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  • Multi-Center Adolescent Clavicle Fracture Trial: Operative Vs. Non-Operative Treatment

    Phase

    N/A

    Span

    690 weeks

    Sponsor

    Boston Children's Hospital

    Ann Arbor, Michigan

    Recruiting

  • Product Surveillance Registry

    Phase

    N/A

    Span

    1466 weeks

    Sponsor

    Medtronic

    Ann Arbor, Michigan

    Recruiting

  • Natural History Study of Synucleinopathies

    α-synuclein is a small protein of 140 amino acids that is highly expressed in the brain. It's function remains poorly understood.10 Synucleinopathies are a group of neurodegenerative diseases associated with the abnormal accumulation of α-synuclein within cytoplasmic inclusions in neurons or oligodendroglia. These α-synuclein containing cytoplasmic aggregates occur throughout the brain, producing cell death and specific motor, autonomic and cognitive dysfunction in four phenotypically distinct synucleinopathies. When α-synuclein deposition occurs in neurons it aggregates into Lewy bodies, producing Parkinson disease (PD), dementia with Lewy bodies (DLB) or pure autonomic failure (PAF). Whereas in multiple system atrophy (MSA) neuronal death probably occurs as a consequence of α-synuclein aggregation in oligodendroglia. A characteristic feature of the synucleinopathies is that they can all begin with varying degrees of autonomic dysfunction as the sole clinical feature - implying an initial diagnosis of isolated (pure) autonomic failure 11. After a variable period of time, but usually less than 5 years, only a small number of patients remain with a pure autonomic failure phenotype, but careful follow-up is lacking 11. Most patients develop cognitive or motor abnormalities (or both) and the patient is then diagnosed with PD, DLB or MSA. This stepwise clinical progression suggests that the neurodegenerative process can in rare cases remain confined to autonomic neurons12, but more frequently spreads to affect additional areas of the central nervous system (CNS). This unique feature of the synucleinopathies poses diagnostic challenges and potential therapeutic opportunities. The challenges are first, to determine whether PAF is a distinct disease or is always a prodromal phase of PD, DLB or MSA and second, to discover biomarkers that predict spread to motor and cognitive neurons. Such biomarkers would allow testing of disease-modifying strategies to delay or stop the neurodegenerative process in the pre-motor or pre-dementia phase. Aim 2 will focus on defining the natural history of MSA, the most aggressive of the synucleinopathies. This prospective observational study will establish disease-specific milestones for use in future clinical trials. Obstacles to identifying biomarkers predicting further CNS involvement are that most medical centers only see patients with synucleinopathies when they already have developed motor and cognitive involvement, and that PAF and MSA are rare disorders. In this context the Autonomic Disorders Consortium (ADC) within the Rare Diseases Clinical Research Network (RDCRN) of the National Institutes of Health (NIH) was created with the objective of providing a better understanding of the variability, progression, and natural history of neurodegenerative synucleinopathies. Continuing this observational study, and increasing its power by including additional academic centers from the U.S., South America, and Europe, will allow us to define the natural history of these diseases and establish the sensitivity and specificity of the proposed biomarkers.

    Phase

    N/A

    Span

    813 weeks

    Sponsor

    NYU Langone Health

    Ann Arbor, Michigan

    Recruiting

  • A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM

    SNAPSHOT-PKP2 is an observational, multicenter study that consists of 2 parts, a retrospective EMR review (up to 2 years) and a prospective observational study (1 year), to evaluate the clinical burden of illness of patients with PKP2-ACM, and to prospectively evaluate changes in key cardiac parameters and patient-reported outcome measures (PROMs) associated with PKP2-ACM progression.

    Phase

    N/A

    Span

    193 weeks

    Sponsor

    Lexeo Therapeutics

    Ann Arbor, Michigan

    Recruiting

  • A Study of PHST001 in Advanced Solid Tumors

    Phase

    1

    Span

    318 weeks

    Sponsor

    Pheast Therapeutics

    Ann Arbor, Michigan

    Recruiting

  • Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

    Phase

    4

    Span

    131 weeks

    Sponsor

    University of Michigan

    Ann Arbor, Michigan

    Recruiting

  • Family Acceptance Project Online (Pilot RCT)

    Research documents epidemic rates of behavioral (e.g., alcohol use), emotional (e.g., depression, suicidality), relational (e.g., dating violence victimization and perpetration), and academic (e.g., academic commitment) problems among sexual and gender minority youth (SGMY), including SGMY of color who experience disproportionate inequities due to their multiply minoritized status. The disproportionally high rates of behavioral, emotional, relational, and academic problems among SGMY can be explained by experiences of minority stress related to oppression and discrimination specific to occupying minoritized social identities, including sexual orientation, gender identity, and race/ethnicity. Research shows that racial discrimination, SOGIE (sexual orientation, gender identity, and expression) discrimination and victimization interact to exacerbate their negative associations on deleterious behavioral, emotional, relational, and academic outcomes. Families, including caregivers, play a critical role in the lives of SGMY by buffering against, exacerbating, and/or serving as a direct source of minority stress. A prevalent form of minority stress experienced by SGMY is family rejection (attitudes and behaviors that demonstrate disapproval of and/or efforts to change one's child's SOGIE) related to their sexual/gender minority identity. Indeed, 71% to 82% of SGMY report family rejection, and family rejection is more pronounced among SGMY of color (compared to white, non-Latinx SGMY). Family rejection predicts a host of deleterious emotional, behavioral, relational, and academic outcomes. For example, youth who are told by their caregivers that something is inherently wrong with them, that they will never have a good future, and engage in damaging behaviors (e.g., expulsion from the home, harsh parenting/abuse), may internalize those experiences. This internalization may result in depression and suicidality. Caregiver rejection may also lead to risk behaviors in SGMY via the lack of positive parent-child relationships, poor communication, absence of modeling of healthy attitudes and behaviors, and poor monitoring/supervision. The absence of these parenting behaviors and parent-child relationship variables may lead to substance use (via poor coping mechanisms and/or lack of parental monitoring) as well as sexual risk taking and/or dating violence (via lack of knowledge about healthy relationship behaviors, the inability to seek guidance about mistreatment from others, and due to internalized oppression which may render SGMY more vulnerable to victimization and less likely to leave an abusive relationship). The etiology of caregiver rejection of their SGMY is complex and multifaceted, Caregivers may engage in rejecting behaviors due to care for their SGMY and desire to help their child "fit in", "have a good life", and "be accepted by others" as well as a lack of information on SOGIE and/or how to support their SGMY. Caregiver rejection of their SGMY is often rooted in negative societal, cultural, and/or religious views about SGM people, including strict notions about gender. Beyond caregiver acceptance (a key component of reducing inequality among SGMY and promoting positive youth development [PYD]), SGMY of color who report a strong sense of connection to other SGM individuals have better outcomes than SGMY of color who do not report these connections. Thus, programs that simultaneously seek to reduce caregiver rejection of their SGMY and provide opportunities for SGMY to connect with other SGMY may be especially powerful in reducing minority stressors and deleterious outcomes and promoting overall PYD. What is more, programs that provide accurate information about SOGIE, teach caregivers how to advocate for their SGMY, and reduce internalized oppression among SGMY may also foster the development of critical consciousness (i.e., the process of understanding social conditions, health inequities, and systems of oppression) in SGMY of color and their caregivers. Critical consciousness not only fosters thriving in the face of adversity but also may lead to action (e.g., vocalizing the need for policy change) to reduce inequality. The Family Acceptance Project The Family Acceptance Project (FAP) is a rigorously developed family-based intervention for caregivers of SGMY as well as SGMY (within the context of their families) in the U.S. FAP seeks to prevent myriad deleterious outcomes and promote PYD for SGMY in the context of their families, cultures, and faith communities. FAP is designed to help families via caregivers to decrease rejection and to support and affirm their SGMY (thereby reducing SGMY behavioral, social, emotional, relational, and academic problems). Whereas to date FAP has been almost exclusively delivered in in-person formats, a highly innovative component of the current project is to create an online version of FAP. FAP includes both caregiver and SGMY components as well as family and group sessions. Work with caregivers focuses on 1) assessing caregivers' reactions to their SGMY; 2) providing psychoeducation about family accepting and rejecting behaviors in the context of their cultural and religious values; and 3) teaching skills to show love and affirmation and acceptance to ones' SGMY as well as advocacy skills to stand up for their SGMY in the face rejection. Youth components focus on 1) psychoeducation on family rejecting and accepting behaviors, 2) reducing internalized oppression and increasing positive identity development, and 3) instilling hope for the future. FAP also offers opportunities to build connections with others (e.g., caregiver peer support, LGBTQ+ sense of community among SGMY) and promotes family bonding and communication, all of which is hypothesized to reduce internalized oppression among SGMY and promote their PYD. In FAP, education and guidance are presented to program participants in ways that resonate with caregivers' cultural and religious values. This allows caregivers to decrease rejecting behaviors that increase risk and increase supportive behaviors that help to protect against risk and support well-being. FAP helps caregivers to develop a different way of thinking about their SGMY that moves from issues of morality to those focused on ensuring the health and well-being of their SGMY. FAP helps youth to understand how their family's cultural and religious beliefs impact their sense of self-worth, their risk behaviors, and hope for the future. Many SGMY see family rejecting behaviors as the price of staying connected to their family, their culture, and their faith. In addition to learning about chosen family, learning that caregivers can change their behavior and learn to support and accept them is liberating and motivates youth to deepen family connections and invest in these relationships. Despite its national recognition and reach, there is little research evaluating the efficacy of FAP. There is an urgent need for rigorous research on FAP to document its efficacy in reducing behavioral, social, emotional, relational, and academic problems especially among SGMY of color for whom FAP was largely developed. Moreover, FAP was initially developed for in-person delivery. Yet, there is also a need for research that examines innovative methods (e.g., online delivery) for implementation so that FAP can reach SGMY of color across the U.S., including rural regions of the U.S. where access to affirming, family-based interventions to support SGMY are rare if nonexistent. The aim of the current study is to evaluate FAP-O via a randomized control trial (RCT) of caregiver-SGMY of color (ages 14 to 20) dyads (45 dyads assigned to the FAP-O and 45 dyads assigned to the waitlist control condition), assess the acceptability and feasibility of the FAP-O via program observations, post-session surveys (n = 90 dyads), and exit interviews (n=20) with SGMY of color and their caregiver(s). Test the FAP-O's efficacy in reducing behavioral, emotional, relational, and academic problems via a baseline survey followed by an immediate post-test and 6-month follow-up survey. Identify mediators (e.g., increases in family bonding, reductions in internalized oppression, decreases in rejection and increases in acceptance of SGMY by caregivers, increases in positive ethnic/racial identities) and examine intervention promise among demographic subgroups (e.g., race and ethnicity, gender identity, sexual identity, religiosity) and those experiencing low or high levels of racial or ethnic discrimination via surveys.

    Phase

    2

    Span

    58 weeks

    Sponsor

    University of Michigan

    Ann Arbor, Michigan

    Recruiting

    Healthy Volunteers

  • Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis

    Phase

    N/A

    Span

    115 weeks

    Sponsor

    University of Michigan

    Ann Arbor, Michigan

    Recruiting

  • PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

    This is a prospective, cohort study with no study investigational therapy prescribed. Patients with non-idiopathic pulmonary fibrosis (non-IPF) fibrosing ILD, including connective tissue disease associated ILD (CTD-ILD), fibrotic hypersensitivity pneumonitis (fHP) and non-IPF idiopathic interstitial pneumonia (IIP) will be recruited. Consented participants with non-IPF ILD will be carefully phenotyped with extensive clinical, physiological, and imaging data. After confirmation of eligibility, participants will undergo protocolized follow-up over 24 months. Clinical data and blood biospecimens will be collected at protocolized time points throughout the study. The primary outcome is 12-month transplant-free survival (TFS), following a 12-month observation period with TFS defined as the time from 12-month PFT to death, lung transplant or censoring at 12 months or earlier if lost to follow-up. This research will determine whether a ≥10% relative decline in FVC occurring during the 12-month observation period is associated with TFS over the subsequent 12 months. The investigators will then explore other proposed PPF criteria using the same approach. Additionally, the investigators will determine test performance characteristics of a novel proteomic biomarker for predicting PPF at 12 months and compare performance of this classifier to a multi-dimensional approach that incorporates clinical data and quantitative CT data.

    Phase

    N/A

    Span

    244 weeks

    Sponsor

    University of Massachusetts, Worcester

    Ann Arbor, Michigan

    Recruiting

  • CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer

    Phase

    N/A

    Span

    64 weeks

    Sponsor

    University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan

    Recruiting

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