Digital Commons Network^™

Rationale And Trial Design Of Ribolaris: A Phase Ii Trial Of Neoadjuvant And Adjuvant Ribociclib Plus Endocrine Therapy For Clinically High-Risk Hr+/Her2-Negative Breast Cancer, Paul Cottu, Cynthia X Ma, Et Al.

2020-Current year OA Pubs

BACKGROUND: Despite advances in endocrine therapy, patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC) remain at risk of recurrence (ROR). Chemotherapy is often used in high-risk cases, but not all patients benefit.

OBJECTIVES: To evaluate whether chemotherapy can be safely omitted in patients with stage II, grade 2/3 HR+/HER2- eBC who convert to low genomic risk (ROR-low) following neoadjuvant ribociclib plus letrozole.

METHODS: RIBOLARIS (NCT05296746) is an open-label, multicenter phase II trial in patients with stage II, grade 2 or 3, HR+/HER2- eBC defined as high risk based on a Ki-67 index ⩾20% …

Establishing Demographic-Based Normative Values For Neurofilament Light Chain And Glial Fibrillary Acidic Protein In Serum And Plasma Samples, Tyler L Borko, Salim Chahin, Et Al.

2020-Current year OA Pubs

BACKGROUND: Interpretation of neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) levels in blood requires reference ranges from healthy cohorts, accounting for demographic features.

OBJECTIVE: To compare serum and plasma NfL and GFAP in healthy individuals, accounting for age, sex, and body mass index (BMI).

METHODS: Adolescents through older adults were recruited at Colorado community events and a senior clinic. A neurologist reviewed self-reported medical histories. Paired serum and EDTA plasma samples were assayed using the Quanterix SR-X Simoa Neuro 4-Plex. Log-linear models estimated percent change per year of age, per BMI unit, and sex ratios. GFAP used …

The Role Of Home Visiting In Addressing Postpartum Care Gaps: Evidence From A Large Community Sample, Aishwarya Vijay, Allison Kemner, Karen Hoerchler, Abigail Edwards, Jeannie C Kelly, Rachel G Tabak, Mark D Huffman, Zainab Mahmoud

2020-Current year OA Pubs

BackgroundMaternal mortality in the United States has doubled over the last two decades, primarily due to cardiovascular disease, with more than half of deaths occurring postpartum. Despite national calls to action, attendance at postpartum clinic visits remains low. The role of alternative care delivery strategies, such as home visiting, remains insufficiently studied.ObjectiveTo describe postpartum clinic visit attendance among participants in a large national home visiting program, identify sociodemographic and clinical factors associated with attendance, and examine how timing and duration of enrollment relate to postpartum follow-up.DesignWe conducted a retrospective cohort study of pregnancy episodes among mothers enrolled in the Parents …

Strategies To Optimize Skill Acquisition And Prevent Skill Decay For The Air Transport Clinician, Mckayley Green, Aaron J Lacy, James L Li, John E Schneider

2020-Current year OA Pubs

No abstract provided.

Participatory Systems Modeling In Implementation Research: Exploring Benefits, Facilitators, And Future Needs, Natalie Riva Smith, Jennifer L Cruz, Jessica Gannon, Stephanie Mazzucca-Ragan

2020-Current year OA Pubs

BACKGROUND: Implementation science increasingly uses participatory systems modeling (PSM) approaches to handle the complexity inherent to implementation science issues. To support the process of integrating PSM with implementation science, we aimed to understand and explicate the benefits, facilitators, and future needs of applying PSM to implementation research.

METHODS: We conducted semi-structured qualitative interviews with 23 researchers (n = 18) and practitioners (n = 5). We purposively sampled participants and identified additional participants through recommendations. Interviews were inductively analyzed. Key concepts were identified via iterative description, comparison, and conceptualization.

RESULTS: Engagement with people in the system was typically focused in earlier …

Relationship Among Sleep Disturbance, Stress, And Suicidal Ideation In Clinical High Risk For Psychosis, Heather M Wastler, Daniel Mamah, Et Al.

2020-Current year OA Pubs

BACKGROUND AND HYPOTHESIS: Sleep disturbance is a well-established risk factor for suicide, though few studies to date have examined whether sleep disturbance contributes to suicide risk among individuals at clinical high risk for psychosis (CHR). The current study addressed this gap in the literature. We hypothesized that sleep disturbance would have a unique relationship with suicidal ideation/attempts when accounting for other variables in the model. We also hypothesized that the interaction between sleep disturbance/attenuated positive symptoms and sleep disturbance/stress would be related to suicidal ideation/attempts in CHR.

STUDY DESIGN: The current study used data generated by the Accelerating Medicines Partnership® …

Concordance Of Fluorescence In Situ Hybridization, Whole-Exome Sequencing, And Chromosomal Microarray For Evaluating High-Risk Molecular Features In Meningiomas, Brenndan Crumley, Emilie Russler-Germain, Sonika Dahiya

2020-Current year OA Pubs

BACKGROUND: Meningiomas are the most common primary intracranial tumors, classified into three WHO grades based on histologic and/or molecular criteria. cIMPACT-NOW Update 8 underscores the increasing importance of molecular testing in grading and risk stratification, noting that morphologically WHO grade 1 tumors with concurrent 1p and 22q losses demonstrate clinical behavior comparable to WHO grade 2 meningiomas. This study aimed to assess the concordance of fluorescence in situ hybridization (FISH), chromosomal microarray analysis (CMA), and whole-exome sequencing (WES) in defining the molecular risk profile of meningiomas.

METHODS: A total of 113 meningiomas were analyzed by WHO grade to assess the …

Organ Chips And Translational Research: Identifying And Examining New Ethical Issues, Melanie Jeske

Center for Medical Ethics and Health Policy Staff Publications

Organ chips, also known as organ-on-a-chip devices, tissue chips, or microphysiological systems, have emerged over the last decade as a promising translational technology amidst growing concern about the translational crisis between laboratory research and patient bedside. Pointing to high rates of failure between nonhuman animal models and safety and efficacy in humans, organ chips and similar new approach methods have attracted substantial public and private investment. As human-cell-based alternatives to animal models, organ chips promise more predictive, efficient, and ethical platforms for pharmaceutical and toxicity testing. Engineered cultivation systems that enable cells to assemble into tissue-like structures (e.g. kidney, brain, …

No Exception For Ultra Vires Discrimination, Rev. James Deboer

American University Journal of Gender, Social Policy & the Law

The Ministerial Exception (“the Exception”) is an affirmative defense that religious institutions may use to obtain dismissal of discrimination claims brought by current and former ministerial employees.The Exception rests on the seemingly straightforward premise that churches and other religious institutions must be free to select and remove their own ministers without interference from secular laws.  It applies with equal force to any kind of discrimination; extends to harassment and retaliation; and is not confined to forms of alleged discrimination motivated by religious belief.

The Supreme Court has only addressed the Exception twice. First, in 2012, through Hosanna-Tabor Evangelical Lutheran Church …

The Ambiguity That Isn’T: Why Same-Sex Marriage Is Legal In American Samoa, Dante Cade Harootunian, Sammi Lawrence

American University Journal of Gender, Social Policy & the Law

After the U.S. Supreme Court ruled in Obergefell v. Hodges that prohibitions on same-sex marriage violate the equal protection guarantees of the U.S. Constitution, several government officials in American Samoa issued statements claiming that the decision had no effect in American Samoa, and, to date, no same-sex couples have

applied for a marriage license in the territory. This Article analyzes the Obergefell decision in light of other federal and territorial court decisions that determined the applicability of constitutional rights to U.S. territories and concludes that, despite the statements of local officials, the Obergefell decision applies in American Samoa, and the …

Cedaw's General Recommendation No. 37: A Sweeping Reconceptualization Of Women’S Rights In The Climate Crisis And A Tool To Assess State’S Compliance With Them, Ingrid Nifosi-Sutton

American University Journal of Gender, Social Policy & the Law

INTRODUCTION: Climate change is one of the most formidable challenges of our time that threatens our way of life and the very existence of humankind. While climate change has negative impacts on all persons, it affects women and girls disproportionately. During floods and severe storms fueled by climate change, for example, women are more likely to die than men because they lack access to essential information on how to survive in these emergencies. In certain regions of the world—such as Sub-Saharan Africa—women smallholder farmers are bearing the brunt of climate change because, in the aftermath of droughts, these women have …

Why Dobbs Is No Roadmap For Deciding State Constitutional Abortion Issues, Daniel A. Small

American University Journal of Gender, Social Policy & the Law

In deciding that Fourteenth Amendment “liberty” does not protect a woman’s decision to end her pregnancy, Dobbs v. Jackson Women’s Health Organization sought to distinguish the precedent that Roe and Casey relied on to recognize an abortion right. The Dobbs majority claimed that this precedent did not support a right to abortion because, in its view, destroying a fetus is more immoral than the conduct at issue in those earlier cases. However, moral concerns about fetal destruction shed no light on the nature or characteristics of a woman’s liberty interest in an abortion decision. These concerns, therefore, cannot show whether …

What Is “The Nation’S History And Tradition?”: Using History To Redefine “Liberty” And Applying A New Deeply Rooted Test To Transgender Rights, Kaori Kawaguchi

American University Journal of Gender, Social Policy & the Law

INTRODUCTION: “In a Constitution for a free people, there can be no doubt that the meaning of ‘liberty’ must be broad indeed.” In Roe v. Wade, the Court considered a woman’s liberty right to decide whether to continue a pregnancy or have an abortion and recognized the constitutional validity of a liberty right to abortion as part of the right to privacy. In Roe, the Court concluded, “[o]nly personal rights that can be deemed ‘fundamental’ or ‘implicit in the concept of ordered liberty’ are included in the guarantee of a right of personal privacy.” Liberty should be “left to …

Extending Appellate Immigration Jurisdiction: Providing Additional Pathways Of Review For Discretionary Determinations Regarding Extraordinary Circumstances For Victims Of Spousal Abuse, Ayashah Anwar

American University Journal of Gender, Social Policy & the Law

INTRODUCTION: Lucila Magana-Magana lived a life marked by tragedy. At the age of fifteen, Lucila was sexually assaulted and became pregnant. As a young pregnant woman with no ability to leave, Lucila was forced to live with her assailant and had more children with him until his death. After several years on her own, she entered another relationship with her work supervisor, Rafael Camacho, but that relationship soon turned abusive. Camacho became addicted to drugs and alcohol, and eventually Lucila was forced to escape the relationship. Out of fear, Lucila fled Mexico to the United States. Once again, Lucila found …

Nonviolent Felony Offenders And The Second Amendment: Reexamining Categorical Disarmament Laws In Light Of Bruen And Rahimi, Nikolay Belardi

American University Journal of Gender, Social Policy & the Law

INTRODUCTION: The Second Amendment ensures that “the right of the people to keep and bear Arms, shall not be infringed.” In a country with more civilian-owned firearms than people—and more gun dealers than McDonald’s, Burger King, Subway, and Wendy’s locations combined—it is no surprise that Americans pride themselves on their right to bear arms. However, a majority of the American population favors stricter gun laws and regulations, a position that seems sensible given that mass shootings are an all-too-familiar occurrence in the United States. The enshrinement of the right to bear arms in the Constitution limits the laws and regulations …