bluuebunny/crossref_metadata_2025_split huggingface dataset:
Characterization of industry relationships in oncology
Authors: Harrison Rebecca A. , Majd Nazanin K. , Johnson Margaret O. , Urbauer Diana L. , Puduvalli Vinay , Khasraw Mustafa 
Published: May 2023

AbstractBackgroundCollaborative relationships between academic oncology and industry (pharmaceutical, biotechnology, “omic,” and medical device companies) are essential for therapeutic development in oncology; however, limited research on engagement in and perceptions of these relationships has been done.MethodsSurvey questions were developed to evaluate relationships between academic oncology and industry. An electronic survey was delivered to 1000 randomly selected members of the American Society of Clinical Oncology, a professional organization for oncologists, eliciting respondents' views around oncology‐industry collaborations. The responses were analyzed according to prespecified plans.ResultsThere were 225 survey respondents. Most were from the United States (70.0%), worked at an academic institution (60.1%), worked in medical oncology (81.2%), and had an active relationship with industry (85.8%). One quarter (26.7%) of respondents reported difficulty establishing a relationship with industry collaborators, and most respondents (75%) did not report having had mentorship in developing these relationships. The majority (85.3%) of respondents considered these collaborations important to their careers. Respondents generally thought that scientific integrity was preserved (92%), and most respondents (95%) had little concern over the quality of the collaborative product. Many (60%) shared concerns over potential conflict of interest if an individual with a compensated relationship promoted an industry product for clinical care/research, yet most respondents (67%) stated these relationships did not shape their interactions with patients.ConclusionsThis study provides novel data characterizing the nature of collaborative relationships between clinicians, researchers, and industry in oncology. Although respondents considered these collaborations an important part of clinical and academic oncology, formal education or mentorship around these relationships was rare. Conflicting findings around conflict of interest highlight the importance of more dedicated research in this area.Plain Language SummaryBusiness enterprises in health care play a central role in cancer research and care, driving the development of new medical testing, drugs, and devices. Effective working relationships among clinicians, researchers, and these industry partners can promote innovative research and enhance patient care. Study of these collaborations has been limited to date. Through distribution of a questionnaire to cancer clinicians and researchers, we found that most participants consider these relationships valuable, though they find establishing such relationships challenging partly because of gaps in educational programs in this area. Our findings also highlight the need for further policy around the potential bias these relationships can introduce.
Pharmacokinetics, Bioequivalence, and Safety Evaluation of 2 Formulations of 10‐mg Rivaroxaban Tablets: A 4‐Period Crossover Trial
Authors: Zhang Canhua , Shen Zihan , Li Jianhao , Wu Yaofen , Xu Zuoheng , Gu Wenzhao , Jian Jianqing , Wu Zixing , Liu Weixiong , Yang Hui , Su Jianfen 
Published: May 2023

AbstractThis study compared the safety, bioequivalence, and pharmacokinetic properties of 2 formulations of 10‐mg rivaroxaban tablets in healthy Chinese participants in fasting and fed arms. The trial was an open, randomized, 4‐period, replicated crossover scheme, and 36 volunteers were recruited separately for the fasting and fed arms. Volunteers were randomly administered a single dose of the test or reference formulation (10 mg) orally, followed by a 5‐day washout period. Rivaroxaban concentrations in the plasma were determined using liquid chromatography–tandem mass spectrometry, and pharmacokinetic parameters were obtained from the concentration‐time profiles. The mean values of the test and the reference product for the area under the plasma concentration–time curve from time 0 to the last measurable concentration, area under the plasma concentration–time curve from time 0 to infinity, and maximum plasma concentration were 996 and 1014 ng • h/mL, 1024 and 1055 ng • h/mL, and 150 and 152 ng/mL in the fasting arm, respectively; the values were 1155 and 1167 ng • h/mL, 1160 and 1172 ng • h/mL, and 202 and 193 ng/mL in the fed arm, respectively. All the parameters were within acceptable limits in terms of bioequivalence. No serious adverse events were observed. This study demonstrated that the 2 rivaroxaban tablets were bioequivalent in healthy Chinese participants under fasting and fed conditions.
Pharmacokinetics and Safety of Coadministered Atogepant and Topiramate in Healthy Participants: A Phase 1, Open‐Label, Drug–Drug Interaction Study
Authors: Boinpally Ramesh , McGeeney Danielle , Borbridge Lisa , Trugman Joel 
Published: May 2023

AbstractAtogepant, an oral calcitonin gene‐related peptide receptor antagonist, and topiramate, a commonly used oral antiepileptic, are approved as preventive migraine treatments. Given the distinct mechanisms of action of these treatments, it is possible that they may be coprescribed for migraine. This open‐label, single‐center, 2‐cohort, phase 1 trial evaluated the potential pharmacokinetic (PK) 2‐way drug–drug interactions (DDIs), safety, and tolerability of atogepant and topiramate in healthy adults. Participants received atogepant 60 mg once daily and topiramate 100 mg twice daily. Cohort 1 (N = 28) evaluated the effect of topiramate on the PK of atogepant; cohort 2 (N = 25) evaluated the effect of atogepant on the PK of topiramate. Potential DDIs were assessed using geometric mean ratios and 90% confidence intervals calculated for maximum plasma drug concentration at steady state (Cmax,ss) and area under the plasma concentration–time curve during the dosing interval at steady state (AUC0−tau,ss). Additional PK parameters were assessed. Atogepant AUC0−tau,ss and Cmax,ss decreased by 25% and 24%, respectively, with topiramate coadministration. Topiramate AUC0−tau,ss and Cmax,ss decreased by 5% and 6%, respectively, with atogepant coadministration. The 25% reduction in atogepant exposure when coadministered with topiramate is not considered to be clinically relevant and would not require dose adjustments.
High‐latitude invasion and environmental adaptability of the freshwater mussel Limnopernafortunei in Beijing, China
Authors: Wang Congcong , Xu Mengzhen , Zhang Jiahao , Zhou Xiongdong 
Published: May 2023

AbstractThe invasive freshwater mussel Limnoperna fortunei (Dunker, 1857) has spread widely throughout Asia and South America, especially via interbasin water diversion and navigation. The middle route of the South‐to‐North Water Transfer Project (SNWTP), whose terminal is Beijing, has diverted more than 60 billion m3 of water from the Yangtze River Basin to Northern China since December 2014. L. fortunei has spread north to Beijing along the SNWTP, biofouling its channels and tunnels. To determine the status of L. fortunei's invasion in Beijing, we systematically inspected the water bodies receiving southern water, including all branches of the SNWTP, water treatment plants, lakes, reservoirs, and rivers. We measured the densities of adults and veligers of L. fortunei and conducted eDNA analyses of water samples. A generalized linear model and canonical correspondence analysis were adopted to investigate the correlations between environmental (e.g., water temperature, conductivity, pH, total nitrogen, and phosphorus) and biological (e.g., chlorophyll a, plankton density, and community composition) variables and the densities of adults and veligers of L. fortunei. Water temperature is the most important factor in determining the densities of D‐shaped and pediveliger veligers, with explanatory variable contributions of 56.2% and 43.9%, respectively. The pH affects the densities of D‐shaped, umbonated, and pediveliger veligers. The density of plantigrade veligers is negatively correlated with the conductivity and positively correlated with the concentration of chlorophyll a. Canonical correspondence analysis shows a weak correlation between the dominant phytoplankton taxa and the density of veligers. The densities of D‐shaped, umbonated, and pediveliger veligers are positively correlated with the density of small phytoplankton (12.54 ± 4.33 μm), and the density of plantigrade veligers is positively correlated with the density of large (16.12 ± 5.96 μm) phytoplankton. The density of planktonic veligers is well correlated with local abiotic variables, and that of plantigrade veligers is less correlated with local abiotic variables. This finding implies that controlling early‐stage veligers by altering water temperature, pH, and food size might effectively control the establishment of further L. fortunei colonies.
Patient profiles in heart failure with reduced ejection fraction: Prevalence, characteristics, treatments and outcomes in a real‐world heart failure population
Authors: Musella Francesca , Rosano Giuseppe M.C. , Hage Camilla , Benson Lina , Guidetti Federica , Moura Brenda , Sibilio Gerolamo , Boccalatte Marco , Dahlström Ulf , Coats Andrew J.S. , Lund Lars H. , Savarese Gianluigi 
Published: May 2023

AbstractAimsThe Heart Failure Association of the European Society of Cardiology has recently proposed to optimize guideline‐directed medical treatments according to patient's profiles. The aim of this analysis was to investigate prevalence/characteristics/treatments/outcomes for individual profiles.Methods and resultsPatients with heart failure (HF) with reduced ejection fraction (HFrEF) enrolled in the Swedish Heart Failure Registry (SwedeHF) between 2013 and 2021 were considered. Among 108 profiles generated by combining different strata of renal function (by estimated glomerular filtration rate [eGFR]), systolic blood pressure (sBP), heart rate, atrial fibrillation (AF) status and presence of hyperkalaemia, 93 were identified in our cohort. Event rates for a composite of cardiovascular (CV) mortality or first HF hospitalization were calculated for each profile. The nine most frequent profiles accounting for 70.5% of the population had eGFR 30–60 or ≥60 ml/min/1.73 m2, sBP 90–140 mmHg and no hyperkalaemia. Heart rate and AF were evenly distributed. The highest risk of CV mortality/first HF hospitalization was observed in those with concomitant eGFR 30–60 ml/min/1.73 m2 and AF. We also identified nine profiles with the highest event rates, representing only 5% of the study population, characterized by no hyperkalaemia, even distribution among the sBP strata, predominance of eGFR <30 ml/min/1.73 m2 and AF. The three profiles with eGFR 30–60 ml/min/1.73 m2 also showed sBP <90 mmHg.ConclusionsIn a real‐world cohort, most patients fit in a few easily identifiable profiles; the nine profiles at highest risk of mortality/morbidity accounted for only 5% of the population. Our data might contribute to identifying profile‐tailored approaches to guide drug implementation and follow‐up.
Prevalence, characteristics and prognostic impact of aortic valve disease in patients with heart failure and reduced, mildly reduced, and preserved ejection fraction: An analysis of the ESC Heart Failure Long‐Term Registry
Authors: Shahim Bahira , Shahim Angiza , Adamo Marianna , Chioncel Ovidiu , Benson Lina , Crespo‐Leiro Maria G. , Anker Stefan D. , Coats Andrew J.S. , Filippatos Gerasimos , Lainscak Mitja , McDonagh Theresa , Mebazaa Alexandre , Piepoli Massimo F. , Rosano Giuseppe M.C. , Ruschitzka Frank , Savarese Gianluigi , Seferovic Petar , Volterrani Maurizio , Crespo Leiro Marisa , Segovia Cubero Javier , Amir Offer , Palic Benjamin , Maggioni Aldo P. , Metra Marco , Lund Lars H. 
Published: May 2023

ABSTRACTAimsTo assess the prevalence, clinical characteristics, and outcomes of patients with heart failure (HF) with or without moderate to severe aortic valve disease (AVD) (aortic stenosis [AS], aortic regurgitation [AR], mixed AVD [MAVD]).Methods and resultsData from the prospective ESC HFA EORP HF Long‐Term Registry including both chronic and acute HF were analysed. Of 15 216 patients with HF (62.5% with reduced ejection fraction, HFrEF; 14.0% with mildly reduced ejection fraction, HFmrEF; 23.5% with preserved ejection fraction, HFpEF), 706 patients (4.6%) had AR, 648 (4.3%) AS and 234 (1.5%) MAVD. The prevalence of AS, AR and MAVD was 6%, 8%, and 3% in HFpEF, 6%, 3%, and 2% in HFmrEF and 4%, 3%, and 1% in HFrEF. The strongest associations were observed for age and HFpEF with AS, and for left ventricular end‐diastolic diameter with AR. AS (adjusted hazard ratio [HR] 1.43, 95% confidence interval [CI] 1.23–1.67), and MAVD (adjusted HR 1.37, 95% CI 1.07–1.74) but not AR (adjusted HR 1.13, 95% CI 0.96–1.33) were independently associated with the 12‐month composite outcome of cardiovascular death and HF hospitalization. The associations between AS and the composite outcome were observed regardless of ejection fraction category.ConclusionsIn the ESC HFA EORP HF Long‐Term Registry, one in 10 patients with HF had AVD, with AS and MAVD being especially common in HFpEF and AR being similarly distributed across all ejection fraction categories. AS and MAVD, but not AR, were independently associated with increased risk of in‐hospital mortality and 12‐month composite outcome, regardless of ejection fraction category.
Effects of dapagliflozin on heart failure hospitalizations according to severity of inpatient course: Insights from DELIVER and DAPA‐HF
Authors: Chatur Safia , Kondo Toru , Claggett Brian L. , Docherty Kieran , Miao Zi Michael , Desai Akshay S. , Jhund Pardeep S. , de Boer Rudolf A. , Hernandez Adrian F. , Inzucchi Silvio E. , Kosiborod Mikhail N. , Lam Carolyn S.P. , Martinez Felipe A. , Shah Sanjiv J. , Petersson Magnus , Langkilde Anna Maria , McMurray John J.V. , Solomon Scott D. , Vaduganathan Muthiah 
Published: May 2023

AbstractAimsDapagliflozin resulted in significant and sustained reductions in first and recurrent heart failure (HF) hospitalizations among patients with HF across the spectrum of ejection fraction. How treatment with dapagliflozin differentially impacts hospitalization for HF of varying complexity is not well studied.Methods and resultsIn the DELIVER and DAPA‐HF trials, we examined the effects of dapagliflozin on adjudicated HF hospitalizations of varying complexity and hospital length of stay (LOS). HF hospitalizations requiring intensive care unit stay, intravenous vasoactive therapies, invasive/non‐invasive ventilation, mechanical fluid removal or mechanical circulatory support were categorized as complicated. The balance was classified as uncomplicated. Of the total 1209 HF hospitalizations reported in DELIVER, 854 (71%) were uncomplicated and 355 (29%) were complicated. Of the total 799 HF hospitalizations reported in DAPA‐HF, 453 (57%) were uncomplicated and 346 (43%) were complicated. Relative to patients experiencing a first uncomplicated HF hospitalization, those with complicated HF hospitalizations had a significantly higher in‐hospital mortality both in DELIVER (16.7% vs. 2.3%, p < 0.001) and DAPA‐HF (15.1% vs. 3.8%, p < 0.001). Dapagliflozin similarly reduced total ‘uncomplicated’ (DELIVER: rate ratio [RR] 0.67, 95% confidence interval [CI] 0.55–0.82 and DAPA‐HF: RR 0.69, 95% CI 0.54–0.87) and ‘complicated’ HF hospitalizations (DELIVER: RR 0.82, 95% CI 0.63–1.06 and DAPA‐HF: RR 0.75, 95% CI 0.58–0.97). Dapagliflozin consistently reduced hospitalizations irrespective of their LOS: <5 days (DELIVER: RR 0.76, 95% CI 0.58–0.99 and DAPA‐HF: RR 0.58, 95% CI 0.42–0.80) or ≥5 days (DELIVER: RR 0.71, 95% CI 0.58–0.86 and DAPA‐HF: RR 0.77, 95% CI 0.62–0.94).ConclusionA substantial proportion of hospitalizations (∼30–40%) among patients with HF irrespective of ejection fraction required intensification of treatment beyond standard intravenous diuretics. Such patients experienced significantly higher in‐hospital mortality. Treatment with dapagliflozin consistently reduced HF hospitalizations regardless of severity of inpatient course or LOS.Clinical Trial Registration: ClinicalTrials.gov, DELIVER (NCT03619213) and DAPA‐HF (NCT03036124).
The youth transformative participatory evaluator education and training approach: The EvalYouth experience
Authors: Bitar Khalil , Hoosen Fazeela , Montrosse‐Moorhead Bianca , Jahid Qudratullah 
Published: May 2023

AbstractIn the face of unprecedented and ever‐changing challenges at the local, national, and global levels, evaluation must change too. Our old ways no longer serve us or the field's social, economic, political, and humanitarian betterment aims. Taking these aims seriously means much must change, including how we educate and train. In this article, we lay out a vision for what must happen within evaluator education and training and examples of how a transformative frame can be successfully integrated. With the great challenges our countries and societies face, we revisit three fundamental questions: what do evaluator education and training ‘done well’ mean? What should such education and training look like? Who should lead it?
Medical cannabis: Roles, responsibilities, and challenges for clinical pharmacists
Authors: Sera Leah , Duncan Nakia 
Published: May 2023

AbstractCannabis is a plant that has been grown for centuries for it is industrial, medicinal, and recreational uses. Over the last few decades, cannabis has been increasingly used therapeutically and recreationally as states increasingly decriminalize or legalize its cultivation and sale. Pharmacists, as medication experts, can play an important role in educating patients and other healthcare professionals about cannabis, the evidence of its potential for therapeutic use, and the risks for short and long‐term adverse effects. This paper aims to broadly review the current policy landscape, describe specific issues and challenges relevant to patients and healthcare providers, and provide a framework for the clinical pharmacist's approach to the patient using cannabis.
Integrating comprehensive medication management in specialty clinics: A feasibility study
Authors: Livet Melanie , Richard Chloe , Pathak Shweta , Blanchard Carrie 
Published: May 2023

AbstractIntroductionPatients dealing with complex medical conditions requiring specialty care and polypharmacy therapy experience many challenges, including the lack of adequate medication optimization services. Pharmacists within specialty clinics are uniquely positioned to improve patient care by offering comprehensive medication management (CMM) services.ObjectivesThis study explores the feasibility of CMM delivery by clinical pharmacists within specialty clinics. More specifically, it aimed to (1) assess the pharmacists, pharmacy managers, and clinic team members' experience with CMM implementation; and (2) evaluate preliminary evidence of treatment effectiveness.MethodsSeven specialty clinics within an academic medical center were recruited to prepare for, implement, and evaluate CMM over an 18‐month period, with two additional clinics joining mid‐project. This exploratory feasibility study used mixed data to understand levels of service adoption, evaluate changes in feasibility indicators (acceptability, appropriateness, practicality, intent to continue use, and satisfaction), collect implementation feasibility insights, and evaluate treatment outcomes, both perceived and based on medication therapy problem (MTP) resolution rates. Data sources included administrative data, surveys, interviews, and MTP documentation.ResultsService uptake was highly context dependent, with three of the five clinics discontinuing participation doing so because of challenges with service fit (appropriateness). For the four clinics implementing CMM throughout the study, the benefits were evidenced by the positive changes in the feasibility indicators ratings, perceived improved patient care, and a 96.2% MTP resolution rate. Gaining an understanding of CMM as a service and its potential role within a specialty clinic, ensuring buy‐in from clinics and management, identifying implementation strategies such as preparation of workflows, and using a standardized MTP documentation form were highlighted as critical to successful implementation.ConclusionProviding CMM as a service option for complex patients in specialty care clinics was deemed feasible and beneficial, providing alignment with the clinic culture, patient care approach, and pharmacist role.
Research and scholarly methods: Writing abstracts
Authors: Dupree Lori H. , Casapao Anthony M. 
Published: May 2023

AbstractAn abstract is a concise summary of scholarly work and is the first impression for the editor, peer reviewer, or journal audience. When presenting or writing up scholarly activity, an abstract is required for submission and guidelines vary depending on the conference, journal, and grant application. Many early career researchers and pharmacists feel unequipped to summarize research activity and need guidance to get started with abstract writing. A stepwise approach can be a valuable tool for all types of learners. From start to finish, this paper provides guidance and specific examples to write a high‐quality abstract effectively for conferences, journals, and grant application submissions. By following the eight sequential steps of abstract writing provided, pharmacists can potentially develop a skillset to advance scholarly work and showcase it to the scientific community.
Amendments of weld formation in human skin laser soldering
Authors: Ryabkin Dmitrii , Meglinsk Igor , Gerasimenko Alexander 
Published: May 2023

AbstractA computational modeling is employed for quantitative assessment of weld formation and area of tissue temperature necrosis during the human skin laser soldering. The evaluation is carried out depending on the components composition of using solders, including bovine serum albumin (BSA), indocyanine green (ICG), and carbon nanotubes (CNTs), as well as the angle of incidence of laser light and its pulse duration. The influence of CNT on the change of thermodynamic characteristics of albumin denaturation and the rate of formation of the laser weld is investigated. The obtained results suggest to limit the duration of laser light pulse by temperature relaxation time to minimize transfer of thermal energy to reduce the heating of human skin tissues. The developed model has a great potential for further optimization of laser soldering of biological tissues technology with greater efficiency in minimizing the weld area.