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NCT01857323
This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler integrated dose counter in a clinical setting.
NCT00927641
The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.
NCT01488929
Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on the function, employment, and social interactions of patients with schizophrenia. Medications used to treat schizophrenia (e.g. atypical antipsychotics) do not improve negative symptoms or CDS. TC-5619 is being developed for use as an add-on therapy in combination with atypical antipsychotics to treat patients with negative symptoms and CDS.
NCT01346293
The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only. Primary Objectives: * To compare the pertussis \[Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)\] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay \[ELISA\]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose. * To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose . * To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. Observational Objectives: * To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. * To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.
NCT00650091
Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups - receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo - in a 1:1:1 ratio.
NCT01235520
This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.
NCT00003325
RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva. PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.
NCT00952900
With the great economic costs and traditionally poor outcomes among chronic temporomandibular joint and muscle disorder (TMJMD) patients, it has become important to treat patients in the acute state, in order to prevent these more chronic disability problems. This has been the goal of two past funded grant projects. Results of the initial project isolated risk factors that successfully predicted the development of chronicity with a 91% accuracy rate. A statistical algorithm was developed which was used in the second project to screen out "high-risk" patients. These patients were then randomly assigned an early intervention or non-intervention group. One-year follow-up evaluations documented the treatment efficacy and cost effectiveness of early intervention. These results have major implications for effective early intervention and significant health care cost savings for this prevalent pain and disability problem. For the present proposed project, we plan to implement this treatment program in order to evaluate its effectiveness in more community-based dental practices. This is in response to NIH's request for the implementation of evidence-based treatment approaches, developed in controlled clinical settings, to the "real world" of diverse practices in the community. Acute TMJMD patients will be recruited from two community-based clinics. Based upon our "risk" screening algorithm, high-risk patients will be randomly assigned to one of two groups (n=225/group): an early biobehavioral intervention or an attention-control group. It is hypothesized that the attention control "high-risk" patients will display more chronic TMJMD problems, relative to the "high-risk" early intervention patients, at one- and two-year follow-ups. A number of biopsychosocial measures will be evaluated, including chewing performance, the RDC/TMD, self-reported pain and stress, etc. Such a multi-level, multi-systems approach has not been applied to better understand the biopsychosocial underpinnings of TMJMD. Results from this component of the project will greatly aid in stimulating future research leading to the better understanding of TMJMD, as well as better tailoring of prescribed treatment regimens.
NCT00389181
The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.
NCT00217633
This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.
NCT00877292
The study will examine the sensitivity and specificity of a circulating cell-free nucleic acid test (DNA/RNA) to identify Down syndrome between about 10 weeks and 21 weeks 6 days gestation. In addition, the new test may be used to identify trisomy 13 and 18 as part of a more complete laboratory developed test. We hypothesize that the new circulating cell-free fetal NA-based test will accurately and precisely measure specific fetal markers in maternal circulation and that measurement will lead to the ability to noninvasively identify with high sensitivity and specificity, fetal chromosome abnormalities, such as Down syndrome.
NCT00757588
The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.
NCT02405039
This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.
NCT02456831
This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.
NCT00621049
Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.
NCT00746759
The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.
NCT01335061
The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
NCT00947882
A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)
NCT01658579
Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening * To compare the incidence and frequency of hypoglycemic episodes * To assess the safety and tolerability of the new formulation of insulin glargine
NCT00420342
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.