Long term health impacts of olfactory dysfunction Save

Date Added
June 17th, 2020
PRO Number
Pro00100591
Researcher
Rodney Schlosser

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Keywords
Alzheimers, Dementia, Geriatrics, Nose
Summary

Loss of smell may affect over 20% of the population, specifically among older age groups and can result in significant health impacts. Smell loss can substantially affect an individual's overall well-being and quality of life. The purpose of this study is to evaluate the impacts of smell loss on neurologic disease (such as Alzheimer's and dementia) and on the risk of death over a 10-year period. We hypothesize that decreased sense of smell is associated with development of neurodegenerative disease and mortality. Participants in this study will fill out an electronic questionnaire (about 30 minutes long) at study entry, and a shortened electronic questionnaire (about 15 minutes long) every year after that for 10 years. No in-person visits are needed.

Institution
MUSC
Recruitment Contact
Kristina Storck
(843) 792-9496
sinus-research@musc.edu

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation Save

Date Added
May 28th, 2020
PRO Number
Pro00096416
Researcher
John Wrangle

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

This study is for patients who have been diagnosed with solid tumor malignancy with KRAS G12C mutation. The investigational drug used in this study is MRTX849. The purpose of this study is to see if patients with cancer with a KRAS G12C mutation will benefit from treatment with MRTX849, what side effects occur and how often they occur and to see how quickly MRTX849 is absorbed into the blood stream and how fast it is removed by the body. Participants can expect to be in this study for as long as the disease does not get worse.

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

Integration of Prolonged Exposure (PE) and Coping Long-Term with Active Suicide Program (CLASP) for PTSD and Suicide Risk in Military Families Save

Date Added
April 7th, 2020
PRO Number
Pro00098186
Researcher
Anouk Grubaugh

List of Studies


Profiles_link
Keywords
Mental Health, Military, Psychiatry
Summary

The purpose of this study is to see whether an integrated treatment for trauma survivors who are thinking about suicide called Prolonged Exposure and Coping Long Term with Active Suicide Program ("CLASP-PE") helps to reduce distress and improve safety. Participants will be asked to attend up to 16 therapy sessions held once or twice each week and complete questionnaires about mood and anxiety levels four times (before treatment, after treatment, and at 3- and 5-month follow-up. Study participation will last 5-6 months (weekly for up to 16 weeks and then once for assessments at 3 and 5 months).

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

Treatment of Symptomatic Spondylolysis and Spondylolisthesis Save

Date Added
March 2nd, 2020
PRO Number
Pro00092708
Researcher
Robert Murphy

List of Studies

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Keywords
Pain, Surgery
Summary

Spondylolysis and spondlyolisthesis are rare conditions in children and adolescents. The long term outcomes of treating these patients are unknown. The purpose of this study is understand the symptom relief and quality of life of this patient population.

Institution
MUSC
Recruitment Contact
Robert Murphy
843-792-9542
murphyr@musc.edu

Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia Save

Date Added
February 6th, 2020
PRO Number
Pro00094221
Researcher
Robert Stuart

List of Studies


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

This study is for subjects that are newly diagnosed with acute myeloid leukemia with FLT3 mutations. The investigation drug in this study is crenolanib. The purpose of this study is to compare the efficacy an investigational drug called crenolanib (also referred to as study drug in this consent) with midostaurin (RYDAPT®) which has been approved for treatment of newly diagnosed acute myeloid leukemia patients with FLT3 mutations. The estimated average time that a subject will receive study drug on this study is about 12 months. The subject will take study drug as long as there is clinical benefit (that is their leukemia does not progress) and they are able to tolerate the study drug.

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

A Multi-Institutional Neurocognitive Discovery Study (MINDS) in Adult Congenital Heart Disease (ACHD): MINDS-ACHD Save

Date Added
January 16th, 2020
PRO Number
Pro00085138
Researcher
John Rhodes

List of Studies

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Keywords
Heart
Summary

This is a multicenter cross-sectional pilot analysis of objective and subjective neurocognitive deficits (NCD) and genetics in the Adults with Congenital Heart Disease (ACHD) population ages 18-30 years with moderate and severe complexity of congenital heart disease (CHD).

The expectation is that studying NCD in ACHD will help to guide access to resources and appropriate medical care for these patients. This research should facilitate the use of targeted interventions in the ACHD population with NCD to enhance both long term quality of care and quality of life (QOL).

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

A Multicenter, Randomized, Controlled Phase 2 study: Efficacy And Safety Of I-131-1095 Radiotherapy In Combination With Enzalutamide In Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Are 18F-DCFPyL Prostate-Specific Membrane Antigen (PSMA)-Avid, Chemotherapy-na Save

Date Added
January 14th, 2020
PRO Number
Pro00094109
Researcher
Michael Lilly

List of Studies


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

You are being invited to take part in this phase 2 clinical study because you have metastatic castration resistant prostate cancer and are planned for enzalutamide therapy. I-131-1095, an investigational drug, and 18F-DCFPyL, an investigational agent, meaning that they have not yet been approved for commercial use by the United States (US) Food and Drug Administration (FDA). In this study, you will first receive an injection of the first investigational agent, 18F-DCFPyL , which is to diagnostically see if your prostate cancer has high likelihood of benefiting from treatment from the second investigational study drug, I-131-1095 which is used for therapeutic therapy.

If so, I-131-1095 is received by IV together with enzalutamide, which is an oral drug. Enzalutamide is an FDA approved standard of care drug typically used in cancer treatments. People who take part in this study will either receive I-131-1095 radiation therapy together with enzalutamide, or enzalutamide alone. The duration of this study is approximately two years long.

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

A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants Save

Date Added
December 10th, 2019
PRO Number
Pro00091762
Researcher
Carol Wagner

List of Studies


Profiles_link
Keywords
Children's Health, Infant, Pediatrics
Summary

Babies that are born extremely prematurely are at higher risk of developing chronic (long term) lung disease (CLD) and other complications (problems). The purpose of this study is to test the safety and effectiveness of an investigational drug called mecasermin rinfabate (rhIGF-1/rhIGTBP-3) or SHP607. The researchers want to find out if SHP607 can help reduce the risk of chronic lung disease in babies born prematurely and if it can help reduce the risk of other complications.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@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

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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

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