Independent Scientists Research Articles

СУЧАСНІ ПІДХОДИ ДО ВИКОРИСТАННЯ ЕЛЕКТРОННИХ КУРИЛЬНИХ ПРИСТРОЇВ ТА КАЛЬЯНУ В ЗАКЛАДАХ РЕСТОРАННОГО ГОСПОДАРСТВА

У статті розглянуті питання щодо нових курильних пристроїв – електронних сигарет. Наведено інформування про проблеми куріння, зокрема кальяну. Дим кальянів, як і дим інших тютюнових виробів, містить токсичні речовини, які викликають рак легень та інші види раку, серцево-судинні, респіраторні та інші захворювання. Небезпека для здоров’я від кальяну може навіть бути більшою через деякі специфічні для кальянів особливості. Під час куріння тютюнова суміш нагрівається за допомогою горіння вугілля, яке кладеться на тютюнову суміш. Тому курці кальяну (і ті, хто перебуває поряд) вимушені вдихати не тільки продукти згорання тютюнової суміші, але і продукти згорання вугілля, насамперед чадний газ. Під час горіння вугілля в кальяні утворюється не лише чадний газ, але і багато канцерогенів, наприклад бенз(а)пірен та поліароматичні вуглеводні, а також важкі метали, такі як свинець, кобальт та нікель, що призводить до небезпечних концентрацій цих шкідливих речовин у повітрі. ВООЗ вважає, що Електронні системи доставки нікотину (ЕСДН) зараз перебувають на етапі становлення, тому мають як загрози, так і перспективи для контролю над тютюном. Небезпека в тому, що більшість таких електронних систем не були тестовані незалежними вченими. Багато електронних сигарет містять нікотин, який негативно впливає на багато біологічних процесів організму людини. Їхні заправні контейнери містять концентровану кількість ароматизаторів, що потенційно вказують на їхню цитотоксичність, тобто здатність руйнувати клітини організму. ЕСДН, що є альтернативою традиційним тютюновим виробам, набули поширення на світовому ринку і відрізняються від традиційних сигарет утворенням високодисперсного аерозолю за відсутності процесу горіння. В українському законодавстві немає визначення електронних сигарет. Вони продаються як електронні пристрої нарівні із флешками. Це означає, що ніхто не знає та не регулює вміст електронних систем доставки нікотину в нашій країні. Класифікована нова продукція як окрема категорія виробів ЕСДН, виділені основні групи споживчих товарів цієї категорії. Надана загальна характеристика зразків рідини для заправки ЕСДН як в’язкої, слабо текучої рідини різних кольорів на основі високоатомних спиртів – гліцерину (пропан-1,2,3- тріол, харчова добавка Е422) і пропіленгліколю (пропан-1,2-діол, харчова добавка Е1520), води, ароматизатора, з нікотином/без нікотину (залежно від зразка), щільність розчину – не менше 1,2 мг/мл, водневий показник рН – 4,5–7,5. У результаті досліджень встановлено: відсутність монооксиду вуглецю в газовій фазі аерозолю ЕСДН одноразового використання – кількісний перехід нікотину з рідини в аерозоль незначний, що є підтвердженням відсутності процесу горіння під час споживання ЕСДН.

Prenatal Diagnosis of Placental Invasion: A Systematic Review and Meta-analysis on Accuracy of Ultrasonography and MRI in Diagnosis of Placental Invasion

Objective: The aim of this systematic review and meta-analysis was to evaluate and compare the diagnostic accuracy of ultrasonography (US) and magnetic resonance imaging (MRI) in the diagnosis of placental invasion. Method: Two independent scientists carried out a series of searches to obtain relevant research, released from January 1, 2009, to December 31, 2018. National databases (Magiran and SID), KoreaMed, and LILACS were reviewed for literature, released in other languages. A series of MeSH keywords was employed as part of the searching strategy (e.g., pregnancy, pregnant, placental invasion, accreta). A forest plot was built with Meta-DiSc, version 1.4. Results: For placental invasion, the sensitivity and specificity of MRI were 89% (95% confidence interval [CI], 83%–93% with a 95% confidence interval) and 97% (95% CI, 93%–99%), respectively. The sensitivity and specificity of US were 73% (95% CI, 66%–79%) and 89% (95% CI, 84%–93%), respectively. In the detection of placenta accreta solely (as the first grade of placental invasion), the sensitivity and specificity of MRI were 89.3% (95% CI, 86%–92%) and 84% (95% CI, 77%–89.6%). The sensitivity and specificity of US detection were 95.4% (95% CI, 93.8%–96.6%) and 87.3% (95% CI, 81.4%–91.9%), respectively. Conclusion: Due to the increased cesarean sections, placental invasion may be increasing. The diagnosis of prenatal placental invasion is important to reduce maternal morbidity and mortality. Recent trends indicate an increased use of MRI to evaluate placental invasion as a complement to US. The most accurate imaging findings are using US for placental lacunae and MRI to detect the dark intraplacental band.

Clinical Characteristics of COVID-19 Patients With Gastrointestinal Symptoms: An Analysis of Seven Patients in China.

Objectives: Patients with novel coronavirus disease 2019 (COVID-19) can present with gastrointestinal symptoms as their initial symptoms or as the main manifestations during disease progression, but the clinical characteristics of these patients are still unknown.Methods: We identified COVID-19 patients who admitted to Xiangyang No. 1 People's Hospital and presented with gastrointestinal symptoms as their initial or main symptoms. Their medical records were reviewed by two independent clinical scientists. The epidemiological and clinical characteristics as well as the clinical outcomes were analyzed.Results: Among 142 confirmed COVID-19 cases, 7 (4.9%) of them presented with gastrointestinal symptoms. Three patients had gastrointestinal symptoms as the initial symptoms and chief complaints, and 4 patients as the main symptoms during disease progression. Six patients had symptoms of diarrhea (3–16 days), 7 with anorexia (7–22 days), 6 with upper abdominal discomfort (1–7 days), and 4 with nausea (1–7 days), 1 with heartburn lasting 2 days, and 2 with vomiting symptoms (1 day). The chest CT scan showed typical COVID-19 imaging features, and associated with the progression of the disease. During treatment, 2 patients died due to organ failure.Discussion: COVID-19 patients with gastrointestinal symptoms are relatively rare and might be misdiagnosed. The clinical features include watery stools, anorexia, and upper abdominal discomfort. These patients may have severe disease and be associated with a poor prognosis. The underlying mechanisms of SARS-CoV-2 related gastrointestinal symptoms need to clarify in future studies.

Artificial Satisfaction - The Brother of Artificial Intelligence

John McCarthy (September 4, 1927 – October 24,2011) was an American computer scientist and cognitive scientist. The term “Artificial Intelligence” was coined by him(Wikipedia, 2020). Satish Gajawada (March 12, 1988 – Present) is an Indian Independent Inventor and Scientist. He coined the term “Artificial Satisfaction” in this article (Gajawada, S., and Hassan Mustafa, 2019a). A new field titled “Artificial Satisfaction” is introduced in this article. “Artificial Satisfaction” will be referred to as “The Brother of Artificial Intelligence” after the publication of this article. A new algorithm titled “Artificial Satisfaction Algorithm (ASA)” is designed and implemented in this work. For the sake of simplicity, Particle Swarm Optimization (PSO) Algorithm is modified with Artificial Satisfaction Concepts to create the“Artificial Satisfaction Algorithm (ASA).” PSO and AS Aalgorithms are applied on five benchmark functions. A comparision is made between the results obtained. The focus of this paper is more on defining and introducing “Artificial Satisfaction Field” to the rest of the world rather than on implementing complex algorithms from scratch.

Science sidelined in approval of Australia’s largest coal mine

State and federal governments in Australia recently approved water management plans for one of the largest coal mines ever proposed. This comes as the role of coal in the world’s future energy mix is being seriously questioned, and global concern over the climate and water implications of further fossil fuel development. Despite repeated advice from multiple independent scientists, governments did not compel the mining company to conduct the investigations required to determine its risks to important nearby groundwater-dependent ecosystems, leaving open the prospect of irreversible ecological and cultural damage. Here we show how scientific advice provided to decision makers was repeatedly ignored or dismissed, while scientists and agencies were subjected to political pressure. We argue that this echoes other examples of scientific evidence being ignored where findings clash with political or economic objectives, and warrants urgent review of decision-making processes for developments with major environmental consequences. While political interference with science is not new, this analysis of Australia’s largest coal mine being approved despite and over the objections of scientific managers provides a thorough case study in how environmental considerations are being ignored.

Eugenia Chiappe

Eugenia Chiappe

My Journey to Open Science

My Journey to Open Science

Privacy and Security Issues with Mobile Health Research Applications

This article examines the privacy and security issues associated with mobile application-mediated health research, concentrating in particular on research conducted or participated in by independent scientists, citizen scientists, and patient researchers. Building on other articles in this issue that examine state research laws and state data protection laws as possible sources of privacy and security protections for mobile research participants, this article focuses on the lack of application of federal standards to mobile application-mediated health research. As discussed in more detail below, the voluminous and diverse data collected by some independent scientists who use mobile applications to conduct health research may be at risk for unregulated privacy and security breaches, leading to dignitary, psychological, and economic harms for which participants have few legally enforceable rights or remedies under current federal law. Federal lawmakers may wish to consider enacting new legislation that would require otherwise unregulated health data holders to implement reasonable data privacy, security, and breach notification measures.

Mobile Research Applications and State Research Laws.

This article assesses the protections provided by state research laws for participants in mobile application (mobile app) mediated health research conducted by independent scientists, citizen scientists, and patient researchers. Prior scholarship in this area focuses on the lack of application of: (1) federal regulations governing research conducted or funded by one of sixteen signatory federal departments and agencies (the Common Rule); and (2) separate federal regulations promulgated by the Food and Drug Administration applicable to research conducted in anticipation of a submission to the FDA for approval of a drug or medical device. This article builds on this prior scholarship by carefully examining state research laws and suggesting ways in which these laws could be improved to better protect participants of mobile appmediated research conducted by independent scientists, citizen scientists, and patient researchers.

Mobile Research Applications and State Data Protection Statutes.

This article focuses on state privacy, security, and data breach regulation of mobile-app mediated health research, concentrating in particular on research studies conducted or participated in by independent scientists, citizen scientists, and patient researchers. Prior scholarship addressing these issues tends to focus on the lack of application of the HIPAA Privacy and Security Rules and other sources of federal regulation. One article, however, mentions state law as a possible source of privacy and security protections for individuals in the particular context of mobile app-mediated health research. This Article builds on this prior scholarship by: (1) assessing state data protection statutes that are potentially applicable to mobile app-mediated health researchers; and (2) suggesting statutory amendments that could better protect the privacy and security of mobile health research data. As discussed in more detail below, all fifty states and the District of Columbia have potentially applicable data breach notification statutes that require the notification of data subjects of certain informational breaches in certain contexts. In addition, more than two-thirds of jurisdictions have potentially applicable data security statutes and almost one-third of jurisdictions have potentially applicable data privacy statutes. Because all jurisdictions have data breach notification statutes, these statutes will be assessed first.

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

Avoiding the TRIPS Trap: A Path to Domestic Disclosure of Clinical Drug Data Consistent with International Norms

Should doctors, patients and policy makers have complete information about new drugs? Although complete transparency may seem like the obvious answer, the reality is that publicly available information is often incomplete. Before a drug may be approved for sale, a regulatory agency such as the Food and Drug Administration (FDA) will review extensive data created by a company seeking approval of such a drug. However, the FDA considers such information to be protected from public disclosure as a commercially confidential trade secret. In the United States, scientific papers concerning new drugs are often based on proprietary data and published articles often present skewed results compared to the complete data possessed by the FDA. The implications of articles based on proprietary data typically get short shrift. However, two articles on Covid-19 were recently retracted after independent scientists questioned the conclusions and the authors admitted that the articles were based on proprietary data that could not be verified, leading to their retraction. Although the intense public spotlight on Covid-19 highlighted this problem, doctors are generally forced to rely on incomplete information based on similar proprietary data in making prescribing decisions. This unnecessarily compromises patient health and safety. Although the EU and Canada have recognized the public health benefit of more transparency and increased publication of clinical data for new drugs, understudied aspects of international intellectual property laws may limit disclosure. In particular, all member countries of the World Trade Organization (WTO), including Canada and the EU member states, must comply with certain intellectual property minimum requirements, including one that governs the data at issue. Article 39(3) of the Trade Related Intellectual Property Agreement (TRIPS) requires WTO countries to protect data submitted to regulatory agencies from “uncommercial fair use.” This highly contested term has never been definitively clarified in the WTO’s dispute settlement process. Moreover, TRIPS permits countries to disclose such data under one of two exceptions that have been largely ignored in the literature so far. This Article provides the first comprehensive analysis of whether domestic disclosure of clinical data is permissible under either of these two exceptions. In doing so, this Article contributes to broader policy issues. First, although some policy makers have long recognized that international obligations may constrain domestic options, this Article provides a concrete case study of the dangers of creating new international intellectual property norms—especially when such norms are created by a select group of stakeholders that may not represent all interests. This is a timely and important issue since nations have generally been entering into international agreements with increasing levels of intellectual property rights since the conclusion of the WTO. Second, the Article suggests actions to consider in both the domestic and international contexts regarding clinical data, including specific suggestions to improve clinical data disclosure in the United States.

A Tribute to Richard M. Crooks on the Occasion of His 65th Birthday

A Tribute to Richard M. Crooks on the Occasion of His 65th Birthday

From Maverick to Mole: John C. Burnham, Tobacco Consultant

From Maverick to Mole: John C. Burnham, Tobacco Consultant

Strategies and Resources for Increasing the PhD Pipeline and Producing Independent Nurse Scientists.

Nurse scientists play an indispensable role in developing new knowledge to advance the health of patients, families, and communities. Yet PhD nurse enrollment has significantly dropped, and many later career nurse scientists are nearing retirement. The purpose of this article is to outline potential strategies to enhance the PhD nurse pipeline. Potential strategies are identified at three distinct time points along the PhD trajectory: (a) prior to a PhD program (increasing the pipeline), (b) during a PhD program (enhancing graduation rates and transitioning into research-focused careers), and (c) in the postdoctoral or early career period (establishing scholarly independence and an active program of research). Talented students should be approached early on in their education to ascertain interest in a scientific research-based career, and all students could be engaged in research opportunities while in undergraduate programs. During a PhD program, supportive mentors are a key component for student success and may provide assistance in obtaining ongoing funding and scholarship support. Throughout doctoral study and into early career, less structured opportunities can be influential, including conference support, online and face-to-face training, and ongoing funding and scholarship support for postdoctoral study or fellowships. At each career stage, there should be a focus on designing scientifically sound nursing research that will impact outcomes in measurable and sustainable ways. We must not focus our attention only on student recruitment. Public messaging efforts are needed to raise awareness of the role of nurse researchers. In addition, several stakeholders play a role in increasing the PhD pipeline and producing independent nurse scientists, and they should be acknowledged in these efforts. The strategies described may be beneficial for any nurse contemplating a research career as well as for those who may serve as mentors to these individuals. More broadly, these strategies may be employed by colleges and universities, funding bodies, professional nursing societies, and healthcare organizations in the United States and abroad. Increasing the PhD pipeline, and fostering a more robust field of independent nurse scientists, will translate into improved patient outcomes.

Professor Mats Karlsson is the BCPT Nordic Prize winner in Basic & Clinical Pharmacology & Toxicology for 2019

Professor Mats Karlsson is a world-renowned scientist in the field of clinical pharmacology and pharmaco-metrics, and he has made extraordinary contributions with a strong commitment to develop the field. In the following, some of his contributions will be highlighted: Mats Karlsson was born in Sweden in 1959. He graduated as a pharmacist from Uppsala University and earned his PhD in pharmacokinetics in 1989 from Uppsala University with the thesis: “Novel methods for estimation of ligand binding kinetics and drug absorption”. Subsequently, he had several post-doc positions, the last of which took place at the University of California San Francisco from 1992 to 1994. This resulted in a long-lasting collaboration with professor S.L. Beal and professor L.B. Sheiner and in several key publications. In 1994, he started the Pharmacometrics Research Group (PMG) at Uppsala University, and he was appointed the first (worldwide) professorship in Pharmacometrics in 2001. The PMG has now grown to the largest academic research group in this area, globally comprising approximately 45 members (7 faculty, 2 system developers, 7 post-docs, >20 PhD students, visiting scientists and several part-time employees). By providing an impressively generous, open and dynamic atmosphere in this cross­disciplinary area, researchers with different backgrounds have been attracted both with respect to competence (pharmacy, medicine, engineering, statistics and computational sciences) as well as origin (past and present researchers represent >20 nations from all parts of the world). While developing his own research, he has allowed younger researchers to grow and become independent scientists in their own right, and so far, two of his PhD students have become full professors and two have become associate professors. Mats Karlsson has outstanding achievements in the education of pharmacometricians. He has enthusiastically supervised 27 students to PhD degree as main supervisor and 29 students as co-supervisor. In addition, he has mentored more than 40 post-docs. The students and post-docs are now in positions at academic institutions, the pharmaceutical industry, contract research organisations and at drug regulatory authorities worldwide. He has developed several courses for PhD students and professionals, including the popular courses on covariate model building and PKPD modelling in NONMEM. He has also established the annual Uppsala Pharmacometric Summer School (UPSS), a free two-week summer course attracting PhD students from around the world. Mats Karlsson has successfully kept a uniquely broad research profile in both development of methodology for analysis of clinical data using non-linear mixed-effects modelling and applied modelling in several therapeutic areas. He has published in more than 300 peer-reviewed research articles, has an h-index of 48 and the top three publications are cited more than 300 times. Methodology improvements include new methods for covariate model building in non-linear mixed-effects modelling, efficient clinical trial design and model diagnostics. The developed methodology is widely available via free and open-source software. He has developed several platform models, now commonly used in drug development of drugs in diabetes, oncology, TB and inflammatory disease (e.g. RA and MS). He has also developed approaches for analysis of categorical type data, enabling efficient analysis of adverse event records. Mats Karlsson is partner of several European research consortia (PreDiCT-TB, Orbito, IDEAL and U-PGx) and was the academic principle investigator of the European research consortium DDMoRe, within which modelling standards, a modelling environment and a library of drug/disease models for the pharmacometrics community were developed. He is also on several editorial boards of scientific journals including being the European Editor of Journal of Pharmacokinetics and Pharmacodynamics.

Obsessive-Compulsive Behavior Isn't Necessarily a Bad Thing.

It is difficult to believe that in about 1960 practically nothing was known about the thymus and some of its products, T cells bearing αβ receptors for antigen. Thus I was lucky to join the field of T cell biology almost at its beginning, when knowledge about the cells was just getting off the ground and there was so much to discover. This article describes findings about these cells made by others and myself that led us all from ignorance, via complete confusion, to our current state of knowledge. I believe I was fortunate to practice science in very supportive institutions and with very collaborative colleagues in two countries that both encourage independent research by independent scientists, while simultaneously ignoring or somehow being able to avoid some of the difficulties of being a woman in what was, at the time, a male-dominated profession.

Meet the First Authors.

Meet the First Authors.

A REVIEW OF BENCHMARKING IN PHOTOGRAMMETRY AND REMOTE SENSING

Abstract. This paper is a preface of the ISPRS/EuroSDR Workshop on the “Evaluation and Benchmarking of Sensors, Systems and Geospatial Data in Photogrammetry and Remote Sensing” that was held in Warsaw University of Technology on 16-17 September 2019. The paper reviews benchmarking in photogrammetry and remote sensing found in the literature relating to geodata. The first part of the paper is a bibliographic analysis based on queries in Scopus and Web of Science databases which shows an increase in research activities based on benchmarking data. In the second part, a review of past and ongoing benchmarking initiatives is presented, providing examples of initiatives within e.g. ISPRS and EuroSDR. The topic of evaluating data, sensors and algorithms with benchmarking activities is interesting as it provides the opportunity to compare, with a unique approach, research results from independent scientists. As hereafter reported, benchmarking has increased in recent years, with many benchmarks being presented in the photogrammetric and remote sensing communities.

Public health and evidence-informed policy-making: The case of a commonly used herbicide.

Public health and evidence-informed policy-making: The case of a commonly used herbicide.