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Discover 20,298 clinical trials near Nashville, Tennessee. Find research studies in your area.
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NCT00099242
The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.
NCT01689675
Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health, quality of life and societal productivity. Early intervention for pain following acute MSIDs may prevent secondary complications of chronic pain, disability, reduced quality of life or lost productivity. The investigators goal is to evaluate the efficacy of a computer-based self-management intervention for reducing pain and improving function in persons treated in on-site physical rehabilitation centers. The specific aims are:1) evaluate the efficacy of a computer-based self-management intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2) determine long term impact during a six month follow-up period; and 3) determine whether reductions of pain and improved function translate into reductions in lost work time days away from work, restricted work days, worker's compensation costs and re-injury rates during the 6 month follow-up. Persons with sprain/strain injuries at risk for poor pain control will randomized to either: 1) control condition - standard care in the rehabilitation center plus computer exposure or 2) standard care plus computer-based self-management pain intervention. Assessment will be at baseline, treatment completion, 3 and 6 months. The primary outcome measures are self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are days away from work, restricted work days worker's compensation costs and re-injury rates. The investigation will also provide unique and valuable information regarding patients acceptance and use of computer-based interventions following acute injury. By establishing the utility and efficacy of computer-based pain management interventions for MSID the investigators have the potential to improve the health and quality of life of persons with injuries, improve productivity and develop new methods for health care delivery.
NCT00259909
The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD). This questionnaire will aim to detect an acute exacerbation and resolution of exacerbation from the patient's perspective. At a later stage of development, this questionnaire will be able to measure the effect of anti bacterials in the treatment of acute exacerbations of COPD (AECOPD). This study will evaluate the factor structure, validity, reliability, and responsiveness of the GSK questionnaire in subjects who experience acute exacerbations of their COPD.
NCT01221597
This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 400 (267 AA4500 and 133 placebo) men will be randomized. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Before dosing, subjects will be stratified by degree of penile curvature deformity (ie, 30º to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either AA4500 0.58 mg or placebo. In this study, qualified subjects may receive up to four treatment cycles; each cycle will be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will receive two injections of study drug with at least 24 hours but not more than 72 hours between injections. After the final injection of each treatment cycle, the investigator or qualified designee will model the penile plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \<15 degrees after the first, second, or third cycle of injections or if further treatment is not clinically indicated, subsequent treatment cycles will not be administered. Following the maximum of four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365 (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol.
NCT00210665
The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.
NCT02537028
The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C administered for 4 weeks in systemic lupus erythematosus subjects (SLE).
NCT01730027
This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when co-administered with montelukast in patients with inadequately-controlled asthma. Patients will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.
NCT02164539
The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.
NCT01225887
This phase II trial studies the side effects and how well nintedanib works in treating patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
NCT01411410
This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will involve multiple participating sites from the US. Following determination of the MTD, an expansion cohort of 20 evaluable subjects with breast cancer was planned. Finally, 16 patients have been enrolled to treatment (Cohort 3). A new expansion cohort with modified dosing cohort is now introduced (Cohort 4: breast cancer expansion cohort with modified dosing) in which another 20 subjects are planned to be enrolled to treatment.
NCT01437345
This study is an observational study that aims to advance our knowledge on infantile onset FSHD. The study will include 50 participants of all ages who have presented with symptoms of FSHD between birth and 10 years of age. Study participation will involve a single day of assessments at one of the participating CINRG centers (to include physical exam, cognitive testing, eye exam, hearing test, strength testing and speech evaluations). The procedures may be split over additional days for scheduling purposes.
NCT01328444
This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI)
NCT01228071
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
NCT01566773
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
NCT02586506
Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2. ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
NCT00263341
The purpose of this 1-year study is to evaluate the efficacy and safety of a new contraceptive vaginal ring (CVR) delivering low doses of Nestorone (NES), a new, nonandrogenic progestin, and ethinyl estradiol (EE), an estrogen used in oral contraceptives. The CVR, which is made of silicone rubber, is designed to be used for 1 year (13 menstrual cycles) before replacement is required.
NCT01846052
The purpose of this study is to identify individuals with achromatopsia caused by mutations in the CNGB3 gene and characterize their clinical condition using several tests of visual function every 6 months for up to 1.5 years.
NCT00586066
The purpose of this study is to see whether memantine improves memory function in participants with bipolar disorder who have minimal symptoms. Secondary analyses will test the role of memantine in improving residual mood symptoms (depression and mania) in participants with bipolar disorder. We hypothesize that in participants with bipolar disorder who have minimal symptoms memantine will be effective in improving cognitive functions, as measured by the difference in neuropsychological test scores at the beginning and at the end of the trial.
NCT02390960
This is a Phase 2a, single-dose, double-blind, placebo-controlled, 2-way crossover study in men with ED. A single 2 gram dose of SST-6006 topical cream 5% w/w (formulated to deliver 100 mg of sildenafil) or a topical placebo cream will be applied to the penile shaft and glans. There are 4 study phases: the Initial Patient Screening Phase (Visit 1, an Off Site 4-Week Run-in Period and Visit 2), the Final Patient Screening Phase (Visit 3), the SST-6006/Placebo Double-Blind Dosing Phase (Visits 4-5), and the Follow-up Phase. Primary outcomes will be be evaluated at Weeks 7 and 8 of the study
NCT00962611
The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
