bluuebunny/crossref_metadata_2025_split huggingface dataset:
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform
Authors: Lotz Gregor P. , Benstein Karin , Bloem Karien , Buddiger Harm , Calonder Claudio , Elm Stefanie , Fernandez Elena , Goodman Joanne , Gorovits Boris , Grudzinska-Goebel Joanna , Janssen Melody , Jawa Vibha , Kramer Daniel , Luo Linlin , Malisauskas Mantas , Michaut Lydia , Schäfer Martin , Spindeldreher Sebastian , Ullmann Martin , Nana Weldingh Karin , Kromminga Arno , Snoeck Veerle 
Published: May 2022

AbstractThe determination of a tailored anti-drug antibody (ADA) testing strategy is based on the immunogenicity risk assessment to allow a correlation of ADAs with changes to pharmacokinetics, efficacy, and safety. The clinical impact of ADA formation refines the immunogenicity risk assessment and defines appropriate risk mitigation strategies. Health agencies request for high-risk biotherapeutics to extend ADA monitoring for patients that developed an ADA response to the drug until ADAs return to baseline levels. However, there is no common understanding in which cases an extension of ADA follow-up sampling beyond the end of study (EOS) defined in the clinical study protocol is required. Here, the Immunogenicity Strategy Working Group of the European Immunogenicity Platform (EIP) provides recommendations on requirements for an extension of ADA follow-up sampling in clinical studies where there is a high risk of serious consequences from ADAs. The importance of ADA evaluation during a treatment-free period is recognized but the decision whether to extend ADA monitoring at a predefined EOS should be based on evaluation of ADA data in the context of corresponding clinical signals. If the clinical data set shows that safety consequences are minor, mitigated, or resolved, further ADA monitoring may not be required despite potentially detectable ADAs above baseline. Extended ADA monitoring should be centered on individual patient benefit.
The investigation of the ignition mechanism of shocked 98 wt% hydrogen peroxide based on transmissivity measurement
Authors: Liao WenQiang , Sun YanYun , Wu Lang , Huang XiCheng , Fan ZhuoNing , Liu FuSheng , Zhang MingJian 
Published: May 2022

Abstract
The behavior of 98 wt% hydrogen peroxide in the delay period under shock loading was researched by optical transmissivity in situ detection system. The time evolution of the transmissivity of 98 wt% hydrogen peroxide in the delay period is firstly presented. The experimental phenomenon shows that when the shock pressure in hydrogen peroxide reaches the ignition level, a large number of clusters will be produced inside the hydrogen peroxide. The formation of new clusters provides the reserve of energy for ignition. Those clusters formed by hydrogen peroxide in the delay period may act as hot spots, which leads the homogeneous explosives to reach the heterogeneous state before ignition. This conclusion is reasonable for revealing the ignition mechanism of homogeneous explosive. The particle behavior in the delay period gives us a new method to detect the ignition pressure. The experiments also confirm that the ignition pressure of 98 wt% hydrogen peroxide is just between 9.3 GPa and 12.1 GPa.
Efficacy of Bariatric Surgery in the Treatment of Women With Obesity and Polycystic Ovary Syndrome
Authors: Hu Lili , Ma Li , Xia Xinyi , Ying Tao , Zhou Minzhi , Zou Shuhua , Yu Haoyong , Yin Jun 
Published: May 2022

Abstract

Context
The comparative effectiveness of drugs and surgical therapy for women with obesity and polycystic ovary syndrome (PCOS) has not been systematically compared.

Objective
We aimed to determine the difference in efficacy between drug and bariatric surgery therapy for women with obesity and PCOS.

Methods
This prospective nonrandomized trial enrolled 90 women aged 18 to 40 years with body mass index (BMI) ≥ 27.5 kg/m2 and waist circumference ≥ 85 cm and fulfilling the 2011 Chinese diagnostic criteria for PCOS; 81 subjects completed the study. In the drug group, patients were administered metformin and an oral contraceptive containing ethinyl-estradiol and cyproterone acetate for the first 6 months, and metformin alone for the second 6 months. In the surgical group, patients underwent laparoscopic sleeve gastrectomies. The follow-up period was 12 months. The main outcome was the complete remission of PCOS, requiring 6 consecutive regular menstruation cycles or spontaneous pregnancy.

Results
Median BMI at endpoint was 30.1 kg/m2 in the drug group and 23.7 kg/m2 in the surgical group; complete remission rate was 15% and 78%, respectively. Except endpoint BMI, no difference was observed in free androgen index, ovarian morphology, homeostasis model assessment for insulin resistance, and total weight loss between remission and nonremission patients. Logistic regression analyses also revealed that the final BMI was the major factor influencing the remission of PCOS. The cutoff points for the final BMI were 27.5 kg/m2 for the drug group and 26 kg/m2 for the surgical group. Overall, nearly 95% of patients with an endpoint BMI below the cutoff values achieved complete remission.

Conclusion
Complete remission of PCOS in patients with obesity depends on the final BMI after weight loss. Thus, bariatric surgery should be prioritized for these patients.
Making Medical Subjects: Regeneration, Experimentation, and Women in the Guatemalan Spring
Authors: Crafts Lydia 
Published: May 2022

AbstractIn the 1940s, US and Guatemalan doctors working with the Pan American Sanitary Bureau (PASB) intentionally exposed at least 1,308 Guatemalan sex workers, prisoners, hospital patients, and soldiers to three sexually transmitted infections (STIs)—syphilis, gonorrhea, and chancroid. The doctors aimed to study the transmission of disease and the effects of penicillin and other chemical solutions in preventing the spread of STIs. This article examines how US and Guatemalan doctors weaponized a bureaucratic registration system to study STIs at what they deemed their main vector—sex workers. The experiments served the purposes of the Guatemalan Revolution (1944–54), a democratizing moment when doctors and political leaders aimed to spur national regeneration. This essay argues that Guatemala's activist state was a critical enabling factor granting US researchers access to Guatemalans' genitals and blood for experimentation.
Nationwide Readmission Rates and Hospital Charges for Patients With Surgical Evacuation of Nontraumatic Subdural Hematomas: Part 1—Craniotomy
Authors: Shaftel Kelly A. , Cole Tyler S. , Jubran Jubran H. , Schriber Tyler D. , Little Andrew S. 
Published: May 2022

BACKGROUND:
Despite patients experiencing high recurrence and readmission rates after surgical management of nontraumatic subdural hematomas (SDHs), few studies have examined the causes and predictors of unplanned readmissions in this population on a national scale.

OBJECTIVE:
To analyze independent factors predicting 30-day hospital readmissions after surgical treatment of nontraumatic SDH in patients who survived their index surgery and evaluate hospital readmission rates and charges.

METHODS:
Using the Nationwide Readmissions Database, we identified patients who underwent craniotomy for nontraumatic SDH evacuation (2010-2015) using a retrospective cohort observational study design. National estimates and variances within the cohort were calculated after stratifying, hospital clustering, and weighting variables.

RESULTS:
Among 49 013 patients, 10 643 (21.7%) had at least 1 readmission within 30 days of their index treatment and 38 370 (78.3%) were not readmitted. Annual readmission rates did not change during the study period (P = .74). The most common primary causes of 30-day readmissions were recurrent SDH (n = 3949, 37.1%), venous thromboembolism (n = 1373, 12.9%), and delayed hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (n = 1363, 12.8%). Comorbidities that independently predicted readmission included congestive heart failure, chronic obstructive pulmonary disease, coagulopathy, diabetes mellitus, liver disease, lymphoma, fluid and electrolyte disorders, metastatic cancer, peripheral vascular disease, psychosis, and renal failure (P ≤ .03). Household income in the 51st to 75th percentile was associated with a decreased risk of readmission.

CONCLUSION:
National trends in 30-day readmission rates after nontraumatic SDH treatment by craniotomy provide quality benchmarks that can be used to drive quality improvement efforts on a national level.
Time Course of Performance Fatigability during Exercise below, at, and above the Critical Intensity in Females and Males
Authors: AZEVEDO RAFAEL DE ALMEIDA , FOROT JONAS , IANNETTA DANILO , ABOODARDA SAIED JALAL , MILLET GUILLAUME Y. , MURIAS JUAN M. 
Published: May 2022

ABSTRACT

Purpose
This study aimed to investigate the time course and amplitude of performance fatigability during cycling at intensities around the maximal lactate steady state (MLSS) until task failure (TTF).

Methods
Ten females and 11 males were evaluated in eight visits: 1) ramp incremental test; 2–3) 30-min constant power output (PO) cycling for MLSS determination; and 4–8) cycling to TTF at PO relative to the MLSS of (i) −15%, (ii) −10 W, (iii) at MLSS, and (iv) +10 W, and (v) +15%. Performance fatigability was characterized by femoral nerve electrical stimulation of knee extensors at baseline; minutes 5, 10, 20, and 30; and TTF. Oxygen uptake, blood lactate concentration, muscle oxygen saturation, and perceived exertion were evaluated.

Results
Approximately 75% of the total performance fatigability occurred within 5 min of exercise, independently of exercise intensity, followed by a further change at minute 30. Contractile function declined more in males than females (all P < 0.05). At task failure, exercise duration declined from MLSS−15% to MLSS+15% (all P < 0.05), accompanied by a greater rate of decline after MLSS+15% and MLSS+10 compared with MLSS, MLSS−10, and MLSS−15% for voluntary activation (−0.005 and −0.003 vs −0.002, −0.001 and −0.001%·min−1, respectively) and contractile function (potentiated single twitch force, −0.013 and −0.009 vs −0.006, −0.004 and −0.004%·min−1, respectively).

Conclusions
Whereas the time course of performance fatigability responses was similar regardless of exercise intensity and sex, the total amplitude and rate of change were affected by the distinct metabolic disturbances around the MLSS, leading to different performance fatigability etiologies at task failure.
In silico comparison between the mutated and wild type androgen receptors and their influence on the selection of optimum androgenic receptor blocker for treatment of prostate cancer
Authors: Akeel Al-Hussaniy Hany , S. Al-tameemi Zahraa , AL-Zobaidy Mohammed J. 
Published: May 2022

Background: Prostate cancer is a disease that occurs in men aged more than 50 years. In Iraq, 8.89 men per 100,000 population suffer from prostate cancer, with the incidence being 14,016 cases and mortality being 6,367 cases. Despite advances in treatment against prostate cancer, it can become resistant to drugs. Therefore, the aim of current study was to search and identify binding sites for the repositioning of drugs by computational methods (docking). Methods: Based on the protein structure of the wild androgen receptor, the analysis parameters (22x22x22 on the X, Y, and Z axes) were established. Results: The interactions of the natural ligands with androgen receptor were 10.0 (testosterone) and 10.8 (dihydrotestosterone) while mutated androgen receptor (T877A) had a low affinity with testosterone and dihydrotestosterone (-5.3 and -6.7, respectively). In the interactions of both receptors with the reported inhibitors (antagonists), a decrease with Bicalutamide (-8.3 and -4.3, respectively) and an increase in affinity with Flutamide and Nilutamide (-7.7 and 8.6, wild AR; -8.7 and -9.3 AR T877A) were observed. As for Enzalutamide and Apalutamide (second-generation antagonists), the change was minimal between wild androgen receptor and T877A (-7.6 and -7.7; -7.3 and -7.3, respectively). The change in the affinity of the ligands with androgen receptor and androgen receptor T877A shows how a mutation alters the bonds between these molecules. Conclusion: The identification of key sites and potent inhibitors against abnormal androgen receptor functions will enrich prostate cancer treatments.
Lessons from COVID-19 for GCR governance: a research agenda
Authors: Rietveld Jochem , Hobson Tom , Avin Shahar , Sundaram Lalitha , Mani Lara 
Published: May 2022

The Lessons from Covid-19 Research Agenda offers a structure to study the COVID-19 pandemic and the pandemic response from a Global Catastrophic Risk (GCR) perspective. The agenda sets out the aims of our study, which is to investigate the key decisions and actions (or failures to decide or to act) that significantly altered the course of the pandemic, with the aim of improving disaster preparedness and response in the future. It also asks how we can transfer these lessons to other areas of (potential) global catastrophic risk management such as extreme climate change, radical loss of biodiversity and the governance of extreme risks posed by new technologies. Our study aims to identify key moments- ‘inflection points’- that significantly shaped the catastrophic trajectory of COVID-19. To that end this Research Agenda has identified four broad clusters where such inflection points are likely to exist: pandemic preparedness, early action, vaccines and non-pharmaceutical interventions. The aim is to drill down into each of these clusters to ascertain whether and how the course of the pandemic might have gone differently, both at the national and the global level, using counterfactual analysis. Four aspects are used to assess candidate inflection points within each cluster: 1. the information available at the time; 2. the decision-making processes used; 3. the capacity and ability to implement different courses of action, and 4. the communication of information and decisions to different publics. The Research Agenda identifies crucial questions in each cluster for all four aspects that should enable the identification of the key lessons from COVID-19 and the pandemic response.
En Route for the Accomplishment of SDG-7 in South Asian Countries: A Retrospective Study
Authors: Katekar Vikrant , Deshmukh Sandip S. 
Published: May 2022

With one-fifth of the world’s population, South Asian nations are home to 37 percent of the world’s poor and 50 percent of the world’s hungry children. This region experiences enormous development and infrastructure challenges. The paper investigates the progress of South Asian countries on Sustainable Development Goal-7, which is associated with access to modern energy to all. The present research also highlights significant issues and challenges behind the slow progress of South Asian countries on SDG-7. This study indicates that Bhutan and India are top-performing countries; however, Pakistan and Afghanistan are lower-performing countries on SDG-7 among all other South Asian countries. It has also been observed that South Asian countries have a narrow focus on renewable energy. South Asian nations will address their energy shortages issue and save a lot of money by using renewable energy instead of importing hydrocarbons. South Asian nations must diversify their main energy consumption patterns to achieve SDG-7. They may address their energy concerns at the policy, economic, technological, and information levels and boost cross-border energy commerce.
Research on the Intelligent Energy Governance of Parallel Hybrid Vehicle Based on Deep Learning
Authors: Wang Feilong 
Published: May 2022

To realize the intelligent energy governance of hybrid vehicles, a Deep-Q-Network energy controller based on the construction of parallel hybrid vehicle model is proposed, which aiming at energy loss problem of parallel hybrid vehicles and combining deep learning with reinforcement learning, and it is simulated through the ADVISOR software platform and compared with the traditional fuzzy logic strategy. The experimental results indicate that the DQN-based control strategy proposed in this paper reduces both the energy consumption and exhaust emissions of parallel hybrid vehicles. Compared with the traditional fuzzy control strategy, fuel consumption is reduced by 0.43L while the fuel economy increases by 10.9%. and exhaust gas such as CO44, CO, NOxx the emission were reduced by 28.9%, 0.2%, and 7.4%, respectively. It shows the feasibility and effectiveness of the proposed methods.
Pulsed laser source digital holography efficiency measurements
Authors: Owens Steven A. , Spencer Mark F. , Thornton Douglas E. , Perram Glen P. 
Published: May 2022

In this paper, a 1064 nm pulsed laser source and a short-wave IR (SWIR) camera are used to measure the total system efficiency associated with a digital holography system in the off-axis image plane recording geometry. At a zero path-length difference between the signal and reference pulses, the measured total system efficiency (15.9%) is consistent with that previously obtained with a 532 nm continuous-wave laser source and a visible camera [Appl. Opt. 58, G19 (2019)APOPAI0003-693510.1364/AO.58.000G19]. In addition, as a function of the temporal delay between the signal and reference pulses, the total system efficiency is accurately characterized by a component efficiency, which is formulated from the ambiguity function. Even with multimode behavior from the pulsed laser source and substantial dark current noise from the SWIR camera, the system performance is accurately characterized by the resulting ambiguity efficiency.
Effectiveness of a tailored web app on sun protection intentions and its implications for skin cancer prevention: A randomized controlled trial
Authors: Nittas Vasileios , Mütsch Margot , Frey Tobias , Braun Julia , Puhan Milo A. 
Published: May 2022

Skin cancers related to sunexposure are rising globally, yet largely preventable. Digital solutions enable individually tailored prevention and may play a crucial role in reducing disease burden. We developed SUNsitive, a theory-guided web app to facilitate sun protection and skin cancer prevention. The app collected relevant information through a questionnaire and provided tailored feedback on personal risk, adequate sun protection, skin cancer prevention, and overall skin health. SUNsitive’s effect on sun protection intentions and a set of secondary outcomes was evaluated with a two-arm randomized controlled trial (n = 244). At 2 weeks post-intervention, we did not find any statistical evidence for the intervention’s effect on the primary outcome or any of the secondary outcomes. However, both groups reported improved intentions to sun protect compared to their baseline values. Furthermore, our process outcomes suggest that approaching sun protection and skin cancer prevention with a digital tailored “questionnaire–feedback” format is feasible, well-perceived, and well accepted.
Trial registration: Protocol registration: ISRCTN registry (ISRCTN10581468).
What does it mean to be the main caregiver to a terminally ill family member in Lithuania?: A qualitative study
Authors: Kuznecovienė Jolanta , Butkevičienė Rūta , Harrison W. David , Peičius Eimantas , Urbonas Gvidas , Astromskė Kristina 
Published: May 2022

Introduction
Family caregivers are a great resource for providing dignified end-of-life care for terminally ill patients. Framed from the perspective of role theory and the relational nature of providing and receiving care, study objectives were as follows: (1) to capture caregivers’ understanding of the process of taking on the role of main caregiver, (2) to conceptualize their understanding of the functions that they assume while being the main caregivers, and (3) to understand how they experienced the consequences they confronted.

Methods
The research team employed the methodological strategy of descriptive thematic analysis using a semi-structured interview guide. The sample consisting of 33 family caregivers was recruited using purposeful and snowball sampling strategies in 2020. Interview data was analyzed using content-driven inductive thematic analysis.

Results
The data analysis revealed four main themes that structure the process of becoming the main care giver of a terminally ill family member and the meaning of the caregiver role: (1) inaccessibility and mistrust of public care services for persons with terminal illness, (2) moral obligations and responsibilities of immediate family and friends, (3) cultural traditions, (4) the caregiver feels responsible for everything. The themes describe the social role of family caregiver in social context, address the process of taking on the role of caregiver and living with systemic corruption.

Conclusions
Recognition of caregiving experiences is essential in planning better systems, in direct practice and in confronting corruption. The study suggests the need for open communication, accessibility of quality services, and the recognition of caregivers as care-team members. The larger implication is that the increasing numbers of distressed caregivers and aging populations can be considered as public health populations, and thus addressable through public health methods.
Role of organizational commitment in career growth and turnover intention in public sector of Oman
Authors: Al Balushi Adil Khamis , Thumiki Venkat Ram Raj , Nawaz Nishad , Jurcic Ana , Gajenderan Vijayakumar 
Published: May 2022

IntroductionCreating a proper career program is the best way to enhance employees’ organizational commitment; it motivates and retains them. This research aims to measure career growth’s influence on turnover intention, mediated by employees’ commitment through self-reported employees’ perceptions. This study identifies the key dimensions of organizational commitment (affective, continuance and normative commitment) that mediate the relationship between career growth and employee turnover intention exploring the indirect effects between career growth and turnover intention. The relationship is examined among the public sector employees in the Sultanate of Oman, a sector currently facing high turnover rates and losing key skilled talent pool.MethodologyData collection was executed through an adopted questionnaire distributed among 500 employees of 38 government units within the Sultanate of Oman. A total of 351 questionnaires were returned, and after the initial screening process, 329 were found to be valid for further analysis. CFA analysis was conducted to identify the factors falling under the three primary constructs of the study. Assessment of the models was explained through Goodness-of-fit Indices. Structural equation modeling, which is most recommended to study the effect of latent variables, was performed using AMOS to evaluate the mediating role of organizational commitment between career growth and employee turnover intention.FindingsThe results indicated that the potential for career growth is an essential motivating element for public sector employees in the Sultanate of Oman to encourage retention and reduce intention to leave. The findings also confirm that effective and continuous commitment significantly mediates the relationship between career growth and employees’ turnover intention.Contribution and originality valueThe results generated could help both researchers and those involved in public sector policy-making to understand how employee turnover intention is influenced by career growth and organizational commitment in the public sector in the Sultanate of Oman.