Systemic sclerosis (SSc) or scleroderma is an autoimmune disease in which a person?s own immune cells attack his/her skin and internal organs, including the joints, lungs, heart, intestinal tract, and kidneys. The effects on the lungs, including pulmonary arterial hypertension (PAH), are among the most serious complications of SSc. In general, PAH is defined as an increase in pressure in the pulmonary arteries (the main blood vessels that lead from the heart to the lungs). Treatments for PAH have focused on symptom management rather than curing the disease.
This study has been designed to look at a new approach to treating the cause of the disease, rather than the symptoms of the disease. Recent research suggests that SSc-PAH may be the result of an ?attack? by immune cells. This study will look at the effect of the drug rituximab on the immune system and the immune ?attack? on the lungs. Rituximab is an immunosuppressive drug that eliminates the B cells for a few months, and therefore may halt the B cell attack on the lungs thought to be associated with this disease.The recovery of your B cells will be closely monitored throughout the study by blood testing.
The primary objective of the study is to assess the safety of Belimumab following treatment with Rituximab and Cyclophosphamide in patients with Lupus Nephritis. The study will last for about 2 years and will involve 20 study visits. Patients who meet criteria will be assigned to one of two groups: Group 1 will have Rituximab plus Cyclophosphamide followed by Belimumab infusions, and Group 2 will have Rituximab plus Cyclophosphamide, but will not have the Belimumab infusions. This study is not blinded, so patients will know what group they are assigned to. Patients will be followed closely by the study doctors to determine their lupus activity levels over the course of 2 years.
People with Cystic Fibrosis (CF) often have thick mucus in the airways of the lungs that is hard to cough up. The mucus can build up and eventually lead to a chronic cough. The mucus is also a good environment for bacteria (germs) to live and grow, rapidly leading to infections. One bacteria, Pseudomonas aeruginosa (Pa) is particularly good at living in the CF lung. People with CF who agree to take part in this study would be those who have had Pa in their lungs for at least 1 year.
The purpose of this research study is to test the effect of an infusion (through a vein) of a drug called gallium nitrate in patients with CF. Laboratory tests suggest that this drug may be able to fight Pa infections. Gallium nitrate is an FDA approved drug that is used to treat high calcium in the blood caused by cancer. The drug also works in other bone diseases and has been used to treat certain cancers.
If the study shows that the drug is safe and may be helpful in treating CF, additional studies with gallium nitrate may be done in patients with CF in the future.
Social stress often leads to drug craving and relapse in cocaine-dependent populations. Currently there are no FDA approved medications for the treatment of cocaine dependence. Therefore, biomedical research studies aimed at investigating the brain mechanisms responsible for controlling emotional responses to social stress could have a significant impact on the development of effective therapeutic treatment strategies for cocaine-dependent individuals.
This study is for individuals with renal cell carcinoma (RCC). The purpose of this study is:
?To find out whether the study treatment can stop your RCC from growing, or prevent it from growing as fast as it would without dalantercept.
?To evaluate the safety of the study treatment in subjects with RCC.
?To find out if the study treatment has an effect on biomarkers (molecules that indicate how well you respond to study treatment) in your blood and/or tissue.
Participants will receive a dose of dalantercept or placebo (a substance with inactive drug that looks the same as dalantercept) plus axitinib. It is expected that a participant will be on this study for a variation of time (total duration will vary per subject).
The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery.
MRI is a medical imaging method that uses magnets to make images of the body. MRI helps doctors to tell the difference between cancer and normal tissue in the body. MRI uses dyes (?contrast agents?) that are injected into the veins to help create the images of the body?s tissues.
Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.
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 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.