Dose Comparison

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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.

Background information
Other unique IDs: 
MDX 1105-01

RAD001 and Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

Trial phase: 
Phase I
Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00729638
Other unique IDs: 
07-288
RV-MM-PI-142
Official title: 

An Open-Label Phase I Study of the Safety of and Efficacy of RAD001 in Combination With Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

Detailed description: 
  • Researchers are looking for the highest doses of RAD001 and lenalidomide used in combination that can be given safely so small groups of people will be enrolled in steps in this trial. The first group will be given a certain dose of RAD001 and a certain dose of lenalidomide. If they have few or manageable side effects, the next small group of people will be enrolled with a higher dose of RAD001 and/or a higher dose of lenalidomide. This will continue until the highest dose of the drugs used is determined.
  • Study treatment will be given in 28 day cycles.
Number to be enrolled: 
40 patients

Air Muscle and Task Practice in Upper Limb Stroke Rehab

Trial phase: 
Phase 0
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00729625
Other unique IDs: 
R21HD045514
7R21HD045514-03
Official title: 

Air Muscle and Task Practice in Upper Limb Stroke Rehab

Detailed description: 

Specific Aim 1: Estimate the effectiveness of using an assistive repetitive motion device (ARM) in conjunction with repetitive task practice (RTP) on motor recovery of patients with sub-acute stroke. This aim will be examined by comparing pre-intervention motor performance levels with the immediate post-intervention and two months post-intervention. The primary outcome variables will be scores on the Fugl-Meyer Motor Assessment Test (FMA) and Wolf Motor Function Test (WMFT).

Number to be enrolled: 
24 patients

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.

Background information
Other unique IDs: 
SIGA-246-PO-005
HHSN266200600014C
N01-AI-60014

China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00728013
Other unique IDs: 
2006BAI01A02-12
Official title: 

China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

Detailed description: 

The CHILLAS study is planned to evaluate whether intensive treatment with statins for 2 years results in a reduction of cardiovascular events in patients with ACS. A total of 1,600 patients will be randomly assigned to receive intensive statin therapy (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins) or moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins). Both groups receive dietary counseling.

Number to be enrolled: 
1600 patients
Acronym: 
CHILLAS

Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.

Trial phase: 
Phase III
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00727857
Other unique IDs: 
01-06-TL-OPIMET-008
Official title: 

A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects Wit

Detailed description: 

Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism.

Number to be enrolled: 
600 patients

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.

Background information
Other unique IDs: 
999908167
08-I-N167

Mechanisms by Which Strength Training Ameliorates the Metabolic Syndrome

Recruitment status: 
Not yet recruiting

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.

Background information
Trial ID: 
NCT00727779
Other unique IDs: 
DK80488
Official title: 

Mechanisms by Which Strength Training Ameliorates the Metabolic Syndrome

Detailed description: 

Life style alterations can be powerful deterrents to developing type 2 diabetes and are cornerstones of the treatment of this condition. Both aerobic and resistance exercise improve diabetes blood glucose control and insulin resistance. These two types of exercise appear to exert their effects on different muscle fiber types - red for endurance and white for strength. Similar to the effects of endurance exercise training, strength training increases muscle glucose transporter isoform 4 (GLUT4), but in contrast, mitochondria numbers do not increase.

Number to be enrolled: 
20 patients

Intramuscular Lipid and Insulin Action:Ethnic Aspects

Recruitment status: 
Recruiting

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:

  1. Verify, using magnetic resonance spectra, that IM lipid is higher in AA vs C;
  2. Determine how IM lipid relates to Si among AA and C subjects.
  3. 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:

  1. IM lipid will be higher in AA vs C;
  2. Greater IM lipid will be associated with lower Si;
  3. Greater IM lipid will explain lower Si among AA vs C.
  4. A low-fat diet will deplete ML and increase Si among both AA and C.
  5. 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.

Background information
Trial ID: 
NCT00726908
Other unique IDs: 
F070322005
R01 DK67538
Official title: 

Intramuscular Lipid and Insulin Action:Ethnic Aspects

Detailed description: 

 

Number to be enrolled: 
60 patients
Acronym: 
QuEST

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).

Background information
Other unique IDs: 
HuLuc63-1702
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