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.
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.
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.
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.
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.