Digital Commons Network^™

Benign Disorders Of The Mediastinum: A Narrative Review, Saad Farooq, Sabiha Armin, Daniel Ocazionez, Rosa M Estrada-Y-Martin, Sujith V Cherian

Faculty, Staff and Student Publications

Background and objective: There are several benign processes that affect the mediastinum with considerable morbidity that may range from reactive entities to neoplastic disorders. This review article will focus on non-neoplastic benign mediastinal diseases which include large vessel vasculitis such as Takayasu and giant cell arteritis, mediastinal granulomas, fibrosing mediastinitis and mediastinal infections. These diseases can cause significant morbidity and mortality; therefore, we aim to familiarize readers with the pathophysiology, epidemiology and diagnosis of these mediastinal diseases and provide an update on the treatment options available.

Methods: We searched various databases such as PubMed and Google Scholar from August 2023 …

Impact Of Maternal Depressive Symptoms On Offspring Executive Functions: A Systematic Review, Júlia De Souza Rodrigues, María Pastor-Valero, Lucas R Trambaiolli, Ana Beatriz Bozzini, Alicia Matijasevich

Faculty, Staff and Student Publications

OBJECTIVE: To conduct a thorough examination of the current understanding of the effect of maternal depression exposure on the executive functions (EFs) of offspring.

METHODS: Following the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) statement, a comprehensive search for peer-reviewed cohort studies was performed on the MEDLINE (via PubMed), ScienceDirect, LILACS, PsycINFO, and SciELO databases. Study quality was assessed using the National Heart, Lung, and Blood Institute (NHLBI) Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. The evidence was evaluated using the Grading of Recommendation, Assessment, Development, and Evaluation framework.

RESULTS: Thirty-three cohort studies from different countries, …

Mental Health Prevention And Treatment Programs For Infants Experiencing Homelessness: A Systematic Review, Megan M Hare, Taylor D Landis, Melissa Hernandez, Paulo A Graziano

Faculty, Staff and Student Publications

Experiencing homelessness in infancy has been linked to negative physical and mental health outcomes. Parental well-being and the parent-infant relationship can also be negatively impacted by experiencing homelessness. While numerous parent-based infant mental health programs have been identified by a recent review, the goal of this study was to further determine the extent to which these existing programs were developed and/or examined with at-risk populations such as families experiencing homelessness. Out of 60 programs identified by Hare et al., in press, only three had been implemented specifically in shelter settings with infants 0-12 months (Parent-Infant Psychotherapy, New Beginnings, and My …

Braf Inhibitor Candidate Molecule Usnic Acid Might Use Both Intrinsic And Extrinsic Pathways Of Apoptosis, Burcu Peli̇n Buyuk, Demet Cansaran Duman, Turker Duman

Turkish Journal of Medical Sciences

Background/aim: Melanoma is one of the most aggressive cancers and treatment methods commonly used for patients with skin cancer include checkpoint and BRAF/MEK inhibitors, traditional chemotherapy drugs, radiation and adjuvant treatment methods. Due to the resistance and toxic effects that the patient develops against the drugs, an effective treatment method has not been developed for melanoma yet. Materials and methods: In this study we evaluated the anti-cancer effect of usnic acid (UA) on A-375 melanoma cells and human epidermal melanocytes by xCELLigence real-time cell analysis system. To determine through which cell death pathway UA exerts its anti-proliferative effect, its apoptotic …

Intouch Week Of January 1, 2024, New York Medical College

InTouch

• NYMC Looks Back at 2023
• Office of Student Mental Health and Wellness Kickstarts the Wellness Ambassador Program
• NYMC Transforms Workout Experience with Upgrades to Asprinio Fitness Center
• Dr. Daohong Lin Awarded $2,050,000 NIH Grant
• WISE to Empower Women in Science Entrepreneurship
• Notable Speakers Slated to Address the Class of 2024

Corrigendum: High-Definition Transcranial Direct Current Stimulation For Upper Extremity Rehabilitation In Moderate-To-Severe Ischemic Stroke: A Pilot Study, Jordan N Williamson, Shirley A James, Dorothy He, Sheng Li, Evgeny V Sidorov, Yuan Yang

Faculty, Staff and Student Publications

No abstract provided.

Relational Database-Based Resource-Provenance Visualization Engine: With An Application To Bican Data, Xiaojin Li, Yan Huang, Lydia Ng, Kimberly A Smith, Wei-Chun Chou, Rashmie Abeysinghe, Ling Tong, Shiwe Lin, Licong Cui, Shiqiang Tao, Guo-Qiang Zhang

Faculty, Staff and Student Publications

Provenance tracking ensures data integrity, security, and accountability in healthcare and biomedical research. As biomedical data grows in complexity, comprehensive tracking mechanisms are needed to maintain reproducibility, transparency, and compliance with regulatory standards, such as GDPR. Traditional log-based and ontology-based approaches capture and standardize data lineage, while cryptographic and blockchain-based methods enhance security and verifiability. However, challenges remain in scalability, security, and usability. To address these, we introduce the Resource-Provenance Visualization Engine (RPVE), an advanced system integrating data lineage tracking and interactive visualization. RPVE employs the Randomized N-gram Hashing Identifier (NHash ID) to establish precise data links within the BRAIN …

Optimizing Educational Environments In Stroke And Neurovascular Fields, Amanda L Jagolino-Cole, Devin L Brown, Nicole Chiota-Mccollum, Andrew M Southerland, David S Liebeskind

Faculty, Staff and Student Publications

No abstract provided.

Geriatric Trauma Triage: Optimizing Systems For Older Adults-A Publication Of The American Association For The Surgery Of Trauma Geriatric Trauma Committee, Tanya Egodage, Vanessa P Ho, Tasce Bongiovanni, Jennifer Knight-Davis, Sasha D Adams, Jody Digiacomo, Elisabeth Swezey, Joseph Posluszny, Nasim Ahmed, Kartik Prabhakaran, Asanthi Ratnasekera, Adin Tyler Putnam, Milad Behbahaninia, Melissa Hornor, Caitlin Cohan, Bellal Joseph

Faculty, Staff and Student Publications

BACKGROUND: Geriatric trauma patients are an increasing population of the United States (US), sustaining a high incidence of falls, and suffer greater morbidity and mortality to their younger counterparts. Significant variation and challenges exist to optimize outcomes for this cohort, while being mindful of available resources. This manuscript provides concise summary of locoregional and national practices, including relevant updates in the triage of geriatric trauma in an effort to synthesize the results and provide guidance for further investigation.

METHODS: We conducted a review of geriatric triage in the United States (US) at multiple stages in the care of the older …

Racial And Ethnic Disparities In Operative Experience Among General Surgery Residents: A Multi-Institutional Study From The Us Rope Consortium, Chukwuma N Eruchalu, James C Etheridge, Austin C Hammaker, Sarah Kader, Jonathan S Abelson, Jalen Harvey, Deborah Farr, Stephen J Stopenski, Jeffry T Nahmias, Ali Elsaadi, Samuel J Campbell, Darci C Foote, Felicia A Ivascu, Kelsey B Montgomery, Polina Zmijewski, Samuel E Byrd, Mary K Kimbrough, Savannah Smith, Lauren M Postlewait, Shah-Jahan M Dodwad, Sasha D Adams, Katherine C Markesbery, Katherine M Meister, Matthew R Woeste, Robert C G Martin, Zachary M Callahan, Joshua A Marks, Purvi Patel, Michael J Anstadt, Bilal Waqar Nasim, Ross E Willis, Jitesh A Patel, Melissa R Newcomb, Christopher C Stahl, Motaz Al Yafi, Jeffrey M Sutton, Brian C George, Ralph C Quillin, Nancy L Cho, Alexander R Cortez

Faculty, Staff and Student Publications

Objective: To determine the relationship between race/ethnicity and case volume among graduating surgical residents.

Background: Racial/ethnic minority individuals face barriers to entry and advancement in surgery; however, no large-scale investigations of the operative experience of racial/ethnic minority residents have been performed.

Methods: A multi-institutional retrospective analysis of the Accreditation Council for Graduate Medical Education case logs of categorical general surgery residents at 20 programs in the US Resident OPerative Experience Consortium database was performed. All residents graduating between 2010 and 2020 were included. The total, surgeon chief, surgeon junior, and teaching assistant case volumes were compared between racial/ethnic groups.

Results: …

Large T Antigen Mediated Target Gene Replication Improves Site-Specific Recombination Efficiency, Zening Wang, Chuan Chen, Xin Ge

Faculty, Staff and Student Publications

With advantages of high-fidelity, monoclonality and large cargo capacity, site-specific recombination (SSR) holds great promises for precise genomic modifications. However, broad applications of SSR have been hurdled by low integration efficiency, and the amount of donor DNA available in nucleus for SSR presents as a limiting factor. Inspired by the DNA replication mechanisms observed in double-stranded DNA virus SV40, we hypothesized that expression of SV40 large T antigen (TAg) can increase the copy number of the donor plasmid bearing an SV40 origin, and in consequence promote recombination events. This hypothesis was tested with dual recombinase-mediated cassette exchange (RMCE) in suspension …

Generation Of Protease Inhibitory Antibodies By Functional In Vivo Selection, Ki Baek Lee, Xin Ge

Faculty, Staff and Student Publications

Targeting dysregulated protease expression and/or abnormal substrate proteolysis, highly selective inhibition of pathogenic proteases by monoclonal antibodies (mAbs) presents an attractive therapeutic approach for the treatment of diseases including cancer. Herein, we report a functional selection method for protease inhibitory mAbs by periplasmic co-expression of three recombinant proteins-a protease of interest, an antibody Fab library, and a modified β-lactamase TEM-1. We validate this approach by isolation of highly selective and potent mAbs inhibiting human matrix metalloproteinase 9 (MMP9).

One-Step Production Of Fully Biotinylated And Glycosylated Human Fc Gamma Receptors, Minhyo Kang, Zening Wang, Xin Ge

Faculty, Staff and Student Publications

Initiating and regulating humoral immunity, Fc gamma receptors (FcγRs) have been identified both as therapeutics and as drug targets, and thus production of biologically active FcγRs is highly demanded for biopharmaceutical development. Focusing on low-affinity FcγRs IIA (131H/R allotypes), IIB, and IIIA (176F/V), this study used human 293-F cells to achieve correct post-translational modifications (PTMs) including biotinylation, N-glycosylation, and disulfides. Approaches involving co-expression of FcγR-AviTag and Escherichia coli biotin ligase BirA, endoplasmic reticulum retention, stable and transient transfections, and optimization of transgene ratio were investigated. Protein electrophoresis under reducing and non-reducing conditions, enzymatic deglycosylation, streptavidin pull-down assays, and binding kinetic …

Advancements In Varicose Vein Treatment: Anatomy, Pathophysiology, Minimally Invasive Techniques, Sclerotherapy, Patient Satisfaction, And Future Directions, Faris Fayyaz, Viralkumar Vaghani, Chukwuyem Ekhator, Muhammad Abdullah, Rashed A Alsubari, Omar A Daher, Danyal Bakht, Hanen Batat, Hareem Arif, Sophia B Bellegarde, Pakeezah Bisharat, Muhayya Faizullah

Faculty, Staff and Student Publications

Varicose veins are a common vascular condition known for causing discomfort and cosmetic concerns. This comprehensive narrative review delves into their anatomy, pathophysiology, and modern treatment options, with a focus on endovenous techniques and sclerotherapy. The review starts by emphasizing the intricate anatomy of lower extremity venous circulation, underlining the significance of both superficial and deep venous networks in venous return. It also addresses how changes in the venous wall, including valvular insufficiency, contribute to the development of varicose veins. Endovenous techniques like endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and mechanochemical endovenous ablation (MOCA) are explored in detail. These …

Practical Quality Improvement Changes For A Low-Resourced Pediatric Unit, Phoebe H Yager, Kevin Mary Callans, Aubrey Samost-Williams, Jose A Bonilla, Luis J G Flores, Susana C A Hasbun, Angel E A Rodríguez, Alejandra B A Cárdenas, Alexia M L Núñez, Asitha D L Jayawardena, Evelyn J Zablah, Christopher J Hartnick

Faculty, Staff and Student Publications

Background: This work describes a sustainable and replicable initiative to optimize multi-disciplinary care and uptake of clinical best practices for patients in a pediatric intensive care unit in Low/Middle Income Countries and to understand the various factors that may play a role in the reduction in child mortality seen after implementation of the Quality Improvement Initiative.

Methods: This was a longitudinal assessment of a quality improvement program with the primary outcome of intubated pediatric patient mortality. The program was assessed 36 months following implementation of the quality improvement intervention using a t-test with linear regression to control for co-variates. …

Development And Validation Of A Scale To Measure Person-Centered Care In Fetal Care Centers, Abigail Wilpers, Marney White, Mary T Austin, Mert Ozan Bahtiyar, Katie Francis, Stephen P Emery, Diane Wall, Lonnie Somers, Charlotte Wool

Faculty, Staff and Student Publications

Introduction: Fetal care centers (FCCs) in the USA lack a standardized instrument to measure person-centered care. This study aimed to develop and validate the Person-Centered Care in Fetal Care Centers (PCC-FCC) Scale.

Methods: Initial items were developed based on literature and input from clinicians and former patients. A Delphi study involving 16 experts was conducted to validate the content and construct. Through three rounds of online questionnaires using open-ended questions and Likert scales, consensus on item clarity and relevancy was established. The resulting items were then piloted with former fetal care center patients via a web-based survey. The instrument's reliability …

High Wall Shear Stress-Dependent Podosome Formation In A Novel Murine Model Of Intracranial Aneurysm, Jiayi Lu, Mengjun Dai, Yuanqing Yan, Louise D Mccullough, Yan-Ning Rui, Zhen Xu

Faculty, Staff and Student Publications

High wall shear stress (HWSS) contributes to intracranial aneurysm (IA) development. However, the underlying molecular mechanisms remain unclear, in part due to the lack of robust animal models that develop IAs in a HWSS-dependent manner. The current study established a new experimental IA model in mice that was utilized to determine HWSS-triggered downstream mechanisms. By a strategic combination of HWSS and low dose elastase, IAs were induced with a high penetrance in hypertensive mice. In contrast, no IAs were observed in control groups where HWSS was absent, suggesting that our new IA model is HWSS-dependent. IA outcomes were assessed by …

A Systematic Review Of Infant Mental Health Prevention And Treatment Programs, Megan M Hare, Taylor D Landis, Melissa L Hernandez, Paulo A Graziano

Faculty, Staff and Student Publications

Although many prevention and treatment programs exist for children and families, there have been no reviews specifically examining their impact on infant mental health at the program level. Therefore, the purpose of the current review was to a) systematically examine prevention and treatment programs targeting infant mental health outcomes (i.e., internalizing problems, externalizing problems, social-emotional development, trauma) or the parent-infant relationship/ attachment in children from pregnancy to 2 years; b) classify each program by level of empirical support; and c) highlight strengths and identify gaps in the existing literature to inform future mental health intervention science. From over 121,341 publications …

Increased Rate Of Multidrug-Resistant Gram-Negative Bacterial Infections In Hospitalized Immunocompromised Pediatric Patients, Sarah Khafaja, Yara Salameh, Celina F Boutros, Cherine Awad, Kawthar Faour, Nadim Tfaily, Sarah Merhi, Zeinab El Zein, Samer Bou Karroum, Dana Oweini, Danielle Fayad, George F Araj, Ramia Zakhour, Ghassan S Dbaibo

Faculty, Staff and Student Publications

Introduction: Multidrug resistant Gram-negative bacterial infections are considered a major public health threat. Immunocompromised pediatric patients are at a great risk of severe or overwhelming infections. The aim of this study was to describe the frequency of infections with multidrug resistant (MDR) Gram-negative bacteria (GNB) in immunocompromised pediatric patients and to determine the risk factors. In addition, we aimed to identify the antimicrobial resistance patterns of these isolates.

Materials and methods: This was a retrospective observational study conducted at the American University of Beirut Medical Center (AUBMC) from 2009 to 2017. The study included immunocompromised patients 18 years of age …

Role Of A Pdlim5:Palmd Complex In Directing Dendrite Morphology, Yogesh Srivastava, Maxsam Donta, Lydia L Mireles, Adriana Paulucci-Holthauzen, M Neal Waxham, Pierre D Mccrea

Faculty, Staff and Student Publications

Neuronal connectivity is regulated during normal brain development with the arrangement of spines and synapses being dependent on the morphology of dendrites. Further, in multiple neurodevelopmental and aging disorders, disruptions of dendrite formation or shaping is associated with atypical neuronal connectivity. We showed previously that Pdlim5 binds delta-catenin and promotes dendrite branching. We report here that Pdlim5 interacts with PalmD, a protein previously suggested by others to interact with the cytoskeleton (e.g.,

Urologists’ Opinion On Treating Asymptomatic Stones: Would We Treat Ourselves As We Treat Our Patients? Survey From European Association Of Urology, Young Academicurologists, Endourology And Urolithiasis Working Party, Tarık Emre Şener, Thomas Tailly, Yılören Tanidir, Etienne Xavier Keller, Amelia Pietropaolo, Juan Gomez Rivas, Zeeshan Hameed, Vincent De Coninck, Tzevat Tefi̇k, Kemal Sarica, Ali Serdar Gözen, Andreas Skolarikos, Olivier Traxer, Christian Seitz, Bhaskar Somani

Turkish Journal of Medical Sciences

Management of asymptomatic kidney stones is an ongoing debate with follow-up and treatment guidelines based on low-level evidence. Our aim was to evaluate current management of asymptomatic urinary stones.Materials and methods: A 70-question survey was designed in collaboration with European Association of Urology, Young Academic Urologists, Section of Uro-Technology and Section of Urolithiasis groups and distributed. Responders filled out hypothetical scenarios from 2 perspectives, either as treating physicians, or as patients themselves.Results: A total of 212 (40.01%) responses were obtained. Median responder age was 39 years. 75% of responders were interested in “urolithiasis”. 82.5% had never experienced a renal colic, …

Pdgfra And B Copositive Fibroblasts Drive Fibrosis In Mouse Salivary Glands Through Tgfβ Signaling, Renae Williams Atkinson

Electronic Theses & Dissertations (2024 - present)

Fibrosis is of significant concern to the medical community as numerous disease processes are characterized by progressive fibrosis leading to organ damage. We begin the process of examining the mechanism of fibrosis to salivary gland hypofunction and briefly consider Sjögren’s Disease (SjD). Method: We employed single-cell RNA sequencing data from a reversible mouse salivary gland injury model and from NOD/ShiLtJ mice, a model of secondary SjD. We performed treatment comparisons with the help of Seurat dotplots and UMAPS. Using differential gene expression analysis and the publicly available R packages: clusterProfiler, WikiPathways and Cytoscape, we identified the processes and pathways …

Multicenter Randomized Controlled Trial Of Exercise In Aortic Dissection Survivors: Rationale, Design, And Initial Hemodynamic Data, Yasmin A Toy, Kayla N House, Leslie M Boyer, Jennifer L Mcnamara, Marion A Hofmann-Bowman, Kim A Eagle, Michelle S Lim, Alan C Braverman, Siddharth K Prakash

Faculty, Staff and Student Publications

Aims: There are currently no evidence-based guidelines for exercise after thoracic aortic dissection (TAD), leading to highly variable recommendations that frequently lead patients to restrict their physical activities. This multicenter randomized controlled trial was intended to evaluate the safety and efficacy of a moderate intensity guided exercise program for TAD survivors.

Methods: Participants were eligible if they had a Type A or Type B dissection at least 90 days before enrollment and could attend two in-person study visits. The guided exercise circuit consisted of six aerobic, isotonic, or isometric exercises that participants continued at home with virtual follow-up sessions. The …

Fa4sans-Gan: A Novel Machine Learning Generative Adversarial Network To Further Understand Ophthalmic Changes In Spaceflight Associated Neuro-Ocular Syndrome (Sans), Sharif Amit Kamran, Khondker Fariha Hossain, Joshua Ong, Ethan Waisberg, Nasif Zaman, Salah A Baker, Andrew G Lee, Alireza Tavakkoli

Faculty, Staff and Student Publications

PURPOSE: To provide an automated system for synthesizing fluorescein angiography (FA) images from color fundus photographs for averting risks associated with fluorescein dye and extend its future application to spaceflight associated neuro-ocular syndrome (SANS) detection in spaceflight where resources are limited.

DESIGN: Development and validation of a novel conditional generative adversarial network (GAN) trained on limited amount of FA and color fundus images with diabetic retinopathy and control cases.

PARTICIPANTS: Color fundus and FA paired images for unique patients were collected from a publicly available study.

METHODS: FA4SANS-GAN was trained to generate FA images from color fundus photographs using 2 …

Sustained Pain And Macrophage Infiltration In A Mouse Muscle Contusion Model, Ibdanelo Cortez, Caitlyn M Gaffney, Caitlin V Crelli, Eric Lee, James M Nichols, Hoang Vu Pham, Syed Mehdi, Jelena M Janjic, Andrew J Shepherd

Faculty, Staff and Student Publications

Introduction/aims: Prior studies have emphasized the role of inflammation in the response to injury and muscle regeneration, but little emphasis has been placed on characterizing the relationship between innate inflammation, pain, and functional impairment. The aim of our study was to determine the contribution of innate immunity to prolonged pain following muscle contusion.

Methods: We developed a closed-impact mouse model of muscle contusion and a macrophage-targeted near-infrared fluorescent nanoemulsion. Closed-impact contusions were delivered to the lower left limb. Pain sensitivity, gait dysfunction, and inflammation were assessed in the days and weeks post-contusion. Macrophage accumulation was imaged in vivo by injecting …

Effects Of Huoxue Qufeng Decoction Combined With Tongguan Liquefying Acupoint Penetration Therapy On Swallowing Function And Quality Of Life In Patients With Ischemic Stroke, Xuzhong Liang, Li Ma, Lixia Zhang, Dongnian Yang, Lanrui Zeng

Faculty, Staff and Student Publications

Objective: To analyze the effects of Huoxue Qufeng Decoction combined with Tongguan Liquefying Acupoint Penetration therapy on swallowing function and quality of life in patients with ischemic stroke.

Methods: A total of 145 patients with post-stroke dysphagia admitted to Dingxi People's Hospital from January 2019 to May 2022 were selected with 65 patients in the control group and 80 patients in the observation group. The control group received Huoxue Qufeng Decoction alone, while the observation group received additional Tongguan Liquefying Acupoint Penetration therapy. Clinical efficacy, NIH Stroke Scale (NIHSS) score, Water Swallow Test, Swallowing Function Assessment (SSA) score, MD Anderson …

Crosstalk Between Breast Cancer-Derived Micrornas And Brain Microenvironmental Cells In Breast Cancer Brain Metastasis, Munazza S Khan, Grace L Wong, Chuling Zhuang, Mariana K Najjar, Hui-Wen Lo

Faculty, Staff and Student Publications

Breast cancer is the most frequent malignancy in women, constituting 15.2% of all new cancers diagnosed in the United States. Distant breast cancer metastasis accounts for the majority of breast cancer-related deaths; brain metastasis is the third most common site for metastatic breast cancer but is associated with worst prognosis of approximately eight months of survival. Current treatment options for breast cancer brain metastasis (BCBM) are limited and ineffective. To help identify new and effective therapies for BCBM, it is important to investigate the mechanisms by which breast cancer cells metastasize to the brain and thrive in the brain microenvironment. …

Placental Co-Transcriptional Activator Vestigial-Like 1 (Vgll1) Drives Tumorigenesis Via Increasing Transcription Of Proliferation And Invasion Genes, Heather M Sonnemann, Barbara Pazdrak, Barbara Nassif, Yimo Sun, Lama Elzohary, Amjad H Talukder, Arjun S Katailiha, Krishna Bhat, Gregory Lizée

Faculty, Staff and Student Publications

Introduction: Vestigial-like 1 (VGLL1) is a co-transcriptional activator that binds to TEA domain-containing transcription factors (TEADs). Its expression is upregulated in a variety of aggressive cancer types, including pancreatic and basal-like breast cancer, and increased transcription of VGLL1 is strongly correlated with poor prognosis and decreased overall patient survival. In normal tissues, VGLL1 is most highly expressed within placental trophoblast cells, which share the common attributes of rapid cellular proliferation and invasion with tumor cells. The impact of VGLL1 in cancer has not been fully elucidated and no VGLL1-targeted therapy currently exists.

Methods: The aim of this study was to …

Perceptions Of The Addictiveness Of Low-Nicotine Cigarettes Versus Typical Cigarettes And Exposure To Tobacco Industry-Sponsored Corrective Campaign, Onyema Greg Chido-Amajuoyi, Dale S Mantey, Efehi Igbinomwanhia, Onyinye Omega-Njemnobi, Henry Onyeaka, Robert K Yu, Israel Agaku, Sanjay Shete

Faculty, Staff and Student Publications

Background: In 2017, the U.S. Food and Drug Administration (FDA) announced a regulatory plan to reduce the nicotine content of cigarettes. This study examines the association of exposure to industry-sponsored corrective statements on perceptions of the addictiveness of low-nicotine cigarettes relative to typical cigarettes within the general US population.

Methods: The study comprised 4975 US adult respondents of the 2019 Health Information National Trends Survey (HINTS 5, Cycle 3). Multinomial logistic regression models were used to examine associations between exposure to tobacco industry corrective messages and perceptions of the addictiveness of low-nicotine cigarettes relative to typical cigarettes.

Results: In the …

Accelerate Vaccine Development Using Seamless Phase 2/3 Trial Designs, Jia-Ying Yang, Guo-Chun Li, Ying Yuan

Faculty, Staff and Student Publications

Background: Traditional vaccine development, often a lengthy and costly process of three separated phases. However, the swift development of COVID-19 vaccines highlighted the critical importance of accelerating the approval of vaccines. This article showcases a seamless phase 2/3 trial design to expedite the development process, particularly for multi-valent vaccines.

Research design and methods: This study utilizes simulation to compare the performance of seamless phase 2/3 design with that of conventional trial design, specifically by re-envisioning a 9-valent HPV vaccine trial. Across three cases, several key performance metrics are evaluated: overall power, type I error rate, average sample size, trial duration, …