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NCT00269230
People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest area. This device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The device may also be able to stop the heart from beating too fast. Three leads are implanted into the chambers of your heart. Two of the leads will be placed on the right side of your heart. The third lead is placed on the left side of your heart and is the lead being studied. The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.
NCT00430898
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
NCT00081380
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
NCT00275769
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
NCT00493857
This study will determine if nimotuzumab provides a benefit in this type of cancer when given in combination with irinotecan. The study will test: * How long any good effects last. * How bad any side effects are. Objectives: Primary: The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer Secondary: * To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction, allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules; * To assess Progression-Free Survival (PFS), defined as time from date of randomization until date of disease progression (clinical or radiological) or death due to any cause, for the two nimotuzumab schedules; * To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly nimotuzumab schedules; * To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab schedules; * To evaluate ORR in patients who are identified as having "primary" irinotecan resistance following weekly or 2-weekly nimotuzumab schedules; * To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules; * To compare the two dosing schedules of nimotuzumab with respect to objective response rates and safety; * To evaluate the overall safety and toxicity profiles of these two dose regimens of nimotuzumab; * To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving the drug on weekly or 2-weekly regimens.
NCT00150410
* Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. * Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.
NCT00157690
The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The investigators hypothesize that in adult CF patients with osteopenia or osteoporosis, alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD that is greater than that observed with placebo at 12 months.
NCT00274313
The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.
NCT00083447
TransMID treatment or best standard of care for patients with advanced glioblastoma multiforme Glioblastoma multiforme (GBM) is a type of brain tumour. GBM tumours are usually treated with surgery and radiotherapy. Unfortunately, this type of brain tumour may continue to grow or come back (recur) despite treatment. This trial will compare a new drug called TransMID with the best standard treatment that is currently available. TransMID is a drug that is a combination of a protein called transferrin and a poison called diphtheria toxin. Cancer cells need iron in order to continue to grow. They need more iron than normal cells. Transferrin helps cells to take up available iron. So the cancer cells are attached to the transferrin in TransMID, and the diphtheria poison kills them. The aim of this treatment is to kill the cancer cells while not affecting the normal brain cells. This treatment for brain tumours may have fewer side effects than other treatments because it targets cancer cells. The best standard treatment will involve giving chemotherapy. You may have chemotherapy as part of the treatment when you are diagnosed. Or it may be kept in reserve to treat your brain tumour if it comes back or continues to grow. Your cancer specialist (consultant) will decide which chemotherapy drugs you should have.
NCT00088088
This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had chemotherapy before for their disease. The first phase of the study recently completed and for the second phase of the study patients are randomly assigned to receive either paclitaxel and carboplatin or paclitaxel and carboplatin and study drug (STA 4783). Treatment will be every 3 weeks for 6 cycles.
NCT00109655
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
NCT00207103
This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
NCT00352742
The purpose of this study is to describe the safety and effect of ATN-224 in combination with bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory to bortezomib.
NCT00307515
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
NCT00681759
The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin
NCT00250627
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression. The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.
NCT00494663
DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated cortisol may contribute to the development of type 2 diabetes. The purpose of this research study is to test the safety of DIO-902 when taken by mouth with metformin and the cholesterol-lowering drug atorvastatin to determine the type and severity of any side effects from this treatment. Other purposes of the study are to see how the treatment affects your blood glucose levels, cholesterol levels, blood pressure, and waist circumference.
NCT00480155
To assess the safety of a vaccine in healthy adults prior to the release of the vaccine (FluMist®) containing it.
NCT00290953
To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 versus placebo, after an initial response (complete or partial response or stable) to first line cisplatin plus etoposide. Primary objective: comparison of overall survival between patients in the control arm and the meclinertant arm. Secondary objectives: comparison of the progression free survival, the time to progression, the clinical benefit, the quality of life, the toxicity and safety between patients in the control arm and the meclinertant arm.
NCT00253955
Primary Objective: * The primary objective of the study is to demonstrate the non-inferiority in clinical efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500 mg every 8 hours in treating adult patients suffering from mild to moderate hospital-acquired pneumonia. Secondary Objectives: The secondary objectives of the study are: * To assess the bacteriological efficacy at the test of cure (TOC) visit * To assess the clinical and bacteriological efficacy at the end of study (EOS) visit, 28 to 32 days after treatment ends * To assess the tolerability of both drugs