV). Study and safety assessments, including blood draws and compression ultrasounds, will be completed at study visits. Participants will be in this study for at least 45 days, but could receive treatment longer depending on HIT severity. You will be hospitalized while you are receiving study drug treatment for a minimum fo 14 days. You will have 4 study follow-up visits after they have been discharged from the hospital.

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu

A Phase II Study of Palbociclib (PD-0332991) in Combination with Ibrutinib in Patients with Previously Treated Mantle Cell Lymphoma Save

Date Added
August 27th, 2019
PRO Number
Pro00091524
Researcher
Irl Greenwell

List of Studies

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

This study is for subjects that have been diagnosed with mantle cell lymphoma (MCL) and have already received at least one form of treatment. This study will evaluate the effects, good and bad, of the study drugs palbociclib and ibrutinib in your type of cancer. The purpose of this study is to study the effects of an investigational combination of ibrutinib and a drug called palbociclib on MCL. The subject will be in the study for as long as you do not experience any unacceptable side effects and your cancer does not become worse.

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

KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis Save

Date Added
August 13th, 2019
PRO Number
Pro00090247
Researcher
Lara Wine lee

List of Studies

Silhouette
Keywords
Drug Studies, Skin
Summary

The main purpose of this study is to see if taking KPL 716 is effective in relieving itch. The study will also assess whether KPL-716 is effective in improving sleep and quality of life or whether it can promote healing of the skin. This study will compare KPL-716 to a placebo. This study is being done to learn if KPL-716 is an effective and safe treatment for participants with moderate to severe prurigo nodularis experiencing moderate to severe itching. KPL is administered through a subcutaneous injection (shot). Participation in the study will take about 13 visits over a period of 20 weeks.

Institution
MUSC
Recruitment Contact
Charnele Handy
843-792-8008
handyc@musc.edu

A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors Save

Date Added
August 13th, 2019
PRO Number
Pro00090771
Researcher
Daniel Reuben

List of Studies

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to explore any changes in tumors after adult subjects (ages 18+) who have advanced pancreatic or colorectal cancer receive an immunotherapy drug, called BMS-813160, alone or together with another immunotherapy drug, called nivolumab or chemotherapy. BMS-813160 and nivolumab belongs to a class of drugs called immunotherapies. ?Immuno' in ?immunotherapy' refers to the immune system. The immune system is the body's natural defense against illnesses like colds, infections, and cancer. There is no defined length of time for this study. The exact time commitment will depend on several factors, such as availability to come for appointments, cancer's response to the study drugs, reaction to the study drugs, and the sponsor's decision of whether to continue the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9300
hcc-clinical-trials@musc.edu

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