A Phase 3b Continuation study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients with Severe Hemophilia A
The purpose of this study is to continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patient (PTPs) aged less than or equal to 75 years of age with severe hemophilia A.
Patients with severe hemophilia A transitioning from other BAX 855 studies may be eligible for this study. Patients with severe hemophilia A who are BAX 855 na
This treatment study is an16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a ?sugar pill?). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.
Cancer is a disease caused by alterations in the functions of genes within the cells. In approximately 15% of patients with non-small cell lung cancer, one of two genes is altered significantly (known as EGFR mutation or ALK rearrangement). Erlotinib, a pill, taken on a daily basis produces significant decrease in the size of tumors in patients with advanced stage lung cancer with EGFR mutation. Similarly, another pill, crizotinib, produces significant decrease in the size of tumors in patients with advanced stage lung cancer with ALK rearrangement. However it is not clear how useful these two drugs will be in patients with a less advanced form of lung cancer in the presence of these gene alterations.
The purpose of this study is to find out what effects, good and/or bad, one of the following treatments have on locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement).
If the tumor has EGFR mutation, subjects will be randomized to either
? Standard treatment: radiation therapy and chemotherapy
? Experimental treatment #1: erlotinib for three months, then radiation therapy and chemotherapy
If the tumor has ALK rearrangement, subjects will be randomized to either
? Standard treatment: radiation therapy and chemotherapy
? Experimental treatment #2: crizotinib for three months, then radiation therapy and chemotherapy
This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma. PET scans will be obtained during the course of therapy. Researchers will evaluate the usefulness of this PET scan to determine whether radiation may be left out in the treatment of disease if the PET scan shows a response to chemotherapy alone. In addition, a small percentage of patients may have disease that is not adequately treated with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and radiotherapy. Researchers hope to identify this group of patients using early PET scans and will change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone).
This study is designed to look at the safety of taking patients whose lupus is not active off the immune suppression medication, Mycophenolate. It will involve two groups of lupus patients. One group will continue taking Mycophenolate Mofetil (MMF), and the other group will taper off their MMF. Both groups will be followed closely by study doctors to determine their lupus activity levels over the course of 16 months.
The purpose of this research study is to test the safety, effectiveness and tolerability of an investigational drug called DAS181 on subjects with a very weak immune system who are diagnosed with PIV. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). DAS181 can be administered as a reconstituted dry powder that is breathed into the respiratory tract (nose, throat and lungs) using a liquid aerosol spray administered using a nebulizer. A nebulizer is an electrically powered machine that turns liquid medication into a mist so that it can be breathed directly into the lungs through a face mask or mouthpiece.
The purpose of this study is to:
? See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
? See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.
In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent). They will not take both.
Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue.
This study is enrolling male and female patients with a diagnosis of advanced solid tumor. The purpose of this research study is to learn about the effects of and to find the best dose of the study drug, PF 05212384, when given in combination with other drugs. This study will determine the highest dose of PF-05212384 that can be tolerated when given in combination with other drugs; this PF-05212384 dose is called the maximum tolerated dose or MTD. Enrolled patients can expect to be in this study for about 6 months. They will need to visit the research site at least 12 times during the study. Patients may stay in the study until the disease gets worse or they decide to stop participating.
This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.
The purpose of this study is to find out if radiation therapy along with the addition of the drugs, cisplatin and gemcitabine, works in treating locally advanced squamous cell carcinoma of the vulva and to find out what side effects or surgical complications are caused by treatment with this combination.