Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy

Date Added
November 5th, 2019
PRO Number
Pro00091874
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Transplant
Summary

This study is for subjects that are about to receive high dose cyclophosphamide before a blood or bone marrow transplant (BMT). The investigational drug in this study is Olanzapine.This research is being done to find out whether adding olanzapine to standard antiemetics will be helpful in controlling CINV in children receiving chemotherapy a blood or bone marrow transplant. To find this out, some of the participants in this study will get olanzapine and others will receive a placebo (a substance that looks like olanzapine but does not have any active or medicinal ingredients). This will allow us to compare treatment of CINV with and without olanzapine.

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

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute ymphoblastic leukemia (B-ALL) who are minimal residual isease (MRD) positive at the end of consolidation (EOC) therapy

Date Added
October 22nd, 2019
PRO Number
Pro00092378
Researcher
Michelle Hudspeth

List of Studies


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

This study is for subjects that have been diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL). The study treatment is called tisagenlecleucel (you may also see it referred to as CTL019, CART-19 or Kymriah™). The purpose of the study is to test an experimental approach called gene transfer in subjects that are considered to have high-risk Acute Lymphoblastic Leukemia (ALL), a type of blood cancer that involves cells in your blood called B cells.
Your study participation in this study will not last for more than 8 years. You will be asked to join another study after this trial so your study doctor can check on you for as long as 15 years after the treatment.

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

A Phase 1/2 Dose-Finding Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

Date Added
October 22nd, 2019
PRO Number
Pro00092360
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to find out what effects, both good and/or bad, of the study drug "NGM120", as well as the combination of NGM120 and standard therapy (gemcitabine and Abraxane) may have on adult subjects and their type of cancer and their cancer associated loss of appetite, weight loss and loss of muscle. Subjects are enrolled into either Part 1 or Part 2 depending on the type of solid tumor and PI assessment. If subjects are enrolled in Part 1 subjects will be on the study for at least 20 weeks not including treatment continuation if applicable and if they are enrolled in Part 2, they will be on the study for at least 19 weeks not including treatment continuation if applicable

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

Development of an Olfactory Screening Instrument

Date Added
October 19th, 2019
PRO Number
Pro00093106
Researcher
Zachary Soler

List of Studies


Keywords
Non-interventional, Nose
Summary

The main objective of this project is to develop a quick and efficient screening instrument to accurately identify individuals with olfactory dysfunction (from all causes of olfactory dysfunction). We hope to systematically develop an olfaction screening instrument that is highly correlated to objective olfaction, as currently, this does not exist. Our overall hypothesis is that we can reliably predict an abnormal objective olfaction score using the screening instrument we develop.

Institution
MUSC
Recruitment Contact
Preeti Kohli
516-713-9934
kohlip@musc.edu

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial

Date Added
October 16th, 2019
PRO Number
Pro00093020
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Inflammation, Surgery
Summary

The goal of the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is to determine if elective colectomy is more effective than best medical management for patients with quality of life-limiting diverticular disease. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

Right Ventricular Reserve Measures with Cardiac MRI

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular, Heart, Sarcoidosis, Scleroderma, Shortness of Breath
Summary

This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)

Date Added
October 7th, 2019
PRO Number
Pro00092649
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The purpose of the study is to compare the effects of apixaban (also known as Eliquis®) with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Subjects will be in the research study for up to 3 years (minimum of 1 year). About 700 people will take part in this study at approximately 125 sites throughout the United States.

Institution
MUSC
Recruitment Contact
Vicki Streets
843-792-8606
streetsv@musc.edu

Operative versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial

Date Added
October 7th, 2019
PRO Number
Pro00088804
Researcher
Josef Eichinger

List of Studies


Keywords
Bone, Joint, Physical Therapy, Surgery
Summary

Patients of age ≥40 to <85 years diagnosed with a rotator cuff tear (with MRI confirmation) who are fit for either arthroscopic rotator cuff surgery or physical therapy will be recruited. The study will compare pain and function in patients undergoing operative versus non-operative treatment of Non traumatic rotator cuff tears at 12 months of follow-up.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

Enhancing Prolonged Exposure Therapy for PTSD with Oxytocin

Date Added
October 1st, 2019
PRO Number
Pro00091548
Researcher
Julianne Flanagan

List of Studies


Keywords
Military
Summary

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that affects our nation's Veterans at staggering rates. The purpose of this study is to examine the ability of a medication (oxytocin) to enhance Prolonged Exposure (PE) therapy for Veterans with Posttraumatic Stress Disorder (PTSD). PE is a widely used cognitive behavioral intervention (talk therapy) for Posttraumatic Stress Disorder (PTSD). In order to accomplish this goal, we are recruiting participants for a clinical trial. Participants enrolled in this trial will complete 10 weeks of a treatment phase, that includes weekly doses of either the investigational study medication or an inactive placebo. In addition, all participants will receive 10 weekly sessions of PE talk therapy. Once per week before each therapy session, participants will take a dose of medication intranasally. This study has the potential to improve patient care practices, advance the science in this area, and decrease public health costs.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

tDCS Combined with a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans

Date Added
October 1st, 2019
PRO Number
Pro00091450
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Brain, Joint, Mental Health, Military, Pain, Psychiatry, Surgery
Summary

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).

This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.

This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). You may benefit in the form of decreased pain and opioid requirements following your knee or hip replacement surgery. However, benefit is only likely if you are randomized to one of the 3 (out of 4) groups.

This study hopes to determine the effects of these interventions and their combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

Institution
MUSC
Recruitment Contact
Georgia Mappin
(843) 789-7104
georgia.mappin@va.gov



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