Digital Commons Network^™

Phase 1 Open-Label Study Of Asp9801, An Oncolytic Virus, In Patients With Advanced Or Metastatic Solid Tumors, John L. Villano, Jason J. Luke, Ricklie Julian, Christos Fountzilas, Manish R. Patel, Michael J. Chisamore, Pranob Bhattacharya, Shigeru Takeshita, Serguei Soukharev, Shunsuke Yamada, Leshi Zhang, Kristopher P. Wentzel

Neurology Faculty Publications

Purpose ASP9801, an oncolytic virus encoding interleukin-7 and interleukin-12, was assessed for safety, tolerability, pharmacokinetics, and antitumor activity in patients with advanced solid tumors in a Phase 1 study. Methods The study comprised Part 1 ASP9801 monotherapy dose escalation and Part 2 dose expansion with ASP9801 monotherapy or plus pembrolizumab. Each part was divided into Groups A (ASP9801 injection into cutaneous/subcutaneous lesions) and B (ASP9801 injection into visceral lesions). Primary objectives were safety and maximum tolerated dose and/or recommended Phase 2 dose expansion (RP2D); secondary objectives included antitumor activity and pharmacokinetics. Results In dose escalation, 17 and 10 patients in …

Commonwealth Times 2026-02-11

Commonwealth Times, 1969-

No abstract provided.

Evaluating Concordance Between Ai-Generated Cartilage Grading And Physician-Reported Systems: A Scoping Review, Alex R. Charlton, Bs, Caroline A. Markmann, Bs, Isabella T. Wu, Md, Mph, Kevin B. Freedman, Md

Phase 1

Introduction: Accurate grading of cartilage pathology is essential for diagnosis and operative planning, yet physician-reported grading systems remain difficult to standardize. Artificial intelligence (AI)has the potential to automate cartilage assessment, but its methodology and clinical applicability remain unclear. This scoping review evaluates current applications of AI for cartilage grading and assesses their translational readiness.

Methods: A scoping review was conducted in accordance with PRISMA-ScR guidelines, including a systematic literature search, predefined eligibility criteria, transparent study selection, and structured data extraction. Eligible studies included English-language human research describing AI models for cartilage evaluation that were assessed against human or clinical grading …

Evaluating The Clinical Utility Of Large Language Models In Otolaryngology Patient Education, Shaunak Ganju, Bs, Adam Luginbuhl, Md

Phase 1

Introduction

Large Language Models (LLMs) have rapidly entered consumer-facing health information platforms, yet their reliability for patient education remains uncertain. Otolaryngology involves complex surgical procedures where clear perioperative counseling is essential for patient understanding and safety. This project evaluates whether LLMs can provide accurate and readable answers to common perioperative questions for septoplasty and cochlear implant procedures. We hypothesized that LLMs would generate accurate responses with readability levels appropriate for patients, with ChatGPT performing best.

Methods

Two common pre-operative and two post-operative questions for septoplasty and cochlear implantation were converted into standardized prompts. Each prompt was submitted to ChatGPT-5.1 and …

Utility Of Neurosurgery-Specific Rag-Llm In Accurate Patient Outcome Prediction, Alexander Hone, Basel Musmar, Joanna Roy, Pascal Jabbour

Phase 1

Large Language Models (LLMs) have been previously utilized in the medical field to successfully generate information. However, LLMs may hallucinate, which generates a response based on false or misleading information. This can negatively impact healthcare outcomes, thus, there is an increasing need to develop a model free of hallucinations.

A multi-target voting ensemble (Random Forest with HistGradientBoosting) algorithm was utilized in the analysis of 454 training data and 114 test data. Raw accuracy and macro-F1 statistics determined that the model is capable of identifying clinically meaningful data for majority classes, while minority-class detection was insignificant. This demonstrates moderate predictive value …

Noninvasive Patient-Level Detection Of Nafld Using Mri Radiomics And Machine Learning, Vladimir Kirichenko, Rajanikanth Vadigepalli

Phase 1

Introduction— Current noninvasive assessment of nonalcoholic fatty liver disease (NAFLD) relies primarily on MRI-based fat quantification, such as proton density fat fraction (PDFF). This study explored the use of an MRI radiomics–based machine learning approach for accurate patient-level classification of NAFLD.

Methods— Liver MRI images from patients with suspected NAFLfD were retrospectively analyzed. Radiomics features were extracted using PyRadiomics from full-liver masks across 4–6 axial slices per patient. Slice-level features were aggregated to the patient level using summary statistics (mean, median, and standard deviation). To reduce redundancy and multicollinearity, features were pruned using Pearson correlation analysis with a threshold of …

Smart Heart: Assessing The Impact Of An Electronic Health Record Intervention On Guideline-Directed Medical Therapy Prescribing In Heart Failure, Shriya Baweja, Bsc, Alan Kubey, Md, Facp

Phase 1

Introduction: Heart failure (HF) affects millions in the U.S., yet guideline-directed medical therapy (GDMT) and the supportive utilization of EHR-based clinical decision support systems (CDSS) for uptake remain underexplored. This project evaluated whether CDSS implementation increased GDMT prescribing at discharge for patients with HFrEF/HFimpEF.

Methods: The analysis included HF patients discharged from 11 hospitals on our enterprise EHR (Epic) from July 2023 to June 2025. Data was extracted from an automated data platform (Qlik). Patients were grouped into matched pre- and post-intervention periods, accounting for seasonality and concurrent financial and multidisciplinary workgroup HF initiatives. CDSS tools implemented in November 2024 …

Shield-Up: Screening For Home Gun Inventory: Education And Lock Distribution In Urban Philadelphia, Brendan Chen, Tinysha Mims, Chanel Sumpter, Kevin Carroll, Wanique Handy, Darnell Gray-Taylor, Patrick Moeller, Quinn Plunkett, Christine Pham, Mph, Nicola Cianci, Christine James, Phd, Lsw, Amy Leader, Drph, Mph, Joria Le, Rn, Bsn, Christopher Wetzel, Jen Geller, Md, Rosemary Frasso, Phd, Msc, Cph, Stanton Miller, Md, Mph

Phase 1

Purpose: Between 2009-2017, there was an average of 42,847 emergency department (ED) visits per year for unintentional nonfatal gun injuries. Current literature shows gun locks are effective in preventing unintentional gun-related injuries. We hypothesize that cancer screening outreach events with community health workers are an effective manner of distributing gun locks and the distribution of gun locks results in behavior modification towards utilization of safe storage practices.

Methods: Community health workers at the screening events register participants through an 8- question consent form. Participants then complete a 24-question baseline survey to consenting participants asking about firearm ownership status, firearm storage …

Comparative Analysis Of Demographic Data For Eligible Lifestyle Medicine Program Participants, Cajetan Ejianreh, Amy Cunningham

Phase 1

Introduction: Obesity is a major comorbidity linked to a myriad of health complications and poor treatment outcomes. Through partnership with the PCORI Institute, a comprehensive lifestyle medicine program is being developed to refer eligible patients within the Jefferson Health System. This comparative analysis aims to identify the demographics of these eligible patients.

Methods: Data was extracted from EPIC electronic health record from patients who had a “qualifying” encounter with one of the following specialties: OB/GYN, Geriatrics, Internal Medicine, and Family Medicine. Qualification of patients in this data collection was based on an encounter with one of the aforementioned specialties within …

Seeing What Sticks: Evaluating Factors That Affect Adoption Of A Novel Heart Failure Order Set At An Academic Medical Center, Maela Whitcomb, Alan Kubey, Md

Phase 1

Introduction: Guideline-directed medical therapy (GDMT) improves heart failure outcomes, yet GDMT prescribing is low. Order sets can alter prescribing behavior. This study seeks to identify characteristics associated with order set use.

Methods: We conducted a retrospective cohort study on 841 adult patients admitted to TJUH with a primary diagnosis of heart failure. Variables included type of service (cardiology, hospital medicine, emergency department and other), whether the service attending was incentivized, and patient status (inpatient, observation). Association with order set use using chi-square tests. Data were extracted using Qlik. Analyses were conducted using Microsoft Excel. P-values of less than 0.05 were …

Sodium-Glucose Cotransporter 2 Inhibitors And Vulvovaginal Candidiasis, Gabriela Skovronsky, Natalie Suozzi, Paul Nyirjesy

Phase 1

Introduction: Sodium-glucose cotransporter-2 inhibitors (SGLT2is) are widely used for type 2 diabetes management, but are associated with increased risk of genital infections. Despite their use, there is limited evidence to quantify this risk. We conducted a systematic review to determine the incidence of vulvovaginal candidiasis (VVC) in patients taking SGLT2is compared to other diabetes treatments. We hypothesized that SGLT2i use would be associated with an increased incidence of VVC compared to other treatments.

Methods: Using PRISMA guidelines, we searched five databases using MESH terms for studies examining VVC in females with type 2 diabetes mellitus treated with SGLT2is versus …

Patient Experiences With Provision Of Telehealth Addiction Treatment Services, Kaleigh Spollen, Shane Nieves, Mph, Gregory Jaffe, Md, Msed, Vanessa Short, Phd, Mph

Phase 1

Introduction: Substance use disorder (SUD) is a nationwide public health crisis, and deaths from opioids have risen significantly since 1999. In recent years, telehealth has emerged as a novel modality for SUD treatment. This study aims to evaluate patient experiences with a telehealth program for SUD, identifying barriers and facilitators to participation in the program, as well as opportunities for program improvement.

Methods: This qualitative study comprises an online survey and semi-structured interview. Individuals 18 years of age or older who have attended at least one session of Jefferson’s telemedicine program for SUD treatment were enrolled in the …

Training Protocol Efficacy On Empowerment And Sustainability In Staff Serving Marginalized Youth In Peru, Hannah Park, Abigail Sugarman, Stephen Didonato, Phd, Lpc, Ncc

Phase 1

Introduction: In Peru, there is limited longitudinal research evaluating trauma-informed care (TIC) training for residential child-care staff, despite evidence that it reduces distress, improves confidence and expertise. This project addresses this gap, studying the impact of a trauma-informed training protocol on staff perceptions of the residential care environment and on staff self-awareness. We hypothesize that an effective protocol would yield improvements in both domains.

Methods: As Phase 3 of a study under Dr. Stephen DiDonato (Jefferson College of Nursing) and Dr. Wayne Centrone (Health Bridges International, HBI), this phase evaluates supplemental training under an established protocol while introducing a self-sustainability …

Healthcare Capital: Leveraging Social Connections To Navigate The Healthcare System, Ona Ichoku, Nicholas Wahba, Rosemary Frasso, Phd, Sm, Cph

Phase 1

Introduction: Navigating the healthcare system can be overwhelming for patients, who face rising costs, long wait times, and complex health information. Many patients leverage personal connections to decode healthcare information, yet little is understood about that process. The objective of this study is to investigate how do patients leverage social connections, “Healthcare Capital,” to navigate their healthcare?

Methods: In this study, qualitative semi-structured interviews were conducted with a sample of adults who sought healthcare within the last 12 months. Participants were selected through convenience and snowball sampling. 30-minute interviews were recorded on Zoom, transcribed, and de-identified. A directed content analysis …

Cardiovascular Outcomes Of Youth Female Athletes: Stratifications Of Risk Using Subdivisions In Sports, Jillian D'Souza, Nikta Nair, David Shipon, Md

Phase 1

Introduction: Sudden cardiac death (SCD) in youth athletes is a rare, but devastating event that may proactively be prevented through identification of pathologic structural, functional and electrical cardiac remodeling changes. Pathological changes in female athletes along with the associated risk and protective factors related to SCD are understudied. This study aims to identify pathological cardiac changes in female athletes and inquire whether strength-based versus endurance-based sports carry different levels of risk.

Methods: The HeartBytes database was compiled from cardiac screenings of youth athletes in Southeastern Pennsylvania conducted from 2014 to 2021. Screenings collected information from health questionnaires, physical …

Sodium-Glucose Cotransporter 2 Inhibitors And Vulvovaginal Candidiasis, Natalie Suozzi, Gabriela Skovronsky, Paul Nyirjesy

Phase 1

Introduction: Sodium-glucose transporter 2 inhibitors (SGLT2is) are associated with an increased risk of vulvovaginal candidiasis (VVC), negatively impacting quality of life. Most studies evaluate risk with individual SGLT2is or the class as a whole, rather than comparing risk between different SGLT2is. The objective of this study was to compare the risk of VVC across individual SGLT2is.

Methods: We conducted a systematic review to find studies examining VVC rates in women taking SGLT2is. Of 74 studies identified, four met inclusion criteria for a meta-analysis, with several others used for background. For canagliflozin, ertugliflozin, and empagliflozin, we calculated risk ratios and …

Leveraging Social Media To Disseminate Evidence-Based Messaging About Substance Use To Reduce Stigma And Promote Harm Reduction In Adolescents And Young Adults, Jacob Mihalic, Gregory Jaffe, Md, Msed

Phase 1

Introduction

Substance use disorder (SUD) remains a major contributor to morbidity and mortality in Philadelphia, with adolescents and young adults (AYAs) particularly vulnerable due to peer influence and digital exposure. However, harm reduction messaging rarely targets AYAs directly. This project will explore how AYAs engage with social media, how these platforms shape their perceptions of SUD, and how digital messaging can be leveraged to reduce stigma and support prevention.

Methods

This qualitative project will conduct three focus groups with Philadelphia AYAs aged 13-18, recruited through local Boys and Girls Clubs. Discussions will explore how AYAs engage with SUD-related content online, …

Deafmed Through Deaf Eyes: A Patient-Centered Approach Of The Deafmed Program, Allie Capik, Julia Croce

Phase 1

Introduction
DEAFMed, a Humanities selective within the JeffMD curriculum, aims to enhance cultural competency in caring for Deaf patients. This study predominantly assesses DEAFMed’s impact from the viewpoint of Deaf patients to determine whether the training improves medical student preparation for culturally competent care.

Methods
Deaf individuals were recruited and trained as Standardized Patients (SPs) for 15-minute history-taking encounters with first-year medical students. Twelve non-DEAFMed-trained and sixteen DEAFMed-trained students were randomized to SPs blinded to their training status. SPs evaluated students quantitatively on trust, eye contact, respect, communication, and comfort, and provided qualitative feedback on strengths and areas for improvement. …

Narrative Perspectives On Providing Gender Affirming Care In Primary Care Settings, Sofia Lemberg, Ma, Robert Mcclowry, Md

Phase 1

Introduction: Gender affirming (hormone) care (GAC) has come under bureaucratic scrutiny over the 21st century despite increasing social support of LGBTQ+ individuals. Primary care healthcare professionals (PCHPs) are uniquely situated to oversee and maintain patients’ GAC. Despite this, there is little research investigating PCHPs’ experiences providing GAC, particularly from a narrative lens. This approach may help us understand these perspectives, by promoting reflection upon personal experiences and emphasizing what PCHPs think is important for providing GAC.

Hypothesis: This study investigates what perspectives and experiences PCHPs hold regarding providing GAC in primary care settings. The investigators hypothesize that PCHPs will have …

Alumni Reflections On The Impact Of Participating In Artz @ Jefferson, Clarissa Martin, Rosemary Frasso

Phase 1

Introduction
Alzheimer’s disease and related dementias (ADRD) are becoming increasingly prevalent, with 13.8 million Americans age 65 and older predicted to be living with ADRD by 2060. Humanities-based interventions in medical education can foster person-centered approaches towards people living with dementia (PLWD). ARTZ @ Jefferson pairs health-studies students (mentees) with PLWD and care partners (mentors) in arts-based sessions that facilitate discussion of the lived experience of dementia. This study aims to explore how health-studies’ alumni reflect on the long-term impact of their participation in ARTZ @ Jefferson.

Methods
A qualitative design was used to capture student alumni reflections on their …

Exploring Music As A Therapeutic Tool For Patients, Andrew Rosario, Josh Robinson

Phase 1

Introduction: Music is a remarkably powerful art form that has the potential to impact people in innumerable ways. This project seeks to explore the many ways patients think about and use music in their lives, whether it be as a source of healing, a reminder of their past memories, an outlet to express emotions, or a companion through whatever challenges they may face.

Methods: This project partnered with an existing workshop run by Josh Robinson for patients in the Headache Unit at Jefferson Methodist Hospital. The first part of these sessions involved a “Soundtrack to My Life” activity where …

The Impact Of Neighborhood Socioeconomic Factors And Insurance Status On Outcomes Following Reduction Mammoplasty, Shin Heng Teresa Chan, Kelsey Van Housen, Emily Isch, Judith Monzy, Julianne Bartz, Matthew Jenkins, David Kim, Andrew Newman, Heather Mcmahon

Phase 1

Introduction: The impact of and neighborhood socioeconomic factors on surgical outcomes in reduction mammoplasty remains unclear. This study evaluated the effect of area deprivation index (ADI) and insurance status on postoperative outcomes following reduction mammoplasty.

Methods: A retrospective review of reduction mammoplasty cases was conducted at a single institution over a 7-year period. Patients ≥18 years old who underwent reduction mammoplasty for benign macromastia were included. Zip-code linked ADI, insurance type, and postoperative complication rate were assessed.

Results: In total, 594 patients were analyzed. Mean age was 36.2 ± 13.1 years, mean body mass index (BMI) was 32.6 ± 5.2 …

Age-Related Challenges Of Blood Pressure Management In Patients With Spinal Cord Injury, Brian Frost, Maclain Capron, Michael Stillman

Phase 1

Introduction/Purpose: Autonomic dysreflexia (AD), orthostatic hypotension (OH), and postprandial hypotension (PPH) are forms of dysautonomia that can affect people with spinal cord injury (SCI). Life expectancy for individuals with SCI has increased in recent decades, so it is critical to understand how triggers of these conditions change throughout the lifespan. This study will answer the question “What challenges do patients with SCI face regarding autonomic dysfunction as they age, and what are their perceptions of these challenges?”

Methods: This survey-based study aims to better understand dysautonomia in order to educate the medical community about specific challenges of growing older with …

Designing A Multilingual Instructional Language Tool For Patient Communication In Interventional Radiology, Ahlam Houssein, Samuel Almodóvar, Gregg Khodorov, Md, Mba, Sahib Sohal, Md, Robert Pugliese, Pharmd, David Dwyer, Md

Phase 1

Introduction: Language barriers in healthcare contribute to medical errors, reduced patient adherence, and increased procedural risk among patients with limited English proficiency (LEP), particularly in interventional radiology (IR), where real-time verbal instruction is essential for procedural success. Current virtual translation services lack the immediacy, specificity, and workflow integration required for intraprocedural communication. This project asks how a digital platform can enable IR professionals to communicate procedural instructions to LEP patients accurately and efficiently in real time, hypothesizing that a structured, phrase-based translation system will improve procedural efficiency and safety.

Methods: On-site interviews and workflow observations were conducted with IR physicians, …

A Novel Ankle Sprain Rehabilitation Device, Ian Argento, Bs, Jack Rifkin, Bs, Brady Stillman, Bs, Robert Pugliese, Pharmd

Phase 1

Background: Ankle sprains are among the most common musculoskeletal injuries across all patient groups. Structured rehabilitation with resistance bands decreases re-injury by improving balance, range of motion, and strength, but protocols vary widely. Furthermore, patients often struggle to perform resistance band exercises correctly, limiting their effectiveness.

Aim: To design and develop a wearable rehabilitation device that standardizes resistance band therapy for ankle sprains by controlling resistance vectors and progressive overload.

Methods/Design: We conducted a needs assessment of current rehabilitation practices and identified limitations in resistance band use, including lack of standardization, variability in patient adherence, and difficulty replicating exercises at …

Design Of A Standardized Resistance-Based Rehabilitation Device For Ankle Sprain Recovery, Jack Rifkin, Bs, Brady Stallman, Bs, Ian Argento, Bs, Robert Pugliese, Pharmd

Phase 1

Introduction: Ankle sprains are among the most common musculoskeletal injuries, particularly in adolescents and athletes. Although many patients recover quickly, a substantial number experience poor healing, leading to chronic ankle instability, weakness, and reinjury. While structured rehabilitation improves outcomes, inconsistent protocols and difficulty performing resistance-based exercises limit effectiveness. This project addresses the need for a standardized and accessible rehabilitation approach for ankle sprain recovery.

Methods: We designed a novel rehabilitation device that reimagines traditional resistance band therapy by standardizing resistance vectors and enabling controlled progressive overload. The design supports reproducible ankle movements targeting strength, range of motion, and proprioception. Iterative …

Analysis Of Predictive Variables For Atrial Fibrillation Detection In Patients With Cryptogenic Stroke, Paranshu Shah, Cindy Fang, Avinash Saraiya, Behzad Pavri

Phase 1

Introduction: Underlying atrial fibrillation (AF) is commonly screened for in patients with stroke of unknown cause, cryptogenic stroke (CS), using implantable loop recorders (ILRs). However, the risk factors correlated with AF detection after CS are poorly identified. Thus our goals were to elucidate which characteristics correlate with AF detection in patients with CS and to investigate if there is an age below which ILR implantation is clinically irrelevant.

Methods: We conducted a retrospective cohort study on patients with CS who underwent ILR implantation at TJUH from 4/2019-4/2021 (n=282). Exclusion criteria were < 6 months of follow-up data, ILR placement >1 year after CS, or pre-existing AF (n=64). Demographics …

Development Of A Novel Resistance-Integrated Device To Optimize Ankle Strength Recovery, Brady Stallman, Bs, Jack Rifkin, Bs, Ian Argento, Bs, Robert Pugliese, Pharmd

Phase 1

Introduction: Ankle sprains occur when ligaments of the ankle are stretched or torn due to excessive force, such as twisting or rolling. Ankle sprains are the most common injury in athletes, with re-injury rates as high as 47%. We aim to design a device with integrated resistance to standardize re-strengthening care in patients with sprained ankles.

Methods: A crucial aspect of ankle rehabilitation involves regaining strength and proprioception through resistance band exercises. Currently, resistance band exercises are difficult to complete alone, which is a necessary part of at-home exercises. Our wearable ankle-strengthening device standardizes the exercises, allowing for easier use …

Pre-Infusion Evaluation Of Pain In Children And Adults With Osteogenesis Imperfecta (Oi) Receiving Cyclic Pamidronate, Andrew Stolfe, Cristina Mcgreal, Sarah Little, Shannon Bonner, Ricki Carroll, Mahim Jain

Phase 1

Introduction/Purpose: Chronic pain is common in OI patients, but standardized pain assessment and treatment is lacking. Pamidronate, a bisphosphonate traditionally administered to OI patients to increase bone mineral density, could play a role in pain management. This study will describe baseline pain before receiving pamidronate to contribute to the characterization of pain in OI and justify the need for evaluating the impact of pamidronate on pain over time.

Methods: 54 patients with mild to severe OI were selected from the Nemours Skeletal Dysplasia Program (mean age 10.5±6.6 years [range 2-31 years]; 54% male, 46% female). Pain was assessed using the …

Improving Options For Prehospital Management Of Hyperthermia, David Azizi, Connor Coyle, Robert Pugliese, Pharmd

Phase 1

Introduction: Hyperthermia, particularly heatstroke, is a life-threatening failure of thermoregulation that requires rapid cooling to prevent serious sequelae. Despite effective hospital-based systems, prehospital and austere environments lack portable solutions capable of achieving timely temperature reduction. This project investigates whether a lightweight, field-ready garment incorporating endothermic salts can improve prehospital hyperthermia management.

Methods: We conducted a literature review and expert interviews with emergency and wilderness medicine clinicians to identify limitations of existing tools and define design requirements. A prototype was designed with a thermally conductive inner layer and insulating outer layer integrating off-the-shelf chemical cold packs. Planned testing includes quantifying heat …