Dose Comparison

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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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.</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:ebe3f86b53c37dbc7c1aa8a0893c6871' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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.</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:f0e33b992f38dbfd3343c04e0614ec19' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:fb5767ad02c67e0fda784738a87c8ac4' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<ul>\n<li>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.</li>\n<li>Study treatment will be given in 28 day cycles. Both RAD001 and lenalidomide are pills that are taken orally. Both drugs will be started on the same day. RAD001 will be taken either every other day or every day for the first 3 weeks (days 1-21) of each 28-day cycle. Lenalidomide will be taken daily for the first 3 weeks (days 1-21) of each cycle.</li>\n<li>Participants will come to the clinic weekly during the first cycle to monitor side effects. The following will be performed at these clinic visits:</li>\n</ul>\n<p> physical examination, medical history update, questionnaires, and blood work.\n<ul>\n<li>On cycles 2-8, participants will come to the clinic on Day 1 of each cycle. The following will be performed at this clinic visit: physical examination, medical history update, questionnaire, and blood word.</li>\n<li>At the end of cycle 8, a skeletal survey, bone marrow aspiration and biopsy will be performed to check response to study treatment.</li>\n<li>Participants may continue to receive RAD001 and lenalidomide beyond 8 cycles if their cancer does not get worse and they do not have unacceptable side effects.</li>\n</ul>\n</p>', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:52563a5c5df3d2392a037b6e8cf12f88' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Subject was previously diagnosed with multiple myeloma bases on standard criteria listed in protocol</li>\n<li>Patients must have relapsed or relapsed/refractory disease</li>\n<li>18 years of age or older</li>\n<li>All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment</li>\n<li>ECOG Performance Status of 0 to 2</li>\n<li>Able to take aspirin (81 or 325mg) daily as prophylactic anticoagulation</li>\n<li>Prior thalidomide/lenalidomide therapy is allowed</li>\n<li>Able to take bactrim</li>\n<li>Female of childbearing potential must have a negative serum or urine pregnancy test</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Renal insufficiency</li>\n<li>Concommitant therapy medications that include corticosteroids or other chemotherapy that is or may be active against myeloma or therapy with chemotherapy within 2 weeks prior to day 1. Nitrosoureas must be discontinued 6 weeks prior to day 1. Concurrent radiation therapy is not permitted.</li>\n<li>Subjects with evidence of mucosal or internal bleeding and/or platelet refractory</li>\n<li>Subjects with poorly controlled diabetes mellitus</li>\n<li>Subjects with an ANC &lt; 10-00 cells/mm3</li>\n<li>Subjects with a hemoglobin &lt; 8.0 g/Dl</li>\n<li>AST (SGOT and ALT (SGPT) greater or equal to 2x ULN</li>\n<li>Prior therapy with RAD001</li>\n<li>Known hypersensitivity to thalidomide or lenalidomide</li>\n<li>Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study</li>\n<li>Clinically relevant active infection or serious co-morbid medical conditions such as recent thromboembolic disease are ineligible if occurred less than 2 weeks prior to enrollment or clinically unstable</li>\n<li>Chronic obstructive or chronic restrictive pulmonary disease, difficult to control diabetes, upper gastrointestinal ulceration, and cirrhosis</li>\n<li>Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or other cancer for which the subject has been disease-free for at least 3 years</li>\n<li>Pregnant or breast-feeding females</li>\n<li>Prior treatment with any investigational drug within preceding 4 weeks</li>\n<li>Major surgery, and or radiation with 2 weeks of study initiation</li>\n<li>Uncontrolled leptomeningeal disease</li>\n<li>Prior treatment with other mTOR inhibitors</li>\n<li>The use of G-CSF is not permitted to render the patient eligible fot the study</li>\n<li>POEMS syndrome</li>\n<li>Known HIV infection</li>\n<li>Known active Hepatitis B or C infection</li>\n<li>Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities</li>\n<li>Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001</li>\n<li>Patients with active, bleeding diathesis or on oral anti-vitamin K medication</li>\n</ul>\n</p>', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:73401cf21714e936a9622aa906700d95' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To evaluate the response to the combination of RAD001 and lenalidomide in subjects with multiple myeloma. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:0a066cc0ec082fe55ceb77bff62dbdf2' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To determine the pharmacokinetics of RAD001 and lenalidomide. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:9b686ad73776dec78d59b5efbb53b7a4' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To identify possible surrogate markers to better define mechanisms of action for the combination of the two drugs. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:38040d490edfd3ff18b7d2ab62480acd' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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 &quot;air muscle&quot; 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.</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:2e6d3af0d8e33ba6b7eb830750632156' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Air Muscle and Task Practice in Upper Limb Stroke Rehab</p>\n', created = 1283570014, expire = 1283656414, headers = '', serialized = 0 WHERE cid = '1:ba75bb003724641be41d2ac873d1ff6c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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). We hypothesize patients in the RTP + ARM group will exhibit greater gains in upper extremity motor recovery/performance than the RTP and ARM only groups. Specific Aim 2: Estimate the effectiveness of using the ARM device in conjunction with RTP on health related quality of life of patients with sub-acute stoke. This aim will be examined through the administration of clinical quality of life questionnaires. The primary outcome variable to assess health related quality of life will be change scores on the Stroke Impact Scale (SIS), controlling for depressed mood as measured by the Center for Epidemiologic Studies Depression (CES-D) scale, from the pre-, immediate post and two-month post intervention testing sessions. We hypothesize patients in the RTP + ARM group will exhibit greater improvements on quality of life measures at the two-month follow-up session than the RTP and ARM only groups. Study Design, Methods and Procedures: Patients will be randomized to one of the following three interventional groups: repetitive task practice, assistive repetitive motion and repetitive task practice plus assistive repetitive motion. Details regarding the activities each group will perform are below.\n<ol>\n<li>Repetitive task practice (RTP) procedure: patients in the RTP group will work closely with rehabilitation professional (supervisor) for four hours per day for three weeks. We are currently accepting applications for this position. At minimum, this individual will be a licensed Physical or Occupational Therapist with clinical experience and a desire to participate and follow the outlined research protocol. Patients will report to the Mellon Center at the Cleveland Clinic Foundation (CCF) around 8:00 AM each day and leave around 12:00 PM. During their stay at the CCF they will be asked to engage in a series of activities that are planned for them to use their weaker or more impaired hand and arm. We will be making some additional measures about the speed at which they can do functional activities (such as reaching and folding a towel) during the testing days immediately before and after the training period and two months after completion of the training (e.g. Wolf Motor Function Test (WMFT) and Fugl-Meyer Motor Assessment (FMA)). Quality of life will be assessed with the Stroke Impact Scale (SIS) controlling for depression using the Center for Epidemiologic Studies Depression (CES-D) scale. These clinical tests require approximately 1.5 hours to administer. Participants will also be encouraged to use their weaker hand and arm at home and during the weekends. </li>\n<li>Assistive repetitive motion (ARM) procedure: Patients will report to the Mellon Center at the Cleveland Clinic Foundation (CCF) around 8:00 AM each day and leave around 12:00 PM. During their stay at the CCF they will be asked to wear an assistive device on their more impaired or affected upper extremity. This device will be placed snugly on their arm and wrist. The device has a small &quot;air muscle&quot; that when activated will slowly lift their fingers and wrist from your resting wrist position. This device is classified as a non-significant risk device by the FDA (see attached letter dated 1-15-05). The patient should not experience any pain or discomfort during this stretching activity. If they do experience any pain or discomfort they can activate a stop switch located on the control box with their unimpaired hand. The SIS, CES-D WMFT and FMA will be administered immediately before and after the training period and two months after completion of the training.</li>\n<li>RTP + ARM Procedure: Patients will report to the Mellon Center at the Cleveland Clinic Foundation (CCF) around 8:00 AM each day and leave around 12:00 PM. During their stay at the CCF they will be asked to wear an assistive device on their more impaired or affected upper extremity for two hours. This device will be placed snugly on their arm and wrist. The device has a small &quot;air muscle&quot; that when activated will slowly lift the fingers and wrist from a resting wrist position. They should not experience any pain or discomfort during this stretching activity. If they experience any pain or discomfort they can activate a stop switch located on the control box with the unimpaired hand. After completion of the two hour ARM intervention they will participate in two hours of RTP therapy. During this time they will engage in a series of activities that are planned for them to use the weaker or more impaired hand and arm. The SIS, CES-D WMFT and FMA will be administered immediately before and after the training period and two months after completion of the training.</li>\n</ol>\n</p><p> The results from this project will provide valuable data as a pre-requisite for submission of a multi-year R01 randomized clinical trial to determine the clinical efficacy of using an assistive device, such as the ARM, as an adjunct to RTP. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke. Inclusion criteria Patients will not be excluded because of somatosensory deficits or the nature of previous physical interventions. We will not randomize patients on the basis of side of stroke or hand dominance but will undertake secondary data analyses examining these variables. In past applications of one form of RTP, CI therapy, to chronic stroke patients in the laboratories of Taub and Miltner, there were no significant differences in treatment effects for patients with right and left-sided strokes. In previous evaluations of CI therapy, Taub did not find any difference in outcomes among the small percentage of patients with pre-morbid left dominance. Therefore, there is no reason to exclude these patients from participation. We believe that the motivation to improve use of an affected pre-stroke non-dominant upper extremity is sufficiently strong to support profound improvement from treating that limb as well as from treating the dominant limb. Distributions of dominance and hand preference have been acquired from patients meeting eligibility criteria in 1998 at several sites for determining participation of sites for the EXCITE trial and side of cerebral pathology showed remarkably equal left-right distribution. Exclusion criteria\n<ol>\n<li>a score of less than 24 on the Folstein Mini-Mental State Examination or a score of 36 or below on the Token Test of the Multilingual Aphasia Examination</li>\n<li>a first stroke less than 3 months or more than 9 months prior to the initiation of therapy</li>\n<li>less than 18 years old</li>\n<li>clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.)</li>\n<li>serious uncontrolled medical conditions</li>\n<li>excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention, as judged by the examining clinician</li>\n<li>passive range of motion less than 45 degrees for: abduction, flexion or external rotation at shoulder, or pronation of forearm; or greater than 30 degrees flexion contracture at any finger joint (patients who pass the motor criteria specified above do not tend to have the type of pain or limitation of movement that would exclude them from treatment)</li>\n<li>unable to stand independently for 2 min., transfer independently to and from the toilet or perform sit-to-stand</li>\n<li>current participation in other pharmacological or physical intervention studies, or have received injections of anti-spasticity drugs into upper extremity musculature within the past 3 months, or wish to have drugs injected in the foreseeable future</li>\n<li>receiving any anti-spasticity drugs orally at the time of expected participation</li>\n<li>received phenol injections less than 12 months prior to receiving therapy</li>\n<li>contemplating a move from proximity to the treatment site in less than 1 year from the randomization date. Prospective patients who qualify but who have profound postural instability will undergo the intervention while walking with contact guarding or, when feasible, using their leg(s) and more involved arm to propel a wheelchair.</li>\n</ol>\n</p>', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:3276a8adb9e5b417b0ac2967184eaaf0' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:a05556fae1fafaf97d93a41ff605e75f' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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 &quot;lower is better&quot;, 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.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:acac6653973fbba92d4f088b6a1f1a71' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:9fc7906ebfb102fca14e01b9bba6e52b' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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. Over a 2-year follow-up period, the primary outcome measure is the time to occurrence of cardiac death, nonfatal acute myocardial infarction, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting, documented unstable angina or severe heart failure requiring emergency hospitalization, and stroke. The planned duration is between December 2006 and December 2009.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:c5aad2da3d974b5f3dfc0ba66edf9468' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Clinical diagnosis of acute coronary syndrome</li>\n<li>Clinically stable for 24 hours</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Hypersensitive to statins</li>\n<li>Receiving therapy with atorvastatin at a dose greater than 20 mg per day before enrollment or lipid-lowering therapy with fibric acid derivatives or niacin that can not be discontinued</li>\n<li>Having a coexisting condition that shortened expected survival to less than two years</li>\n<li>Having obstructive hepatobiliary disease or other serious hepatic or kidney disease</li>\n<li>Having an unexplained elevation in the creatine kinase level that was more than three times the upper limit of normal and that was not related to myocardial infarction</li>\n<li>Having undergone surgery or serious trauma within the preceding two months</li>\n<li>Having been in the final stage of chronic congestive heart failure</li>\n<li>Having a baseline level of LDL cholesterol less than 50mg/dl</li>\n</ul>\n</p>', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:8f7cfb823202d020f270813c7dc05fdb' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The secondary endpoints include total mortality [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:549b6b7dc389eeac3eff781155315458' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>LDL cholesterol success rate [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:579e54ad853c04649f6f3ec9361f88b4' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Percentage rate of plaque regression [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:9a303902d42d10d11b52bdde17ce3290' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d6af615e69c9333b35d45d7bf81823ef' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>In addition, changes in CRP from baseline to specified measurement time points will be calculated [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:d6af615e69c9333b35d45d7bf81823ef' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6cabcdabcaa158643915b2fa5b621f1c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:6cabcdabcaa158643915b2fa5b621f1c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:349c28368deaecfa07b30f6905f7326a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:349c28368deaecfa07b30f6905f7326a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8040aba6c5f0482e842f0da6c5a38812' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Pioglitazone hydrochloride (ACTOS&#174;) 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. Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents. This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy. Study participation is anticipated to be approximately 6.5 months.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:8040aba6c5f0482e842f0da6c5a38812' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ae2ff5c707d2fa318086dc6490a29d8b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria\n<ul>\n<li>Has type 2 diabetes.</li>\n<li>Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days.</li>\n<li>A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening.</li>\n<li>Body mass index less than or equal to 45 kg/m2.</li>\n<li>Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise.</li>\n<li>Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.</li>\n<li>Stable condition as determined by a physician.</li>\n</ul>\n</p><p> Exclusion Criteria\n<ul>\n<li>Type 1 diabetes.</li>\n<li>Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.</li>\n<li>History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening.</li>\n<li>Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.</li>\n<li>Has a triglyceride level greater than 500 mg per dL.</li>\n<li>Male participant has a hemoglobin level less than 10.5 g per dL or female subject has a hemoglobin level less than 10.0 g per dL.</li>\n<li>Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.</li>\n<li>History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within 2 years prior to Screening.</li>\n<li>Has been discontinued from a thiazolidinedione or metformin therapy due to lack of efficacy or clinical or laboratory signs of intolerance.</li>\n<li>Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.</li>\n<li>History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.</li>\n<li>Any disease or condition at Screening or Randomization that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.</li>\n<li>Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.</li>\n<li>Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:\n<ul>\n<li>Antidiabetic medications other than study medication</li>\n<li>Chronically used oral or parenteral glucocorticoids</li>\n<li>Niacin greater than 200 mg per day, including niacin-containing products such as Advicor</li>\n<li>Chronically used steroid-joint injections</li>\n</ul>\n</li>\n</ul>\n</p>', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:ae2ff5c707d2fa318086dc6490a29d8b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cd22028ae50dfd5f4e56c251d76d489f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Triglycerides [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:cd22028ae50dfd5f4e56c251d76d489f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5461bc3127bb1ebbd524e794d7527db8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Total Cholesterol [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:5461bc3127bb1ebbd524e794d7527db8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bf23ac81a621ef306b5aff2cabf7e01e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Fasting Plasma Glucose [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:bf23ac81a621ef306b5aff2cabf7e01e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1fb343de3ec4e8c45cb973f8d960e6aa' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Fasting Insulin [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:1fb343de3ec4e8c45cb973f8d960e6aa' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d4d6d863747c398d1c0788d5498c4353' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Homeostasis Model Assessment [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:d4d6d863747c398d1c0788d5498c4353' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:315fb5310326ad192619beeeb198285e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in High Sensitivity C-reactive Protein [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:315fb5310326ad192619beeeb198285e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c0870a215eddec6f4fc86c436fccec03' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Adiponectin [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:c0870a215eddec6f4fc86c436fccec03' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5179350ee9a9d6271dc136af6f659cc6' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Low-Density Lipoprotein cholesterol [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:5179350ee9a9d6271dc136af6f659cc6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9cdd4fa96484fb45247f40444228fdf5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in High-Density Lipoprotein cholesterol [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:9cdd4fa96484fb45247f40444228fdf5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:34a27baa84f00987552a605692f0ff50' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change from Baseline in Lipid Fractionation [&nbsp;Time&nbsp;Frame:&nbsp;Week 24 or Final Visit&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:34a27baa84f00987552a605692f0ff50' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c47e9c7a8471a06a5ff0bfa9c35e3eca' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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:\n<ul>\n<li>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.</li>\n<li>Medical history.</li>\n<li>Physical examinations each month during treatment.</li>\n<li>Sputum collections once a week or more until 3 weeks after the patient is no longer contagious.</li>\n<li>Blood draws every week for 16 to 24 weeks and then once a month.</li>\n<li>Urine collections at several time points.</li>\n<li>Nerve and eye examinations before starting treatment and then monthly to look for possible LZD side effects.</li>\n<li>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.</li>\n</ul>\n</p><p> 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.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:c47e9c7a8471a06a5ff0bfa9c35e3eca' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:15f6ecf2979600a4c450d685c3a4f76b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:15f6ecf2979600a4c450d685c3a4f76b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0b065c2f3cf6f25097cdb8eb46969b29' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Mechanisms by Which Strength Training Ameliorates the Metabolic Syndrome</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:0b065c2f3cf6f25097cdb8eb46969b29' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a85fe1af8b4f6ecaa4fe8a0fa74b9e5b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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. We hypothesize (1) that strength training in persons with pre-diabetes may be effective in reversing insulin resistance by novel mechanisms that are distinct from the endurance training-induced mitochondrial biogenesis. We further hypothesize (2) that resistance exercise training enhances whole body insulin action primarily by increasing the white fiber size via the protein kinase mammalian target of rapamycin (mTOR) and improves insulin-stimulated glucose uptake by increased GLUT4 expression primarily in white fibers of the trained muscles. In this proposal, we will perform eight weeks of progressive strength training on ten subjects with the Metabolic Syndrome who are at high risk for developing type 2 diabetes and on ten sedentary control subjects. This project builds on our experience with a study of focused resistance training whose results are presented in this application. In this pilot study, subjects exercised on stationary bicycles for six weeks causing muscle GLUT4 and phopho-mTOR to increase substantially, but maximal oxygen uptake (VO2max), phospho-AMP-activated protein kinase (AMPK), peroxisome proliferator-activated receptor-&#947; co-activator (PGC-1&#945;), and mitochondrial markers did not change. Our hypotheses will be tested by two Specific Aims. (1) Subjects at high risk for diabetes will undergo progressively increasing intensity resistance exercise training and increased strength and improved insulin responsiveness will both be quantified to demonstrate significant benefit, and (2) quantify the effect of resistance exercise training on anatomic and functional adaptation in muscle. We will characterize fiber type, fiber size, fiber-specific changes in mitochondrial DNA and enzymes, fiber-specific changes in the principle glucose transporters in muscle (GLUT4, GLUT5, and GLUT12), and evaluate changes in two distinct intramuscular pathways (AMPK, mTOR) and regulatory factors (PGC-1&#945;, PPAR&#947;, PPAR&#948;) using immunoblots of muscle subcellular fractions and immunohistochemical techniques. These evaluations of molecular mechanisms will also include assessing changes in full human Affymetrix gene array data that may move us to new potential resistance training-regulated gene targets. It is the long-term goal of this team of investigators to understand the interplay between life style changes and pharmacological agents in the prevention and treatment of diabetes. Our results will facilitate the development of more effective clinical options to turn back the epidemic of obesity and diabetes in the United States.</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:a85fe1af8b4f6ecaa4fe8a0fa74b9e5b' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria: obese family history of diabetes Exclusion Criteria: non-obese diabetes</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:9dc07f7459d745f1c2a42b5113dacc4a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dce57c65fd07a7b8b79e03295795791d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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:\n<ol>\n<li>Verify, using magnetic resonance spectra, that IM lipid is higher in AA vs C;</li>\n<li>Determine how IM lipid relates to Si among AA and C subjects.</li>\n<li>Determine if manipulation of ML via dietary intervention alters Si in healthy AA and C subjects.</li>\n</ol>\n</p><p> 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:\n<ol>\n<li>IM lipid will be higher in AA vs C;</li>\n<li>Greater IM lipid will be associated with lower Si;</li>\n<li>Greater IM lipid will explain lower Si among AA vs C.</li>\n<li>A low-fat diet will deplete ML and increase Si among both AA and C.</li>\n<li>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.</li>\n</ol>\n</p>', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:dce57c65fd07a7b8b79e03295795791d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Intramuscular Lipid and Insulin Action:Ethnic Aspects</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:7b19b3aa41c72b3cfea80ba77578a077' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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).</p>\n', created = 1283570015, expire = 1283656415, headers = '', serialized = 0 WHERE cid = '1:562270f26bbb24ad94df30bcebc3b1e9' in /persistent/html/includes/cache.inc on line 109.

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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