A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study) Save

Date Added
November 12th, 2019
PRO Number
Pro00092860
Researcher
Edwin Smith

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Keywords
Autoimmune disease, Drug Studies, Immune System, Rare Diseases, Scleroderma, Stage III
Summary

The purpose of this study is to find out more information about the study drug iloprost for the treatment of symptomatic Raynaud's phenomenon (RP) attacks in people with scleroderma. A Raynaud's attack is defined as one where you notice at least one color change of your finger(s) (blue, white, or red) associated with at least one symptom (pain, numbness, tingling, and/or discomfort of the finger[s]). Your participation in this study will last approximately 9 weeks and will include 8 visits to the study center and 1 phone call from the study staff.

Institution
MUSC
Recruitment Contact
Nathan Wilson
843-792-8613
wilsonn@musc.edu

A preliminary study to investigate the unique needs to survivorship care in advanced-stage prostate cancer survivors. Save

Date Added
October 18th, 2019
PRO Number
Pro00091217
Researcher
Alejandra Schimmel

List of Studies

Keywords
Cancer/Genitourinary, Prostate, Stage III, Stage IV
Summary

This preliminary study proposes to explore the unmet survivorship care needs of advanced-disease prostate cancer survivors. The study will use a qualitative approach by giving this population the opportunity to voice their attitudes, perceptions, and preferences regarding their current survivorship care. The overarching goal is using these results to inform the need for a larger scale study in the future to increase the knowledge base regarding late-disease prostate cancer survivors.

Institution
MUSC
Recruitment Contact
Michael Lilly
843-792-0592
lillym@musc.edu

A RANDOMIZED CONTROLLED STUDY TO COMPARE THE SAFETY AND EFFICACY OF IPX203 WITH IMMEDIATE-RELEASE CARBIDOPA-LEVODOPA IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Save

Date Added
July 28th, 2019
PRO Number
Pro00088773
Researcher
Vanessa Hinson

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Keywords
Drug Studies, Parkinsons, Stage III
Summary

IPX203 is an investigational extended-release (i.e. releases drug more slowly) capsule formulation of carbidopa-levodopa (CD-LD) administered orally (by mouth). "Investigational" means that IPX203 is being tested and has not been approved for marketing.

IPX203 is being investigated to determine whether the drug is safe and potentially has a better effect than currently approved IR CD-LD. If successful, the drug could possibly improve the daily control of motor symptoms in people with Parkinson's disease.

IPX203 is provided as a capsule containing 140 mg LD and 35 mg CD. The study doctor may adjust the IPX203 dosing regimen based on your response to the study drug during the 4 week dose conversion period. Your study doctor will instruct you on the dose of IPX203 or IPX203 placebo that you will receive during the 13-week portion of the study.

Your total participation time in the study will be approximately 24 weeks (6 months), which includes 4 weeks for your initial assessment (screening) period to determine if the trial is suitable for you.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu

Hyperbaric Oxygen Radiation Sensitization for Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck Save

Date Added
May 22nd, 2019
PRO Number
Pro00079382
Researcher
Richard Clarke

List of Studies

Keywords
Cancer/Head & Neck, Stage III, Stage IV
Summary

This study is designed to answer the question "Does the addition of hyperbaric oxygen to radiation and chemotherapy improve outcomes in locally advanced head and neck squamous cell carcinomas?"
There is reason to believe that provision of hyperbaric oxygenation immediately (within 15 minutes) prior to radiation therapy will improve radiation's effect on tumor cells, particularly those that reside in a low oxygen environment.This concept has been proven in implanted tumor-bearing animals. Several small case series suggest there is a modest extension of survival in malignant gliomas.
Squamous cell carcinomas are particularly suited to hyperbaric sensitization as they have a relatively large number of hypoxic cells.
Patients concurrently receiving chemo-radiation standard of care will be placed into a hyperbaric chamber and randomized to receive either pressurized oxygen (the experimental group) or pressurized air (the sham control group).This process will be repeated prior to each scheduled radiation treatment.
Primary outcomes to be assessed are progression-free survival and disease-free survival at two years.
Several other institutions with join in this research initiative, both in the US and internationally.

Institution
Palmetto
Recruitment Contact
Richard Clarke
803.600.3510
dick.clarke@palmettohealth.org

Establishment of a Registry for Patients Treated with Photodynamic Therapy (PDT) Save

Date Added
October 18th, 2018
PRO Number
Pro00082282
Researcher
Gerard Silvestri

List of Studies


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Keywords
Cancer, Cancer/Lung, Stage I, Stage II, Stage III, Stage IV
Summary

Photodynamic therapy (PDT) is a type of treatment used to treat cancer. The purpose of this research study is to collect information on patients treated with PDT so that we can determine if patient characteristics affect their response to PDT. We will collect information about medical history, life style habits like smoking, reports from the tissue taken during biopsy, and outcome of the treatment to include in the registry.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin Save

Date Added
May 18th, 2018
PRO Number
Pro00077581
Researcher
Anand Sharma

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Head & Neck, Stage II, Stage III
Summary

This study is for patients that have been diagnosed with stage III-IVB Head and Neck cancer. The investigational drug in this study is MEDI4736 (Durvalumab). The purpose of the safety lead-in portion of the study is to determine whether adding the study drug MEDI4736 to radiation is safe in patients with head and neck cancer who cannot take the drug cisplatin. The purpose of the phase II/III portion is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. Participants in the safety lead-in portion can expect to be in this study for approximately 2.5 years. Participants in the Phase II/III portion can expect to be in the study for up to 32 weeks, and then followed by their study doctor to monitor for side effects every year.

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

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