bluuebunny/crossref_metadata_2025_split huggingface dataset:
Nicotine Delivery of a Menthol-Flavored Heat-not-Burn Tobacco Product During Directed Use
Authors: Yingst Jessica M , Bordner Candace , Hrabovsky Shari , Hobkirk Andrea L , Trushin Neil , Richie John P , Foulds Jonathan 
Published: July 2023

Abstract

Introduction
IQOS was authorized by the U.S. Food and Drug Administration (FDA) as a modified-risk tobacco product. We conducted a pharmacokinetic study evaluating the nicotine delivery and subjective effects of IQOS use among current menthol cigarette smokers to better understand if IQOS is an acceptable cigarette alternative in light of the proposed menthol cigarette ban.

Aims and Methods
Participants were adult smokers of &gt;4 menthol cigarettes per day. After 14-hour nicotine abstinence, participants were provided an IQOS device and menthol heatstick to puff every 20 seconds for a total of 14 puffs. Blood samples were collected at baseline and during active use to calculate nicotine boost from baseline to peak concentration. Nicotine withdrawal symptoms were collected before and after IQOS use. In addition, a modified Product Evaluation Scale for IQOS was collected after use.

Results
Participants (n = 8) were a mean age of 43.9 years, 63% were female, 88% identified as White, and they smoked a mean of 17.1 menthol cigarettes per day. After IQOS use, the mean nicotine boost obtained was 15.96 ng/mL (SD = 6.91) (range 9.31 to 30.55 ng/mL). Most (75%) participants reported enjoying use of the product “a lot” or greater and more than half (62.5%) reported reduced cigarette cravings. Most participants reported no side effects after use; however, two experienced dry mouth, three experienced dizziness, one experienced throat irritation, and one experienced headache.

Conclusion
We found that directed use (14 puffs) of menthol IQOS delivered a mean nicotine boost of 15.96 ng/mL which reduced craving for a cigarette. The majority of participants enjoyed use of IQOS and reported mild side effects.

Implications
Menthol IQOS delivered a sufficient dose of nicotine perceived as satisfying by menthol cigarette smokers and it reduced craving with mild side effects. Menthol IQOS has potential to serve as a less harmful alternative for menthol cigarette smokers. The availability of modified risk products like IQOS should be considered by FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation.
Intramuscular vs Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Noninferiority Clinical Trial
Authors: Shapiro Adrienne E , Sarkis Elias , Acloque Jude , Free Almena , Gonzalez-Rojas Yaneicy , Hussain Rubaba , Juarez Erick , Moya Jaynier , Parikh Naval , Inman David , Cebrik Deborah , Nader Ahmed , Noormohamed Nadia , Wang Qianwen , Skingsley Andrew , Austin Daren , Peppercorn Amanda , Agostini Maria L , Parra Sergio , Chow Sophia , Mogalian Erik , Pang Phillip S , Hong David K , Sager Jennifer E , Yeh Wendy W , Alexander Elizabeth L , Gaffney Leah A , Kohli Anita 
Published: July 2023

Abstract

Background
Convenient administration of coronavirus disease 2019 (COVID-19) treatment in community settings is desirable. Sotrovimab is a pan-sarbecovirus dual-action monoclonal antibody formulated for intravenous (IV) or intramuscular (IM) administration for early treatment of mild/moderate COVID-19.

Method
This multicenter phase 3 study based on a randomized open-label design tested the noninferiority of IM to IV administration according to an absolute noninferiority margin of 3.5%. From June to August 2021, patients aged ≥12 years with COVID-19, who were neither hospitalized nor receiving supplemental oxygen but were at high risk for progression, were randomized 1:1:1 to receive sotrovimab as a single 500-mg IV infusion or a 500- or 250-mg IM injection. The primary composite endpoint was progression to (1) all-cause hospitalization for &gt;24 hours for acute management of illness or (2) all-cause death through day 29.

Results
Sotrovimab 500 mg IM was noninferior to 500 mg IV: 10 (2.7%) of 376 participants vs 5 (1.3%) of 378 met the primary endpoint, respectively (absolute adjusted risk difference, 1.06%; 95% CI, −1.15% to 3.26%). The 95% CI upper limit was lower than the prespecified noninferiority margin of 3.5%. The 250-mg IM group was discontinued early because of the greater proportion of hospitalizations vs the 500-mg groups. Serious adverse events occurred in &lt;1% to 2% of participants across groups. Four participants experienced serious disease-related events and died (500 mg IM, 2/393, &lt;1%; 250 mg IM, 2/195, 1%).

Conclusions
Sotrovimab 500-mg IM injection was well tolerated and noninferior to IV administration. IM administration could expand outpatient treatment access for COVID-19.

Clinical Trials Registration
ClinicalTrials.gov: NCT04913675.
A Graphical Overview of the Histopathology of Human Melioidosis: A Case Series
Authors: Savelkoel Jelmer , Tiemensma Marianne , Birnie Emma , Wiersinga W Joost , Currie Bart J , Roelofs Joris J T H 
Published: July 2023

Abstract

Background
Melioidosis, caused by the Gram-negative bacterium Burkholderia pseudomallei, has a major global health impact and a wide range of different disease manifestations. Histopathological descriptions of melioidosis remain limited. Granulomatous inflammation with multinucleated giant cells are considered classic features. We aim to present a graphical overview of histopathological manifestations of melioidosis, serving as an aid in diagnosing this disease.

Methods
We performed a retrospective international multicenter laboratory-based analysis of formalin-fixed paraffin-embedded (FFPE) tissue from culture-confirmed melioidosis autopsy and biopsy cases. Available FFPE tissue was stained with hematoxylin and eosin and immunostainings including a monoclonal antibody targeting the capsular polysaccharide (CPS) of B pseudomallei. Tissue with site-specific cultures and/or positive CPS staining were included in the graphical histopathological overview.

Results
We identified tissue of 8 autopsy and 5 biopsy cases. Pneumonia and soft tissue abscesses were the leading foci of disease displaying mainly necrosis and suppuration. Infrequent disease manifestations included involvement of bone marrow and adrenal glands in an autopsy case and biopsied mediastinal tissue, the latter being the only case in which we identified multinucleated giant cells. Using the CPS staining, we demonstrated granulomata as part of rare gastric tissue involvement.

Conclusions
We found fatal melioidosis to be a necrotizing and suppurative inflammation, usually without multinucleated giant cell formation. Gastric and mediastinal involvement points to ingestion and inhalation as possible routes of infection. The CPS staining proved beneficial as an aid to establish a histopathological diagnosis. Our graphical overview can be used by infectious diseases specialists, microbiologists, and pathologists.
Pharmaceutical Pollution from Human Use and the Polluter Pays Principle
Authors: Malmqvist Erik , Fumagalli Davide , Munthe Christian , Larsson D G Joakim 
Published: July 2023

Abstract
Human consumption of pharmaceuticals often leads to environmental release of residues via urine and faeces, creating environmental and public health risks. Policy responses must consider the normative question how responsibilities for managing such risks, and costs and burdens associated with that management, should be distributed between actors. Recently, the Polluter Pays Principle (PPP) has been advanced as rationale for such distribution. While recognizing some advantages of PPP, we highlight important ethical and practical limitations with applying it in this context: PPP gives ambiguous and arbitrary guidance due to difficulties in identifying the salient polluter. Moreover, when PPP does identify responsible actors, these may be unable to avoid or mitigate their contribution to the pollution, only able to avoid/mitigate it at excessive cost to themselves or others, or excusably ignorant of contributing. These limitations motivate a hybrid framework where PPP, which emphasizes holding those causing large-scale problems accountable, is balanced by the Ability to Pay Principle (APP), which emphasizes efficiently managing such problems. In this framework, improving wastewater treatment and distributing associated financial costs across water consumers or taxpayers stand out as promising responses to pharmaceutical pollution from human use. However, sound policy depends on empirical considerations requiring further study.
Ethical Considerations for Augmenting Surveys with Auxiliary Data Sources
Authors: Struminskaya Bella , Sakshaug Joseph W 
Published: July 2023

Abstract
Survey researchers frequently use supplementary data sources, such as paradata, administrative data, and contextual data to augment surveys and enhance substantive and methodological research capabilities. While these data sources can be beneficial, integrating them with surveys can give rise to ethical and data privacy issues that have not been completely resolved. In this research synthesis, we review ethical considerations and empirical evidence on how privacy concerns impact participation in studies that collect these novel data sources to supplement surveys. We further discuss potential approaches for safeguarding participants’ data privacy during data collection and dissemination that may assuage their concerns. Finally, we conclude with open questions and suggested avenues for future research.
Psychopharmacological Considerations for Gender-Affirming Hormone Therapy
Authors: Kim Hyun-Hee , Goetz Teddy G. , Grieve Victoria , Keuroghlian Alex S. 
Published: July 2023

AbstractThe field of transgender health has grown exponentially since the early 2010s. While this increased visibility has not been without controversy, there is growing acknowledgement of the needs of transgender, nonbinary, and gender expansive (TNG) patients and the health disparities they experience compared to the cisgender population. There is also increased interest among clinicians and trainees in providing gender-affirming care in all medical specialties. This is particularly relevant in psychiatry as mental health disparities in TNG patients have been well-documented. TNG patients experience significant minority stress and higher rates of psychiatric illness, self-harm, suicidality, and psychiatric hospitalization compared to their cisgender peers. In this review, we will cover potential interactions and side effects relevant to psychiatric medication management for the three most common medication classes prescribed as part of gender-affirming hormone therapy (GAHT): gonadotropin-releasing hormone receptor agonists, estradiol, and testosterone. Although no studies directly examining the efficacy of psychiatric medications or their interactions with GAHT for TNG patients have been published yet, we have synthesized the existing literature from both cisgender and TNG patients to shed light on health care disparities seen in TNG patients. Since clinicians’ lack of comfort and familiarity with gender-affirming care contributes significantly to these disparities, we hope this narrative review will help psychiatric prescribers provide TNG patients with the same quality of care that cisgender patients receive.
Perception of eHealth Programs for Cardiovascular Health
Authors: Su Jing Jing , Bayuo Jonathan , Abu-Odah Hammoda , Lin Rose S.Y. , He Qijun , Molassiotis Alex 
Published: July 2023

BackgroundDespite emerging evidence on the effectiveness of eHealth interventions in improving cardiovascular health, little is known about the perception of use and efficacy of these interventions and real-world application.ObjectiveWe sought to develop an in-depth understanding of the perceptions of eHealth interventions in improving cardiovascular health.MethodsThis is a systematic review and meta-synthesis of qualitative studies. A comprehensive search of multiple databases and a manual search of the references list were conducted. Meta-synthesis of qualitative data was performed to review and interpret the findings. The study report followed the ENTREQ checklist.ResultsFour themes emerged regarding perceptions of eHealth interventions: preferred eHealth intervention design features, enabling healthcare professionals' support, eHealth engagement for health benefits, and barriers to eHealth engagement. Intervention design features should integrate motivational elements, use an eHealth literacy lens, and enhance cultural relevance. Healthcare professionals appreciated these new working methods but voiced concern about competency building. Real-world usage initiation was driven by perceived needs and usefulness, whereas persistent engagement was inspired by intrinsic motivation in participants.ConclusionseHealth interventions were appreciated as a valuable opportunity for providing alternative/supplementary cardiac care for health optimization. Participants commented on the need for more explicit and accurate health information presentation, and they appreciated the motivational elements in empowering them with self-determination over daily self-care behaviors. Professionals raised the need for specific guidance to enhance competency and intervention fidelity when delivering eHealth care.
Comparison of Predictive Models for Prevention of Missed Endoscopy Appointments- failure of a Predictive Model to Outperform Overbooking Model
Authors: Hookey Lawrence , Lu Thomas , Khan Sana , Reed Joshua , Day Andrew , Norman Patrick 
Published: July 2023

Background:Patient late cancelation and nonattendance for endoscopy appointments is an ongoing problem affecting the productivity and wait times of endoscopy units. Previous research evaluated a model for predictive overbooking and had promising results.Study:All endoscopy visits at an outpatient endoscopy unit during 4 nonconsecutive months were included in the data analysis. Patients who did not attend their appointment, or canceled with 48 hours of their appointment were considered nonattendees. Demographic, health, and prior visit behavior data was collected and the groups compared.Results:1780 patients attended 2331 visits in the study period. Comparing the attendee versus non-attendees, there were significant differences in mean age, prior absenteeism, prior cancelations, and total number of hospital visits. No significant differences were seen between groups in winter versus non-winter months, the day of the week, sex distribution, type of procedure booked, or whether the referral was from specialist clinic or direct to procedure. The visit cancelation proportion (calculated excluding current visit) was substantially higher in the absentee group (P<0.0001). A predictive model was developed and compared to current booking as well as a straight overbooking of 7%. Both overbooking models performed better than the current practice, but the predictive overbooking model did not outperform straight overbooking.Conclusions:Developing an endoscopy unit specific predictive model may not be more beneficial than straight overbooking as calculated by missed appointment percentage.
The Impact of Chronic Cannabis Use on Esophageal Motility in Patients Referred for Esophageal Manometry
Authors: Ugwuegbu Obinna , Shibli Fahmi , Kim Yeseong , Rangan Vikram , Kurin Michael , Ayoub Fares , Ganocy Stephen , Kavitt Robert , Fass Ronnie 
Published: July 2023

Background:
Tetrahydrocannabinol, the main psychoactive compound in cannabis, binds with high affinity to the cannabinoid 1 receptor. Small randomized controlled studies using conventional manometry have shown that the cannabinoid 1 receptor can modulate esophageal function, namely transient lower esophageal sphincter relaxation frequency and lower esophageal sphincter tone. The effect of cannabinoids on esophageal motility in patients referred for esophageal manometry has not been fully elucidated using high-resolution esophageal manometry (HREM). We aimed to characterize the clinical effect of chronic cannabis use on esophageal motility utilizing HREM.

Methods:
Patients who underwent HREM from 2009 to 2019 were identified at 4 academic medical centers. The study group consisted of patients with a noted history of chronic cannabis use, a diagnosis of cannabis-related disorder, or a positive urine toxicology screen. Age and gender-matched patients with no history of cannabis use were selected to form the control group. Data on HREM metrics based on the Chicago classification V3, and the prevalence of esophageal motility disorders were compared. Confounding effects of BMI and medications on esophageal motility were adjusted for.

Results:
Chronic cannabis use was found to be an independent negative predictor of weak swallows (β=−8.02, P=0.0109), but not a predictor of failed swallows (P=0.6890). The prevalence of ineffective esophageal motility was significantly lower in chronic cannabis users compared with nonusers (OR=0.44, 95% CI 0.19–0.93, P=0.0384). There was no significant difference in the prevalence of other esophageal motility disorders between the 2 cohorts. In patients with dysphagia as their primary indication for HREM, chronic cannabis use was found to be independently associated with increased median integrated relaxation pressure (β=6.638, P=0.0153) and increased mean lower esophageal sphincter resting pressure (β=10.38, P=0.0084).

Conclusions:
Chronic cannabis use is associated with decreased weak swallows and reduced prevalence of ineffective esophageal motility in patients referred for esophageal manometry. In patients referred for dysphagia, chronic cannabis use is associated with increased integrated relaxation pressure and lower esophageal sphincter resting pressure, though not to levels above the normal range.
Preventing biological waste: Effective use of viable tissue in traumatized lower extremities
Authors: Lansford Jefferson L. , McCarthy Conor F. , Souza Jason M. , Saberski Ean R. , Potter Benjamin K. 
Published: July 2023

Abstract

Severe open lower extremity trauma requires debridement to remove contamination and devitalized tissues. Aggressive debridement should be balanced with preservation of viable tissue. These often damaged but preserved viable tissues are “spare parts” that augment the options available for reconstruction. The long-term goal of reconstruction should be functional limb restoration and optimization. Injury patterns, levels, and patient factors will determine whether this endeavor is better accomplished with limb salvage or amputation. This article reviews the rationale and strategies for preserving spare parts throughout debridement and then incorporating them as opportunistic grafts in the ultimate reconstruction to facilitate healing and maximize extremity function.

Level of Evidence:
5.
Unique Genomic Alterations and Microbial Profiles Identified in Patients With Gastric Cancer of African, European, and Asian Ancestry
Authors: Abate Miseker , Walch Henry , Arora Kanika , Vanderbilt Chad M. , Fei Teng , Drebin Harrison , Shimada Shoji , Maio Anna , Kemel Yelena , Stadler Zsofia K. , Schmeltz Joseph , Sihag Smita , Ku Geoffrey Y. , Gu Ping , Tang Laura , Vardhana Santosha , Berger Michael F. , Brennan Murray F. , Schultz Nikolaus D. , Strong Vivian E. 
Published: July 2023

Objective:
Here, we characterize differences in the genetic and microbial profiles of GC in patients of African (AFR), European, and Asian ancestry.

Background:
Gastric cancer (GC) is a heterogeneous disease with clinicopathologic variations due to a complex interplay of environmental and biological factors, which may affect disparities in oncologic outcomes..

Methods:
We identified 1042 patients with GC with next-generation sequencing data from an institutional Integrated Mutation Profiling of Actionable Cancer Targets assay and the Cancer Genomic Atlas group. Genetic ancestry was inferred from markers captured by the Integrated Mutation Profiling of Actionable Cancer Targets and the Cancer Genomic Atlas whole exome sequencing panels. Tumor microbial profiles were inferred from sequencing data using a validated microbiome bioinformatics pipeline. Genomic alterations and microbial profiles were compared among patients with GC of different ancestries.

Results:
We assessed 8023 genomic alterations. The most frequently altered genes were TP53, ARID1A, KRAS, ERBB2, and CDH1. Patients of AFR ancestry had a significantly higher rate of CCNE1 alterations and a lower rate of KRAS alterations (P < 0.05), and patients of East Asian ancestry had a significantly lower rate of PI3K pathway alterations (P < 0.05) compared with other ancestries. Microbial diversity and enrichment did not differ significantly across ancestry groups (P > 0.05).

Conclusions:
Distinct patterns of genomic alterations and variations in microbial profiles were identified in patients with GC of AFR, European, and Asian ancestry. Our findings of variation in the prevalence of clinically actionable tumor alterations among ancestry groups suggest that precision medicine can mitigate oncologic disparities.
Swelling of Atrophic Optic Discs in Idiopathic Intracranial Hypertension
Authors: Xie Jim Shenchu , Donaldson Laura , Margolin Edward A. 
Published: July 2023

Background:
Monitoring patients with idiopathic intracranial hypertension (IIH) and optic atrophy may be difficult as papilledema may not be appreciable on ophthalmoscopy. This retrospective chart review evaluated whether papilledema recurrence can be detected in this population using optical coherence tomography (OCT).

Methods:
Serial clinical assessments, ophthalmoscopy, and peripapillary OCT were reviewed in a cohort of patients with IIH and optic atrophy. Atrophy was defined as moderate if average peripapillary retinal nerve fiber layer (pRNFL) thickness was ≤80 μm and severe if average pRNFL thickness was ≤60 μm on at least 2 consecutive high-quality OCT scans. Based on the upper tolerance limit of test–retest variability, mean pRNFL elevation of ≥6 μm with subsequent decrease to baseline thickness was considered papilledema.

Results:
In a cohort of 165 patients with IIH, 32 eyes of 20 patients and 22 eyes of 12 patients demonstrated moderate and severe optic atrophy, respectively. Over a median follow-up of 198.5 weeks (range, 14.0–428.9), 63.3% (19 of 30) of patients had at least 1 episode of relapse, and 50.0% (15 of 30) had at least 1 episode of papilledema. There was a total of 36 relapse episodes, of which 7 occurred in patients with clinical signs and symptoms but no OCT evidence of relapse, 12 occurred in patients with OCT changes but no clinical signs and symptoms of relapse, and 17 occurred in patients with both clinical and OCT evidence to support relapse. The median percent pRNFL increase in the latter 2 groups was 13.7% (range, 7.5–111.8), and 7 eyes (13.0%) of 5 patients (16.7%) showed thickening greater than 20.0% from baseline. The rate, magnitude, and concordance of pRNFL swelling were similar between moderately vs severely atrophic eyes.

Conclusions:
Papilledema recurrence can be detected in atrophic optic discs using OCT. All patients with atrophic IIH should be longitudinally monitored with pRNFL measurement. Concurrence of other relapse-suggestive features should prompt further evaluation.