Medicine and Health Sciences Commons^™

Antibiotic Prophylaxis With Urodynamic Studies In Spinal Cord Injury: Assessing Practice Patterns And Outcomes To Guide Future Practice In A Single Center, Du Pham, Bradley Chi, Felicia Skelton, Donna Huang

Faculty, Staff and Students Publications

Context/objective: Despite urinary tract infections (UTIs) being a common problem in patients with spinal cord injuries (SCIs), and a well-known complication of invasive urologic procedures, little consensus exists regarding the standard of care for peri-procedural antibiotic use for SCI patients undergoing urodynamics studies (UDS). Our research seeks to evaluate local antibiotic prophylaxis pattern in SCI patients undergoing UDS, assess incidence of post-procedural UTI, describe local antibiotic resistance trends, and provide antibiotic stewardship considerations to guide future practice.

Design/setting/participants: Retrospective cohort study of SCI patients undergoing UDS from January 2010 to January 2020 at a Veterans Affairs SCI Center. Data on …

Repeat Ascaris Challenge Reduces Worm Intensity Through Gastric Cellular Reprograming, Yifan Wu, Charlie Suarez-Reyes, Nina L Tang, Alexander R Kneubehl, Jill E Weatherhead

Faculty, Staff and Students Publications

Ascariasis (roundworm) is the most prevalent parasitic nematode infection worldwide, impacting approximately 500 million people predominantly in low- and middle-income countries (LMICs). While people of all ages are infected with Ascaris, infection intensity (defined by worm burden) paradoxically peaks in pre-school and school-aged children but then declines with age. The cause of age-dependent Ascaris worm intensity is not well understood but may be dependent on cellular changes in mucosal barrier sites. We have previously found that the gastric mucosa is a critical barrier site for Ascaris infection as ingested Ascaris larvae use acidic mammalian chitinase (AMCase) secreted by gastric chief …

Establishing A Peritoneal Dialysis Technique Survival Core Outcome Measure: A Standardised Outcomes In Nephrology-Peritoneal Dialysis Consensus Workshop Report, Emma H Elphick, Karine E Manera, Andrea K Viecelli, Jonathan C Craig, Yeoungjee Cho, Angela Ju, Jenny I Shen, Martin Wilkie, Samaya Anumudu, Neil Boudville, Josephine Sf Chow, Simon J Davies, Patricia Gooden, Tess Harris, Arsh K Jain, Adrian Liew, Andrea Matus-Gonzalez, Noa Amir, Annie-Claire Nadeau-Fredette, Thu Nguyen, Angela Yee-Moon Wang, Daniela Ponce, Rob Quinn, Alison Jaure, David W Johnson, Mark Lambie, Peritoneal Dialysis International

Faculty, Staff and Students Publications

Background

Methods

Results

Optimal Delay Time To Initiate Anticoagulation After Ischemic Stroke In Atrial Fibrillation: A Pragmatic, Response-Adaptive Randomized Clinical Trial, Steven J Warach, Lisa A Davis, Patrick Lawrence, Byron Gajewski, Jo Wick, Fred Shi, Ty T Shang, Daiwai M Olson, Sidarrth Prasad, Lee Birnbaum, Jody M Richardson, Sean I Savitz, Mark P Goldberg, Salvador Cruz-Flores, Israel Alba, Jane Anderson, Barbara Kimmel, Chethan P Venkatasubba Rao, Ben King, Adrienne N Dula, Truman J Milling

Faculty, Staff and Students Publications

Importance: Clinical practice guidelines recommend initiation of anticoagulation within 2 weeks after stroke with atrial fibrillation. It is unknown whether there is an optimal starting day within the 14-day period that balances the risks of recurrent embolic events against serious hemorrhagic events.

Objective: To determine if there is an optimal delay time to initiate treatment with a direct oral anticoagulant after atrial fibrillation-related stroke that minimizes the risk of a composite outcome of ischemic or hemorrhagic events.

Design, setting, and participants: This phase 2, pragmatic, response-adaptive randomized clinical trial was conducted between June 2017 and June 2023 at acute care …

Older Adults' Experiences Of Emergency Department Admission Decisions: A Qualitative Study In A Public Safety Net Hospital, Anita N Chary, Annika Bhananker, Beatrice Torres, Victoria Sofia Martell, Manish N Shah, Aanand D Naik

Faculty, Staff and Student Publications

Background: Hospital admission is a significant event in the healthcare trajectory of older adults (age 60 +). Numerous harms such as delirium, falls, and adverse medication events can arise that outweigh the benefits of admission. Little is known about how older adults feel about being hospitalized or what they think admission will achieve for them. These issues are particularly important to understand in socioeconomically disadvantaged patients, who have poor access to outpatient care and higher hospitalization rates.

Methods: We performed semi-structured interviews with emergency department (ED) patients aged 60 and older who were being admitted. The study site was a …

Navacaprant, A Novel And Highly Selective Kappa Opioid Receptor Antagonist, In Adults With Major Depressive Disorder: A Randomized, Double-Blind Phase 2 Clinical Trial, Sanjay J Mathew, Andrew J Cutler, Nicole C Visitacion, Michael Gold, Jason Yuan, Bill Aurora

Staff and Researcher Publications

PURPOSE/BACKGROUND: This phase 2a randomized, double-blind, placebo-controlled, 8-week trial assessed the efficacy and safety of navacaprant, a highly selective kappa opioid receptor antagonist, in adults with major depressive disorder (MDD).

METHODS/PROCEDURES: Participants with 17-Item Hamilton Depression Rating Scale (HAMD-17) scores of 14 to 30 were randomized 1:1 to once-daily navacaprant 80 mg or placebo (n = 102 each). The primary endpoint was HAMD-17 change from baseline (CFB) to week 8. Secondary endpoints included CFB in Snaith-Hamilton Pleasure Scale (SHAPS). No adjustment for multiple comparisons was made.

FINDINGS/RESULTS: At week 8, HAMD-17 CFB was not statistically significantly improved with navacaprant vs …

The Dialysis Foot- The Impact Of Presenting Estimated Glomerular Filtration Rate On Clinical Outcomes In Patients Hospitalized With Diabetic Foot Infections, Arthur Tarricone, Tyler L Coye, Allen Gee, Bijan Najafi, Michael C Siah, Lawrence A Lavery

Center on Aging Staff Publications

To evaluate the association between presenting estimated glomerular filtration rate (eGFR) and clinical outcomes in patients hospitalized with diabetic foot infections. This retrospective cohort study included 344 patients with moderate to severe diabetic foot infections. Patients were categorized into three groups based on presenting estimated eGFR: eGFR ≥60 (eGFR >60 mL/min), eGFR 30-60 (eGFR 30-60 mL/min) and eGFR < 30 (eGFR < 30 mL/min). Outcomes assessed included wound healing, time to heal, re-infection, amputation, mortality and re-hospitalization for infection. Compared with patients with eGFR < 30, patients with eGFR ≥60 had significantly lower rates of retinopathy, peripheral arterial disease and use of beta blockers or calcium channel blockers. Glycated haemoglobin levels were inversely related to eGFR, decreasing as eGFR severity increased. Haemoglobin levels were significantly lower, and inflammatory markers (ESR and CRP) were significantly higher in patients with eGFR < 30. There were no significant differences among eGFR groups in rates of wound healing, time to heal, re-infection or amputation. However, mortality increased with decreasing eGFR (1.9% in eGFR ≥60 vs. 3.2% in eGFR 30-60 vs. 8.1% in eGFR < 30; p = 0.04). Similarly, re-hospitalization for infection at a different site also increased with decreasing eGFR (20.5% in eGFR ≥60 vs. 28.1% in eGFR 30-60 vs. 48.4% in eGFR < 30; p <  0.01). In diabetic foot infections, presenting eGFR severity did not affect rates of wound healing, time to heal, re-infection or amputation. However, decreasing eGFR was associated with increased mortality and re-hospitalization for infection at a different site. In this study, presenting eGFR was not a predictive value for wound healing or time until healing, however was associated with rehospitalization and overall mortality this diabetic foot population.

Social Anxiety Moderates The Association Between Adolescent Irritability And Bully Perpetration, Michael T Perino, Jennifer C Harper-Lednicky, Alecia C Vogel, Chad M Sylvester, Deanna M Barch, Joan L Luby

2020-Current year OA Pubs

BACKGROUND: Preliminary work suggests anxiety moderates the relationship between irritability and bullying. As anxiety increases, the link between irritability and perpetration decreases. We hypothesize that any moderation effect of anxiety is driven by social anxiety symptoms. We sought to explicate the moderating effect of anxiety, while clarifying relations to other aggressive behaviors.

METHODS: A sample of adolescents (

RESULTS: Irritability was significantly related to bullying (

CONCLUSIONS: Understanding how psychopathology interacts with social behaviors is of great importance. Higher social anxiety is linked to reduced relations between irritability and bullying; however, the link between irritability and other aggression remains positive. …

Clinical Validation Of A Vaginal Cervical Cancer Screening Self-Collection Method For At-Home Use: A Nonrandomized Clinical Trial, Megan B Fitzpatrick, Colleen Mcnicholas, Lindsay Kuroki, Et Al.

2020-Current year OA Pubs

IMPORTANCE: One-quarter of US women who are at risk for cervical cancer delay screening. Self-collected (SC) cervical screening was recently US Food and Drug Administration (FDA)-approved in the US for use in a health care setting only; an at-home SC option is crucial to address clinic-related barriers to screening.

OBJECTIVE: To clinically validate the use of an SC device that was designed for optimal at-home performance, safety, ease-of-use, and dry storage and transport.

DESIGN, SETTING, AND PARTICIPANTS: This nonrandomized clinical trial used a prospective method comparison study design. Participants aged 25 to 65 years were recruited from 16 clinical sites …

High-Dimensional Mediation Analysis For Longitudinal Mediators And Survival Outcomes, Lili Liu, Haixiang Zhang, Yinan Zheng, Tao Gao, Cheng Zheng, Kai Zhang, Lifang Hou, Lei Liu

2020-Current year OA Pubs

Mediation analysis with high-dimensional mediators is crucial for identifying epigenetic pathways linking environmental exposures to health outcomes. However, high-dimensional mediation analysis methods for longitudinal mediators and a survival outcome remain underdeveloped. This study fills that gap by introducing a method that captures mediation effects over time using multivariate, longitudinally measured time-varying mediators. Our approach uses a longitudinal mixed effects model to examine the relationship between the exposure and the mediating process. We connect the mediating process to the survival outcome using a Cox proportional hazards model with time-varying mediators. To handle high-dimensional data, we first employ a mediation-based sure independence …

Early-Life Factors And Body Mass Index Trajectories Among Children In The Echo Cohort, Chang Liu, Katherine Rivera-Spoljaric, Et Al.

2020-Current year OA Pubs

IMPORTANCE: Identifying atypical body mass index (BMI) trajectories in children and understanding associated, modifiable early-life factors may help prevent childhood obesity.

OBJECTIVE: To characterize multiphase BMI trajectories in children and identify associated modifiable early-life factors.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included longitudinal data obtained from January 1997 to June 2024, from the Environmental influences on Child Health Outcomes (ECHO) cohort, which included children aged 1 to 9 years with 4 or more weight and height assessments. Analyses were conducted from January to June 2024.

EXPOSURES: Prenatal exposure to substances and stress (smoking, alcohol, depression, anxiety), maternal characteristics (prepregnancy …

Three-Year Analysis Of Adult Patients With Relapsed Or Refractory B-Cell Acute Lymphoblastic Leukemia Treated With Brexucabtagene Autoleucel In Zuma-3, Bijal D Shah, Armin Ghobadi, Et Al.

2020-Current year OA Pubs

Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 CAR T-cell therapy approved in the US to treat adults aged ≥18 years (≥26 years in the EU) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Brexu-cel showed an overall complete remission (CR)/CR with incomplete hematologic recovery (CRi) rate of 73% (CR rate 60%) and median overall survival (OS) of 25.4 months in 78 patients with R/R B-ALL after 2 years in ZUMA-3. Here, we report updated outcomes after >3 years median follow-up. As of July 23, 2022, median follow-up in all patients (N = 78) was 41.6 months. Median OS (95% CI) …

Differentiating Pathology Of Acute Disseminated Encephalomyelitis From Multiple Sclerosis In Children Using Diffusion Magnetic Resonance Biomarkers, Esra Pehlivan, Martin Kinuthia Mwangi, Vihas Abraham, Urmi Mange, Sheng-Kwei Song, Peng Sun, Soe Soe Mar

2020-Current year OA Pubs

BACKGROUND: To investigate the pathologic differences in patients with pediatric-onset multiple sclerosis (POMS) and acute disseminated encephalomyelitis (ADEM) using diffusion tensor imaging (DTI) and diffusion basis spectrum imaging (DBSI).

METHODS: Fifteen children with POMS and eight children with ADEM underwent DTI and DBSI. The comparison of DTI and DBSI diffusivity measures of POMS (31 scans) and ADEM (17 scans) was performed as group comparison and association over time.

RESULTS: In univariate analysis of average measures of DBSI and DTI over time, DBSI fractional anisotropy is lower in POMS than ADEM (P = 0.002), indicative of axonal injury of POMS. Higher …

Sensitivity Of Lung Point-Of-Care Ultrasound (Pocus) To Predict Oxygen Requirements In Emerging Viral Infections, Daniel L Theodoro, Di Coneybeare, Penelope Lema, Nicholas Renz, Laura Wallace, Enyo Ablordeppey, Sean Stickles, Alek Rosenthal, Ian Holley, Sirivalli Chamarti, Josie Acuña, James Patterson, Rachel Ancona, Srikar Adhikari

2020-Current year OA Pubs

OBJECTIVES: The prognostic characteristics of lung point-of-care ultrasound (L-POCUS) to predict respiratory decompensation in patients with emerging infections remains unstudied. Our objective was to examine whether scored lung ultrasounds predict hypoxia among a nonhypoxic, ambulatory population of patients with COVID-19.

METHODS: This was a diagnostic case-control study. Three academic emergency departments across the United States collected a convenience sample of nonhypoxic subjects with COVID-19, scored subjects' hemithorax at 7 locations using lung ultrasound, and followed outcomes for 40 days. We defined cases as hypoxia (≤91% by pulse oxygenation) from 2 hours after index presentation to day 40. Follow-up was by …

Wb5, A Novel Biomarker For Monitoring Efficacy And Success Of Mass Drug Administration Programs For Wuchereria Bancrofti Elimination, Rachel E. Pietrow, Catherine Bjerum, Benjamin G. Koudou, Taniawati Supali, Philip J Budge, Peter U. Fischer, Thomas B. Nutman, Sasisekhar Bennuru

2020-Current year OA Pubs

The success of mass drug administration at reducing the prevalence of lymphatic filariasis in endemic areas has led to an increased need for highly sensitive and specific diagnostic assays. To be useful in post-elimination surveillance in areas with low to zero prevalence, high test performance characteristics are required to enable the early detection of infection recrudescence. As current testing suffers from either sensitivity or specificity levels that fail to meet adopted target product profiles, additional targets that could be used as confirmatory tests or in multiplexed assays could overcome these issues. To this end, bioinformatic analyses coupled with stage-specific expression …

Plasma P-Tau217 And Tau-Pet Predict Future Cognitive Decline Among Cognitively Unimpaired Individuals: Implications For Clinical Trials, Rik Ossenkoppele, Tammie L S Benzinger, Suzanne E Schindler, Randall J Bateman, Et Al.

2020-Current year OA Pubs

Plasma p-tau217 and tau positron emission tomography (PET) are strong prognostic biomarkers in Alzheimer's disease (AD), but their relative performance in predicting future cognitive decline among cognitively unimpaired (CU) individuals is unclear. In a head-to-head comparison study including nine cohorts and 1,474 individuals, we show that plasma p-tau217 and medial temporal lobe tau-PET signal display similar associations with cognitive decline on a global cognitive composite test (R

Functions Of Communication During Emergency Care Of Children With Medical Complexity: Caregiver Perspectives, Julia A Ciurria, Jennifer Reyes Lin, Cassandra M Pruitt, Bryan A Sisk

2020-Current year OA Pubs

OBJECTIVE: We investigated communication experiences of caregivers of children with medical complexity (CMC) during emergency care.

METHODS: Fifteen caregivers of CMC participated in semi-structured interviews regarding communication while seeking care for their child in the emergency department (ED). Thematic analysis was applied using a previously established functional communication model as an a priori framework.

RESULTS: Each of the previously established 8 core functions of communication were identified in this population. "Building relationships" manifested as clinicians soliciting caregiver input and responding to the needs of the caregiver. "Exchanging information" included clearly explaining next steps to caregivers. "Responding to emotions" acknowledged the …

Assessing Hypersight Iterative Cbct For Dose Calculation In Online Adaptive Radiotherapy For Pelvis And Breast Patients Compared To Synthetic Ct, Jingwei Duan, Joel A Pogue, Dennis N Stanley, Sui Shen, Natalie N Viscariello, Carlos E Cardenas, Richard A Popple, Joseph Harms

2020-Current year OA Pubs

PURPOSE/OBJECTIVES: Recent technological advancements have increased efficiency for clinical deliverability of online-adaptive-radiotherapy (oART). Previous cone-beam-computed-tomography (CBCT) generations lacked the ability to provide reliable Hounsfield-units (HU), thus requiring oART workflows to rely on synthetic-CT (sCT) images derived through deformable-image-registration (DIR) between the planning CT (pCT) and the daily CBCT. These sCTs are prone to errors stemming from DIR, potentially contributing to dosimetric errors. This study aims to evaluate the capability of direct dose calculation using a novel CBCT platform, HyperSight (Varian-Medical-Systems), as an alternative for sCT.

METHODS/MATERIALS: To validate the HyperSight iterative CBCT (HS-iCBCT) HU accuracy, 125 kV and 140 kV …

Brain Morphometry In Infants Later Diagnosed With Autism Is Related To Later Language Skills, Luke E Moraglia, Kelly N Botteron, Natasha Marrus, Et Al.

2020-Current year OA Pubs

Autism spectrum disorder (ASD) presents early in life with distinct social and language differences. This study explores the association between infant brain morphometry and language abilities using an infant-sibling design. Participants included infants who had an older sibling with autism (high likelihood, HL) who were later diagnosed with autism (HL-ASD; n = 31) and two non-autistic control groups: HL-Neg (HL infants not diagnosed with autism; n = 126) and LL-Neg (typically developing infants who did not have an older sibling with autism; n = 77). Using a whole-brain approach, we measured cortical thickness and surface area at 6 and 12 …

Clinical Correlates Of A High Cardiorespiratory Risk Score For Very Low Birth Weight Infants, Sherry L Kausch, Claire C Slevin, Amanda Duncan, Karen D Fairchild, Douglas E Lake, Jessica Keim-Malpass, Zachary A Vesoulis, Brynne A Sullivan

2020-Current year OA Pubs

BACKGROUND: A pulse oximetry warning system (POWS) to analyze heart rate and oxygen saturation data and predict risk of sepsis was developed for very low birth weight (VLBW) infants.

METHODS: We determined the clinical correlates and positive predictive value (PPV) of a high POWS score in VLBW infants. In a two-NICU retrospective study, we identified times when POWS increased above 6 (POWS spike). We selected an equal number of control times, matched for gestational and chronologic age. We reviewed records for infection and non-infection events around POWS spikes and control times. We calculated the frequencies and PPV of a POWS …

Multi-Omic And Spatial Analysis Of Mouse Kidneys Highlights Sex-Specific Differences In Gene Regulation Across The Lifespan, Siqi Chen, Ruiyang Liu, Chia-Kuei Mo, Michael C Wendl, Andrew Houston, Preet Lal, Yanyan Zhao, Wagma Caravan, Andrew T Shinkle, Atieh Abedin-Do, Nataly Naser Al Deen, Kazuhito Sato, Xiang Li, André Luiz N Targino Da Costa, Yize Li, Alla Karpova, John M Herndon, Maxim N Artyomov, Joshua B Rubin, Sanjay Jain, Sheila A Stewart, Li Ding, Feng Chen, Et Al.

2020-Current year OA Pubs

There is a sex bias in the incidence and progression of many kidney diseases. To better understand such sexual dimorphism, we integrated data from six platforms, characterizing 76 kidney samples from 68 mice at six developmental and adult time points, creating a molecular atlas of the mouse kidney across the lifespan for both sexes. We show that proximal tubules have the most sex-biased differentially expressed genes emerging after 3 weeks of age and are associated with hormonal regulations. We reveal potential mechanisms involving both direct and indirect regulation by androgens and estrogens. Spatial profiling identifies distinct sex-biased spatial patterns in …

Pelabresib Plus Ruxolitinib For Jak Inhibitor-Naive Myelofibrosis: A Randomized Phase 3 Trial, Raajit K Rampal, Stephen T Oh, Et Al.

2020-Current year OA Pubs

Janus kinase (JAK) inhibitors provide limited depth and durability of response in myelofibrosis. We evaluated pelabresib-a bromodomain and extraterminal domain (BET) inhibitor-plus ruxolitinib (a JAK inhibitor) compared with placebo plus ruxolitinib as first-line therapy. In this phase 3 study (MANIFEST-2), JAK inhibitor-naive patients with myelofibrosis were randomized 1:1 to pelabresib 125 mg once daily (QD; 50-175 mg QD permitted) for 14 days followed by a 7-day break (21-day cycle), or to placebo in combination with ruxolitinib 10 or 15 mg twice daily (BID; 5 mg QD-25 mg BID permitted). Primary endpoint was reduction in spleen volume of ≥35% from baseline …

Amivantamab Plus Lazertinib In Patients With Egfr-Mutant Nsclc After Progression On Osimertinib And Platinum-Based Chemotherapy: Results From Chrysalis-2 Cohort A, Benjamin Besse, Saiama N Waqar, Et Al.

2020-Current year OA Pubs

INTRODUCTION: Treatment options for patients with EGFR-mutated NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy are limited.

METHODS: CHRYSALIS-2 cohort A evaluated amivantamab plus lazertinib in patients with EGFR exon 19 deletion- or L858R-mutated NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy. Primary end point was investigator-assessed objective response rate (ORR). The patients received 1050 mg of intravenous amivantamab (1400 mg if ≥ 80 kg) plus 240 mg of oral lazertinib.

RESULTS: In cohort A (N = 162), the investigator-assessed ORR was 28% (95% confidence interval [CI]: 22-36). The blinded independent central review-assessed ORR …

Trends In Urology Residency Applications: Results From The American Urological Association Medical Student Survey From 2022 To 2024, Michael Creswell, Kirsten Greene, Lee Richstone, Simone Thavaseelan, Erica Traxel, Aaron Tverye, Casey Kowalik, Gina Badalato, Thomas Jarrett, Kate Kraft, Mathew Sorensen, Moben Mirza

2020-Current year OA Pubs

OBJECTIVE: To provide a comprehensive overview of the American Urological Association Medical Student Surveys and includes data 2022, 2023, and 2024.

METHODS: Data collected through surveys distributed prior to match day and were distributed to all medical students who submitted a rank list for urology residency. Questions consisted of various topics, including applicant demographics, application metrics, and experiences with preference signals and virtual interviews.

RESULTS: 440 (79%), 428 (84%), and 387 (77%) applicants participated in surveys for the years 2022, 2023, and 2024, respectively. Applicants continue to participate in research at a high level. Additionally, United States Medical Licensing Exam …

For Girls And Women (4gw) Hpv Rct Protocol: A Crowdsourced, Pragmatic Stepped-Wedge Cluster Randomized Trial To Improve Uptake Of Hpv Vaccination And Screening Among Mother-Daughter Dyads In Nigeria, Juliet Iwelunmor, Ekenechukwu Kokelu, Temitope Ojo, Olufunto Olusanya, Titilola Gbaja-Biamila, Peter Kalulu, Angel Obiorah, Maria Afadapa, Nkiruka Obodoechina, Onyeka Anikamadu, Et Al.

2020-Current year OA Pubs

BACKGROUND: Expanding human papillomavirus (HPV) vaccination for girls and HPV self-collection for women can reduce the global burden of cervical cancer. However, HPV vaccination and self-collection services are rarely implemented simultaneously in mother-daughter dyads, leaving a critical gap in cervical cancer prevention. From 2023 to 2024, a community-engaged model for combined HPV vaccination and screening was co-designed using crowdsourcing open calls and designathons with mother-daughter teams and pilot-tested by trained research facilitators. This study explores the impact of this crowdsourced, community-engaged mother-daughter campaign and implementation strategy bundle on HPV vaccination among girls and HPV screening among their mothers in Nigeria …

Widespread Pain Phenotypes Impact Treatment Efficacy Results In Randomized Clinical Trials For Interstitial Cystitis/Bladder Pain Syndrome: A Multidisciplinary Approach To The Study Of Chronic Pelvic Pain Network Study, John T. Farrar, Siobhan Sutcliffe, Et Al.

2020-Current year OA Pubs

Pain clinical trials are notoriously complex and often inefficient in demonstrating efficacy, even for known efficacious treatments. A major issue is the difficulty in the a priori identification of specific phenotypes to include in the study population. Recent work has identified the extent of widespread pain as an important determinant of the likelihood of response to therapy, but it has not been tested in clinical trials for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). We explored this hypothesis using data from 3 previously published trials testing treatments for IC/BPS, which suggested modest benefits but did not meet a priori …

Subclinical Atherosclerosis And Cardiovascular Events Among Patients With Colorectal Cancer, Julia A Levy, Adetunji T Toriola, Et Al.

2020-Current year OA Pubs

BACKGROUND: Prior studies have documented that patients with colorectal cancer (CRC) are at an increased risk of cardiovascular disease (CVD).

OBJECTIVES: To examine coronary artery calcium (CAC) as a marker of subclinical atherosclerosis and its association with major adverse cardiovascular events (MACE) in patients with CRC across the cancer treatment trajectory.

METHODS: Adults with newly diagnosed CRC were enrolled in the prospective ColoCare study from 2017 to 2024. CAC was measured from routine diagnostic computed tomography (CT) and positron emission tomography-CT scans at CRC diagnosis until 5 years post-diagnosis. Atherosclerosis was defined as the presence of CAC. We used multivariable-adjusted …

Phase 1, First-In-Human, Single-/Multiple-Ascending Dose Study Of Iluzanebart In Healthy Volunteers, Andreas Meier, Spyros Papapetropoulos, Andrew Marsh, Kelly Neelon, David Stiles, Ryan O'Mara, Evan A Thackaberry, Marco Colonna, Raj Rajagovindan

2020-Current year OA Pubs

OBJECTIVE: To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of iluzanebart, a fully human monoclonal antibody TREM2 (triggering receptor expressed on myeloid cells 2) agonist, after single- (SAD) and multiple-ascending-dose (MAD) administration.

METHODS: Healthy adult volunteers (N = 136) received intravenous placebo or iluzanebart 1-60 mg/kg (SAD) or 10-60 mg/kg (MAD) followed by serial pharmacokinetics and safety assessments. Safety assessments included adverse events (AEs), vital signs, electrocardiograms, and clinical laboratory evaluations. Pharmacokinetics were assessed through noncompartmental analysis. The study also included open-label cohorts (3, 10, 20, 40, 60 mg/kg SAD; 10, 20, 40 mg/kg MAD) for cerebrospinal fluid (CSF) collection …

Development Of A Reference Standard To Assign Bacterial Versus Viral Infection Etiology Using An All-Inclusive Methodology For Comparison Of Novel Diagnostic Tool Performance, Coburn Allen, J Kate Deanehan, Yaniv Dotan, Matthew A Eisenberg, Andrew M Fine, Jonathan Isenberg, Ann Kane, Dani Kirshner, Todd W Lyons, Yasmin Maor, Ami Neuberger, Daniel G Ostermayer, Sharona Paz, Oded Scheuerman, Shachaf Shiber, Victoria A Statler, Michal Stein, Renata Yakubov, Shirly Yanai, Roy Navon, Lior Kellerman, Tanya M Gottlieb, Eran Eden

Faculty, Staff and Student Publications

Background: Diagnostic test evaluation requires a reference standard. We describe an approach for creating a reference standard for acute infection using unrestricted adjudication and apply it to compare biomarker tools.

Methods: Adults and children with suspected acute infection enrolled in three prospective studies at emergency departments and urgent cares were included. Adjudicators, blinded to C-reactive protein, procalcitonin, and MeMed BV (MMBV), labeled each case (bacterial/viral/non-infectious/indeterminate). Initial adjudication involved 3 adjudicators. Reference standard cohorts were defined: Microbiologically confirmed (3/3 adjudicators concur with high confidence and a concordant microbiological finding), unanimous (3/3 adjudicators concur with high confidence), suspected (3/3 adjudicators concur with …

Use Of Natural Language Processing To Identify Patients With Inflammatory Breast Cancer Across A Health-Care System, Ramez Kouzy, Megumi Kai, Huong T Le-Petross, Sadia Saleem, Wendy A Woodward

Faculty, Staff and Student Publications

Early identification and referral of inflammatory breast cancer remains challenging within large health-care systems, limiting access to specialized care. We developed and evaluated an artificial intelligence-driven platform integrating natural language processing (NLP) with electronic health records to systematically identify potential inflammatory breast cancer patients across 5 campuses. Our platform analyzed 8 623 494 clinical notes, implementing a sequential review process: NLP screening followed by human validation and multidisciplinary confirmation. Initial NLP screening achieved 55.4% positive predictive value, improving to 78.4% with human-in-the-loop review. Notably, among 255 confirmed patients with inflammatory breast cancer, our system demonstrated 92.2% sensitivity, identifying 57 patients …