bluuebunny/crossref_metadata_2025_split huggingface dataset:
How to Determine a Therapeutic Reference Range for a Psychotropic Drug Systematically? Recommendations of the TDM Task Force of the AGNP
Authors: Hart Xenia M. , Amann Friederike , Baumann Pierre , Havemann-Reinecke Ursula , Schoretsanitis Georgios , Steimer Werner , Unterecker Stefan , Zernig Gerald , Gründer Gerhard , Hiemke Christoph 
Published: February 2025

Background:
Therapeutic drug monitoring (TDM) is essential for controlling pharmacogenetic and pharmacokinetic variations and for optimizing pharmacotherapy. However, its value is often underestimated because of nonsystematic recommendations for target ranges in the literature. The purpose of this study was to emphasize transparency and systematization in the forthcoming Updates to the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP)-TDM Consensus Guidelines.

Methods:
Here, a stepwise method for determining therapeutic reference ranges (TRRs) in psychiatry is introduced. By using various data types, a multidimensional approach for establishing a range is presented. The data types were classified based on how effectively they supported the target ranges. This method was demonstrated for 3 drugs commonly used in psychiatry (aripiprazole, olanzapine, and escitalopram).

Results:
Despite the methodological shortcomings in published concentration-effect studies, the approach used here enabled the determination of reference ranges by combining multiple types of data. The lower limit of the TRR is ideally derived from studies that link blood drug concentrations to clinical effectiveness, particularly symptom-specific responses, after fixed-dose treatment. The upper limit depends on the concentrations associated with adverse reactions or maximal response. Thresholds can be estimated using receiver operating characteristic analyses. Preliminary thresholds were derived from responder concentration data or from expected drug concentrations under approved doses. Positron emission tomography studies were used to further validate these ranges.

Conclusions:
This study proposed a new standard for determining the TRR of psychotropic drugs, thereby enhancing their clinical utility and validity. Adjusting blood levels to these ranges should improve response rates and medication tolerance.
Peripheral Nerve Stimulation Thresholds Based on Waveform Shape and Implications for Guideline Limits
Authors: Gajda Gregory B. 
Published: February 2025

Abstract
The objective of this paper is to derive basic restrictions for induced internal electric field and reference levels for external magnetic flux density for a class of periodic non-sinusoidal waveforms as multiples of the existing limits applicable to sinusoidal waveforms in current exposure standards. The Law of Electrostimulation and the Spatially Extended Nonlinear Node computational model were used to derive peripheral nerve stimulation thresholds of the internal electric field for both non-sinusoidal and sinusoidal waveforms. Threshold ratios (non-sinusoidal to sinusoidal) permitted basic restrictions and reference levels to be derived as multiples of the sinusoidal ones. Intercomparisons of threshold ratios from both models suggest that they are in agreement for flat-topped flux density waveforms with fast rise-times relative to the period but showed a discrepancy for the continuous sinusoid. Results from the computational model were used to establish the threshold ratios used in the conversion. Resulting non-sinusoidal basic restrictions and reference levels were found to have the same functional relationship with frequency as the sinusoidal ones, consisting of two ranges: a flat rheobase and a frequency-dependent (basic restriction) or inverse frequency-dependent (reference level) portion that intersects the rheobase at a transition frequency that is waveform-dependent. Above the transition frequency, the non-sinusoidal basic restriction was found to be inversely related to the flux density rise-time, resulting in an increased limit for fast-rising waveforms. The transition frequencies of fast-rising waveforms were found to be lowered relative to the sinusoidal one. Above the same transition frequency, the non-sinusoidal reference level is flat with frequency and was found to be approximately 79% lower than the sinusoidal one.
Likelihood Functions for Bioassay Measurements for Development, Selection, and Calibration of Biokinetic Models
Authors: Klumpp John , Poudel Deepesh 
Published: February 2025

Abstract
Internal dosimetrists are concerned with the development, selection, and calibration of biokinetic models to calculate radiation doses from incorporated radionuclides. This is accomplished using measurements of radionuclides in organs, tissues, and excreta, i.e., bioassay measurements. Each bioassay measurement has a corresponding likelihood function, which represents the relative likelihood of different biokinetic model parameters resulting in the measurement value. In order for a bioassay measurement to be interpreted properly, the correct likelihood function must be determined. Failing to use the correct likelihood function for each bioassay measurement results in improperly weighting certain measurements over other measurements, which in turn leads to incorrect dose estimates. This paper describes the correct likelihood functions to use for a wide variety of bioassay measurements, as well as a description of how to use them. These likelihood functions represent the vast majority of those likely to be needed for interpreting bioassay measurements. Therefore, this paper may serve as a tool kit that can be used by academic and occupational internal dosimetrists.
Study on the Assessment Method of Occupational Radiation Dose to Interventional Radiology Staff Wearing Two Personal Dosimeters in China for the Period 2015–2021
Authors: Fan Shengnan , Zhou Wenshan , Li Mengxue , Wang Tuo , Deng Jun , Sun Quanfu 
Published: February 2025

Abstract
Considering workers in interventional radiology occupationally exposed to relatively higher radiation dose, it is imperative to reasonably and reliably assess the occupational exposure of these workers. This paper presents a method to evaluate the occupational exposure to the interventional radiology workers monitored by using two personal dosimeters, based on data from 115,997 workers collected by the Chinese Registry of Radiation Workers in China during the period 2015–2021. It was observed that only 17.7% (20,572 in 115,997) of interventional radiology staff had a meaningful measurable result. The scatter plot of H
p(10)over-H
p(10)under vs. H
p(10)over was obtained to classify between the proper use group and misuse group. In addition, it was found that the effective dose calculated using the single-dosimeter approach proposed by Martin and Magee was close to those obtained using two other double-dosimeter approaches. Furthermore, the Swiss ordinance algorithm was chosen to assess the occupational exposure as a conservative estimation method. Meanwhile, it was also found that the average annual effective dose in tertiary hospitals is significantly higher than that in secondary hospitals in China (Z = −2.491, p < 0.05/3 = 0.017). Based on these observations, rigorous surveillance, quality control measures, and better workload management are still necessary to correctly evaluate the occupational exposure of interventional radiology staff. Our results are expected to provide a feasible and accurate method for the evaluation of occupational radiation dose to interventional radiology staff wearing two personal dosimeters and contribute to effective prevention and control of radiation health risks.
Research Priorities for Maternal Immunization
Authors: Englund Janet A. , Kachikis Alisa 
Published: February 2025

Background:
The maternal immunization platform has multiple vaccines already being utilized with more vaccines being considered.

Methods:
We describe areas with knowledge gaps regarding maternal immunization including (1) pathogen, (2) vaccine product, (3) vaccine strategy, (4) implementation research and (5) Regulatory and Public Health Policy.

Results:
Despite advances in clinical research during pregnancy, many questions remain regarding vaccine administration, products, coadministration of vaccines and vaccine acceptance. Issues regarding maternal antibody transfer in high-risk pregnancies need further study.

Conclusions:
Moving new maternal vaccines forward will take support from a broad array of experts.
Protecting Against Respiratory Syncytial Virus: An Online Questionnaire Study Exploring UK Parents’ Acceptability of Vaccination in Pregnancy or Monoclonal Antibody Administration for Infants
Authors: Paulson Simone , Munro Alasdair P. S. , Cathie Katrina , Bedford Helen , Jones Christine E. 
Published: February 2025

Background:
Maternal vaccination and infant monoclonal antibodies are promising avenues to protect young infants from respiratory syncytial virus (RSV) infection. Successful inclusion into the UK immunization schedule depends on parental acceptability, among other factors.

Methods:
An online cross-sectional survey from August to September 2023 exploring the likelihood of accepting, and preference for, either method of RSV prophylaxis, and reasons given for these. A questionnaire was distributed via social media networks to UK participants with a child under the age of 2 years and/or pregnant.

Results:
A total of 1620 participants completed the survey. Participants’ median age was 33 years [interquartile range (IQR), 31–36], 92% were of White ethnicity. Acceptability was high, but higher for a maternal vaccine than an infant monoclonal antibody (P < 0.0001). Concerns about safety, need for more information and number of vaccines given to infants already were common reasons for hesitancy. Lacking knowledge about RSV was associated with a lower likelihood of accepting either option [maternal vaccine: odds ratio (OR): 0.32, 95% confidence interval (CI): 0.16–0.68, P = 0.002; infant monoclonal antibody: OR: 0.35, 95% CI: 0.19–0.68, P = 0.002], as was identifying as Black, Black British, African or Caribbean ethnic group, or having declined the routinely recommended antenatal vaccines.

Conclusions:
While most parents would accept a maternal vaccine or infant monoclonal antibody to protect their infant against RSV, understanding preferences, influencing factors and concerns is essential to optimize immunization programs. This study highlights the information parents require to make an informed choice about RSV protection.
Immunogenicity of COVID-19 Vaccines During Pregnancy: A Systematic Review and Comparison of Pregnant Versus Nonpregnant Persons
Authors: Ballivian Jamile , Parker Edward P.K. , Berrueta Mabel , Ciapponi Agustín , Argento Fernando , Bardach Ariel , Brizuela Martin , Castellana Noelia , Comande Daniel , Kampmann Beate , Mazzoni Agustina , Sambade Juan M. , Stegelmann Katharina , Xiong Xu , Munoz Flor M. , Stergachis Andy , Buekens Pierre 
Published: February 2025

Background:
The COVID-19 pandemic induced the rapid deployment of novel vaccines with pregnant persons identified as an at-risk population due to their increased risk of severe outcomes. Limited data on the immunogenicity of COVID-19 vaccines in pregnant persons were available at the time of implementation. To address this data gap, we developed a living systematic review summarizing emerging evidence on vaccine immunogenicity in pregnancy.

Methods:
Following Cochrane, World Health Organization, and Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines, we included studies on COVID-19 vaccines during pregnancy. We carried out comprehensive biweekly literature searches from March 2022 to October 2023, covering multiple databases. Study selection, data extraction and risk of bias assessment were conducted by pairs of authors independently. Immunogenicity outcomes, primarily post-vaccination neutralizing or binding antibody concentrations, were analyzed descriptively. Post-vaccination antibody ratios in pregnant versus nonpregnant individuals were calculated for the subset of studies that included nonpregnant comparators.

Results:
By October 2023, our review encompassed 62 studies predominantly analyzing maternal sera (87%), with limited investigation regarding cord, neonatal and infant sera. Most studies investigated mRNA vaccines (97%) and focused on primary vaccination (82%), with some investigating booster doses (15%). Immunogenicity end points included spike-specific IgG (84%) and neutralizing antibodies (24%), with limited data on T-cell responses (3%). Antibodies were detectable after primary vaccination in most pregnant individuals, with similar or modestly attenuated concentrations compared to nonpregnant individuals (ratios > 0.7 for 5/6 estimates of spike-specific IgG), albeit with modest differences in antibody quality and kinetics. Long-term antibody-waning trajectories were similar between pregnant and nonpregnant individuals for up to 8 months after vaccination.

Conclusions:
mRNA COVID-19 vaccines induce a robust antibody response during pregnancy comparable (or modestly attenuated) relative to nonpregnant individuals. Immunogenicity data on non-mRNA vaccines are notably underrepresented in the existing literature.
Sociodemographic Factors Associated With Established and Novel Antenatal Vaccination Uptake in a Cohort of Pregnant Women in Uganda
Authors: Sturrock Sarah , Davies Hannah , Rukundo Gordon , Komugisha Cleophas , Kipyeko Sam , Nakabembe Eve , Mboizi Robert , Sekikubo Musa , Le Doare Kirsty 
Published: February 2025

Introduction:
Vaccination is a key strategy to safeguard the health of pregnant women and newborns. Although vaccine acceptance is often higher in low- and middle-income countries, the COVID-19 pandemic has highlighted increasing vaccine hesitancy. Vaccine hesitancy, specifically in pregnant women, must be understood to increase uptake. We used data from a Ugandan pregnancy registry study to examine sociodemographic factors linked to uptake of vaccines (tetanus toxoid and later COVID-19) in pregnancy.

Methods:
Pregnant women were recruited in Kampala, Uganda, as part of the PREPARE (Prevention of invasive Group B Streptococcus disease in young infants: a pathway for the evaluation & licensure of an investigational maternal GBS vaccine) study from September 1, 2020 until February 24, 2022. Demographic, socioeconomic and obstetric data were collected alongside COVID-19 and tetanus vaccination.

Results:
One thousand five hundred sixty-eight participants were included: 151 (10%) were unvaccinated, 11 (1%) received COVID-19 vaccine only, 1230 (78%) received a tetanus vaccine only and 176 (11%) received both. Lower vaccination rates were seen in participants attending fewer than 4 antenatal care episodes (P < 0.001), and those with higher parity (P = 0.036). Higher vaccination rates were seen with a managerial or professional occupation or higher maternal education level, but paternal occupation was not significantly associated with maternal vaccination. Parish vaccination rates varied from 0% to 100%, with 49 (29%) of parishes showing a vaccination rate <90%.

Conclusions:
This study highlights antenatal care as a key route for health promotion, and the stark difference in uptake between new and established antenatal vaccines. Further qualitative studies should investigate effective interventions to establish the safety and benefit of newer maternal vaccines across all demographic groups.
Vaccine Utilization and Timing of Administration in Pregnant Women: A South African Perspective
Authors: Bourne Julia , Sawry Shobna , Le Roux Jean , Fairlie Lee , Barnabas Shaun , Cutland Clare L. 
Published: February 2025

Background:
Maternal immunization is a valuable public health measure protecting the mother, fetus and newborn infant against targeted infectious diseases, playing an integral role in pregnancy outcomes. Limited literature exists from the African continent pertaining to the timing and utilization of maternal influenza and tetanus toxoid immunization. Maintaining high vaccine coverage is imperative for successful disease control, highlighting the importance of continued maternal immunization. We aimed to describe the utilization and timing of influenza and tetanus vaccinations during pregnancy, within South African publicly financed antenatal care facilities.

Methods:
A secondary analysis was conducted of clinical antenatal, vaccination and delivery data collected during a retrospective review of randomly selected maternity charts of women who delivered between July 2018 and June 2019 in Johannesburg and Cape Town, South Africa.

Results:
Influenza vaccination uptake within the sampled population was 16.6% (806/4851), with significantly higher odds of influenza vaccination in women 21-30 years of age and women with ≥6 antenatal care visits. Of 7031 (99.0% of the population) women who received at least 1 dose of tetanus toxoid–containing vaccine (TTCV), 39.2% (2759) received 1 dose; 51.0% (3590) received 2 and 9.7% (682) received 3 doses in their index pregnancy.

Conculsions:
Antenatal facilities are ideally suited to administer vaccines to pregnant women; however, targeted educational campaigns and immunization promotion by antenatal staff will improve maternal influenza immunization coverage. There is high utilization of TTCV in South Africa, with over 99% of women receiving at least 1 dose of TTCV, which is encouraging, especially considering that South Africa is implementing a single dose of a combination tetanus-diphtheria-acellular pertussis vaccine to replace tetanus toxoid (TT) in pregnancy.
Maternal and Placental Antibody Responses in SARS-CoV-2 Vaccination and Natural Infection During Pregnancy
Authors: Sturrock Sarah , Cavell Breeze , Alexander Frances , Apostolakis Kostis , Barro Camille , Daniel Olwenn , Dixon Louisa , Halkerston Rachel , Hall Tom , Hesp J. Richard , Hill Andrew M. , Leung Stephanie , Lim Suzy , McStraw Nikki , Otter Ashley , Ramkhelawon Laxmee , Watts Robert , Etti Melanie , T. Heath Paul , Lee-Wo Chelone , Greening Vanessa , Khalil Asma , Turner Kim , Taylor Stephen , Le Doare Kirsty , Ladhani Shamez 
Published: February 2025

Background:
As COVID-19 becomes endemic, understanding antibody response and transfer during pregnancy is crucial to inform policy and vaccination schedules. While good immunogenicity has been shown from SARS-CoV-2 vaccines, few data are available demonstrating functional responses in pregnant populations and infants.

Methods:
A prospective, multi-site observational study was completed across 14 centers in England from April 23, 2020, to December 21, 2022. Demographic, COVID infection and vaccination data were collected. Maternal and cord blood samples were taken at delivery, with maternal and neonatal blood samples taken at 6 weeks for participants who had been infected or vaccinated. Antibody concentrations were measured using antibody-dependent complement deposition, antibody-dependent neutrophil phagocytosis, ACE2 inhibition and Roche and EuroImmun antibody binding assays at the UK Health Security Agency.

Results:
Maternal vaccination and infection both produced an antibody response in 100% of mothers and 93.8% and 92.9% of neonates, respectively, which persisted at 6 weeks in 95%. The strongest response was seen in mothers who were both vaccinated and infected. Anti-spike antibody response decreased almost 25-fold from first to third trimester vaccination (P=0.013). Placental transfer of antibodies post-infection showed varied results depending on the assay used, with higher transfer ratios observed in assays measuring Fc-mediated antibody effector functions and IgG-specific responses.

Conclusions:
Maternal vaccination is associated with good immunogenicity and successful antibody transfer to the neonate, particularly with vaccination in early pregnancy. Further study is needed to determine the mechanism by which the timing of vaccination affects antibody transfer. When measuring placental transfer of antibodies, consideration of the assay to use is essential.
Risk of Vulvar HSIL and Penile Neoplasias in Anogenital Lichen Planus: A Case-Control Study
Authors: Hieta Niina K. , Tapana Lotta , Söderlund Jenni M. , Huvila Jutta K. , Talve Lauri A.I. , Haataja Marjut A.M. 
Published: February 2025

Objective
Lichen planus (LP) is a chronic inflammatory skin disease that may affect the skin, scalp, nails, and mucosa. The aim of this study was to investigate the risk of genital premalignant and malignant conditions in patients with anogenital LP (agLP).

Methods
We identified 60 male and 56 female patients with agLP by searching the biobank archives for a genital or perianal skin biopsy showing LP between 2004 and 2020. We also included 10 randomly selected age- and sex-matched controls for each patient. The risks of genital cancers and their precursors were evaluated.

Results
The incidence of agLP was 1.54 per 100,000 men and 1.36 per 100,000 women. There was no statistical difference between male and female incidence (p = .5721). The odds ratio (OR) for high-grade squamous intraepithelial lesion (HSIL) of the vulva was 31.2 (95% CI = 2.46–1645.00; p = .01). The OR for penile neoplasias could not be calculated because control patients had no neoplasias, but the difference was suggestive of statistical significance (95% CI = 1.90–infinite; p = .008). The mean age at the time of diagnosis of agLP was 59.9 years (median 62 years) in female patients and 40.8 years (median 33 years) in male patients. The difference in the mean ages of female and male patients was statistically significant (95% CI = 11.92–26.13; p < .001).

Conclusions
Patients with agLP may have an increased risk for vulvar HSIL and penile neoplasia.
Hearing Preservation and Functional Outcomes After Resection of Epidermoid Lesions of the Cerebellopontine Angle With High Hearing Risk
Authors: Papazian Michael , Cottrell Justin , Yang Jackie , Kay-Rivest Emily , Friedmann David R. , Jethanamest Daniel , Kondziolka Douglas , Pacione Donato , Sen Chandranath , Golfinos John G. , Thomas Roland J. , McMenomey Sean O. 
Published: February 2025

Objectives
To assess a decade of experience of treating patients with high hearing risk cerebellopontine angle (CPA) epidermoid lesions and examine factors influencing postoperative outcomes, particularly hearing preservation.

Study Design
Retrospective chart review.

Setting
Single tertiary-referral center.

Patients
Adults with CPA epidermoid lesions who presented with hearing loss or evidence of lesion involving vestibulocochlear nerve.

Interventions
The studied intervention was microsurgical resection.

Main Outcome Measures
Main outcome measures included extent of resection, hearing preservation rate for patients with postoperative audiograms, and disease progression.

Results
Twenty-three adults with an average tumor volume of 15.63 ± 16.2 cm3 were included. Five lesions (22%) involved the full internal auditory canal (IAC), 11 (48%) had partial involvement, and 5 (22%) were IAC sparing. Most patients with IAC involvement (88%) had circumferential invasion of the canal. Patients underwent either a retrosigmoid (18, 79%) or combined retrolabyrinthine transpetrosal approach (5, 22%), and gross total resection was achieved in most cases (13, 57%). Of 12 patients with postoperative audiograms, 10 (83%) had preoperative hearing preserved. There was no statistically significant change in hearing scores with treatment based on preoperative extent of IAC involvement. Ten patients (43%) had residual lesions postoperatively, and 6 exhibited progression. One patient ultimately required reoperation 6 years after initial surgery.

Conclusions
Preoperative hearing was preserved in the majority of the patients who underwent resection of CPA epidermoids via a retrosigmoid or transpetrosal approach. CPA epidermoids often invaded the IAC; however, degree of invasion was not associated with hearing outcomes.