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Discover 18,161 clinical trials near Denver, Colorado. Find research studies in your area.
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Showing 10241-10260 of 18,161 trials
NCT01714596
The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics for 6 weeks. Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that require surgery \>2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other. Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection, non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment costs at 1 year will be lower in Group 1 than in Group 2. Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2. Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior to adherence in Group 2. Specific Aim 2: To build and validate a risk prediction model for failure of treatment of early post-op wound infections after fixation of fractures and joint fusions.
NCT02369874
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.
NCT00318591
The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.
NCT00676403
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
NCT04743531
Obesity is a multi-dimensional problem that has roots in infancy and tracks into adulthood. Obesity is represented disproportionately among children and families from low socioeconomic and minority backgrounds, particularly in rural areas that have limited access to food, activity, and health-related services. There is a need for culturally-tailored, effective interventions that can positively impact the environments (home, preschool, community) in which young children grow and develop their eating and activity behaviors. Developing family interventions, particularly for families with limited resources, requires improving caregivers' health literacy and home food/activity environments, and also requires tailoring to accommodate the realities of stressful and unpredictable family settings. The overall objective of this proposed HEROs Study (HEalthy EnviROnments Study) is to develop a companion, technology-based, interactive family intervention that will promote healthy lifestyles for young children in both Head Start and family settings.
NCT02593006
STOP-JIA is a PCORI funded prospective observational study which compared the clinical effectiveness and impact on patient reported outcomes of 3 Childhood Arthritis \& Rheumatology Research Alliance (CARRA) consensus derived treatment strategies (CTPs) in new-onset polyarticular JIA (pJIA) patients to answer the critical question of when is the best time to begin biologic medications to achieve the optimal clinical and patient reported outcomes. Because the CARRA Registry will be used for data collection, all patients will be enrolled in the CARRA Registry. The standard of care treatments are chosen by the treating physician and patient/caregiver and are not randomized.
NCT02267876
The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results
NCT02303184
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).
NCT00413010
The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.
NCT02433158
This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).
NCT03727087
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
NCT00412113
The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.
NCT01297959
This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being developed for direct application to a surgical incision.
NCT01912274
The purpose of this study is to determine the safety and effectiveness of pracinostat when combined with azacitadine for patients who are 65 years of age or older and have Acute Myelogenous Leukemia (AML)
NCT00437281
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.
NCT03280121
Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device
NCT01628393
This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).
NCT03040986
This phase II trial studies how well selumetinib sulfate works in treating patients with pancreatic cancer with Kirsten rat sarcoma (KRAS) G12R mutations that has spread from where it started to nearby tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT00292188
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
NCT00368745
GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.
