Colorado Springs, CO Paid Clinical Trials

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861. Read Less

The RSSearch® Registry is an international multi-year database designed to track SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) utilization, treatment practices and outcomes to help determine, over time, the most effective use of these systems in management of patients with life threatening tumors and other diseases. (This study was formally called ReCKord and included the CyberKnife only; The ReCKord study continues as a CyberKnife subset of RSSearch.) Read Less

This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients. Read Less

This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution. Read Less

Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Read Less

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Read Less

This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. Read Less

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Read Less

Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with Asthma," seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D\&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D\&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 \& 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care. Read Less

The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are: * Does the implementation of exercise or psychosocial stress effect circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? * Is there an additive effect of combined exercise and psychosocial on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? Participants will be asked to do the following over the \~3 month enrollment period: * attend a laboratory visit at the beginning and end of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, daily perceived stress levels, physical activity, and diet each month * provide several urine and saliva samples each month * either maintain their usual physical activity and lifestyle habits (control group), increase the duration of their weekly running or cycling mileage by 30% (exercise stress group), complete cognitive function tasks designed to be stressful (psychosocial stress group), or increase the duration of their weekly running or cycling mileage by 30% and complete cognitive function tasks designed to be stressful (exercise + psychosocial stress group) during the final month of enrollment. Researchers will compare control, exercise stress, psychosocial stress, and exercise + psychosocial stress groups to see if there is an effect on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length. Read Less

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK) Read Less

The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \<30% and we anticipate similar rates in this trial. Read Less