Eli Lilly and Company

  • 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 = '1:3c98015abb925a65fd01b5820927bb95' 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 is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:3c98015abb925a65fd01b5820927bb95' 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 = '1:33ab2b184b8af9eb4c6006af1d24e399' 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>Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:33ab2b184b8af9eb4c6006af1d24e399' 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>&nbsp;</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' 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 = '1:8d2f43143d67bdb1308fa54b762d86e5' 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>Have type 2 diabetes</li>\n<li>Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.</li>\n<li>Have a fasting glucose concentration &lt;280 mg/dL at Visit 1</li>\n<li>Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.</li>\n<li>Are between 18 and 70 years of age, inclusive.</li>\n<li>Have body mass index &#8805;25 kg/m2 and &#8804;45 kg/m2.</li>\n<li>Have a history of stable body weight (not varying by &gt;10% for at least 3 months prior to screening).</li>\n<li>Can swallow oral study drug capsule, without splitting or crushing.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:\n<ul>\n<li>Are breastfeeding.</li>\n<li>Test positive for pregnancy at the time of screening.</li>\n<li>Intend to become pregnant during the study.</li>\n<li>Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant&#174;; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.</li>\n</ul>\n</li>\n<li>Treated with any of the following medications:\n<ul>\n<li>Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening</li>\n<li>Alpha-glucosidase inhibitor within 2 months of screening.</li>\n<li>Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.</li>\n<li>Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.</li>\n<li>Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.</li>\n</ul>\n</li>\n<li>Have a history of renal transplantation or are currently receiving renal dialysis.</li>\n<li>Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.</li>\n<li>Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.</li>\n<li>Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.</li>\n<li>Have had organ transplantation.</li>\n<li>Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.</li>\n<li>Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.</li>\n</ul>\n</p>', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:8d2f43143d67bdb1308fa54b762d86e5' 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:f0e4549b6c24370f889e8c22ffd8f0e9' 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 REFLECTIONS Study is a 12-month, prospective observational study that will be utilized in approximately 100 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of 2500 adult patients diagnosed by their physician with fibromyalgia (FM) and who are starting any &quot;new pharmacologic agent&quot; for FM. The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize the management of FM. This study will address current gaps in a rapidly growing body of literature for FM.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:f0e4549b6c24370f889e8c22ffd8f0e9' 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:de5638894ea852ae604227b28bc8d4da' 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>To examine patient characteristics, FM profile, and physician characteristics that influence baseline and longitudinal treatment [&nbsp;Time&nbsp;Frame:&nbsp;12 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:de5638894ea852ae604227b28bc8d4da' 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:ce131a241336f916fc1164e9b66105e6' 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>To describe reasons for \'new\' pharmacologic treatment in FM patients at baseline and changes post-baseline [&nbsp;Time&nbsp;Frame:&nbsp;12 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:ce131a241336f916fc1164e9b66105e6' 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 = '1:16aa363c174279e6b9d4b0c1658f37d0' 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>To examine patient and physician characteristics that are associated with a reduction in opioid use [&nbsp;Time&nbsp;Frame:&nbsp;12 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:16aa363c174279e6b9d4b0c1658f37d0' 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 = '1:840b5f150dd332149b575bdf6056f091' 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>To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom\'s Macroglobulinemia or Multiple Myeloma based on response.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:840b5f150dd332149b575bdf6056f091' 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 = '1:595876cefbb52a1cbdb073b3b2588318' 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>Time to progressive disease [&nbsp;Time&nbsp;Frame:&nbsp;Baseline to measured progressive disease&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:595876cefbb52a1cbdb073b3b2588318' 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 = '1:6c1e118c0c8b93400f38182184259483' 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>Safety and Adverse Events [&nbsp;Time&nbsp;Frame:&nbsp;Every cycle&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:6c1e118c0c8b93400f38182184259483' 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 = '1:354d59006a4fb4c5f2f12e440bc73626' 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>Duration of response [&nbsp;Time&nbsp;Frame:&nbsp;time of response to progressive disease&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:354d59006a4fb4c5f2f12e440bc73626' 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 = '1:70e8a8b486fdb7e6e8363c0bcb54bdc0' 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 a safe dose of LY573636-sodium to be given to patients with relapsed or refractory acute myeloid leukemia and to determine any side effects that may be associated with LY573636-sodium in this patient population. Efficacy measures will also be used to assess the activity of LY573636-sodium in this patient population.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:70e8a8b486fdb7e6e8363c0bcb54bdc0' 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>Phase 1 Study of LY573636-Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:dd76a2630d41a2bd3c53d30963f84498' 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:cc7819055cde3194bb3b136bad5cf58d' 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>&nbsp;</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' 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:cdf4e396de19b0cffad2e6e47847645e' 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>Patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to at least one prior standard treatment. If patients have acute promyelocytic leukemia, they must be resistant and/or intolerant of both all trans retinoic acid (ATRA) and arsenic trioxide.</li>\n<li>Are at least 18 years of age.</li>\n<li>Have given written informed consent approved by Lilly and the ethical review board (ERB)/institutional review board (IRB) governing the site.</li>\n<li>Must have adequate hepatic and renal function.</li>\n<li>Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug and recovered from the acute effects of therapy. Hydroxyurea used to control peripheral blood blast count is permitted within these respective periods, but it must be stopped at least 24 hours before study drug administration.</li>\n<li>Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug.</li>\n<li>Females of child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.</li>\n<li>Patients with chronic myeloid leukemia (CML)</li>\n<li>Have received an autologous or allogenic stem cell transplant within 75 days of the initial dose of study drug for the dose escalation phase or within 60 days of the initial dose of study drug for the dose confirmation phase. Recipients of an allogeneic stem cell transplant must have discontinued immunosuppressive therapy at least 24 hours before study drug administration with no more than Grade 1 acute graft-versus-host disease.</li>\n<li>Have previously completed or withdrawn from this study or any other study investigating LY573636 sodium.</li>\n<li>Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.</li>\n<li>Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study.</li>\n<li>Have a known coagulopathy or bleeding disorder, other than leukemic related thrombocytopenia. Patients with severe or life-threatening bleeding refractory to platelet transfusions are also excluded from this study.</li>\n<li>Major surgery within 4 weeks of study enrollment.</li>\n<li>Are receiving warfarin (Coumadin).</li>\n<li>Females who are pregnant or breast feeding.</li>\n<li>Have known positive results of HIV, hepatitis B or C.</li>\n</ul>\n</p>', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:cdf4e396de19b0cffad2e6e47847645e' 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:cf20cea92ebf3f4e9a8942ac9f7caa3c' 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>Estimate pharmacokinetic (PK) parameters of LY573636-sodium [&nbsp;Time&nbsp;Frame:&nbsp;Throughout the study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:cf20cea92ebf3f4e9a8942ac9f7caa3c' 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 = '1:7d9585312ef775a1d1ee0d293ee60c3c' 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>Explore pharmacodynamic (PD) biomarkers [&nbsp;Time&nbsp;Frame:&nbsp;Throughout the study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:7d9585312ef775a1d1ee0d293ee60c3c' 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 = '1:9014f2e67e4448a9509eb922a2256ae2' 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>Estimate response rate by bone marrow response [&nbsp;Time&nbsp;Frame:&nbsp;Day 28 of Cycle 1&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:9014f2e67e4448a9509eb922a2256ae2' 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 = '1:358e8e0677870926eba45e50f2560443' 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>Safety and tolerability of LY573636-sodium in patients with relapsed or refractory AML [&nbsp;Time&nbsp;Frame:&nbsp;Throughout the study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:358e8e0677870926eba45e50f2560443' 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 = '1:20d468b54762fc7849e7c094c8772e5b' 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 will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in patients ages 10 to 16 years old with ADHD and comorbid dyslexia</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:20d468b54762fc7849e7c094c8772e5b' 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 = '1:540c49a5ca1fe4a396563c9a979c20f5' 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>For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and toxicity of standard chemotherapy followed by IMRT.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:540c49a5ca1fe4a396563c9a979c20f5' 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 = '1:62db201b39026db48e66b0d0fda026b6' 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>Phase II Toxicity Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:62db201b39026db48e66b0d0fda026b6' 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:cc7819055cde3194bb3b136bad5cf58d' 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>&nbsp;</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' 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 = '1:6608b704f4171eb971c35340addff9cf' 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>Patients must have a pathologically confirmed diagnosis of malignant pleural mesothelioma.</li>\n<li>Patients must have unresectable disease, defined as locally advanced and surgically unresectable or medically inoperable.</li>\n<li>No prior chemotherapy or radiation therapy.</li>\n<li>Patient age &#8805; or = to 18 years on day of signing informed consent.</li>\n<li>Karnofsky performance status &#8805; or = to 70%</li>\n<li>Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.</li>\n<li>Patient must have the ability to interrupt NSAIDS 2 days before (5 days for longacting NSAIDs), the day of, and 2 days following administration of pemetrexed.</li>\n<li>Pulmonary Function Tests:</li>\n<li>FEV1 &#8805; 30% of predicted postoperative (ppoFEV1) (as if the patient underwent a pneumonectomy) based on the following formula using the quantitative</li>\n</ul>\n</p><p> V/Q scan:\n<ul>\n<li>Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the quantitative V/Q scan report.</li>\n<li>DLCO &gt; 35% predicted</li>\n<li>Patient must have adequate organ function as indicated by the following laboratory values:</li>\n<li>Hematological:</li>\n<li>Absolute neutrophil count &#8805; or = to 1,500 /mcL</li>\n<li>Platelets &#8805; or = to 100,000 / mcL</li>\n<li>Renal Calculated creatinine clearance (CrCl) &#8805; or = to 55 mL/min (Creatinine clearance must be calculated using Cockcroft &amp; Gault method)</li>\n<li>Hepatic</li>\n<li>Serum total bilirubin &#8804; or = to 1.5 X upper limit of normal (ULN) AST (SGOT) or ALT (SGPT) &#8804; or = to 3.0 X ULN</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Pregnant or lactating women, or men or women not using effective contraception.</li>\n<li>Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments.</li>\n<li>Patients with a concurrent active malignancy.</li>\n<li>Patients with serious unstable medical illness.</li>\n<li>Presence of third space fluid that cannot be controlled by drainage. For patients who develop or have baseline clinically significant pleural effusions before or during initiation of pemetrexed therapy consideration should be given to draining the effusion prior to dosing.</li>\n</ul>\n</p>', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:6608b704f4171eb971c35340addff9cf' 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:f48caab32cc32d4356457b6f54ada17b' 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>To determine the pattern of progression: local recurrence versus metastatic disease. [&nbsp;Time&nbsp;Frame:&nbsp;conclusion of study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:f48caab32cc32d4356457b6f54ada17b' 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:a45079536778962f8ff2874d1e97537b' 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>Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will decrease the number of hospitalizations in patients with schizophrenia or schizoaffective disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:a45079536778962f8ff2874d1e97537b' 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 = '1:9f305f957ad482c7b50b61660e4b5936' 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>EWSQ 10P and 10FM sensitivity, specificity, positive predictive value [&nbsp;Time&nbsp;Frame:&nbsp;November 2008-November 2009&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:9f305f957ad482c7b50b61660e4b5936' 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:cb5400450ee42cced881099791762932' 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>No. of hospitalization days [&nbsp;Time&nbsp;Frame:&nbsp;November 2008-November 2009&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:cb5400450ee42cced881099791762932' 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 = '1:08356497b2d1ea1caea9195474352921' 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>Assessment of the natural course of the psychotic illness [&nbsp;Time&nbsp;Frame:&nbsp;November 2008-November 2009&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:08356497b2d1ea1caea9195474352921' 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:c85de0c958c715e4918e5265fcbb6bfe' 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>Correlation between baseline CGI and the No. of hospitalizations at the endpoint [&nbsp;Time&nbsp;Frame:&nbsp;November 2008-November 2009&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:c85de0c958c715e4918e5265fcbb6bfe' 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:ed2fa668c386c87838c55936f7aecc1e' 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 will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:ed2fa668c386c87838c55936f7aecc1e' 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 = '1:1cfcab40b2557cb2a9e3a0724131399e' 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>Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:1cfcab40b2557cb2a9e3a0724131399e' 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:e81108c7d0bc2523a674948c40fe1675' 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 is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in patients with metastatic renal cell carcinoma, containing 2 parts. Part 1 is a safety lead-in study with 12 patients and possible dose escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 patients.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:e81108c7d0bc2523a674948c40fe1675' 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:f281ccfde37cd8fe0e4c2da73f622a64' 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>Patients with metastatic RCC who have not received prior treatment with systemic (adjuvant or neoadjuvant) therapy for RCC (including targeted therapy such as tyrosine kinase inhibitors or bevacizumab, immunotherapy, chemotherapy, hormonal, or investigational therapy)</li>\n<li>Histologically confirmed RCC with metastases with a component of clear (conventional) cell histology</li>\n<li>Evidence of unidimensional measurable disease, measured by CT scan or MRI.</li>\n<li>Primary tumor has been surgically removed by nephrectomy or nephron-sparing surgery</li>\n<li>ECOG performance status score of 0 or 1.</li>\n<li>Patients must sign an informed consent document</li>\n<li>Patients must be at least 18 years of age</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Have received prior treatment with sunitinib or enzastaurin</li>\n<li>Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry</li>\n<li>Have had any of the following within 12 months prior to study drug administration:\n<ul>\n<li>myocardial infarction,</li>\n<li>severe/unstable angina,</li>\n<li>coronary/peripheral artery bypass graft,</li>\n<li>symptomatic congestive heart failure (CHF),</li>\n<li>cerebrovascular accident,</li>\n<li>transient ischemic attack, or</li>\n<li>pulmonary embolism</li>\n</ul>\n</li>\n<li>Note: Ongoing treatment with therapeutic doses of Coumadin&#174; (warfarin) or a derivative of Coumadin or phenprocoumon is not allowed, but prophylactic, low-dose Coumadin (&#8804; 2 mg daily) for deep vein thrombosis is allowed. In such cases, PT/INR should be very closely monitored as clinically indicated.</li>\n<li>Ongoing cardiac arrhythmias &gt;New York Health Association Class II, atrial fibrillation of any grade, or prolongation of the QTc interval to &gt;450 msec for males or &gt;470 msec for females.</li>\n<li>Have uncontrolled hypertension (&gt;150/100 mm/Hg despite optimal medical therapy), or history of poor compliance with antihypertensive treatment</li>\n<li>Require concomitant use of potent CYP3A4 inducer, for example, rifampicin or potent CYP3A inhibitors, such as ketoconazole.</li>\n<li>Significant surgery or radiation therapy &lt;4 weeks of starting study treatment. Prior palliative radiotherapy to metastatic lesion(s) is/are permitted, provided there is at least 1 measurable lesion that has not been irradiated</li>\n<li>Patients who are pregnant or breast feeding</li>\n</ul>\n</p>', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:f281ccfde37cd8fe0e4c2da73f622a64' 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 = '1:7af5f29f72ad11eca363fe511a6a465a' 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>Overall survival [&nbsp;Time&nbsp;Frame:&nbsp;baseline to date of death from any cause&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:7af5f29f72ad11eca363fe511a6a465a' 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:e5a97e8b66bc29e4253dc556d758edb1' 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>Time-to-tumor progression [&nbsp;Time&nbsp;Frame:&nbsp;baseline to the date of objectively determined progressive disease&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:e5a97e8b66bc29e4253dc556d758edb1' 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:eed445b67dc562876f4e7ff0542cef22' 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>Assess the safety and adverse events in both treatment arms [&nbsp;Time&nbsp;Frame:&nbsp;every cycle&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:eed445b67dc562876f4e7ff0542cef22' 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:a03d8d5c8a25a065fc3ead6040af579f' 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>To characterize the pharmacokinetics of enzastaurin and sunitinib when administered in combination [&nbsp;Time&nbsp;Frame:&nbsp;During lst cycle of patient treatment&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:a03d8d5c8a25a065fc3ead6040af579f' 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 = '1:497fefd88fd45d2e82de7678cfc7010e' 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 compare the effects (good and bad) of chemoradiotherapy with or without Bevacizumab (Avastin). Chemoradiotherapy is the combination of chemotherapy (the drugs pemetrexed and cetuximab) and radiation. Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Cetuximab is also approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy. In this study, the use of bevacizumab is investigational.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:497fefd88fd45d2e82de7678cfc7010e' 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 = '1:2ea59b1b03d88b533984de57a18c3f25' 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>Phase II Randomized Trial of Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:2ea59b1b03d88b533984de57a18c3f25' 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:d9044d23d517d6c4798de1bc47df5237' 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>Background Patients with squamous cell carcinoma of the head and neck (HNSCC) are increasingly treated with primary chemoradiotherapy. The incorporation of novel targeted therapies to chemoradiotherapy is of major interest since it may potentially improve efficacy without significantly increasing toxicity. Radiation and cetuximab, a chimeric anti-epidermal growth factor receptor monoclonal antibody, has emerged as a standard non-surgical therapy for stage III/IV HNSCC. Bevacizumab, an anti-vascular endothelial growth factor antibody is currently being investigated in HNSCC with promising results. A phase II study investigating the combination of pemetrexed and bevacizumab in recurrent or metastatic HNSCC is currently ongoing at our institution with encouraging results (UPCI# 05-002). In addition, we are completing a phase I trial of radiation, cetuximab plus pemetrexed (UPCI #05-005). Pemetrexed was dose escalated in successive cohorts of patients on 3 dose levels: starting dose level (0) 350 mg/m2, dose level (-1) 200 mg/m2, dose level (+1) 500 mg/m2. Currently three patients have been treated at dose level +1 (pemetrexed 500 mg/m2) which will be the pemetrexed dose in this study. No dose limiting toxicities (DLTs) have been observed at this dose level, which was the maximum tolerated dose (MTD) for the combination regimen in previously non-irradiated patients. Specific aims To evaluate the progression-free survival at 2 years (primary endpoint), locoregional and distant disease-free survival, overall survival, toxicities and quality of life with the combination of radiation, cetuximab and pemetrexed with or without bevacizumab in patients with locally advanced HNSCC. Also, we plan to collect tumor tissue from previous diagnostic procedures and baseline blood specimens for future correlative studies. Subject population We will enroll patients with previously untreated stage III/IV squamous cell carcinoma or undifferentiated carcinoma of the head and neck (except nasopharynx and unknown primary). Patients should not have active bleeding due to HNSCC or history of persistent bleeding due to HNSCC that required major intervention (surgery or embolization) to be controlled. Please see section 3 for detailed eligibility criteria. Treatment plan Patients will be randomized in two arms. In arm A, patients will be treated with radiation 2Gy/day for 7 weeks to a total of 70 Gy, cetuximab 250mg/m2 weekly, after a loading dose of 400mg/m2 one week prior starting radiation, and pemetrexed 500mg/m2 every 21 days. In arm B, patients will be treated with the same regimen with the addition of bevacizumab 15mg/kg every 21 days. After the completion of the combination treatment, if there is no progression, bevacizumab 15mg/kg every 3 weeks will be administered alone in arm B. Bevacizumab maintenance will continue for 24 weeks post radiation therapy completion (8 additional cycles of bevacizumab) unless disease progression or intolerable toxicity (see section 5 for detailed treatment plan and dose modifications). Statistical design and sample size Phase II, randomized, multi-center study with progression-free survival at 2 years as the primary endpoint. The historical control is a 2-year progression-free survival of 46% with radiation plus cetuximab alone. We assume a 2 year progression free survival of 64% (40% relative improvement in progression-free survival over historical control) as worthy of further testing. We will require 40 evaluable patients per arm for a total of 80 patients. Alpha = 0.1, beta = 0.1; all tests one-tailed.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:d9044d23d517d6c4798de1bc47df5237' 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 = '1:4911fff5558852a6b8d8caccffb78caa' 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>Phase II</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:4911fff5558852a6b8d8caccffb78caa' 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 = '1:0b2a0c8c7deb7562f0d555cf2e65b5e5' 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 multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:0b2a0c8c7deb7562f0d555cf2e65b5e5' 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 = '1:34c3d17624e4ea265a3dc2a9e9936fe3' 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>Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:34c3d17624e4ea265a3dc2a9e9936fe3' 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>&nbsp;</p>\n', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' 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 = '1:6c63c7bc8c7d9134bc084a6443ae2daa' 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>Patients between 18 and 85 years of age, inclusive.</li>\n<li>Patients with type 2 diabetes</li>\n<li>Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1</li>\n<li>Patients have HbA1c of 7.0% to 8.9%, inclusive.</li>\n<li>Patients have a body mass index &gt;27 kg/m2 and &lt;40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index &gt;25 kg/m2 is acceptable as the lower limit.</li>\n<li>Patients have a history of stable body weight (not varying by &gt;2 kg in the 3 months prior to Visit 1).</li>\n<li>Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit 1.</li>\n<li>Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.</li>\n<li>Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.</li>\n<li>Have a history of renal transplantation, or are currently receiving renal dialysis.</li>\n<li>Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.</li>\n<li>Have known hemoglobinopathy or clinically significant, chronic anemia.</li>\n<li>Known or are likely to become transfusion dependent during the study.</li>\n<li>Have active, symptomatic proliferative retinopathy.</li>\n<li>Are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use of macrolide antibiotics)</li>\n<li>Have severe gastrointestinal disease, including gastroparesis.</li>\n<li>Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 months immediately prior to Visit 1.</li>\n<li>Have taken exenatide in the past 6 months, either in a clinical study or as commercially available medication. Patients with known allergy to exenatide should be excluded.</li>\n<li>Have used any prescription or over the counter drug to promote weight loss within 3 months prior to Visit 1, or intend to use such a drug during the study. (Examples: Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Acomplia [rimonabant]).</li>\n<li>Have participated in a structured weight loss program within 3 months prior to Visit 1, or intend to participate in such a plan during this study.</li>\n<li>Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides.</li>\n<li>Are taking warfarin, or a coumarol derivative.</li>\n</ul>\n</p>', created = 1283572240, expire = 1283658640, headers = '', serialized = 0 WHERE cid = '1:6c63c7bc8c7d9134bc084a6443ae2daa' in /persistent/html/includes/cache.inc on line 109.

Comparison of the Effect of Exenatide Versus Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Trial phase: 
Phase IV
Recruitment status: 
Not yet recruiting

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Background information
Trial ID: 
NCT00729326
Other unique IDs: 
H8O-US-GWCV
Official title: 

Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Detailed description: 

 

Number to be enrolled: 
64 patients

Fibromyalgia Health Outcome Study on Cost of Treatments

The REFLECTIONS Study is a 12-month, prospective observational study that will be utilized in approximately 100 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of 2500 adult patients diagnosed by their physician with fibromyalgia (FM) and who are starting any "new pharmacologic agent" for FM. The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize the management of FM. This study will address current gaps in a rapidly growing body of literature for FM.

Background information
Other unique IDs: 
11540
F1J-MC-B020

A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma

To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.

Background information
Other unique IDs: 
11481
H6Q-MC-S042

Study of LY573636-Sodium in Acute Myeloid Leukemia

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to determine a safe dose of LY573636-sodium to be given to patients with relapsed or refractory acute myeloid leukemia and to determine any side effects that may be associated with LY573636-sodium in this patient population. Efficacy measures will also be used to assess the activity of LY573636-sodium in this patient population.

Background information
Trial ID: 
NCT00718159
Other unique IDs: 
12266
H8K-MC-JZAJ
Official title: 

Phase 1 Study of LY573636-Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Detailed description: 

 

Number to be enrolled: 
45 patients

Effects of Atomoxetine on Brain Activation During Attention and Reading Tasks in Patients With ADHD & Comorbid Dyslexia

This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in patients ages 10 to 16 years old with ADHD and comorbid dyslexia

Background information
Other unique IDs: 
12212
B4Z-US-LYEI

Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma

Trial phase: 
Phase II
Recruitment status: 
Recruiting

For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and toxicity of standard chemotherapy followed by IMRT.

Background information
Trial ID: 
NCT00715611
Other unique IDs: 
08-053
Official title: 

Phase II Toxicity Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma

Detailed description: 

 

Number to be enrolled: 
28 patients

Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia

Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will decrease the number of hospitalizations in patients with schizophrenia or schizoaffective disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.

Background information
Other unique IDs: 
ITA-04-2008

A Study for Patients With Metastatic Renal Cell Carcinoma

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.

Background information
Trial ID: 
NCT00709995
Other unique IDs: 
11531
H6Q-MC-S061
Official title: 

Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

Detailed description: 

This is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in patients with metastatic renal cell carcinoma, containing 2 parts. Part 1 is a safety lead-in study with 12 patients and possible dose escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 patients.

Number to be enrolled: 
122 patients

Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer

Trial phase: 
Phase II
Recruitment status: 
Recruiting

The purpose of this study is to compare the effects (good and bad) of chemoradiotherapy with or without Bevacizumab (Avastin). Chemoradiotherapy is the combination of chemotherapy (the drugs pemetrexed and cetuximab) and radiation. Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Cetuximab is also approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy. In this study, the use of bevacizumab is investigational.

Background information
Trial ID: 
NCT00703976
Other unique IDs: 
UPCI 07-021
Official title: 

Phase II Randomized Trial of Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer

Detailed description: 

Background Patients with squamous cell carcinoma of the head and neck (HNSCC) are increasingly treated with primary chemoradiotherapy. The incorporation of novel targeted therapies to chemoradiotherapy is of major interest since it may potentially improve efficacy without significantly increasing toxicity. Radiation and cetuximab, a chimeric anti-epidermal growth factor receptor monoclonal antibody, has emerged as a standard non-surgical therapy for stage III/IV HNSCC.

Number to be enrolled: 
80 patients

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Trial phase: 
Phase II
Recruitment status: 
Recruiting

A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.

Background information
Trial ID: 
NCT00701935
Other unique IDs: 
H8O-CA-GWCE
Official title: 

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Detailed description: 

 

Number to be enrolled: 
94 patients
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