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NCT00403286
The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
NCT00613340
Cervical facet arthropathy is a common cause of chronic neck pain. The "gold standard" for diagnosis is either blocking the facet joints, or more commonly blocking the medial branch nerves that innervate the joints. However, many studies have found a high false-positive rate when the nerves are blocked using 0.5 ml of local anesthetic. We will randomize patients to receive either cervical facet medial branch blocks with 0.25 ml of local anesthetic and contrast, or 0.5 ml. We will then do a CT scan to determine the accuracy and specificity of each block. Our hypothesis is that using the higher volume (0.5 ml) might be responsible for the high false-positive rate.
NCT00445809
Some patients who undergo cardiovascular surgery requiring cardiopulmonary bypass will develop a kidney injury following their surgery. The purpose of this study is to take a blood sample from patients before they have this type of surgery and then at nine time points after their surgery to test their plasma for a biomarker called NGAL and compare the NGAL levels to their creatinine levels. We hypothesize that NGAL is an earlier marker for kidney injury than creatinine.
NCT00946400
The purpose of this study is to evaluate a scoring tool to help determine the presence of Heparin Induced Thrombocytopenia (HIT), which is an adverse reaction to heparin. We hypothesize that this scoring tool will be very useful in excluding patients who are suspected of having HIT.
NCT00091741
The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional antiretroviral (HAART) therapy and for whom no alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is the management of virologic failure and metabolic complications of anti-HIV treatment. Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance remains the single most important reason for virological failure and rapidly limits treatment options.
NCT00734175
In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H6N1 influenza vaccine candidate.
NCT00105989
The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.
NCT00325962
The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes.
NCT00683761
The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.
NCT00702676
This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.
NCT00053105
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
NCT00475748
ABSTRACT/EXECUTIVE SUMMARY BACKGROUND, SIGNIFICANCE \& RATIONALE: Between 10-20% of the more than 6000 cases of spinal cord injury seen annually in the North America have the clinical pattern of traumatic central cord syndrome (TCCS). These patients are usually older, most likely have sustained a fall, and have incomplete spinal cord injury characterized by dysesthetic and weak upper extremities. CT scan of the cervical spine in patients with TCCS often shows disc/osteophytes complex superimposed on degenerative or congenital spinal stenosis and MRI reveals signal changes at one or multiple skeletal segments. A minority of these patients suffer from fracture/subluxations, however, this group of patients are younger and have been involved in a more dynamic trauma. Since 1951, when Schneider et al reported this syndrome, controversy has dominated its surgical management. The current "Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries" recommendations are only at the level of options, since prospective outcome data are unavailable. HYPOTHESIS: in acute traumatic central cord syndrome, surgical decompression of the spinal cord within five days will result in more rapid motor recovery, than decompression 6 weeks following injury. To test this hypothesis, we will pursue the following specific aims: SPECIFIC AIM I: To compare American Spinal Injury Association (ASIA) Motor Scores after three months post injury in patients with central cord syndrome operated on within five days of injury to a similar group of patients operated on 6 weeks following injury. SPECIFIC AIM II: To compare functional outcome, health related quality of life and posttraumatic syrinx size in patients with traumatic central cord syndrome operated on within five days to a similar group of patients operated on 6 weeks following injury. DESIGN: Single center prospective randomized study. PROCEDURE: In a two-year period thirty patients with traumatic central cord syndrome and cord compression (15 patients in each group) will be randomized to undergo surgical decompression either within the first five days or at 6 weeks following spinal cord injury. ASIA motor, functional recovery and health related quality of life between the two groups will be compared at admission, discharge from rehab facility 3 months and 12 months after surgery.
NCT00820859
The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.
NCT00334880
The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder (ADHD).
NCT00843453
This study was designed to determine whether elderly residents of long term care facilitated who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal spray improved these subjects' vitamin B12 status.
NCT00126724
The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in adults with inflammatory arthritis who have persistent moderate or severe swelling in one or more joints, without a disease severe enough to warrant a change in regimen for the next three months. The study will permit subjects who are concurrently on anti-tumor necrosis factor (TNF)-alpha antagonists. For subjects on disease modifying antirheumatic drugs (DMARDs), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening will be required. The primary objectives are: 1. to evaluate the safety of intra-articular administration of tgAAC94 in subjects currently taking TNF-alpha antagonists, and 2. to evaluate the safety of repeat intra-articular administration of tgAAC94 (gene therapy vector).
NCT00813826
The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.
NCT00467415
The investigators are studying the effects of a 12-week exercise program, consisting of either: 1. Walking on a treadmill with partial body weight 2. Functional exercise program The investigators would like to know the effects these two exercise programs have on the quality of life, muscle strength and control, coordination, walking, and functional movement of children with cerebral palsy who are marginal ambulators. This is a randomized control trial with subjects randomly assigned to one of the 2 groups.Subjects in both groups will be seen twice a day for two weeks at our hospital for intervention and parent training, and then participate in a 10 week home-based program. During each subject's two-week clinic-based training, a parent or caregiver is trained in all home program exercises and/or equipment usage. This person must be able to safely perform the exercise program with the child. Each subject will also need to participate in three separate 5-hour long data collection sessions scheduled over the 4 month study period.
NCT00931034
The purpose of this study is to examine the effectiveness of the South Beach Diet and products compared to the American Diabetic Association Diabetes Meal Plan.
NCT00104273
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.