Dose Comparison
Phase 1 Open Label Study of MDX-1105 in Subjects With Solid Tumors
The primary purpose of this study is to determine the safety of MDX-1105. The study will also evaluate the preliminary effectiveness of the study drug in various types of solid tumors. How MDX-1105 is absorbed,distributed,metabolized and eliminated from the body will also be studied.
RAD001 and Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma
The purpose of this research study is to determine the highest dose of lenalidomide and RAD001 that can be given without causing too many serious side effects. Another goal of this research study is to look at how the participants cancer may respond to the study treatment. Additionally, we wish to learn more about how the body breaks down and gets rid of the study drugs. We will also try to find substances in the blood (biomarkers) that may help predict how myeloma will respond to study treatment.
- Adult
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Dose Comparison
- Massachusetts General Hospital
- Mayo Clinic
- Medical College of Wisconsin
- Memorial Sloan-Kettering Cancer Center
- Multiple Myeloma
- Non-Randomized
- Open Label
- OTHER
- Safety/Efficacy Study
- Senior
- Single Group Assignment
- Treatment
Air Muscle and Task Practice in Upper Limb Stroke Rehab
Many patients who have sustained strokes are unable to effectively use their hemiparetic upper extremity. Limited mobility in the performance of daily activities, such as eating or dressing, adversely affects their quality of life and compromises independence. Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may improve upper extremity function and quality of life in patients with stroke, but costs limit the number of patients that can utilize this type of therapy. Advances in microprocessor design and function make the use of an assistive device as an adjunct to RTP plausible. An innovative assistive repetitive motion (ARM) device using an "air muscle" has been developed specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of the proposed study is to collect pilot data to estimate the clinical effectiveness of using the ARM device in conjunction with RTP to improve upper extremity motor function and the quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4 hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical motor function and quality of life measures will be taken before and after the interventions and two months later. We hypothesize that the ARM + RTP group will exhibit greater improvements in motor function and quality of life measures than the RTP only group.
Phase I Trial of an Investigational Small Pox Medication
The purpose of this study is to evaluate the pharmacokinetic properties of a single does of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome
In summary, the CHILLAS study will be the first multicenter study performed in a Chinese population using a patient-level analysis to compare the effects and safety of intensive statin therapy with that of moderate statin therapy. Therefore, it will determine whether "lower is better", that is, whether LDL cholesterol lowering to a level of approximately 100mg/dl provides a benefit inferior to that of LDL cholesterol lowering to a much lower level; examine the role of inflammatory markers in predicting cardiac events and response to statin therapy; and evaluate the effects of statin therapy on regression of coronary atherosclerosis using IVUS.
Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
The purpose of this study is to determine the efficacy of pioglitazone combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.
Linezolid to Treat Extensively-Drug Resistant Tuberculosis
This study, conducted in Masan, South Korea, will investigate the effectiveness of linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB). Because regular medicines do not work well against XDR TB, many more people die from it than from regular TB, which can be successfully treated by taking TB medication for 6 months. Linezolid has been used to treat other kinds of infections, but has not been well studied for TB. This study will look at the side effects and effectiveness of prolonged treatment with linezolid at two different doses. People 20 years of age and older who have XDR TB may be eligible for this 3-year study. Participants undergo the following tests and procedures:
- LZD treatment: Patients are randomly assigned to one of two study groups. Group 1 patients are observed for 2 months before starting LZD, while group 2 patients begin taking LZD right away. Both groups begin with a 600 mg daily dose of LZD. After patients stop coughing up TB germs (or after 4 months on LZD) they are randomly assigned either to continue taking 600 mg of LZD for the rest of the study or to take a decreased dose of 300 mg. In addition to LZD, patients continue to take their currently prescribed TB medications.
- Medical history.
- Physical examinations each month during treatment.
- Sputum collections once a week or more until 3 weeks after the patient is no longer contagious.
- Blood draws every week for 16 to 24 weeks and then once a month.
- Urine collections at several time points.
- Nerve and eye examinations before starting treatment and then monthly to look for possible LZD side effects.
- CT scans of the lungs three to four times the first year and once more later in the study. For this test the patient lies on a table within the doughnut-shaped CT scanner while special X-ray pictures are taken.
Patients who participate in a substudy will have PET scans instead of the CT scans. For this test, the patient is given an injection into a vein of a radioactive chemical that can be detected by a special camera and viewed on a screen. The patient lies on a table within the doughnut-shaped scanner while pictures are taken.
Mechanisms by Which Strength Training Ameliorates the Metabolic Syndrome
Prevention and treatment strategies for diabetes use exercise as the cornerstone. Even though endurance training and strength training both improve insulin resistance, strength training may be better suited for persons at risk for type 2 diabetes. We will expand our pilot studies of muscle adaptation induced by resistance exercise training to determine the biochemical mechanisms that will cause people with the Metabolic Syndrome to secure major benefit from intense strength training.
Intramuscular Lipid and Insulin Action:Ethnic Aspects
African-American (AA) individuals are less sensitive to insulin than Caucasian (C ) individuals, a difference that may bear upon the greater prevalence of type 2 diabetes among AA. Lower insulin sensitivity (Si) among AA is independent of body composition, body fat distribution, diet, and physical activity. To date, no explanation has been uncovered for lower Si among AA. The PI's recent research has indicated that intramyocellular (IM) lipid, as estimated using attenuation values from a single-slice computed tomography scan of the quadriceps muscle, is higher among AA vs C postmenopausal women. Accumulation of IM lipid has been associated with impaired Si. The Specific Aims of this proposal are to:
- Verify, using magnetic resonance spectra, that IM lipid is higher in AA vs C;
- Determine how IM lipid relates to Si among AA and C subjects.
- Determine if manipulation of ML via dietary intervention alters Si in healthy AA and C subjects.
A. Quantify ML and Si before and after treatment with a low- vs moderate-fat diet. Preliminary data from the investigative team have shown that a low-fat diet will deplete IMCL. B. Quantify ML and Si before and after treatment with a low- vs moderate-carbohydrate (CHO) diet. Preliminary data from the investigative team have shown that a low CHO diet reduces AIRg. The specific hypotheses to be tested are that:
- IM lipid will be higher in AA vs C;
- Greater IM lipid will be associated with lower Si;
- Greater IM lipid will explain lower Si among AA vs C.
- A low-fat diet will deplete ML and increase Si among both AA and C.
- A low-CHO diet will decrease glucose-stimulated insulin secretion, which will result in an increase in adiponectin. The increased adiponectin will lead to an increase in ML oxidation, and a decrease in measured ML; as a result, Si will increase. These effects will be apparent primarily among AA, who have greater first-phase insulin secretion than C.
A Phase 1/2, Multi-Center, Open-Label, Dose-Escalation Study of HuLuc63 (Humanized Anti CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.
This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of HuLuc63 and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, HuLuc63 will be administered by intravenous (IV) injection at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of IV bortezomib at 1.3 mg/m2. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). HuLuc63 will be administered as a separate infusion within 30 minutes following the bortezomib infusion on the same days as the first and last dose of each bortezomib cycle (ie, Days 1 and 11).
