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NCT00651118
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
NCT00463606
The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.
NCT01145755
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
NCT01032837
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.
NCT01241331
The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its vehicle in the treatment of moderate-severe acne vulgaris.
NCT00229801
Clinical measurement of renal function is generally performed using either laboratory tests or nuclear medicine techniques, however, both of these techniques suffer from some limitations. Notably the lab tests only assess global, rather than individual kidney, function and the nuclear medicine tests are demanding to perform well. Children with brain tumors are often treated with chemotherapeutic in order to try and kill the cancer. Amongst the known side effect of some of the drugs used in the chemotherapy is the fact that they may damage the kidneys. For this reason the function of the kidneys is assessed using a laboratory test at 3 or 6 months intervals during the treatment. In addition, to the problem mentioned above the tests also require a separate visit to the hospital. Children with brain tumors who are undergoing chemotherapy also routinely have contrast-enhanced MRI of the brain performed at intervals of three months in order to evaluate the response of the tumor to the chemotherapy. Recently, MRI techniques have been developed which can evaluate single kidney renal function. The aim of this study is to establish if a single MRI exam can be used to assess both the effect of the chemotherapy on both the tumor and the renal function. The results of the MRI measurement of the single kidney renal function would be combined to provide a measure of global renal function and this would be compared with that obtained from the laboratory test. The MRI exam will require only require an extra 10 minutes of scanning time and will not affect the rest of the MRI exam in any way. This study is being performed to validate a new technique for measuring kidney function. Patients are being asked to volunteer for this study because they require serial contrast enhanced MR scans to monitor their response to chemotherapy. Because some chemo-therapeutic agents can be toxic to the kidney the patient's kidney function will also be evaluated using conventional methods, and the results of these tests can be compared to those obtained using MRI. We plan to study 50 children in this study. The additional procedure for measuring renal function will add 10 minutes to the duration of the MRI exam and will have no effect on the routine brain study. If validated the proposed MRI technique would allow renal function to be evaluated at the time of a routine, contrast enhanced MRI exam and would avoid additional testing using radioactive tracers or urine collection over 24 hours. If successful, MRI could be used to measure single kidney renal function in all any patient undergoing a routine MRI exam by simply extending the scanning time by a maximum of 10 minutes. This would save such patients additional visits to the hospital and would have the advantage of measuring single kidney, rather than global, renal function.
NCT00229814
Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of 10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and spectroscopic features. There is debate whether they truly represent brainstem tumors or whether they are a site of benign cellular overgrowth. The majority of these tumors are pathologically benign and show no or minimal growth. Not all tectal plate tumors, however, have this typically benign course. Some can manifest a more aggressive behavior. There have been reports in the past attempting to analyze the histology and behavior of these tumors. None of the prior series looking at these tumors have included Magnetic Resonance Spectroscopy (MRS) analysis. It is interesting that according to where tumors occur in the brainstem usually indicates what their histology and behavior is. Although not absolute, we know that tumors can have a very poor prognosis versus an extremely good prognosis depending on their location in the brainstem. Yet there are always the cases that do not act in the typical fashion and this is where MRS can prove helpful. This study is being done to look at a region of the brain, called the tectal plate, in children. This part of the brain can be involved by tumors. Because of the location of the tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can look at the chemical make up of the brain. MRS may allow us to better understand the nature and behavior of these tumors. However, in order to understand disease in this area, we need to look at the normal chemical make up of the brain in children without tectal plate tumors. Healthy patients are being asked to participate as a normal volunteer. We anticipate having a total of 10 to 12 normal volunteers in the MRS study.
NCT00833248
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
NCT00457821
The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
NCT00796705
Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.
NCT01358240
This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
NCT00147576
Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects compared to placebo.
NCT00862524
This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine. The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed). In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
NCT01257542
15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.
NCT00912288
No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.
NCT01247818
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
NCT00796744
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
NCT00063635
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
NCT00785369
The purpose of this study is to image pigmented skin lesions suspicious for melanoma with an imaging technology called in vivo reflectance confocal microscopy. This technology uses low intensity laser to image below the surface of the skin. The confocal images of the suspicious skin lesion will be examined. The goal of this study is to compare the results of the confocal image examination to the pathologic diagnosis of the skin lesion. The technique being evaluated in this study uses reflectance confocal microscopy in vivo. The term "in vivo" means in/on a living subject. In this study you will be the living subject and the confocal microscope will be placed on your skin to look at your skin lesion. The confocal microscope uses a weak laser light and a sophisticated lens to image the individual cells that make up the skin. Your lesion will be photographed with high resolution photography.
NCT01104246
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.