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Discover 18,161 clinical trials near Denver, Colorado. Find research studies in your area.
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Showing 15441-15460 of 18,161 trials
NCT01430754
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
NCT00525447
This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.
NCT01246960
The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.
NCT01069965
This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone in patients with Type 2 Diabetes Mellitus.
NCT00594165
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease.
NCT01419756
Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with Tetralogy of Fallot following repair; a comparison study to cMRI. The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical repair. Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical sites. The analyses will be the same for EDV and ESV. For either right ventricular volume, the primary effectiveness measure is the % difference between VMS and cMRI results, i.e. (VMS-cMRI)\*100%/average of VMS and cMRI results. There will be two null hypotheses for the primary analysis: H0+: true mean % difference \> 10% and H0-: true mean % difference \< -10% The observed mean % difference will be presented with 95% confidence intervals. The VMS right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the overall type I error rate for both EDV and ESV is 0.05.
NCT00097708
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
NCT00206583
The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.
NCT00109928
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.
NCT00499590
The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.
NCT00082095
The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.
NCT01946425
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to \< 9 years at enrollment, divided into 2 age strata (6 months to \< 36 months and 3 years to \< 9 years) Primary Objective: * To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Observational Objectives: * To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to \< 9 years of age. * To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
NCT01993225
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
NCT01196052
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.
NCT01636362
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
NCT00888069
This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
NCT00792857
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.
NCT00211172
The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings designed to increase patient's adherence to prescribed beta-blockers following an acute myocardial infarction (AMI). Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an acute myocardial infarction (AMI) to identify the issues and information that patients felt were important to include in our materials as well as the best way to present the information. Additionally, patient materials were "pre-tested" with AMI patients to ensure that the materials were clear and easy to read and that the key messages were understood.
NCT00953095
The goal of this project is to test an intervention program for caregivers and their young children with autism that is focused on improving social communication. This study specifically targets underserved populations, specifically children from low SES and racial/ethnic minority families. Participants will include 40 children (aged 24 months to 60 months) and their caregivers who will be randomized (as if by flipping a coin) to one of the two treatments: Parent education sessions for two hours a week for 12 weeks or parent-child intervention sessions with the child for one hour, twice a week for 12 weeks. Young children with autism have difficulty with engaging in joint attention with others (e.g. pointing, showing. Joint attention skills are important to later development of language. Therefore, targeting this problem in young children may result in better language outcomes for these children. In order to examine the effects of the interventions, all participants will be complete cognitive, language, communication and play-based assessments prior to treatment, at the end of the first 12 weeks of the intervention, and post-treatment immediately following the intervention (approximately 2.5 to 3 hours each).
NCT00700180
This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
