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.
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.
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.
Exercise adoption enhances well-being and recovery from breast cancer. In two previous studies, we have trained community volunteers with the American Cancer Society to provide exercise counseling for breast cancer survivors and the survivors increased their exercise in the short-term (R01 CA132854). This randomized controlled study examines the effects of three maintenance conditions following the 3-month exercise counseling provided by the community volunteers on exercise participation among breast cancer patients at longer follow-ups.
To begin, all study participants (n=150) will receive a 3-month telephone-based exercise program from Reach to Recovery (RTR) volunteers at the American Cancer Society. This will be followed by three maintenance programs during Months 4-9: Reach Plus (participants will receive exercise logs and feedback reports), Reach Plus Phone (monthly counseling calls from coaches, exercise logs and feedback reports) and 3) Reach Plus Messages (monthly email/text messages, exercise logs and feedback reports).
We will enroll 150 women who have completed treatment for breast cancer and assess their exercise behavior, fatigue, quality of life, and mood at baseline (before the 3 month exercise program), 3, 6, 9 and 12 months. The costs and effectiveness of the three groups will be examined to help guide future dissemination of this peer mentoring approach in community-based organizations to enhance cancer survivorship.