Digital Commons Network^™

Navigating The New Norm: The Fda’S Final Rule On Laboratory Developed Tests (Ldts) And Its Impact On Clinical Laboratory Operations, Rob E. Carpenter

Human Resource Development Faculty Publications and Presentations

On April 29, 2024, the U.S. Food and Drug Administration (FDA) issued a transformative final rule impacting the regulatory landscape for laboratory-developed tests (LDTs). This new regulation categorizes in vitro diagnostics (IVDs) used as LDTs under the same stringent oversight applied to other medical devices, thereby phasing out the agency’s long-standing policy of enforcement discretion. This paper offers a concise historical overview and examines the FDA’s revised regulatory framework scheduled for the next four years, examining its impact on laboratory operations in terms of safety, efficacy, and innovation. It explores how the new rule’s increased compliance demands and economic implications …

Generamen Enables Integration, Comparison, And Meta-Analysis Of Multiple Ranked Gene Lists To Identify Consensus, Unique, And Correlated Genes, Meisam Yousefi, Wayne Ren See, Kam Leng Aw-Yong, Wai Suet Lee, Cythia Lingli Yong, Felic Fanusi, Gavin J.D. Smith, Eng Eong Ooi, Shang Li, Sujoy Ghosh, Yaw Shin Ooi

Division of Basic Science Faculty Publications

High-Throughput experiments often produce ranked gene outputs, with forward genetic screening being a notable example. While there are various tools for analyzing individual datasets, those that perform comparative and meta-Analytical examination of such ranked gene lists remain scarce. Here, we introduce Gene Rank Meta Analyzer (GeneRaMeN), an R Shiny tool utilizing rank statistics to facilitate the identification of consensus, unique, and correlated genes across multiple hit lists. We focused on two key topics to showcase GeneRaMeN: virus host factors and cancer dependencies. Using GeneRaMeN 'Rank Aggregation', we integrated 24 published and new flavivirus genetic screening datasets, including dengue, Japanese encephalitis, …

Retinoblastoma Malignance And Exosome Mechanisms Facilitating Optic Nerve Head Metastatic Niche Formation, Cui Shi

Dissertations, Theses, and Capstone Projects

Retinoblastoma (RB) is a rare pediatric ocular tumor that occurs before five years of age and it is the most common intraocular cancer of childhood with more than 300 children in the United States and 8000 diagnosed globally each year. RB arises from the proliferation of cone photoreceptor precursor cells in the retina as a result of mutations in the RB1 gene. The influence of RB secreted factors on cells in the retinal environment has not been fully elucidated. Cancer cell released exosomes have been shown to transform their microenvironment through transfer of metastasis promoting molecular cargo. Cancer cell extracellular …

Understanding Primate Immunity To African Trypanosomes Through The Characterization Of Trypanosome Lytic Factor Formation And Function, Sara Fresard

Dissertations, Theses, and Capstone Projects

African trypanosomes cause an annual loss of over 1 billion USD due to their economic and agricultural burden in Sub-Saharan Africa. These parasites are unicellular, extracellular parasites, that infect humans, cattle, and other livestock. Humans and some non-human primates are protected against most species of trypanosomes due to an innate immunity factor, Trypanosome Lytic Factor (TLF). This modified High Density Lipoprotein (HDL) contains two unique proteins, Haptoglobin Related Protein (HPR), a ligand to a trypanosome surface receptor, and Apolipoprotein-L1 (APOL1), the lytic component. Our overall goal is to use our understanding of primate immunity to create genetically modified cattle that …

Health Behaviors And Physical Health Among Young Adults With Varying Psychometric Schizotypy, Christopher Liong

Dissertations, Theses, and Capstone Projects

Schizophrenia has consistently been associated with increased rates of physical illness and early mortality. One explanation for this association might be poor health behaviors, as people with schizophrenia are more sedentary, less physically active, and more likely to engage in substance use compared to the general population. Schizotypy may be conceptualized as the phenotypic expression of increased risk for schizophrenia spectrum disorders, and dimensional models of schizotypy suggest that it varies on a continuum ranging from non-clinical (i.e. low schizotypy) to clinical (i.e. high schizotypy and dysfunction, as in schizophrenia). Though schizotypy and schizophrenia appear to share similar deficits and …

Antimicrobial Efficacy Of Different Intracanal Medicaments Used In Regenerative Endodontics Against A Mature Multi-Species Biofilm Model (An Ex-Vivo Study), Shehabeldin Mohamed Saber Prof.Dr.

Dentistry

Introduction: The aim of this study was to compare the efficacy of different antimicrobial agents, including Ciprofloxacin, Doxycycline, Clindamycin, Metronidazole, Amoxicillin and Clavulanate, Triple antibiotic paste (TAP) and Calcium hydroxide (CH), as intra-canal medications for regenerative endodontics against an aged, multispecies ex-vivo biofilm model.

Methods: A total of one hundred fifty single-rooted human teeth were used in this study. Fifteen teeth were used to monitor the formation and maturation of a multispecies biofilm model consisting of Enterococcus faecalis, Staphylococcus epidermidis and Candida albicans. After 21 days of incubation, the other one-hundred and thirty-five teeth were divided into 9 equal …

Detection And Prevalence Of A Novel Bandavirus Related To Guertu Virus In Amblyomma Gemma Ticks And Human Populations In Isiolo County, Kenya, Hellen Koka, Solomon Langat, Samuel Oyola, Faith Cherop, Gilbert Rotich, James Mutisya, Victor Ofula, Konongoi Limbaso, Juliette R. Ongus, Joel Lutomiah, Rosemary Sang

All Peer-Reviewed Publications

Introduction Emerging tick-borne viruses of medical and veterinary importance are increasingly being reported globally. This resurgence emphasizes the need for sustained surveillance to provide insights into tick-borne viral diversity and associated potential public health risks. We report on a virus tentatively designated Kinna virus (KIV) in the family Phenuiviridae and genus Bandavirus. The virus was isolated from a pool of Amblyomma gemma ticks from Kinna in Isiolo County, Kenya. High throughput sequencing of the virus isolate revealed close relatedness to the Guertu virus. The virus genome is consistent with the described genomes of other members of the genus Bandavirus, with …

Characterization Of High-Risk-Other Human Papillomavirus Genotypes In Papanicolaou Tests, High-Grade Squamous Intraepithelial Lesions, And Cervical Cancer, Caitlin E. Witt, Elizabeth F. Sutton, Ashley M. Stansbury, Ashley N. Winters, Luke C. Konur, Meng Luo, Jennifer E. Cameron, Beverly Ogden

School of Medicine Faculty Publications

Background: The objective of this study was to determine the human papillomavirus (HPV) genotypes of high-risk-other HPV Papanicolaou (Pap) tests and of biopsy tissues from patients with high-grade squamous intraepithelial lesion (HGSIL) or cervical cancer. High-risk-other HPV status was determined with the cobas HPV Test (Roche Diagnostics, North America) that identifies 12 high-risk, non-16/18 HPV genotypes. We hypothesized that we would find genotypes of HPV in our population that are not covered by the 9-valent HPV vaccine. Methods: For this retrospective cohort study, we randomly selected 50 high-risk-other HPV Pap test samples from 2018 from our pathology department registries for …

Taking The Lead On Climate Action And Sustainable Development: Recommendations For Strategic National Transition Planning At The Centre Of A Whole-Of-System Climate Response, Mark Manning, Riona Bowhay, Megan Bowman, Peter Knaack, Lisa E. Sachs, Agnieszka Smolenska, Fiona Stewart, Thomas Tayler, Perrine Toledano, Harald Walkate

Columbia Center on Sustainable Investment

As the global economy transitions to a just, low-emissions, climate-resilient, and nature-positive future, we can expect every sector to transform. However, systemic transformation requires strategic transition planning, effective coordination, and communication across the economy. To facilitate this, governments can play a decisive role by managing change and setting incentives and constraints for private actors. Similarly, private sector actors can enhance their corporate strategies and financing decisions to support this transition. Transition plans serve as a roadmap to transformation by outlining a strategic vision and identifying capital needs, external factors, and dependencies.

CCSI is collaborating with experts at CETEx, King’s College, …

Public Sector Use Of Private Sector Personal Data: Towards Best Practices, Teresa Scassa

Dalhousie Law Journal

Governments increasingly seek to use personal data sourced from the private sector for purposes that range from the generation of statistics to municipal planning. The data collected by companies is often high volume and rich in detail. Location and mobility data—which have many applications—are collected by multiple private sector actors, from cellular service providers to app developers and data brokers. Financial sector organizations amass rich data about the spending and borrowing habits of consumers. Even genetic data is collected by private sector companies. The range of available data is constantly growing as more and more data is harvested, and as …

Control And Management Of Type-Ii Diabetes Among People Living With Hiv (Plwh) Compared To Hiv-Negative Patients And By Clinic Type In The Bronx, Nyc, Aprielle Wills

Dissertations and Theses

ABSTRACT

Control and Management of Type-II Diabetes Among People Living with HIV (PLWH) compared to HIV-Negative Patients and by Clinic Type in the Bronx, NYC

by

Aprielle Wills

Advisor: Heidi E Jones, MPH PHD

Background: The Centers for Disease Control (CDC) estimated that approximately 1.3 million people in the United States (U.S.) were living with an HIV diagnosis by the end of 2021. With advancements of antiretroviral therapy (ART) and improved access to care, HIV has become a chronic condition in the U.S. As PLWH age, they are experiencing higher rates of other chronic conditions, specifically type-II diabetes (type-II …

From Turf To Turf: Fungal Invasion Of Ascocoryne Turficola In A Northern Michigan Bog, Evan L. Coscarelli-Trott

All NMU Master's Theses

This is the first paper to report Ascocoryne turficola Boud. 1905 (Helotiales: Ascomycota) within the United States. It is an obligate bog fungus native to Europe and Siberia, where it is extremely rare across most of its range. A. turficola appeared at Lily Pond Bog in Marquette, Michigan (87.47º W, 46.59º N) in 2019, almost contemporaneous with anecdotal reports in Minnesota and Ontario. Since 2019, the Lily Pond population has exploded and become the dominant fungus in this bog but has yet to spread to similar bogs nearby. This species is adapted to long distance dispersal and carries the potential …

Ahrc 252.01: Respiratory Care Review, Paul J. Crockford

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Macro Level Sensegiving Of Disruptive Innovation In Sterile Processing, Marjorie Wall

Executive DBA Dissertations

This dissertation examines how macro-level actors in the sterile processing industry utilize social connectedness and experiential surfacing to facilitate the sensegiving process in the adoption of disruptive technologies. Drawing on the institutional work theory, this study focuses on the actions of individual actors aimed at creating, maintaining, and disrupting institutions in the context of sterile processing—a critical yet often overlooked sector of healthcare.

This research specifically explores how the sterile processing industry responded to the adoption of disruptive technologies during the COVID-19 pandemic. By analyzing over 1,100 podcast episodes, the study examines the rhetorical strategies used by industry leaders and …

Putting Gpt-4o To The Sword: A Comprehensive Evaluation Of Language, Vision, Speech, And Multimodal Proficiency, Sakib Shahriar, Brady D. Lund, Nishith Reddy Mannuru, Muhammad Arbab Arshad, Kadhim Hayawi, Ravi Varma Kumar Bevara, Aashrith Mannuru, Laiba Batool

All Works

As large language models (LLMs) continue to advance, evaluating their comprehensive capabilities becomes significant for their application in various fields. This research study comprehensively evaluates the language, vision, speech, and multimodal capabilities of GPT-4o. The study employs standardized exam questions, reasoning tasks, and translation assessments to assess the model’s language capability. Additionally, GPT-4o’s vision and speech capabilities are tested through image classification and object-recognition tasks, as well as accent classification. The multimodal evaluation assesses the model’s performance in integrating visual and linguistic data. Our findings reveal that GPT-4o demonstrates high accuracy and efficiency across multiple domains in language and reasoning …

Scale-Dependent Population Drivers Inform Avian Management In A Declining Saline Lake Ecosystem, Aimee M. Van Tatenhove, John Neill, Russell E. Norvell, Erica F. Stuber, Clark S. Rushing

Wildland Resources Faculty Publications

Shrinking saline lakes provide irreplaceable habitat for waterbird species globally. Disentangling the effects of wetland habitat loss from other drivers of waterbird population dynamics is critical for protecting these species in the face of unprecedented changes to saline lake ecosystems, ideally through decision-making frameworks that identify effective management options and their potential outcomes. Here, we develop a framework to assess the effects of hypothesized population drivers and identify potential future outcomes of plausible management scenarios on a saline lake-reliant waterbird species. We use 36 years of monitoring data to quantify the effects of environmental conditions on the population size of …

Complete Genome Sequence Of An Indian Outbreak Strain Of Chikungunya Virus, Eshna Laha, Deepak Jena, Viplov K. Biswas, Sharad Singh, Sunil K. Raghav, Asit K. Pattnaik, Soma Chattopadhyay

Nebraska Center for Virology: Faculty Publications

Here, we report the complete genome sequence of an Indian strain of chikungunya virus isolated from an infected patient from Hyderabad, Andhra Pradesh, India, during a massive outbreak in 2005–2006. The genome length spans 11,811 nucleotides and has a poly(A) tail of 29 residues at the 3′ end.

The Internist's Post V.1 N.7, The University Of Texas Rio Grande Valley. School Of Medicine, Diana Othon Martinez, Edgar Dorsey Trevino, Barbara Malaga-Espinoza, Ramon Elizondo Romo, Carlos Alejos Aguero, Roque Mifuji Lira, Martha Solis, Cesar Gutierrez

School of Medicine Publications

No abstract provided.

Ahrc 150.01: Respiratory Care Laboratory I, Paul J. Crockford

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Biom 327.01: Vector-Borne Diseases: Public Health Perspectives, Brent J. Ryckman

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Ecns 410.01: Health Economics And Policy, Katrina L. Mullan

University of Montana Course Syllabi, 2021-2025

No abstract provided.

A Pilot Program To Improve Tb Care With Primary And Specialty Care Coordination In Tb Public Health Clinic, Priyanka Jadhav, Gabrielle Boudoin, R Miles, Shandrica Seymour, J Parham, Amy Wolfe, Juzar Ali

School of Medicine Faculty Publications

BACKGROUND: The Wetmore Tuberculosis (TB) Clinic in New Orleans serves patients who often lack primary care (PC) or specialty care (SC), which is complicated by comorbidities. An initiative to provide on-site PC and coordinate care aims to enhance TB patient management. METHODS: Data collection involved categorizing patients based on their PC status: Group I (regular PC), Group II (intermittent PC), and Group III (no PC), with on-site Nurse Practitioner-based Bridge Care (NPBC) provided as needed. RESULTS: Over 12 months, 209 out of 354 patients required NPBC and PC/SC coordination, with a 20% shift from Group III to Group I, reducing …

Panel Stacking Is A Threat To Consensus Statement Validity, Kasper P Kepp, Preben Aavitsland, Marcel Ballin, Francois Balloux, Stefan Baral, Kevin Bardosh, Howard Bauchner, Eran Bendavid, Raj Bhopal, Daniel T Blumstein, Paolo Boffetta, Florence Bourgeois, Adam Brufsky, Peter J Collignon, Sally Cripps, Ioana A Cristea, Nigel Curtis, Benjamin Djulbegovic, Oliver Faude, Maria Elena Flacco, Gordon H Guyatt, George Hajishengallis, Lars G Hemkens, Tammy Hoffmann, Ari R Joffe, Terry P Klassen, Despina Koletsi, Dimitrios P Kontoyiannis, Ellen Kuhl, Carlo La Vecchia, Tea Lallukka, John Lambris, Michael Levitt, Spyros Makridakis, Helena C Maltezou, Lamberto Manzoli, Ana Marusic, Clio Mavragani, David Moher, Ben W Mol, Taulant Muka, Florian Naudet, Paul W Noble, Anna Nordström, Peter Nordström, Nikolaos Pandis, Stefania Papatheodorou, Chirag J Patel, Irene Petersen, Stefan Pilz, Nikolaus Plesnila, Anne-Louise Ponsonby, Manuel A Rivas, Andrea Saltelli, Manuel Schabus, Michaéla C Schippers, Holger Schünemann, Marco Solmi, Andreas Stang, Hendrik Streeck, Joachim P Sturmberg, Lehana Thabane, Brett D Thombs, Athanasios Tsakris, Simon N Wood, John P A Ioannidis

Faculty, Staff and Student Publications

Consensus statements can be very influential in medicine and public health. Some of these statements use systematic evidence synthesis but others fail on this front. Many consensus statements use panels of experts to deduce perceived consensus through Delphi processes. We argue that stacking of panel members toward one particular position or narrative is a major threat, especially in absence of systematic evidence review. Stacking may involve financial conflicts of interest, but nonfinancial conflicts of strong advocacy can also cause major bias. Given their emerging importance, we describe here how such consensus statements may be misleading, by analyzing in depth a …

Wild 591.03: Current Topics In Disease Ecology, Angela D. Luis

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Ahms 270e.01: Medical Ethics, Victor N. White

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Ahms 270e.50: Medical Ethics, Mary B. Mchugh

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Ahrc 129.01: Patient Care And Assessment - Cardiopulmonary Anatomy & Physiology, Paul J. Crockford

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Ahrc 235.01; Cardiopulmonary Anatomy And Physiology, Paul J. Crockford

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Nrsg 256.01: Pathophysiology, Ginger M. Sillars

University of Montana Course Syllabi, 2021-2025

No abstract provided.

Anty 210n.01: Introduction To Biological Anthropology, Randall R. Skelton

University of Montana Course Syllabi, 2021-2025

No abstract provided.