Digital Commons Network^™

Sickle Cell Crisis-Induced Painless Bilateral Orbital Bone Infarction: A Case Report, Luke Farson, Marina Shenouda, Agni Kakouri, Ashkan Kashanchi, Clark Sitton, Timothy Mcculley, Ying Chen

Faculty, Staff and Student Publications

Introduction: Sickle cell disease is associated with painful vaso-occlusive crises, bone infarction, avascular necrosis, and osteomyelitis. Sickle cell orbitopathy is a rare manifestation with signs similar to periorbital cellulitis and has subtle radiologic features.

Case presentation: We report a case of a five-year-old girl with sickle cell who presented with bilateral orbital infarctions and subperiosteal hematomas, notably without periorbital pain, and was treated with antibiotics and steroids.

Conclusion: Physicians should be aware of this rare manifestation, especially in the pediatric population, as it can affect subsequent management.

Glaucoma Risk With Metformin And Sulfonylurea Therapies In Type 2 Diabetes: A Retrospective Cohort Study., Jared Lim, Jingru Zhou, Hulin Wu, Ziqi Liu, David A Lee

Faculty, Staff and Student Publications

Background: Research on metformin, sulfonylureas, and open-angle glaucoma risk in type 2 diabetes mellitus (T2DM) has yielded inconsistent findings. This study examined associations between hypoglycemic treatments and glaucoma diagnosis rates.

Methods: This retrospective cohort study analyzed electronic health records of newly diagnosed T2DM patients from the Merative™ Explorys® Therapeutic Dataset (2010-2022), comparing three groups: metformin monotherapy, sulfonylureas plus metformin combination, and untreated controls. Propensity score matching balanced demographics, glycemic control, body mass index, blood pressure, lipid levels, and comorbidities. Cox proportional hazards models calculated adjusted hazard ratios for incident glaucoma.

Results: After 1:1 propensity score matching, metformin monotherapy (N=100,387) showed …

Fostering Connection And Shame Resilience Through Self-Compassion: An Innovative Elective For Health Professions Learners, Gioconda Mojica, Peggy Hsieh, Andrew J Revell, Rex Marco

Faculty, Staff and Student Publications

Background: Shame is an emotional experience in health professions education, often contributing to burnout, isolation, and threats to professional identity. Self-compassion has been identified as a protective factor against shame. This study describes the development and evaluation of an elective designed to foster shame resilience and cultivate self-compassion among health professions students.

Methods: A 6-h elective, Fostering Connection and Shame Resilience Through Self-Compassion, was offered over 3 monthly 2-h sessions. Each session included a shared meal, abbreviated large-group conceptual learning, reflective writing, guided self-compassion practices, and small-group discussions. Participants completed the Self-Compassion Scale-Short Form (SCS-SF) at the beginning and …

Open Capsulorrhaphy With Capsular Shift And Open Coracohumeral Ligament Reconstruction For Chronic Recurrent Multidirectional Shoulder Instability, Anna E Sumpter, Christopher S Frey, Matthew T Provencher, Lance E Leclere

Faculty, Staff and Student Publications

Background: This case features the surgical reconstruction of the coracohumeral ligament (CHL) in conjunction with open capsulorrhaphy and capsular shift for the management of chronic, recurrent, multidirectional shoulder instability (MDI). While there is a paucity of existing literature examining the clinical outcomes of this technique, biomechanical studies have implied its potential to restore stability. This procedure may be of particular benefit to patients who have failed previous conservative management and/or attempts at surgical stabilization, as well as those with severe joint hyperlaxity or connective tissue disorders.

Indications: This patient failed extensive physical therapy, as well as previous arthroscopic labral repair …

Healthcare Utilization Following Implementation Of A Pediatric Social Needs Screening Program, Ashley Gibson, Kaleigh Riggs-Harpur, Midhat Jafry, Mallika Mathur, Yen-Chi Le, Sandra Mckay

Faculty, Staff and Student Publications

Objective: This study evaluated differences in healthcare utilization among a pediatric primary care population following implementation of a universal social needs screening and referral program. It was hypothesized that emergency, sick, and hospitalization visits would decrease post-implementation, with stable or increased preventive care.

Methods: A retrospective, observational study was conducted using electronic health record data from 2 cohorts at different time periods at a large academic pediatric primary care clinic. The pre-implementation group included patients with a well-child visit from 08/2021 to 07/2022; the post-implementation group included patients from 09/2022 to 08/2023. Healthcare utilization measures of emergency department visits, hospitalizations, …

Conduction Abnormalities After Tavi And Their Role In Patient Management: A Systematic Review, Ionuț Tudorancea, Irene Paula Popa, Mihai Ștefan Cristian Haba, Ștefan Popa, Viviana Onofrei, Dragomir Nicolae Șerban, Ionela Lăcrămioara Șerban, Irina Iuliana Costache-Enache, Radu Iliescu, Cătălin Loghin

Faculty, Staff and Student Publications

Objective: Transcatheter aortic valve implantation (TAVI) is associated with a relatively high incidence of permanent pacemaker implantation (PPM-I). We aimed to evaluate the existing literature on electrocardiographic (ECG) changes before and after TAVI, identify predictors for PPM-I, and suggest a standardized post-TAVI ECG monitoring protocol.

Methods: A systematic literature review was conducted across multiple databases, including PubMed, Web of Science, and JSTOR, to identify studies published between 2001 and 2024.

Results: From an initial pool of 24,170 records, 17 studies met the inclusion criteria. Pre-existing right bundle branch block and significant prolongation of ECG intervals were identified as strong predictors …

Risk Factors And Outcomes Of Reintubation Following Combined Heart-Lung Transplantation, Ye In Christopher Kwon, Michael Keller, Alan Lai, Brian Bao, Joshua Pei, Matthew Ambrosio, Jay Patel, Motaz Al-Yafi, Zachary Fitch, Josue Chery, Patricia Nicolato, Vigneshwar Kasirajan, Zubair A Hashmi

Faculty, Staff and Student Publications

Background: Unplanned reintubation after combined heart-lung transplantation (HLT) significantly affects morbidity and mortality, yet national data are limited. We evaluated the incidence, predictors, timing, and outcomes associated with reintubation after HLT.

Methods: We retrospectively reviewed adults undergoing primary HLT in the UNOS registry from January 2004 to September 2024. Patients were stratified by reintubation status (defined as re-established mechanical ventilation (MV) after initial extubation). Propensity matching (1:1) balanced recipient and donor characteristics. Multivariable logistic regression models identified independent risk factors.

Results: Among 609 adult HLT recipients, 165 (27.1%) required postoperative reintubation. After 1:1 propensity score matching, 146 patients who were …

Collision Tumors Involving Metastatic Carcinoma And Plasma Cell Myeloma: Report Of Two Cases, Ahmed A Ahmed, Muhammad Hassaan Khalid, Asad Ur Rehman, Nghia D Nguyen, Xinhai Robert Zhang

Faculty, Staff and Student Publications

Synchronous coexistence of plasma cell neoplasms (PCNs) and metastatic carcinoma is not a common phenomenon and poses a significant diagnostic challenge requiring meticulous histopathological and immunophenotypic analysis for accurate lineage assignment. We report two cases of collision tumors comprising PCN and metastatic lung carcinoma. Case 1 involved a 68-year-old male with metastatic non-small cell lung adenocarcinoma who developed intracranial lesions; resection revealed metastatic adenocarcinoma intermingled with clonal plasma cells. Case 2 was a 73-year-old woman with a lytic iliac crest lesion whose bone marrow and lesion biopsies showed diffuse infiltration by both carcinoma and atypical plasma cells. Comprehensive immunohistochemical profiling, …

“Do Everything” Versus Realistic Surgical Interventions: Navigating The Road To Shared Decision-Making In Trauma Surgery, Victoria E Wagner, Ashna S Karpe, Martin L Blakely, Lillian S Kao, Thaddeus J Puzio

Faculty, Staff and Student Publications

"DO EVERYTHING!!" How many times have you heard that phrase from a distressed family member? We routinely receive this desperate plea, and our knee-jerk reaction is to press on, push harder, be more aggressive. We, as acute care surgeons, have spent our lives learning a craft geared towards "doing everything" to heal patients so this response comes naturally. However, how do we respond to "do everything" when the probability of a meaningful recovery is extremely low or non-existent? These situations create moral tension for surgeons who must reconcile the desire to preserve life with the obligation to avoid harm, respect …

Blood Flow Regulates Metabolism In Hematopoietic Development, Pamela L Wenzel

Faculty, Staff and Student Publications

Blood flow modifies oxygen availability and biomechanical forces within the vasculature of the embryo as the hematopoietic system develops. The aorta-gonad-mesonephros (AGM) envelops the largest artery in the body and is a critical site for the emergence of hematopoietic stem cells (HSCs). Herein, I discuss the role of hypoxia-inducible factors (HIFs) and force as determinants of metabolism and fate determination. To address the effects of blood flow on hematopoietic development, I employ mouse embryo models and biomimetic culture. Real-time cell metabolic analyses show that oxygen consumption rates (OCR) and extracellular acidification rates (ECAR) are altered by flow in cultures of …

Host Modulation Therapy In Periodontitis: From Established Therapies To Emerging Technologies, Aonjittra Phanrungsuwan, Jiaqi Huang, Neeraja Dharmaraj, Alejandra Cobos Perez, Omid Veiseh, Simon Young, Chun-Teh Lee

Faculty, Staff and Student Publications

Periodontitis is a biofilm-induced chronic inflammatory disease, characterized by gingival inflammation and alveolar bone loss. According to a national survey, approximately half of the U.S. adults are affected by periodontal disease. To effectively prevent and treat periodontitis, it is essential to address its underlying causes. The primary etiological factors include polymicrobial synergy and dysbiosis of the oral microbiota, and a dysregulated immune response. The standard therapeutic approach, mechanical removal of biofilm through debridement, sometimes demonstrates limited efficacy, particularly in cases of severe periodontitis, which may require adjunctive or additional therapy. Emerging evidence indicates that periodontal tissue destruction is initiated by …

Integrative Multi-Omics Profiling Identifies Infiltrative Hepatocellular Carcinoma As An Immunotherapy-Resistant Subtype With Distinct Molecular Features, Won Suk Lee, Seonjeong Woo, Sung Hwan Lee, Gae Hoon Jo, Ilhwan Kim, Hyeyeong Kim, Chansik An, Sanghoon Jung, Gwangil Kim, Haeyoun Kang, Beodeul Kang, Jung Sun Kim, Ho Yeong Lim, Incheon Kang, Hannah Yang, So Jung Kong, Dahyeon Son, Dong Jun Shin, Woo Young Kwon, Da-Yeon Lee, Ju-Seog Lee, Junho Park, Youngsoo Kim, Sohyun Hwang, Chan Kim, Hong Jae Chon

Faculty, Staff and Student Publications

Background/aims: Hepatocellular carcinoma (HCC) exhibits substantial morphological and biological heterogeneity. Clinical and molecular relevance of the infiltrative subtype remains poorly defined in the context of cancer immunotherapy. We aimed to evaluate the prognostic impact and molecular features of infiltrative HCC in patients treated with first-line atezolizumab plus bevacizumab (Ate/Bev).

Methods: We included 307 patients with advanced HCC treated with Ate/Bev and classified them into four gross morphological types based on imaging. Multi-omics profiling was conducted on tumor samples. Type IV infiltrative signature was derived and externally validated using five independent HCC cohorts, including IMbrave150.

Results: Infiltrative morphology, encompassing pure and …

Engineering Mutation Clones In Mammalian Cells With Crispr/Cas9, Zijun Huo, Jian Tu, Rachel Shoemaker, Dung-Fang Lee, Ruiying Zhao

Faculty, Staff and Student Publications

CRISPR, Clustered Regularly Interspaced Short Palindromic Repeat, as a powerful genome engineering system, has been widely accepted and employed in gene editing of a vast range of cell types. Compared to zinc finger nucleases (ZFNs) or transcription activator-like effector nucleases (TALENs), CRISPR shows a less complicated process and higher efficiency. With the development of different CRISPR systems, it can be used not only to knock out a gene but also to make precise modifications, activate or repress target genes with epigenetic modifications, and even for genome wide screening. Here we will describe the procedure of generating a stable cell line …

Uncertainty-Guided Test-Time Optimization For Personalizing Segmentation Models In Longitudinal Medical Imaging, Jaehee Chun, Austin Castelo, Mckell Woodland, Caleb O'Connor, Mais Al Taie, Mohamed Eltaher, Aashish Gupta, Bilel Daoud, Shanli Ding, Jeddy Bennett, Anirban Maitra, Matthew A Firpo, Kimberly Kirkwood, Eugene J Koay, Kristy K Brock

Faculty, Staff and Student Publications

Background: Accurate and consistent image segmentation across longitudinal scans is essential in many clinical applications, including surveillance, treatment monitoring, and adaptive interventions. While personalized model adaptation using patient-specific prior scans has shown promise, current approaches typically rely on fixed training durations and lack mechanisms to determine optimal stopping points on a per-patient basis, particularly in the absence of validation labels.

Purpose: We propose an uncertainty-guided test-time optimization (TTO) framework that dynamically adjusts the personalization duration for each patient using a validation-free stopping criterion based on predictive uncertainty.

Methods: Our framework personalizes a generalized segmentation model using patient-specific prior imaging and …

Poly(A) Probe Hcr Rna-Fish Specifically Marks Pyriform Nurse Cells In The Brown Anole Lizard Ovary, Zoe B Griffin, Bonnie K Kircher, Richard R Behringer

Faculty, Staff and Student Publications

Hybridization chain reaction RNA-fluorescent in situ hybridization (HCR RNA-FISH) is a powerful and increasingly used method for visualizing gene expression in cells and tissues. A probe set against polyadenylated RNA (poly(A)) is often used as a positive control for RNA integrity and staining quality. While optimizing this technique in the ovary of the brown anole lizard (Anolis sagrei), we found that the poly(A) probe produced a strikingly specific and intense signal in pyriform cells, a specialized lizard-specific nurse cell type. This staining pattern was found in both whole-mount samples and paraffin sections, suggesting that poly(A) signal intensity can serve as …

Application Of The Lancet Commission Criteria For The Diagnosis Of Obesity To A Clinical Trials Population: The Leap Trial, Faith Anne N Heeren, Kathleen R Ruddiman, Courtney Simmons, Brian N White, Byron C Jaeger, Nicholas M Pajewski, Stephanie A Hooker, Deborah B Horn, Katy Martin-Fernandez, Kimberly A Gudzune, Caroline Blackwell Young, Jamy Ard, Kristina Henderson Lewis

Faculty, Staff and Student Publications

Objective: This study aimed to apply The Lancet Diabetes & Endocrinology criteria for diagnosing obesity among clinical trial participants and understand participants' characteristics by obesity status.

Methods: The criteria were operationalized and applied to baseline data from the Long-term Effectiveness of the Anti-obesity medication Phentermine (LEAP) trial (NCT05176626). Excess adiposity, organ and tissue dysfunction, and limitations to daily activities were assessed. We examined differences between participants with "no obesity," "pre-clinical obesity," and "clinical obesity."

Results: Among the 860 participants, 0.8% had no obesity (mean BMI 29.0 kg/m2 [SD 0.6]), 18.7% had pre-clinical obesity (mean BMI 35.2 kg/m2 [SD …

Physical Activity, Telomere Length, And Cardiometabolic Syndrome In Older Women: The Cardiovascular Health Study, Jeni Page, Melissa Richard, Elizabeth Lyons, Elizabeth Baumler, M Terese Verklan, Michelle C Odden, Elizabeth Lorenzo

Faculty, Staff and Student Publications

Background: Cardiometabolic syndrome (CMS) affects approximately 39% of US women and increases risk for cardiovascular disease, diabetes, and stroke. Telomere length, a biomarker of cellular aging, is associated with CMS and may be influenced by physical activity (PA), potentially mitigating telomere shortening. Black women have higher CMS prevalence compared to white women and may exhibit distinct telomere length dynamics influenced by interactions between CMS and PA.

Methods: Data were drawn from the Cardiovascular Health Study and included black and white women who provided data on PA, CMS risk factors, and telomere length (N = 417). Linear regression models examined the …

Sex And Gender Differences Between Experiences Of Discrimination And Physical Health: A Systematic Review, Saam Honarvar, Maryam Ajose, Bronwyn Sutherland, Alejandra Fernandez, Shakia T Hardy, Miguel Ángel Cano, Samaah Sullivan

Library Staff Publications

Background: Despite a plethora of previous research on experiences of discrimination and physical health outcomes, there has been less attention to sex/gender differences, although some research suggests a greater stress-related biological and behavioral impact on women.

Methods: Five databases were reviewed up to May 2023 using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We included studies that examined self-reported experiences of discrimination and physical health outcomes among adults (aged 18+) in the United States if results were either stratified by sex/gender or tested a sex/gender-by-discrimination interaction term.

Results: A total of 3,397 articles were extracted, and 50 …

Using Lotilaner Ophthalmic Solution, 0.25% To Treat Demodex Blepharitis In Patients Who Were Initially Misdiagnosed: A Case Series, Laura M Periman, Richard Lindstrom, Paul Karpecki, Brandon Ayres, Eric Donnenfeld, Marjan Farid, Ian Benjamin Gaddie, Preeya K Gupta, Selina Mcgee, Kelly K Nichols, Stephen Pflugfelder, Christopher E Starr, Nandini Venkateswaran, Elizabeth Yeu, Cecelia Koetting

Faculty, Staff and Students Publications

Introduction: Demodex blepharitis (DB) is a chronic ocular inflammation caused by Demodex mite infestation of the eyelid. DB is often misdiagnosed, as some of its clinical findings and patient-reported outcomes overlap with those of other ocular surface diseases. The Demodex Expert Panel on Treatment and Eyelid Health (DEPTH) has reached consensus on the symptomatology, diagnosis, and treatment of DB. Consensus findings from the DEPTH group include that collarettes are pathognomonic for DB and that lotilaner ophthalmic solution, 0.25%, the first and only FDA-approved treatment for DB, should be the first-line treatment for the disease. This case series highlights two instances …

Functional Analysis Of Genes Enriched In Male Reproductive Organs: Validation Via Fertility Assessment Of 14 Knockout Mouse Lines, Kazumasa Takemoto, Katarzyna Kent, Kaori Nozawa, Shingo Tonai, Ahn H Pham, Terumi Fujimoto, Thomas X Garcia, Martin M Matzuk, Masahito Ikawa, Keizo Tokuhiro

Faculty, Staff and Students Publications

Tissue-restricted gene expression serves as a key indicator of functional importance within specific organs. Despite advances in high-throughput sequencing and genome editing over the past decade, this principle remains the gold standard for identifying candidate genes for functional studies. In reproductive biology, testis-restricted expression is anticipated to indicate genes crucial for gametogenesis, given the conserved features shared between spermatogenesis and oogenesis. Concurrently, rapid evolution of spermatogenesis-related genes is well documented and thought to arise through duplication and subsequent mutation of ubiquitously expressed genes. In this study, we established 14 knockout (KO) mouse lines for male reproductive organ-enriched genes, all of …

A Strategy To Identify Biliary Atresia Efficiently: A Perspective From A Texas Center, Sanjiv Harpavat, Tebyan A Rabbani, Ashley M Upton, Sridevi Devaraj, Jose A Hernandez, Benjamin L Shneider

Faculty, Staff and Students Publications

Infants with biliary atresia are often diagnosed after 60 days of life because the disease is difficult to detect in its early stages. However, infants treated before 30-45 days of life have the best long-term outcomes. To help accelerate the biliary atresia diagnosis, we have developed a streamlined strategy that involves two sequential tests: (1) direct or conjugated bilirubin measurements and (2) a feeding abdominal ultrasound exam. In this review, the strategy is shared to encourage others to provide feedback as well as to consider incorporating portions into their own clinical workflows.

Pd-L1-Centric Whole Blood-Based Immune Signature Profiles Of Tuberculosis Patients During Therapy, Johanna Eggeling, Martina Sester, Christoph Lange, Jan Heyckendorf, Barbara Kalsdorf, Anna M Mandalakas, Andrew R Dinardo, David Lewinsohn, Dagmar Schaub, Tina Schmidt, Eva Tolosa, Maja Reimann, Patricia M Sánchez Carballo

Faculty, Staff and Students Publications

This prospective study investigated whole blood-based immune cell biomarkers for pulmonary tuberculosis (TB) immunoprofiling. Blood samples from 34 healthy controls and 51 tuberculosis patients were analyzed at three timepoints: Prior to therapy (T0), after 14 days of therapy (T1), and at the end of treatment (Te). Using multiparameter flow cytometry, 386 immune cell populations were analyzed. Predictive models were developed using two machine learning algorithms. A TB5LF change score, which was based on five cell populations, effectively distinguished tuberculosis patients from controls (AUC = 0.89) and tuberculosis patients before and at the end of treatment (AUC = 0.92). Similarly, the …

Updates In The Management Of Peanut Allergy, S Shahzad Mustafa, Aikaterini Anagnostou, Matthew Greenhawt

Faculty, Staff and Students Publications

Peanut allergy is a significant rising public health problem affecting both children and adults. Early peanut introduction has been adopted in multiple westernized nations as a preventative strategic measure to reduce the risk of developing peanut allergy, although implementation faces barriers. Multiple therapies to treat peanut allergy have been developed, including oral immunotherapy and omalizumab as approved treatments to provide protection against reactions from accidental exposure and reduce the risk of anaphylaxis, offering options beyond strict avoidance. Strategies in the developmental pipeline include epicutaneous immunotherapy and sublingual immunotherapy. The future is bright for individuals with peanut allergy, as these breakthroughs …

Sodium Supplementation Algorithm To Promote Growth In Infants Who Are Preterm: Randomized Clinical Trial, Brianna M Liberio, Gregory M Sokol, Hannah Rakow, Kelly Mosesso, Valerie Hole, William W Wong, Shaji K Chacko, Jeffrey L Segar

Faculty, Staff and Students Publications

Objective: Evaluate the effectiveness of an algorithm using urine sodium (Na) concentration to guide dietary Na supplementation compared with standard care to promote growth in infants who are preterm.

Methods: A randomized trial was conducted in 4 neonatal units in Indianapolis, Indiana, involving infants between 250/7 to 296/7 weeks gestation with birthweight > 500 g. Study arms consisted of standard care or use of algorithm beginning at 14 to 17 days postnatal age. The primary outcomes were somatic growth (weight, length, and head circumference) measured by change in Z-score between aged 2 weeks and 36 weeks postmenstrual age (PMA). Secondary outcomes …

Tracheobronchial Mucoepidermoid Carcinoma In Four Pediatric Patients, Kalen Hendra, Muhammad Ijlal Khan, Mitali Thanawala, Manuel Silva-Carmona, Eric D Zee

Faculty, Staff and Students Publications

Pediatric tracheobronchial mucoepidermoid carcinoma (MEC), also called pulmonary MEC, is a rare malignant primary lung neoplasm that is typically found in the large airways. Patients may present with symptoms such as cough, pneumonia, fever, hemoptysis, dyspnea, wheezing, chest pain, weight loss, and fatigue. These nonspecific symptoms (or lack of symptoms in some cases) often result in a delayed diagnosis. Chest CT typically demonstrates findings consistent with bronchial obstruction and diagnosis is made via histopathology. Surgical resection is the mainstay of treatment and children often have favorable outcomes. Here we present four cases of tracheobronchial MEC in children treated at three …

Variability In Documentation Of Neurological And Psychiatric Examinations Among Emergency Department Patients With Behavioral Health-Related Presentations: A Retrospective Study, Heba Mesbah, Payton Kim, Jide Oluwadare, Abdulelah Almanie, Inaara Malick, Nidal Moukaddam

Faculty, Staff and Students Publications

Background: Emergency departments (EDs) serve as a critical safety net for individuals experiencing acute behavioral health crises, a population that faces substantial medical morbidity and well-documented disparities in healthcare delivery. Thorough physical and neuropsychiatric assessment is essential in this setting to identify medical conditions that may mimic or exacerbate psychiatric symptoms. Incomplete documentation of these assessments may reflect gaps in care processes and represent a potential marker of inequity.

Objective: To characterize the completeness of documented neurological and psychiatric examinations among adult ED patients presenting with primary behavioral health-related chief complaints and to assess whether documentation patterns suggest persistent gaps …

Chemoradiation After Chemotherapy For Metastatic Cervical Cancer Can Provide Chemo-Free Time, Spoorthi Kamepalli, Ashley Chavana, Michelle Ludwig, Madeline Flanagan, Shelly Sharma, Tracilyn Hall, Anthony Costales, Jan Sunde, Claire Hoppenot

Faculty, Staff and Students Publications

Introduction: Stage IVB cervical cancer is treated with a life-prolonging and palliative intent with systemic chemotherapy and immunotherapy. The purpose of this study was to evaluate the number of these patients who had an adequate response to chemotherapy to be eligible for consolidative radiosensitizing chemotherapy and radiation (chemoradiation) and subsequent outcomes.

Materials and methods: This is a retrospective review of metastatic cervical cancer patients treated with chemotherapy and evaluated for treatment with consolidative pelvic chemoradiation at a single safety-net hospital system from 2016 to 2024. Demographic data and clinical information were collected from electronic medical records. Stata was used for …

Phase I Study Of Niraparib With Radiotherapy For Treatment Of Metastatic And Locally Advanced Invasive Carcinoma Of The Cervix (Nivix), Piyush Pathak, Eunji Jo, Susan Hilsenbeck, Matthew L Anderson, Alfredo Echeverria, Shelly Sharma, Jan Sunde, Tracilyn Hall, Anthony Costales, Claire Hoppenot, Michelle Ludwig

Faculty, Staff and Students Publications

Introduction: This Phase I study evaluated the safety and tolerability of concurrent niraparib, an oral poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor, with definitive radiotherapy in women with locally advanced or platinum-sensitive metastatic cervical cancer. Dose escalation followed a Bayesian Optimal Interval (BOIN) design with a target dose-limiting toxicity (DLT) rate of 30%.

Methods: Women ≥18 years with FIGO stage IIIC2 (bulky nodes >1 cm) or stage IV cervical cancer demonstrating response to platinum-based induction chemotherapy were eligible. Niraparib 100 mg was administered daily concurrent with pelvic radiotherapy (45-57.5 Gy via IMRT with nodal boosts) and brachytherapy, continuing 28 days post-radiation. Per …

Phase 1 Trial Of Withania Somnifera Leaf Extract (Rh324) In Advanced Non-Small Cell Lung Cancer Including [18f]Fdg Pet/Ct As A Short-Term Metabolic Biomarker To Assess Efficacy: A Novel Model For Assessment Of Complimentary Therapies In Early Phase Human Clinical Trials, Jin Uk Heo, Santosh Rao, Herbert B Newton, Afshin Dowlati, Raymond F Muzic, Arash Kardan

Faculty, Staff and Students Publications

Background: Withania somnifera (WS), commonly known as ashwagandha, has been used in the traditional medical system of India. It has shown significant activity against numerous solid tumor varieties in pre-clinical in vitro and in vivo studies. This study focuses on RH324 (ReHeva Biosciences, Columbus, OH), a pharmaceutical-grade formulation derived from WS, which has received FDA allowance for clinical development as a botanical drug in the treatment of cancer.

Methods: A phase 1 open label dose ranging study of oral RH324 in advanced non-small cell lung cancer (NSCLC) was conducted. The primary endpoint of the study was assessment of short-term safety …

Survodutide For Treatment Of Obesity: Baseline Characteristics Of Participants In A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial (Synchronize™-1), Carel W Le Roux, Sean Wharton, Biykem Bozkurt, Elke Platz, Gabriele Bleckert, Samina Ajaz Hussain, Martina Brueckmann, Elena Startseva, Isabel M Kloer, Lee M Kaplan

Faculty, Staff and Students Publications

Aims: Survodutide, a novel glucagon receptor and glucagon-like peptide-1 (GLP-1) receptor dual agonist, elicited significant weight loss in a phase 2 trial in individuals with obesity without type 2 diabetes (T2D). Two multinational phase 3 trials are investigating survodutide for obesity management in individuals with or without T2D. We report the baseline characteristics of participants in the SYNCHRONIZE-1 trial in adults with obesity without T2D (ClinicalTrials.gov: NCT06066515).

Materials and methods: Participants aged ≥18 years with BMI ≥30 or ≥27 kg/m2 with ≥1 obesity complication without T2D were randomized 1:1:1 to double-blind, once-weekly, subcutaneous injections of survodutide (up-titrated to 3.6 …