Colorado Springs, CO Paid Clinical Trials

Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report measures; and parental health literacy, self-efficacy, and mental health at 3, 6, and 12 months after discharge. Child's academic performance will be assessed using school records. The study evaluates a flexible and scalable intervention using mobile phones to aid transitions of care, improve treatment adherence and TBI outcomes. It addresses the needs of an understudied population and can serve as a model for TBI family centered care for at risk groups. Read Less

The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks. 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

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment. Read Less

This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II. Read Less

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II. Read Less

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV. Read Less

The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies. Read Less

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab The total duration of the study is planned to be 75 months. Read Less

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase. Read Less

Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold. Read Less

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916). Read Less