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Discover 13,773 clinical trials near Denver, Colorado. Find research studies in your area.
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NCT01156415
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study. Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
NCT01110889
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
NCT00411242
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
NCT00615693
The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.
NCT00492869
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
NCT00082589
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
NCT01491932
This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).
NCT01092065
This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.
NCT00608062
The purpose of this study is to find out why women's arteries stiffen as they go through menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with the loss of estrogen because of "oxidative stress," the production of molecules that can damage cells and tissues in the body, and because the arteries lose their ability to expand, or dilate.
NCT01064791
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
NCT00232180
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients. The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population. On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone
NCT00411099
NCT02780115
This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).
NCT01268059
The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).
NCT03800303
In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to: 1. evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity); 2. evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.
NCT01128335
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
NCT03029624
The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.
NCT02738944
Background: Community Health Centers care for over 20 million rural, low income and minority Americans every year. Patients often have complex mental health problems such as Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers located in rural areas face substantial challenges to managing these patients due to lack of onsite mental health specialists, stigma and poor geographic access to specialty mental health services in the community. As a consequence, many rural primary care providers feel obligated, yet unprepared, to manage these disorders, and many patients receive inadequate treatment and continue to struggle with their symptoms. While integrated care models and telepsychiatry referral models are both promising approaches to managing patients with complex mental health problems in rural primary care settings, there have been no studies comparing which approach is more effective for which types of patients. Objectives: The central question examined by this study is whether it is better for offsite mental health specialists to support primary care providers' treatment of patients with PTSD and Bipolar Disorder through an integrated care model or to use telemedicine technology to facilitate referrals to offsite mental health specialists. We hypothesize that patients randomized to integrated care will have better outcomes than patients randomized to referral care. Methods: 1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be recruited from Community Health Centers in three states (Arkansas, Michigan and Washington) and randomized to the integrated care model or the referral model. Patient Outcomes: Telephone surveys will be administered to patients at enrollment and at 6 and 12 month follow-ups. Telephone surveys will measure access to care, therapeutic alliance with providers, patient-centeredness, patient activation, satisfaction with care, appointment attendance, medication adherence, self-reported clinical symptoms, medication side-effects, health related quality of life, and progress towards life goals. A sub-sample of patients will be invited to participate in qualitative interviews to describe their treatment experience using their own words. Likewise, primary care providers will be invited to participate in qualitative interviews to voice their perspective.
NCT00147615
To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.
NCT02608125
This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.
