Headington, United Kingdom

  • Featured

    A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

    * Interventional Study * Estimated Enrollment:170 participants * Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations. * This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. * There is no difference in the treatment regimen between the cohorts.

    Phase

    2

    Span

    Sponsor

    Dallas, Texas

    Recruiting

  • Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults

    PREVENTABLE will randomly assign atorvastatin 40 mg daily or matching placebo daily to approximately 20,000 community-dwelling adults 75 years of age or older without clinically evident cardiovascular disease, significant disability, or dementia, and follow them for up to 5 years (estimated median of 3.8 years). The study will enroll participants from approximately 100 US sites. Community engagement efforts will leverage community groups and practices as collaborators for recruitment. We plan to partner with participants, caregivers, and clinicians in all aspects of the study. The enrolling sites are non-VA and VA sites. To assist in recruitment, sites will apply a study-specific cohort identification algorithm to their electronic health record to create a list of eligible participants based on study inclusion and exclusion criteria. The cohort identification will exclude individuals with clinically evident cardiovascular disease, significant disability, or dementia and other exclusions obtainable from data queries to define a potential cohort. Additionally, the PREVENTABLE CCC will provide a centralized support team to assist with recruitment and retention efforts. This includes mass mailings and/or phone calls to potential participants and a toll-free number for potential participants to call for information and pre-screening. Interested and potentially eligible participants will be referred to an enrolling site near them, if applicable, otherwise, they will be referred to the PREVENTABLE Telesite which is capable of enrolling English and Spanish-speaking participants across the U.S. remotely. Sites will screen potential participants to confirm eligibility and consent and randomize those interested in joining the study. Specifically related to dementia, the qualifying exclusion is a clinical diagnosis in the chart or clinician's assessment that dementia may be present. Sites will enter contact information, mailing address for study drug, demographic information, height, weight, statin history (if any), Social Security Number, and aspects of the medical history not obtainable from EHR. In addition, a Short Physical Performance Battery (SPPB) and Activities of Daily Living (ADL) screen will be site-performed at baseline. SPPB will provide an objective assessment of function for understanding frailty and physical function of the enrolled population. Baseline lipid panel (core lab) and biospecimen samples will be obtained using the same blood draw for 20cc of blood. Blinded lipid testing will be performed at baseline on all participants (n=20,000) and repeated at 3 months in a random subset (n=2,000). Lipid panels will be sent to the PREVENTABLE Core Lab to maintain study blind. Future testing of lipid panels during routine clinical care will be actively discouraged, but other laboratory testing as indicated by clinical care is permitted. Sites will have the option for telehealth enrollment. Baseline SPPB and Biorepository Labs are not required, but encouraged. As part of the study operations, with the rationale of providing patient centricity, ease of participation, and access for vulnerable and at risk participants, follow up will be performed by a central call center. The baseline and annual assessments performed centrally will include a phone screen for cognitive function (TICS-M) and physical function (Patient-reported Outcome Measurement Information System-Physical Function [PROMIS-PF]). After year 1, if baseline calls indicated by crossing pre-specified cutpoints, in-person assessments will be completed by trained and certified research staff at a mutually agreed upon time and a standardized interview of a knowledgeable informant. Cardiovascular event ascertainment will be via a systematic approach to data curation from the EHR, Medicare, and National Death Index. For convenience and compliance, the study pharmacy will mail a supply of study drug, sufficient for 90 days, directly to participants. This will start immediately after randomization and continue as long as the participant is on study drug.

    Phase

    4

    Span

    331 weeks

    Sponsor

    Duke University

    Dallas, Texas

    Recruiting

    Healthy Volunteers

  • The Role of Social Determinants in Cardiovascular Health and Vascular Function

    This study aims to identify the influence of social determinants of health domains on vascular function in a low income, racial, and ethnic minority population at risk for disparities. We hypothesize that individuals of a lower social economic position are at greater risk of impairment in the large organ that is responsible for blood movement in the body and artery stiffness. Additional sims include identifying the influence of depression on vascular function and measure the interaction between depression and social determinants of health. We hypothesize that impairment will be greater in individuals with depression than in individuals without. Finally we will compare a comprehensive metabolic project against the social determinants of health and depression, hypothesizing that more severe social determinants of health and depression will increase the risk of cardiovascular disease.

    Phase

    N/A

    Span

    27 weeks

    Sponsor

    Baylor Research Institute

    Dallas, Texas

    Recruiting

    Healthy Volunteers

  • Expanded Population Health Model Evaluation

    The specific aims of this study are to 1) evaluate whether a population health model integrated into a community setting improves cardiometabolic health and quality of life in adults 18 years or older and 2) evaluate which programs and services provide the most impact for specific sub-groups of individuals, e.g., elderly, individuals with diabetes, etc. Participants will receive programs from the existing population health model from Baylor Scott & White Health and Wellness Center with additional programs from a local community organization. Individuals will complete study measures at baseline, 6 months, and 12 months.

    Phase

    N/A

    Span

    166 weeks

    Sponsor

    Baylor Research Institute

    Dallas, Texas

    Recruiting

    Healthy Volunteers

  • Brain Health on College Campuses

    ONLINE Procedures Assessments (3 times over 9 months): BrainHealth Index - An online battery of cognitive measures and questionnaires. Periodic surveys to assess new research questions (as IRB approved) and to assess participant experience Training, habits, resources (available over 9 months): Micro-learning video modules that include Strategic Memory Advanced Reasoning Tactics (SMART) and other trainings such as stress management, sleep, and lifestyle. The habit tool supports accountability and consistency of building new and personalized habits. Curated resources (articles, podcasts, videos) around the topic of brain health are also available. Coaching Periodic access to group and one-on-one brain-health related virtual coaching sessions. Link wearable data Participants have the option to link their wearable data with their data collected through the BrainHealth Platform IN-PERSON Procedures The investigators will offer in-person and/or virtual/hybrid educational sessions on a variety of high-interest topics such as stress management, sleep, resilience, and mental well-being, with an emphasis on how practicing and implementing brain healthy strategies can impact everyday life. For faculty/staff, the investigators will also offer interactive workshops on how to create a brain healthy environment and classroom, including ways to implement and provide brain-healthy strategies and resources in their everyday operations involving students (e.g., ways to enhance mental energy and focus in the classroom, brain-based approaches to promoting growth mindset and confidence, etc.).

    Phase

    N/A

    Span

    51 weeks

    Sponsor

    The University of Texas at Dallas

    Dallas, Texas

    Recruiting

    Healthy Volunteers

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